IMPLANT AND METHOD FOR FACET IMMOBILIZATION
20180221064 ยท 2018-08-09
Inventors
Cpc classification
A61F2/4405
HUMAN NECESSITIES
A61F2310/00029
HUMAN NECESSITIES
A61F2220/0075
HUMAN NECESSITIES
A61F2310/00023
HUMAN NECESSITIES
A61F2310/00017
HUMAN NECESSITIES
A61F2002/30754
HUMAN NECESSITIES
A61F2002/30433
HUMAN NECESSITIES
A61F2002/30507
HUMAN NECESSITIES
A61F2002/2821
HUMAN NECESSITIES
A61F2220/0025
HUMAN NECESSITIES
A61F2310/00239
HUMAN NECESSITIES
A61F2220/0041
HUMAN NECESSITIES
A61B17/7064
HUMAN NECESSITIES
International classification
Abstract
Devices and methods are provided for immobilizing facet joints of the vertebral column. Embodiments of the invention provide an implant that is inserted in a facet joint from which cartilage has been removed, and which retains the approximate original spacing of the facets in the joint. A retaining arrangement, such as an adhesive, a threaded fastener, or a screw is then used to secure the implant in the joint.
Claims
1. A device for treating spinal disorders by inhibiting movement at a facet joint, the device comprising: an implant having a first face and a second face, wherein an entire periphery of the implant has a thickness that is greater than a thickness measured from the first face to the second face of a central region of the implant; wherein the first face is configured to be secured to the adjacent articular surface of a first facet of the facet joint, and the second face is configured to be secured to the adjacent articular surface of a second facet of the facet joint.
2. The device of claim 1, wherein the implant is dimensioned to fit substantially within a joint capsule of the facet joint, and has a thickness that is approximately the same as the normal anatomic spacing between the first and second facets of the facet joint.
3. The device of claim 1, wherein the shape of the first face of the implant is configured to conform to the articular surface of the first facet of the facet joint, and the second face of the implant is configured to conform to the articular surface of the second facet of the facet joint.
4. The device of claim 1, wherein the implant comprises at least one of a polymer, polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene, a ceramic, zirconia, alumina, silicon nitride, a metal, titanium, a titanium alloy, cobalt chromium, or a stainless steel.
5. The device of claim 1, wherein the implant comprises at least one of an autograft material or an allograft material.
6. The device of claim 1, wherein each of the first face and the second face comprises a roughened surface.
7. The device of claim 1, wherein each of the first face and the second face comprises a porous surface.
8. The device of claim 1, wherein the implant has an average thickness that is between about 0.5 mm and about 3 mm.
9. The device of claim 1, wherein the implant has an average thickness that is between about 1 mm and about 2 mm.
10. The device of claim 1, wherein the implant has an average lateral dimension that is between about 5 mm and about 25 mm.
11. The device of claim 1, wherein the implant has an average lateral dimension that is between about 10 mm and about 20 mm.
12. The device of claim 1, wherein the device is configured to be bonded to the articular surfaces of the first and second facets using at least one of an adhesive or a sealant.
13. The device of claim 1, further comprising an anchoring arrangement configured to maintain the first face in a fixed position relative to the adjacent articular surface of the first facet, and to maintain the second face in a fixed position relative to the adjacent articular surface of the second facet.
14. The device of claim 13, wherein the anchoring arrangement is configured to provide a compressive force between the implant and each of the adjacent articular surfaces of the facet joint.
15. The device of claim 13, wherein the anchoring arrangement comprises a rigid fastener.
16. The device of claim 13, wherein the anchoring arrangement comprises a threaded retainer.
17. The device of claim 13, wherein the anchoring arrangement comprises at least one of a bolt or a screw.
18. The device of claim 13, wherein the anchoring arrangement comprises a bone screw.
19. The device of claim 13, wherein the anchoring arrangement comprises a threaded retainer that is curved along a primary axis thereof.
20-29. (canceled)
30. A device for treating spinal disorders by inhibiting movement at a facet joint, the device comprising: an implant having a first face and a second face, wherein the implant is a circular disc dimensioned to fit substantially within a joint capsule of the facet joint, wherein at least a portion of a periphery of the implant has a thickness that is greater than a thickness measured from the first face to the second face of a central region of the implant; wherein the first face is configured to be secured to the adjacent articular surface of a first facet of the facet joint, and the second face is configured to be secured to the adjacent articular surface of a second facet of the facet joint.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Further objects, features and advantages of the invention will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments, results and/or features of the present invention, in which:
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[0054] Throughout the drawings, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the present invention will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments and is not limited by the particular embodiments illustrated in the figures.
