CN107072698A

CN107072698A - Composite spinal implant

Info

Publication number: CN107072698A
Application number: CN201580058465.5A
Authority: CN
Inventors: 莫德洽·贝亚; 欧仁·格洛伯曼
Original assignee: Carbon Fixation Department Of Orthopedics LLC
Current assignee: Carbon Fixation Department Of Orthopedics LLC
Priority date: 2014-09-01
Filing date: 2015-09-01
Publication date: 2017-08-18
Anticipated expiration: 2035-09-01
Also published as: CN107072698B; IL250879A0; IL250879B; EP3188678A1; WO2016035010A1

Abstract

A kind of pedicle screw implant infrastructure set group, including：An at least pedicle screw；An at least collar, including for accommodating an at least recess for a rod member, the collar is configured to connect a head of the pedicle screw；One extension rod member, for connecting the collar and one or more extra collars, to be connected between the pedicle screw and one or more additional bolts；And a locking ring, it is dimensioned so as to be positioned on an at least distal portions for the collar, to suppress the relative motion of the screw head and rod member by applying radial compression force to the collar.In certain embodiments, the multiple component of the set group is made up of carbon reinforced composites, and is alternatively free of radiation-blocking material.In some exemplary embodiments of the present invention, the set group comprising two the locking ring in collar, and alternatively both all under the rod member.

Description

Composite spinal implant

Association request case

This application claims the PCT/IL2014/050782 submitted for 1st in September in 2014 priority.

The part for the U.S. Patent Application No. 14/421,158 that the application was still submitted for 2 months on the 12nd in 2015 continues Case, the thenational phase application for the PCT/IL2014/050782 that the U. S. application was submitted on the 1st in September in 2014.The application is so that will Seek the priority for Beyar et al. U.S. Provisional Patent Applications the 61/872728th submitted for 1st in September in 2013；It is required that For the priority of Beyar et al. U.S. Provisional Patent Applications the 61/926328th submitted on January 12nd, 2014；It is required that For the priority of Beyar et al. U.S. Provisional Patent Applications the 61/980076th submitted on April 16th, 2014；And will Ask the priority for Beyar et al. U.S. Provisional Patent Applications the 62/030084th submitted on July 29th, 2014, institute The content for having these documents is incorporated herein by reference in their entirety.

Technical field

The present invention in certain embodiments, relates to multiple composite bone implantation equipment, such as on multiple ridges Vertebra equipment, such as multiple pedicle screws (pedicle screw) structure, and/or on manufacturing multiple methods of this equipment, And/or operation instrument and multiple programs on being used when being implanted into and removing the composite skeleton implant.

Background technology

Spinal fusion (spinal fusion) is a kind of common operation, for treating various vertebral diseases.In order to disappear Except the abnormal motion as caused by various lesions (disc degeneration), during a spinal fusion, two or more spinal fusions Together.It is used in and is closed with the sufferer natural bone growth course from the complementarity skeletal tissue of the sufferer or a donor And use, to merge the vertebra.

Reached using the importing of the internal fixation device as a kind of supplementary means for spinal fusion in vertebra The improvement of fusion.The fixing device contributes to the stabilization and immobilization of the treated spinal segment.Such one sets Standby is a structure of multiple pedicle screws and multiple rod members：Two-screw is put into the multiple vertebral arch of each treated vertebra In root, and multiple rod members are used for longitudinally connected the multiple screw, use multiple locking elements.

No matter when there is amixis, multiple pedicle screw systems are used for example in stable damaged vertebra until recovery from illness (bone Folding healing), multiple oncology cases and treatment vertebra gryposis, such as scoliosis (scoliosis) and scheuermann kyphosis (kyphosis).Further, also carry out now using pedicle screw system without the dynamic stabilization methods of spinal fusion (dynamic stabilization method)。

For Richelsoph et al. U.S. Patent No. 5683392, " one kind is used in and a rod member is locked to for announcement The locking mechanism of one bone part.The locking mechanism is included：One bone anchoring elements, for being connected to the bone part, the bone Bone fixture has a spherical part；One inner housing part, with for receiving a passage of the rod member, and with for engaging One spherical part of the bone anchoring elements of the bone anchoring elements；And an Outer casing member, for the inner housing part is locked Surely the spherical part of the rod member and the bone anchoring elements is arrived ".

Common, the pedicle screw-rod part structure is to be made of metal, such as titanium and stainless steel.Although metal is planted Enter thing and many advantages are provided, they also have some shortcomings.When use fluoroscopy (fluoroscopy), computerized tomography (CT) and during nuclear magnetic resonance (MR) imaging, multiple metals hinder the visualization of the implant and surrounding tissue.It should be noted that Substantially 20% to 30% sufferer continues to receive the subsequent procedures using interior pedicle of vertebral arch implant.When the multiple pedicle screw Position is in place of the neighbouring spinal cord and nerve, and this imaging means are high-importances for further evaluation, comprising for recognizing The exact position of multiple screws and judge whether the reason for the multiple screw is pain.This problem exists in cervical vertebra hand Art, wherein for example generally during fusion hand is stated, multiple metallic plates and screw, which are used for stabilization, has various symptom [such as interverbebral disc Degeneration, fracture, tumour, stenosis (stenosis)] neck bone.Further, in multiple oncology cases, due to by described Multiple artifacts produced by multiple metal implants, the assessment of tumour progression may be limited.Furthermore, multiple metal implants are done Disturb the radiation for giving tumour sufferer.The larger electron mass and scattering phenomenon reduce radiation effect and need higher dosage Radiation, it further stimulates multiple side effects in surrounding tissue.

In addition, the commonly provided sufficient bending of metal structure and torsional strength, many of implant fracture are relevant to reduce Individual problem.However, with the elastic rigid metal implant different from the bone, stress shielding may be facilitated to show As.Furthermore, multiple metals of such as stainless steel may cause the biocompatibility issues for being associated with corrosion and sensitivity response (main Due to the allergy to nickel).In addition, multiple metals may be more similar for one than some composites for an impedance of fatigue loads Fatigue loads an impedance it is also poor.

Nonmetallic, composite, vertebral bones implant can be attained on the market, such as by carbon-polyether-ether-ketone at present (PEEK) retainer and vertebral body prosthesis equipment being made.Lumbar vertebrae and/or cervical vertebra retainer can also be gathered by PEEK, carbon fiber reinforcement Compound or carbon are made.

Multiple metal pedicle screw systems with the multiple rod members being made up of polymeric material (such as PEEK) also may be used Obtaining on the market.But, compared to hardware, those equipment provide relatively low rigidity, and in limited idicatio. In addition, with the multiple rod members being made up of carbon fiber reinforcement polymer (such as PEEK or PEKEKK) or multiple metal vertebras of plate Pedicle screw system is also obtainable.

The multiple composite materials skeleton implants being for example made up of carbon fiber reinforcement PEEK, being also used for other bones should With such as intramedullary nail and bone plate [CarboFix Orthopaedics Incs (CarboFix Orthopedics Ltd.)].

The content of the invention

Some embodiments of the present invention illustrate it by following multiple examples.It is noted that in multiple examples Feature can be incorporated into some embodiments of the present invention.And some embodiments of the present invention include the spy of multiple examples Levy, the multiple example is selected from any combinations of multiple examples herein.

A kind of pedicle screw implant infrastructure set group of example 1., it includes：

An at least pedicle screw, comprising a head, the screw includes many in a polymer substrate containing being embedded in The composite of individual reinforcement filiform；

An at least monoblock type collar, the collar is included containing the multiple reinforcement filiforms being embedded in a polymer substrate Composite, the collar includes an at least recess, and the recess defines a hole, and the shape and size in the hole are set Count into for accommodating a rod member, size, shape and the configuration of the collar are designed to connect the pedicle screw The head；

One extension rod member, size and shape is designed for connecting the collar and one or more extra collars, so that Described in being connected between an at least pedicle screw and one or more additional bolts, the rod member includes poly- containing being embedded in one The composite of multiple reinforcement filiforms in polymer matrix；And

An at least locking ring, the ring is included containing the compound of the multiple reinforcement filiforms being embedded in a polymer substrate Material, the size and shape of the ring is designed to be positioned at least part of the collar and by applying radial compression Power is to limiting relative fortune of the one or both of which relative to the collar of the screw head and rod member in the collar It is dynamic.

Example 2. is according to the set group of example 1, wherein the composition surface of the collar and the ring between both does not have Screw thread.

Example 3. is according to the set group of foregoing any example, wherein the set group includes the multiple originals for being less than 1% by weight Son, the atomic number of the atom is more than 25.

Example 4. according to the set group of foregoing any example, wherein the set group comprising be less than by weight 0.01% it is multiple Atom, the atomic number of the atom is more than 25.

Example 5. is according to the set group of foregoing any example, wherein the set group does not include radiopaque mark.

Example 6. shape and is dimensioned so as to institute for accommodating a rod member according to the set group of foregoing any example, wherein Stating hole has different from the section of the rod member and/or the rotationally symmetrical skew without relative to the rod member shape.

Example 7. shape and is dimensioned so as to the hole for accommodating a rod member according to the set group of example 6, wherein Be extended along a direction, the direction relative to the hole the longitudinal axis radially.

Example 8. is according to the set group of example 7, wherein the prolongation exceedes the entire length in the hole.

Example 9. is according to the set group of example 7 or example 8, wherein the prolongation is different from institute at the hole two ends State any prolongation at hole center.

Example 10. is according to the set group of any example in example 7-9, wherein the multiple straight bars of prolongation support engagement The hole of part and multiple rod members with least 30 millimeters bendings of radius of curvature.

Example 11. is according to the set group of any example in example 7-10, wherein the prolongation is in relative to the collar Vertically.

Example 12. is according to the set group of foregoing any example, wherein before the ring causes mobile limit, the ring is set In in the collar.

Example 13. is according to the set group of example 12, wherein the ring is arranged at the stenosis of the outline of the collar, vertically Ground is configured to by friction lock to the width at a progressive width of the outline.

Example 14. is according to the set group of example 13, wherein the ring one dashing forward of being arranged to vertically adjacent to the outline At right width.

Example 15. is according to the set group of any example in example 12-14, wherein the set group includes at least two rings, both All it is arranged in the case of the limitation is not caused in the collar.

Example 16. is according to the set group of any example in example 12-15, wherein the collar is slotted in one near-end and one Distally.

Example 17. is according to the set group of foregoing any example, wherein the set group is used for the locking of the collar comprising two Ring, wherein the collar includes two regions, for locking the ring to the collar.

Example 18. is according to the set group of example 17, wherein the ring is all pre-loaded with described before the limitation is caused In collar.

Example 19. is according to the set group of example 17 or example 18, wherein the collar includes an at least radial extension, it is kept away Exempt from an at least ring to skid off from the collar.

Example 20. is according to the set group of any example in example 17-19, and the ring of wherein at least one is from the neighbouring collar away from The collar is in more and more narrow.

Example 21. is according to the set group of any example in example 17-20, wherein the collar is slotted in one near-end and one Distally, and each ring is provided in the upright position of the different grooves of correspondence.

Example 22. is according to the set group of any example in example 17-21, wherein the collar shapes are designed in locking one The rod member and the motion of the head one of which of the screw can be only limited during ring.

Example 23. is according to the set group of any example in example 17-22, wherein to be designed to locking described for the collar shapes Two rings need the motion in the same direction of two ring.

Example 24. is according to the set group of any example in example 17-22, wherein to be designed to locking described for the collar shapes Two rings need the counter motion of two ring.

Example 25. according to the set group of any example in example 17-24, wherein two ring be arranged on the rod member it Under.

Example 26. is according to the set group of foregoing any example, wherein the collar shapes are designed to：Allow a locking ring can It is disposed thereon without the limitation, and in the axle during being then locked in place and being not used in installment state or lock-out state One millimeter is extended beyond under ring.

Example 27. is according to the set group of example 26, wherein the collar shapes are designed to remote in order to allow the ring to pass through Motion locking of the end away from two hole is lived.

A kind of fastening collar of example 28. is in the method for pedicle screw, and it is included：

A collar is provided, there is the collar a compound locking ring to be arranged on；

Position of at least one of the rod member and a screw head of adjustment in the collar relative to the collar And/or orientation；

The locking ring is moved to another configuration of the collar from a kind of configuration of the collar, thus causes institute State collar dimensionally radially reduced and engage the rod member and/or the screw head.

A kind of fastening collar of example 29. is in the method for pedicle screw, and it is included：

One collar is provided；

At least two locking rings are moved relative to the collar, radially to reduce the hole in the collar, thus are connect Close the rod member and/or the screw head.

Example 30. is according to the method for example 29, and wherein methods described comprising moving in the opposite direction along the axle of the collar Dynamic at least two locking rings.

Example 31. includes the axle along the collar with phase according to the method for example 29 or example 30, wherein methods described At least two locking rings described in equidirectional movement.

Example 32. is contained in same time movement institute according to the method for any example in example 29-31, wherein methods described State at least two locking rings.

Example 33. is according to the method for any example in example 29-32, and wherein methods described, which includes to pass through, respectively moves institute Two locking rings are stated respectively to lock the rod member and the screw head.

A kind of method for selecting to be used in the set group component that backbone fixes operation of example 34., this method is included：

The required layout of two rod members is determined, includes the different bendings of two rod member；The different bendings have comprising one First bending and one of the crooked process radius between 30 millimeters and 60 millimeters have the second bending of at least twice crooked process radius；With And

Identical collar is selected for two rod member, is not dominated by the different bendings.

A kind of method for providing patient radiation treatment of example 35., it is included：

Judge that the patient needs to carry out radiation treatment near its backbone or via its backbone；

Judge that selecting one to be combined backbone entirely fixes set group according to described, the degree of its interference radiation is no more than aluminium；

Insert the system；And

Radiation treatment is provided to the patient.

Example 36. is according to the method for example 35, wherein before the selection and after the judgement, also comprising removing one Both the backbone fixation kit containing metal deposited.

Example 37. is according to the method for example 35 or example 36, and wherein methods described is included abuts the ridge with no metal The mode of post and the association set group provides radiation treatment to the patient.

A kind of lock collar of example 38., is fixed to be used together with a rod member with a pedicle screw in vertebra, described Lock collar is included：

An at least collar body, the collar is included containing the multiple reinforcement filiforms being embedded in a polymer substrate Composite, the collar includes an at least recess, and the recess defines a hole, the shape in the hole and is dimensioned Into for accommodating a rod member, size, shape and the configuration of the collar are designed to connect the institute of the pedicle screw State head；And

Example 39. is according to the collar of example 38, wherein the collar has two locking rings, two locking ring is to lock Two different vertical positions relative to vertebra in the collar；And/or wherein described collar have it is sufficiently resilient and described The shape in hole is designed to the rod member for allowing the collar to mismatch the hole along bending towards a direction and/or bending amount It is pushed into；And/or wherein described collar is offered groove and is laterally positioned in sufficiently resilient on a rod member, the bar Part is adapted to be locked in using the locking ring in the hole.

A kind of lock collar of example 40., is fixed to be used together with a rod member with a pedicle screw in vertebra, and it is special Levy and be：The lock collar is included：

An at least integrated shaft ring body, the collar is included containing the multiple reinforcement silk being embedded in a polymer substrate The composite of shape thing, the collar includes an at least recess, and the recess defines a hole, the shape and size in the hole It is designed to accommodate a rod member, size, shape and the configuration of the collar are designed to connect the pedicle of vertebral arch screw The head of nail；And

Example 41. is according to the lock collar of example 40, wherein the lock collar includes at least two locking rings.

Example 42. is according to the lock collar of example 41, wherein the ring is positioned in the collar and for accommodating a bar Under the hole of part.

Example 43. is according to the lock collar of any example in example 40-42, wherein the collar and the ring are in both Between a composition surface do not have screw thread.

A kind of pedicle screw implant infrastructure set group of example 44., it includes：

An at least collar, the collar is included containing the compound of the multiple reinforcement filiforms being embedded in a polymer substrate Material, the collar includes an at least recess, and the recess defines a hole, the shape in the hole and is dimensioned so as to use To accommodate a rod member, size, shape and the configuration of the collar are designed to connect the head of the pedicle screw Portion；

Example 45. is according to the set group of example 44, wherein the composition surface of the collar and the ring between both does not have There is screw thread；And/or wherein described set group includes the multiple atoms for being less than 1% by weight, the atomic number of the atom 25 with On；And/or wherein shape and the hole being dimensioned so as to for accommodating a rod member has cutting different from the rod member Face and/or the rotationally symmetrical skew without relative to the rod member shape；And/or wherein cause in the ring and described limit it Before, the ring is arranged in the collar；And/or the set group is used for the locking ring of the collar comprising two, and wherein The collar is used for locking the ring to the region of the collar comprising two；And/or wherein described set group is used for comprising two The locking ring of the collar, and wherein described collar comprising two be located at the rod member under be used for lock the ring to the axle The region of ring.

Example 46. is a kind of to fasten two locking rings in the device in a collar, and the shape and size of the collar are set Meter is used for supporting a vertebral column rod and a pedicle screw, and described device is included：

(a) an at least arm, it has an at least engagement of loops portion；

(b) an at least element is used to engage the collar or one second ring；And

(c) control-rod, it has one handle and is connected to the arm, and is separably coupled to the element and causes Relative motion therebetween.

A kind of pedicle screw implant infrastructure set group is provided with according to some embodiments of the invention, including：

An at least locking ring, the ring is included containing the compound of the multiple reinforcement filiforms being embedded in a polymer substrate Material, the size and shape of the ring is designed to be positioned at least part of the collar and by applying radial compression Power is to limiting the relative motion of the screw head and rod member in the collar.

In some exemplary embodiments of the present invention, the collar includes at least two parts, can be perpendicular to the axle Moved toward each other on one direction of one major axis of ring.Selection or replacement, the collar includes an integral type lid Section, is designed to surround a part of the rod member away from the screw.Selection or replacement, the collar it is described Some is the slot that extends laterally by least one axial direction part along the collar to separate, and its described in ring It is arranged to close to the multiple collar portion, so as to reduce a width of the slot.

In some exemplary embodiments of the present invention, the ring includes a non-threaded inwall.

In some exemplary embodiments of the present invention, an inwall of the ring with one passage of definition, and its described in The diameter of passage is reduced on a distal direction.Selection, a pointed cone angle of the inwall is relative to through the one of the ring One axis at center is between 1 to 5 degree.

The present invention some exemplary embodiments in, the multiple reinforcement filiform be multiple carbon fibers and its described in Polymer substrate is polyether-ether-ketone (PEEK).

In some exemplary embodiments of the present invention, the collar is recessed comprising define an approximately spherical cavity at least one Mouthful, for being connected to the screw head, and its described in screw head include spherical or subglobular a profile, define one Surface region, the inner surface of spherical notch described in the surface area contact 50% and 95% between, even so that When the collar is closed on the screw head, the multiple wall and the screw head in the recess are still left Between multiple spaces.

In some exemplary embodiments of the present invention, the collar is recessed comprising define an approximately spherical cavity at least one Mouthful, for being connected to the screw head, and its described in screw head include an approximately spherical profile, wherein when the screw Vertically it is pointed to the collar and during with an angular range between 20 and 80 degree, position is in the collar recess and described A contact surface between screw is defined as a frequency band of at least 90% equatorial line for being located around the head of screw, and its In in the frequency band, the recess of the collar contacts the screw head more than the contact table between 75% and 95% Face.

In some exemplary embodiments of the present invention, the set group also encircles structure comprising one, configures to be positioned at State on screw head, the structure of encircling includes an at least adapter, and an at least adapter is defined for the screw One recess on head, and its described in locking ring as an external shell, to keep the collar when being implanted into the collar In at least top of an adapter.Selection, an at least adapter includes multiple adapters, orientable and phase Mutually coordinate to define a cylindrical shape or conical outer profile.

In some exemplary embodiments of the present invention, a distal portions of the collar include one second hole position, configuration To accommodate at least a portion of the screw head.

In some exemplary embodiments of the present invention, reinforced composites in all set groups One ray is sufficiently high by property degree, in the presence of the structure, to support the imaging treated spinal column segment.

In some exemplary embodiments of the present invention, there is the multiple component a sufficiently low metal to constitute to allow It is imaged apart from the structure between 1.5 and 2.5 millimeters using CT or MRI.

In some exemplary embodiments of the present invention, there is the multiple component a sufficiently low metal to constitute so as to big Visualization is not disturbed when CT or MRI is imaged on causing.

In some exemplary embodiments of the present invention, at least one bag of the pedicle screw, collar, rod member and ring One or more radiopaque labels are included, to allow the visualization in imaging.

In some exemplary embodiments of the present invention, the radiopaque label is along the one of the pedicle screw At least one setting in one major axis of major axis and the rod member.

In some exemplary embodiments of the present invention, radiopaque mark be incorporated in the pattern of powder it is described Within the one or more composites in pedicle screw, collar, rod member and ring, the powder occupy 0.2% to 2% content volume.Selection, the powder includes gold.

In some exemplary embodiments of the present invention, the rod member, which is included, to be presented along the one of the rod member Longitudinal extending One mark of the pattern of tantalum wire, wherein the collar is positioned at the tantalum pin in a proximal part of the collar comprising presentation One mark of pattern, wherein the ring includes the tantalum wire mark that the pattern of a non-close ring is presented；And its described in pedicle of vertebral arch Screw includes the type that the metal dust being embedded within least a portion of the composite of the pedicle screw is presented One mark of formula.

In some exemplary embodiments of the present invention, an exterior contour of the ring include a larger-diameter part and A part for small diameter.

In some exemplary embodiments of the present invention, an exterior contour of the ring not Axial changes.Replace, institute Stating exterior contour includes a general cylindrical shape profile, a sharp cone distal profile, a cone shape profile and with diametrically changing suddenly It is one or more in the stepped configuration become.

In some exemplary embodiments of the present invention, an exterior contour of the ring includes being dimensioned so as to be used to Nie At least one projection being radially directed towards or recess of unification instrument.

In some exemplary embodiments of the present invention, it is columnar that an exterior contour of the ring, which is included on profile, A part at least 50% axial degree of one diameter of the ring.

In some exemplary embodiments of the present invention, positioned at the one of the collar of a distal portion office of the collar Exterior contour is included in a far end party and is upwardly formed the section of pointed cone, and it is with and due to the locking on the collar The positioning of the ring at position.

In some exemplary embodiments of the present invention, at least a portion coating of the pedicle screw has between 1 Micron to the thickness between 100 microns a metal level, wherein the metal level do not disturb generally the screw in CT or Visualization when MRI is imaged.

In some exemplary embodiments of the present invention, the multiple reinforcing fiber of the pedicle screw is at least 50% is to be substantially parallel to multiple elongated fibers that a longitudinal axis of the screw is extended.

In some exemplary embodiments of the present invention, when applying the radial compression force by the ring, the axle The reinforced composites of at least one in ring, screw head and rod member are flexible enough, to reach slight change Shape is with least part of multiple spaces for filling up position between the multiple component.

In some exemplary embodiments of the present invention, size and shape is designed to accommodate the hole of a rod member Cave includes one in (a) inner cylinder profile and (b) inside curved profile.

In some exemplary embodiments of the present invention, size and shape is designed to accommodate the hole of a rod member Cave includes an insert, and the insert changes a geometry of multiple inwalls of the recess to define the hole.

A kind of collar is provided with according to some embodiments of the invention, and size and shape, which is designed to be used in, is connected to a rod member And one pedicle screw or the screw one or more adapters between, the collar includes：

One distal end, an including geometry, its shape be designed to Nie close it is following at least one：(a) vertebral arch One head of root screw；It is one or more suitable on the head of the pedicle screw and (b) is if any Orchestration；

One near-end；And

A part for the neighbouring near-end, the part defines a hole, the shape in the hole and is dimensioned so as to At least a portion of a rod member is accommodated, collar wall in the hole is the one of the rod member being positioned in hole defined in it Extend at least the 60% of one top semi-circular arc of cross section.Selection, multiple walls in the hole, which are surrounded, is contained in institute State at least the 70% of a circumference of a rod member in hole.Selection or replacement, the distal end of the collar it is described several What shape defines one second hole, shape and at least a portion for being dimensioned so as to accommodate the pedicle screw.Selection Or substitute, the collar includes a slot, and a distal portions of the collar are divided at least two secondary parts.Selection , the collar wall for being defined on the hole extended on the top semi-circular arc of the rod member is circular arc, And be considered as a bridging load transfer element, the bridging load transfer element position by the slot come separated from each other Between first and second secondary part of the collar.Selection, the collar includes multiple reinforcing fibers, in inverted U-shaped mode Arrangement, to be coincident with a profile of the collar wall.

In some exemplary embodiments of the present invention, a distal portions of the collar include one or more slots, Extend on the proximal direction from the distal end of the collar, to allow be assemblied in a screw the one of the collar compression On head.

One kind is provided with according to some embodiments of the invention, and a composite vertebra is connected using a collar and a locking ring The method of pedicle screw and a rod member, including：

The rod member is passed through one first hole of the collar；

One second hole of the collar is positioned on a head of the screw；And

At least a portion of collar described in radial compression is to fasten the collar at least one in the rod member and screw It is individual, so that at least 5% entrance position of the composite of at least one in the screw head and collar is in the screw Multiple recesses between multiple walls in head and second hole.

A kind of method for assembling a vertebral pedicle bolt structure is provided with according to some embodiments of the invention, including：

An at least pedicle screw is implanted into a pedicle of vertebral arch of a vertebra, wherein a locking ring slip is installed in An at least pedicle of vertebral arch screw is nailed on, and the ring extends beyond the screw head to accommodate a collar；

An at least collar is positioned on a rod member and outside the body；

The combination of the rod member and collar is implanted into by the way that the collar is positioned on a head of the screw, together When the ring as an external shell to be connected between the screw head and the collar when；And

By lifting the ring to an axial location, wherein the ring applies radial compression to the collar to suppress The motion of screw head and rod member relative to each other is stated, to fasten the collar on the rod member and screw head.Selection, Methods described is included：Before the combination of the rod member and collar is implanted into, the locking ring is set to be positioned at relative to the vertebral arch At one selection orientation of one longitudinal axis of root screw.Selection or replacement, the screw head is to be used for the spiral shell by definition The one or more adapters of one recess of nail head are encircled, and its described in collar be positioned at a near-end of the adapter On surface, at the same the ring as an external shell to keep the collar relative to the fixation of the adapter.Selection Or substitute, the locking ring is lifted to close at least two collar portions separated from each other toward each other, the multiple part Definition is used in a hole of the rod member, so that it is described close to the rod member is connected to oppress the multiple part, to press down Make the rod member in the hole axial direction and rotary motion at least one.The locking ring is lifted to apply one First strength is in the collar close to multiple relatively low collar portions, and the induction compressing collar is connected to the rod member One second strength.

An a kind of composite rod member of the vertebral pedicle bolt structure of plastotype again one is provided with according to some embodiments of the invention Method, including：

Heat at least a portion of the composite rod member；And

Apply a strength on the heating part of the rod member, so that the part is relative to the pre- modification bar One longitudinal flexion of part, while in the rod portion being approximately perpendicular to after a modification of the rod member on a direction of the longitudinal axis A diameter of the change relative to the rod member before being deformed of a cross-sectional diameter be less than 5%.

One kind is provided with according to some embodiments of the invention to be used for driving a pedicle screw to enter a vertebra for Nie conjunction The device for the locking ring being positioned on the screw, including：

One axostylus axostyle, including：

One distal end, an including recess, the recess shape is designed to lifting the locking ring in the screw at least In the case of on a part, the head to accommodate the pedicle screw；

One near-end, can Nie close or integrally formed can be attached to for the proficiency handled by a doctor described Hand handle is configured to connect the pedicle screw and the equipment, and next to rotate the distal end to rotate the axostylus axostyle Reach and twist the screw in the pedicle of vertebral arch；And

One extension, extends on a distal direction from the distal end of the axostylus axostyle, and the extension includes one radially Towards inner process position in its far-end, the shape of the projection and it is dimensioned so as to Nie and closes a part for the ring and by near End retracts the extension to withdraw the ring.Selection, the axostylus axostyle includes rod member in one, axially movable in the axostylus axostyle Within, the rod member includes a distal end, configures to be advanced to encircle between one group of adapter of the screw head, with even The equipment is connect to the screw encircled.

A kind of relative fortune for the multiple components for suppressing a vertebral pedicle bolt structure is provided with according to some embodiments of the invention Dynamic method, including：

A rod member and a pedicle screw are connected using a collar；And

The compression collar of radial direction is to suppress motion of the rod member relative to the pedicle screw.Selection, institute Stating radial compression includes one locking ring of lifting on the collar.

Unless otherwise defined, otherwise all technologies used herein and/or scientific terminology have the neck as belonging to the present invention The identical meanings that those of ordinary skill in domain is generally understood that.Although can similar or equivalent to method described herein and material So that in the practice or test of the embodiment of the present invention, illustrative methods and/or material are illustrated following.In the situation of conflict Under, by based on the patent specification including definition.In addition, material, method and embodiment are merely illustrative, being not intended to must It is so restricted.

Brief description of the drawings

Some embodiments of the present invention are only described herein by way of example and with reference to appended accompanying drawing.Referring now particularly to Accompanying drawing specifically, it be stressed that depicted details be by way of example and in order to the present invention multiple embodiments The purpose of illustrative discussion., how can be with for those skilled in the art with reference to the description of the multiple accompanying drawing in this respect Implementing the embodiment of the present invention becomes obvious.

In the accompanying drawings：

Fig. 1 shows a vertebral pedicle bolt structure according to some embodiments of the invention；

Fig. 2 is the stereogram of the pedicle screw of Fig. 1 according to some embodiments of the invention；

The Fig. 1 of Fig. 3 according to some embodiments of the invention illustrates a section of the rod member；

The Fig. 1 of Fig. 4 according to some embodiments of the invention shows a collar component；

The Fig. 1 of Fig. 5 according to some embodiments of the invention shows a locking ring；

An insertion instrument of the display that Fig. 6 illustrates according to some embodiments of the invention for a pedicle screw；

The display that Fig. 7 A-7F illustrate according to some embodiments of the invention is used for the process that vertebral pedicle bolt structure is implanted into Multiple processes；

The pedicle screw of display one and a collar component that Fig. 8 A-8B illustrate according to some embodiments of the invention；

The multiple components for the display vertebral pedicle bolt structure that Fig. 9 illustrates according to some embodiments of the invention；

One axle of one multiaxial type pedicle screw-rod part structure of display that Figure 10 illustrates according to some embodiments of the invention Several figures of ring assemblies；

One multiaxial type pedicle screw-rod part structure of display that Figure 11 A-11F illustrate according to some embodiments of the invention A rod member component several embodiments；

One multiaxial type pedicle screw-rod part structure of display that Figure 12 illustrates according to some embodiments of the invention；

An insertion instrument of the display that Figure 13 illustrates according to some embodiments of the invention used in a pedicle screw；

What Figure 14 and 15 illustrated according to some embodiments of the invention shows the several of multiaxial type pedicle screw-rod part structure Figure；

The display that Figure 16 A-16C illustrate according to some embodiments of the invention is used in the dress that an implant is bent in operation Put；

The display that Figure 17 A-17B illustrate according to some embodiments of the invention be intended to used in pedicle screw combination insertion and The induction system locked used in implant assembly；

The vertebral pedicle bolt structure of display one that Figure 18 A-18B illustrate according to some embodiments of the invention；

The vertebral pedicle bolt structure of display one that Figure 19 A-19B illustrate according to some embodiments of the invention；

The display that Figure 20 A-20D illustrate according to some embodiments of the invention is intended to the combination insertion used in pedicle screw One screwdriver；

The vertebral pedicle bolt structure of display one that Figure 21 A-21B illustrate according to some embodiments of the invention；

The vertebral pedicle bolt structure of display one that Figure 22 A-22C illustrate according to some embodiments of the invention；

The collar component of display one that Figure 23 A-23D illustrate according to some embodiments of the invention；

The display that Figure 24 A-24B and 25A-25D illustrate according to some embodiments of the invention is connected to a vertebra used in a rod member One instrument of pedicle screw；

The display one that Figure 26 A-26C illustrate according to some embodiments of the invention locks ring assemblies (as the portion of a structure Point)；

Display locking ring and multiple collar components that Figure 27 A-27D illustrate according to some embodiments of the invention；

Display locking ring and multiple collar components that Figure 28 A-28C and 29A-29C illustrate according to some embodiments of the invention；

The collar component of display one that Figure 30 A-30C illustrate according to some embodiments of the invention；

The collar component of display one that Figure 31 A-31C illustrate according to some embodiments of the invention；

The collar component of display one that Figure 32 A-32C illustrate according to some embodiments of the invention；

An insertion instrument of the display that Figure 33 A-33B illustrate according to some embodiments of the invention used in a pedicle screw；

An insertion instrument of the display that Figure 34 A-34C illustrate according to some embodiments of the invention used in a pedicle screw；

The display that Figure 35 A-35D illustrate according to some embodiments of the invention is used in a locking tool；

The display that Figure 36 A-36F illustrate according to some embodiments of the invention is used in from the rod member of a screw disassembling and collar One puller；

Figure 37 A-37B are that the multiple strength of display of signal act on a single component collar according to some embodiments of the invention In (37A) and a dual element collar (37B)；

Figure 38 is that the head of screw of display one and receiving shape of signal are designed to have position according to some embodiments of the invention The hole of one or more grooves between the head of screw and the hole, the hole is at least partly during locking Full of deformation screw and/or collar material；

Figure 39 A-39B are to show that two exemplary arc structures of a rod member are included to be positioned at according to some embodiments of the invention Multiple collars on the rod member；

Figure 40 is the upper section for showing a collar according to some embodiments of the invention, includes the profile with the collar The fiber alignment being consistent；

Figure 41 is used in a flow chart of a method of the vertebral pedicle bolt structure of construction one according to some embodiments of the invention；

Figure 42 is used in a flow of the another method of the vertebral pedicle bolt structure of construction one according to some embodiments of the invention Figure；

Figure 43 is an exemplary lateral connection of the position between two structures according to some embodiments of the invention；

Figure 44 A are illustrated a post arrangement and one shown with what the natural curvature with vertebra was consistent according to some embodiments of the invention Example property curvature；

Figure 44 B and 44C is shown with arc and/or the different collars of asymmetric inner chamber according to an exemplary embodiment of the present Different designs；

Figure 44 D show the stereogram of a collar with perpendicular elongate passage, the axle according to some embodiments of the invention Ring is applied to the rod member and straight rod member vertically bent；

Figure 44 E show multiple visual angles of Figure 44 D collar according to some embodiments of the invention, and collar has the rod member of a bending It is located therein；

Some exemplary embodiments of the collar of Figure 45 A-45H top closures used according to the invention, with pair wise The a variety of locking mechanisms based on collar of display；

Some exemplary embodiments of the collar of Figure 46 A-46H top end openings used according to the invention, with pair wise The a variety of locking mechanisms based on collar of display；

Figure 47 A and 47B show two locking rings of fastening in the mechanism in single collar according to some embodiments of the invention.

