CN101330878A - Devices and methods for vertebral augmentation - Google Patents

Abstract

The apparatus comprises elongated members (2200) which are inserted into vertebrae and secured to an arcuate fixation rod (2300) by clamps (2400) which when moved along the rod cause the elongated members and attached vertebrae to pivot. The method may further include passing through a cannula (2100) and into the damaged vertebra a disruption tool for fracturing the damaged vertebral body. Once the cortical bone is broken or otherwise disrupted, the height of the damaged vertebral body may be restored, for example by removing the disruption tool and inserting through the cannula another tool, implant, device and/or material to restore the height of the vertebral body and to restore normal spinal curvature in the affected area. Grafting material or filler may be added with or without an implanted device to augment the damaged vertebral body.

Description

Devices and methods for vertebral augmentation

technical field

The present invention relates to surgical implants, and in particular the present invention relates to minimally invasive devices and methods for augmenting vertebrae and reducing lordosis.

Background technique

Vertebral compression fractures, as shown in Figure 1, represent an injury that is often present in the spine and can lead to long-term disability. These fractures involve the resulting collapse of one or more vertebral bodies 12 in the spine 10 . Compression fractures of the spine usually occur in the lower vertebrae of the thoracic spine or in the upper vertebrae of the lumbar spine. They typically involve fractures of the anterior portion 18 (opposite the posterior portion 16 ) of the affected vertebra 12 . Spinal compression fractures can cause distortions in the normal alignment or curvature of the vertebral bodies in the affected area of the spine, such as lordosis. Spinal compression fractures and/or associated spinal deformities may be caused, for example, by metastatic disease of the spine, by trauma, or may be associated with osteoporosis. Until recently, doctors were confused about how they could treat this compression fracture and associated deformity. Drug therapy for pain, bed rest, brace immobilization, or invasive spinal surgery are the only options currently available.

More recently, minimally invasive surgical procedures have been developed to treat vertebral compression fractures. These procedures generally involve the insertion of a rigid cannula, needle or trocar that is inserted into the interior of a collapsed or otherwise damaged vertebral body. The cannula may include a cavity or central passageway through which another tool, implant or filler material may be passed to reposition and/or augment the vertebral body. A common surgical approach to the interior of the vertebral body is from the posterior side, for example through one or two pedicles as shown in FIG. 2 .

The most basic of these procedures is vertebroplasty, which literally means immobilizing a vertebral body and can be achieved without first repositioning the bone. Briefly, a cannula or specialized bone needle is slowly passed through the soft tissues of the back. Image-guided x-rays with a small amount of x-ray dye make it possible to see where the needle is at all times. A small amount of polymethylmethacrylate (PMMA) or other orthopedic bone cement is pushed through the needle and into the vertebral body. Polymethylmethacrylate is a medical grade substance that has been used in a variety of plastic surgery procedures over the years. Typically, cement is mixed with antibiotics to reduce the risk of infection and with powders containing solutions of barium, tantalum or iodine that make the cement visible under X-rays.

Vertebroplasty can effectively reduce or eliminate fracture pain, prevent further collapse, and restore mobility to the patient. However, this procedure does not reposition the fractured bone and thus does not address spinal deformities resulting from the fracture. The procedure is usually performed only if the kyphosis between adjacent vertebral bodies in the affected area is less than ten percent. Furthermore, the process requires high-pressure cement injection with low-viscosity cement and, according to recent studies, causes cement leakage 30-80% of the time. In most cases, cement spills are indeed harmless. However, in rare cases, polymethyl methacrylate or other cement leaks into the spinal canal or paravertebral venous system and causes a pulmonary embolism, resulting in the patient's death.

A variety of more advanced methods of treating vertebral compression fractures are known and generally involve two stages: (1) Repositioning or restoring the original height of the vertebral body and thus anterior spinal curvature to the curvature of the spine; convex correction; and (2) adding or adding material to support or strengthen the fractured bone. For vertebroplasty, this procedure typically involves the use of a cannula, catheter, needle, trocar, or other introducer to gain access to the interior of the affected vertebral body.

For example, Figures 3A-3D illustrate one such treatment procedure, Balloon Kyphoplasty (Kyphon, Inc.). A catheter with an expandable balloon tip is inserted through a cannula, sheath, or other introducer into the central portion of the fractured vertebral body, which consists of relatively soft cancellous bone surrounded by fractured cortical bone (FIG. 3A). Kyphoplasty subsequently achieves reconfiguration of the lordosis or normal curvature by inflating a balloon that expands within the vertebral body to restore it to its original height (Fig. 3B). The balloon is removed, leaving a void in the vertebral body, and polymethylmethacrylate or other filler material such as bone cement is then injected through the cannula into the void (Fig. 3C), as described above for the vertebral body Plastic surgery as described. The sleeve is removed and the cement is cured to reinforce, fill or fix the bone (Fig. 3D).

Disadvantages of this procedure include higher cost, loss of vertebral body height after removal of the balloon catheter, high pressure required to apply sufficient force to separate or maintain separation of the vertebral endplates, and possible perforation of the vertebral endplates during the procedure. For vertebroplasty, the most dreaded complication involving kyphoplasty can occur, associated with leakage of bone cement, although extremely unlikely. For example, leakage of bone cement into the spinal canal can lead to neurological deficits. Leakage of this cement may occur through the low resistance blood vessels of the vertebral body or through previously unnoticed cracks in the bone. Other complications include: additional adjacent horizontal vertebral fractures, infection, and cement embolism. The mechanism of cement embolism is similar to that of cement leakage. Cement can be forced into the low resistance venous system and travel to the lungs or brain causing pulmonary embolism or stroke. Additional details related to balloon kyphoplasty can be found, for example, in US Patent Nos. 6,423,083, 6,248,110, and 6,235,043 to Riley et al., each of which is incorporated herein by reference in its entirety.

Another procedure used to treat vertebral compression fractures is the Optimesh system (Spineology, Inc., Stillwater, MN), which utilizes an expandable mesh bag or seal to deliver cement or Allograft or bone allograft. The bag or graft remains inside the vertebral body after it has been expanded, which prevents detrimental repositioning during surgery, such as when the ball is withdrawn during kyphoplasty. as may be the case with capsules. The Optimesh system also prevents leakage of cement or bone material captured or contained in the bag. However, one disadvantage of this system is that the mesh implant is not well integrated in the vertebral body. This can lead to relative movements between the implant and the vertebral body and thus to impaired repositioning after surgery. The system is also complex and relatively expensive. Additional details related to this process can be found, for example, in US Patent Publication No. 20040073308, which is hereby incorporated by reference in its entirety.

Yet another procedure utilized in the treatment of vertebral compression fractures is an expandable polymer reinforcement material known as the SKy Bone Expander. The device can be expanded in a controlled manner to pre-designed dimensions and cubic or trapezoidal configurations. Similar to the Kyphon Balloon, once the optimal vertebral height and void is achieved, the SKy Bone Expander is removed and PMMA cement or other filler is injected into the void. This procedure therefore suffers from many of the same disadvantages and disadvantages described above for kyphoplasty.

Thus, a common disadvantage of most known systems and procedures for repositioning and augmenting damaged vertebrae is that they all involve the use of relatively complex devices guided through rigid introducers. This rigid introducer can damage the pedicle and/or surrounding tissue during insertion and/or manipulation of the augmentation device. Accordingly, there remains a need in the art to provide safe and effective devices and methods for minimally invasive repositioning of vertebral bodies and osteopathic augmentation for lordotic reduction.

Regardless of the type of implant or augmentation method used, however, any such treatment of a collapsed or otherwise fractured vertebra must generally be performed within about six weeks of the injury. Otherwise, the fractured bone may tend to heal in its collapsed state, making it difficult or impossible to reposition and reposition the affected vertebra without first breaking or fragmenting the improperly healed fracture. /or to reset the lordosis. Furthermore, since the spine is often located in close proximity to nerves, blood vessels, and other sensitive soft tissues, any method used to fracture the affected area of a collapsed vertebra should be minimally invasive and controlled in order to avoid causing such damage. The surrounding tissue is damaged. Therefore, there remains a need in the art to provide appropriate tools or methods to safely and effectively fracture such improperly healed bones in a micro-invasive manner.

Contents of the invention

The present invention provides devices and methods for performing minimally invasive vertebral augmentation and lordosis reduction. In one embodiment, a cannula includes a rigid member having a rigid member lumen and a flexible member having a flexible member lumen sized for passage of an implement. The flexible member is coupled to the rigid member such that the cavity of the rigid member and the cavity of the flexible member form a passage through which an instrument may pass.

In another embodiment, an appliance for correcting the spine includes at least two body segments, each body segment having a distal end and a proximal end, at least one point connecting the distal end of the first body segment to the An end is connected to the proximal end of an adjacent body segment, the point allowing the body segments to be articulated relative to each other. The implement further comprises an elongated flexible element attached to the distal end of one body section, the elongated element extending the length of at least two body sections. The distal body section is articulated relative to an adjacent body section when the elongate element is drawn toward the proximal end of the body section.