DETAILED DESCRIPTION
[0055] In one aspect, embodiments of the present invention provide a device for immobilizing a facet joint, and which can further maintain a spacing between the two facets of the immobilized facet joint. As shown in
[0056] The implant can be formed from any of a variety of materials known in the art, including but not limited to a polymer such as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), or polyethylene. Alternatively, the implant can be formed from a ceramic such as zirconia, alumina, or silicon nitride. The implant may also be formed from a metal including, but not limited to, titanium, a titanium alloy, cobalt chromium, or a stainless steel. The implant can also be formed from a wafer of allograft material or autograft material, which can promote growth of bone tissue from the facets into the implant. The implant can also be formed from a combination of two or more of the materials cited herein.
[0057] In one embodiment, the implant 34 has a generally circular profile and is sized to fit substantially within the joint capsule of the facet joint 28.
[0058] In one embodiment, the implant has a diameter between about 4 mm and about 30 mm. In another embodiment, the implant has a diameter between about 5 mm and about 25 mm. In still another embodiment, the implant has a diameter between about 10 mm and about 20 mm. If the implant is not circular in shape, the diameter can refer to the longest dimension measured across one of the two faces thereof. The diameter of a particular implant can be selected based on the size of the articular surfaces in the facet joint to be immobilized, which varies with location in a particular vertebral column. Preferably, the diameter of the implant should not be so large that the implant protrudes significantly beyond the edges of the articular surfaces, and is large enough such that the faces of the implant contact a substantial portion of the articular surfaces. Further, the implant should not protrude past the periphery of the facet joint closest to the vertebral column, as such protrusion may interfere with a disc or the spinal cord.
[0059] The implant preferably has a thickness approximately the same as the anatomic spacing between two facets of the facet joint to be immobilized. For example, the implant generally has a thickness between about 0.5 mm and about 3.0 mm. In certain embodiments, the implant has a thickness between about 1 mm and about 2 mm. In further embodiments, the implant has a thickness between about 0.5 mm and about 1.5 mm. The thickness of the implant may also be slightly larger than the anatomic spacing between two facets of the facet joint. A thicker implant can improve contact between the implant faces and the articular surfaces when the implant 34 is placed between the facets 20, 222 as shown, for example, in
[0060] The implant can be configured to provide an improved fit with the articular process and/or joint capsule. In certain embodiments, the thickness of a particular implant is nonuniform. For example, in
[0061] In certain embodiments, the implant may also be shaped to better conform to the shape of the articular surfaces of a facet joint. For example, the implant 49 shown in
[0062] In embodiments of the present invention, the facet joint capsule is incised and at least a portion of the cartilage is removed from the joint space between the facets before the implant is placed therein. Preferably, enough of the cartilage in the facet joint is removed such that all or a substantial portion of the articular surfaces of the facets are exposed. One or both of the adjacent articular surfaces can be roughened to improve contact with the implant and reduce slippage between the implant faces and the articular surfaces of the facets.
[0063] Preferably, at least a portion of each face of the implant is porous and/or roughened. In one embodiment, shown in
[0064] In a further embodiment, at least a portion of the surfaces 53, 54 of the implant 50 are porous as shown in
[0065] A curved implant 56 is shown in
[0066] In certain embodiments of the invention, the implant is maintained between the two facets of the facet joint by taking advantage of the joint capsule and/or other body tissue surrounding the facet joint to limit the migration of the implant out of the facet joint. For example, the shape of the implant itself may be capable of resisting displacement of the implant from its position generally between the facet joint surfaces. A concave or biconcave configuration, such as that shown in
[0067] In one embodiment, an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate, or another biocompatible adhesive, is used to bond the faces of the implant to the adjacent articular surfaces of the facet joint. Such bonding can promote fusion of the facet joint. In a further embodiment, bone growth facilitators, electrical current, or other conventional techniques may be used to accelerate osteoincorporation of textured or porous anchoring surfaces of the implant.
[0068] In further embodiments, the device further includes an anchoring arrangement configured to secure the implant in a fixed position relative to the adjacent facets. The anchoring arrangement preferably provides a compressive force between the implant and the facets to promote adhesion and/or osteoincorporation of the implant with the articular surfaces of the facets.
[0069] In one embodiment of the invention, a hole 78 is provided through the implant 76 between opposite faces 82, 84, as shown in
[0070] A hole is formed through both articular processes 20, 22 of the facet joint to be immobilized or fused, as shown in
[0071] The diameter of the hole 78 in the implant 76 and the diameters of the holes in the articular processes 20, 22 are preferably at least slightly larger than the diameter of the retainer member 72. This allows the retainer member 72 to be easily inserted through the holes, and can also allow the implant 76 and the articular processes 20, 22 to move freely with respect to the retainer member 72 when the nuts 94 are tightened onto the threaded ends 96. This can assist in providing compressive forces between the faces of the implant 76 and the adjacent facet surfaces when the nuts 94 are tightened on the retainer member 72.
[0072] The hole 78 can be formed in the implant 76 before it is inserted into the facet joint. Alternatively, the hole 78 can be formed together with the holes through the articular processes 20, 22 after the implant 76 is placed in the facet joint. Such holes can be formed by drilling, by using a punch, or by other conventional techniques suitable for creating a hole in the bone and implant materials.