Embodiment

In some embodiments of the invention, multiple composite bone equipment are related to；It is primarily but not limited to, it is multiple Spinal implant, such as a vertebral pedicle bolt structure, and/or on a set of of multiple components including a vertebral pedicle bolt structure Group, and/or it is multiple on the set group used in this equipment, and/or on what can be used with the structure or its multiple component Instrument, the multiple instruments for example used during being implanted into.More particularly, used the invention relates to this equipment and conduct By multiple methods of multiple implantation equipment of fibrous reinforcement polymer substrate construction.

Some embodiments of the present invention are related to by following a constituted vertebral pedicle bolt structure：One or more vertebras Pedicle screw (such as two pedicle screws)；One or more rod members；Multiple holding fixing means (holding means), example Such as a collar, configuration to couple between the rod member and the screw)；And multiple locking means, for example come with ring configuration Fasten the pattern of the collar of the position on the rod member and/or screw.In some embodiments of the invention, the structure It is made up of following：Within at least four pedicle screws, the multiple pedicle of vertebral arch for being placed at least two vertebras；Two rod members, edge The major axis for the backbone connects the multiple screw；And fixed the multiple pedicle screw and multiple rod members are together Multiple means.In certain embodiments there is provided a set group of the one or more components including the structure, such as comprising four Pedicle screw, two rod members and four locking means, each locking means for example comprising：One collar, configures to accommodate the rod member And at least a portion of the collar of selectivity；And a locking ring, it can be positioned at least a portion of the collar. In certain embodiments, the multiple set group component is before the surgery and/or period is installed by a doctor.In some realities Apply in example, multiple components of the structure are assembled outside the body, such as before being inserted into the body, two or More collars are positioned on the rod member.Extra or replacement, multiple components are assembled within the body, for example institute Collar is stated to be positioned on the screw.It is extra or replacement, in certain embodiments, multiple components of the structure, example Such as the ring of multiple adapters (adapters) or configuration on a screw, assembled during manufacture.

State as some embodiments of the present invention be on a kind of set group for spinal fusion, its comprising a rod member and At least two are used for accommodating the collar of the rod member；Wherein each collar is comprising a passage and each collar has one Vertical axis is designated as in the overall state perpendicular to a vertebra.In some exemplary embodiments of the present invention, the passage Axle relative to one perpendicular to the vertical axis is not in rotationally symmetrical.In certain embodiments, the collar also includes a hole Cave, its size and dimension is configured to receive the head of a pedicle screw.

In some exemplary embodiments of the present invention, shortage is symmetrically in non-by the passage relative to the vertical axis Vertical angle and/or caused by being transversely offset from the vertical axis.

In some exemplary embodiments of the present invention, the passage is in its one end or two ends, for example, facing upward or downward Bending is (towards the vertebra).

The present invention some exemplary embodiments in, the section of the passage it is non-rounded and/or, if the rod member is not With circular cross-section, the rod member otherwise can not be matched.Optionally, the change in section allows the rod member of a bending to install and/or wear Cross the passage.

In some exemplary embodiments of the present invention, the passage is the synthesis in two holes, and one of them is straight line circle Cylindricality hole；Another is additional moon shape channel part, and it makes the passage expand in its one end or two ends.

In some exemplary embodiments of the present invention, the passage extends along a vertical direction, for example, and with two The semicircular section connected with straight line.

In some exemplary embodiments of the present invention, comprising one or more projections in order in fastening in the passage The rod member (for example, by elastic deformation of the rod member and/or the passage) is engaged during the collar.

In some exemplary embodiments of the present invention, the passage is designed to clamp the rod member of various configurations, example Such as include the straight or curved rod member of pen, such as bending radius scope between 30 to 240 millimeters, for example, with depression and One of projection or both (such as towards or away from the vertebra) and/or towards other directions bending.In certain embodiments, may be used Support only support larger bending radius towards the design that two or more directions are bent.

In certain embodiments, the passage includes the above-mentioned feature of two, three or more.

In some exemplary embodiments of the present invention, the size and/or shape of the passage are designed to be adapted to a variety of Rod member diameter, scope is done between about 3 to 8 millimeters, such as with 1 to 2 millimeter for interval to be changed, a diameter of 5 to 6 milli of such as rod member Between rice.Selection or replacement, the design be adapted to single rod member diameter (such as 6 millimeters) but have a variety of bending radius and/ Or bending direction.

It is extra or replacement, different rod members shapings (such as square and/or elliptic cross-section or other polygonals and/or Arc section).It is the axle using the rod member of circular cross-section and/or at least close to the potential advantage in rotation in symmetrical rod member Ring can rotate during being implanted into around the rod member.

State as some embodiments of the present invention be on a kind of set group for spinal fusion, its comprising a rod member and At least two are used for accommodating the collar of the rod member；Wherein each collar is comprising a passage and each collar has one Vertical axis is designated as the overall perpendicular state in a vertebra, and wherein described passage is configured as with curved bar and straight Rod member is operated together.In some exemplary embodiments of the present invention, the passage, which is configured as rigidly engaging, has identical straight Footpath but the rod member of different designs, such as straight and curved bar.Selectable or interchangeable, the collar and passage have foot Elasticity is reached to allow a collar to advance along a curved bar and/or allow to be horizontally set at a rod member with sufficiently resilient On.In some exemplary embodiments of the present invention, one have preferred member bending direction and/or amount of bow collar tool Have it is sufficiently resilient come have along one the rod member of differently curved amount and/or bending direction traveling.

State as some embodiments of the present invention is to be used for locking a collar in a vertebral column rod and/or one on one kind The locking member of screw head, particularly for composite vertebra system, wherein the locking ring is worn by the rod member It is arranged on before crossing the collar in the collar.In some exemplary embodiments of the present invention, so have described in reducing The potential advantage in space between collar and bone a, because ring need not be positioned in the position.It is selection or replacement, so may be used Risk and/or fastening system can be simplified that reduction locking ring drops during performing the operation, because the ring is determined by the collar Position and support in space.In some exemplary embodiments of the present invention, the collar has the outside half increased comprising one The part in footpath and the ring are to be vertically movable and (for example rotate and/or slide) to lock and compress in the region of the part The collar.In some exemplary embodiments of the present invention, the ring is simultaneously set in advance in the collar and not extended super The collar is crossed in any time and/or not after its fastening to extend.It, which does not extend or extended, is less than, such as 1 millimeter, 2 millimeters, 3 millimeters, potential advantage be screw that the ring will not hinder to be accommodated in an angle to the collar.Otherwise the screw Angle may be locked by being contacted with the ring for extending downward beyond collar.Another potential advantage is institute A space may be needed to install the ring and/or one fastening tool by stating between collar and bone.

If the potential advantage in the space reduced between the collar and the bone is that the space is bigger, the collar with The screw that bone is supported more may bending.One smaller space can reduce such risk and/or degree of crook.

State as some embodiments of the present invention is on by reducing the position for the bone that a ring is connected towards the collar Put to lock the collar.The ring can be set in advance in the collar, also can need not.

State as some embodiments of the present invention is on locking a collar using two locking rings.Optionally, it is described Collar is divided into two or more parts so that the ring locks the collar and supports its some together simultaneously.

The characteristics of certain embodiments of the present invention, is to be used in single part collar in two rings.So use Potential advantage is, for example, as described in this, selectively/different lock mode and/or selectively/different Locking strength in the locking strength and screw head of the rod member.Another potential advantage is can to bestow less strength, if for example The ring is respectively moved.Optionally, because force is reduced, the mobile device of ring can be made lighter.

One single position, the collar of single-piece can be included only in its lower position and/or multiple the splitting of higher part position formation Seam.If the plurality of crack is only located at side, those cracks selectively reached across a hole or across collar its His hole (rod member/screw hole).If being provided with two cracks, a not fissured border may be present between hole.At this In some exemplary embodiments of invention, the top of the collar does not have crack.It can so support and bodily tissue preferably phase The risk that interaction and/or reduction ring are removed from device, for example, two rings by all positions under the rod member.

In some exemplary embodiments of the present invention, the ring is locked with reverse path movement, for example, direction Each other or away from each other.In some exemplary embodiments of the present invention, there are two rings, rather than only one ring, be position in bar The phase homonymy of part, for example, that side of bone or the side relative to bone.

State as some embodiments of the present invention be on there is the collar of two rings, wherein two rings all be located at rod member it Under.Optionally, the one or both of which of the ring is position on the screw.

State as some embodiments of the present invention is on while two locking rings of the operation in collar.In the present invention Some exemplary embodiments in, a device includes a lever, and the lever is applicable to engage ring comprising two parts, for example, one One ring of individual part correspondence, e.g. holds the design for relying the ring/collar.Using upper, the lever is manually (or with other Mode) moved, thus the mobile engagement of loops part and and then mobile ring.

In some exemplary embodiments of the present invention, the two engagement of loops part is in institute relative to a lever pivot axle position State the phase homonymy (such as when two ring is to be moved along equidirectional) on the mechanical location of lever.Optionally, institute State device and include a pedestal, it is against a part of the collar to provide an opposing force, and it is relative to the work for imposing on the ring Firmly.Optionally, when a ring arrives at its position, the ring support departs from from the ring, for example, being by the domed supporting member Move and reach one for the collar greatly to the radial distance of the ring can not be engaged, once the ring is Positioning.

In some exemplary embodiments of the present invention, the two engagement of loops part is position pivot on mechanical location Opposite side.So it can help to, for example, most active force is implemented between multiple rings rather than the collar and bone On head.

In some exemplary embodiments of the present invention, the motion of the multiple ring is not synchronous.For example, a ring can have There is higher frictional force.It is selection or replacement, between two engagement of loops parts described in the spacing between the two Spacing (such as 0.5 millimeter, 1 millimeter, 2 millimeters or median or bigger distance or smaller distance) be different from the ring between Spacing, thus there is a ring to be first engaged.

The present invention some exemplary embodiments in, the distance between the pivot and the multiple ring be it is different, Different relative motions and/or different active forces thus are provided, as expected.

In some exemplary embodiments of the present invention, the length at the position interconnected between a ring and pivot is adjustable Whole, for example, using the telescopic arm for having internal thread, it can be changed distance by rotation.The mechanism of other variable in length also may be used Used.

State as some embodiments of the present invention be on providing a kind of metal-free spinal fusion set group, such as it is low In 2%, 1%, 0.5%, 0.05% or even substantial 0% weight ratio and/or volume, the metal is, for example, free gold Category, metal alloy and/or metallic crystal and/or other substantially with radiation (such as photon radiation and/or proton and/or other examples Such as it is used in the particle for the treatment of of cancer) interactive material.It is to reduce and radiation to avoid the potential advantage containing any metal The reciprocation for the treatment of, such as proton therapeutic.It is worth noting that, compared with MRI (magnetic resonance imaging) or CT, (electronic computer breaks Layer scanning) imaging, radiotherapy to metal (for example, heating, reflection, stop, secondary radiation) it is more sensitive.Another potential advantage It is to reduce the reciprocation with imaging, the imaging is possibly used for calculating dosage and aiming scheme.

In some exemplary embodiments of the present invention, the set group, in its implantable part, comprising low by weight In 5%, 1%, 0.5%, 0.05% or substantially 0% atom, the atomic number of the atom is such as 40,30,20,13 And/or on 11.

In some exemplary embodiments of the present invention, it is 1 cubic millimeter that the set group, which does not include any volume, and tool There is radiopacity to exceed planting for 200%, 100%, 50% or smaller or its median percentage of the radiopacity of aluminium Enter part.

In some exemplary embodiments of the present invention, the set group does not include can be at CT (CT scan) Cause more than 15 millimeters, 10 millimeters, 1 millimeter or smaller or median length striped artifact implantable part.

In some exemplary embodiments of the present invention, the set group does not include with magnetic susceptibility and/or supports vortex flow The implantable part of (being enough to cause image distortion in 5T MRI spin-echo imaging agreements in its quantity).

In some exemplary embodiments of the present invention, the implantable part of the set group does not include except carbon and/or had Colouring agent outside machine compound.

, it is necessary to radiotherapy and the patient with metal spinal fixation element in some exemplary embodiments of the present invention Radiation is subjected in the following manner：First remove the hardware and it replaced with nonmetallic component (as described herein), Then the patient is irradiated.

Selection or replacement, it is necessary to the patient of radiotherapy be selected with non metal implant rather than metal implantation Thing.

In some exemplary embodiments of the present invention, the implant does not have metal, is less radiopaque mark Thing.Optionally, radiopaque instrument, for example, radiopaque k lines that have a radiopaque label or complete, are used in Imaging is lower to be positioned.

State as some embodiments of the present invention is on being locked by the rotation of locking ring.The one of the present invention In a little exemplary embodiments, the ring and/or the collar are provided with screw thread, to make rotation cause vertical displacement.Optionally, exist Screw thread on the ring, for example, it is metal threaded, can voluntarily it be arranged in the collar when the ring is rotated.

However, be the characteristics of certain embodiments of the present invention without screw thread be arranged on the system any part and/ Or in the locking ring or collar.Optionally, so allow to avoid using metal parts.

State as some embodiments of the present invention be on connecting a pedicle screw and a rod member using a collar, And suppress the motion of the rod member by the radial compression of the collar.In certain embodiments, by lifting a ring in institute State on collar to apply radial compression, make some of the collar is close to each other to extrude the bar therebetween Part.In certain embodiments, the one or more components of the collar, such as described ring, collar, screw and/or rod member be by One reinforced composites are formed.Selection, the elasticity of the composite is enough to allow in the structure latches One slight material deformation, to obtain the collar on the rod member and/or on a head of the screw One is fitted closer.In certain embodiments, the collar includes surrounding an integration top of the rod member, the top of the closing Portion effectively shifts and disperseed multiple strength, for example, be applied to multiple strength of a more distal portions of the collar, example Radial compression strength is such as applied by the ring.

In an example arrangement of the structure, each of the multiple pedicle screw includes pre-determined bit described A locking ring on multiple screws, the multiple pedicle screw is implanted in multiple pedicles of vertebral arch of vertebra, such as adjacent Vertebra.In certain embodiments, the ring moved (such as axial lifting and/or rotation and/or inclination and/or other Orientation) arrive the axial direction and/or angle position of a selection relative to the pedicle screw, such as so that through in the one of the ring It with the longitudinal axis of the screw is in an angle that one longitudinal axis of the heart, which is, a such as angle between 5-70 degree, such as 10 degree, 40 degree, 60 Degree or middle, larger or smaller angle.In certain embodiments, outside the sufferer body, described two or more axles Ring is positioned on a rod member, such as so that the rod member is through within multiple holes of the multiple collar.Afterwards, institute The rod member and multiple collars for stating outer assembling are inserted into the body, and the collar is positioned at the multiple of the multiple screw On head, selective at least part of position is within the passage defined by the ring.In certain embodiments, one Collar configures to accommodate at least a portion of the screw head and be positioned on the screw head.Selection, the axle Ring can relative to the screw tilt with position with the screw axis be in an angle the collar, for example, an angle between, A such as angle is between 5-70 degree, such as 10 degree, 40 degree, 60 degree or middle, larger or smaller of angle.It is extra or replace Change, a supernumerary structure, one group of adapter for for example encircling the head of screw is used, and when the ring is positioned and as one Housing with keep the screw-multiple adapters combination with while combining of the collar-rod member, the collar It is positioned in the top of the multiple adapter.In certain embodiments, the every of the collar is arrived in lifting after the locking ring On one, apply radial inward strength, the radial inward strength is in the screw rod and/or head of screw effective in fastening position On collar and suppress their motions relative to each other.

State as some embodiments of the present invention relates to a vertebral pedicle bolt structure, wherein the multiple component is It is made up of fiber reinforced composite material, wherein a geometry of the structure and the fiber reinforced composite material is described more Individual property (such as elasticity and load transfer ability) same-action, with the relative fortune for the multiple component for suppressing the structure It is dynamic.

In certain embodiments, being mutually tightened for composite structure component causes in the multiple component to be suppressed One or a slight deformation of the composite of the two.Selection, the slight deformation cause in the material some change Become shape (for example, by scattering and/or being pushed out) and the multiple grooves entered between multiple components of the coupling.Example Such as, during the collar is fastened on the rod member end, and in certain embodiments, it is contained within the collar During on the screw head, the composite of the collar and/or screw head and/or rod member is slight deformation, choosing The result for causing to apply radial compression by the ring of the lifting of selecting property.In certain embodiments, the screw head bag Include subsphaeroidal but be not fully spherical shape structure, it causes position in the spherical notch of the collar and/or by being contained in One or more spaces between the spherical notch that the multiple adapter within the screw head is defined.In lockup period Between, material may be flow within these spaces.In at least part filler between the collar and the rod member, and/or One potential advantages of the material of multiple grooves between the collar and the screw head can be included and are provided as described Geometry locking between multiple components, such as in addition to one is based on friction lock, suppress the fortune of the rod member and/or screw Move and strengthen their earth-grasping force by collar.Another potential advantages of one composite rod member and collar can include the collar To a certain extent for the rod member a curvature suitability.

In certain embodiments, selection one construction package a fiber alignment come provide the component have it is one or more Engineering properties, such as elasticity and/or load transfer ability.In certain embodiments, the multiple fiber is aligned to one or more Multiple carbon poly ether ether ketone adhesive tapes, each adhesive tape includes multiple elongated carbon fibers arranged in parallel.In an example, including one falls One collar portion of U-shaped is included with multiple polyether-ether-ketone adhesive tapes of a similar U shape profile arrangement.Selection, the institute of the collar State multiple inverted U-shaped fibers and can help to the strength that the scattered ring by a lower part of the collar applies (such as radial inward strength) arrives a upper part of the collar, and the rod member is housed inside within the rod member, potential By the collar obtain the rod member one it is relatively strong keep, to suppress the motion of the rod member in the collar hole (such as axial direction and/or rotary motion).In another example, a locking ring includes wrapped PEEK adhesive tapes to form a spiral shell Rotation, it can increase the impedance of the ring for radially strength, for example, applied on which ring by two collar portions, Two collar portion is close to each other by the ring.In another example, multiple elongated members of the structure, such as screw And/or rod member includes multiple PEEK adhesive tapes for being respectively parallel to a longitudinal axis of the screw and/or rod member to extend.The screw Multiple longitudinal fibers, can for example increase the screw impedance for axial tension load.

Extra or replacement, the multiple component of such as screw, rod member, collar and/or ring, which is included, to be had in a side Multiple polyether-ether-ketone adhesive tapes of the multiple elongated carbon fibers arranged upwards, the direction and hereinbefore the multiple polyethers ether The direction of ketone adhesive tape is in an angle, such as direction with an axis oriented normal of the screw, such as along the screw A diameter.

In some embodiments of the invention, multiple shredded fibres can be used with multiple longitudinal fibers, for example generally edge Multiple fibers of the screw axis extension.Replace, the structure or its multiple components or its some include not having Multiple shredded fibres of Longitudinal extending fiber.

In one embodiment of this invention, the volume content [example of the multiple stiffener within the composite Such as, multiple carbon fibers (CFR)] be at least 50%, 60%, at least 70%, at least 80%, the 55%-65% of selectivity or in Between, larger or smaller scope.The high level of multiple reinforcing fibers can help to the load bearing capacity of the structure.

In certain embodiments, the fiber reinforced composite material includes multiple filiforms, for example, be embedded in a polymer Multiple carbon fibers of Medium Culture, such as, but not limited to, polyether-ether-ketone, PEKK (polyetherketoneketone； ) and/or other polymer based on polyketone PEKK.

In certain embodiments, the radiolucent composite structure enables a doctor to see through during performing the operation The saturating structure and it can promote easily to manipulate the vertebra and/or structure in imaging (for example, described compound using being incorporated in The help of radiopaque label in material) with the contraposition for the needs for obtaining the vertebra.The composite (for example than Compared with metal) potential advantages of relative transparency can be included in one of vertebra during imaging relatively clearly visualization, with A doctor is allowed to position and/or lock the system in more accurate anatomical position.The ray of the composite structure can be saturating Property can be especially advantageous during follow-up, such as when carrying out CT imagings, with allow to organize described in a doctor diagnosed a situation, One fusing stage of the multiple bone and/or other that can be seen clearly that due to a transparency of the composite Parameter.In an example, due to a radioparency of the composite screw, such as during being implanted into, it can be simpler The damage avoided to tissue, such as nerve fiber.In another example, a radioparency of the composite screw, One situation of the skeletal tissue of such as described treatment can be simply observed during follow-up, for example, assess the cure rate.

It is extra or replacement, for composite, in certain embodiments, the pedicle screw it is one or more It is that component is made of metal or include metal, such as titanium.In an example, a ridge of the pedicle screw is by a thin gold Belong to shell cladding.Inventor it has been observed that because the structure do not include or only include a minute metallic content, for example compared to If compared with multiple artifacts produced by the structure being made up of pure titanium in MRI or CT, with a thickness between 5-20 One pattern of the ridge shell of one screw of micron, for example, subtracted with 50%, 70,90%, 95% or middle or larger percentage example Less or avoid multiple artifacts in such as MRI and/or the CT imagination.

In one example embodiment of the present invention, it is to avoid the one of the artifact of/reduction in CT and/or MRI imagings is special Pattern, is a kind of artifact for stopping viewing close to the other parts of the surface of the pedicle screw and/or the structure.At this In one exemplary embodiment of invention, using a compound set group with allow it is hard and/or parenchima image in it is described Within the distance of structure is small at 3 millimeters, 2 millimeters, 1 millimeter or middle or even more, selection, within a diagnosis quality. For example, when using the composite construction according to some embodiments of the present invention, for some embodiments, even if the structure has Multiple metal inserts and/or coating, the tissue in 1-3 or 1-2 millimeters of the distance is imageable.Selectivity, this It is for detecting inflammation and/or other symptoms, skeletal fixation (bone anchoring) problem and/or implantation position not just (example Such as relative to bone, multiple nerves).Selection or replacement, the multiple artifact for reducing/avoiding is drawn by metal artifacts The multiple stripeds (such as in CT) risen.Selection, this artifact is reduced (such as in diagnosis qualitative effects by percentage Multiple pixels) arrive a degree as described above.

State as some embodiments relates to the vertebral pedicle bolt structure for including a composite locking ring.At some In embodiment, the ring be it is axially movable at least a portion of the screw and further in the collar at least On a part, the collar is configured on the screw.In certain embodiments, the ring does not include an internal thread.Institute The ring on the outer surface of the collar can be pulled comprising promotion by stating the potential advantages without internal thread of ring. In some embodiments, the axle does not include an external screw thread also.In certain embodiments, as long as the ring is not by internal thread , or the collar is not that, by external screw thread, the ring slip is drawn on the collar, without rotate with Promoted and/or locked.Replace, in certain embodiments, the ring includes a ridge.In certain embodiments, carry Rise the ring and the collar is fastened on the collar on a rod member, the rod member is accommodated within it, and/or On at least a portion of one head of screw, the head of screw is accommodated within it, to suppress the rod member and multiple screw groups Part is relative to the collar and thus relative to mutual motion.It is extra or replacement, as the ring of a shell body, One structure of the shell body holding encircles the head (such as one group adapter) of the screw and the collar is together.Extra Or replace, the one or more rings that the structure includes configuration to slide on the rod member, so that the axle of the ring is flat Row is in the axle of the rod member, an axial location of the axle with lock collar relative to the rod member, such as by positioning two rings On the dual side-edge of the collar.

In some embodiments, the ring includes an interior conical profile, including diameter is reduced on a distal direction One passage.By axially lifting the ring on collar, the internal sharp cone distal profile applies radial inward strength described in On collar, and/or to encircling on the structure of the head of screw, and/or on the head of screw.Selection, institute The inwall for stating ring is tilted with a smaller angle, generally 1 degree, 3 degree, 5 degree, 7 degree or middle, larger or smaller of angle with Produce tapered configurations.(for example can when the radial direction strength applied by the ring is converted into only one small axial forces Cause the strength that the ring is skidded off) when, the small axial forces can be by between multiple surfaces of the multiple component Friction overcomes, and a potential advantages of a smaller pointed cone angle of the ring can skid off the one of the collar comprising the ring is reduced Risk.Another potential advantages of one small pointed cone angle can be comprising increase in the radial direction being applied to by the ring in the collar The size and needs of compressing force apply to lift the ring to the ratio between the axial forces of a latched position.Subtract Few slanted angle can promote the axial pulling ring.Replace, in certain embodiments, the in-profile of the ring is not It is pointed cone, is, for example, cylinder.

In certain embodiments, the composite material ring can provide to lock the increase using the ring compared with wallette wall thickness Intensity, for example, be compared to a wall thickness of a becket of size for bearing similar tensile force.Selection, it is described to mend The structure (such as reinforcing fiber volume, fiber alignment and/or other specification) of strong composite is selected as than a metal substantially On more anti-0.9-10 times of tear, the e.g. titanium with a similar wall thickness.

In certain embodiments, the ring is drawn on multiple collar portions, and the multiple collar portion is in a nothing The configuration of suppression is separated by the groove extended in the length between the multiple collar portion, and the collar it On the advance of the ring make the multiple collar portion toward each other.Multiple collar portions of the suppression can provide a counteracting Radially strength on the multiple inwall of the ring, it avoids the ring from being skidded off from the collar, for example from Slid on one distal direction.

In certain embodiments, the in-profile of the ring is pointed cone, is, for example, cone.In some embodiments In, the exterior contour of the ring is cylindric, pointed cone (such as on the distal direction or replaces, in the near-end On direction), formed with one or more circumferential protrusions or " ladder " and/or other forming modes.In certain embodiments, it is described Multiple projections and/or multiple ladders, which can be used in, to be lifted the ring and/or removes the ring, for example, close described many by configuring come Nie One instrument of individual projection or multiple ladders.

Replace, the inside of the ring and/or exterior contour are not pointed cones.In certain embodiments, the collar is not Including a sharp cone distal profile.Selectivity, in certain embodiments, wherein the ring and the in-profile of the collar all right and wrong Sharp cone distal, in the multiple component one or the two may include that there is provided pull in the collar different geometries The ring.In an example, the geometry includes position on the inwall of the ring and/or on the outer wall of the collar Squeezable multiple protrusions or multiple projections, when it is on ring lifting to the collar, may be urged towards (respectively It is the ring or collar) wall.

State as some embodiments relates to configuration to couple a pedicle of vertebral arch screw of a rod member and a pedicle screw One component of pin structure, wherein the shape of the component is designed to the rod member covered from above.In certain embodiments, institute State component shape be designed to surround the rod member a circumference at least 60%, at least 80%, at least 95%, the rod member It is accommodated within it.In certain embodiments, at least 50%, 60%, the 80% of the top semi-circular arc of the rod member is described Component is covered.In one exemplary embodiment, top semi-circular arc (such as edge of the covering rod member of the component completely The 100% length extension of the arc).

In certain embodiments, the component is that, with the collar pattern including a hole, the rod member is accommodated in institute State in hole.In certain embodiments, the component includes the hole of one second lower, a part for the screw, for example The head of screw is accommodated within the hole of second lower.Replace, the collar does not include and the head of screw One direct-coupling in portion, and interchangeable it is connected to the structure for accommodating the head of screw, such as one group adapter.In some realities Apply in example, the collar includes one or more slots, the lateral insert for example extended from a following hole, the rod member Be accommodated in the hole, with a lower spaced-apart of the collar into can close two secondary portions towards each other Point.In certain embodiments, cover the rod member the collar the top section as position in two secondary portions / a bridgeware.

In certain embodiments, the top section is arch, for example, configured with one inverted U-shaped (or shape of a hoof).

In certain embodiments, when applying external strength to a lower part of the collar, such as by carrying Radial inward strength of the locking ring on the lower part of the collar is risen, position is in a upper portion of the collar Multiple walls in the rod member hole of office are extruded relative to the collar, and the bar is kept by the collar to obtain The effect of part, wherein the collar effectively suppresses axial direction and/or the rotation fortune of the rod member in the collar hole It is dynamic.When mentioning a central point of the top section as a theoretical rotary shaft, provided by the ring described in being applied One generation moment of strength to a lower part of the collar is by described from the collar portion of the upper The distance on the point that heart point (such as rotary shaft) is applied to judges.In an example, the collar is acted on The power of the generation of the upper part, it is stronger to obtain one by the collar that the collar compresses the rod member in turn Earth-grasping force, the power of the generation is to be acted on by position in the central point (such as rotary shaft) and the ring exerted forces amount One ratio of the distance between the position increases, and the power of the generation (for example rotated in the central point by position Axle) and an approximate centre of the rod member between a distance separate.

Wherein described rod member generally can by a potential advantages of the circular collar of multiple walls in the hole of the collar Include the axial direction for reducing the rod member in the collar and/or rotary motion.Cover the top of the closing of the rod member Portion collar portion can have advantage especially for composite collar described herein because the composite be for example than One correspondence metallic collar is more resilient, and covers from above the rod member and contribute to limit the rod member in the collar hole Motion within cave.

State as some embodiments is related to for driving a pedicle screw to enter in a vertebra and closed for Nie One equipment of the locking ring being positioned on the screw, for example, make the ring stretchy on a collar.In some implementations In example, the equipment includes：One axostylus axostyle, with a distal end, the shape of the distal end and is dimensioned so as to accommodate the screw Head；And/or one encircle structure (such as one group adapter), the head of the screw is encircled；And/or a ring, at least partly Be lifted on the head of the screw and/or be lifted on the multiple adapter.In an example, the distal end is determined The columnar inner chamber (lumen) of justice, and meet an outer cylinder profile of the ring.(it is noted that the ring is outer Contouring can be beyond cylindrical shape, a such as sharp cone distal profile, such as a cone shape profile including more projections or ladder One profile and/or other profiles.)

In certain embodiments, a near-end of the axostylus axostyle connects a handle, so that a user, a such as doctor can grasp It is vertical.Selection, the multiple structure on the head of the screw and/or the head for being coupled to the screw passes through the equipment Distal end come Nie close after, the axostylus axostyle of the equipment is distally advanced and rotates the screw to be screwed into the pedicle of vertebral arch.

In certain embodiments, the extension of the axial class ligule from a distal end of the equipment to distal end extension, with Nie Close at least a portion of the ring.Selection, the extension is included in the remote of it below the distal end that can be positioned at the ring A radial inward projection at end, after pedicle of vertebral arch described in the screw placement, by pulling institute on a proximal direction State equipment, with can relatively described screw and/or collar pull the ring.

One aspect of some embodiments relates to a pedicle screw head, including a subsphaeroidal shape.At some In embodiment, the subsphaeroidal screw head defines a volume, fills up a volume of the spherical notch between 85-95%, described Screw head is accommodated in the spherical notch, for example, the recess that is defined in the collar or fitted for example, by being one group The recess that the one of orchestration encircles part to define.In certain embodiments, by the composite of the screw head and/or The multiple walls deformed during the structure are fastened, such as due to the radial compression strength that the ring applies, in the screw head And the residual volume between multiple walls of the recess is at least part of is filled.One slight deformable screw head One potential advantages can be comprising the tight fit obtained between the screw head and its contained structure, so as to potentially increase It is added in the stiffness of coupling between the other assemblies of the screw of the implantation and the structure, the other assemblies example of the structure The collar and/or multiple adapters in this way.In certain embodiments, the subsphaeroidal shape of the screw head includes：One stands Square interlude；And two class dome portions, configuration on the cube interlude and under.In certain embodiments, The screw head includes one or more near-ends towards slot, the single slot for example extended through the head of the screw, And/or a distal end of an instrument of the screwdriver for example including each row projection or cross-like projection may be housed in the inside One cross slot.