In yet another embodiment, an apparatus for repositioning a vertebra includes at least one elongated member, each of the elongated members having a first end and a second end, wherein each elongated member The first end of the elongated member is configured for insertion into a vertebral body. The apparatus further includes a securing rod having an arcuate shape, and at least one clamp configured to adjustably secure the second end of one of the elongate members to the on the fixed rod. The jig is configured to move along the rod to pivot the elongate member to reposition the vertebral body.

The present invention also provides bending instruments and implants that can be passed through the cannula of the present invention and into bone or other body parts such as damaged vertebrae. Such an implant may be used, for example, to reposition the endplate of a damaged vertebral body and/or to reinforce the vertebral body.

The cannula and/or bending instrument of the present invention may be used in combination with other devices and methods. For example, after repositioning a vertebral body using a bending instrument applied through a partially flexible cannula, one or more implants may be inserted into the vertebral body to further strengthen the vertebral body. One or more other instruments or devices, such as external fixation devices, may also be utilized to help reposition vertebrae adjacent to the collapsed vertebrae, for example, to reduce compressive forces on the vertebrae.

The cannula and/or repositioning rod of the present invention may comprise any biocompatible material having desired properties, such as biocompatible polymers, metals, ceramics, Nitinol (nickel-titanium memory alloy), PEEK (polymer ether ether ketone), complexes or any combination thereof. In some embodiments, the sleeve and/or repositioning rod or other implant or device may be resorbable.

In some embodiments, a method for treating a damaged vertebral body comprises the steps of: reducing lordosis in the region of the damaged vertebral body, fracturing the damaged vertebral body, restoring the damaged vertebral body body height and strengthens the vertebral body.

In another embodiment, a kit includes various combinations of components and parts. A kit may comprise, for example, a sleeve according to the invention and one or more devices and/or implants for restoring vertebral height and/or for strengthening the vertebral body. For example, a kit may include a sleeve having a rigid member and a flexible member coupled to the rigid member and a curved instrument for restoring vertebral body height. Other kits may include another implant in place of or in addition to the curved appliance. In other embodiments, a kit may include a sleeve, an outer drum fixation or tension member, and/or a longitudinal fixation member. Such an embodiment may also include a syringe or other device for injecting cement or other fillers into the vertebral body.

Description of drawings

The invention and further developments and features of the invention are shown in even more detail in the following typical drawings. The present invention may be better understood in conjunction with the following drawings, wherein like reference numerals are used to designate like elements. The drawings are merely exemplary in order to show particular features that may be used alone or in combination with other features and the invention should not be limited to the embodiments shown.

Figure 1 shows a spine with a vertical compression fracture in one vertebral body;

Figure 2 shows the spine showing the posterior surgical approach through the pedicles;

3A-3D illustrate prior art methods for treating vertical compression fractures;

FIG. 4 is a flowchart of a method for reducing lordosis and for strengthening a vertebral body according to one embodiment of the present invention;

Figure 5 is a perspective view of an external fixation device for use in the spine according to one embodiment of the present invention;

Figure 6 is a side view of the external fixation device shown in Figure 5;

Figure 7 is a schematic side view showing a sleeve inserted into a vertebral body according to a method of the present invention;

Figure 8 is a schematic side view showing the sleeve shown in Figure 7 for repositioning the vertebral body;

Figure 9 is a perspective view of an external fixator for use with a model spine;

Figure 10 is a close up perspective view of a fixation rod according to one embodiment of the present invention;

Figure 11 is a side view of a clamp fastened to a fixed rod according to one embodiment of the present invention;

Fig. 12 is a side sectional view of the clamp shown in Fig. 11;

13A and 13B are schematic side views illustrating the operation of the clamp and the fixing rod shown in FIG. 11;

Figure 14 is a perspective view of the fixing device comprising the clamp and fixing rod shown in Figure 11;

Figure 15 is a perspective view of a fixation device having elongate members intersecting each other;

Figure 16 is a perspective view of a fixation device having elongate members intersecting each other from an angle different from that shown in Figure 15;

Figure 17 shows an adjustable sliding mechanism;

Figure 18 shows another embodiment of an adjustable sliding mechanism;

Figure 19 shows another optional device for repositioning the vertebrae;

Figure 20 is a side view of a fracture device inserted into a vertebra according to one embodiment of the present invention;

Figure 21 is a top view of two fracture devices inserted into a vertebra according to one embodiment of the present invention;

Figure 22A is a close-up top view of the fracture device and vertebra shown in Figure 16;

Figure 22B is a close-up side view of the fracture device and vertebra shown in Figure 21;

Figure 23 is a perspective view showing the operation of inserting a cannula into a vertebra from the back of the spine;

Figure 24 is a schematic side cross-sectional view of a fracture device and a sleeve according to one embodiment of the present invention;

Figure 25 is a side view of a fracture device inserted into a vertebra according to one embodiment of the present invention;

Figure 26 is a top view of a fracture device inserted into a vertebra according to one embodiment of the present invention;

Figure 27 is a side view of a fracture device inserted into a vertebra according to one embodiment of the present invention;

28 is a schematic side view of a strike instrument and two fracture devices inserted into a vertebra according to various embodiments of the present invention;

Figure 29 is a side view of a fracture device inserted into a vertebra showing the axis of motion according to one embodiment of the present invention;

Figure 30 is a top view schematically illustrating a tip of a breaking device according to various embodiments of the present invention;

31A and 31B are top views of different device tips according to one embodiment of the invention;

32A and 32B are end perspective views of two device tips according to one embodiment of the invention;

Figure 33 is a schematic side view showing the device and method for breaking a fractured vertebra;

Figure 34 is a schematic side view showing a fractured vertebral body;

35A-35D are schematic side views illustrating a method of restoring the height of a fractured vertebral body;

Figure 36 is a top view of a cannula inserted into a vertebra according to one embodiment of the present invention;

Figure 37 is a close up top view of the sleeve shown in Figure 36;

Figure 38 is a schematic side cross-sectional view of a cannula according to one embodiment of the present invention;

Figure 39 is a side cross-sectional view of a sleeve according to another embodiment of the present invention;

Figure 40 is a top view showing a rigid member of a cannula according to one embodiment of the present invention;

41A and 41B are schematic side cross-sectional views of a rigid member and stem of a cannula according to one embodiment of the present invention;

42A and 42B are schematic side cross-sectional views of a sleeve and rod for use in a vertebra according to one embodiment of the present invention;

Figure 43 is a perspective view illustrating various shapes of implements or implants that may be used according to various embodiments of the present invention;

Figure 44 is a schematic side view illustrating various curvatures of an appliance or implant that may be used according to various embodiments of the present invention;

45 is a side sectional view showing a sleeve and a reinforcing rod according to another embodiment of the present invention;

Figure 46 is a side cross-sectional view showing a needle and catheter positioned through a cannula in accordance with the present invention;

47A-47C are perspective views illustrating a device that may be adapted to deliver vertebral body filler material according to one embodiment of the present invention;

Figure 48 is a schematic side view showing a device for reinforcing a vertebral body by a filler material;

Figure 49 is a perspective view of one embodiment of an appliance of the present invention;

Figure 50 is a perspective view of a cannula inserted through a pedicle of a fractured vertebra;

Figure 51 is a perspective view of the device of Figure 49 inserted into the sleeve of Figure 50;

Figure 52 is a perspective view of the appliance shown in Figure 49 with the front end of the appliance raised;

Figure 53 is a perspective view of a vertebral body restored to its original height;

Figure 54 is a perspective view of the mechanism for pulling the wire of the appliance shown in Figure 49;

Figure 55 is a perspective view of another exemplary embodiment of a mechanism for pulling the wire of the implement shown in Figure 49;

Figure 56 is a perspective view of another exemplary embodiment of a mechanism for pulling the wire of the implement shown in Figure 49;

57A-57C are perspective views of other exemplary embodiments of utensils of the present invention;

58A and 58B are perspective views of an exemplary embodiment of a ball joint of the appliance shown in FIG. 49;

Figure 59 is a perspective view of another exemplary embodiment of an appliance of the present invention; and

Figure 60 is another perspective view of an exemplary embodiment of the appliance of the present invention.

Detailed ways

A method 1000 of reducing lordosis and augmenting a vertebral body, eg, to treat a vertebral compression fracture, will be described below (see FIG. 4 ). In general, method 1000 may include one or more of the following steps: Step 1100, inserting one or more sleeves into the damaged vertebral body and/or into a vertebra adjacent to the damaged vertebral body in vivo. Step 1100 can be performed from a posterior approach. Step 1200 involves repositioning the vertebrae with a cannula. Step 1200 may be performed in conjunction with an external fixation device. Step 1300, fracture the fractured bone in the damaged vertebrae. Step 1400, restoring the height of the vertebral body; and step 1500, augmenting the restored vertebral body, such as with an implant or filler material. Some or all of steps 1100, 1200, 1300, 1400, and/or 1500 of method 1000 may be performed in the order shown in FIG. 4 or in any other order and used in conjunction with other methods. Additional details and examples relating to each of steps 1100, 1200, 1300, 1400, and 1500 of method 1000 are described in more detail below.