[0073] The cross-sectional shape of the retaining member 72 can be selected from a variety of shapes, including but not limited to circles, ovals, squares, rectangles, other polygons, or other shapes. A circular shape is preferred to better conform to the threaded ends 96 and to provide a close fit with the drilled or punched holes in the articular processes 20, 22. The retaining member 72 generally has a diameter between about 0.25 mm and about 2 mm, or between about 0.5 mm and about 1.25 mm, or preferably between about 0.75 mm and about 1.25 mm. The diameter of the retaining member 72 may optionally vary along its length. The diameter of a particular retaining member 72 may be selected based on the facet joint being immobilized. For example, a larger diameter can be used for immobilizing facet joints in the lower vertebrae (e.g., lumbar vertebrae) which tend to have larger facets. Similarly, a smaller diameter can be used for immobilizing facet joints in the upper vertebrae (e.g., cervical vertebrae) which tend to have smaller facets.
[0074] The retaining member 72 has a length that is generally between about 5 mm and about 60 mm, or between about 10 mm and about 40 mm. The retaining member 72 can have a length of about 20 mm to about 30 mm. The length of a particular retaining member 72 may be selected based on the facet joint being immobilized. For example, a longer retaining member 72 can be used for immobilizing facet joints in the lower vertebrae (e.g., lumbar vertebrae) which tend to have thicker articular processes 20, 22. Similarly, a shorter retaining member 72 can be used for immobilizing facet joints in the upper vertebrae (e.g., cervical vertebrae) which tend to have thinner or smaller articular processes 20, 22. In general, it is preferable that the ends of the retaining member 72 do not protrude too far from the surfaces of the articular processes 20, 22 when inserted into the holes therethrough, but the retaining member 72 should be long enough to allow engagement of the nuts 94 onto the threaded ends 96.
[0075] In a further embodiment, shown in
[0076] In another embodiment, the retaining member 72 of the anchoring assembly has a bend or a curve along the main axis, as shown in
[0077] In a further embodiment, shown in
[0078] In another embodiment, shown in
[0079] In one embodiment, the force on the retaining member 99 is capable of creating a friction fit or a mechanical fit to resist movement between the retaining member 99 and the retaining ring 98, thereby securing the retaining member 99 to the articular process 20 or 22. As shown in
[0080] In another embodiment, depicted in
[0081] In still further embodiments, the retaining member is configured to accept a retaining ring 98 or a retaining disc 120 at or near one end, and has a single threaded end 96 at the opposite end. The retaining member can be inserted through holes in the implant and articular processes 20, 22, and the retaining ring 98 or retaining disc 120 can be fastened at or near the one end of the retaining member as described herein. A single nut 94 can then be threaded onto the threaded end 96 to immobilize the facet joint and more easily provide a compressive force across the joint.
[0082] In a still further embodiment, shown in
[0083] In a further aspect, embodiments of the invention provide a method for immobilizing a facet joint. First, a midline skin incision is made over the desired vertebrae, or a paraspinous skin incision is made over the particular facet joint to be immobilized. The facet joint capsule is incised and at least a portion of the cartilage is removed from the joint space between the facets. Preferably, substantially all of the cartilage is removed from the joint space to expose all or a substantial portion of the articular surfaces of the facets. One or both of the adjacent articular surfaces can be roughened to improve contact with an implant and reduce slippage between the implant faces and the articular surfaces of the facets. Such roughening may also promote osteoincorporation of the implant with the articular surfaces.
[0084] An implant is provided as described herein that is configured to be positioned within the facet joint. Preferably, at least a portion of each face of the implant is porous and/or roughened. The implant 56 is then inserted into the facet joint 28 between the articular surfaces 20, 22 as shown in
[0085] In one embodiment, the implant is bonded to at least a portion of the articular surfaces using an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate, or another biocompatible adhesive. Preferably, the thickness of the implant is slightly larger than the natural distance between the opposing articular surfaces. A thicker implant can provide some compressive force between the implant and the articular surfaces, which can help to maintain the implant in a desired position and result in a more secure bond.
[0086] In further embodiments, a hole is then formed through the articular surfaces 20, 22 as shown in
[0087] An anchoring arrangement is then used to secure the implant in a fixed position relative to the adjacent facets. The anchoring arrangement can also provide a compressive force between the implant and the facets to promote adhesion and/or osteoincorporation of the implant with the articular surfaces of the facets. Any appropriate anchoring arrangement, such as those described herein, may be used. The surgical site is then closed, cleaned and dressed.
[0088] The foregoing merely illustrates the principles of the invention. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. It will thus be appreciated that those skilled in the art will be able to devise numerous techniques which, although not explicitly described herein, embody the principles of the invention and are thus within the spirit and scope of the invention. All patents, patent applications, and other publications cited herein are incorporated herein by reference in their entireties.