State as some embodiments relates to a vertebral pedicle bolt structure, wherein being marked using a radiopaque material The radioparency compostie implant, such as titanium and/or other radiopaque materials are remembered, with imaging (such as fluorescent Perspective) when can reach visualization.In certain embodiments, the multiple label indicate a component a position and/or Orientation, such as other assemblies and/or the spinal column segment relative to the treatment relative to the structure.In certain embodiments, One position of the one or more labels of multiple components is chosen so as to point out the multiple component relative to each other, and/or Relative to an orientation of the multiple bone, such as elongated axial wire tag relative to the pedicle screw, the locking The non-close loop wire mark of ring can be visualized, to point out the flat orientation of the ring township for the screw axis. In some embodiments, the ring is a closed-loop.

Extra or replacement, the multiple label is positioned to point out the edge or end of the component, such as institute State multiple ends of rod member, and/or a screw a distal end, such as to avoid the damage to tissue, such as nerve fiber.Additionally Or replacement, the multiple label is positioned to point out the multiple component from each other and/or from the multiple bone One distance, multiple top surfaces of the multiple collars being for example marked on a rod member are to point out a distance between them.Bag The potential advantages for including a structure of multiple components that substance markers are marked with radiopaque promote described when can be included in imaging The adjustment of structure, to obtain the one of vertebra of the treatment selected contraposition and the fixed vertebra in the selected configuration.

In certain embodiments, the label is provided with a line style formula.In certain embodiments, the label is one The pattern of shallow layer.In certain embodiments, the label is the pattern that powder is incorporated in the composite materials.One In a little embodiments, the mark of variously-shaped and/or size (such as shape is line, point, ring, small latch, rod member and/or other shapes) Note thing can be incorporated into that in multiple components of the structure.

In certain embodiments, the multiple label, which is positioned in, suitable is used to refer to the multiple component relative to each other At multiple positions in one position and/or orientation, such as a flat orientation of a longitudinal axis of the described relatively described screw of ring, the bar Part is relative to a curvature of a longitudinal axis of the collar, and/or other relations between the multiple component.

In one exemplary embodiment, the rod member is included with the type of the slender threads extended along the lengthwise of the rod member One label of formula, such as with the diameter between 0.1-0.2 millimeters；The collar is included using a tantalum pin or line as type One label of formula, such as length with 0.5 millimeter of a diameter and 0.5 millimeter, for example, be positioned at the one of the collar Close end office (at or adjacent in the point described herein for being referred to as " central point ")；The locking ring is included with a non-envelope Closed loop marks for a tantalum wire of pattern, and the line is for example with 0.1-0.2 millimeters of a diameter；The pedicle screw include with In powder and/or the label that multiple particles are pattern, such as bronze end, the composite for being embedded in the screw.

State as some embodiments relates to again a rod member component of the vertebral pedicle bolt structure of plastotype one, and selection is Carried out in operation.In certain embodiments, for example by bending or other described rod members of deformation come rod member, example described in plastotype again Such as to obtain contraposition necessarily and/or the distance between the neighbouring pedicle screw, so that it is the multiple to define implantation The relative positioning of the vertebra of screw.In certain embodiments, the relative positioning includes a selected angle, and position is described Between one longitudinal axis of pedicle screw and a longitudinal axis of the rod member.In certain embodiments, the composite wood of the rod member Material is bent under heating.Selection, the rod member is curved under heating to be taken, while applying the strength such as compression stress to deform the bar Part is to a selected curvature.In certain embodiments, the deformation does not influence a section profile (such as cross-sectional area of the rod member One size and shape in domain).Selection, then plastotype is including bending the rod member relative to a longitudinal axis of the pre- plastotype rod member At least partially.

In certain embodiments, multiple collars are positioned on the rod member, and the rod member is arc and/or with it His mode deforms to obtain the selected distance and/or orientation between the collar.In some embodiments of the invention, The rod member is linear, and can provide the user given as such.Replace there is provided the rod member of arc, for example The arc with a constant radius of curvature is bent to, or bends to the S-shaped for meeting the vertebra curvature.Replace, institute State that rod member is provided as bending or use multiple means, a such as flector during performing the operation to bend it.The present invention's In one exemplary embodiment, a flector is used for bending rod member configuration (such as curvature) needed in operation. In certain embodiments, the instrument is configured to heat the rod member, while apply strength is needed with the moulding rod member to one Curvature.In certain embodiments, by multiple heating members to provide the heating of one or more times, the multiple heating member is configured To heat a guiding piece (leading element), the rod member is contained in the guiding piece.In certain embodiments, should The rod member is deformed with strength to be provided by the relative motion of two parts of the instrument on the rod member.

In certain embodiments, multiple components of the structure, such as described collar and ring, the collar and screw, institute Any other combination for stating collar and rod member, the screw and ring, and/or its multiple component is to combine in advance.Selection , the multiple component is by allowing a pine connection of multiple degrees of freedom to couple, so that the user of doctor can select as described Select the position (for example, position and/or contraposition) of the multiple component relative to each other.In an example, the ring is advance Combination is on the screw, and the fixed configurations needed for once obtaining the vertebra selected, is lifted at the collar On, to lock the collar to being contained on the multiple component inside it, such as described rod member and/or the head of screw Portion.

In certain embodiments, the collar includes two or more components, such as including being each a complete body Two half parts are to define：One one, the rod member is accommodated in the hole of the upper of the inside；And both one, it is described Screw head is accommodated in the hole of the lower of the inside.In certain embodiments, the collar portion includes a groove, for example The groove that one between them laterally and longitudinally extends.In certain embodiments, at least described lower portion of the collar Dividing includes outer conical configuration, for example, be pointed cone (such as towards a tip of the screw) on a distal direction.Choosing Select, when a locking ring is positioned on the collar, such as on a lower part of the collar, the multiple time It is partly close towards each other, the rod member and screw head are closed with Nie and they are clamped in a tong-like mode.The plant of this configuration Enter and can for example be opened by be defined between the collar half part one comprising the rod member is placed in the collar from top Mouthful.

In certain embodiments, the collar includes an outer conical profile.In certain embodiments, the collar One diameter is reduced on a distal direction, so that the distal end of the collar is cone-shaped.In certain embodiments, the circular cone The locking ring that shape profile avoids positioning surrounding the collar is from the slip in the collar upward.It is extra or replace Change, the collar includes a ladder or the one or more projections radially extended relative to the collar, the collar Limit advance of the ring on a proximal direction and/or distal direction.

In certain embodiments, the compostie implant or its part, such as described vertebral pedicle bolt structure One or more components, be to be coated with using a material, the material is applicable to strengthen the implant and/or implant table The one of face needs property.In one embodiment, using be intended to strengthen and/or improve the implant/surface hardness a thin layer It is coated with the skeleton implant.For example, the screw is threaded through a metal coating to be coated with.One in the present invention is exemplary Embodiment, the implant, such as titanium and/or other metals are coated with using a material harder than bone.One in the present invention shows Example property embodiment, the scope of the thickness of the shell be several microns to 100 microns, a such as thickness be between 10-20 microns, 40-60 microns, 50-70 microns or middle, larger or smaller of thickness.For example, a screw a threaded portion and selectivity The remote tip of screw can use such a thin layer shell to be coated with.It is extra or replacement, a near-end of the screw, example Such as on the head of the housing, it is coated with by the thin layer.In an example, the insertion that Nie closes a such as screwdriver is intended to The one or more near-end surfaces of the screw of part are coated with for example, by a thin layer of the material of metal.Coating is intended to contact One potential advantages of one bolt portion of one insertion instrument can include the rigid and reduction damage spiral shell for increasing the part Nail a risk, such as described screw head it is damaged or broken.

It is extra or replacement, except the one or more components of the structure of the screw, such as described structure Rod member and/or the collar and/or the locking ring are coated with by the thin layer.In an example, the ring one in The outer surface that surface and/or the ring are positioned the superincumbent collar is coated with by a thin metal-back.One metal One potential advantages of coating can include the fragmentation for reducing the composite and/or other fractures.

This shell can be comprising making the implant and/or multiple construction packages to be visualized under imaging means, together When the visualization (for example, create artifact) that does not have a negative impact, such as it is as described further below.

In one embodiment, the housing for being coated with the implant is made up of sheet metal.According to inventor Carry out multiple experiments, for example by titanium (pure titanium (Ti) or as Ti-6Al-4V titanium alloy) be made a sheet metal it is described Intensity and surface nature, are generally an advantage over other coatings, such as using vacuum plasma spray coating (vacuum plasma spray；VPS) titanium/titanium nitride/titanium oxide of technology manufacture.The latter is mechanical strength too crisp and without the sheet metal (such as one radially and/or on axial direction).

In certain embodiments, the coating includes the material (such as metal material) of a less amount, in such as CT or During MRI imaging, the implant property (such as described visualization implant size and/or position) is had little influence on.

In certain embodiments, the radioparency compostie implant is marked using a radiopaque material Note, such as tantalum and/or other radiopaque materials, so that visualization can be reached when being imaged (such as fluoroscopy).Selection , it is incorporated to a radiopaque longitudinal screw along the longitudinal axis (such as screw axis and/or rod member axle) of the implant.Replace or Extra, the label is positioned at one or two ends of the implant, and/or along its any position.Selection, institute State a shape of the label with a screw thread, point, ring, fine needle and/or other shapes.Selectivity, the implant includes one Label, with identical or dissimilar shape and/or size, such as including variously-shaped and/or size multiple labels.

In certain embodiments, if the compostie implant is coated with using a thin layer of the metal of such as titanium Or partial coating, the addition of a radioparency label can be unnecessary, and in imaging means, the layer can also fill When watching the implant.In certain embodiments, the powder and/or particle of radioparency material are incorporated into the plant Enter within thing.In certain embodiments, the powder that the implant includes a thin layer of metal and is incorporated to.In one embodiment, The content of powder is relatively low, such as the scope of the volume content of described powder is that the material of the component is being made The 0.2%-2% of volume, so that the addition of the radioparency powder uncompromising (compromise) is in the implantation Multiple engineering properties of thing.In certain embodiments, the content of powder is less, so that in MRI and/or CT scan phase Between, insignificant influence of the addition with multiple artifacts for metal inducement of the radiopaque powder.The present invention's In one exemplary embodiment, the powder is made up of noble metal or other metals, such as gold, platinum, rhenium, tungsten, tantalum, and/ Or a combination of the multiple material, and/or be made from other radiopaque materials.In certain embodiments, the powder is Homogeneous along ray can pass through implant distribution.It is replacing, it is necessary to which an inhomogeneous distribution of the powder is positioned or concentrated The powder is on particular locations (such as implant periphery).This can be important, such as in many cases, wherein penetrating During line photographing imaging (radiographic imaging), one specific implant assembly of monitoring or part：For example, powder can be with In the threaded portion for being incorporated in the pedicle screw, with visualized when screw is inserted into pedicle of vertebral arch the screw thread and/or Distally；And/or after surgery during, minimize for nerve compromise (neurological compromise) the wind This compromise is detected in danger.If being coated with the implant or its part, such as with metal (such as titanium) coating or polymer (such as PEEK) is coated with, and the powder can be added before the coating and/or afterwards.In one embodiment, the powder can Multiple particles of size including nm particle to hundreds of micron particles, preferably generally 1 micron -10 microns, 10-20 it is micro- Multiple particles of rice, 50-100 microns or middle, larger or smaller diameter.In one embodiment, in the compression of the implant Before shaping, place and the concentration with needs, add CFR-PEEK adhesive tape of the powder in the prepreg at the desired position Between.In certain embodiments, a size of the metallic particles is at least homogeneous to a certain extent.Replace, it is described Multiple particles include various sizes.

The contrast test realized according to inventor, is compared to CFR-PEEK screws and the reference to be made up of nylon Screw, the threaded portion of addition (a) titanium shell to a CFR-PEEK screws, and (b) are incorporated to have along screw and are less than 0.25 milli One tantalum line of one diameter of rice, and/or be incorporated to a micro bronze end and (for example occupy the spiral shell handle and spiral shell to the spiral shell handle and screw thread Line volume 1%), it is only very small or analog quantity artifact to be caused during MRI.Selectivity, the multiple artifact is not Interference imaging.Selection, the metal level does not disturb visualization during imaging, such as multiple artifacts occurred when being imaged generally Quantity and/or size be enough small, with during performing the operation and/or during follow-up, it is allowed to which the user of a such as doctor comes The screw is implanted into a selected anatomical position and/or the bone and/or soft tissue of the viewing treatment.Opposite, a titanium Alloy screw (a such as screw of titanium alloy formation) produces substantial amounts of artifact.It is worth noting that, all tested screws It is of the same size.

In one embodiment, the compostie implant does not include metal, or including an a small amount of metals, so that described plant Enter thing and neither disturb radiotherapy, and do not produce back scattering (backscattering).In an exemplary embodiment, a composite Screw marks (example comprising thin titanium layer shell on its threaded portion, and/or along an at least part of tantalum wire of its major axis Such as along without coated portion), and/or a radiopaque powder.Due to few amount of metal, the amount of metal is in imaging It is not significant, and the interference/back scattering during radiating is insignificant.By inventor carry out to having a competition Test using CT scan and the pedicle screw-rod part structure by different materials, support this argument.

There is provided a uniaxially or biaxially composite pedicle screw in certain embodiments.In certain embodiments, one In uni-axial screws, the screw and the collar and/or ring include a similar longitudinal axis.In another embodiment, it is the multiple Composite pedicle screw is multiaxis.In certain embodiments, in a multi-axial screws, the ring and/or collar can phases For screw positioning, so that the ring and/or the collar the longitudinal axis is configured to vertical relative to the screw One angle of axle.For example by being intended to the pivotable collar in head and/or ring of relatively described screw, it can so promote described The application of multiple rod members

In one embodiment, the pedicle screw include a thread rod part (handle) and a head, selection be it is spherical or Part-spherical.Selection, the distal end of the diameter of the threaded portion along the screw changes, so that the part (bar Portion or its part) towards the distal end of the screw be pointed cone.In certain embodiments, when the driving screw is described in In bone, the pointed cone bar portion is arranged to compress skeletal tissue.Selection, an outer dia of screw thread is along the bar portion Length stays constant, while the distal end of a core of the screw is in sharp vertebra shape.Selection, the pedicle screw is hollow , enable it to insert on a guide wire.

In certain embodiments, the pedicle screw head includes one or more near-ends towards slot, such as single The compatible protuberance of slot or a screwdriver may be housed in a cross slot of the inside, to promote to be screwed into the bone Within.

In one embodiment, the vertebral pedicle bolt structure includes, selective during performing the operation, and is placed on the multiaxis spiral shell Multiple suppression means on the spherical head of nail.In one example embodiment of the present invention, the multiple suppression means by It is following to be constituted：More than one component, such as two half parts matching of the collar with internal geometry is (for example, logical Cross a proper fit or by one some be separated out the matching of (spaced-out)) shape of the screw head and the rod member Shape；And a ring, it is placed on the collar, and (inwardly) pressing structure of radial direction is to ensure the rod member and screw Head is relative to each other.Selectivity, the collar and/or the slight pointed cone of ring so that their diameter be at rear compared with Big.Replace, the collar and/or the slight pointed cone of ring, so that their diameter is increased in a forward direction.Choosing Select, one/multiple element (such as multiple projections or multiple recesses) use on which ring is multiple auxiliary at the collar Element (such as other multiple recesses or multiple projections) is helped to carry out Nie conjunction, to ensure that ring is fixed in position.Selection, institute Multiple element is stated to be positioned to align the ring relative to the collar.

In one embodiment, the definition rod member is accommodated in multiple inwalls of the collar in a hole of the inside, bag Containing a non-smooth surface, an e.g. grain surface is for example including multiple projections or multiple projections, further to suppress rod member axle To and/or rotary motion.The non-smooth surface can increase the friction between the rod member and the collar, potentially The axial direction of the rod member of the reduction in a hole of the collar and/or rotary motion.In an example, described in institute State rod member specified jack or hole at the interior surface of the collar can be threaded.In one embodiment, it is described Rod member comprising one/multiple complementary screw-threads, such as at its end points or along at the other positions of the rod member.Other not rounded are drawn Surface, such as a rough surface, an arrangement for a radial direction woods, and/or the surface with multiple projections, also in the guarantor of the present invention Within the scope of shield.

In certain embodiments, multiple designs of multiple suppression means, not including a threaded components, such as screw or screw thread Locking lid, is also contained within protection scope of the present invention.

In one embodiment, when radial direction, the pressing surrounding ring inwardly, the collar and/or multiple screw heads Component be designed to extra locking (for example can preferably described in impedance the motion of screw rod and/or screw increased intensity A locking).In one example embodiment of the present invention, the multiple collar half part includes a slot or an inner-concave Mouthful, such as plane in the common plane for being approximately perpendicular to the rod member and the screw.Selection, when the lifting locking Such as ring presses the multiple collar half part and screw head, the multiple collar half part is footpath to its final position To and/or be axially directed and be pressed against each other to compress the head, and the spherical head can be deformed slightly so that The material of the screw head charging within the collar slot/recess slightly.Replace or extra, a subsphaeroidal screw Head includes an aspherical part, such as including the cylindrical portion between two relative generally dome-shaped parts. In an example, the screw head includes a recess, such as a cylinderical surface or the reduction at the part in the region Diameter, it carrys out Nie using the collar and closed.In certain embodiments, the screw head described subsphaeroidal but be not complete It is spherical to leave a short space, between the circular inner wall and the screw head of the collar.Selection, the screw head A volume only occupy in a volume of the recess being defined in the collar and/or within one or more adapters 80%th, 90%, 95%, the head of screw is accommodated within the adapter.Selection, a surface of the screw head is only 70%, 80%, 90% in one surface of the multiple inwall for contacting the recess.

When mentioning a curvature of the rod member, in certain embodiments, when the rod member is configured including an arch, one presss from both sides Angle is set at a longitudinal axis of the screw and tangent (tangential) between an axle of the rod member.Selectivity, institute The scope of angle is stated between 70-110 degree, 60-120 degree or centre, larger or smaller angle.

In some embodiments of the invention, the rod member is linear, and can give the use as this mode is provided Family.Replace, the rod member be provided as bending or with multiple means, such as a flector, with curved during performing the operation It is bent it.In one example embodiment of the present invention, a special heater is used in operation, is arrived with bending the rod member The angle needed and configuration (such as curvature) (or, it is similar, bent during performing the operation a bone plate a to configuration needed with Match the sufferer anatomic construction).Selection, the bending of the rod member is included during BENDING PROCESS using the covering rod member A guide member, and avoid its damage, such as damage to the rod member surface.In one exemplary embodiment, it is this to lead Drawing part can be made up of two metallic plates, for example, be made up of stainless steel and/or Nitinol (Nitinol), and it is included or relative to each other Positioning accommodates the rod member between them to define a recess.In certain embodiments, it is described during BENDING PROCESS The adjustment also slight in heating of multiple plates.Selection, the whole bending apparatus is provided as sterile.Replace, only The part (such as the multiple guide member) of described device is provided as sterile in the bag special for resisting the flexure temperature.

In certain embodiments, the present invention provides multiple equipment and multiple methods, used in locking polyaxial pedicle screw knot Structure, is made with metal, composite or its combination.In certain embodiments, the structure does not include a screw thread locked component (example Such as a screw or lid).In one embodiment, reach and ensure using a circular cone ring of the pressing structure of radial inward The multiple construction package is together.

Some embodiments of the present invention propose multiple methods of the multiple skeleton implants of implantation, comprising used in configuration and locking The multiple methods and multiple equipment of one vertebral pedicle bolt structure, in certain embodiments, the vertebral pedicle bolt structure include nothing Multiple means of screw thread suppression/locking.In certain embodiments, before the multiple construction package is locked, the locking ring It is placed on the screw, to surround the screw neck.Replace, before locking, the locking ring is non-final with one Latched position is placed on the collar.Substantially, for multiple methods in some of embodiment and multiple equipment One common attribute include holding from below the ring (such as Nie closes a distal end or part for the ring, such as by instrument) and/ Or Nie closes the one or more hooks of configuration on which ring, so that the ring can be pulled, and the instrument is operated (for example to make institute State the advance of instrument near-end), to reach the final position (such as around the screw head) for lifting the ring to it.

Replace, a locking ring or an extra locking ring can be placed on the implant with direction directed downwardly, For example, by ring described in a near-end to far end party upward sliding on the collar, it is selective the rod member implantation On thing.

In certain embodiments, the one or more rings with the center longitudinal axis similar in appearance to the rod member axle are used to limit Make motion of the collar on the rod member (along the rod member axle).Selection, multiple rings are positioned in the collar Two sides on (such as lateral to the collar).

In certain embodiments, one or more equipment or instrument are used to assist to combine the bolt structure or its is multiple Component.Selectivity, the operation of this equipment can include using a mechanical schemes, hydraulic pressure mechanism, electronic mechanism and/or other Mechanism.In an example, a mechanical schemes include a cable, and a such as knitted/braided fiber (is for example manufactured by DSM N. V. Ultra-high molecular weight polyethylene Di Nima purity (ultra-high-molecular-weight-polyethylene Dyneema Purity；UHMWPE Dyneema Purity) be made) be used to lift the ring.

The state according to as some embodiments of the present invention, in the phase of the implantation process of the vertebral pedicle bolt structure Between, multiple specific purpose tools are used.This instrument can be used in pedicle screw insertion and/or multiple suppression means and/or configuration And/or locking.

Some embodiments of the present invention are pointed out, the screw are threaded into its " rotation spiral shell (tulip) " in the lump described It is in order to promote the combination of multiple components during the process, and when reducing operation as the ability of single piece in bone Between.In one embodiment, a pedicle screw, such as multi-axial screws with a spherical head, are presented to use an axle Ring and/or locking ring are come the user that combines；Be installed in a predetermined induction system, using be intended to position it is one basic, The ring at non-final position.In an example, the ring is pre-positioned on the screw.In an embodiment In, other and/or additional assemblies are with the multi-axial screws and be provided and be combined to the screw and/or installed in the conveying In system, such as class rotation spiral shell component, one/multiple adapters, extra ring and/or other assemblies.Selection, the conveying System is not only considered as a screwdriver of the insertion for allowing pedicle screw to combine, and also locks implant assembly in next stage (screw and rod member), such as by removing the suppression ring to its final, latched position.

Some embodiments of the present invention are pointed out, connect the ability of the rod member and the screw, and the screw has With " the rotation spiral shell " connect the rod member with as single element (for example by combine in advance the collar the rod member it On, the function of the secondary combination of the rod member and collar can be used as single element), it is to promote during the process Multiple component combinations and reduction operating time.In one embodiment, the collar being placed on the rod member and/or multiple suppressions Means (ring for for example defining central shaft corresponding with the rod member axle) processed are connected with a non-locked position, the use of selection One keeps the help of equipment.Selection, it is this to keep equipment also to use one of the locking ring in the early stage, such as on the collar The non-final locking of straining element.Extra or replacement, the holding device configuration is into the fastening straining element described in Its final, locking position of collar.

In certain embodiments, it is connected more than a rotation spiral shell with the rod member, for example, revolves the number that spiral shell is connected with the rod member It is coincident with the number for the screw for being intended to be connected with rod member.In one embodiment, only described collar is combined in the rod member in advance On, and ring position is on the screw.

It is emphasized that being set as described herein for connection and one pedicle screw of locking and the multiple of a rod member Standby and multiple methods can also be used using the change needed, to reach two implantation rod members of lateral connection and locking.

Some embodiments of the present invention point out, the method for extracting skeleton implant, such as a pedicle screw-rod part knot Structure.

In certain embodiments, the composite skeleton implant is made of using compressing and forming process.According to some Embodiment, equipment is by pre-preg (preimpregnation) adhesive tape of carbon fiber reinforcement polyether-ether-ketone forms come construction.Selection, it is molded it Afterwards, the equipment is worked into its final design and/or shape.

In one embodiment of this invention, a screw, such as a pedicle screw, are formed, for example carbon with a composite Fibrous reinforcement polyether-ether-ketone.In one embodiment, using compression forming, a rod member or other elongated forms are by a polymer The pre- treated tape of the longitudinal strengthening fiber of Medium Culture is made.It is processed after the rod member, to create the configuration of the needs And the screw thread of the screw.

In another embodiment, the screw, the screw thread comprising it is to use compressing and forming process, gathered by fibrous reinforcement The pre- treated tape of compound is made.During the technique, in heating and the pressure in the mould configured with the screw When, the material is by the pressing (such as parallel to the fiber and equipment major axis) of axial direction, so as to create multiple gauffers described thin In long filiform and the material is forced to obtain the shape of the screw thread located around the mould.

In another embodiment of the invention, the screw includes, e.g. the longitudinal core of the one of carbon fiber reinforcement polymer The heart, and further comprise that the wheel for example wound with triangular cross-section is wealthy, the profile creates the spiral shell around the core Line.

Selection, screw is produced by a combination of the multiple method described herein realizing.

According to some embodiments of the present invention, a thin shell covers a part for a screw, a such as composite screw The threaded portion, such as a pedicle screw.In one embodiment, the thin-layer coating is a sheet metal, e.g. one Titanium thin slice.Manufacturing the screw of this coating can carry out in various ways, comprising：

(1) in certain embodiments, a composite bone screw (example is manufactured with one or more method described hereins As using include screw thread form a mould compression forming, post-processing be made the screw thread；And/or use includes spiral shell The compression forming of one mould of line shape, using being compressed axially).Replace, the composite bone with a non-threaded bar portion Bone screw is, to build, and not process after shaping using the mould for not including a screw thread form.

(2) in certain embodiments, with single screw tooth (or more) a sheet metal of a width used. In some embodiments, the sheet metal is forced to accommodate one " tooth " (or multiple teeth, according to its width) of Similar size Shape, and be designed to the shape of the screw tooth, such as using special mandrel and pulley.

(3) in certain embodiments, the sheet metal (such as preforming sheet metal) is positioned or is wrapped in one On the screw thread of composite screw and/or a composite screw point upper (such as section above of a unthreaded shank Fall described in (1)), with formed with the screw thread identical size and size geometry a shell (also not with The mode connects for screw).Selection, the sheet metal is wrapped in the composite material presoaked adhesive tape of appropriate size and volume with shape Into a screw needed.In certain embodiments, the sheet metal position is being intended to be formed the place of the screw thread Upper (such as a selected part of the volume of pre- treated tape).Replace, the sheet metal, which is wrapped in have, is same as institute State on the special equipment of size one (such as a mandrel) of the threaded portion of screw, and afterwards laser welding to form the screw One shell of the shape of threaded portion；Afterwards, the shell on a composite screw or a composite screw one without spiral shell Screw thread is formed on line handle portion (as described in preceding paragraphs (1)), or in the composite material presoaked of suitable size and volume The screw needed on adhesive tape with formation one.

(4) in certain embodiments, screw (having none screw thread) the experience compression forming of the coating.Selection, at this Stage, the shell and the mode connects for screw, and if using a unthreaded shank, while manufacturing a composite wood when being compressed axially Expect screw thread.It is extra and/or replacement, biocompatibility bonding means are added, for example, are implanted into the resin or silicon compound of grade, To further confirm that the firm connection of the housing and the screw.Selection, low-energy laser welding titanium layer can complete pressure Shorten implementation after type into.

In an alternative embodiment, the shell of the screw thread is made in compressing and forming process, without undergoing Previous processing.In this embodiment, the shell, e.g. a sheet metal or light wall pipe are selective with I, II and V grades of titanium systems Into being placed on the shank of the screw of composite non-threaded, the screw of the composite non-threaded is using pressure The type of shortening into carrys out construction and formed.The thickness of the sheet metal/pipe can be 4-5 microns, selective, and scope is in 1-200 millis Between rice, such as 10-50 millimeters, 2-9 millimeters, 70-90 millimeters or middle, larger or smaller of scope.In certain embodiments, Axial compression, institute under pressure and heating (such as 400 DEG C or higher) after the screw and shell of the non-threaded in a mould Stating mould has the configuration of the threaded screw.The fact that carry out the technique under heating increases the extension of the shell material, So as to promote its " plastotype again " to the screw thread arrangement needed.Archive of were published in 2007 according to Tan MJ Materials Science and Engineering, Vol.28, p.5-11 in " Microstructure evolution Of CP titanium during high temperature deformation ", according to strain rate, CP titanium alloys are 600 DEG C or 700 DEG C at can obtain almost 200% maximum extension.

In another embodiment, for example it is described without being compromised by for the higher extension for providing the shell material Multiple properties of composite structure, a sheet metal or a light wall pipe are placed on a unthreaded shank of a screw point, with It may be handled as an imaginary part, and afterwards.The settable screw is by can be in the mould configured with a screw The material of experience compression forming is made under high temperature (such as 600 DEG C and more) in tool.In certain embodiments, with being compressed into Type, removes the core of the screw of the coating, leaves a screw thread shell.In this stage, the shell is placed to a composite spiral shell On nail and the coating screw meet with suitable for the composite compression forming.Extra or replacement, addition is biological Compatible bonding means, for example, be implanted into grade resins or silicon compound, to further ensure that the firm of the shell and the screw Connection.Selection, low-energy laser welds the titanium layer and can carried out after compression forming is completed.

In another embodiment, the shell used in the coating is manufactured using superplastic formation.In this embodiment, The shell, the thin plate or pipe being for example made up of titanium alloy (such as Ti-6Al-4V), is placed in a mould, the mould The form of screw thread arrangement containing the needs.Internal pressure (for example using) is placed on the plate or in the pipe It is interior, relative to the mould, in the environment (such as in vacuum, in an oxygen-free environment) of a control, and in (such as 850 DEG C of grade ) high temperature.In this stage, the shell of the formation is placed on a composite screw and the coating screw is being suitably employed in Compression forming is undergone at a temperature of stating composite.It is extra and/or replacement, bio-compatible bonding means are added, for example The resin or silicon compound of level are implanted into, to further confirm that the firm connection of the shell and the screw.Selectivity, low energy Laser welding titanium layer can be carried out after compression forming is completed.

In one embodiment, the sheet metal includes a coarse and/or textured inner surface, such as using sandblasting or Chemical technology is reached, for example, stick together effect in compression forming for the sheet metal to strengthen the composite.

In some embodiments of the invention, the vertebral pedicle bolt structure includes a high degree of rigidity rod member, such as a gold medal Category rod member, the rod member being for example made up of the titanium alloy of CP titaniums or such as Ti-6Al-4V, and/or by containing with higher fiber volume The rod member that the fibrous reinforcement polymer of amount is made, for example, at least 55% CFR-PEEK.In certain embodiments, the rigidity Rod member fixes the motion of the spinal segment of the treatment, fixes the vertebra relative to each other when locking the multiple component, example Such as during performing the operation.

For multiple embodiments, wherein the structure includes the metal rod of a metal rod or a part, it is worth mentioning , when the rod member is positioned at for the certain distance on the treatment section (for example backward), may go out during being imaged Existing multiple artifacts may be generally without interference with the bone and/or tissue for watching the treatment.

Replace, in certain embodiments, the structure includes a less rigid rod member, and there is provided the treatment spinal segment Dynamic stability.An one less rigid potential advantages are can be comprising the pressure reduced in neighbouring interverbebral disc and Minor articulus. Reduced by a less rigid bar pressure another potential advantages can be included in fusion during increase bone growth Speed.

In certain embodiments, a less rigid bar includes：One polymer, such as PEEK；One rod member, by with one compared with The CFR-PEEK of low volume fibres in amounts (such as 30% fiber) is made；One rod member, with a CFR-PEEK cores and PEEK outside Shell；One rod member, with PEEK cores and CFR-PEEK shells；The CFR-PEEK of a braiding rod member；And/or other materials component, The rod member is given for providing some flexibility.Used in the other materials and/or design for manufacturing semi-rigid rod member, and/or it is any on State and mention the combination used in the option for manufacturing this rod member also within protection scope of the present invention.

It is to be noted that also including the above-mentioned side used in screw and coating screw manufacture in some embodiments of the invention The combination of method.

It is emphasized that the coating method is not limited to multiple screws or multiple composites, and it is every to apply to coating Individual material, the material may be applied in above-mentioned multiple methods.

It is further noted that, the one or more components of the vertebral pedicle bolt structure can be used in other application, for example A kind of multipurpose skeletal fixation screw can be used into the vertebral pedicle bolt structure.

In certain embodiments, the structure or its one or more component be used in treatment it is acute and/or it is chronic not Stable and/or deformity of spine, including but not limited to degenerative disc disease, lumber spondylolisthesis, fracture, dislocation, spinal canal stenosis, backbone Lateral bending, scheuermann kyphosis, ithylordosis, tumor of spine and/or pseudarthrosis are formed.In certain embodiments, the structure or one Or more component be employed as a kind of auxiliary of fusion.In certain embodiments, using the structure or its is one or more Component is without spinal fusion.In certain embodiments, the structure or its one or more component are used collapses vertebra in treatment Bone, recess vertebra, damaged vertebrae (such as the result and/or a such as tumour of wound) and/or other spinal applications.

It is noted that such as in the multiple term " neighbouring vertebra (adjacent disclosed herein Vertebrae) " and/or " adjacent vertebra (neighboring vertebrae) ", may refer to be intended to by the structure come Two or more vertebras being connected to each other, and need not be vertebra anatomically located adjacent one another.In certain embodiments, it is described Multiple terms " neighbouring vertebra (adjacent vertebrae) " and/or " adjacent vertebra (neighboring Vertebrae vertebra anatomically located adjacent one another) " is referred to.

Before at least embodiment of the detailed description present invention, it should be appreciated that the present invention is not required to be limited in it Multiple methods of elaboration in being applied to the arrangement of the details of structure and the multiple component and/or being described below and/or The explanation of the accompanying drawing and/or the multiple example.The present invention can have other embodiment or carry out in a variety of ways or real Trample.