Insert cannula (step 1100)

FIG. 7 illustrates the operation of inserting the cannula 2100 into the damaged vertebra 12b. A different elongate member 2200 that is the same or similar to the cannula 100 described later may be utilized, for example, in step 1100 shown in FIG. 4 . For example, sleeve 2100 may be inserted into fractured or otherwise damaged vertebral body 12b, and one or more members 2200 may be inserted into or otherwise attached to vertebrae 12a and 12c Above, the vertebrae 12a and 12c may be located above and/or below the damaged vertebral body 12b. One or more of the elongate members 2200 may be a sleeve.

The size of the one or more members 2200 and/or the sleeve 2100 may be the same or different, and may have a diameter of, for example, between about 2 mm and 10 mm. Elongated member 2200 and/or sleeve 2100 may be sized to extend beyond the vertebrae and surrounding soft tissue and may be of any desired length, such as between about 10 cm and about 30 cm or longer. Elongate member 2200 may comprise stainless steel, metal, metal alloys, polymers, composites, ceramics, or combinations thereof.

Elongated member 2200 and sleeve 2100 may be configured and sized for insertion into a vertebra, for example, into central portion 50 of vertebral body 12 from a posterior approach through pedicle 24 . When inserted, the elongated member 2200 and sleeve 2100 extend out of the vertebra 12, through the soft tissue covering the spine 10, and out of the patient's body. In some embodiments, each elongated member 2200 and/or sleeve 2100 may be inserted into the vertebral body through a hole, which may be a hole formed through the outer cortical bone of the vertebra 12, such as through the pedicle 24. , for example by means of a drill, trocar or other instrument. In some embodiments, elongated member 2200 may include external threads (not shown) on an outer surface that engages vertebral bodies 12a and 12c to secure elongated member 2200 therein. . The external threads can extend along the distal portion 2210 of the elongate member 2200 , along the entire length of the elongate member 2200 , or along any desired portion of the elongate member 2200 . A handle (not shown) can be attached to the proximal end 2220 of the elongated member 2200 and used to manipulate and/or insert the member 2200 through the pedicle 24 .

Elongated member 2200 and sleeve 2100 may be sized to extend beyond the vertebrae and surrounding soft tissue. Member 2200 may be a sleeve such as sleeve 2100 or may be another type of sleeve, trocar rod, introducer, wire, pin or suitable for attachment to or engagement with vertebrae 12 and Other devices suitable for applying force to reposition vertebrae. Cannula 2100 and/or elongated member 2200 can be cylindrical or any other shape and can include lumens 2110 and 2230, respectively, for access, through which tools, implants, fillers, or other materials or devices can be passed Inserted into the vertebral body 12. Elongate member 2200 may be solid or hollow and may be semi-rigid or substantially rigid, for example, to apply torque or other force to the vertebra to which elongate member 2220 is attached.

Refer to the discussion of cannula 100 for additional details on cannula 2100 and/or elongated member 2200 .

Repositioning the vertebrae (step 1200)

In step 1200, a fixation device may be used to help reposition the vertebrae. 5 and 6 illustrate a fixation device 3000 for positioning, fixing and/or stabilizing a bone, such as the vertebrae 12 of the spine 10 . Device 3000 may be used, for example, to apply force on vertebral body 12 in order to reposition vertebral body 12 and to correct lordosis of spine 10 , for example in the region of a fractured vertebral body 12 . Fixation device 3000 may be applied in other areas of the bone structure to reposition damaged or diseased bone.

Device 3000 may include one or more elongate members 2200 , one or more longitudinal (fixation) members 2300 , and one or more clamps 2400 for securing elongate members 2200 to fixation members 2300 . In some embodiments, a hole 60 may be formed through the outer cortical bone of the vertebra 12, such as through the pedicle 24, such as by a drill, trocar, or other instrument. Handle 2500 may be attached to the proximal end of elongated member 2200 and used to manipulate and/or insert member 2200 through pedicle 24 .

Optionally, one or more sleeves 2100 may be included within, attached to, or used in conjunction with the device 3000 . For example, the sleeve 2100 can be inserted into a fractured or otherwise damaged vertebral body 12, and one or more members 2200 can be inserted into the vertebrae 12 above and/or below the damaged vertebral body 12 or in other ways. way attached to the vertebrae. Member 2200 may be used as a cement injection sleeve to perform prophylactic vertebroplasty in the superior and/or inferior vertebrae and thereby reinforce the vertebral bone structure. In addition, cement injected into the vertebral body above and/or below the damaged vertebral body 12 and into the casing may enhance the mechanical properties of the segment when repositioning is later performed using external force.

The longitudinal member 2300 may be arcuate and may have a radius of curvature corresponding approximately to the distance between the entry point of the member 2200 into the vertebral body and the handle 2500 of the member 2200 . The longitudinal members 2300 can also have any desired length and curvature.

One or more clamps 2400 may secure each elongate member 2200 to the longitudinal member 2300 . Each clamp 2400 may be adjustable relative to the elongate member 2200 and/or the longitudinal member 2300, eg, to secure the member 2200 to the longitudinal member 2300 in any desired orientation. With one end of each elongated member 2200 inserted into or otherwise attached to the vertebral body 12 and the other end of each member 2200 secured to the longitudinal member 2300 by a clamp 2400, The position of members 2200 may be stable or fixed relative to each other.

Figure 7 shows a member 2200, which may or may not be a cannula, inserted into the vertebral bodies 12a and 12c. The distal end 2210 of each member 2200 may, for example, be inserted into the central portion 50 of the vertebral bodies 12a and 12c. The member 2200 may have a cavity 2230 through which cement, bone particles or other filler may be inserted, for example, into the vertebral bodies 12a and 12c. Such cement, bone particles or other fillers may be used, for example, to help secure member 2200 within vertebral bodies 12a and 12c.

Figure 7 also shows a cannula 2100 having a distal end 2120 inserted into the collapsed vertebral body 12b. The cannula may include a lumen 2110 through which a tool, implant, cement, bone particles, or other filler may pass and be inserted into the vertebral body 12b, eg, to strengthen and/or stabilize a damaged vertebral body. Elongated member 2200 may be inserted into one or more vertebrae 12a and 12c, which may be adjacent to damaged vertebra 12b, as shown in FIG. 7 .

FIG. 8 shows a method for repositioning vertebral bodies 12a-12c prior to strengthening or stabilizing fractured vertebral body 12b, thereby, for example, restoring the normal curvature in the region of damaged vertebra 12b or making the spine in the region of said damaged vertebrae. Methods of lordosis reduction. The distal end 2220 of the member 2200 is adjustably engageable with the fixation member 2300, for example using a clamp 2400, thereby allowing the members 2200 to be fixed relative to each other or to be repositioned. The end 2130 of the sleeve 2100 may also be attached to the fixation member 2300, such as by a clamp 2400, to stabilize and fix the position of the vertebra 12b during repositioning of the vertebra 12a. End 2220 of elongated member 2200 secured to vertebra 12a may translate along longitudinal member 2300 , for example, in the direction indicated by arrow 2700 . Such translation may cause the elongated member 2200 to pivot about the center of rotation 2600 and exert a moment or torque on the vertebral body, which may tend to reposition the vertebral body 12a, thereby resetting the normal lordosis of the spine 10, for example.

Repositioning, eg, vertebral body 12a or 12c adjacent to fractured vertebral body 12b, can reduce compressive forces on vertebral body 12b and help enhance or restore vertebral height, eg, with tools, implants, fillers, and the like. In other embodiments, one or more members 2200 may be utilized to apply different rotational or translational forces to the vertebral body. For example, the member 2200 may be pushed or pulled laterally relative to the spine 10 such that, for example, instead of or in addition to rotating about the pivot 2600, the lateral pushing or pulling may be performed to one or more Each vertebral body 12 is oriented or positioned so as to form the desired alignment. In some embodiments, sleeve 2100 is not fastened to fixation member 2300 . 14 shows a perspective view of the fixation device comprising the clamp shown in FIG. 11 and the fixation rod, when force is applied in different directions along the fixation rod to the elongated members in the vertebrae 12a, 12c to temporarily restore the alignment of the vertebrae. The aligned state thus facilitates reduction of the vertebrae 12b.

FIG. 9 shows an embodiment of a device 3000 showing member 2200 inserted into vertebrae 12 of spine 10 and fastened to one or more fixation members 2300 that can Has an arcuate shape. The member 2200 may be fastened to the fixing member 2300 using a clamp 2400, which may for example be a standard fixing clamp known in the art. A handle 2500 on each member 2200 may be used to insert and/or manipulate the members 2200 .

Fig. 10 shows a side view of a rod 900, which may be used as a longitudinal member 2400, for example, to secure the member 2200 and/or sleeve 2100 in a desired position. The rod 900 can include a ridge or notch 910, which can be crenated or notched, for example, to allow a clamp or other device (such as the clamp 4000 shown in FIG. 11 ) to move in one direction 920 rather than the opposite. direction 930 to move.

FIGS. 11 and 12 show side views of a selectively engageable clamp 4000 that may be used in combination with a rod 900 to replace clamp 2400 , for example. Clamp 4000 may include a first portion 4100 configured to selectively engage rod 900, and a second portion 4200 associated with portion 4100 and configured to adjustably engage a sleeve or other elongate member, the sleeve A tube or other elongated member may be secured to the vertebral body. The selectively engageable first portion 4100 can include, for example, a housing 4110 having an open end 4111 and an inner body 4112 that can be partially disposed within the housing 4110 and extend from the open end 4111 . The biasing member 4120 may be disposed in a space 4150 within the housing 4110 , for example between the inner body 4112 and the member 4211 of the bolt 4210 of the portion 4200 . Biasing member 4120 can provide a biasing force that can tend to force inner body 4112 out through opening 4111 .

