WO1998042269A1 - Dispositif et procede d'immobilisation spinale - Google Patents
Dispositif et procede d'immobilisation spinale Download PDFInfo
- Publication number
- WO1998042269A1 WO1998042269A1 PCT/US1998/004777 US9804777W WO9842269A1 WO 1998042269 A1 WO1998042269 A1 WO 1998042269A1 US 9804777 W US9804777 W US 9804777W WO 9842269 A1 WO9842269 A1 WO 9842269A1
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- WO
- WIPO (PCT)
- Prior art keywords
- cage
- bone
- segments
- spinal
- immobilization device
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
- A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1671—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
- A61B17/1659—Surgical rasps, files, planes, or scrapers
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/3094—Designing or manufacturing processes
- A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- the present invention relates to a spinal immobilization device and a surgical method of employing the device to facilitate the fusion of bone segments to correct medical conditions such as degenerative disc diseases.
- a degenerative disc disease is characterized by a disorder which effects the proper functioning of a disc between two adjacent bones. There are numerous reasons for this which include herniated, ruptured, or slipped discs. Due to the defect in the disc, the vertebrate goes out of alignment and tends to produce problems with posture and pain.
- the deviated arrangement of the vertebrate can lead to a visible contortion of the spine resulting in disorders such as idiocies (a swayed back posture) , kyphosis (shoulders being rolled forward) , and scoliosis (sideways curvature of the sine) .
- This exaggerated posture can have bleak social consequences and comport a potentially negative psychological perspective to the person affected. Yet this is but one detrimental result of the disorder.
- the spinal cord and related nerves are necessarily effected. This can lead to pain as the nerves are moved out of place and more force is placed upon them. The pain is also increased as movement will tend to irritate the already abnormal condition.
- Surgical stabilization techniques have been employed to correct these conditions. This involves the use of an immobilization device which both secures the spine in position and promotes fusion of the adjacent bone segments. The goal being a return of the curvature of the spine to a more normal condition and the reduction of physical pain.
- a partial discectomy (removal of the disc material) is performed to remove enough disc material to allow the insertion of the immobilization device. Then the opposing surfaces of adjacent bone segments may be cut to allow for the insertion of the immobilization device.
- the device may be filled with bone material before insertion so that the bone can fuse from the bone segments through the device.
- One such method uses a hollow circular post with threads on the outside.
- the opposing bone surfaces are cut in a semicircular shape to accommodate the device.
- This type of shaping of the bone surfaces tends to cut deeply into the body of the vertebrate due to the arc of the circle.
- the result is that the strongest part of the body of the vertebrate (i.e., the outside layer) is weakened, because of the removal of so much bone to accommodate the circular shape.
- the device is filled with bone material and then screwed in the space created between the bone segments.
- Another drawback to this device is that the threads are not secured into place resulting in a tendency of the device to unscrew and become dislodged; thus defeating both the structural support and bone fusing objectives.
- the device upon movement from its initially placed position, can intrude upon and irritate soft tissues within the body. This can lead to further pain and other complications that require surgery to correct. Furthermore, each surgery presents a patient with a risk of danger including the risk of being under anesthesia and related problems.
- Another method uses a hollow circular metal cage.
- the cage is filled with bone material and at least one end of the cage is cut to a length approximating the distance between the segments to be immobilized.
- the cutting operation is often imprecise resulting in a length which is either too short or too long for the space between the bone segments.
- the tool used to cut the cage tends to produce a sharp surface on the end of the cage. This sharp surface has a tendency to cut into the bone so that the cage fails to adequately correct the spinal displacement when it digs too deeply into the bone. As a result, the spine may not be corrected completely and the pain is not effectively eradicated. Also, the structural integrity of the bone may be further compromised by the deeply cutting edges. The problems associated with the metal cage may require further surgery for correction.
- the cage may be difficult to remove if it is buried deeply within the bone due to the cutting produced by the sharp edges.
- a spinal immobilization device, and method of utilizing the device that results in a more secure placement than can be achieved with a screw type device and does not undermine the support of the spine by cutting too deeply into the bone as with the prior art metal cage.
- the present invention addresses the stabilization of bone segments. This is accomplished through the use of an immobilization device, composed of a cage chosen from a number of cages of different lengths, and a method of; preparing the bone surfaces for receiving the cage, choosing the proper length cage, and installing the cage.