Referring now to Fig. 1, Fig. 1 illustrates an exemplary multi-axis vertebral pedicle bolt structure 10 according to some embodiments of the invention, Including：Two pedicle screws 12 and 14；One rod member 16；And include multiple suppression means of multiple collars 18 and 20；And multiple locks Determine ring 26 and 28.Multiple components of the structure be by it is following be made or comprising：One or more composite (such as carbon fibers Reinforcement polyether-ether-ketone), metal (such as titanium), other polymeric materials and/or its any combination.In certain embodiments, it is actual On, two screw 12 with 14 be it is vertical imported into two pedicles of vertebral arch of adjacent vertebrae (such as waist or thoracic vertebral), Two screw 12 is with 14 on phase homonymy, such as described phase homonymy is relative to the major axis of the spinal cord.In some embodiments In, it is locked to the screw 12 and 14 with 28 come couple rod member 16 and selectivity using collar 18 and 20 and ring 26.

The exemplary collar 18 in figure is made up of with 20 two same components 22 with 24.Replace, at some In embodiment, a collar includes more than two components, such as 3,4,5 components.In certain embodiments, the multiple component is Differ, and formed with a different shape and/or size.In certain embodiments, the collar component is complete each other with shape It is generally columnar structured into one.In certain embodiments, that complete time of the multiple component is to form a cone knot substantially Structure, is, for example, to be upwardly formed pointed cone in a far end party.It is extra or replacement, when the multiple component or its some for example By the locking ring 26 and 28 come close to each other, to obtain a conical structure.

In certain embodiments, a similar structure is implanted on the opposite side.

Fig. 2 illustrates the component of a pedicle screw 30 (figure of a vertebral pedicle bolt structure according to some embodiments of the invention 1).In certain embodiments, screw 30 includes spherical (or Part-spherical) head 32, configures the near-end in the screw Place.Replace, the screw head is molded with other configurations, a such as hexagonal head, square head portion, a rounded nose Portion and/or any other configuration.In certain embodiments, screw 30 includes a shank 34.Selection, at least the one of shank 34 Part is threaded.In certain embodiments, shank 34 extend in the screw a neck 36 and the screw it is one remote Between tip 38, the neck is coupled between head 32 and shank 34.In certain embodiments, neck 36 is not threaded 's.Replace, neck 36 is threaded at least in part.

In certain embodiments, screw 30 be by it is following be made or including：One or more composites, multiple metals or One is combined.

In certain embodiments, screw 30 is orientable relative to the collar, and it is accommodated in the collar, example Before the structure as described in locking, the screw head is pivotable in the collar hole.Selectivity, the edge of screw 30 The major axis of the collar one continues and extended.Replace, screw 30 relative to an angle of the collar to extend.Example It is 10 degree, 20 degree, 50 degree, 60 degree or middle, larger, smaller angle such as relative to the collar, to obtain the implantation vertebral arch One in root needs angle.One potential advantages on one ball screw head 32 can be included：Placed with an angle needed described Screw, such as angle relative to the collar, screw are placed in the collar.One spherical, multiaxis screw it is another One potential advantages can be included：Promote to place a rod member, for example, promoted by changing the collar relative to the positioning of the screw Enter the insertion of the rod member.

In certain embodiments, for example before the structure is locked, the collar is rotatable relative to the screw , such as rotatable and/or otherwise oriented relative to the spiral shell handle 201, it includes shank 34 and/or neck 36.One rotatable collar can provide an advantage and be used in the multiple pedicle screw with an irregular skeleton dissection In multiple situations in multiple bones.In this case, it is probably to be difficult to align the head of screw relative to the collar Portion, the collar is that a configuration of the deployment for passing through the collar in the permission rod member is interior, and the collar is relative to described The rotation of screw can be assisted.

In certain embodiments, screw 30 is inserted and (not illustrated in figure), for example with permit take screw be inserted in a guide wire it On.In certain embodiments, a diameter of the spiral shell handle is changed (such as with the screw thread along the various pieces of the shank The handle a whole diameters or a diameter of the shank without a screw thread).Selection, the spiral shell handle is described in Remote tip 38 and pointed cone, or its part is pointed cone.

In certain embodiments, screw sizes are similar in appearance to the size of commercially available typical pedicle screw, such as a screw Include the model of a diameter (diameter of such as a diameter of the handle with the screw thread or shank without the screw thread) Be trapped among 4.5-8.0 millimeters, a such as proximal end there is a larger diameter to be directed towards the distal end reduce, and a length scope Be 30-65 millimeters (or more) between, used in preceding prominent vertebra.Selection, the screw with reduced size is implanted to one Less vertebra.

The screw thread 36 being shown in figure is only for explanation, and can have different geometries and size.

In certain embodiments, screw 30 includes a radiopaque label.The label can be with variously-shaped (example Such as, screw thread, point, ring, prong or other shapes) and/or various sizes formed, can be at the various positions of the screw (for example In the distal end of head 32 38 and/or along shank 201) positioning, and may include various materials, such as description specifically described herein.Additionally And/or replacement, a radiopaque powder (or multiple particles) is added to the screw, such as described herein.

In certain embodiments, the screw 30, for example, be made up of composite, is come using a thin layer of different materials Coating, it potentially improves the property needed of the implant and/or its surface (not illustrated in figure), for example, strengthens institute Surface (so that potentially providing extra intensity in the implant), the round and smooth surface, and/or other modes are stated to correct The implant (such as described screw).Selection, the shell only covers a part for the screw 30.In an example, Generally a titanium shell of 1-100 micron thickness covers the threaded portion of the screw 34.Extra or replacement, the shell covers Cover the distal end of the screw 38 and/or the neck of the screw 36.It is to be noted that such shell can be also inserted into screw When in the bone and with being visualized during the operation around screw, while not producing artifact or interference substantially in imaging Radiotherapy.Multiple embodiments on shell material, size and manufacture method are referred in this document slightly before.It should be appreciated that It is that this method is not limited to multiple pedicle screws, but can be also used in the manufacture of other implants, includes various bone spiral shells Nail.

Selectivity, a composite screw, it includes a thin metal-back (such as on its threaded portion), also wrapped Containing a radiopaque label.For example, a line of 0.1-0.35 mm dias, is made up of tantalum, it is, for example, along the screw The near-end, unthreaded portion is incorporated to.It is extra or replacement, the screw (or one part, such as into the ridge The part of vertebra) and/or the shell include radiopaque powder.

In certain embodiments, a diameter on the head of the screw, such as the one of a subsphaeroidal head as described herein The scope of maximum gauge is such as 6 millimeters, 7 millimeters, 8.3 millimeters or middle, larger or smaller diameter between 5-9 millimeters.

Fig. 3 is that a longitudinal direction of the rod member component 42 for illustrating a vertebral pedicle bolt structure according to some embodiments of the invention is cutd open Face (see Fig. 1).In certain embodiments, rod member 42 be by it is following be made or including：One or more composites, Duo Gejin Category, other polymers material or its combination.In certain embodiments, multiple rod member diameters are similar in appearance to other commercially available multiple rod members Diameter, a rod member of such as 4.5-6.5 mm dias, and a diameter are 35-180 millimeters or middle, longer or shorter of length Degree, with used in preceding prominent vertebra.Selection, the rod member with reduced size is used in smaller vertebra.Selection, with large-size A rod member be used in multilayered structure, be for example coupling in more than the multilayered structure between two vertebras.

In certain embodiments, a radiopaque label is added to the rod member 42.Previously it had been described in detail in this document Each in the shape, size, position and/or the material of multiple labels can be used.In an example, rod member 42 is wrapped A tantalum line of 0.10-0.35 mm dias is included, is placed along the longitudinal axis 301 of the rod member.It is extra or replacement, other marks Thing, such as 303, be incorporated in the rod member, such as multiple labels be with multiple lines (for example by multiple lines formed it is many Individual lines) or multiple points (the multiple points for example formed by multiple aculeoluses) pattern be arranged on the rod member 42 opposite end Place.Extra and/or replacement, a radiopaque powder (or multiple particles) is added to the rod member, is such as previously described in detail in this Text.

In certain embodiments, rod member 42 is linear, such as depicted in figure and can be provided and give with this pattern User.Replace, the rod member can be bent come provide give user and/or with a special purpose device provide give the use Family, the special purpose device, selection during performing the operation, need curvature suitable for bending the rod member to one.

In certain embodiments, the rod member is deformed by heating, for example, be described further below (Figure 16 A-16C). Extra or replacement, the rod member is by applying pressure, heat and or deforming suitable for the other method of rod member described in plastotype again

In certain embodiments, during a pedicle screw is implanted into, the rod member should be fixed to the multiple vertebra Pedicle screw.The screw thread mechanism locked for pedicle screw-rod part (for example locks lid with a threaded screw or a screw thread Pattern) shown by prior art., may be less need for this screw thread mechanism when being related to multiple composites.At some In embodiment, due to friction, the multiple component (such as screw and rod member) is kept by the collar.Fig. 4 of lower section And 5 describe non-threaded lock means an example, including a collar and one outside suppress ring.

Fig. 4 illustrates multiple figures of a collar component according to some embodiments of the present invention, illustrates to form described in this example One component of the half part (22 in Fig. 1 and 24) of collar.Perspective view 52, forward sight (inside) Figure 54 and longitudinal profile is presented 56。

In certain embodiments, the collar be by it is following be made or including：One or more composites, multiple metals Or one combination.Selection, the collar includes a radiopaque label.In certain embodiments, in its lower portion Divide 401, the collar encircles the ball screw head.In certain embodiments, the rod member position is in the collar upper Part 403.

According to multiple embodiments on this schema, two collars of identical half part construction one are (for example, be each One complete body is to form a collar, the selective groove having between them.But, it be stressed that the invention is not restricted to This collar design.For example, a collar of additional assemblies, or replace is a unimodule collar, selection in its upper (vertebra Bone) slot at part 403, it can be used as.

The exemplary 2- components collar-collar that reference picture 1 and 4 is presented is configured including a tubular outer, is had A diameter for pointed cone (forming a cone) is formed towards lower (above) part 58 of the collar.In some embodiments In, it is round that the interior surface of each collar half part, which includes a socket 60, selectivity, and position is in the lower end of the component Divide 401.In certain embodiments, the geometry of socket 60 and size match the screw head, for example, match a ball Shape screw head.In certain embodiments, by including match the rod member shape and/or size a geometry and/or Size a, hole of the position at the upper part 403 of the component configures to accommodate the rod member.In certain embodiments, Position is at the upper (below) end, and the component 52 is terminated with a linear, and selective is smooth surface 64.Selection , surface 64 is flat.Replace, surface 64 is non-flat forms, for example, formed with one or more concave surfaces.In some realities Apply in example, for example, be explained in detail below, during performing the operation, two half parts of the collar are placed to surround the pedicle of vertebral arch screw Nail head, and the screw rod are inserted into the tubulose hole, and the tubulose hole is created by two half parts of the collar Make.

Figure 10 illustrates another design of the collar component (half part) according to some embodiments of the invention.One collar half portion The outside divided is shown in Figure 200 and 202.Figure 20 4 and 204 is shown in inside collar.In certain embodiments, the collar Including the combination of one or more composites, multiple metals or one, and it may include a radiopaque label.In an example In, a tantalum line of 0.1-0.35 mm dias is located at along in place of the axle (such as vertical or horizontal axle) of the collar half part. Selection, a tantalum pin is positioned at the surface of upper (vertebra) of each collar half part.It is extra and/or replacement, one Radiopaque powder (or multiple particles) is added to the collar, for example, previously described in this document.In some embodiments In, each collar half part at the lower part includes：One circular recess 208, including it is dimensioned so as to basis The geometry and multiple sizes on the ball screw head, to encircle the screw head, such as slightly less than described spiral shell Nail head is so that the deformation of the screw head slightly is to be suitable in the recess.In certain embodiments, they relatively on Square part, the collar half part defines a tubulose recess 210, matches the shape and size of the rod member.As for example can be Observed in 204 and 206, the upper recess 210 that the rod member is accommodated in the inside is threaded.In some realities Apply in example, screw thread 212 matches a screw thread (such as following in fig. 11) of (such as complementary) position at the rod member.Selection, The screw thread 212 of the collar recess defines (mother) screw thread in one, and outer (public affairs) screw thread for the rod member is accommodated in described In (mother) screw thread.In certain embodiments, the screw thread of the matching provides geometry locking, such as in the collar and institute State between rod member, so that potentially increase the grip strength of the pedicle screw-rod part structure, such as described axial strength. In certain embodiments, in its outer surface 200 and 202, the collar half part includes a ladder 214, so that relative to it Upper part, reduce the combination at its lower part (in place of the locking ring) collar it is straight Footpath.Selection, when lifting the ring, ladder 214 is as a stop member, to ensure ground that the appropriate position of the ring is specified at it Side.Extra or replacement, the collar half part includes one or more projections, and it is relative to the collar radially towards extension Stretch.Selection, such as during the bolt structure is assembled, the one or more projections avoid described as a stop member The excessive advance of ring in the proximal direction.Selection, the one or more projections avoid the cunning of the relatively described collar of the ring It is dynamic.

Figure 11 A-11F schematically illustrate several configurations of a rod member, the rod member according to some embodiments of the present invention Including：One screw thread, being complementary to the collar internal thread, (such as described screw thread lines the tubulose recess of the collar.Figure 11 A are in An existing linear rod member 220, a length 1101 of single single vertebra degree (two vertebras) is treated with being applicable.Selection, The scope of length 1101 is between 30-55 millimeters.In certain embodiments, rod member 202 includes, respectively in every one end (such as one Near-end and one distal end) place a screw thread 222 and 224.Selection, multiple screw threads 222 include opposite right-hand man's (right hand with 224 Screw thread and Left-hand threads).In certain embodiments, when coupling the rod member and the multiple screw, such as using the collar And locking ring, the rod member can such as rotation be directed to the vertebra of the treatment take to a needs dissection distance and/ Or align relative to each other.A linear rod member 226 is presented in Figure 11 B, with suitable for two vertebra degree (three vertebras) for the treatment of One length 1103.Selection, the scope of length 1103 is between 55-95 millimeters.In certain embodiments, rod member 226 is included in A screw thread at each end 228,230 and the additional thread at rod member center 323.

Figure 11 C and 11D illustrate two curved bars 234 and 240, respectively with length 1105 and 1107, and one is corresponded to respectively Individual one way degree (single level) and round trip degree (two-level) operation.Selection, the scope of length 1105 is in 30- Between 55 millimeters.Selection, the scope of length 1107 is between 55-95 millimeters.In certain embodiments, one or more screw threads Part 236,238,242,244 and 246 is also bent to certain curvature.

In certain embodiments, a rod member includes a wire, linear configuration.Replace, a rod member include one or More multi-curvature and/or bending.

In certain embodiments, a rod member is provided as bending, for example, provide and give the user such as a doctor to realize In the process of a predetermined option and installment.Extra or replacement, the rod member is bending and/or otherwise deformed And/or during performing the operation plastotype again, selection according to sufferer dissection and demand.In certain embodiments, the multiple bar Part 234 and 240 bending radius are constant along the whole rod member.In certain embodiments, it is intended to connect two pedicle of vertebral arch screw Described compared with short member 234, two screw threads 236 and 238 included in its multiterminal (such as proximal and distal end) place of nail.In some implementations In example, it is intended to connect the described compared with long pole 240 of three pedicle screws, comprising three screw threads-two screw threads 242 and 244 at it Multiterminal at (such as proximal and distal end), and an additional thread 246 is in its centre.

Extra two curved bars 248 and 256 of the explanations of Figure 11 E and 11, respectively with one one way degree of correspondence and a round trip The length of the operation of degree.In certain embodiments, a rod member is provided as bending.It is extra or replacement, according to the disease Suffer from dissection and demand, the rod member is bending and/or otherwise deformed during performing the operation.

In certain embodiments, it is intended to connect the shorter rod member 248 of two pedicle screws, comprising position at its end Two screw threads 250 and 252.In certain embodiments, it is intended to connect the longer rod member 256 of three pedicle screws, comprising Three screw threads-two screw threads 258 and 260 are at its multiterminal, and an additional thread 262 is in its centre.In some implementations In example, the rod member 248 and 256 bending (such as curvature) are not continuous；In this example, the multiple rod member is multiple Unthreaded portion 254,264 and 266 is bending, while the multiple threaded portion 250,252,258,260 is more straight with 262 Linear.Selection, the one or more parts of the rod member include the one or more other parts relative to the rod member A different curvature (a such as different curvature radius).

Selection, be threaded along other or the extra region and/or section of the rod member.Selection, described one/ The part of multiple screw threads is that big fishery products are less than the multiple threaded portion illustrated in figure.Selectivity, the overall rod member It is threaded.Selectivity, the rod member is with an on-plane surface curvature bending, such as with a three-dimensional arrangement.

Figure 12 illustrates the side view diagram and two profiles 272 and 274 of a vertebral pedicle bolt structure 270.In some embodiments In, structure 270 includes two pedicle screws 276 and 278, an and rod member 280, uses multiple collars 282 and 284 and/or multiple Locking ring 286 and 288 fixes the screw 286 and 288.In certain embodiments, multiple implant assemblies are made up of following Or including：Composite, such as CFR-PEEK.Selection, the implant includes one or more radiopaque labels, example Such as multiple tantalum lines.Selection, the shape of the multiple label is prong shape, point-like and/or other shapes, and is incorporated in institute State in multiple components and/or be installed to the multiple component (not illustrated in figure).In certain embodiments, radiopaque powder It is incorporated in the multiple component.In the example being previously described in Fig. 2, screw 276 includes one spherical (or part ball Shape) head 277；One threaded shanks 290；One non-threaded neck 279, connects the head 277 and the screw thread shank 290；And one far sophisticated 294.In certain embodiments, the screw not include a neck, and the threaded shanks 290 directly with Head 277 is coupled.

The potential advantages of one spherical, multiaxis screw head 277 can be included needs angle to place the screw, example with one An angle of the collar of the inside is such as accommodated in relative to screw.Another potential advantages of one ball screw can be included relative to institute State the ability that screw carrys out locking ring described in spatial orientation.In an example, it is implanted into using the connected locking ring described Screw, the ring is by for example relative to keeping around multiple adapters of the head of screw.Selection, arrived lifting the ring Before one latched position, the ring for example tilts to be positioned with an angle of the longitudinal axis relative to the screw.It is such Positioning can promote to couple the rod member and multiple collars on the screw head, and (the multiple collar is pre-positioned in described On rod member) a combination.

Selectivity, the screw shank is directed towards remote sophisticated 294 pointed cone or its part is pointed cone.

In certain embodiments, screw sizes are similar in appearance to the size of commercially available typical pedicle screw, such as a screw bag Include a diameter of the scope between 4-8.0 millimeters, and scope 30-60 millimeters (or more) between a length, with before Prominent vertebra.Selectivity, the screw with reduced size is implanted in smaller vertebra.

The screw thread being shown in figure is intended merely to explanation, and may have different geometries and size.

In certain embodiments, the threaded portion of the multiple screw 290 and 292, and/or the screw distal end 294 with 296, a thin layer shell can be used to be coated with, selective (such as pure titanium (not illustrated in figure) is made by metal.In some realities Apply in example, depicted such as in section 272, multiple screws 276 and 278 are hollow 298, so that their importing can be led one On lead.In certain embodiments, multiple rod member ends 300 and 302 are threaded (such as respectively with the right hand and left hand spiral shell Line).Selectivity, the screw thread of the rod member matches the collar internal whorl (not illustrated in figure).The rod member and collar Potential advantages of complementary threads can be comprising the axial grip intensity of the structure be increased, such as in the rod member and the axle The intensity of a coupling between ring, the collar avoids movement of the rod member relative to the collar hole (such as axially sliding It is dynamic).Another potential advantages can be comprising enabling the structure to manipulate (such as by threaded or go many of the threaded rod member Individual threaded portion within the collar hole and/or outside, rotate the rod member and decreased or increased with reaching in two spiral shell The distance 1201 between nail).

In some cases, the implant is removed from the body.In certain embodiments, removing the structure can be with One conventional method is carried out, such as being rendered in other pedicle screw systems.In one embodiment of this invention, for removing The method that the one of pedicle screw-rod part structure replaces includes：

The rod member of a, cut-out position between the screw.Selection, the rod member is divided into two or more parts.

One of b, rod portion of the cut-out are counterclockwise relative to a longitudinal axis of the rod member or, in some embodiments In turn clockwise (selectivity manual), so that pedicle screw is screwed out and (such as back-outed) from the bone；Selection, keep The coupling of the suppression between the rod member and collar, and the collar and screw, with allow using the rod member as The screwdriver that the screw is screwed out from the bone.

C, repeat step b for remaining screw, (or under the arrangement including more than two pedicle screws Remaining screw).

Fig. 5 illustrate according to some embodiments of the invention the locking ring of the vertebral pedicle bolt structure several Figure 72, 74 and 76.In certain embodiments, ring 72 is designed to (such as structure and/or be dimensioned to) around the collar and screw Spherical head and suppress the structure action by applying radial inward strength.

In certain embodiments, ring 72 be by it is following be made or including：One or more composites, multiple metals or its One combination.Selection, ring 72 includes a radiopaque label.In an example, a tantalum line of 0.10-0.35 mm dias, (be for example incorporated in the material in and/or install) is positioned along the ring periphery, such as on the outer wall of the ring, described The inwall of ring or within the wall of the ring.It is extra and/or replacement, radiopaque powder (or multiple particles) quilt It is added to the ring, for example, is previously described in this document.

In certain embodiments, the ring has an interior conical shape.As shown in this example, the width of the ring It is not constant (such as being less in the upper part) to spend (wall thickness) 74, causes ring inside diameter 76 towards ring Lower (above) end 78 be pointed cone (reduction).(not illustrated in figure) replaced, the ringwall wall thickness is permanent It is fixed, and inside and out it diameter with same ratio towards lower part pointed cone.Selection, the ring circle Cone-shaped has the angle α that scope is 1-10 degree, such as when the lower end from the upper end of the ring to the ring, The open angle e.g. inside and out the ring between the walls.Angle α can be referred to as the multiple of the ring One of inwall relative to a major axis 501 (such as through a central axle of the inner chamber defined by the ring) of the ring Pointed cone angle, for example in various embodiments, wherein an outer wall of the ring be not parallel to the axis of centres (if for example, The outer wall includes a circular cone and/or " ladder " profile).Selectivity, such as described herein, the ring 72 is the rod member The screw is locked to, to ensure the multiple group of the fixation of structure, such as limitation such as rod member, screw head and/or collar Part is relative to each other and/or relative to the relative motion of the vertebra.

It is to be noted that multiple results of the multiple experiments carried out by inventor show, it is generally many applying During individual load, such as compression load, such as when being applied on a near-end of the collar, multiple vertebral pedicle bolt structures it is described Ring include circular cone ring and 2-4 degree collar (such as the pointed cone angle of described collar and the position of selectivity the outer and inwall it Between one matching opening angle α) do not slide downwards.

Fig. 6 illustrates that a screw inserts instrument 80 according to some embodiments of the invention.In certain embodiments, the insertion work Tool 80 is designed to clamp the screw spherical head 84 and the screw 82 is inserted in (screw-in) described bone.One In a little embodiments, insertion instrument 80 is included in two arcs, class soupspoon shape the multiple element 86 and 88 of its far-end, configuration Carry out the firm clamping screw head 84.In certain embodiments, the distal end of the arch-shaped elements 86 includes having a recess 87, the recess 87 has the geometry and/or size for being complementary to the screw head 84, to be increased by the instrument The chuck strength of the screw.In certain embodiments, position is in its proximal end, and the insertion instrument 80 includes two handles 90 With 92.Selectivity, what handle 90 and 92 was operated respectively carrys out coupling element 88 and 86.In certain embodiments, the handle 90 and 92 relative the opposing party pressed (for example the multiple handle with a scissors-like motion by way of toward each other It is close), as a result closed-loop clamps the screw around the arch-shaped elements 86 and 88 of the screw head.In certain embodiments, It is described to be rotated and as a screwdriver in order to which the screw is inserted the bone.

In certain embodiments, the screw is self tapping (self-tapping), such as including position in the screw One sheared edge corner of far-end or groove (flute).Selection, the tapping screw is inserted into one one pre- in the bone In the hole being first molded.

Figure 13 illustrates another insertion instrument used in a pedicle screw according to some embodiments of the invention.In some implementations In example, insertion instrument 310 is hollow (not illustrated in figure), for example, be transported on a guide wire.In some embodiments, Position includes a ring 312 and the class tong-like component 314 with interior spherical slot 316, quilt in its distal end degree, the instrument 310 It is designed to (shape and/or be dimensioned so as to) around the screw spherical head.Selection, during performing the operation, the screw Head (not illustrated in figure) is positioned in the tong-like slot 316, and the ring 312 in the pincers 314 by hand Dynamic pushing away is remote, with the fixed insertion instrument 310 and the screw.Selection, insertion instrument 310 includes a limiter of moment (not illustrated in figure).Selection, insertion instrument 310 includes a depth gauge (not illustrated in figure), such as described for measuring The degree that screw is come into the vertebra.

According to some embodiments of the invention, subsequent paragraphs illustrate an operation of the pedicle screw system using the discussion An example for process (see Fig. 7 A-7F).

1st, (Fig. 7 A) in certain embodiments, prepares the vertebra 100 of the treatment, such as using the common practice.Institute State in figure, mark the pedicles of vertebrae 102, vertebral body 106 and spinal canal 101.

2nd, in certain embodiments, a passage is created in the pedicles of vertebrae 102, and verifies its integrality, example If common implementation is in this operation.Selectivity, the passage is created by using an awl and one or more probes, To produce by interior pedicle of vertebral arch cancellous bone (not illustrated in figure) to the approach in the vertebral bodies.

3rd, (Fig. 7 B) in certain embodiments, the special insertion instrument of selective use one (for example seeing Fig. 6 and 13) passes through The multiple pedicle screw 104 is imported into the multiple vertebral bodies 106 by the multiple passage.

4th, (Fig. 7 C) in certain embodiments, a specific purpose tool (not illustrated in figure) is using in this stage, to grab simultaneously Locking ring 108 and the collar component 110 and 112 are stated in residence, and dispose the multiple component in correct position, for example, position The collar is enabled it to couple with the screw, and for example the head with the screw is coupled, and/or the collar is positioned at institute State on screw.Selection, the instrument can realize the multiple action (catch and dispose) simultaneously, used in two adjacent spiral shells Nail, such as it is described further herein.Selection, the connecting rod is kept and disposed to connect institute when they are disposed State multiple screws.With the help of this instrument, for example, describe below, the quilt of locking ring 108 and collar component 110 and 112 Correct position is positioned at, the lower part with the collar being positioned on screw head 114.In some realities Apply in example, (such as threaded or other described rod members of positioning are passing through the multiple collar component definition for follow-up rod member storing A tubulose hole 126 within), the instrument (or different instruments for selectivity), which is used to lift the locking ring 108, to be arrived One centre position (such as relative to the screw and/or an axial location of collar) and afterwards to a final position, it is described in Between position and final position correspond respectively to the vertebral pedicle bolt structure multiple components temporary locking and final locking.

5th, (Fig. 7 C) in certain embodiments, such as lower section more detailed description, with the help of the instrument, the locking Ring 108 and multiple collar components 110 and 112 are on place screw head 114.Selection, the collar 110 and 112 Two half parts are placed around the screw head, with the encapsulation of the circular socket 116 and 118 of each collar half part almost The mode of the half of the circular screw head, and the ring 108 is around the collar and the lower portion of screw head 114 Point.In this stage, the lower part 120 of the ring is in the position more than the screw head and collar, such as distal end The distal end for extending beyond the collar so that the length of the ring a part adaptation the circular collar.One In a little embodiments, a slight distance (such as gap) 122 be present in the collar 110 and 112 two components (half part) it Between, to allow its specified location that the rod member is subsequently inserted into the collar upper part.Selection, gap 122 diameter than tubulose hole 126 on width is also narrow, to be accommodated within the hole when it, encapsulation or at least portion The covering rod member divided.Selection, such as during locking, when the collar half part is close toward each other, gap 122 exists Reduced on width, to be enclosed in the rod member in the hole.

6th, (Fig. 7 D) in certain embodiments, is imported in place a rod member 124 in described two uppers adjacent to collar In the tubulose hole 126 at part, described two neighbouring collar positions are in identical backbone side.Selection, distance 122 is enough It is big so that the rod member can be inserted by the near-end gap of the position between multiple components of each collar.Additionally Or replacement, the horizontal insertion tubulose of the rod member is for example passed through by the collar by the threaded rod member one side In hole 126.Selection, the rod member is by a hole of first collar, and passes through the one of second collar afterwards Hole and it is threaded.

7th, (Fig. 7 E) in certain embodiments, the use identical instrument of selection, the slight lifting of the locking ring 108 is arrived On the lower part of the collar, so that the mutual Nie of the collar half part is closed in their front (lower) part. Selection, the opposite segments of the inner surface of the collar half part are contacted with each other, example such as disposed in the screw head on Some.This temporary transient, part and/or reversible locking structure provided.Selection, it is described in this stage Collar is still rotatable on the screw, and such as axial-rotation and the doctor can be realized in the supraspinal final manipulation (such as increase and/or reduce tension force) and so as to adjust the instrument.

8th, (Fig. 7 F) in certain embodiments, when the radiology checking of the satisfied positioning for completing vertebra and instrument, and selection When, the final positioning of multiple components of the vertebral pedicle bolt structure is carried out, by further lifting the ring 108 in place in institute State the final of it on collar and specify place.Selection, ring 108 is thus lifted to a position, wherein the ring maintains the bar Under part 124, such as directly under rod member 124 or in place of having a certain distance with the rod member.Selection, this is also to use The help of the instrument is carried out, to promote the lifting of ring while applying rational load.(the court of the radial direction of locking ring 108 It is interior) the pressing structure is to fix its multiple components, such as by the pressing wall application pressure of the collar in the rod member And/or on screw head, to avoid the rod member and/or screw head from moving, for example, slide axially and/or rotate.Carry Although to be that the ring is not contacted with rod member, it is described it is final locking avoid rod member from moving, such as by applying enough footpaths Their inner surface is pressed relative to the rod member at hole 126 on the collar component to strength, with reduce or Rod member is avoided to move.

9th, extra or replacement, the rod member can be fixed by an extra locked component (not illustrated in figure) or It is further fixed.The latter can be a ring, be placed on the collar on the rod member；Or threaded components (screw/lid), screw in To lock the rod member in correct position.The threaded components of the locking can be another at the collar upper end with position Inner or outer screw thread Nie is closed.

10th, in certain embodiments, the identical step is implemented at the offside of the vertebra, and the operation position Put is closed using conventional method.

For the alternative of the above-mentioned steps of the insertion of pedicle screw, the pedicle screw is inserted into the vertebra Within bone, while the collar and/or the ring or the ring partially surround it.Before screw is imported, the screw, axle Ring and/or locking ring are held togather so that collar and screw head described in the envelope wall of the ring slightly, are with for multiple The grasping of component is also enough reversible manners.Selectivity, the ring is in the lump with reference to the collar and screw.Selectivity , the combination is enough loose axial and/or rotary motions to provide the screw in the collar, until fastening The ring.In certain embodiments, the emerging specific purpose tool of use one is selected, the screw thread is directed in the vertebra (while the collar and/or the ring or its part surround it).If desired, the ring can be pushed away slightly down Dynamic, selective is manual.Extra step is similar in appearance to steps described above.

Figure 14 and 15 schematically illustrates multiple exemplary pedicle screws-rod member knot according to some embodiments of the invention Structure, including the multiple features that can be additionally locked between the construction package.According to some embodiments of the invention, the locking ring (at its final position) around the collar lower part and screw spherical head, and radial direction the pressing collar and Screw head come suppress they movement and the locking structure at a position needed.According to being associated with many of Figure 14 and 15 Individual embodiment, due to the secondary deformation that the composite material assembly can undergo when the ring is radially pressed, and is further able to Lock multiple construction packages.Selection, it is described to deform so that the material of the screw and/or collar and/or rod member enters in institute State multiple spaces between multiple components, the multiple component be intended to by the collar (such as rod member and screw) and the collar come Coupling, it is potential allow (such as multiple walls in the multiple hole) collar to the rod member and screw head one compared with It is fitted close.

Figure 14 illustrates that (part for the only screw is shown in figure to the pedicle screw 322 with spherical head 323 In) and two of the join domain of the rod member part of the rod member (only be shown in figure) with the end of thread 326 Figure 32 0 and 321, the collar being made using a locking ring 328 and by two half parts 330 and 332.Figure 32 0 illustrates multiple groups The structure before part locking：The ring 328 surrounds the pedicle screw neck 3250.Figure 32 1 is illustrated with multiple groups The structure-ring of part locking is elevated and around the collar 330 and 332 and screw head 323.Such as the institute in figure Point out, Figure 32 1 horizontal section 336 be also presented, illustrate the locking ring 328 of " latched position ", collar 330 and 332 and screw head.

In certain embodiments, each of the half part 330 and 332 of the collar includes a slot 324, perpendicular to institute The common plane of rod member and the pedicle screw is stated, positioned at the lower portion for the collar for encircling the screw head 323 Office.Selection, slot 324 extends across a wall of the collar half part.Selection, it is different that slot 324 includes one The shape and/or size illustrated in Yu Tu.For example, the slot is configured including " zigzag " line, definition can be mutually Mutually the multiple collar portions of locking increase stability.Selection, collar half part 330 and 332 including more than a slot and/ Or different slot positions.Selection, collar half part 330 and 332 includes an inner-concave of whole collar wall described in not insertion Mouthful, a recess for example radially from an inside face of the collar wall towards an exterior face of the wall, but does not cross institute State wall.