The one or more apertures 4113 in the housing 4110 may be sized to pass a pin 4130 which may, for example, pass through the elongated opening 4114 of the inner member 4112 such that the inner body may move relative to the housing 4110 , but will be held within the housing 4110 by the pin 4130. A dimple 4115 or hole or other feature in housing 4110 positioned opposite hole 4113 as shown in FIG. 12 may be configured to engage pin 4113 and secure the pin.

The housing 4110 may include a side opening (not shown) and the inner body 4112 may include a side opening 4117 (shown in FIG. 12 ). Openings 4116 and 4117 may be circular, oval, or any other desired shape. For example, as shown in FIG. 12, the opening 4117 of the inner body 4112 is generally oval in shape. The inner body 4112 may act as a button relative to the housing 4110 . For example, pushing the inner body 4112 into the housing 4110 and against the force of the biasing member can align the openings 4116 and 4117 so that the rod 900 is free to move along its length. When the button is released, the biasing member can force the inner body 4112 outward, which can change the alignment of the holes 4116 and 4117, for example so that the cutout 910 of the rod 900 engages the housing edge around the hole 4116 and along at least One direction prevents movement of the jig 4000 relative to the rod 900 . With this mechanism, and because of the scalloped cutouts 910, the clamp 4000 is allowed to slide on the rod 900 in one direction, but not in the opposite direction, unless the inner body 4112 (eg, a button) is depressed into the housing 4110 to align openings 4116 and 4117.

Portion 4200 of clamp 4000 may be configured to engage and secure a member, such as elongated member 2200 or a cannula, rod, trocar, introducer, wire, pin, or other suitable for insertion. Any other elongate member within or otherwise attached to the vertebral body 12. Portion 4200 may include a bolt 4210 or screw associated with housing 4110, one or more vise plates 4220, 4230 engaged with bolt 4210, a biasing member 4240 that may tend to maintain plates 4220, 4230 in a closed state, and may Nuts 4250 tend to oppose the biasing member 4240 and tend to tighten the vise plates 4220, 4230 around the member 2200 (not shown). The bolt 4210 may include a member 4211 located within the housing 4110 and attached to a shaft 4212 . The end 4213 of the shaft 4212 may be threaded 4214 .

Vise plates 4220, 4230 may have openings 4221, 4231, respectively, through which bolts 4210 may pass. In this way, the vise plates 4220 , 4230 may be fastened on the bolt 4210 , eg, between the nut 4250 and the housing 4110 . Each vise plate 4220, 4230 may also have a receiving portion 4222, 4232, respectively, for engaging and retaining the member 2200 or other elongated member.

A biasing member 4240 (eg, coil spring, wave washer, radial spring) may be disposed between the first vise plate 4230 and the housing 4110 . In this way, when the nut 4250 is coupled to the bottom 4210 but not fully fastened to the bottom, the bone connecting element can be clamped or snapped between the vise plates 4220 and 4230, for example by This is accomplished by inserting the bone connecting element into the receiving portion. This configuration may allow the bone connecting element to be temporarily held between vise plates 4220 and 4230 , eg, in front of nut 4250 .

Additionally, the vise plates 4220, 4230 have features that facilitate proper alignment of the vise plates. For example, the second vise plate 4230 can have at least one protrusion (not shown) extending therefrom, and the at least one protrusion can be received in at least one recess (not shown) in the first vise plate 4220. from. In this way, the vise plates 4220 , 4230 may both rotate together to orient the receiving portions 4222 , 4232 . Those skilled in the art will appreciate that various other pins, protrusions, notches, couplers or other alignment features may be utilized.

For tightening the nut 4250, the nut 4250 may have a gripping portion 4251 (eg, a serrated portion or a knurled portion), which may facilitate tightening the nut 4250 by hand. Alternatively, or in addition, other features may be provided on the nut 4250 to facilitate engagement with a wrench or other tool. Those skilled in the art will appreciate that with the external fixation system shown and described, other clamps can also be utilized.

13A and 13B are schematic diagrams illustrating a rod 900 having cutouts 910 or other features that may engage one or more clamps 4000 . Clamp 4000 is engageable with cutout feature 910 and moves along rod 900 in a particular direction, eg, depending on the orientation of cutout feature 910 .

The two rods 900 may be attached together by a connector 950 such that the directions of the cutouts 910-1 and 910-2 are in opposite directions. Thus, repositioning of the clamps, ie movement of the clamps, can be done in the opposite direction, as indicated by arrows 2710 and 2720 in FIG. 14 .

In order to further distract/move the spine using fixation device 3000 as shown in FIGS. Mechanism 3500 (Fig. 17 and Fig. 18) realizes. 15 and 16 illustrate adjustable slide mechanism 3500 coupled to elongated member 2200 .

Figures 17 and 18 illustrate two embodiments of an adjustable slide mechanism 3500 that have similar functionality. The adjustable sliding structure 3500 shown in FIG. 17 includes a slidable member 3510 which may have an "I-bar" configuration in which a vertical member 3511 has cutouts 3512 on both sides to allow the positioning members 3520, 3530 The movement is made along the length of the slidable member 3510. The positioning members 3520 , 3530 fit between the horizontal members 3513 and 3514 of the slidable member 3510 and mate with the vertical member 3511 . Each positioning member 3520 , 3530 may have a protrusion or other means 3524 on the mating side 3523 , 3533 that corresponds to the notch 3512 on the slidable member 3510 . The positioning members 3520, 3530 may also include a release button 3522, 3532 which is movable along the slidable member 3510 when activated, for example by depressing the button. That is, for example, the protrusion 3524 is disengaged from the notch 3512 and the positioning members 3520 , 3530 can slide along the length of the slidable member 3510 between the horizontal members 3513 , 3514 . The positioning members 3520, 3530 may be retained between the horizontal members 3513, 3514, for example, by a lip (not shown) extending from each horizontal member. Each positioning member 3520, 3530 may have an attachment unit 3521, 3531 to allow the elongated member 2200 to be attached to the positioning member 3520, 3530. The attachment units 3521, 3531 may be rotated to adjust the angle of the elongated member 2200 such that they may cross relative to each other, for example.

FIG. 18 illustrates another alternative embodiment of a slidable member 3550 of an adjustable slide mechanism 3500 . In this embodiment, the slidable member 3550 has two tracks 3551, 3552 parallel to each other. Each track 3551, 3552 may have teeth 3553 or other means to allow incremental movement of the positioning members 3520, 3530. The positioning members 3520, 3530 with attachment units 3521, 3531 and release buttons 3522, 3532 function similarly to those in the previous embodiments.

Figure 19 shows another alternative device for repositioning vertebrae. Instead of the fixation device 3000 as previously described, the elongated member 2200 extending from the vertebrae may have a Velcro fastener 3600 attached to the proximal end 2220 thereof. After manipulating the elongate member 2200 to reduce the lordosis, such as by manually manipulating and controlling the elongate member 2200, the elongate member 2200 can be fixed by gluing together the elongate member 2200 equipped with Velcro fasteners 3600. The position of the elongated members 2200 relative to each other is secured. The Velcro fastener 3600 may be attached directly to the handle 2500 of the elongated member 2200 or an additional cover (not shown) may be slid over the handle 2500 . Other alternative methods for attaching Velcro fastener 3600 to handle 2500 are also contemplated.

Once the spinal segment is decompressed and repositioned, the fractured vertebra can be surgically treated.

Fracture the healed fracture site (step 1300)

Before or after repositioning the vertebrae 12a and/or 12c in the region of the fractured vertebral body 12b, it may be necessary to refracture, dissociate, or otherwise refracture the anterior portion 22 of the collapsed vertebral body 12b and particularly the cortical shell 14. Other ways to break. Such a process may be particularly useful in preparing the vertebral body for repairing the vertebral endplates 20 and 30, for example where the fractured bone has healed or partially healed over a period of time, such as six weeks or more. Reposition and/or make enhancements. Various types of fracture devices may be used to fracture the damaged cortical bone 14, such as a chisel 800 as shown in FIG. 20, a laser 900, or another instrument.

Figure 20 shows a snap-off device or chisel-like device 5000, which can include an elongated member 5410 having a proximal tip 5420 that can be configured to The separation of bones or other rigid structures. The elongated member 5410 may be approximately cylindrical, although other shapes are envisioned. The tip 5420 can have various shapes as described herein, for example, the tip 5420 can be tapered, as shown in FIG. 20, to provide a knife-like tip for breaking bones. Tip 5420 may be at least partially blunted to help minimize damage to surrounding tissue. The handle 5430 can be attached to a distal end 5432 of the elongated member 5410 , eg, opposite the tip 5420 .

As shown in Figure 20, the fracture device 5000 can be inserted into the vertebrae, for example, by using a cannula 5440 inserted through the posterior approach so that the tip 5420 passes through the central portion 50 of the vertebral body 12 and is in contact with the vertebral body. Cortical bone 14 on the anterior side 22 of 12 contacts. The sleeve 5440 may or may not be similar to the sleeves previously described.

