Device and method for reinforcement of a facet

In some embodiments, a device for reinforcement of a facet joint is provided. The device comprises a lumen configured to receive a fastener member. In some embodiments, a second segment comprises a second lumen configured to receive a fastener member or fastener. In some embodiments, kits are provided with a fastener member and a facet reinforcement device. Methods are also provided for treating a spine. In some embodiments, the fastener member is placed through both articular processes of a facet joint and a facet reinforcement device.

BACKGROUND OF THE INVENTION

Some embodiments described herein relate generally to methods and implants for fusing bone, for example, fusing vertebrae by securing the articular processes of the vertebrae.

Traumatic, inflammatory, and degenerative disorders of the spine can lead to severe pain and loss of mobility. One source of back and spine pain is related to degeneration of the facets of the spine or facet arthritis. Bony contact or grinding of degenerated facet joint surfaces can play a role in some pain syndromes. While many technological advances have focused on the intervertebral disc and artificial replacement or repair of the intervertebral disc, little advancement in facet repair has been made. Facet joint and disc degeneration frequently occur together. Thus, a need exists to address the clinical concerns raised by degenerative facet joints.

The current standard of care to address the degenerative problems with the facet joints is to fuse the two adjacent vertebrae. By performing this surgical procedure, the relative motion between the two adjacent vertebrae is stopped, thus stopping motion of the facets and any potential pain generated as a result thereof. Procedures to fuse two adjacent vertebrae often involve fixation and/or stabilization of the two adjacent vertebrae until the two adjacent vertebrae fuse.

Injuries and/or surgical procedure on and/or effecting other bones can also result in the desire to fixate and/or stabilize a bone until the bone, or bone portions, can fuse, for example, to stabilize a sternum after heart surgery, to stabilize a rib after a break, etc. Current procedures to fixate and/or stabilize adjacent vertebrae and/or other bones can be slow and/or complex

Accordingly, a need exists for an apparatus and a procedure to quickly and/or easily stabilize and/or fixate a bone.

SUMMARY OF THE INVENTION

In some embodiments, a device for reinforcing a facet joint implant is provided. The device comprises a first securing segment comprising a proximal surface and a distal surface. The first securing segment comprises a first lumen disposed between the proximal surface and the distal surface. The first lumen is adapted for receiving a fastener member. The device comprises a second securing segment comprising a proximal surface and a distal surface. The second securing segment comprises a second lumen. The device comprises a central portion between the first securing segment and the second securing segment.

In some embodiments a longitudinal axis of the first securing segment is disposed at an angle relative to a longitudinal axis of the second securing segment. In some embodiments, a plane of the distal surface of the first securing segment is not parallel to a plane of the distal surface of the second securing segment. In some embodiments, the distal surface of the facet reinforcement device is configured for engaging a bony surface of a facet. In some embodiments, the distal surface of the facet reinforcement device comprises sharp engagement members.

In some embodiments, a kit for treating a spine is provided. The kit comprises a fastener member. The kit comprises a facet reinforcement device. The facet reinforcement device comprises a proximal surface and a distal surface. The facet reinforcement device comprises a lumen disposed between the proximal surface and the distal surface. The lumen is adapted for receiving the fastener member.

In some embodiments, the facet reinforcement device further comprises a second portion adapted to attach to a spinous process of a vertebra. In embodiments, the second portion of the facet reinforcement device comprises at least one lumen. Some embodiments of the kit, further comprise a fastener for securing the facet reinforcement device to the vertebra. In some embodiments, the fastener secures the facet reinforcement device to the spinous process of the superior vertebra. In some embodiments, the fastener is a screw or bolt.

In some embodiments, a method for treating a spine is provided. The method may include placing a facet reinforcement device comprising a lumen adjacent to a first vertebra. The method may include passing a fastener member through the lumen. The method includes passing the fastener member through a first articular process of a facet joint. The method may include passing the fastener member through a second articular process of the facet joint. The method may include securing one end of the fastener member to the other end of the fastener member, thereby retaining the facet reinforcement device.

In some embodiments, a method for treating a spine is provided. The method may include the step of preparing a facet joint for fixation. The method may include passing a fastener member through a first articular process of a facet joint. The method may include passing a fastener member through a second articular process of the facet joint. The method may include placing a facet reinforcement device with a lumen for receiving the flexible fastening band against a surface of the first articular process. The method may include passing a fastener member through the lumen. The method may include securing the fastener member. The method may include securing the facet reinforcement device to a spinous process with a fastener. The methods may further comprise inserting a facet implant with an interface configured to receive the fastener member into the facet joint. The methods may further comprise passing the fastener member through the interface of the facet implant.