In certain embodiments, it is (such as upper to reach in the collar with final position of the locking ring 328 to it is lifted The ladder 334 at surrounding), the collar half part 330 (is for example mutually connected with 332 one collars of formation by least part Tactile is close), it is selective with the short space 338 and 340 remained between its multiple half parts.In some implementations In example, when pressing the collar and screw spherical head, the experience that the spherical head 323 can be slight is deformed, and its material Can be slight for example in being projected within the collar slot/recess 324 and 327 shown in 324,344,346 and 348, and/or Within the short space 338 and 340 between collar half part 330 and 332.Selection, into and/or multiple collars The projection 342,344,346 and 348 of the screw head material between half part provides further geometry locking (selection , except friction), therefore increase for the mobile impedance between the multiple component.

Figure 15 increases that schematically explanation one is extra or replacement method is to complete multiple component movements are limited, such as described Movement of the screw head relative to the collar.The brief description of the drawings is with a pedicle screw 354 compared with spherical head 356 The part of the screw (only be shown in a figure) and rod member 358 (the only part of the rod member with the end of thread 360 Be shown in figure) the join domain two Figure 35 0 and 352, using a locking ring 362 and by two half parts 364 with 366 collars being made.Figure 35 0 illustrates the structure before multiple component lockings：The ring 362 surrounds the pedicle of vertebral arch screw Follow closely neck 368.It is elevated and around the collar that Figure 35 2 illustrates the structure-ring 362 locked with multiple components 364 and 366 and screw head 356.It is pointed such as in figure, also present respectively Figure 35 0 and 352 two longitudinal profiles 370 with 372, to illustrate the locking ring 362, collar 364 and 366, and screw head 356, before locking (section 370) and one (transversal 372) (notice that 370 be actually the collar half part 366 in specified location with collar half part 366 to latched position Figure 35 0 section, and for simplicity, do not illustrated in Figure 35 0).

In certain embodiments, screw head is spherical.Replace, screw head 356 is not spherical, or part Spherical.In certain embodiments, pedicle screw head 356 have relatively spherical shape, with along opposing parallel in institute State the diameter of around the screw head of ring 362 376 reduction.In certain embodiments, the screw head can be described as tool Have a substantially rectangular cross-sectional profiles in the middle part on the head, and on the rectangle part and under A circular cross-sectional profile substantially at the proximal and distal part on the head.Selection, it is used as the knot of the reduction diameter 374 Really, before the ring 362 is lifted, the inwall of part and collar of the short space 376 along around screw head 374 is (such as Depicted in 370) exist.Selection, due to applying the radial direction strength by the locking ring 362, its is thus lifted at it Behind final position, the deformation of experience that the collar half part 364 and 366 can be slight so that material slightly be pushed to the sky Between within 376 (as depicted in 372), to provide further geometry locking (selection, except friction), and therefore increase The impedance for being moved between the multiple component, such as by being fitted closer on the screw head.

In one example embodiment of the present invention, screw head 356 is generally only held in the equatorial line around it Frequency band.For example, such frequency band can be (such as perpendicular to the one of the screw body in the screw head equatorial line Plane) on and/or under 15,30,45, a number of degrees of 60 or 80 degree or intermediate number.Selection, this holding is to pass through Screw head 356 is provided, the screw head 356 be included in its this at a radial lift frequency band, a cylindrical section and/or one Or more projection.Selection, screw head 356 has a spherical geometry, except such one lifting frequency band. Selection or replacement, such frequency band is provided as one or more prominent on an inside of collar 364 and 366 Rise.In one example embodiment of the present invention, in such frequency band, with the screw head and the collar it Between the contact between 70 and 90%.In one example embodiment of the present invention, the frequency band is at the arch The lifting between 0.1 and 1.5 millimeter is carried out relative to a surface of the screw head.

In one example embodiment of the present invention, an arcuate segment of the screw head does not connect directly with the collar Touch.Selection, the colored cover of the correspondence arcuate segment includes the shape of a cylindrical shape otch or a different non-arcuate, from And avoid the contact with the screw head.Selection or replacement, the base portion of the screw head is not in contact with, for example because There is no corresponding collar section, to allow the rod member relative to the Articulating of the screw.

In one example embodiment of the present invention, the recess has the larger diameter than the screw head, with Make contact generally only in an equator frequency band for surrounding the recess.

In one example embodiment of the present invention, it is to avoid the contact of the arch of the screw head, because it may not Contribute to the stability of the structure, and the contact being likely to reduced between the other parts of the head of screw and the structure Quality (such as by reducing pressure here).

Fig. 8 A and 8B illustrate the different designs for a pedicle screw and collar respectively.In fig. 8 a, pedicle of vertebral arch screw Nail 130 includes a head assembly 132, the configuration with a ball Allen wrench (ball Allen key).In some implementations In example, the screw shank 134 includes a neck portion, close to the remote tip of the screw head 132, a threaded portion and one (neck, threaded portion and remote tip are not illustrated in figure).In certain embodiments, shank 134 is towards the remote tip It is pointed cone, or its part is pointed cone.Other screw head designs and correlated characteristic, for institute is described in detail State the other embodiment of spherical head screw can also apply here (such as multiple materials, size, coating, the screw its Design of his part etc.).

Fig. 8 B show a collar half portion subassembly 150, and the screw head with Fig. 8 A is mutually compatible.In some embodiments In, collar half portion subassembly 150 includes a socket 152 mutually compatible with the shape of the ball Allen wrench of the screw head. The other assemblies of the vertebral pedicle bolt structure can be similar in appearance to the other assemblies described in previous this document.

The screw head and a potential advantages of the design of collar being for example presented in Fig. 8 A-8B can be included, and work as vertebra Pedicle screw is inserted into there is provided the transfer of improved torque when in the bone, such as in multiple situations, wherein carrying out screw Insertion, while collar and ring (are such as pinioned) with the screws clamp in the lump.

Fig. 9 illustrates a single shaft vertebral pedicle bolt structure 160 according to some embodiments of the invention.Multiple materials and/or multiple Size is similar in appearance to the above-mentioned description for other vertebral pedicle bolt structures.In the example shown herein, the structure bag Include two locking means of two uni-axial screws 162, a rod member 164 and the fixed rod member and the screw.In some embodiments In, the multiple locking means are made up of an adapter 166 and a locking lid 168.In certain embodiments, the uni-axial screws 162 be the component of individual unit, is made up of a head 170, neck 172, a threaded portion 174 and a remote tip 176.At some In embodiment, there is the screw head 170 class to revolve spiral shell shape, open to reach the storing of the rod member 164 backward.Selection , rod member 164 is accommodated within the recess 901 in the class rotation screw head portion.In certain embodiments, the head is included for example The internal thread 178 configured along the multiple wall of recess 901, is compatible to the locking lid screw thread 180.

In certain embodiments, the shank of the screw towards its remote tip be pointed cone.

In certain embodiments, screw 162 is hollow, for example, it can be made to transmit on a guide wire.

In certain embodiments, for example above described herein, the rod member 164 may be provided as arc or straight Linear (not illustrated in figure).Further, as already mentioned it is possible to so as to bend its multiple means in operation to provide State rod member.

In certain embodiments, the locking lid 168 and its adapter 166 provide the fixed rod member to the screw A double component locking mechanism.In certain embodiments, the locking lid 168 includes a screw thread 180, matches the head of screw Portion's internal thread 178.Selection, at its upper (rear end) place, the locking lid includes a socket 182, is configured to accommodate One screwdriver.In certain embodiments, the lower section for the locking lid adapter 166 being placed on the rod member 164 is (preceding Side) part, it is curved to match the post arrangement.Backward, what the lid adapter was selected includes a ring 184, and it is choosing The position selected (can for example provide position at the end of the pedicle screw head 188 within a peripheral groove specified A peripheral notches).

Figure 16 A-16C schematically illustrate according to some embodiments of the invention, such as in order to which the dissection for meeting given patient is needed Will, for bending a device 400 of an implant in operation.Selection, the implant is made up of composite, for example CFR-PEEK.Selection, the implant is a rod member component, a bone plate and/or other implantation for vertebral pedicle bolt structure Portion.In certain embodiments, device 400 includes the fixation kit 402 of a lower, the movable-component 404 of a upper. In some embodiments, the implant, the component to reach are bent by each of the heating-component 402 and 404 Each of 402 and 404 is included for the one of a heating member (multiple heating members are not shown in figure) special place (such as in one Chamber or recess) 406 and 408.In certain embodiments, the upper surface 410 of the component 402 of the fixation is prominent；And The lower part 412 of the movable-component 404 includes a complementary sunk surface.The depression/protrusion surface is with one The radius and/or angle needed is configured, an angle for example relative to each other.Selection, in order to be provided most for each situation Suitable configuration, can replace the multiple surface.Selection, the multiple surface is made up of some sections, each to have one Need the radius needed in plane.This is for example with multiple sufferers of multiple pedicle screws and the treatment of multiple long poles In, it will it is beneficial, for example, treats scoliosis.

In certain embodiments, a special handle (not illustrated in figure) is attached to a screw 413, the special handle with The movable-component 404 is connected.Selection, the operation of the handle promotes the movable-component down in the lower Component.In certain embodiments, for example the dress is manipulated using the structure of a mechanical schemes, a hydraulic pressure mechanism and/or electronic machine Put 400.

In certain embodiments, combined to use described device 400 with two guiding pieces 414, one of them is shown in figure 16C.In certain embodiments, each guiding piece 414 is that a metal assembly (is for example made by such as stainless steel or NiTi (Nitinol) Into it includes a recess) 416, to house the implant.In an example, guiding piece 414 includes a longitudinal direction configuration, has Match the shape of a linear rod member implant and an interior notches of size.In certain embodiments, (for example exist at high temperature During the bending process for the temperature being still below in the range of the one of the fusion temperature of the implantation polymeric material, for example Scope is 200 DEG C -400 DEG C, preferably 250 DEG C -320 DEG C), the multiple guiding piece protects the implant from damage.

In certain embodiments, when actual use, the rod member implant is guided to the recessed of two guiding pieces 414 Within mouth 416, so that the rod member is completely capped, for example, covered by the surrounding guiding piece.Replace, the bar Part is by the multiple guiding piece come the covering of part.Afterwards, in certain embodiments, the guiding piece with the rod member 414 are disposed respectively in, between the fixation of middle described device and movable-component 402 and 404.Selectivity, when The temperature needed is reached, manipulates the handle to press and/or promote the movable-component 404 down.In some embodiments In, during the bending process, the guiding piece also slight modification under heating, such as slight deformation.

Selection, the implantation for having flexible dummy/template using the one of the implant to verify a needs is configured, described Implant can bend and configure (such as shape is designed to and/or deformed) at the sufferer position/on (such as one can Flexible rod member, configuration (such as plastotype and/or other modes adjustment again) type required on the vertebra that the sufferer is related to Formula.Afterwards, in certain embodiments, configuration (such as plastotype and/or other modes adjustment again) template is placed in the dress Put at 400, a dedicated location (compartment of such as described device) for position configuration needed for " reading " for example passes through optics hand Section.Afterwards, in certain embodiments, during the bending process of implantation, device automatically changes implant structure and arrived Required structure, is measured according to the flexible template, such as according to multiple parameters, such as the length of the template of described adjustment, Width, radius of curvature and/or other sizes.In certain embodiments, described device includes a controller.Selectivity, it is described Controller configures to accommodate the multiple parameters of adjusted template, and operation described device, such as relative to the fixation kit To position the movable-component.

In certain embodiments, described device configures to use in a gnotobasis, for example, can be used during performing the operation.Choosing Selecting property, the whole bending apparatus 400 and multiple guiding pieces 414 are provided as sterile, and can be imported into place in institute State the aseptic area in operating room.Replace, the part (such as the multiple guiding piece 414) of only described device is to provide into It is sterile, for example provide and be compatible within one/multiple bag specials of the flexure temperature.This bag can be for example by silicon, PTFE And/or sheet metal is made.Selection, in this example, wherein the part of only described device be provided as it is sterile, it is described Device 400 is placed in outside the aseptic area in the operating room.In the illustrative methods used, described sterile Within the surgeon in region, the guiding sterile ocular insert to the sterile guiding piece, and afterwards the multiple group Within part insertion described one/multiple sterile bags.(within the multiple guiding piece) described aseptic packaging implant is now The nurse of one " non-sterile " is given to, it is dropped it into the bending apparatus.Selectivity, (for example pass through institute after bending State the bending of a rod member of the vertebral pedicle bolt structure of bending apparatus acquisition), described one/multiple bags are unlocked so that described Multiple sterile sets return to the aseptic area, and proceed the operation.

According to some embodiments, illustrate a surgical technique and tools (induction system) 500 referring now to Figure 17 A-17B, its can be used in The multiaxis vertebra that its " rotation spiral shell " (such as collar 504 and 506 and/or multiple suppression means, such as a locking ring 508) is inserted together Pedicle screw 502, and be in order to firm for lifting the ring 508 to its final position after the placement of rod member implant The fixation rod member to the screw.Figure 17 A and 17B, illustrate before the ring 508 is lifted and afterwards described defeated respectively Send system 500.

In Figure 17 A-17B, the induction system 500 for being connected to pedicle screw combination is illustrated.In some embodiments In, the induction system, which is shown, removable is coupled to the screw association.In certain embodiments, the pedicle screw combination Including a polyaxial pedicle screw 502；One collar, is formed by two half parts 504 and 506；And a locking ring 508.Ying Liao Solution, can include different multiple collars/multiple adapters and/or multiple locking rings (such as more than one locking ring；One lock Determine ring, position is different from the position depicted in Figure 17 A-17B one；One class revolves spiral shell component, with a locking ring；One unimodule Collar；Etc.) multiple pedicle screws combination other multiple configurations, also can be similar with described in Figure 17 A-17B Device uses to contrast.In certain embodiments, at least part of the pedicle screw combination is by one or more compound Material is made, for example CFR-PEEK, with the extra material/component for example described in the whole text in this document, such as radiopaque Label and/or radiopaque powder/granule and/or coating/shell, etc..In certain embodiments, the portion of the multiple component Point (such as some of some and/or its multiple component in multiple components of described combination) can be made of metal, for example Titanium/titanium alloy.In certain embodiments, the size of multiple implant assemblies is also similar to previously herein for similar component Description.

In certain embodiments, the induction system 500 is made up of several components：

(a) body 510, encircles upper (dorsal part) end of the multiple collar half part 504 and 506.In detail in this figure In the example illustrated, the body has a hollow circle tube, is included in some embodiments：One recess, distal part of the position at it；And One slot, close end of the position at it.In certain embodiments, the body 510 includes one or more various bio-compatibles The metal of material, preferably such as stainless steel；

(b) distance piece 513, be positioned within the recess 512 and protrude from the collar half part 504 and 506 it Between (for example extend the gap in place between the collar half part) to maintain position certain between the multiple half part Adopted space, the rod member implant will be positioned and/or be transported in the multiple half part or by the multiple half portion Point.In certain embodiments, the distance piece includes one or more various bio-compatible materials, includes multiple polymer And/or multiple metals；

(c) rope 518, position (the direction locking ring of such as distal end) and is intended under the locking ring 508 The ring 508 is lifted on the collar 504 and 506 and screw spherical head, as described below.The rope can include several 520 centres in the rope of the circle of circle-one, position is under the ring 508 and around the pedicle screw 502 Shank；And two circles 522 and 524, position is screwed in the multiple of a horizontal bars 526 at the multiple rope ends On end, it is position within the slot 514 of the apparatus body 510.Selection, circle 520 is by being substantially parallel to lock Determine a plane defined in ring 508 to position and the extension of multiple circles 522 and 524 is generally with respect to the ring On the horizontal direction of the plane of definition.In certain embodiments, the rope includes one or more with enough tensile strength Individual bio-compatible fibrous material, such as UHMWPE (such as enlightening Buddhist nun code).Selection, the bio-compatible material is with various sides The woven or knitting of formula is made.

(d) it is used for pulling the rope ends and therefore lifts a mechanism of the ring 508.In certain embodiments, it is described Multiple mechanical means, multiple hydraulic pressure means, multiple electronicallies etc. can be used in mechanism.In the example illustrated in figure, position is in institute State the rope 522 and 524 at multiple ends of rope 518 to be placed on multiple ends of horizontal cord lock 526, it is delivered in Within the apparatus slot 514.In certain embodiments, the rod member 526 is connected with another internal rod 528, described interior Portion's rod member 528 is perpendicular with the horizontal bars 526 within the apparatus body 510.In certain embodiments, it is described Internal rod 528 is connected with a handle (not illustrated in figure), such as using a screw thread 530.Selection, it is provided separately described hold The grip assembly is connected component, and during operation is to the induction system 500.

Figure 17 A illustrate combined with pedicle screw connection one described in induction system 500, give the user as offer, Such as described doctor.Selection, the structure is provided as sterile.In exemplary configuration described in Figure 17 A, the lock Determine 508, ring slightly to loosen in main, non-final locking a position, and the cord lock 518.Selection, each axle Ring half point 504 and 506 includes a groove (not illustrated in figure), and the ring 508 is to depend on the groove (such as to remote Side) position.Selection, the rope 518 is provided as the advance load with less strength, to avoid the ring 508 from gliding, It may cause the decomposition of the collar 504 and 506.Selection, in order to maintain the rope light tension, the equipment sheet Body 510 includes a spring (not illustrated in figure).Selection, the spring is coupled with the rope, and configures described to pull At least a portion of rope maintains some tension of the rope.

Subsequent paragraphs describe an example of a surgical procedure, and the surgical procedure includes some realities according to Figure 17 A-17B Apply the one or more components of example.In certain embodiments, in for example common implementation in multiple pedicle screw implant surgeries After the preparation of the bone, multiple pedicle screws are directed to-four pedicles of vertebral arch within multiple pedicles of vertebral arch of adjacent vertebrae Screw is directed within multiple pedicles of vertebral arch of two vertebras.

In certain embodiments, each pedicle screw 502 is provided as and two collar half parts 504 and 506 and one Locking ring 508 is combined, and each pedicle screw 502 is arranged in an induction system 500.Selection, the induction system 500 is What is be intended for single use abandons equipment.During performing the operation, the induction system 500 is special with one for example by a screw thread 530 Handle (handle (multi-use handle) is used for multiple times in selective one) is attached.In certain embodiments, select Property the induction system 500 that is connected with a handle can be used in will (have collar 504,506 and ring 508) described pedicle of vertebral arch screw Nail 502 is screwed in the bone.Selection, in this position, the ring 508 keeps the two collars half part 504 and 506 Enough openings, such as at a position, wherein with enough big gap digits between the collar half part, so that institute Stating rod member implant can subsequently imported within the specified recess 532 of the collar 504 and 506 ((such as by by institute State the collar half part close recess to define toward each other), such as further described in Figure 17 B)；And provide in institute Enough frictions between screw head and the collar half part 504 and 406 are stated, so that the screw 502 can be screwed into Within the bone, at the same the equipment room spacing body 516 maintain between the two collars half part 504 and 506 it is one appropriate Distance (being for example enough in the distance for importing the rod member).It is to be noted that the friction is (such as by position described many The friction that the ring on multiple outer surfaces of individual collar half part applies) it is still enough low so that the screw " rotation spiral shell " being capable of multiaxis movement.

In certain embodiments, it is described whole in order to which the pedicle screw 502 is inserted within (screw-in) described bone Device (induction system being connected with a handle) is rotated.Selection, the connection of the handle is disconnected afterwards, is left and the vertebra The induction system 500 of pedicle screw combination connection.It is to be noted that the induction system 500 can be it is hollow (figure In do not illustrate), and therefore can use on a guide wire.Selection, induction system 500 includes a limiter of moment and/or one Depth gauge (is not illustrated) in figure, can be used when importing pedicle screw.

In certain embodiments, extra pedicle screw combination, such as three extra screw associations, selectivity are imported Use identical process or some of step, ((by using their collar 504 and 506 and multiple locking rings 508) so that The one of four pedicle screws 505 is overall to be implanted, and each is connected with an induction system 500, depicted in such as Figure 17).It Afterwards, the gap part 516 is removed (such as by being pulled away) from two structures, and disposes the rod member implant and (such as existed Pointed by the 534 of Figure 17 B), with two pedicle screws 502 of link of longitudinal direction.As alluded to earlier, the implant assembly is set Meter make the screw " rotation spiral shell " can multiaxis movement, to promote the storing of the rod member.In certain embodiments, by the rod member Position is inserted in its specified recess between the collar half part 504 and 506, described in apparatus body 510 Recess 512.

It is to be noted that can use other full dog point socket set bottle openers that the pedicle screw is combined insertion, such as it is interior Hexagon wrench, so that the screw is screwed in the bone.

In certain embodiments, in this stage, the checking of the implant being adapted to and vertebra positioning is carried out.If described hold It is selective that it is reconnected with the induction system 500 being disconnected before, so that the rod member and the spiral shell Nail can be locked, depicted in such as Figure 17 B.

Referring now to Figure 17 B, illustrate the conveying after the final locking of the rod member 534 and the screw 502 System 500 and implant.It can be appreciated that the locking ring 508 is thus lifted to its final latched position, around the spiral shell Follow closely the lower part of spherical head and the collar 504 and 506, position in the underface of the rod member 534 (for example distally ).In certain embodiments, the ring 502- selectivity is lifted using the induction system 500, manipulates the handle (example Such as turning clockwise for a T-shaped handle) vertical member 528 and horizontal bars 526 are lifted (such as due in vertical member A coupling between 528 and vertical member 526), this pulls the rope 518 to lift the ring in turn.As painted in figure Show, the rope 518 is to tense in this configuration.As alluded to earlier, with the change of needs, it is possible to use described defeated System 500 is sent, with other pedicle screw Combination Designs.For example, during pedicle screw is inserted into the bone, Installed in a locking ring of the induction system 500, holding position is in the induction system (such as with the induction system coupling Close)；Afterwards, using the induction system, the ring position is on the upper part that the pedicle screw is combined, and position is in institute State on rod member, with the fixed rod member and the screw.Selection, suppress ring multiple implantation are firmly fixed using two Component, one be placed on the rod member implant-and another under the rod member implant.

In certain embodiments, in order to connect and lock the rod member and the multiple screw at offside, carry out identical Stage or some stages.Selection, after the confirmation of final fluoroscopy, four induction systems 500 are planted from described Enter thing to disconnect.The multiple rope can be for example removed using a scalpel.

Figure 18 A-18B illustrate another design for being used in a polyaxial pedicle screw structure 600, bag according to some embodiments Include a pedicle screw 602；One rod member 604；And multiple suppression means comprising a collar, the collar includes two half parts 606 and 608；One lower locking ring 610；And a upper locking ring 612.Figure 18 A illustrate many with what is locked together The combining structure 600 of individual component, while for simplicity, Figure 18 B show the multiple of the structure that does not combine Component (explosive view).

In certain embodiments, in actual use, two screws 602 are directed within two pedicles of vertebral arch of adjacent vertebrae (such as waist or thoracic vertebral), on phase homonymy.In certain embodiments, by using a collar 606 and 608 and/or many Individual locking ring 610 and 612 a, rod member 604 is connected and locked with the multiple screw 602.Selection, a similar structure is implanted On offside.

In certain embodiments, the one or more components of the structure 600 are that (such as CFR- is made by composite PEEK), multiple metals (such as titanium), other polymers material and/or its any combination.As this document in the whole text described in it is extra Multiple materials/multiple components, such as radiopaque label and/or radiopaque powder/granule and/or coating/shell, etc., It can be incorporated into that in multiple implant components.In certain embodiments, multiple sizes of multiple implant assemblies are also similar to elder generation The preceding multiple sizes described in this document for similar component.

In certain embodiments, the component of pedicle screw 602 includes：One spherical (or Part-spherical) head 614；One Threaded shanks 616；One non-threaded neck 618, connects the head 614 and the threaded shanks 616；And one far sophisticated 620. In some embodiments, screw 602 is hollow, for example, allow screw to be inserted on a guide wire.In certain embodiments, along The screw shank of the various pieces of the shank a diameter (such as an integral diameter of the shank with the screw thread, Or a diameter of the shank without a screw thread) be changed.Selection, the screw shank is towards described remote by sophisticated 620 It is pointed cone or its part is pointed cone.

In certain embodiments, such as the rod member component 604 is linear, depicted in figure, and can be with this sample Formula provides and gives user.Replace, during performing the operation, the rod member has bent and/or bent to one and need curvature, The special purpose device of use one of selection reaches member bending, (Figure 16 A-16C) as described above.

In certain embodiments, during implantation vertebral pedicle bolt structure 600, the rod member 604 should be with the multiple vertebra Pedicle screw 602 is fixed.According to some embodiments of the invention, a locking piece of selective non-threaded, be by：One collar, by two Individual half part 606 and 608 is constituted；And two external locking collar 610 constituted with 612.In certain embodiments, position at them most Final position puts the multiple ring 610 and 612 at place, is designed to suppress the structure motion, such as by applying radially towards internal force Measure and/or by bending the multiple component in the lump.

In certain embodiments, including two half parts 606 and 608 the combination collar, in its lower part Place encircles the spherical head 614 of the screw 602；The rod member 604 is at the collar upper part.According to being associated with Some embodiments of accompanying drawing, two identical collars of 606 and 608 construction of half part one.But, it be stressed that the invention is not restricted to This collar design.A collar of multiple additional assemblies can also for example be used；Or the half part differed；Or a unimodule axle Ring, is recessed at its upper or lower part.In certain embodiments, there is the collar relative tubular outer to match somebody with somebody Put.The collar half part 606 includes with each of 608：Two interior notches：One circular recess 622, position is in lower point At part, for the screw head 614；And a tubulose hole 624, position is at upper part, for the rod member 604. Selection, when the half part is close toward each other, relative one first hole of recess formation, the screw head is held It is contained in first hole.Selection, one or two recess includes a non-round and smooth interior surface, to provide further locking institute State multiple components.In certain embodiments, if one arc-shaped rod 604 of implantation, the rod member 604 is forced to the collar half portion Within the tubulose hole divided.Replace, bend the interior tubulose hole of the collar half part, to promote to put an arc-shaped rod (not illustrated in figure).In another embodiment, if using an arc-shaped rod, an insert is placed in the tubulose of the collar Within hole；The insert has：One outer tubular is configured, and matches the collar tubulose hole；And internal arc inner chamber (example Such as there is the shape of a class banana), match the arc configuration of the rod member.

In certain embodiments, an outer surface of the collar 606 and 608 includes two ladders, so that in it The outer dia of the collar at 626 is entreated to be more than the axle of the position at its lower part 228 and its upper part 630 The outer dia of ring.Selection, a cylindrical portion of the collar is formed with a larger diameter.It is extra or replacement, The collar includes one or more projections, with respect to the extension of other collar portions radially.The multiple ladder and/or compared with One potential advantages of diameter portion and/or projection can place two locking rings 610 and 612 comprising promotion：It is described relatively under Square (at its final latched position) position of ring 610 is in the lower part around the spherical head 614 and the collar 628 Part, under the rod member 604；And (at its final latched position) position of upper ring 612 is around the axle In place of the upper part of ring 630, on the rod member 604.Another potential advantages can include the axle for avoiding the multiple ring To slip.Selection, one or two locking ring 610 and 612 includes internal and/or outer conical shape.It is to be noted that having Only stop a similar Design of a locking ring, position is in place of more than the rod member implant (such as below the rod member implant Or away from rod member implant) or replace, it is also within protection scope of the present invention on the rod member component.

In one embodiment, the pedicle screw 602, which can be provided, gives using collar half part 606 and 608 and uses institute The user that the locking ring 610 of lower is combined is stated, so that 610, the ring is relative to its final latched position It is similar to the multiple embodiments described in Figure 17 A and 17B at one lower position.The pedicle screw combination can be provided Specified into installed in (such as similar in appearance in Figure 17-17B and/or 20A-20D descriptions) one in induction system, can both be used in and insert Enter, such as, by the way that pedicle screw 602 is screwed in the vertebral bones, the lifting lower ring 610 can be used in again and arrives it Final latched position.In certain embodiments, after placing the rod member 604 and lifting the lower locking ring 610, The induction system can also include the upper locking ring 612, be deployed to its locking bit on the rod member 604 Put, wherein it is around the upper part of the collar 630.

Figure 19 A-19B illustrate another design of a polyaxial pedicle screw structure 700 according to some embodiments of the invention. Figure 19 A illustrate a longitudinal profile of the structure 700.Figure 19 B illustrate the uncombined component of the structure 700.In some implementations In example, the polyaxial pedicle screw structure 700 includes a pedicle screw 702；One rod member 704；And multiple suppression means, bag Containing multiple adapters 706 and 708；One collar 710；And a locking ring 712.

In certain embodiments, multiple components of the structure 700 include one or more composites (such as CFR- PEEK), multiple metals (such as titanium), other polymers material and/or its any combination.As this document in the whole text described in it is extra Multiple materials/multiple components, such as radiopaque label and/or radiopaque powder/granule and/or coating/shell, etc., It can be incorporated into that in multiple implant components.In certain embodiments, multiple sizes of multiple implant assemblies are also similar to elder generation The preceding multiple sizes described in this document for similar component.

In certain embodiments, pedicle screw 702 includes spherical (or Part-spherical) head 714；One threaded shanks 718；One non-threaded neck 716, connects the head 714 and the threaded shanks 718；And one far sophisticated 720.In some implementations In example, screw 702 is hollow, such as to allow screw to be inserted on a guide wire.In certain embodiments, along described An a diameter (such as integral diameter of the shank with the screw thread, or do not have for the screw shank of the various pieces of shank Have a diameter of the shank of a screw thread) it is changed.Selection, the screw shank is point towards described remote sophisticated 720 Be tapered or its part is pointed cone.

In certain embodiments, such as the rod member component 704 is linear, depicted in figure, and can be with this sample Formula provides and gives user.Replace, the rod member can be that the offer bent gives the user and/or uses a special purpose device Give the user to provide, the special purpose device be applied to bent during performing the operation the rod member to one need curvature, as above (Figure 16 A-16C).

In certain embodiments, during implantation vertebral pedicle bolt structure 700, the rod member 704 and the multiple vertebral arch Root screw 702 is fixed.According to some embodiments of the invention, a selective non-threaded locking piece, is made up of following：One axle Ring 710, at least a portion around an axial part of the rod member 704；One adapter, by two half parts 706 with 708 compositions, around at least a portion of the screw spherical head 714；And an external locking collar 712.In certain embodiments, The external rings 712 are designed to suppress the structure motion by applying radial inward strength.

In certain embodiments, the multiple adapter 706 and 708 encircles the spherical head 714 of the screw.According to pass Multiple embodiments of the accompanying drawing are coupled to, the multiple adapter 706 and 708 is identical, it is each to include being used in the screw The one inner spherical recess 722 on head 714.In certain embodiments, when combined (be for example positioned to it is closer to each other and/ Or at least part of be in contact with each other), there is the adapter 706 and 708 a relative cone outer to configure.Selection, when being led During the combination wanted (such as before locking), the adapter upper surface 724 is not contacted each other with 726, leaves position described A space between two adapters 706 and 708.This space can be used in the pedicle screw 702 inserting the bone It is interior, for example closed by the Nie provided using a screwdriver, such as in multiple situations, wherein during the insertion, it is described Multiple adapters 706 and 708 are incorporated into the screw 702.In the one or more projections of a screwdriver far-end, selection The surface detail of use screw head 714 come complementary, the screwdriver can be imported by space 728, close described with Nie Screw head, such as slot 728 into position at the surface of the screw head.By increasing position in the screw head And the contact area (such as by complementary multiple protrusions and multiple recesses) between the screwdriver distal end, it can promote The screw is inserted within the bone.In addition, in certain embodiments, when locking the structure 700, the locking ring 712 movements for applying radial direction strength to fix the multiple construction package and suppress them, and the permission one of the slot 728 are secondary , selective, two adapters 706 are limited close toward each other with 708.

In certain embodiments, the upper surface 724 and 726 of the multiple adapter is placed only in the head of the screw In the part on the surface in portion, for example, leave a top central portion of the screw head being exposed.

In certain embodiments, the collar 710 has a relative tubular outer configuration, with a ladder (and/or one or More projections, the projection around one and/or it is applicable come the position for defining the locking ring and/or the axle of the limitation ring To any other mobile structure) so that collar 710 can be imported within the locking ring 712, until certain adopted position is put. In some embodiments, the collar 710 includes an inner tubular hole 732, to accommodate the rod member 704.Selectivity, it is described Hole 732, with a non-round and smooth inner surface, the multiple component is further locked to provide at least a portion, for example, lead to Cross friction of the increase between the rod member and multiple inwalls in the hole.Selectivity, the collar hole 732 it is non- Round and smooth inner surface batch fits over a complementary not rounded skating area domain of rod member outer surface, such as described rod member and the inner surface include The multiple projections matched somebody with somebody and multiple recesses.

In Figure 19 A-19B in depicted embodiment, collar 710 is single unit, with from the extension of its lower end A slot 736, and until and/or more than the circular hole 732.But, other designs are also in protection scope of the present invention Within, the slot for example extended from the upper end of the collar, or the collar being made up of two or more components, selection Two identical half parts of property.As described above for the explanation of the slot 728 between the multiple adapter 706 and 708, opened with one If or the collar 710 that opens up of part, during the multiple construction package is locked, by using the locking ring 712 to permit Perhaps the collar portion is fastened.