In some embodiments, the sleeve 5440 includes a rigid member 5442 that can be threaded within a hole in the pedicle 24 and includes an elongated member 5444 that can be cylindrical and sized to Extending out of the vertebrae and surrounding soft tissue allows the device 5000 to approach and enter the vertebral body in a micro-invasive manner. The elongated member 5444 can be flexible and can be associated with the rigid member 5442 at a coupling 5446, such as permanently or releasably. Rigid member 5442 may be configured and sized for insertion into a vertebra, for example inserted into the central portion of vertebral body 12 from a posterior approach through pedicle 24 . In some embodiments, holes may be made through the outer cortical bone of vertebrae 12, such as through pedicles 24, such as by a drill, trocar, or other instrument. Linkage 5446 at which rigid member 5442 is coupled to member 5444 may be located at a location internal or external to pedicle 24 of vertebra 12 . In other embodiments, another type of cannula, trocar, or other guide may be utilized to approximate the fracture device 5000 to the vertebra 12 or other bone.

The diameter of member 5410 of device 5000 may, for example, be between about 2 mm and 10 mm. The member 5410 of the device may have any desired length, for example between about 20 cm and 70 cm. The handle 5430 may also have any desired length, such as between about 4 cm and 20 cm. Device 5000 may comprise stainless steel, metal, metal alloys, polymers, composites, ceramics, or combinations thereof.

The elongate member 5410 can include a sleeve 5422 or other device or member disposed around and/or attached to the member 5410, and the sleeve 5422 can be sized to limit the movement of the member 5410 into the vertebrae. The amount of axial movement in the body 12 is achieved, for example, by the contact coupling 5446, as will be described in more detail later.

As shown in FIG. 21 , one, two or more fracture devices, such as 5000-1 and 5000-2, may be inserted into the vertebral body 12, eg, through one or more cannulae 5440 as shown above in connection with FIG. 20 . The sleeve 5440 may have a rigidizer 5442, and the rigidizer 5442 may include threads 5443 to be fastened to a vertebra, such as by the pedicle 24 as shown. In some embodiments, the rigidizer 5442 can include a nut feature 5447 having a generally flat surface or other surface that can be configured to engage the rigidizer 5442 and/or otherwise A wrench or other tool that fits into the bone 12 is engaged. Linkage 5446 may, for example, provide a releasable coupling between member 5444 and rigid member 5442 .

Device 5000 may have different configurations, such as shown in devices 5000-1 and 5000-2 of FIG. 21, for example. Device 5000-1 is shown having an elongated member 5410-1 having a relatively uniform diameter. In such an embodiment, the member 5410-1 is free to move through the cannula in an axial direction, for example towards the cortical bone 14 at the front end 22 of the vertebral body. In other embodiments, such as in device 5000-2, member 5410-2 may include a stop 5512 or other feature that limits axial movement of member 5410-2 within sleeve 5440. For example, as member 5410-2 moves proximally toward back face 22 of vertebra 12, stop 5512 may contact edge 5510 of coupler 5446, thereby inhibiting or preventing further movement of member 5410-2 into the vertebral body. The stop 5512 may be provided, for example, by a sleeve 5422 surrounding a portion of the member 5410-2 and may be sized and/or adjustable so as to provide the desired axial movement of the member 5410-2 into the vertebral body 12. scope.

22A and 22B show close-up views of tips 5420, such as tips 5420-1 and 5420-2. Tip 5420 may have any desired configuration, for example, so as to cut through, fracture, or otherwise fracture cortical bone 14 through vertebrae 12, such as in the event of bone 14 being injured, for example, due to a vertebral compression fracture. Carried out after having healed in a collapsed state. Tip 5420 may be tapered in one or more dimensions, eg, tapered to provide a knife-like or chisel-like tip as shown by tip 5420-1. In other embodiments, tip 5420 can have another configuration, such as the paddle-shaped configuration shown by tip 5420-2, where the tip can have a width that is greater than the diameter of member 5410-2. Additional details related to the configuration of tip 5420 and/or member 5410 are described elsewhere herein, eg, in connection with FIGS. 28-30 .

23 shows a perspective view of the spine with a cannula 5440 or other introducer inserted into the back of the vertebra 12, for example, using a tool 5700 with a handle 5710 that is used to place the cannula Tube 5440 is inserted through pedicle 24 . Various types of cannulas are available that can be adapted to introduce device 5400 into vertebra 12 .

FIG. 24 shows a cross-sectional view of a snap-off device 5000 that may or may not be used in conjunction with a sleeve 5440 as described above. Fracture device 5000 may include elongate member 5410 sized to pass through cannula 5440 , such as through rigid member 5442 and member 5444 . A sleeve 5422 or other member may be disposed around the member 5410 and may be sized and/or positioned such that when the device 5000 is advanced axially into a vertebral body or other bone, the end 5512 of the sleeve 5422 may In contact with the proximal end 5510 of the coupler 5446 of the rigid member 5442 . Sleeve 5422 may be attached to member 5410 and/or may be slidable or adjustable thereon, eg, to provide a desired range of motion for movement of device 5000 into the vertebrae.

The proximal end 5432 of the member 5410 can be configured and sized as desired to engage the handle 5430, as described in more detail, eg, in connection with FIG. 26 .

FIG. 25 is another side view of the fracture device 5000 used in the vertebra 12. FIG. Elongated member 5410, tip 5420, and cannula 5440 may be in the form described above. In this example, sleeve 5422 may be sized to fit inside sleeve 5410 . The sleeve 5422 can include a protrusion 5433 that can extend outwardly and longitudinally along the longitudinal axis of the member 5410 . This protrusion 5433 can be used to provide a limit stop for the device 5000, for example by having the protrusion engage the implant when the device 5410 is pushed through the space 50 of the sleeve 5440 and vertebra 12 towards the bone 14. This is accomplished by contacting the distal end of rigid portion 5442 of 5440.

Figure 26 is a top view of a fracture device 5000 having a tip 5420 inserted through a cannula 5440 and inserted into a vertebra 12 to contact and fracture a bone 14. The device 5000 may include a sleeve 5422 or other mechanism to limit or control the penetration depth of the tip 5420 into the cortical bone 14 located on the anterior portion of the vertebra 12 (shown as "T"). The distal end 5432 of the elongated member 5410 can be secured or otherwise coupled to the handle 5430 , eg, within the recess 5434 . In some embodiments, sleeve 5422 can contact end 5432 at dimple 5434 . The dimple 5434 and end 5432 may be configured and sized to releasably, adjustably, or fixedly couple to each other. For example, the recess 5434 may be threaded and the end 5432 may be correspondingly threaded such that, for example, the penetration depth of the device may be adjusted by adjusting the amount by which the end 5432 is disposed within the recess 5434 of the handle 5430. T".

27 is a side view of a fracture device 5000 used in a vertebral body 12 to dissociate bone that has healed in a collapsed or fractured position. Device 5000 includes sleeve 5422 as described above, and sleeve may be used to limit movement of tip 5410 through bone 14 . Such confinement may be desirable, for example, where there may be fragile or sensitive tissue surrounding the area to be dissociated. Arrow 1 indicates an area of bone 14 that may be damaged and may be fractured and possibly later repaired using the methods described herein.

As shown in FIG. 28 , the end of the device 5000 can be inserted into the vertebra 12 by entering the device 5000 into the anterior portion of the vertebra 12, for example, using a hammer 2, such as by using the pointed end. 5420, the tip 5420 is configured to have a sharp, semi-sharp or blunt tip to make contact with the bone. That is, the device 5000 can be impacted on the bone, for example, with a hammer 2 . In other embodiments, a vibrator or other device is attached, for example, to handle 5430 and/or elongate member 5410, and is used to move elongate member 5410, for example, longitudinally, laterally, and/or in another direction Enters into the vertebra 12 and travels towards the damaged bone 14 .

FIG. 29 shows a close-up side view of vertebra 12 and device 5000 having elongate member 5410 and tip 5420 and illustrates the motions that can be achieved with device 5000 , such as lateral motion 3 and longitudinal motion 4 .

Figure 30 shows a schematic illustration of examples of various tips 1512, 1522, 1532 that may be used to fracture bones. Figure 31 shows a top close-up view of member 5420-2 and tip 5420-2. Figure 31 shows a top view of device 5410-2 used in a vertebral body. 32A and 32B are close-up views of different types of tips 1720 and 1722 .

As shown in Figure 33, a laser 9000 or other tool used to cut or fracture bone may be used instead of or in addition to the chisel or fracture device 5000 to fracture the injured vertebral body 12b. The cortical bone 14 separates or otherwise fractures (Fig. 34). Laser 9000 may be sized to pass through cannula 2100 and into interior portion 50 of vertebra 12b.

FIG. 35 shows a schematic view of a vertebral body 12 b with cortical bone 14 that has been refractured, for example using a fracture device 5000 or a laser 9000 . Fracture device 5000 or laser 9000 has been removed from sleeve 2100, eg, during preparation for repositioning endplates 20 and 30 to restore the height of vertebral body 12b.