- Disc material between adjoining bone segments is removed in an area that approximates the external volume of the cage. Then the opposing sides of adjacent bone segments are shaved using a bone shaving device. Initially the opposing bone segments need not be parallel and in many cases will not be. The bone is shaved to provide opposing substantially parallel surfaces that will receive the cage. Due to the use of a flat surface, the amount of bone removed (particularly from the hardest proximal end of the spinal segments) is minimized and the structural integrity of the hardest part of the bone is maintained. The cavity produced by removing the disc material and shaved bone closely resembles the shape of the cage. After the cavity is created, the distance between the opposing parallel surfaces of the bone segments is measured. A variety of cages of varying lengths are made available so that at least one will approximate the height of the cavity. The advantage of using a pre-formed cage is twofold.
- each of the several cages has groups of ridges or serrations separated by substantially flat areas.
- the ridges are designed to come into contact with and burrow into the bone. These ridges have a short height which is adequate for engaging the bone and securing the cage in a single position, but not enough to deeply penetrate to a point that compromises the structural integrity of the bone.
- the flat surfaces between the groups of ridges and the valleys between the ridge peaks act to limit the penetration of the ridges into the bone.
- a cage is chosen that is slightly longer than the height of the cavity to accommodate the minor penetration of the ridges of the cage into the bone. Bone material is then placed in the hollow center of the chosen cage to allow for bone fusion.
- a placement assembly is inserted into the cage and is used to position the cages between the bone segments. The placement of the selected cage requires application of force on a placement assembly which is fitted (e.g., via a threaded connected) into a tool engaging surface formed on one side of the cage) . When the cage is in position, it fits securely in a single place and cannot be dislodged in the same manner as a screw can become unscrewed. When securely situated, the placement assembly is then removed and the cage is left to facilitate bone fusion and stabilization of the bone segments.
- Figure 1 is a side elevational view of the cage with the placement tool engaging surface in the foreground;
- Figure 2 is a perspective view of the cage of Figure 1;
- FIG. 1 is top view of the cage
- Figure 4 is a top cross sectional axial view of the cage taken along line 4-4 of figure 1;
- FIG. 5 is a top plan view of another embodiment of the T ⁇ cage having a narrow width
- Figure 6 is a side elevational view of the cage of Figure 5 with the bone engaging surface and side wall perforations visible;
- Figure 7 is a top plan view of another embodiment of the 2Q cage having an internal polygonal, i.e., octagonal, surface;
- Figure 8 is a side elevational view of the cage of Figure 7 with the side wall perforations showing;
- Figure 9 is a side elevational view of a bone shaving device entering a patient's body and in preparation of shaving the 25 opposing surfaces of spinal bone segments;
- Figure 10 is a perspective view of one type of bone shaving device suitable for use in the present invention.
- Figure 11 is a perspective view of another type of bone shaving device
- Figure 12 is a top plan view of the bone shaving device of figure 10 shaving the upper face of one spinal segment
- Figure 13 is a side elevation view of a group of cages of varying lengths supported on a rod;
- Figure 14 is a side elevation view of the placement assembly 35 engaging the cage and in preparation for placement of the cage between a cavity formed between adjacent bone segments;
- Figure 15 is a top plan view of the cage in place on the upper face of the lower bone segment;
- a spinal immobilization device in accordance with the present invention comprises a cage 18 having a peripheral wall 19 which terminates at an upper first end 20 and at a lower or second end 21.
- a longitudinal axis x-x extends through the center of the cage at right angles to the planes passing through the ends 20, 21, as illustrated.
- Groups of ridges or serrations 22 are provided on each end of the cage.
- the groups of ridges 22 are separated by flat surface areas 24. As illustrated in Figure 2, the individual ridges are composed of peaks 26, which extend above the flat surfaces 24 and valleys 28 with the bottom of the valley being about level with the flat surfaces 24 as shown.
- the ridges are adapted to engage the bone and penetrate to a depth adequate to secure the cage in place.
- the flat surfaces between the groups of ridges and the valleys act to halt the boring of the ridge peaks into the bone. This control of depth penetration of the ridges insures that the structural integrity of the bone is not compromised.