In certain embodiments, the external locking collar 712：At its lower part, around the spherical head 714 and multiple adapters；At its upper part, ring 712 is around the lower part of the collar 710.In some realities Apply in example, the ring 712 is included in a ladder of its outer surface, so that the external diameter phase of the ring in its lower part 734 Reduced for a upper part of the ring.Selectivity, this recess/depression 734 allows to such as screwdriver and locking The connection of the operation tool of driver, such as in description in Figure 20 A-20D of lower section.Locking ring 712 has an inner conical Shape.

According to some embodiments of the present invention, a part for the reinforcing fiber of material, such as multiple longitudinal carbon are implanted into Fiber, is configured and/or is oriented on a specific direction to form the equipment or group of tool engineering properties in need and preferred Part, for example, strengthen the implantation impedance for applying load.For example, the collar 710 and/or locking ring 712 can be by following Construction is formed：(a) there is an adhesive tape of long, parallel carbon fiber polyether-ether-ketone, wind to form a relative tubular configuration, Such as described ring 712 or collar 710, wherein the fiber (level) extension on circular direction；And (b) multiple polyethers ethers Ketone adhesive tape, with the carbon fiber of length oriented perpendicular to the direction of the multiple fiber of the description in (a)；And (c) is multiple Polyether-ether-ketone adhesive tape, with any angle relative to the direction of the multiple fiber of the description in (a) come the length that orients Carbon fiber (for example presss from both sides +/- 20 degree) relative to the level.Other orientation of multiple fibers and arrangement, such as multiple fibers with The U-shaped orientation of the shape of the collar 710, also within protection scope of the present invention.In certain embodiments, the vertebral arch Root screw includes the one or more adhesive tapes of polyether-ether-ketone, and each adhesive tape includes elongated carbon fiber, is substantially parallel to described The longitudinal axis of screw.

In one embodiment, the pedicle screw 702, which can provide to give, uses the adapter 706 and 708 and locking ring 712 users being combined, so that the pedicle screw 702 is screwed within the vertebra, while using the adaptation Device 706 is combined with 708 and locking ring 712.In this stage, the locking ring 712 is not close and other described groups Part is connected, and is that position is less than depicted in Figure 19 A, such as at its non-final latched position at some.

In certain embodiments, as described in Figure 20 A-20D, the pedicle screw combination 801 (including a pedicle of vertebral arch Screw 702；Multiple adapters 706 and 708 (not illustrated in figure)；And locking ring 712) connect with the screwdriver 800 that one specifies Connect.For simplicity, Figure 20 A illustrate the pedicle screw combination 801 and the screwdriver 800 not combined.In some realities Apply in example, screwdriver 800 includes a distal end curved bend tune 802, with multiple means 803, for example one in the radial direction One projection of extension, to keep the locking ring 712, such as distal end from the ring from below；One axostylus axostyle 804 is included in one Rod member 806, terminal has two projections 808 and 810；One tubulose, moveable component 812, for locking the screwdriver Component combines 801 with the pedicle screw；And (do not illustrate) handle at place in figure in proximal segment, with screwdriver axostylus axostyle 804 connections.

Figure 20 B illustrate the connection (but not locking) of the pedicle screw assemblies 801 and the screwdriver 800. In some embodiments, in order to firmly keep the pedicle screw combination 801, an extra ARCS 814 is (such as in figure Depicted in 20C) be attached to the distal ports of the screwdriver, such as it is in 180 degree (example relative to the previous ARCS 802 As being diametrically opposed to one another) positioned, with the part 816 for clamping the locking ring 712 from below (see Figure 20 C).Selection , in this stage (Figure 20 D), the mobile movable-component 812 is (selective by screwing in (such as being screwed on) and/or sliding It is dynamic) on the distal ports of the screwdriver 800, so that the screwdriver 800 and the pedicle screw is firmly fixed Combination 801.In certain embodiments, the handle (not illustrated in figure), a such as T-shaped handle is rotated to promote position to exist Rod member 806 is positioned at two adapters 706 in the projection 808 and 810 in screwdriver at rod member 806, the screwdriver With 708 between a slot therebetween (see Figure 19).Selection, when the slight forward movement of interior rod member 806 and relative institute State the upper surface 724 and 726 of adapter 706 and 708 to promote and (illustrate in Figure 19), the locking ring 712 is slight Elevated (but be not final latched position) to it.Now, the dextrorotation of whole screwdriver 800 is transferred described in screw-in Pedicle of vertebral arch screw is pinned in the bone.

Selection, the screw 702 and screwdriver 800 are hollow (not illustrated in figure) and therefore can be in a guidings Used on line.Selection, screwdriver includes a limiter of moment and/or a depth gauge (not illustrated in figure), can lead Used when entering pedicle screw.

Replace, screwdriver 800 is provided into two rectilinear segments, such as multiple slender arms, in its distal end (for example extending from a far-end of the screwdriver) catches the locking ring (not illustrated in figure) at place.Selection, at this In the case of sample, two parts are the parts of screwdriver, and they are not required to be connected one compared with last stages.Further, Each of the part is linear (not including Radius) and also narrower than the part 802 described in Figure 20 A.So In the case of, the movable-component 812 being shown in Figure 20 A-20D is probably unnecessary.

Selection, the handle of screwdriver 800 includes a locking plug-in unit (not illustrated in figure), in final connecting screw Bottle opener 800 locks the handle after 801 are combined with pedicle screw.

What is selected can be used to the pedicle screw or pedicle screw screw-in institute there is provided other of rotation means State within vertebra, two or more recesses of such as position at the upper part of the locking ring, and in the screwdriver Far-end multiple projections it is complementary；Or position, in a recess of the screw head, the remote tip with the screwdriver is complementary. Position the screw head recess can with variously-shaped, such as shape be an elongate socket shape, cross and/or other match somebody with somebody Put.

In certain embodiments, after the pedicle screw 702 is inserted in the multiple pedicle of vertebral arch, for example-will Four pedicle screws are inserted in two adjacent vertebraes, two rod members 704 are disposed, with every in longitudinally connected multiple screws 702 A pair.In certain embodiments, each rod member 704 (linear or bending) is deployed to be combined with two collars 710, each Position is at rod member end, or one of multiple ends close to rod member place.The potential advantages of the design of multiple implant assemblies can be wrapped Containing make the screw " rotation spiral shell " can multiaxis movement, to promote the storing of the rod member, for example, pass through two or more screws The rod member is inserted in multiple holes of " multiple rotation spiral shells ".Be suitably implanted and backbone positioning checking after, use one locking Driver realizes the locking of implant assembly.In certain embodiments, the concept of the locking driver in Figure 20 A-20D with saying The bright equipment it is similar, but it is described locking driving be both configured to bear higher strength, for example even 1000 kilograms. In addition, the locking driving area does not include the multiple projections for existing and being located in the screwdriver at rod member, so as to ought finally lock During fixed the multiple implant assembly, the space of the position between multiple adapters can be closed, or partial closing.Work as manipulation When locking driver, such as, by the handle for rotating it, the device interior rod member is moved forward and suitable relative to the multiple The upper surface of orchestration is promoted, further to lift the locking ring to its final latched position (such as seeing Figure 19 A).

Referring now to Figure 21, one polyaxial pedicle screw structure 900 of explanation is another according to some embodiments of the invention Design.Figure 21 A are a longitudinal profiles of the structure 900.Figure 21 B illustrate the uninstalled of multiple components of the structure 900 Explosive view.In certain embodiments, the polyaxial pedicle screw structure 900 includes a pedicle screw 902：One rod member 904；And multiple suppression means, include collar 906 and 908；And two locking rings 910 and 912.

In certain embodiments, the one or more components of the structure 900 are made up or including one or more of following Individual composite (such as CFR-PEEK), multiple metals (such as titanium), other polymers material or its any combination.As herein Extra multiple materials/multiple components that part is described in the whole text, such as radiopaque label and/or radiopaque powder/granule and/ Or coating/shell, etc., it can be incorporated into that in multiple implant components.In certain embodiments, multiple chis of multiple implant assemblies The very little multiple sizes for being also similar to previously describe for similar component in this document.

In certain embodiments, pedicle screw 902 includes spherical (or Part-spherical) head 914；One shank 916, It is threaded in certain embodiments；One neck 918, is threaded in certain embodiments, the neck 918 connects institute State head 914 and the threaded shanks 916；And one far sophisticated 920.Screw 902 can be hollow, allow screw to insert Enter on a guide wire.In one embodiment, along the diameter alterable of the screw shank, so that it is described in Remote tip 920 is pointed cone or its part is pointed cone.

In certain embodiments, the rod member component 904 is linear, and can give user, example with the offer of this pattern It is depicted in such as figure.Replace, during performing the operation, the rod member can be to provide into having bent or be bent to a needs Curvature, the special purpose device taken for member bending of selection, for example as described above (Figure 16 A-16C).

In certain embodiments, during implantation vertebral pedicle bolt structure 900, the rod member 904 and the multiple vertebral arch Root screw 902 is fixed.A non-threaded locking piece according to some embodiments of the invention is made up of following：One collar, including two Half part 906 and 908, the structure of the collar is designed to around the spherical of the rod member 904 and the pedicle screw 902 Head 914；And two locking rings 910 and 912, at the multiple ends for being placed on the collar 906 and 908.

In certain embodiments, the collar half part 906 is included with each in 908：One tubulose hole 922, position At the upper part of its interior surface, to accommodate the rod member 904；And a circular recess 924, position is in its interior surface At lower part, for the screw head 914.Selection, tubulose hole 922 is elongated, for example, be dimensioned so as to Extend along at least a portion of the rod member, the rod member is accommodated in its inside.In certain embodiments, two locks Determine ring 910 and 912 to be placed on the collar end 926 and 928.

Figure 22 A-22C illustrate another design of a multi-axial screws structure 1000 according to some embodiments of the invention.Figure 22 A Illustrate uncombined multiple components of structure 1000.Figure 22 B illustrate the structure 1000 of the combination.Figure 22 C explanation along It is depicted in a section of the structure 1000 of Figure 22 B line A-A.In certain embodiments, the polyaxial pedicle screw structure 1000 include a pedicle screw 1040；One rod member 1020；And multiple suppression means, include a collar 1010 and a locking ring 1030。

In certain embodiments, multiple components of the structure 1000 include one or more composites (such as CFR- PEEK), multiple metals (such as titanium), other polymers material or its any combination.As this document in the whole text described in it is extra multiple Material/multiple components, such as radiopaque label and/or radiopaque powder/granule and/or coating/shell, etc., can quilt It is incorporated into multiple implant components.In certain embodiments, multiple sizes of multiple implant assemblies are also similar to previously exist The multiple sizes described in this document for similar component.

In certain embodiments, pedicle screw 1040 includes：One spherical (or Part-spherical) head 1044；One shank 1046, it is threaded in certain embodiments；Selection, a neck 1048, be in certain embodiments it is threaded, it is described Neck 1048 connects the head 1044 and the threaded shanks 1046；And one far sophisticated 1049.In certain embodiments, screw 1040 be hollow, with sleeve pipe 1042 (such as an inner chamber), to allow screw to be inserted on a guide wire.In some embodiments In, change the diameter along the screw shank, so that the screw shank is pointed cone towards described remote sophisticated 1049 Or its part is pointed cone.In certain embodiments, pedicle screw head 1044 includes a connection thin portion 1045, for example Within the respective joint detail of one recess or projection to accommodate and/or be fitted to an insertion instrument.Connecting thin knot 1045 can be with It is arbitrary shape to meet the connection thin portion (for example, a slot) of an insertion instrument.

In certain embodiments, the rod member component 1020 is linear, and can give user, example with the offer of this pattern It is depicted in such as figure.Replace, during performing the operation, the rod member can be to provide into having bent or be bent to a needs Curvature, the special purpose device taken for member bending of selection, for example as described above (Figure 16 A-16C).

In certain embodiments, during implantation vertebral pedicle bolt structure 1000, the rod member 1020 and the multiple vertebra Pedicle screw 1040 is fixed.A non-threaded locking piece according to some embodiments of the invention is made up of following：One collar 1010, ring Around rod member 1020；And an external locking collar 1030.In certain embodiments, the external rings 1030 are designed to by applying footpath Suppress the structure action to strength inwardly.

In certain embodiments, the collar 1010 for example also illustrated in Figure 23 A-23D, is incorporated to：One inner tubular hole 1012, to accommodate a rod member 1020；And a hole 1013, to accommodate the head 1044 of a pedicle screw 1040.Selection , hole 1012 and hole 1013 have a non-round and smooth interior surface, and selectivity is textured, to provide further locking institute Multiple components are stated, such as by increasing the friction between multiple surfaces and the collar in the rod member and/or head of screw.Choosing Selecting property, the multiple non-round and smooth surface matching position is outside the multiple not rounded skating areas domain and/or multiple head of screws at the rod member Portion surface.In some embodiments, collar 1010 includes slot 1014, and a slot 1016, to be pressed from both sides with the formation of slot 1,014 one Angle is positioned.Such angle is, for example, 90 degree, 75 degree, 45 degree or middle, larger or smaller angle.Pair of the axle also 1010 Socket designs allow to press the collar to connect the screw head 1044 by relatively described screw head.Selection, institute State multiple slots and provide the adaptation axle of compression also on the screw head.Collar 1010 can have multiple additional slots, Such as slot 1016, it is selective with relative to each other and/or the different angles of slot 1014 are positioned.

In certain embodiments, ring 1030 is around the collar for closing the screw spherical head 1044 and the rod member 1012 1010.Selectivity, ring 1030 includes：One ladder, position is in its outer surface, to reduce outside the ring under ladder 1032 directly Footpath, such as the upper part relative to the ring.This allows the connection of operation tool, for example, lock driver, for example, describe Figure 35 A-35C in lower section.Selection, locking ring 1030 has an interior conical shape, as already described above.

Figure 23 A-23D further illustrate collar 1010 according to some embodiments of the invention.Figure 23 A illustrate in unlocked position In collar a perspective view.Figure 23 B provide a bottom view of the collar in unlocked position.In some embodiments In, the design of the dual slot part 1018 of the collar 1010, when in unlocked mould-fixed, make part 1018 profile some be in Ellipse (so as at bottom view, be compared to multiple region 1019a and 1019b, multiple region 1017a and 1017b have been seen Carry out relatively thin (such as narrower)).Since the in-profile (Figure 22) of ring 1030 is circular, once ring 1030 is pulled to To lock the structure on the section 1018 of collar 1010, multiple sections of the part 1018 by collar 1010 are compared to The pressure that 1015a and 1015b are undergone, it discharges higher along the multiple sections of 1011a and 1011b of the part 1018 of collar 1010 Pressure.This provides the reduction (1014a and the 1014b part of the slot are all) of slot 1014, without influenceing to insert The width of groove 1016 (1016a and the 1016b part of the slot are all).Figure 23 C and 23D explanation are when in a locking mode In collar 1010.Reduce the width (1014a and the 1014b part of the slot are all) of slot 1014, without shadow Ring the width of slot 1016 (1016a and the 1016b part of the slot are all).Selection, once complete locking, portion It is circular to divide 1018 exterior contour, is consistent with the in-profile of ring 1030 (so that multiple at bottom view Region 1017a and 1017b seem identical with multiple region 1019a and 1019b width.

In one embodiment, collar 1010 can provide the user for giving advance combined member bar 1020 and/or ring 1030. Figure 24 A-24B and 25A-25D illustrate the equipment 1050 for connecting the collar 1010, rod member 1020 and ring 1030, in order to Promote to place the combination (depicted in such as Fig. 7 B) on the pedicle screw in a vertebra.Figure 24 A and 24B are said (selective is advance with one or more collars for the bright slotting different views for eating equipment 1050 for giving the user as providing 1010th, rod member 1020 and/or ring 1030 are combined, such as described in detail below；Figure 25 A-25D illustrate in an exemplary configuration The insertion equipment 1050 different views, wherein it be presented to the user, such as with screw 1040.

In certain embodiments, rod member 1020 is placed on the position through the hole 1012 of collar 1010.Collar 1010 And the combination of rod member 1020, with the ring 1030 being placed in the distal ports of collar 1010, in unlocked position, position is set in insertion Within standby 1050 body 1056, so that the multiple arm 1059a and 1059b of insertion equipment 1050 maintain ring 1030, such as it is horizontal To the clamping ring.In certain embodiments, the offer of the selectivity of apparatus body 1056 is into multiple openings on two sides 1055, towards opposite direction, so that the insertion equipment 1050 on the combination of collar 1010 and rod member 1020 can be put Put and remove.The user is given there is provided rod member 1020 in an exemplary embodiment, rod member 1020 is some above it with being placed on Individual insertion equipment 1050 (with multiple collars 1010 and multiple rings 1030), such as along the rod member at multiple positions Major axis is distributed, and wherein pedicle screw will couple the rod member (such as by the collar).Selectivity, position is in the rod member On the multiple insertion equipment number and the number for the multiple pedicle screws 1040 for being intended to be connected by the rod member 1020 Mesh is consistent.

In one embodiment, user's pressing insertion equipment 1050, combines collar 1010, rod member 1020 and ring in advance 1030 on screw 1040, such as by promoting the equipment towards a distant place on the screw, so that the screw head The 1044 Nie conjunctions within the hole 1030 of collar 1010.If several combinations are provided on single rod member, whole combinations It is pressed against on the multiple screw, for example, advancing to fit on the multiple screw head towards a distant place.Selection, In this stage, handle 1052 (such as T-shaped handle) is manipulated so that component 1057 of the position within body 1056 is moved downward (selective by by the conversion linear movement of rotation).In certain embodiments, component 1057 is relative passes through multiple arms The ring 1030 that 1059a and 1059b are kept presses collar 1010, to provide initial stage locking or coupling of the rod member 1020 with screw 1040 Close (by the collar connected between the rod member and screw), so that the ring on collar 1010 being capable of relative fortune It is dynamic.If desired, handle 1052 can be manipulated to promote ring 1030 from collar 1010 in the opposite direction, in locking at the initial stage of implementation Afterwards, for example a more loose position (such as on the screw) is looped back to described in making, to allow the multiple component again Positioning, such as collar relative to each other and screw.Selection, completion is locked after technique initial stage, and user's pressing is more Individual arm 1058a and 1058b, so that multiple arm 1059a and 1059b moves and discharged ring 1030 outwardly.Insertion can be removed afterwards Equipment 1050.

Figure 26 A-26C illustrate the non-threaded locking ring assemblies of a pedicle screw system according to some embodiments of the invention 1060.Multiple locking rings that locking ring 1060 is designed similar in appearance to above-mentioned non-threaded, for example for multi-axial screws use (for example, Figure 22 A locking ring 1030 and Figure 19 B locking ring 712), and in certain embodiments, can in material, generally design and/ Or it is similar to the locking ring described herein in multiple sizes.In certain embodiments, for example such as the institute in locking ring 1060 Illustrate, the structure of a body 1064 of the locking ring be designed to so that one " shoulder " (protuberance or ladder) 1062 by The close end office of the nearly collar 1070, such as at the degree of rod member 1020.One potential advantages of this design can be included It is easier to connect multiple insertion/pullers (for example, screwdriver 800 in Figure 20 A-20D), it is the multiple to insert/pull out " shoulder " 1062 Nie for going out instrument and the ring 1060 is closed, because the join domain is further away from the screw, and therefore can be entered There is provided be easier to be connected to a doctor further away from the sufferer body for one step.Collar 1070 can be that as above this document is retouched in the whole text That states is arbitrarily devised (for example, having the axle of multiple adapters 706 and 708 in collar 1010, Figure 19 A-19B in Figure 23 A-23D Ring 710 is designed according to any other collar of the invention that can be used together with this non-threaded ring).

Figure 27 A-27D illustrate that a non-threaded ring 1080 and the another of collar 1090 set according to some embodiments of the invention Meter.Locking ring 1080 and collar 1090 in certain embodiments, can be designed and multiple similar in appearance to non-threaded for example as described above Multiple locking rings of collar, are used for example in and multi-axial screws (such as Figure 22 A locking ring 1030 and Figure 19 B locking ring 712； Figure 23 A-23D collar 1010) use in the lump, and in certain embodiments, can in material, generally design and/or multiple chis It is very little upper similar to the locking ring described herein.In certain embodiments, ring 1080 includes an inner step 1082 (such as one Periphery projection), and including a ladder 1092, (a such as periphery is recessed collar 1090, the selective ladder for being compatible with the ring 1082).Figure 27 A and 27B illustrate the perspective view and a profile of collar 1090 and ring 1080 in a non-integrated mode respectively；Figure 27C and 27D illustrate the perspective view and a profile of collar 1090 and ring 1080 in locking mode respectively.In some embodiments In, collar 1090 is incorporated to：One inner tubular hole 1093, to accommodate a rod member；And one hole 1095 be used for accommodate a pedicle of vertebral arch The head (such as Figure 22 A screw 1040) of screw.

In certain embodiments, the gradient 1086 of the ring portion office of the position under ladder 1082 (such as described ring Tilt internal wall) it is different from the gradient 1084 of (comparison for including a different angles) the ring portion office of the position on ladder 1082 (such as the tilt internal wall of described ring).The different gradient of ring 1080 is coincident with the shape of collar 1090, and it includes ladder 1092.Choosing Select, the gradient 1096 of the collar portion under ladder 1092 is coincident with the gradient 1086 of ring 1080.Selection, in rank The gradient 1094 of the collar portion on ladder 1092 is coincident with the gradient 1084 of ring 1080.The different gradient 1084, The axle of the 1094 radial direction strength (such as one change radial load) different from 1086,1096 offer applications at those different zones Ability on ring, therefore variable locking strength is provided on the part, the screw head is accommodated in the part It is interior.This can influence the locking strength that must apply in turn, to reach the locking for positioning the ring on the collar At position.

Figure 28 A-28C and 29A-29C illustrate collar 1110 and locking ring 1120 to be formed according to some embodiments of the invention Combination 1100.Figure 28 A-28C illustrate the collar and ring in a latch-up-free position；Figure 29 A-29C illustrate in a latched position The collar and ring.Figure 28 A and 29A provide a perspective view of the combination；Figure 28 B and 29B provide the side of the combination View；Figure 28 C and 29C provide a section for the combination (respectively along Figure 28 B and 29B line A-A)

It is described combination 1100 multiple components be by it is following be made or including：Material (such as CFR-PEEK), multiple metals (such as titanium) and/or its any combination.In certain embodiments, as this document in the whole text described in extra multiple materials/multiple groups Part, such as radiopaque label and/or radiopaque powder/granule and/or coating/shell, etc., can be incorporated into that multiple plant Enter in thing component.In certain embodiments, multiple sizes of multiple implant assemblies are similar in appearance to previously in this document for similar Multiple sizes of component description.

In certain embodiments, collar 1100 is incorporated to：One inner tubular hole 1116, to accommodate a rod member；And a hole 1118, for accommodating the head (such as Figure 22 A screw 1040) of a pedicle screw.Collar 1110 can be for example such as That this document is described in the whole text above is arbitrarily devised, and (such as Figure 23 A-23D collar 1010, Figure 19 A-19B have adapter 706 With 708 collar 710 or designed according to any other collar of the invention that can be used together with this non-threaded ring).

In certain embodiments, the radius (or diameter) in the collar part office including hole 1118 is compared to, The gradient 1112 (such as the inclination of described collar wall) of collar 1110 is oriented so that the radius (or diameter) of collar in bag It is less to include in the collar portion in hole 1116, to form a sharp keen (such as cone, with position in axle of angle 1115 Its larger diameter at the bottom 1111 of ring 1110, the pointed cone on a proximal direction).

In certain embodiments, ring 1120 includes an inside gradient 1114 (a such as tilt internal wall), once in locking bit Place is put, the internal gradient 1114 is coincident with the outside gradient 1112 of collar 1110.Generally, as described above, in some implementations Locking ring 1120 similar to what is previously described in this document (such as Fig. 5 locking ring, Figure 22 A locking ring 1030, figure in example 19B locking ring 712 etc.), only its inside gradient 1114 is pointed cone upward.

As an example, in order to lock the multiple component of combination 1100, position a rod member in hole 1116 and After one screw is in the hole 1118, ring 1120 is for example pulled relative to collar/promote.Selection, due to passing through The radial pressure that ring 1120 applies, the slot 1117 of collar 1110 narrows.Selection, in this stage, relative axle The gradient 1112 of ring 1110 puts the gradient of ring 1120.

In certain embodiments, ring 1120 is provided as combination in advance on collar 1110.Selection, combination 1100 can To provide the user given using a rod member to combine in advance.Replace, can be before a rod member is inserted through hole 1116 Ring is seated on collar 1100 during operation.

Figure 30 A-30C, 31A-31C, 32A-32C illustrate according to some embodiments of the invention some collars design (1130, 1140、1150).Figure 30 A, 31A and 32A provide a perspective view of the multiple collar；Figure 30 B, 31B and 32B provide described many The side view diagram of individual collar；Figure 30 C, 31C and 32C provide the multiple collar a section (respectively along Figure 30 B, 31B and 32B line A-A).

Multiple collars 1130,1140,1150 and/or its any combination are made or wrapped by following in certain embodiments Include：Composite (such as CFR-PEEK), multiple metals (such as titanium) and/or its any combination.As this document in the whole text described in Extra multiple materials/multiple components, such as radiopaque label and/or radiopaque powder/granule and/or coating/shell, etc. Deng can be incorporated into that in multiple implant components.In certain embodiments, multiple sizes of multiple implant assemblies are similar in appearance to previous The multiple sizes described in this document for similar component.

In certain embodiments, generally, multiple collars 1130,1140,1150 are incorporated to：One inner tubular hole, to hold Receive a rod member；And a hole, for accommodating the head (such as Figure 22 A screw 1040) of a pedicle screw.Selection, Collar 1110 can be for example as this document above in the whole text described in arbitrarily devised (such as Figure 23 A-23D collar 1010, figure 19A-19B (being used in the lump with adapter 706 and 708) collar 710 or according to provide individual unit collar it is of the invention Any other collars design).In certain embodiments, the hole for inserting (being 1132,1142,1152 respectively) used in rod member can be with One linear or a curved bar are consistent, as detailed below, for example, be used in two partial collars with what previous text part was described A same way (for example, Figure 18 A collar 606 and 608).

Figure 30 A-30C illustrate a kind of collar 1130, are designed to use in the lump with a linear rod member.Inserted used in rod member Hole 1132 is linear (for example directly transversely extending across the collar), diameter and/or curvature with the rod member. In some embodiments, an inwall in hole 1132 is formed with being coincident with a geometry of a curvature of the rod member. In some embodiments, before the final locking of the vertebral pedicle bolt structure, in the collar around the rod member major axis and institute It is possible to state the relative motion between rod member.

Figure 31 A-31C illustrate a kind of collar 1140, are designed to that the rod member with a bending and/or arc is used in the lump.It is used in The hole 1142 of rod member insertion, is bending and/or arc, is coincident with the diameter and configuration (such as one song of the rod member Rate).In certain embodiments, collar 1140 is configured to be set in a position of the rod member in the collar, such as in institute Before the final locking for stating vertebral pedicle bolt structure, prevent the rod member within the collar hole 1142 from rotating.

Figure 32 A-32C illustrate a kind of collar 1150, are designed to use with curved bar collocation.Hole 1152 is linear (for example directly transversely extending across the collar).In certain embodiments, hole 1152 includes a diameter, more than the bar The diameter of part.In certain embodiments, an insert 1154 is provided as being placed within hole 1152.In certain embodiments, Insert 1154 has：One outer tubular configures and matched multiple sizes in the collar tubulose hole；And one in the arc of inside Chamber is configured and multiple sizes with the arc for matching the rod member.Insert 1154 can be provided that into along its entire length Slot 1156, to promote to lock the structure (for example, with a non-screw thread type locking ring).It is described slotting including an at least slot The potential advantages for entering part can be comprising the accordance of the collar-rod member combination be increased, because the slot allows the insertion The outer peripheral portion of part overlaps, so that potentially acquisition one is firmer, be more closely grasped on the rod member, the rod member is determined Position is within the insert.Another potential advantages for the insert being positioned between the collar hole and the rod member can Comprising for example there is provided relative between the collar and the rod member before the final locking of the vertebral pedicle bolt structure Motion, such as movement around the rod member major axis, such as rotary motion.In certain embodiments, the tubulose hole includes One or more teeth and/or projection, the insert is aligned used in relatively described collar hole, and/or used in limitation movement, example The rotation and/or axial movement of the plug-in unit such as in the hole.In certain embodiments, a tooth 1158 (such as one Radial projection) end in tubulose hole 1152 is disposed on, it is used as with being inserted in insert 1154 within the tubulose hole One stop member, and/or when screwing within insert 1154, reach the stopping of the rod member.

Figure 33 A-33B illustrate another insertion instrument used in pedicle screw according to some embodiments of the invention.At some In embodiment, insertion instrument 1200 can be hollow (not illustrated in figure), example as used in a guide wire on.At some In embodiment, in its far-end, instrument 1200 includes multiple teeth 1202, forms an inner circular socket (such as in the circle Between shape arrangement tooth), it is designed to surround the head of a multi-axial screws.In certain embodiments, multiple teeth 1202 are surrounded Within a sleeve 1204.Figure 33 A illustrate the insertion instrument 1200 in open to the outside world position.During operation, the institute of screw 1201 Head is stated to be placed within the socket created by the multiple tooth 1202.In certain embodiments, turn knob 1206 with Moving sleeve 1204 is forward to lock multiple teeth 1202 on the screw head, setting tool 1200 and screw 1201. In some embodiments, handle 1208 (selective, a T-shaped handle) promotion instrument is for inserting the screws within the pedicle of vertebral arch Use, such as by being inserted the screw within the pedicle of vertebral arch by the user of such as doctor rotation.

Figure 34 A-34C illustrate that another is used in the insertion instrument 1210 that pedicle screw combines 1220, pedicle screw group 1220 are closed for example including pedicle screw 702 (such as being illustrated in Figure 22 A) and a locking ring 712, selective including is multiple Adapter 706 and 708 (such as depicted in Figure 19 A-19B).Replace, the pedicle screw combination, which is included, to be had arbitrarily Screw, with the connection thin portion (such as the thin portion 1045 of the screw 1040 in Figure 22 A) at its head, and any annular Locking member, selective has an outer step, around the screw head.

In certain embodiments, insertion instrument 1210 is including a distal end segmental arc 1212, the interior surface profile with it, With the profile of a locking ring, multiple means 1213 (such as a radial projection, the fixture of the locking ring are kept with being applicable And/or other means), for example Nie closes the ring from below, and/or at an outer step of the ring.In addition, in some realities Apply in example, instrument 1210 includes an inside axostylus axostyle 1215 and an outer shaft 1217.In certain embodiments, internal axostylus axostyle 1215 Connection thin portion 1214 is terminated in, is consistent with the connection thin portion at the screw head.In certain embodiments, axostylus axostyle 1217 Multiple teeth 1219 are equipped with, Nie closes multiple teeth 1218 of handle 1216 (such as T-shaped handle), for example, provide axostylus axostyle 1217 and handle A detachable surface between 1216.Figure 34 A illustrate the instrument 1210 in " locking " pattern, with prominent within part 1212 The connection thin portion 1214 risen, and with multiple teeth 1218, closed with multiple Nie of tooth 1219.Figure 34 B explanations are by screw association 1220 Before in inserter 1210, in the instrument 1210 of a non-locking pattern.In certain embodiments, handle 1216 is pulled rearwardly To depart from multiple teeth 1218 from multiple teeth 1219, and therefore connection thin portion 1214 is also pulled backward, for example, move axostylus axostyle 1215 to One in intracavitary.

Figure 34 C illustrate the locking of screw association 1220 and insertion instrument 1210.In one exemplary embodiment, screw association 1220 are placed within instrument 1210, so that ring 712 is placed within distal portions 1212, the ladder with relative ring 712 The thin portion 1213 that the 712a lower part is placed.Replace, thin portion 1213 can be put relative to the surface 712b of ring 712 Put (for example, in ring for no outer step).Selectivity, once the screw association is in correct position, handle 1216 are pulled to discharge multiple teeth 1218, and rotation handle 1216 until the connection Nie of thin portion 1214 conjunction from multiple teeth 1219 backwards Connection thin portion (thin portion 1045 of such as screw 1040, Figure 22 A) at the screw head.Selectivity, handle 1216 can Further rotated, somewhat to press screw 702 and adapter 706 and 708 relative to ring 712, so that they provide enough Stable connection is to allow the screw to screw in the bone, but it is (such as relative still to provide relatively described ring tilting screw The screw that the ring is pivoted).In certain embodiments, handle 1216 is returned forward, it is selective by Manual press it, To make multiple Nie of tooth 1218 close multiple teeth 1219 again.In certain embodiments, once the Nie of multiple teeth 1218 and 1219 is closed, handle 1216 can for promotion instrument 1210 for inserting the screws into the use within the pedicle of vertebral arch, such as during inserting, By rotating the handle to rotate the screw.