Restoring the height of the vertebral body (step 1400)

After the cortical bone 14 of the vertebral body 12b is refractured or otherwise fractured in step 1300 of FIG. The height of the vertebral body 12b) increases in the direction.

One example of a method of restoring vertebral body height is shown in more detail in Figures 35A-35D. For example, Figure 35A shows a partially flexible cannula 6000 inserted into a vertebral body 12b. The cannula 6000 can include, for example, a proximal member 6100 and a distal member 6200, which can be the same as or similar to the cannula 100 described later. A rigid cannula, needle, trocar, or other introducer 6500 may be utilized to facilitate placement of the cannula 6000 . For example, as is known to those skilled in the art, an introducer 6500 may first be inserted into the vertebral body through the pedicle, and the introducer may be sized to fit within the lumen 6300 of the sleeve 6000 . The cannula 6000 can then be slid over the guide 6500 and into position so that the distal member 6200 passes through the pedicle 24 and into the central portion 50 of the vertebral body 12b.

Proximal member 6100 may be attached or coupled to distal member 6200 and extend from the back of the spine through the patient's soft tissues, such as skin and muscle. The proximal member 6100 may be flexible or semi-flexible to allow insertion of curved instruments or tools and to help minimize trauma to the pedicle 24 and surrounding soft tissue.

After inserting the cannula 6000, the introducer 6500 can be removed, as shown in the steps in FIG. 35B , for example, to open the lumen 6300 of the cannula 6000 to provide for the insertion of the curved rod 6700 or another instrument, the implant. Or filler is inserted into the passageway in the central portion 50 of the vertebral body.

An instrument for repositioning the collapsed endplate of the damaged vertebral body may then be inserted through the cannula 6000 as shown in FIG. 35C . For example, a rod 6700 , which may be curved and have a head 6750 , may be inserted through cavity 6300 and may be used to push against upper endplate 20 . As shown in Figure 35C, the rod 1130 can be advanced into the central portion 50 of the vertebral body 12b, and the curved rod 6700 can push the end plates 20 and 30 apart to restore the height of the vertebra 12b, for example from the height shown in Figure 35C h1 returns to the height h2 shown in Figure 35D. The rod 6700 may have a different configuration than that shown in FIGS. 35C and 35D and may include more than one component or element and may include articulating components.

One embodiment of a device for strengthening a vertebra provides a sleeve in more detail. FIG. 36 illustrates a partially flexible sleeve 100 that may include a rigid member 110 and a flexible member 120 . The flexible member 120 may be coupled to the rigid member 110 at a link/joint 130, such as a permanent coupling or a releasable coupling. Rigid member 110 may be configured and sized for insertion into a vertebra, for example, from a posterior approach through pedicle 24 into central portion 50 of vertebral body 12 . In some embodiments, a hole 60 may be formed through the outer cortical bone of the vertebra 12, such as through the pedicle 24, such as by a drill, trocar, or other instrument. Joint 130 may be located at a location internal or external to pedicle 24 of vertebra 12 where rigid member 110 is coupled to flexible member 120 .

Cannula 100 may have a lumen 140 (eg, lumen 140 shown in FIGS. 38 and 42 ) that may form a passageway through rigid member 110 and flexible member 120 . The cavity 140 may be used to insert implants, instruments, tools, bone fillers or other materials into the central portion 50 of the vertebrae. The relative flexibility of flexible member 120, such as that represented by curved flexible member 120-b, may facilitate the insertion or manipulation of various implants, instruments, tools, bone fillers, or other materials. Damage to the pedicle and/or surrounding tissue during the procedure is minimized or prevented. The flexible member is generally located in and provides access through the patient's soft tissue, such as skin and muscle.

As shown in FIG. 36 , one, two or more cannulas 100 may be inserted or implanted within the vertebral body 12 . Where two cannulas are utilized, both cannulas 100 may be used to introduce instruments, implants and/or bone fillers into the interior 50 of the vertebra 12 . The outer diameter of the cannula 100 may, for example, be between about 3 mm and 12 mm, and the inner diameter may be between about 2 mm and 10 mm. Cannula 100 may have any desired length, for example between about 10 and 30 cm. Rigid member 110 of cannula 100 may have a length of between about 20 mm and 70 mm, and may or may not correspond approximately to the length of pedicle 24 . Sleeve 100 may comprise any material of stainless steel, metal, metal alloy, polymer, composite, ceramic, or combinations thereof.

FIG. 37 provides a close-up top view of one of the cannulae 100 shown in FIG. 36 inserted through the pedicle 24 of a vertebra 12 . In particular, rigidizer 110 is shown inserted through pedicle 24 of vertebra 12 . Rigid member 110 may be coupled to flexible member 120 at linkage 130 just outside the back of vertebra 12 . Rigid member 110 may include threads 112 or ridges or other features that may facilitate insertion of rigid member 110 through vertebra 12, for example. Rigid member 110 may further include a pointed, serrated and/or toothed end (proximal end) 111 which may or may not work in conjunction with threads 112 to facilitate boring And through the bones.

38 and 39 show additional details of the cannula 100 . In some embodiments, rigidizer 110 may have a shaft portion 113 having a length approximately equal to the width of pedicle 24 such that rigidifier 110 may be fully implanted within pedicle 24, for example such that Only a small portion of the rigid member extends from the posterior portion of the pedicle. As shown in the cross-sectional view of FIG. 38 , rigid member 110 and flexible member 120 may include generally cylindrical wall portions 114 and 124 , respectively, having inner and outer diameters and defining cavities 115 and 125 , respectively. Lumens 115 and 125 may be joined, for example at coupling 130 , to form lumen 130 through cannula 100 .

Rigid member 110 may include a shaft or tube 113 which may or may not include threads 112 . Proximal end 111 may be configured with teeth 116 or other cutting features extending from the end of tubing 113 . The coupling 130 of the cannula 100 can releasably or permanently couple the rigid member 110 with the flexible member 120 . For example, as shown in FIG. 38 , coupling 130 may include a slip fitting 131 that fits within cavity 125 of flexible member 120 and secures flexible member 120 and rigid member 110 together. Stopper 132 on coupling 130 may provide a limit and/or seal for the coupling of flexible member 120 to rigid member 110 . The stopper 132 may include a generally flat surface 133 or other feature that may be configured to engage a tool (not shown), such as for attaching the rigid member 110 A wrench or other device that screws and/or otherwise fits into the bone 12. Linkage 130 may provide a releasable coupling between flexible members and/or rigid members.

Referring to FIG. 39 , another embodiment of a cannula 100 may include a rigid member 110 and a member 120 . However, instead of being joined by coupling 130 that allows member 120 to be disconnected from rigid member 110 , rigid member 110 and member 120 may be formed as a one-piece sleeve 200 . In such an embodiment, the link or joint 210 may include a ridge 215 or other feature that provides flexibility or controlled bending of the sleeve. More particularly, member 120 may also be rigid similarly to rigid member 110 , but with a flexible joint 210 between rigid members 110 and 120 . Member 120 may also exhibit relative flexibility relative to rigid member 110, as provided in other embodiments.

FIG. 40 shows the rigid member 110 portion of the cannula 100 inserted through an access hole, such as the hole 60 in the pedicle 24 . Rigid member 110 may have a length that generally corresponds to the length of pedicle 24 through which rigid member 110 is to be inserted. One or more instruments 810 , 820 may be inserted through the cannula 100 into the interior portion 50 of the vertebral body 12 . The utensil may be generally straight like utensil 810 or curved like utensil 820 . The flexible portion 120 of the sleeve 100 (not shown in FIG. 40 for ease of viewing the implements 810 and 820) allows curved or curved implants or implements to be inserted through the sleeve 100 and pedicle 24 into the inner portion 50 of the vertebral body 12. The operating range 830 of a curved implant or instrument 820 inserted through the cannula 100 may be greater than that of a straight implant or instrument 810 .

41A and 41B illustrate examples of the use of curved implements 300 and 302 in combination with rigid members 310 and 312, respectively. Rigid members 310 and 312 may be similar to rigid member 110 described above and have separate labeling here to illustrate the relationship between the length of the rigid member and the curvature of an implement or rod that may be inserted through the rigid member. Rigid members 310 and 312 may be associated with flexible member 120 as described above, but such flexible member 120 is not shown in the figures for simplicity of illustration. Rigid member 312 shown in FIG. 41B is significantly shorter than rigid member 310 shown in FIG. 41A. As shown, rigid member 312 may receive rigid member 302 having a greater curvature than a rigid member that may be received by longer rigid member 310 . Accordingly, the degree of curvature of a device or implant that may be used with cannula 100 may depend, at least in part, on the length of rigid members 310, 312 (and 110), the diameter of the rigid members, and the diameter of the device or implant shaft.

Turning now to FIGS. 42A and 42B , curved rod 500 may be configured with a desired diameter and curvature to fit through partially flexible sleeve 100 and may be used, for example, to restore vertebral height in a collapsed vertebra 12 . When the rod 500 is inserted within the cannula 100 , the flexible member 120 can bend with the rod 500 and the rigid portion 110 serves to constrain and limit translation of the rod 500 within the vertebra 12 . In some embodiments, the proximal end of the rod can include a bulb or bulb 510 that can enter the central portion 50 of the vertebral body 12 and engage the upper endplate 20 of the vertebral body 12 . The bulb 510 can be used to blunt the end of the rod 500 and spread the pressure over a larger area. When the rod 500 is advanced, as shown in FIG. 42B , the end 510 of the rod 500 pushes against the endplate 20 and can increase the vertebral body height between the upper endplate 20 and the lower endplate 30 . The end of the rod 500 with or without the bulb 510 can also compress cancellous bone in the vertebral body to form a space, void or cavity.