- the cage is hollow thus forming a cavity 30 therein.
- This cavity is adapted to receive bone material which will migrate through the cavity and fuse adjacent bone segments.
- the peripheral wall 19 has an inner surface 32 and an outer surface 34.
- the inner and outer surfaces have a polygonal shape with the shape of the outer surface being in the form of an octagon while the inner surface is in the form of a circle.
- perforations 40 extending through the wall 19, i.e., from the outer surface to the inner surface, as illustrated in Figures 2 and 4.
- the shape and size of the perforations or holes are sufficient to allow for the bone material within the hollow cavity to migrate out of the cage and fuse with the adjacent bone segments.
- bone material may migrate into the cavity during the fusion process.
- the cage is provided with a tool engaging surface 42 which comprises a threaded opening 44 as is illustrated in Figures 2, 3 and 4.
- a placement assembly or tool 46 (Fig. 14) is used between the spinal segments after such segments have been properly prepared, as will be explained in more detail.
- the placement assembly 46 is in the form of an elongated rod 47 with a threaded end 48 that engages the threads of the tool engaging surface 42 on the cage .
- the peripheral wall of the cage has an inside diameter (ID) and on outside diameter (OD) as shown in Figure 3.
- Figure 3 further illustrates the width (W) of the cage.
- the width of the cage is determined by the strength of the material from which the cage is made and perhaps the amount of flat surface 20 needed to restrict the progress of the ridges within the bone.
- the cage of Figures 1-4 is preferably made of a thermoplastic material containing or impregnated with carbon fibers to provide the necessary strength to support the spinal segments during the fusion process. Most preferably such a carbon fiber/plastic material has a modulus of elasticity approximating or similar to the modulus of elasticity of the spinal bone segments.
- the elastic modulus of the carbon fiber/plastic material may be within the range of 4 to 8 or more.
- Cortical bone has an elastic modulus of about 12-18. The similarity of the elastic modulus served to reduce stress shielding.
- Figures 5, 6, 7 and 8 illustrate alternative embodiments of a cage manufactured of a metal such a titanium ( Figures 7 and 8) or stainless steel ( Figures 5 and 6) .
- the peaks within a group of ridges of all of the embodiments are preferably equally spaced as illustrated at F in Figure 6.
- the peaks are preferably spaced apart at a distance within the range of about .05 to 2.0mm ad most preferably about 1.0mm.
- the height of the peaks (H) is measured from the bottom (or valley) of a ridge (which is substantially coplanar with the flat surface 24) to the top of a peak.
- the height H of the peaks is preferably within the range of about 0.3 to 2.0mm and most preferably about 1.0mm.
- the preparation of the bone segments is achieved through the use of a bone shaving device 52 (Fig. 9) as will be explained in more detail.
- the bone shaving device 52 is inserted through the anterior body portion 50 of a patient with a sharp end 60 thereof (Fig. 10) engaging the lower face 54 of the upper segment 55 as well as the upper face 56 of the lower bone segment 57 of the spinal vertebrates.
- Figures 10 and 11 illustrate varieties of the shape of the cutting surface 60 and graduated measurement markings 58 in the form of millimeter measurements from the distal end 61 of the instrument to allow the surgeon to determine the amount of penetration of the instrument within the bone segments by means of appropriate imaging devices such as flourscopes.
- Figure 12 illustrates the movement of the bone shaving instrument within the body portion of a vertebrate 62.
- the lateral motion of the instrument removes bone from the faces of the adjacent bone segments.
- the top 54 and bottom 56 faces of the vertebrates are not initially parallel as explained above.
- the shaving is performed to create two surfaces which are parallel and thus capable of receiving the cage.
- the advantage to a minimal shaving becomes clear because of the varying density and strength of the bone segments.
- the outside of the bone appears to be the toughest and provides the greatest load carrying capacity as compared to the interior bone structure.
- the result of the shaving produces a polygonal cavity 64, as illustrated in Figure 14. Once the cavity is formed, the distance between the adjacent shaved faces 66 and 68 is measured as is illustrated in Figure 14. It should be noted that the height of the cavity can be measured, for example, by means of an instrument of the type shown in Figure 11 or by any other appropriate method.
- This measurement is compared to the lengths (L) of a number of cages provided in Figure 13.