Figure 35 A-35D illustrate a locking tool according to some embodiments of the invention.In certain embodiments, for example described After the initial stage of locking piece (such as locking ring) is seated in the collar, locking tool 1230 is used in a multiaxis pedicle of vertebral arch The final locking of bolt structure.Figure 35 A illustrate the locking tool 1230 in an exemplary configuration, and wherein it, which can be provided, gives the use Family, does not connect the vertebral pedicle bolt structure.In Figure 35 B-35D, locking tool 1230 is depicted as and a pedicle of vertebral arch screw Pin structure 1250 is connected.In certain embodiments, locking tool 1230 is configured to apply a high strength relatively plants described Enter on thing, and the user of a such as doctor need not directly apply such high strength.In certain embodiments, lock Determine instrument 1230 and be designed to enable it to apply high strength on the implant, it is sufficient to lock the pedicle screw knot Structure (such as 500 kilograms), can reach the equipment of manipulation with the strength (such as 10 kilograms) of artificial hand is used.In some embodiments In, locking tool 1230 provides strength amplification effect, and scope preferably is 10 to 100 times.

In these exemplary illustrations, structure 1250 is by a screw 1252, a collar 1258, a rod member 1256 and a locking Part 1254 is constituted.The structure can also include multiple adapter 1260a and 1260b.Collar 1258 can be single unit or It can be made up of two half parts, for example as described above.It can also be seen that its of the vertebral pedicle bolt structure of such as each present invention He configure be also it is similar contrast, with the instrument described in Figure 35 A-35D.In certain embodiments, multiple implantation The multiple materials and/or multiple sizes of component similar in appearance to previously in this document for similar component describe multiple materials and/ Or multiple sizes.

In certain embodiments, locking tool 1230 is made up of following several components：

(a) distal end 1232, by some arms (such as two (2) are constituted), defines the vertebral pedicle bolt structure that is consistent 1250 interior shape, such as one generally tubular form.In certain embodiments, distal end 1232 is included with a projection 1231 Carry out a ladder of the Nie conjunction along the periphery of the locking piece 1254, and/or Nie closes the bottom end of the locking piece.

(b) pipe fitting 1233, connection distal end 1232 and body 1235 (seeing below), and closing (such as containing) rod member 1242。

(c) sleeve 1234, such as after the vertebral pedicle bolt structure is properly positioned in distal end 1232, manual It is pushed on distal end 1232, so that the locking tool firmly is attached into the structure.Selection, once complete the knot The locking of structure, sleeve 1234 to be separated out the multiple arm of distal end 1232, and allows locking tool 1230 from structure by being pulled back 1250 remove.

(d) body 1235, closes the locking tool mechanism.The mechanism being enclosed in body 1235 can include one Spring (is not illustrated), so that after each activation, arm 1238 (seeing below detailed description) returns to its position (such as relative to body 1235 primary position).

(e) handle 1236 (for example, a knob handle), used in making the internal mechanism of locking tool 1230 advance, leads Rod member 1242 is caused to advance so that its contact structures 1250.

(f) lever arm 1238, promotes rod member 1242 (seeing below) used in opposed configuration 1250, causes collar 1258 relative The movement of ring 1254, so that they carry out Nie conjunction towards the structure is locked.

(g) rod member 1242 (Figure 35 C-35D), lever arm 1238 is connected by the mechanism being enclosed in body 1235. In some embodiments, each activation (such as by depressing the arm towards body 1235) of arm 1238 makes rod member 1242 advance one group (such as predetermined) distance (such as 1 millimeter).

(h) there is provided the stage indicated as locking process for an indicator 1240.

Subsequent paragraphs description is according to some embodiments of the invention for the example process using instrument 1230.At some In embodiment, after by vertebra described in the multiple screw placement, instrument 1230 is connected with structure 1250, the rod member and institute Multiple mode connects for screw (using the help of the collar and locking piece) are stated, realize that locking at initial stage is (manual or use another work Tool), and obtain the final contraposition of the multiple construction package and (for example set the multiple screw relative to the multiple rod member One needs angle).

In certain embodiments, the distal end of instrument 1,230 1232 is on a structure 1250, so that multiple projections are placed on Along under the ladder on the periphery of ring 1254.Permitted what is selected, sleeve 1234 is pushed down to press the multiple arm of distal end 1232, So that their firm holding structures 1250.In this stage, arm 1238 is to be without pressing position, and indicator 1240 at it At proximal most position.

In certain embodiments, until the contact structures 1250 of rod member 1242, (selection, contact is carried out rotation handle 1236 Between one distal end of rod member 1242 and a near-end of collar 1258).Selection, in this stage, depress arm 1238；This makes rod member 1242 advance one group of distance, therefore promote collar 1258 relative to ring 1254.Selection, indicator 1240 is towards before a distant place Enter.Selection, in this stage, what arm 1238 was released and returned to it (for example utilizes the help of a spring without pressing position；Not Illustrate).It can repeat to rotate handle 1236 and this process by pressure arm 1238, such as until indicator 1240 reaches it Final position.Selection, in this stage, latch-up structure 1250, such as by described in being intended to be positioned on the collar Ring, the collar position is at the position for being adapted to apply enough radial direction strength, so that multiple components of the structure are reduced or avoided Relative to each other and/or relatively described backbone motion.

It is (such as described that Figure 35 B provide the explanation being connected in the early stage by pressure arm 1238 period structure 1250 with instrument 1230 Arm is close towards body 1238).Selectivity, close position of the indicator 1240 at it.Figure 35 C illustrate the mistake in locking Structure 1250 in journey, with the indicator 1240 at any of the scale along it, such as an intermediate point；Figure 35 C's is thin Portion A illustrates space of the position between the bottom end of ring 1254 and the multiple adapter 1260a and 1260b bottom end 1262, it is indicated that its final position of the ring 1254 also not on collar 1258.Figure 35 D illustrate after final lock step Structure 1250 and the connection of instrument 1230, use the indicator 1240 at it most remote location；Figure 35 D thin portion A explanations exist Structure 1250 after the last activation of arm 1238, with the locking ring 1254 fully locked with collar 1258.

In certain embodiments, once structure 1250 is fully locked, sleeve 1234 is pulled rearwardly to discharge in instrument The connection between 1230 distal end 1232 and structure 1250.Selection, each such structure 1250 is repeated most The process locked eventually, to lock the rod member and all screws being used in surgical procedure.

In some cases, withdraw the ring while, the collar may advance, for example 0.1 and 1 millimeter it Between.Selection, by being avoided with the collar remainder, the collar remainder is relative to the screw head One dome.Replace, allow this fortune by providing the groove between the dome and the collar of the screw head It is dynamic.

Selection, the operation of instrument 1230 is manual.Replace, the operation of instrument 1230 passes through multiple electronic hands Section is realized, whether complete or partial.

Figure 36 A-36F illustrate a rod member according to some embodiments of the invention, depart from a rod member used in from a screw.Figure 36 A- 36B illustrates the puller 1270 being connected with vertebral pedicle bolt structure 1250 (structure 1250 is for example as described above).Figure 36 C-36D The distal portions of specification tool 1270, without structure 1250, and Figure 36 E-36F illustrate the instrument that is connected with structure 1250 1270 distal portions.

In certain embodiments, instrument 1270 is made up of body 1274, the selective proximal end at it and a handle 1272 (such as T-shaped handles) are connected, and the selective far-end at it is connected with a pipe fitting 1276.In certain embodiments, manage The connecting pipe 1278 of part 1276, the pipe fitting 1278 is connected with distal end 1284.In certain embodiments, multiple pipe fittings 1276 and/ Or 1278 closing terminate at distal end 1286 (multiple) pipe fitting.In certain embodiments, multiple indicators 1280 and 1282 are by simultaneously Enter in multiple pipe fittings 1276 and 1278.In one embodiment, distal end 1284 has two opening 1288a and 1288b, so that work Have 1270 Nie and close structure 1250.

Subsequent paragraphs are described for the example process using instrument according to some embodiments of the invention.In some implementations In example, what instrument 1270 was connected-selected with structure 1250, the distal end 1284 of the instrument be placed on collar 1258 and ring 1254 it On, and ring 1254 is with the rod member 1256 (Figure 36 C) inserted by multiple slot 1290a and 1290b.Selection, rotate afterwards Instrument 1270 is so that implantation rod member 1256 Nie closes multiple opening 1288a and 1288b.In this stage, multiple indicators 1280 with 1282 at their proximal most positions, and the complete distal end for withdrawing rod member 1256.

In certain embodiments, in order to discharge the locking of structure 1250, the handle 1272 of throw 1270.Rotate handle 1272 cause the advance of rod member 1286, with the multiple indicators 1280 and 1282 distally moved.In certain embodiments, bar The described of part 1286 ends remotely at a slot 1292, for example, extended laterally by rod member 1286 close to the one remote of the rod member End.Selection, once the distal advancement of rod member 1286, implantation rod member 1256 is positioned within slot 1292, and distal end or bar Part 1286 is put relative to the upper surface of ring 1254.Selection, handle 1272 further rotates relative ring The distal end of 1254 pressing rod members 1286, so that the ring is urged away from collar 1258.Once ring 1254 departs from from collar 1258, Throw 1270 is so as to be implanted into rod member 1256 in the position relative to multiple slot 1290a and 1290b (for example, avoiding Rod member 1256 departs from a configuration of the instrument, and plurality of slot 1290a and 1290b multiple walls support the rod member) and Instrument 1270 is pulled rearwardly to remove rod member 1256 from the multiple implant, such as from one or more screw implants.

The bolt structure related to can be repeated for the process using instrument 1270.Selection, After collar 1258 removes ring 1254, the collar 1258 with rod member 1256 can depart from from screw 152.It is to be noted that Instrument 1270 can be used in the removal of multiple implants or past release locks a structure during the operation, and/or lock again Determine before structure 1250 otherwise adjusting screw 1252 and/or a relative position of rod member 1256.

Figure 37 A-B be multiple strength act in unimodule collar (37A) and double component collars (37B) it is multiple schematically Explanation.

Figure 37 A illustrate that unimodule collar 3701 (is shown in an isometric chart (isometric view), side view and section to regard Figure), and a ring 3703, it is configured to be positioned at least a portion of the collar.

In certain embodiments, collar 3701 includes a upper part 3707 of a hole 3711 formation, a rod member It is accommodated in the hole 3711.In certain embodiments, lower part 3705 includes a hole 3708, a screw head It is at least part of to be accommodated within the hole 3708.In certain embodiments, one slot 3717 is extended laterally in hole Extend between 3709 and hole 3711, lower part 3705 is separated into multiple secondary parts 3719 and 3721.In some realities Apply in example, an exterior contour of lower part 3705 is configured including a circular cone, is pointed cone on a distal direction, for example As described above.

In certain embodiments, form a top 3709 of upper part 3707, generally configure hole 3711 it On, the top does not have any recess, slot and/or indenture.Selection, part 3709 is as a bridgeware, and position is in the axle It is by slot 3717 that the collar is at least part of between the secondary part 3719 and 3721 of the lower part 3705 of ring It is spaced apart.In certain embodiments, the top 3709 of closing increases the size around the rod member, the rod member contact The multiple wall in hole 3711.Selection, wherein slot 3717 connects the region 3729 in hole 3711, is wherein to be accommodated in The rod member within the collar is not in contact with unique region of multiple walls of the collar.In some embodiments In, the multiple wall in hole 3711 include the periphery of the rod member at least 85%, 90%, 95% or middle, it is larger or compared with Small scale.It is this by with a closure tip part 3709, to increase the contact between the rod member and the collar One potential advantages in region, can firmly keep the rod member comprising providing by collar.The top 3709 of closing can enter one The step protection rod member is by the compressing force acted in the collar on a distal direction.

In certain embodiments, part 3709 includes an arcuate profile profile.Replace, part 3709 may include a rectangle Section profile, trapezoidal cross-section profile and/or arbitrary disposition.

In certain embodiments, for example during enhancing ring 3703 is arrived on the lower part 3705 of the collar And/or afterwards, apply a radial direction strength on the lower part 3705.Strength F2 is schematically illustrated to act on from top The one of 3709 central point 3725 is at L2.With respect to central point 3725, strength F2 moments can be calculated with M2=F2*L2. In certain embodiments, strength F2 is applied on lower part 3705, it potentially makes the direction of secondary part 3719 and 3721 It is close to each other, to induce one second strength F1 on upper part 3707, exemplary illustration one at L1, institute It is the central point 3725 at top 3709 between a center in hole 3711 to state apart from L1.Strength F1 moment can be with M1= F1*L1 is calculated.Because the moment applied is equal to each other, it is assumed that strength F1 is approximately equal to strength F2 and is multiplied by apart from L2 and L1 Between ratio, in other words, F1=(L2/L1) * F2.Potentially, by making the energy close to each other of secondary part 3719 and 3721 Power enables F1 to amplify relative to F2, such as when applying radial inward strength by ring 3703 to many of the multiple secondary part Individual outer surface.One potential advantages of this disperses force are comprising the increased pressure of application in one be positioned within hole 3711 On rod member, a such as collar of the multiple secondary parts wide relative to the cone opinion for not including spaced-apart works as applying power During amount, e.g. radial direction strength, the multiple secondary part can be close toward each other.Selection, it is applied to by collar 3701 The increased pressure on the rod member, reinforcing and the Nie of the rod member are closed, so that potentially enhancing passes through position in the bar The coupling that collar 3701 between part and the screw is provided, the screw is accommodated within hole 3708.

Figure 37 B illustrate a kind of two components collar 3731.In certain embodiments, collar is by two shapes of component 3733 and 3735 Into.In certain embodiments, shape is integral each other for multiple components 3733 and 3735, to form two holes, one first hole For accommodating the rod member, and the second hole 3739 is used for accommodating the screw head.In certain embodiments, insertion one is locked Ring 3743 potentially makes multiple components 3733 and 3735 toward each other on an at least lower part 3741 for collar 3731 It is close.Selection, during locating ring 3743 is on the collar and/or afterwards, a strength F3, such as radial direction strength, It is applied on lower part 3741.Selection, it is applied to the strength F3 inductions on the circular cone lower part of the collar A similar strength F4 on upper part 3745, the rod member is accommodated within the upper part 3745. Multiple components 3733 and 3735 are extruded toward each other in a class tong-like mode, described in catching and be accommodated within hole 3737 Rod member, the hole 3737 is between multiple components, and so as to couple the rod member and the screw being contained within hole 3739.

In certain embodiments, the scope of a length 3791 of the collar for example between 12-17 millimeters or it is middle, compared with Long or shorter length.In certain embodiments, from a distance of a distal end of the distal end in hole 3711 to the collar 3763 scope is for example between 5-9 millimeters or middle, longer or shorter length.Selectivity, selection length 3763 is It is enough big, it is by institute so as to for example be applied to the radial compression of a distal portions of the collar by the locking ring State a factor of distance to increase, for example as described above.In certain embodiments, the scope example of a diameter 3765 of the collar In this way between 8-12 millimeters or middle, larger or smaller scope.Selectivity, length of the diameter 3765 along the collar Change.

Figure 38 illustrates to be contained in the exemplary aspherical pedicle screw head 3803 within a spherical hole 3801, example A hole of a collar of screw and a rod member as described in being used for coupling.

In certain embodiments, when head 3803 is accommodated within the multiple spherical wall in hole 3801, head 3803 shape design is shaped as one or more gaps, such as 3805 and 3807.In certain embodiments, in the fixed axle Ring is to during on the screw head, such as by positioning a locking ring on the collar, hole 3801 it is described Multiple walls are extruded by headward 3803.Selection, the strength of the application causes the head material and/or the hole wall One slight deformation of material, enters multiple gaps 3805 and/or 3807 with this some material 3815.In certain embodiments, institute State material and fill at least one of gap 3805 and 3807.The material enter position the hole and the screw head it Between the potential advantages in multiple gaps can be comprising the hole wall be obtained to a tight fit of the screw head, it can lead to The grasping effect that collar strengthens the screw is crossed, and one is provided by the cooperation the being close to screw head and preferably keeps effect Really.In certain embodiments, the material is composite, and it is described compound that the head and/or multiple hole walls are constituted Material.

One exemplary geometry on head 3803, suitable for obtaining above-mentioned multiple gaps, is shown in this accompanying drawing.One In a little embodiments, head 3803 includes：One generally cylindrical central part 3809；And two Dome shaped portions 3811 and 3813, configuration on the central cylindrical portion and under.Selection, gap 3805 and 3807 is formed in cylindrical portion Between 3809 the multiple wall and the multiple spherical wall in hole 3801.

Figure 39 A-B illustrate two exemplary arcuation configurations of a rod member, the rod member according to some embodiments of the invention 3901 include being positioned at multiple collars 3903 on the rod member.It is in certain embodiments, for example depicted in Figure 39 A, Form the rod member 3901 with a constant curvature.Replace, such as it is depicted in Figure 39 B, formed with a change curvature Rod member 3901.In certain embodiments, the multiple collar 3903 is equidistant on the rod member.Replace, it is described many Individual collar is distributed with distance different from each other.In certain embodiments, position the multiple collar on the rod member it Before, carry out the bending of the rod member.Extra or replacement, the multiple collar is positioned on the rod member, and described Rod member is bent to the curvature of the needs.In certain embodiments, the bending of rod member section, such as 3905 and/or 3907, example The extension between adjacent collar such as rod member section, by separated implementation.

Figure 40 illustrates a upper part of a collar 4001, including a fiber alignment according to some embodiments of the invention, It is coincident with a profile of the collar.In the example illustrated herein, multiple reinforcing fibers 4003, such as multiple carbon fibers, bag An inverted U-shaped curvature is included, the shape of the collar is coincident with.In certain embodiments, the multiple fiber extension is with circular rod member At least a portion in hole 4005.In certain embodiments, strength is applied when (such as by the locking ring), for example radially Strength 4007 is to a lower of the multiple fiber, generally linear segment 4009 inwardly, and the strength is transferred to described Upper, the class bridge portion 4011 of multiple fibers.The generally linear segment 4011 of the multiple inverted U-shaped fiber.It is described One potential advantages of multiple inverted U-shaped fibers can be included and are dispersed between the upper of the collar and lower part and/or institute State the load between multiple lateral parts (such as some on the opposite side of the longitudinal axis of the collar) of collar.Separately One potential advantages can include the bridging part (uppermost component) of transfer strength to the collar, to suppress in the hole The rod member.

Figure 41 is the illustrative methods used in the vertebral pedicle bolt structure of construction one according to some embodiments of the invention One flow chart, such as a structure, wherein the collar does not include the hole for being used for accommodating the head of the screw, such as in figure Described in 19.

In certain embodiments, an at least composite (such as carbon reinforcement polyether-ether-ketone) screw is implanted in a vertebra Within one pedicle of vertebral arch (4101).In certain embodiments, some of a screw are selected according to the dissection of the sufferer and demand Property, such as length, diameter, the axial degree and/or multiple parameters of screw thread.Selection, pass through all manufactured in the tissue The mouth implantation screw.In certain embodiments, before the screw is inserted, the passage in the pedicle of vertebral arch is expanded. In certain embodiments, the screw encircles structure including one, for example, formed by one or more adapters, and the adapter holds Receive the screw head at least a portion.In certain embodiments, the screw includes a composite (such as carbon reinforcement Polyether-ether-ketone) locking ring, it is positioned on the screw.In certain embodiments, for example during manufacture, the locking ring is Combination in advance is at least a portion of the multiple adapter, so that a near-end of the ring extends beyond the multiple fit Orchestration, to form a recess of the position on the multiple adapter, at least a portion of the collar may be accommodated in institute State within multiple adapters.

In certain embodiments, one rod member of selection (4103).Selection, selection with a length-specific and/or diameter and/ Or a rod member of curvature, to obtain a selected contraposition and/or the distance between the vertebra of the treatment.In some embodiments In, a doctor inserts one or more rod member plates within the area for treatment, to determine the rod member parameter used.Selection, One doctor bends the rod member to a selected curvature, such as by using the texturing machine as described in figure 16.

In certain embodiments, outside the body, one or more collars are positioned on the selected rod member (4105).Selection, the number of collar corresponds to the number of pedicle screw.In certain embodiments, the rod member is described in Multiple holes of multiple collars.

In certain embodiments, the ring is axial and/or angled positioned relative to the pedicle screw (4107) ring and/or the inclination ring of being slid axially on the screw (and/or multiple adapters), are for example passed through. The secondary combination of the rod member and collar and the coupling of the screw can be promoted by tilting the ring.

In certain embodiments, be implanted into rod member-multiple collars combination of the outside combination, and the collar at least one Part is positioned through within the recess that ring is defined, on the multiple adapter, so that the ring is as outside one Housing, to keep the multiple adapter and collar (4109) together.Selection, relative to the ring on a distal direction To press the collar, selectivity is manual.This can provide a part of locking, suppress the rod member and screw relative to the axle At least some motions of ring.

In certain embodiments, the ring, which is lifted, on the multiple adapter and/or collar, and reaches a locking matches somebody with somebody Put, wherein it applies enough radial compressions to suppress the rod member and multiple adapters (and its screw) relative to the collar Motion (4111).In certain embodiments, the collar is relative to the multiple adapter (and its head of screw encircled Portion) motion even may be suppressed before locking, for example, passing through friction and/or the radial direction strength applied by the ring. Selection, the ring is lifted by an instrument as described herein.It is extra or replacement, institute is directly lifted by the doctor State ring.It is extra or replacement, towards relative to the ring distant place come promote it is described encircle part (multiple adapters) so that the ring On the larger-diameter part for being positioned at the collar and/or multiple adapters, wherein it is for applying radial compression Effectively.

Figure 42 is used in the one of an illustrative methods of the vertebral pedicle bolt structure of construction one according to some embodiments of the invention Flow chart, such as a structure, wherein the collar includes being used for accommodating a hole on the head of the screw, such as in fig. 22 It is described.

In certain embodiments, it is implanted into a composite (such as carbon reinforcement polyether-ether-ketone) pedicle screw (4201), example As discussed.Selection, the pedicle screw includes being positioned at a composite (such as carbon reinforcement polyethers ether above it Ketone) locking ring.In certain embodiments, as realized the multiple step described in Figure 41 above：A rod member is selected, selectivity The bending rod member (4203)；And position one or more collars (4205) on the rod member.

In certain embodiments, it is implanted into the secondary combination (4209) of the rod member and multiple collars.Selectivity, institute That states that collar compressed fits on the screw head, so that at least a portion of the head of screw is accommodated in the axle Within one recess of ring.

Selectivity, at this point, the direction on from the screw to the collar lifts the ring to a locking Position, wherein the ring applies enough radial compressions to suppress the rod member and/or screw head relative to the collar Move (4209).In some embodiments, suppress the collar relative to the motion of the head of screw, for example, said above with reference to Figure 41 It is bright.

Figure 43 is the exemplary lateral connection between two structures according to some embodiments of the invention, and for example can be with Rod member-screw accessories above any are used in the lump, and are not limited to depicted specific Coupling Design.

In certain embodiments, the one or more connections between two or more structures are produced on, for example, are positioned at institute State on the opposite side of backbone, such as horizontal stationary phase is to spinal column segment.In this exemplary configuration, a transverse bar member 4301 is two Extend between individual structure 4303 and 4305.

In one example embodiment of the present invention, carry out Nie using collar design (such as one or two part) and close described many Individual rod member, it is compression closing that the collar design, which is kept into by a circular ring relative to the rod member,.It can use pair Locked and/or advance and/or multiple designs of collar pointed cone and/or multiple slots in ring.It is however mentioned that when disconnection Two rod members, in certain embodiments, the coupling create multiple tension force between the multiple rod member, to assist its Nie Close.

In certain embodiments, at multiple ends of transverse bar member 4301, make transverse bar member 4301 respectively with multiple structures 4303 couple with 4305 rod member 4309 and rod member 4309.In certain embodiments, the coupling includes the (example of a claw 4311 As depicted in cross section A-A), be designed to catch at least a portion of rod member 4307 and/or 4309, once and Nie close, do not discharge The rod member.In certain embodiments, Nie closes the rod member (being described in lower section) between the hook and element 4315.At some In embodiment, when also Nie unifies rod member at an opposite side of bar meter 4301 (exemplified by such as on 270 degree), the hook is enclosed The rod member one enough partly come avoid from its depart from.Selectivity, hook 4311 includes a linear extension portions 4313, from Hook extension and the parallel rod member 4301 are configured.In certain embodiments, the coupling includes one second and extended linearly Part 4315, configures to position parallel to rod member 4301 at an opposite side of element 4311.In certain embodiments, it is defined on The space between element 4315 and 4311 is closed to reduce by it by a ring Nie, for example as described below.Selection, it is multiple Element 4315 and 4311 is integrally formed connection and/or provided as single module that selective can be unlocked to allow The adaptation of rod member 4307 or 4309 inside and afterwards by by a ring compress and close (such as 4317).

In certain embodiments, element 4311 and 4315 defines a sharp cone distal profile, such as in rod member 4301 away from coupling The region direction on reduce.

In certain embodiments, the coupling includes a ring 4317, can be positioned on hook 4311 and element 43150 at least On the linear extension portions, to lock the coupling, such as on a direction in relatively described pointed cone direction, by making The ring advances to be placed on the cone-shaped part of the multiple element.

In certain embodiments, an inwall of the ring is pointed cone, for example, coupled in this paper for one screw-rod member Description.Selection, the inwall defines a cone shape profile, for example, define the passage that diameter is reduced in one direction, institute Direction is stated similar in appearance to the pointed cone direction of multiple element 4311 and 4315.

The example illustrated herein, ring 4317 includes an exterior contour, including one " ladder ", wherein away from the coupling A part include a diameter, less than close to the coupling a part.Replace, the ring may include other exterior contours, Such as cylindrical shape or conical or other sharp cone distal modes and/or comprising one or more labels (tabs) or recess, pass through one Aid is used in its Nie and closes effect.

Figure 43 illustrates multiple 4317 examples between multiple rod members 4307 and 4309 of ring.In some realities of the present invention Apply in example, one or both of multiple rings 4317 (or an Equivalent components) are not positions between multiple rod members 4307 and 4309.At this In one exemplary embodiment of invention, transverse bar meter 4307 extends across one or both of multiple rod members 4307 and 4309. Same mechanism described in Figure 43 could be used that when from (multiple) free end described in rod member 4301 towards multiple rod members 4307 and 4309 when being employed and when outside the structure, ring 4317 passes through the transverse movement towards a rod member 4307 or 4309 During fixing.A potential advantages from such mirror to arrangement, in the structure and multiple rod members 4307,4309 and 4301 just After true position, multiple rings 4317 easier can be installed.It is selection or replacement, if one end of rod member 4301 is Freely, can more easily apply strength to ring 4317.Some latent defects realized are possible to increase the knot The lateral dimension of structure.However, this can aid in installing extra object over the structure.

The exemplary of arc-shaped rod is used

Figure 44 A illustrate the rod member for being configured to be consistent with a natural curve of vertebra according to some embodiments of the invention 4401 exemplary curve.

In certain embodiments, rod member 4401 includes a S-shaped curvature, as shown in this figure.Optionally, the S-shaped curvature with Curvature in the structure of vertebra is consistent.In certain embodiments, the arc-shaped rod is configured to be connected to multiple pedicle of vertebral arch screw Between nail, such as four screws.As shown in this example, four collars 4403 are located on rod member 4401.In some realities Apply in example, the rod member can be optionally shortened during performing the operation, to be connected between small number of screw, such as by cutting The distal end of the disconnected rod member and/or near-end.

In certain embodiments, the recess of one or more collars 4403 includes a geometry position, and it is described that it is adapted to receiving One arc part of rod member, for example, the geometry position determined according to the axial location of the collar relative to the rod member. For example, the recess can be formed and have a concavity and/or a convexity in its inner surface, meet the rod member to be more nearly Arc part.

The accurate fit of rod member curvature and collar rod member passage curvature can interfere the collar on any curved bar Setting.In an exemplary embodiment of the invention, arc collar is inserted with a proper orientation, so that its channel plot is matched The rod member curvature.For example, the collar (such as two right axle rings) for having U-shaped (such as recessed) internal channel can be from the bar of the description Part 4401 and having is inserted on the right side of the collar (such as two, the left side, is inserted from left side) of inverted U-shaped (such as convex) passage. Selection or replacement, the passage rotated around the axle center of the rod member after such insertion, with match the rod member curvature and/ Or help the change of past rod member curvature direction of navigating.Selection or replacement, the collar has sufficiently resilient and/or logical Road size (when being, for example, unconfinement configuration) enables them to be advanced on the arc-shaped rod, has also been advanced to non-matching The position in rod member passage curvature direction.In certain embodiments, two-piece type collar or the collar for having sufficiently wide groove are adopted With so that they are laterally positioned on rod member, and without the rod member longitudinal axis of passing through.

Figure 44 B and 44C according to an exemplary embodiment of the present, display have asymmetric inner chamber and/or be adapted to receiving it is many The different designs of the collar of individual rod member geometrical construction.For example, the inner chamber can be arc, tubaeform and/or several with other What is constructed, as described below, comprising rotate simultaneously upper symmetric and asymmetric inner chamber and/or not with one or more collars The inner chamber of axle alignment.

More particularly, it is that identical collar is adapted to engagement and has differently curved half the characteristics of some embodiments of the invention The rod member in footpath, for example, between 30-240 millimeters scope bending radius, the rod member for 5-6 mm dias.

Figure 44 B show the asymmetric inner chamber 4412 in a collar 4410 according to some embodiments of the invention.One rod member 4414, It is not bent, adapts in the inner chamber 4412.Optionally, (it is not illustrated in figure) inner chamber 4412 can be laterally inclined from its position Move.Selection or replacement, (being also not illustrated in figure) inner chamber 4412 can be not orthogonal to the vertical axis of the collar 4410, for example, from Up or down is at an angle.

It is a groove 4416 to be also illustrated in the figure.As shown, the groove is vertical and symmetrically arranged, However, in some alternative embodiments (as described herein and/or other collars), the groove can have different geometric forms Shape.For example, the groove can have angle, for example, angle between 2 degree and 25 degree of Relative vertical line.Select or replacement , the groove can be removed laterally from center line, for example, remove collar of the distance between 5% and 30% maximum straight Footpath.Selection or replacement, the groove can form (example with curved and/or by different shape and/or orientation multiple parts As in a zigzag and/or include an ancon).

Figure 44 B display that a collar 4420, and inner chamber 4422 therein is all wider than rod member diameter at either end.In this way, For example, when the rod member 4424 (up curved) of a bending is inserted into the inner chamber, space can be formed at an edge 4428.It is optional , inner chamber 4422 (as shown), for not being made both wider at one end (or not wider), therefore is not free in interphase Between formed at position 4426.Optionally, so an identical inner chamber (and collar) is allowed to engage bending and un-flexed rod member (such as in two ends and/or centre).In certain embodiments, the inner chamber has an identical general shape at two ends and centre, Thus a space is also formed at position 4426.

Figure 44 B display that a relative geometrical construction, which use the axle with the inner chamber for downward bent rod part Ring 4430.As shown, when rod member 4434 is inserted into, a space can be formed at a position in the edge of passage 4432 4438, between the collar and the rod member；The middle bottom formed without space between the rod member and collar On the position 4436 in portion.

The word " width " may be defined as from inner chamber 4412,4422,4432 radially away from any direction, for example, width It can be increased on a vertical direction, horizontal direction or any direction placed in the middle.Widen (relative to the inner chamber centre and/ Or the general shape of the rod member) can also be in the two directions, for example, in a upwardly direction and a downwardly direction (in the phase homonymy of collar).

Similarly, it is notable that a collar is designed to for more complex-curved, for example, becoming sufficiently wide And/or to be designed to support a side in collar up curved and in opposite side down curved rod member for shape.

It is described to widen 10% He that be situated between in the length of the inner chamber in some exemplary embodiments of the present invention Between 100%, for example, being situated between the 20% of its length and 60%.Optionally, 1% He widened between the diameter Between 10%, for example, being situated between 2% and 8%.Reached for example, the collar inner chamber of 6 mm dias can be widened in its two ends 6.2 millimeter.

Figure 44 C show a collar 4440, wherein an inner chamber 4442 has a section over the whole length, the section is The semicircle for connecting (such as described widen be position in centre) by straight line by two is constituted.So mean that one is identical Collar can be used for the rod member of various shapes, such as linear and bent.Optionally, the inner surface of inner chamber 4442 is thick It is rough and/or with one or more projections, to engage the rod member after the locking of collar 4440.

Figure 44 C display that a collar 4450, wherein an inner chamber 4452 is in asymmetric relative to a side.Selection or replace Change, inner chamber 4452 can laterally bend (for example, rather than show such as Figure 44 B vertically bending).

It is worth noting that, in the accompanying drawings, the locking ring is usually that rotation is upper symmetrical.Optionally, it is asymmetrical. Optionally, the groove in collar can be made sufficiently wide, in order to provide a projection energy radially inside of the ring Enough it is adapted into the groove.Optionally, the ring is so allowed to bestow direct active force in for example, the screw and/or being used as institute State a wall in hole.

Fig. 4 D are the stereograms for the collar that display one according to some embodiments of the invention has perpendicular elongate passage, for example, Figure 44 C collar 4440 is applied to the rod member and straight rod member vertically bent；And Figure 44 E show according to some embodiments of the invention Multiple visual angles of diagram 44D collar, the rod member that collar has a bending is located therein.

As shown in Figure 44 D, in certain embodiments, passage 4442 is constituted in two semi-cylindrical shapeds 4444 and 4448 General shape, semi-cylindrical shaped 4444 and 4448 is separated by square position 4446 (being only capable of seeing from the stereogram).

Figure 44 E show that a rod member 4441 inserts passage 4442.Section A-A display channel 4442 is not covered by rod member 4441 Exposed position, be designated as space 4443.Rod member 4441 is in minimum supported flexure radius and touches the passage 4442 position in the channel between and passage either end wall.