In some embodiments, the rod 500, or a portion of the rod 500, remains in place after restoring the vertebral height and thus reducing the lordosis, so as to strengthen the vertebral body. For example, one or more portions of the rod 500 , such as 510 , can be selectively separated from the remainder of the rod 500 and used to retain an implant within the central portion 50 to augment the vertebral body 12 . In other embodiments, additional implements, implants, bone particles, bone cement, and/or other filler materials may be used in conjunction with rod 500 and/or sleeve 100 to enhance and/or match vertebral body height.

Following repositioning of the vertebral body using sleeves 100 and an instrument such as rod 500, some or all of sleeves 100 may remain in place. For example, the flexible member 120 can be separated from the rigid member 110, and the rigid member 110 can remain in place within the vertebral body.

As shown in Figures 43 and 44, various configurations of devices and implants can be utilized. For example, a rod or other implement may have any desired shape, such as shape 610, 620, 630, 640 or 650. Similarly, rods or other implements that may be used in conjunction with the partially flexible sleeve may have any desired curvature, such as the curvatures of rods 710, 720, 730, and 740 as shown. Each rod 740 may include a spherical body 741 .

Enhanced vertebral body (step 1500)

After repositioning the vertebrae 12 to reduce the lordosis, and after restoring the height of the vertebral body 12b, a filler such as bone cement, bone pellets, demineralized bone, another filler material or inserted An implant in the central portion 50 of the vertebral body reinforces the vertebral body 12b.

Figure 45 shows a curved rod 6800 that can be used to reposition the vertebra 12b in the manner described above, wherein the rod 6800 can include a position on the proximal cap or bulb 6820, e.g., the distal end. One or more holes 6810 at. Aperture 6810 may be used to remove bone material from the vertebrae or to introduce bone cement or other bone filler into space 50 to, for example, stabilize or enhance a reduced vertebral body. For example, the hole 6820 can communicate with the hollow cavity 6830 of the rod 6800 through which bone filler, cement, bone particles, etc. can be injected. It is contemplated that bone fillers, bone cements, bone particles, etc. may be inserted simultaneously with rod 6800 to reposition the endplates of the vertebrae, and it is also contemplated that bone fillers, bone cements, implants, etc. Bone particles and the like can be inserted into the damaged vertebrae without applying any force to the rod in order to reposition the endplate.

In other embodiments, as shown in FIG. 46, a curved implement, such as a curved rod, may be removed from the vertebra 12b. Needle 6900 and/or catheter or cannula may then be inserted through cannula 2100 to inject, for example, bone filler, bone particles, bone cement, or the like into the vertebrae. Bone fillers, bone pellets, bone cement, implants, or other augmentation devices may be inserted into the vertebrae with or without first repositioning the endplates of the damaged vertebrae , and can be inserted with sufficient force to reposition the vertebral endplates without the aid of additional instruments or devices.

In some embodiments, the desired filler material may be too thick or include particles that are too large to be transported through a rod 6800 as shown in FIG. 45 or a syringe needle 6900 as shown in FIG. 46 . In this case, the particulate or other non-fluid filler material may be inserted into the vertebral body 12b by other means, for example using a screw conveyor or other means for transporting the filler material.

Figure 47 shows examples of devices 10000 and 10100 comprising commercially available screw conveyors 10200 (MEVA Shaftless Screw Conveyor (shaftless screw conveyor), VoR Environmental, Botany, NSW, Australia) and 10300 (Spiroflow Flexible Screw Conveyor (flexible screw conveyor), Spiroflow Inc., Monroe, NC) so as to transport granular material 10400. The screw feature of such an auger device may be adapted or used to deliver filler material to reinforce the vertebral body 12 . Such an auger mechanism may, for example, deliver the filler material at lower pressures than, for example, injecting via a syringe. Utilizing lower pressures during augmentation of a fractured vertebra can help avoid leakage of filler material.

FIG. 48 shows an example of an auger device 11000 for augmenting a vertebral body 12 . The hopper 11100 may be adapted to hold filler material to be inserted into the vertebral body, for example, through the cannula 2100, which is inserted into the vertebral body in the manner described above. The hopper 11100 may be in communication with the cavity 2110 of the cannula 2100, such as through a valve 11200. A screw 11500 may pass from the valve 11200 through the sleeve 2200 and into the central portion 50 of the vertebral body 12 . The crank 11300 or other mechanism may be rotated to turn the screw 11500, for example, manually or with a motor (not shown). During rotation, the filler material 11400 from the hopper 11100 may enter the space between the threads 11510 of the screw 11500 and be transported along the length of the screw 11500 and into the space 50 .

Those skilled in the art will appreciate that each of the steps, methods, and devices described herein can be used in various combinations and/or in conjunction with various other methods and devices . For example, a kit for performing one or more steps or portions of the methods described herein may include various combinations of components and parts described herein in one or more packages. A kit may include, for example, one or more sleeves, a fracture device, an external fixator, and implant or filler material to reinforce the bone. Such embodiments may also include one or more syringes, delivery devices, or other devices for injecting fluid, semi-viscous fluid, or non-fluid filler material into the vertebral body.

In another embodiment for enhancing the vertebral body, an appliance 13000 as shown in FIG. 49 may be used for minimally invasive lordotic correction of the spine. The appliance 13000 may comprise at least two body sections 13100 connected together by a joint 13200 . The joints between the body sections are preferably ball joints, universal joints, or some other type of joint. The joint preferably allows polyaxial rotation of the body sections relative to each other, or at least provides rotation or pivoting about one axis. Body section 13100 may have a cylindrical shape. Alternatively, the body section may be flat or have another cross-sectional shape. The body section is preferably rigid such that a pushing force applied to the proximal end 13001 of the instrument 13000 will be transmitted to the distal end 13002. Elongated member 13300 may be made of metal, polymer ceramic, composite material, or combinations thereof.

Additionally, those skilled in the art will appreciate that the length of the body sections can vary. A wire, filament or other elongate member, preferably a flexible elongate member 13300, may be attached to the most distal or distal body section 13100a. The term the most distal or distal portion of the instrument 13000 refers to the end of the instrument 13002 located at a location away from the portion held by the surgeon. However, the caudal, posterior, or distal end 13001 of the instrument 13000 refers to the end of the instrument that is not located in the vertebral body held by the surgeon.

In the normal or rest position of the body section, when no force is exerted on the elongate element 13300, the body section 13100 and joint 13200 are preferably configured such that the body section 13100 is along a line or longitudinal axis 13003 of the appliance 13000 is aligned. When the elongate member 13300 is pulled, the body section 13100 at the distal end 13002 to which the elongate element 13300 is attached no longer coincides with the longitudinal axis 13003, so that a bend 13004 occurs in the implement place.

To use the instrument 13000, the cannula 2100 is inserted through the pedicle of the fractured vertebral body 12 (Fig. 50). The instrument 13000 is inserted through the cannula 2100 such that the distal end 13002 of the instrument 13000 is positioned within the body of the collapsed vertebra 12 (Fig. 51). The device 13000 is inserted along the cannula 2100 by applying a pushing force on the proximal end 13001 . The implement 13000 has sufficient stiffness so that force is transmitted along the implement 13000 to move the implement within the cannula 2100 and into the vertebral body. The distal end 13002 of the implement 13000 can then be bent/raised by pulling at the elongated element 13300 ( FIG. 52 ) in a direction towards the proximal end 13001 of the implement 13000 . If sufficient force is applied, the endplates 20, 30 of the collapsed vertebral body 12 can be pushed apart due to the force exerted by the body section 13100 on the endplates 20, 30, and the vertebral body can return to its original height (Fig. 48). Furthermore, the bone in the vertebral body 12 is compressed around the distal end 13002 of the device 13000 or around the most distal body section 13100a, which may reduce the risk of cement leakage. Moving the endplates 20, 30 and/or compressing the bone can create a cavity 51 in the vertebrae.

54-56 illustrate different mechanisms for pulling the elongated member 13300 of the implement 13000. These various mechanisms may form part of the appliance 13000 or may be separate components used in conjunction with the appliance 13000.

FIG. 54 illustrates a spool 14000 that may be used to pull the elongated member 13300. The spool 14000 may include two supports 14300 attached to the platform 14200 and the shaft 14400 attached to the two supports 14300 . A knob 14100 is attached to the shaft and may be used to rotate the shaft, thereby pulling the elongate element 13300 and thereby lifting the distal end 13002 of the instrument 13000 .