- a cage is chosen such that the length (L) is slightly more than the distance (Ch) by such an amount as to allow the ridges to penetrate the bone while preserving the proper spinal alignment.
- Figure 14 illustrates the placement assembly engaged with the cage in preparation for inserting the cage into the cavity. Since the cage is slightly longer than the height of the cavity, force must be applied to the placement assembly to insert the cage securely within the cavity. The placement assembly is then removed form the cage and the cage is left securely in place between the bone segments as illustrated in Figure 16.
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Abstract
L'invention a trait à un dispositif d'immobilisation spinale prenant la forme d'une cage creuse (18), disponible dans une pluralité de longueurs, destinée à soutenir des segments d'os adjacents et à permettre audits segments de fusionner ensemble. Lesdits segments sont préparés à recevoir une des cages grâce à la formation de faces parallèles (66, 68) entre des segments adjacents et ce, par l'intermédiaire d'instruments de rabotage d'os (52). On choisit une cage parmi une pluralité de cages présentant différentes longueurs de telle manière que la longueur de la cage soit légèrement plus grande que la distance existant entre les faces préparées des segments d'os adjacents. La matière os est placée à l'intérieur de la cavité (30) de la cage en vue de faciliter la migration et la fusion des os entre les segments d'os adjacents. La cage comporte des cannelures (22) au niveau de chaque extrémité, elles sont destinées à être insérées dans les segments d'os en vue de maintenir la cage en place au cours du processus de fusion.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US82350997A | 1997-03-24 | 1997-03-24 | |
US08/823,509 | 1997-03-24 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998042269A1 true WO1998042269A1 (fr) | 1998-10-01 |
Family
ID=25238963
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/004777 WO1998042269A1 (fr) | 1997-03-24 | 1998-03-12 | Dispositif et procede d'immobilisation spinale |
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WO (1) | WO1998042269A1 (fr) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6096080A (en) * | 1998-05-06 | 2000-08-01 | Cortek, Inc. | Apparatus for spinal fusion using implanted devices |
WO2001008611A1 (fr) * | 1999-07-28 | 2001-02-08 | Tutogen Medical Gmbh | Implant en matiere osseuse |
WO2001062191A2 (fr) * | 2000-02-22 | 2001-08-30 | Sdgi Holdings, Inc. | Greffe osseuse anterieure et instruments d'entrainement |
WO2002034144A1 (fr) * | 2000-10-20 | 2002-05-02 | Sdgi Holdings, Inc. | Methodes et instruments pour interventions chirurgicales intervertebrales |
EP1570222A2 (fr) * | 2002-11-13 | 2005-09-07 | SYNTHES AG Chur | Implant intervertebral pour procedure de fusion intervertebrale lombaire posterieure trasnforaminale |
WO2007127629A1 (fr) * | 2006-04-27 | 2007-11-08 | Warsaw Orthopedic, Inc. | Implants intervertébraux et méthodes d'utilisation |
AU2004202053B2 (en) * | 2000-02-22 | 2008-08-21 | Warsaw Orthopedic, Inc. | Anterior impacted bone graft and driver instruments |
CN102488574A (zh) * | 2011-12-09 | 2012-06-13 | 中国科学院深圳先进技术研究院 | 椎间融合器 |
US9216096B2 (en) | 2010-03-16 | 2015-12-22 | Pinnacle Spine Group, Llc | Intervertebral implants and related tools |
US9380932B1 (en) | 2011-11-02 | 2016-07-05 | Pinnacle Spine Group, Llc | Retractor devices for minimally invasive access to the spine |
US10070970B2 (en) | 2013-03-14 | 2018-09-11 | Pinnacle Spine Group, Llc | Interbody implants and graft delivery systems |
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US5192327A (en) * | 1991-03-22 | 1993-03-09 | Brantigan John W | Surgical prosthetic implant for vertebrae |