When the passage 4442 is displayed as symmetrically, it is not necessarily upright position and/or the width in the collar side Degree (extent) can be differently configured from the width of its opposite side.Similarly, passage 4442 can be twisted (such as its two perforates one Relative to another one rotation).

Exemplary collar locking mechanism

Some exemplary implementations of Figure 45 A-H top closures used according to the invention and/or the collar of other single-pieces Example, a variety of locking mechanisms based on collar are shown with pair wise.Figure 45 A, 45C, 45E, 45G be shown in the fastening ring with Before, the collar 4501 (and 4511,4521 and 4531, respectively) and multiple rings 4503,4505 (and 4513,4515； Component 4523,4525 and 4533,4535, respectively)；Figure 45 B, 45D, 45F, 45H are shown in after the fastening ring Component.

In certain embodiments, as shown here, the collar (such as 4501,4511,4521,4531) is single group The collar of part (single-piece), it has a groove (such as 4509,4519,4529,4539) described for being adapted in distal site Screw head.Interchangeable, the collar can be formed by two or more components, as stated above.

In certain embodiments, as shown here, described relatively low and distal end ring (such as 4503,4513,4523, 4533) with described higher and near-end ring (such as 4505,4515,4525,4535) be positioned at the collar (such as 4501, 4511,4521,4531) on, even if thus when being moved to a restraint location, the ring can be located in a recess on end (such as 4507,4517,4527,4537), wherein a rod member is accommodated in the recess.One difference of the various embodiments is to close In the kenel of the relative motion of the ring, it can influence the design of the moving member of ring and/or bestow the active force of implantation.Another difference The different ring being between not be the same as Example relative to the pivot (top of collar) orientation and it is described be used for accommodate The hole of rod member and screw.Difference in the design is applied for the application form of active force and direction and/or which kind of object It is probably important with the active force.For example, in Figure 45 A/B, the active force (by the moving member of ring) bestowed is described Between the top of collar (or described rod member) and the bottom of the ring.In Figure 45 C/D and 45G/H, the ring moving member is bestowed The active force is between described two rings relative to each other, thereby increases and it is possible to do not having any contact with the top of the collar In the case of, or at least in the case where not applying a large amount of active forces to it.In Figure 45 E/F example, the effect Power is alternatively applied between the rod member and the ring, for example, between the bottom of the rod member and the ring.

In some exemplary embodiments of the present invention, the ring is (such as real for any locking ring described herein Apply example) be to be formed by a composite, such as the fiber in a polymer substrate.In some exemplary embodiments of the present invention In, (in the weight) at least 50%, 70%, 90% of the fiber or its median percentage or more are along general circumference Direction alignment (for example locks ring scission) to be resisted by the power applied by collar.

In some exemplary embodiments of the present invention, a locking ring has a radial thickness between 0.5 millimeter or 1 millimeter And between 4 millimeters, such as between 2.5 millimeters and 3 millimeters.Selection or replacement, a locking ring has a vertical height Between 0.5 millimeter and 5 millimeters, such as between 2 millimeters and 4 millimeters.Selection or replacement, a locking ring has interior Footpath is between 5 millimeters and 15 millimeters, such as between 8 millimeters and 12 millimeters.Selection or replacement, a locking ring is light Sliding.Interchangeable, the ring includes one or more grooves (groove), grooving (notch) and/or disturbance unit (perturbation), for example, circumferential ridge, it can be used in engagement and the mobile locking ring.In some implementations of the present invention In example, the ring includes one or more radiopaque labels, for example, a circumference (can be optionally embedded) fiber, and/or it is multiple Round dot or cylinder.

In some exemplary embodiments of the present invention, one of described ring or both is to be set in advance in the collar On.Selection or replacement, the ring (such as 4503) in distal end, which is located at, makes it not extend in the collar (such as 4501) under.Or such as 3 millimeters, 2 millimeters or 1 millimeter is not extended at least, alternatively before locking and/or lock Do not extend afterwards.

Figure 45 A and 45B show a relatively low ring 4503 and the exemplary configuration of a restraint location be increased to compared with epipodium 4505, The restraint location is close in the collar portion of the opposite side of groove 4509, the groove 4509 and the screw head phase each other Match somebody with somebody.As illustrated, ring 4505 is abutted against in the one of collar 4501 step optionally radially extended, to prevent unnecessary motion And it can be made towards the near-end gradually upward sliding, and then fasten the collar of collar 4501.In certain embodiments, in institute State locking ring fastening before and/or afterwards, frictional force supports the locking ring in position.In certain embodiments, Contact surface between the ring and the collar includes one or more juts, the jut in optional direction, to improve engagement And/or prevent sliding.

In some exemplary embodiments of the present invention, a general part cone is gradually widened defined in collar Tee section.

Approximate mechanism can be used in distal loop 4503.Optionally, the first ring 4503 is tightened, followed by ring 4505.It can replace Ground is changed, they are to be tightened in reverse order.Alternatively, they are alternately tightened up, and a ring is tightened, and then change another Ring, then changes the first ring and is tightened again.

In some exemplary embodiments of the present invention, for example, locked and filled using the ring as shown in Figure 47 A and 47B Put, the ring is optionally locked to together.Optionally, these devices ensure the relative rearmost position of two ring.In some realities Apply in example, the absolute position of the ring is similarly set.

In some exemplary embodiments of the present invention, mode is tightened up for example following.Proximal loop 4505 is used for connecting institute Rod member is stated to the collar, and distal loop 4503 is used for attachment screw to the collar.Optionally, proximal loop 4505 is being closed Before, allowing the collar to be slided on the rod member with adjust between adjacent collar apart from the case of, distal loop 4503 The angle fixed between the screw and the collar can be used for.In certain embodiments, the proximal loop 4505 is first It is closed, and the angle between the screw and the collar can be adjusted between the distal loop 4503 is closed.

In some exemplary embodiments of the present invention, the present embodiment and/or the distal end of other embodiment and near-end Ring is identical (can for example reduce stock).Selection or replacement, different rings are used, for example, different height, diameter and/ Or the ring of thickness.

Figure 45 C and 45D show that relatively low ring 4513 is enhanced and is reduced to the exemplary of a locking position compared with epipodium 4515 Configuration, the restraint location is close in the collar portion of the opposite side of groove 4519, the groove 4519 and the screw head It is mated with one another.The collar mechanism gradually widened for having an optional step of same form is shown in figure.The one of the present invention In a little exemplary embodiments, described widen is in 0.1 degree and 10 degree of angular range, for example between 1 degree and 5 degree, again For example between 2 degree and 3 degree.The angle can be fixed, and can be dull and/or various, optionally be included one negative Angle (such as define a stop place).Optionally, for a upright position, the angle is circumferentially uniform.

In some exemplary embodiments of the present invention, between a ring is designed to mobile 1 millimeter and 5 millimeters, for example, Between 1.5 millimeters and 2.5 millimeters (and described widen is added to the point and/or terminates at a step).Optionally, it is described to prevent ring The radial dimension of the step of motion is between 0.2 millimeter and 4 millimeters, such as between 1 millimeter and 3 millimeters.

The potential advantage of the design is that the ring can be moved in the way of one is relative to another one and hung down without applying Straight active force is in the implantation.As shown, collar 4513 can extend through collar 4511 before tightening up.

Figure 45 E and 45F show relatively low ring 4523 and the exemplary configuration of a locking position, institute are reduced to compared with epipodium 4525 Restraint location is stated close in the collar portion of the opposite side of groove 4529, the groove 4529 and the screw head phase each other Match somebody with somebody.

Figure 45 G and 45H show that relatively low ring 4533 is lowered and is increased to the exemplary of a locking position compared with epipodium 4535 Configuration, the restraint location is close in the collar portion of the opposite side of groove 4539, the groove 4539 and the screw head It is mated with one another.Figure 45 G and 45H display that the design variations (such as in the present embodiment and/or other implementation profits) of the ring, its In, a ring includes a grooving, is optionally the grooving of circumferentially extending, and it can assist the ring movement instrument to be engaged.Selection Or replacement, if the ring is close together or even contacted, the grooving is used to allow the ring movement work Between the tool insertion ring.

The potential advantage of component of the one kind comprising multiple locking rings (such as two locking rings), for example, carried out with single locking ring Compare, being can be comprising the angular range increase positioning screw relative to the collar.In certain embodiments, it is the multiple Less-restrictive and/or the multiple ring of the ring when making screw be oriented relative to the collar can reduce the vertical section of system (vertical profile)。

Reduce a locking ring (such as relatively low locking ring 4503) to be fixed in collar, rather than improve the ring, its Potential advantage can be comprising the wheelbase reduced between the screw head and the surface of the bone, because the ring fixed in advance Positioning be proximate to the distal site towards the bone surface of the screw head, and be inserted into bone in head of screw Period is close to bone surface without interference with by head of screw.The bar portion that such configuration can reduce screw extends the screw head Bottom and the bone surface between length, the bar portion length of the screw is to occupy (before locking) simultaneously by the ring in advance And keep exposed such as acting under the active force of the bending load on implant assembly.

Optionally, the ring is fixed one by one and non-concurrent is fixed, it is allowed to which the component is gradually locked.

Some exemplary embodiments of the open-topped collars of Figure 46 A-H used according to the invention one, it is aobvious with pair wise Show a variety of locking mechanisms based on collar, such as collar of a single component offers groove at its near-end position with distal site. It is described configuration generally corresponding diagram 45A-H configuration, wherein difference be a near-end locking ring (such as 4605,4615,4625, 4635) it is optional status in the one relative of the rod member compared to a far-end locking ring (such as 4603,4613,4623,4633) Side.So allow the screw head and the rod member more individually to lock and/or provide less mechanism to fail and other Connection between mechanism failure.This configuration can be exchanged with Figure 45 A-H design, and two of which ring shares the locking action Power.In some embodiment (not shown)s, the collar is separated over the entire length.This collar is pre-loaded with locking ring to help Even keeping its shape in it and it is also easier to operate to before locking.Optionally, although it is described proximally and distally Groove as shown seem to be generally aligned in the same plane, two groove be not in same plane, be, for example, it is vertical each other.Herein Groove design described by reference picture 46A-H can be used together with other locking mechanisms.

In some exemplary embodiments of the present invention, the potential advantage with separated proximally and distally groove is wherein every It is individual dividually to be locked (completely or partially), it is allowed to carry out the adjustment of implantation step (for example when being locked to screw, together When allow to manipulate the rod member, vice versa).Generally it is being so potential advantage using two locking rings, but when each ring During corresponding to a slot, the advantage can be more obvious.

In certain embodiments, as shown here, the collar (such as 4601,4611,4621,4631) is single-piece axle Ring, it includes groove (such as 4609,4619,4629,4639) of the position in its distal end, to be adapted to the screw head, and One groove (such as 4608,4618,4628,4638) in its near-end, can allow the rod member to pass through to be positioned at the recess In 4607.

In certain embodiments, as shown here, the ring is located in collar 4601, to cause compared with epipodium 4605 Position is in the position close to recess 4607, and 4603, relatively low ring is in the position away from recess 4607, even if when ring is moved to tightly Maintenance is put.

Figure 46 A and 46B show relatively low ring 4603 and the exemplary configuration of a locking position be increased to compared with epipodium 4605, compared with Epipodium 4605 make it that the collar portion on the opposite side of groove 4608 is bringing together, and relatively low ring 4603 causes the opposite side of groove 4609 On collar portion it is bringing together.

Figure 46 C and 46D show that relatively low ring 4613 is enhanced and is reduced to the exemplary of a locking position compared with epipodium 4615 Configuration；Ring 4615 make it that the collar portion on the opposite side of groove 4618 is bringing together, and ring 4613 causes the opposite side of groove 4619 On collar portion it is bringing together.

Figure 46 E and 46F show relatively low ring 4623 and the exemplary configuration of a locking position are reduced to compared with epipodium 4625；Ring 4625 make it that the collar portion on the opposite side of groove 4628 is bringing together, and ring 4623 causes the collar on the opposite side of groove 4629 Part is bringing together.

Figure 46 G and 46H show that relatively low ring 4633 is lowered and is increased to the exemplary of a locking position compared with epipodium 4635 Configuration；Ring 4635 make it that the collar portion on the opposite side of groove 4638 is bringing together, and ring 4633 causes the opposite side of groove 4639 On collar portion it is bringing together.

It is understood that collar (ring design such as based on Figure 45 and 46) can be comprising such as one in distal side and/or near The crack of side and a locking ring are covered on the crack, and/or maintain a distance with the crack, depending on its implementation.It is special Other to be, if the position of the both sides of collar connection (such as permanently connected or connected by ring) is identified as into pivoting point, a ring can With position element (such as rod member or screw head) that will be engaged phase homonymy pivotally or in its opposite side.

Two exemplary ring locking mechanisms

Figure 47 A show a kind of can be used in the mechanism 4700 of Figure 45 A collar 4501.One or more arms 4702 are by ring 4503 and ring 4505 engage.Optionally, the engagement is respectively by jut 4704 and 4706.Although only two-arm 4702 is shown Show, the arm of more or less quantity is all likely to be used.Each jut 4704 and 4706 can be extended circumferentially over upon, for example Between 5 degree and 350 degree, between 10 degree and 40 degree and/or it can and for example extend circumferentially over upon more than arm 4702.

In some exemplary embodiments of the present invention, active force is artificially to apply manually.The shape of one block 4708 It is designed to be resisted against the top of collar 4501 and one handle 4714 is connected to by hinge 4710.Optionally, hinge 4710 It is used as the fulcrum of a lever.The arm 4702 is connected to handle 4714 in a second hinge 4712 (allows it parallel to described Collar is moved).Optional there is provided have two handles 4714 so that in extruding, the He of ring 4503 is withdrawn relative to collar 4501 4505.Can be used other design and/or be designed as moving downward for ring changed (such as shape of block 4708 be designed to by Insertion rod member is engaged from beneath).

Figure 47 B show the similar mechanism 4750 based on lever of (equally on section) one, and it can be used in Figure 45 C axle Ring 4511 moves toward each other ring 4513 and 4515 (such as described compared with epipodium rather than the collar by promoting).Ring 4513 It is engaged in by the jut 4754 of an arm 4752 beneath.Ring 4515 is engaged in by the extension 4756 of a block 4758 Side.Two handles 4764 are optionally used to provide the phase between (such as forcing together) described jut 4754 and extension 4756 To motion.Optionally, arm 4752 is attached on handle 4764 by hinge 4762, and the handle is (to be used as branch by hinge 4760 Point) it is attached to block 4758.

Although the mechanism advantage only realized using two lever manuals is illustrated, other designs can be used as, and for example can The other modes of mechanical advantage, such as screw or hydraulic pressure are enough provided.Selection or replacement, ratchet mechanism can be used, therefore institute Each " compressing " for stating handle promoted by be allowed the ring and locked the arm mechanism on a position using ratchet, to allow application volume Outer compressing.Optionally, hinge 4712 (and 4762) can be replaced by ratchet mechanism and/or strengthen to reach the effect.For manual For force application alternatively or alternatively, kinetic energy can be provided by other means, such as electro-motor in use device, Use pneumatic and/or use hydraulic way (such as from the outside of device, for example, being exported via a standard hospital).

It is exemplary to use

In some exemplary embodiments of the present invention there is provided one kind without metal and/or heavy element (for example metal or Heavy element content is less than 0.5% and with " no metal " low 0%).Optionally, atomic wts are 40,30,25,20,15,13 Element above is provided.The potential advantage of such set group can avoid metal or other may interfere with patient radiation treatment Material.Another potential advantage is to be minimized the artifact (artifacts) in MRI and/or CT and/or NM imagings.It is worth note Meaning, however, in imaging method, the artifact for being not adjacent to key area can be acceptable.For radiotherapy, along Any material in radiation path is probably a problem.

The connection that one feature of some embodiments of the invention is between the locking ring and collar be non-threaded and Use frictional force.It is worth noting that, in general, nonmetallic screw thread is difficult to, due to the dynamic of such as composite And/or the relation of static friction coefficient, the friction lock in composite may relatively be better than the friction lock of metal.With some gold Symbolic animal of the birth year ratio, the elasticity of composite can allow the scope that more motions and/or active force apply.

The operation nursing of the patient shifted with Primary tumour and backbone usually requires to utilize spinal instrumentation (rear bar And pedicle screw) permanent stabilization.It is postoperative generally to recommend radiotherapy.Treat and successfully depend on there are enough radiation lifes Agent amount is delivered to tumour, and radiation can be avoided to cause permanent damage to spinal cord often adjacent with the tumour.Spinal cord Tolerance (45 dagger-axe thunders are in 23-25 fractions) determines the narrow treatment window of this treatment.With low-grade malignant tumor (such as notochord Knurl, chondrosarcoma) for, it is particularly challenging that local disease control units cure patient in these cases.These Tumour is not especially sensitive to radiation therapy, it is necessary to more than the radiological dose of 70 dagger-axe thunders.

Traditional metal implant may hinder safely and effectively auxiliary treatment.Titanium (and other metal alloys) is with showing For imaging technique (CT or MRI) poor compatibility, accurate postoperative evaluation can be covered.Adjuvant radiation therapies requirements of plan is clearly Imaging, because accurately Rapid Dose Calculation is based on CT values (Hausfeld unit Hounsfield Units, HU) and then by school Standard is that the relative emission line calculated for dosimetry stops power, and is influenceed by hardware artifact.It is false by metal in CT data The agent that treatment may cause the tissue in the region adjacent with metal implant to reduce 5% to 10% is carried out under conditions of shadow destruction Amount, for example, because the diagnosis of mistake and/or the part of implant cause artifact to can also interfere with radiation in itself.Radiation may be come from The further radiation disturbance of back scattering and the decay of light beam can further interference calculation and/or transmission.

Several Clinical and experimental studies have investigated this problem.It was reported that, to treatment chordoma and chondrosarcomatous The presence of titanium implant is the important risk factor of local treatment failure for patient.Report is also indicated that due to for proton The disturbance of dosage distribution produced by the patient of the bilateral hip prosthesis (and photon and electronics plan) of plan, is occurred in that tight The low dosage of weight is given.Tantalum label for positioning of the eyes in uveal melanoma treatment is found agent of the meeting in absorption Significant disturbance is produced in amount distribution, and may cause to exceed the significant dosage shades for clamping (clips) more.

In some exemplary embodiments of the present invention, not using metal marker thing.Alternatively, operation is open hand Art, does not have any radiopaque label on any part of system.

Selection or replacement, the set group includes cannula part, such as screw, and such as insert of k lines, and it is adapted to insert Manage and including radiopaque mark.Selection or replacement, the set group is one or more including what is used during being implanted into The radiopaque component installed.However, these components are removable after the implantation.In an example, the connection of these parts To bracing wire or suture, and body (such as temporary attachment, for example, using adhesive and/or fitting in set group group can be drawn out In the socket or groove of part).Selection or replacement, as described in United States Patent (USP) 6626936 and the disclosure of which is incorporated by reference into This paper multiple soluble radiopaque marks are used.

In some exemplary embodiments of the present invention, non-metal stabilization system is used on this patient.Selection Or replace, existing systems stabilisation is removed and substituted by non-metallic system, for example as described herein.

In some exemplary embodiments of the present invention, set group as described herein has following size：Major diameter of thread scope For 3 to 8 millimeters, such as 4,5,5.5,6,5.5,7,7.5 millimeters；And/or reach be 30 to 70 millimeters, such as 35,40, 45,50,55 millimeters；And/or a diameter of 5 to 9 millimeters of screw head, such as 8,8.3 millimeters；And/or rod member diameter range be 4 to 7 millimeters, such as 6 millimeters.The collar and/or the size of locking ring alternatively adapt to the screw and rod member, and with most Small added size a, for example, intensity is enough to resist its minimum dimension in body implosion.

Generally

The various features of multiple devices and multiple methods are described, it will be appreciated by those skilled in the art that the present invention is not limited In the content for being specifically set forth above and describing.Opposite, protection scope of the present invention includes the group of various features described above Close and sub-portfolio, and those skilled in the art read aforementioned specification after it is contemplated that, it is unexistent in the prior art Its various change and modification.

It should also be understood that, although some embodiments are described merely as method or are described merely as device, but the protection of the present invention Scope includes the method using the utensil or the utensil with methods described.The scope of the invention is also covered by being used to produce the device The machinery of tool.In addition, the scope of the invention also using, component, the method calibrated and/or repair utensil described herein.Work as institute Attached claim and term " comprising " used above, " including ", "comprising", " including ", " having " and their knot Close, it is intended that " including but not limited to ".The term " being made up of .. " generally means " include and be limited to ".

The term " substantially by ... constitute (essentially consisting of) " refers to constituent, side Method or structure may include extra composition, step and/or part, but only when extra composition, step and/or part are substantial The essential characteristic and new feature of composition claimed, method or structure are not changed.

As it is used herein, " one (a, an, the) " of singulative is unless the context comprising plural number Form.For example, term " compound (a compound) " or " an at least compound (at least one compound) " can With including multiple compounds, including its mixture.

In whole application, various embodiments of the invention can be presented in a range format.It should be understood that, scope shape The description of formula is for convenience and simplicity only, and is not necessarily to be construed as imposing restrictions on the scope of the present invention.Therefore, scope Description should be considered as having specifically disclosed the single number in all possible subrange and scope.For example, scope Description, should be taken into account with specifically disclosed subrange from 1 to 6, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, From 3 to 6 etc., and number is in the scope, and such as 1,2,3,4,5 and 6, no matter the width of scope is all applicable.

Pointed out herein whenever number range, it refers to include (decimal in the scope indicated by any reference numeral Or integer).The phrase " in the range of/scope between (ranging/ranges between) " is in the first designation number and second Designation number, and " ranging/from scope (ranging/ranges from) " the first designation number " to (to) " second indicated number Word is used interchangeably herein, and is to include the first and second designation numbers all fractions therebetween and integer number.

The term " method (method) " as used herein refers to the mode, means, skill for completing Given task Art and program, include but is not limited to, those modes, means, technology and program are known, or pass through chemistry, pharmacology, life The practitioner of thing, biochemistry and medical domain, easily develops from known mode, means, technology and program.

As used herein, the term " treatment ", which includes, eliminates, generally suppresses, slows down or reverse entering for a situation Exhibition, the clinic or outward appearance symptom that generally improve a situation or clinic or the appearance of outward appearance symptom for generally avoiding a situation.

It is understood that some features of the present invention, for the sake of clarity described in the context of separate embodiments, It can also combine and be provided in single embodiment.On the contrary, the various features of the present invention, for simplicity in single implementation Example context described in, can also individually or with any suitable sub-portfolio, or as be applied to the present invention any other The embodiment of description is provided.Some features described in the context of various embodiments are not considered as the embodiment Essential feature, unless the embodiment does not have the element to be inoperable.

Although the present invention has been described in conjunction with the specific embodiments thereof, it will be apparent that many replace, change and become Change is obvious for those those familiars.It is, therefore, intended that covering the spirit and model for falling into appended claims All such replacements, modifications and variations in enclosing.

All disclosures referred in this manual, patent and patent application are in their entirety incorporated herein by reference this In specification, same degree, just as each single disclosure, patent or patent application specifically and individually shown by It is incorporated herein by reference.In addition, any reference that the present invention quoted or identified in this application is not construed as recognizing Such bibliography can be used as prior art.To a certain extent, the use of chapter title is not construed as necessary limit System.

Claims

1. a kind of pedicle screw implant infrastructure set group, it is included：

An at least pedicle screw, comprising a head, the screw is included containing the multiple benefits being embedded in a polymer substrate The composite of strong filiform；

An at least monoblock type collar, the collar includes answering containing the multiple reinforcement filiforms being embedded in a polymer substrate Condensation material, the collar includes an at least recess, and the recess defines a hole, the shape in the hole and is dimensioned so as to For accommodating a rod member, size, shape and the configuration of the collar are designed to connect described in the pedicle screw Head；

One extension rod member, size and shape is designed for connecting the collar and one or more extra collars, so as to connect Between an at least pedicle screw and one or more additional bolts, the rod member, which includes containing, is embedded in a polymer The composite of multiple reinforcement filiforms of Medium Culture；And an at least locking ring, the ring, which includes containing, is embedded in a polymer The composite of multiple reinforcement filiforms of Medium Culture, the size and shape of the ring is designed to be positioned at the collar extremely The one of which of the screw head and rod member is limited on small part and by applying radial compression force to the collar Or both relative to the collar relative motion.

2. set group as claimed in claim 1, wherein, the composition surface of the collar and the ring between both does not have spiral shell Line.

3. the set group as described in any one of previous claims, wherein, the set group is comprising more less than 1% by weight Individual atom, the atomic number of the atom is more than 25.

4. the set group as described in any one of previous claims, wherein, the set group is comprising by weight less than 0.01% Multiple atoms, the atomic number of the atom is more than 25.

5. the set group as described in any one of previous claims, wherein, the set group does not include radiopaque mark.

6. the set group as described in any one of previous claims, wherein, shape and it is dimensioned so as to for accommodating a bar The hole of part has different from the section of the rod member and/or without rotationally symmetrical inclined relative to the rod member shape Move.

7. set group as claimed in claim 6, wherein, shape and it is dimensioned so as to the hole edge for accommodating a rod member A direction to be extended, the direction relative to the hole the longitudinal axis radially.

8. set group as claimed in claim 7, wherein, the prolongation exceedes the entire length in the hole.

9. set group as claimed in claim 7 or 8, wherein, the prolongation is different from the hole at the hole two ends Any prolongation at cave center.

10. the set group as any one of claim 7 to 9, wherein, the multiple straight rod members of the prolongation support engagement With the hole of multiple rod members with least 30 millimeters bendings of radius of curvature.

11. the set group as any one of claim 7 to 10, wherein, the prolongation is relative to the collar in vertical Directly.

12. the set group as described in any one of previous claims, wherein, it is described before the ring causes mobile limit Ring is arranged in the collar.

13. set group as claimed in claim 12, wherein, the ring is arranged at the stenosis of the outline of the collar, vertically Ground is configured to by friction lock to the width at a progressive width of the outline.

14. set group as claimed in claim 13, wherein, it is one unexpected that the ring is arranged to vertically adjacent to the outline Width at.

15. the set group as any one of claim 12 to 14, wherein, the set group includes at least two rings, and both are all It is arranged in the case of the limitation is not caused in the collar.

16. the set group as any one of claim 12 to 15, it is characterised in that：The collar is slotted in one near-end With a distal end.

17. the set group as described in any one of previous claims, wherein, the set group is used for the collar comprising two Locking ring, wherein the collar includes two regions, for locking the ring to the collar.

18. set group as claimed in claim 17, wherein, the ring is all pre-loaded with the axle before the limitation is caused On ring.

19. the set group as described in claim 17 or 18, wherein, the collar includes an at least radial extension, its avoid to A few ring is skidded off from the collar.

20. the set group as any one of claim 17 to 19, wherein, an at least ring is from the neighbouring collar to away from institute Collar is stated in more and more narrow.

21. the set group as any one of claim 17 to 20, wherein, the collar is slotted remote in one near-end and one End, and each ring is provided in the upright position of the different groove of correspondence.

22. the set group as any one of claim 17 to 21, wherein, the collar shapes are designed to locking a ring When can only limit the rod member and the screw head one of which motion.

23. the set group as any one of claim 17 to 22, wherein, the collar shapes are designed to locking described two Ring needs the motion in the same direction of two ring.

24. the set group as any one of claim 17 to 22, wherein, the collar shapes are designed to locking described two Ring needs the counter motion of two ring.

25. the set group as any one of claim 17 to 24, wherein, two ring is arranged under the rod member.

26. the set group as described in any one of previous claims, wherein, the collar shapes are designed to：Allow a locking Ring can be disposed thereon without the limitation, and during being then locked in place and being not used in installment state or lock-out state One millimeter is extended beyond under the collar.

27. set group as claimed in claim 26, wherein, the collar shapes are designed to allow the ring to pass through distal end Motion locking away from two hole is lived.

28. a kind of fastening collar is in the method for pedicle screw, it is included：

Adjust at least one of rod member in the collar and a screw head relative to the position of the collar and/or Orientation；

The locking ring is moved to another configuration of the collar from a kind of configuration of the collar, thus causes the axle Ring is dimensionally radially reduced and engages the rod member and/or the screw head.

29. a kind of fastening collar is in the method for pedicle screw, it is included：

One collar is provided；

At least two locking rings are moved relative to the collar, radially to reduce the hole in the collar, thus engagement institute State rod member and/or the screw head.

30. method as claimed in claim 29, wherein, methods described is included and moved in opposite directions along the axle of the collar The locking ring.

31. the method as described in claim 29 or 30, wherein, methods described includes the axle along the collar with equidirectional The mobile locking ring.

32. the method as any one of claim 29 to 31, wherein, it is described that methods described is contained in same time movement At least two locking rings.

33. the method as any one of claim 29 to 32, wherein, methods described is included by respectively mobile described Two locking rings respectively lock the rod member and the screw head.

34. a kind of method for selecting to be used in the set group component that backbone fixes operation, this method is included：

The required layout of two rod members is determined, includes the different bendings of two rod member；The different bendings have bending comprising one First bending and one of the radius between 30 millimeters and 60 millimeters have the second bending of at least twice crooked process radius；And

35. a kind of method for providing patient radiation treatment, it is included：

According to it is described judge to select one entirely compound backbone fix set group, the degree of its not interference radiation exceedes aluminium；

Insert the system；And

Radiation treatment is provided to the patient.

36. method as claimed in claim 35, wherein, before the selection and after the judgement, also comprising removal one Both the backbone fixation kit containing metal deposited.

37. the method as described in claim 35 or 36, wherein, methods described is included abuts the backbone and pass with no metal The mode for joining the set group provides radiation treatment to the patient.

38. a kind of lock collar, is fixed to be used together with a rod member with a pedicle screw in vertebra, it is characterised in that： The lock collar is included：

An at least collar body, the collar is included containing the compound of the multiple reinforcement filiforms being embedded in a polymer substrate Material, the collar includes an at least recess, and the recess defines a hole, the shape in the hole and is dimensioned so as to use To accommodate a rod member, size, shape and the configuration of the collar are designed to connect the head of the pedicle screw Portion；And

An at least locking ring, the ring includes the composite wood containing the multiple reinforcement filiforms being embedded in a polymer substrate Material, the size and shape of the ring is designed to be positioned at least part of the collar and by applying radial compression force Relative motion of the one or both of which relative to the collar of the screw head and rod member is limited on to the collar.

39. collar as claimed in claim 38, wherein, the collar has two locking rings, and two locking ring is to lock Two different vertical positions relative to vertebra in the collar；And/or wherein described collar have it is sufficiently resilient and described The shape in hole is designed to the rod member for allowing the collar to mismatch the hole along bending towards a direction and/or bending amount It is pushed into；And/or wherein described collar is offered groove and is laterally positioned in sufficiently resilient on a rod member, the bar Part is adapted to be locked in using the locking ring in the hole.

40. a kind of lock collar, is fixed to be used together with a rod member with a pedicle screw in vertebra, wherein, the lock Dead axle ring is included：

An at least integrated shaft ring body, the collar is included containing the multiple reinforcement filiforms being embedded in a polymer substrate Composite, the collar includes an at least recess, and the recess defines a hole, and the shape and size in the hole are set Count into for accommodating a rod member, size, shape and the configuration of the collar are designed to connect the pedicle screw The head；And

41. lock collar as claimed in claim 40, wherein, the lock collar includes at least two locking rings.

42. lock collar as claimed in claim 41, wherein, the ring is positioned in the collar and for accommodating a rod member The hole under.

43. the lock collar as any one of claim 40 to 42, it is characterised in that：The collar and the ring are at it A composition surface between the two does not have screw thread.

44. a kind of pedicle screw implant infrastructure set group, wherein, the pedicle screw implant infrastructure set group Bao Han ︰

An at least collar, the collar includes the composite wood containing the multiple reinforcement filiforms being embedded in a polymer substrate Material, the collar includes an at least recess, and the recess defines a hole, the shape in the hole and be dimensioned so as to for A rod member is accommodated, size, shape and the configuration of the collar are designed to connect the head of the pedicle screw；

One extension rod member, size and shape is designed for connecting the collar and one or more extra collars, so as to connect Between an at least pedicle screw and one or more additional bolts, the rod member, which includes containing, is embedded in a polymer The composite of multiple reinforcement filiforms of Medium Culture；And

45. set group as claimed in claim 44, wherein, the composition surface of the collar and the ring between both does not have Screw thread；And/or wherein described set group includes the multiple atoms for being less than 1% by weight, the atomic number of the atom is more than 25； And/or wherein shape and the hole being dimensioned so as to for accommodating a rod member have the section different from the rod member And/or the rotationally symmetrical skew without relative to the rod member shape；And/or wherein cause in the ring and described limit it Before, the ring is arranged in the collar；And/or the set group is used for the locking ring of the collar comprising two, and wherein The collar is used for locking the ring to the region of the collar comprising two；And/or wherein described set group is used for comprising two The locking ring of the collar, and wherein described collar comprising two be located at the rod member under be used for lock the ring to the axle The region of ring.

46. a kind of to fasten two locking rings in the device in a collar, the shape and size of the collar are designed to branch A vertebral column rod and a pedicle screw are held, described device is included：

(a) an at least arm, it has an at least engagement of loops portion；

(b) an at least element is used to engage the collar or one second ring；And

(c) control-rod, it has one handle and is connected to the arm, and is separably coupled to the element and causes therebetween Relative motion.