FIG. 55 shows a screw nut assembly 15000. The screw nut assembly 15000 may form the tail portion of the implement 13000 or be attached to the proximal end 13001 of the implement 13000 . Screw nut assembly 15000 may include threaded shaft 15100 , nut 15200 and housing 15300 . The elongate element 13300 can be connected to the threaded shaft 15100. By turning the screw-nut assembly, the elongate member 13300 is pulled back as the threaded shaft 15100 moves relative to the nut 15200 and sheath 15300, thereby lifting the distal end 13002 of the instrument 13000. As the distal end section 13100a is bent and lifted, the body sections 13100 are articulated relative to each other as the joints 13200 allow movement. A biasing force may be applied through the joint 13200 by means of, for example, a spring member, thereby maintaining the body sections biased to a normal rest position in which the body sections 13100 are aligned in a straight line or along the longitudinal axis 13003 . Although longitudinal axis 13003 is shown as a straight line in the figures, it should be appreciated that longitudinal axis 13003 could also be curved.

Similarly, a screw assembly 16000 is shown in FIG. 56 . Screw assembly 16000 may include a screw 16100 and a housing 16200. One end of the elongated element 13300 is connected to a screw 16100. As the screw 16100 is turned, the elongate member 13300 is correspondingly pulled back, thereby lifting the distal end 13002 of the instrument 13000.

57A-57C illustrate other configurations of the appliance 13000. Depending on the application, the number of body sections 13100 and joints 13200 may vary. FIG. 57A shows an appliance 13000 having three body sections 13100 and two joints 13200 . FIG. 57B shows an appliance 13000 with two body sections 13100 and one joint 13200 , and FIG. 57C shows an appliance 13000 with five body sections 13100 and four joints 13200 .

Figures 58A and 58B illustrate two different types of connectors 13200 that may be used. FIG. 58A shows a universal joint 13201 , and FIG. 58B shows a ball joint 13202 . However, it is contemplated that other types and configurations of linkers may be utilized. Those skilled in the art will appreciate that joint 13200 can be sized and configured for rotation about x, y and/or z axes.

In another alternative embodiment of the invention, the implement 1700 other than the joint or joints may be constructed of a polymer, or the implement 1700 may be constructed of a memory alloy such as Nitinol (FIG. 59) . When the elongated element 17200 is pulled, the distal end of the section 17100 of the instrument 17000 bends upward so that the distal end is laterally offset from its original position along the longitudinal axis of the instrument, thereby pushing the endplate of the collapsed vertebral body so that It separates and restores the vertebral body to its original height.

In yet another embodiment of the invention, an implement 18000 as shown in FIG. 60 may comprise a main body section 18100, at least one adjustable section 18200 (two adjustable sections are shown in FIG. 60 ), and an elongated Element 18300. The implement 18000 may also include a mechanism 18400 for pulling the elongate element 18300, thereby lifting the adjustable section 18200.

Although the invention and its advantages have been described in detail, it should be understood that various changes, equivalents and others can be made therein without departing from the spirit and scope of the invention as defined by the appended claims. optional. Furthermore, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. Those skilled in the art will readily appreciate from the disclosure of the present invention that existing or slightly different embodiments that perform substantially the same function or obtain substantially the same results as the corresponding embodiments described herein can be utilized in accordance with the present invention. The process, machine, manufacturing process, composition of matter, device, method or steps to be developed later. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.

Although the devices and methods described herein have been described so far in the context of vertebrae being repositioned, fractured, and augmented in the presence of vertebral compression fractures and curvature deformations of the spine, various and other uses and methods such as repositioning and reinforcement of long bones, ribs, and other skeletal structures. Further, in some embodiments, the implant may be inserted using a partially flexible catheter, such as one or more flexible links of an associated body. Bone cement, bone particles, or other fillers may also be used to help with reinforcement. In other embodiments, another implant 3430 may be inserted.

In some embodiments, the implants and methods described herein may be used in combination with other devices and methods to reduce lordosis and strengthen the vertebral body. For example, one or more partially flexible sleeves 100 may be used in conjunction with other known procedures, such as vertebroplasty or balloon kyphoplasty, which may be used by Used to initiate repositioning of the vertebral body and/or create space within the vertebral body for an implant.

In other embodiments, various microinvasive implants and methods for alleviating spinal-related discomfort may employ the anchors and other implants described herein. For example, an implant comprising one or more associated bodies may be implanted between the spinous processes of adjacent vertebrae in order to distract the spinous processes and relieve pain and symptoms such as those caused by spinal stenosis, lumbar spondyloarthropathies, and similar conditions. Other problems, the implant is for example located in an expandable container (not shown). For example, the augmentation systems described herein may be used in place of, or in addition to, the expandable spinous process devices and methods described in U.S. Patent Publication No. 2004/018128 and U.S. Patent Application 6,419,676 to Zucherman et al. other than using the augmentation system described herein.

Although the foregoing description and drawings have shown a number of preferred embodiments of the present invention, it should be understood that various additions, Variations and Alternatives. In particular, it should be clear to those skilled in the art that the present invention may be embodied in other specific forms, structures, arrangements, proportions and by other elements, materials and components without departing from the spirit or essential characteristics of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, with the scope of the invention being defined by the appended claims and not limited by the foregoing description.

Claims (20)

CLAIMS 1. An apparatus for repositioning a vertebra, said apparatus comprising: at least one elongated member, each of said elongated members having a first end and a second end, wherein said first end of each elongated member is configured to be inserted into a vertebral body; a fixed rod having an arcuate shape; and at least one clamp configured to adjustably secure the second end of one of the elongate members to the securing rod, Wherein the jig is configured to move along the rod to pivot the elongate member to reposition the vertebral body. 2. The apparatus of claim 1, further comprising a handle engaged with the second end of the elongated member. 3. The apparatus of claim 1, wherein the two or more elongate members are tubular bodies having a cavity along their length. 4. The device of claim 1, wherein: the securing rod includes a plurality of surface features arranged along the longitudinal axis of the securing rod; and The clamp has a first configuration in which the clamp is movable in a first direction along the longitudinal axis of the pole and engages the surface feature to prevent The longitudinal axis of the fixed rod moves in a second direction. 5. The apparatus of claim 4, wherein the clamp includes a button and has a second configuration, wherein the button disengages the clamp from the surface feature of the pole and allows the clamp to move along The second direction moves. 6. The apparatus of claim 1, further comprising a sleeve having a first end, a second end, and a channel providing access from the first end through the sleeve to the second end. cavity, the first end is configured to be inserted into the fractured vertebra. 7. The apparatus of claim 1, wherein said elongated member comprises at least one of the group of substances comprising stainless steel, metal, metal alloy, polymer, composite, ceramic, or combinations thereof . 8. A method for treating a damaged vertebral body, said method comprising the steps of: Applying force in the area to reduce the lordosis in the area of the damaged vertebrae; fracture the damaged vertebra; restoring the height of the damaged vertebral body; and Strengthen the vertebral bodies. 9. The method of claim 8, wherein said step of reducing the lordosis comprises: inserting a first elongate member into a first vertebral body, wherein the first vertebral body is adjacent to the first end of the damaged vertebral body; inserting a second elongate member into a second vertebral body, wherein the second vertebral body is adjacent a second end of the damaged vertebral body opposite the first end; moving the first elongate member to change the position of the first vertebral body relative to the damaged vertebral body; and The first elongated member is positioned on the fixed rod. 10. The method of claim 9, wherein the elongate member is positioned on the fixation rod prior to moving the first elongate member relative to the damaged vertebral body. 11. The method of claim 9, wherein the moving step includes positioning the first elongated member relative to the damaged vertebral body. 12. The method of claim 9, wherein the positioning step includes securing the first elongate member to an arcuate fixation rod by a first clamp. 13. The method of claim 12, wherein said moving step comprises: disengaging the first clamp from the fixed rod; pivoting the elongate member; and The first clamp is re-engaged with the fixation rod to fix the position of the first vertebral body. 14. The method of claim 12, wherein the moving step includes moving a position of the clamp connected to the elongate member along the longitudinal axis of the fixed rod. 15. The method of claim 12, wherein the step of reducing the lordosis further comprises inserting a cannula into the damaged vertebral body and securing the cannula to the fixation rod. 16. The method of claim 8, wherein said step of fracturing said damaged vertebra comprises: inserting a cannula into said damaged vertebral body by means of a posterior approach, said cannula having a lumen sized to provide access into said vertebral body; inserting a snap-off device through the cannula; and The damaged vertebral body is fractured using the fracture device. 17. The method of claim 8, wherein said step of restoring the height of said damaged vertebra comprises: inserting a cannula into the damaged vertebral body, the cannula having a lumen sized to provide access into the vertebral body; inserting a tool through the cannula and into the vertebral body; and The endplate of the damaged vertebral body is moved by the tool to restore the height of the damaged vertebral body. 18. The method of claim 17, wherein: the access tool includes a curved rod having a longitudinal axis and a distal end configured to contact the bone; and The step of moving the end plate includes advancing the curved rod through the sleeve to bring the end plate into contact with the distal end of the curved rod, and passing the curved rod along the curved rod. Applying a force along the longitudinal axis moves the endplate away from an opposing endplate of the vertebra to reposition the vertebral endplate. 19. The method of claim 8, further comprising inserting a cannula into said damaged vertebra prior to performing said restoring step, said cannula having a lumen sized for Access to the vertebral body is provided. 20. The method of claim 8, wherein said fracture step is performed prior to said step of reducing lordosis.

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