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US4834757A (en) * | 1987-01-22 | 1989-05-30 | Brantigan John W | Prosthetic implant |
US5192327A (en) * | 1991-03-22 | 1993-03-09 | Brantigan John W | Surgical prosthetic implant for vertebrae |
Cited By (26)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6096080A (en) * | 1998-05-06 | 2000-08-01 | Cortek, Inc. | Apparatus for spinal fusion using implanted devices |
WO2001008611A1 (fr) * | 1999-07-28 | 2001-02-08 | Tutogen Medical Gmbh | Implant en matiere osseuse |
AU774707B2 (en) * | 2000-02-22 | 2004-07-08 | Warsaw Orthopedic, Inc. | Anterior impacted bone graft and driver instruments |
WO2001062191A3 (fr) * | 2000-02-22 | 2002-02-07 | Sdgi Holdings Inc | Greffe osseuse anterieure et instruments d'entrainement |
WO2001062191A2 (fr) * | 2000-02-22 | 2001-08-30 | Sdgi Holdings, Inc. | Greffe osseuse anterieure et instruments d'entrainement |
US6984245B2 (en) | 2000-02-22 | 2006-01-10 | Sdgi Holdings, Inc. | Anterior impacted bone graft and driver instruments |
AU2004202053B2 (en) * | 2000-02-22 | 2008-08-21 | Warsaw Orthopedic, Inc. | Anterior impacted bone graft and driver instruments |
US8092537B2 (en) | 2000-02-22 | 2012-01-10 | Warsaw Orthopedic, Inc. | Anterior impacted bone graft and driver instruments |
US7635371B2 (en) | 2000-02-22 | 2009-12-22 | Warsaw Orthopedic, Inc. | Anterior impacted bone graft and driver instruments |
WO2002034144A1 (fr) * | 2000-10-20 | 2002-05-02 | Sdgi Holdings, Inc. | Methodes et instruments pour interventions chirurgicales intervertebrales |
US6599291B1 (en) | 2000-10-20 | 2003-07-29 | Sdgi Holdings, Inc. | Methods and instruments for interbody surgical techniques |
US7803161B2 (en) | 2000-10-20 | 2010-09-28 | Warsaw Orthopedic, Inc. | Methods and instruments for interbody surgical techniques |
US7169152B2 (en) | 2000-10-20 | 2007-01-30 | Sdgi Holdings, Inc. | Methods and instruments for interbody surgical techniques |
US8142438B2 (en) | 2000-10-20 | 2012-03-27 | Warsaw Orthopedic, Inc. | Methods and instruments for interbody surgical techniques |
US8690949B2 (en) | 2001-05-03 | 2014-04-08 | DePuy Synthes Products, LLC | Intervertebral implant for transforaminal posterior lumbar interbody fusion procedure |
USRE46647E1 (en) | 2001-05-03 | 2017-12-26 | DePuy Synthes Products, Inc. | Intervertebral implant for transforaminal posterior lumbar interbody fusion procedure |
EP1570222A4 (fr) * | 2002-11-13 | 2008-10-29 | Synthes Gmbh | Implant intervertebral pour procedure de fusion intervertebrale lombaire posterieure trasnforaminale |
EP1570222A2 (fr) * | 2002-11-13 | 2005-09-07 | SYNTHES AG Chur | Implant intervertebral pour procedure de fusion intervertebrale lombaire posterieure trasnforaminale |
WO2007127629A1 (fr) * | 2006-04-27 | 2007-11-08 | Warsaw Orthopedic, Inc. | Implants intervertébraux et méthodes d'utilisation |
US9216096B2 (en) | 2010-03-16 | 2015-12-22 | Pinnacle Spine Group, Llc | Intervertebral implants and related tools |
US9649203B2 (en) | 2010-03-16 | 2017-05-16 | Pinnacle Spine Group, Llc | Methods of post-filling an intervertebral implant |
US9788973B2 (en) | 2010-03-16 | 2017-10-17 | Pinnacle Spine Group, Llc | Spinal implant |
US9380932B1 (en) | 2011-11-02 | 2016-07-05 | Pinnacle Spine Group, Llc | Retractor devices for minimally invasive access to the spine |
CN102488574A (zh) * | 2011-12-09 | 2012-06-13 | 中国科学院深圳先进技术研究院 | 椎间融合器 |
CN102488574B (zh) * | 2011-12-09 | 2014-12-24 | 中国科学院深圳先进技术研究院 | 椎间融合器 |
US10070970B2 (en) | 2013-03-14 | 2018-09-11 | Pinnacle Spine Group, Llc | Interbody implants and graft delivery systems |
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