In some embodiments, a method for treating a spine is provided. Methods may further comprise preparing a second facet joint at a same level of the spine for fixation. The method may include placing a second facet reinforcement device against a first articular process of the second facet joint. The method may include passing a second fastener member through a first articular process of the second facet joint. The method may include passing a second fastener member through a second articular process of the second facet joint. The method may include securing the second fastener member. The method may include securing the second facet reinforcement device to a spinous process with a fastener. The methods may further comprise inserting a second facet implant with an interface configured to receive the fastener member into the facet joint. The methods may further comprise passing the second fastener member through the interface of the second facet implant.

In some embodiments, a device for placement on a facet joint is provided, the purpose of the device being to provide reinforcement to the bone when a fastener member is used to secure the joint. The device may include sharp engagement members on a bone contact side to prevent migration. The device may include a through-opening to accept a primary facet fixation device. In some embodiments, the device for placement on a facet joint has a second through-opening for accepting at least one additional fastener. In some embodiments, a screw may be provided for placement through the second through-opening.

DETAILED DESCRIPTION

As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a ratchet” is intended to mean a single ratchet or a combination of ratchets. As used in this specification, a substance can include any biologic and/or chemical substance, including, but not limited to, medicine, adhesives, etc, and/or a bone graft, including, but not limited to, autograft, allograft, xenograft, alloplastic graft, a synthetic graft, and/or combinations of grafts, medicines, and/or adhesives. While exemplary references are made with respect to vertebra, in some embodiments another bone can be involved. While specific reference may be made to a specific vertebra and/or subset and/or grouping of vertebrae, it is understood that any vertebra and/or subset and/or grouping, or combination of vertebrae can be used.

As shown inFIG. 1, the vertebral column2comprises a series of alternating vertebrae4and fibrous discs6that provide axial support and movement to the upper portions of the body. The vertebral column2typically comprises thirty-three vertebrae4, with seven cervical (C1-C7), twelve thoracic (T1-T12), five lumbar (L1-15), five fused sacral (S1-S5) and four fused coccygeal vertebrae.FIGS. 2A and 2Bdepict a typical thoracic vertebra. Each vertebra includes an anterior body8with a posterior arch10. The posterior arch10comprises two pedicles12and two laminae14that join posteriorly to form a spinous process16. Projecting from each side of the posterior arch10is a transverse18, superior20and inferior articular process22. The facets24,26of the superior20and inferior articular processes22form facet joints28with the articular processes of the adjacent vertebrae (seeFIGS. 3A and 3B). The facet joints are true synovial joints with cartilaginous surfaces and a joint capsule.

The orientation of the facet joints vary, depending on the level of the vertebral column. In the C1 and C2 vertebrae, for example the facet joints are parallel to the transverse plane.FIGS. 4A to 6Bdepict examples of the orientations of the facet joints at different levels of the vertebral column. In the C3 to C7 vertebrae examples shown inFIGS. 4A and 4B, the facets are oriented at a 45-degree angle to the transverse plane30and parallel to the frontal plane32, respectively. This orientation allows the facet joints of the cervical vertebrae to flex, extend, lateral flex and rotate. At a 45-degree angle in the transverse plane30, the facet joints of the cervical spine can guide, but do not limit, the movement of the cervical vertebrae.FIGS. 5A and 5Bdepict examples of the thoracic vertebrae, where the facets are oriented at a 60-degree angle to the transverse plane30and a 20-degree angle to the frontal plane32, respectively. This orientation is capable of providing lateral flexion and rotation, but only limited flexion and extension.FIGS. 6A and 6Billustrate examples of the lumbar region, where the facet joints are oriented at 90-degree angles to the transverse plane30and a 45-degree angle to the frontal plane32, respectively. The lumbar vertebrae are capable of flexion, extension and lateral flexion, but little, if any, rotation because of the 90-degree orientation of the facet joints in the transverse plane. The actual range of motion along the vertebral column can vary considerably with each individual vertebra.

In addition to guiding movement of the vertebrae, the facet joints also contribute to the load-bearing ability of the vertebral column. One study by King et al. Mechanism of Spinal Injury Due to Caudocephalad Acceleration, Orthop. Clin. North Am., 6:19 1975, found facet joint load-bearing as high as 30% in some positions of the vertebral column. The facet joints may also play a role in resisting shear stresses between the vertebrae. Over time, these forces acting on the facet joints can cause degeneration and arthritis.

In some embodiments described herein, a vertebral facet joint implant can be used to stabilize, fixate, and/or fuse a first vertebra to a second vertebra to reduce pain, to reduce further degradation of a spine, or of a specific vertebra of a spine, and/or until the first vertebra and the second vertebra have fused. In some embodiments, the vertebral facet joint implant can be implanted and deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra. In some embodiments, the vertebral facet joint implant can be implanted and deployed to help stabilize adjacent vertebrae with adhesives, and/or can be implanted and deployed to deliver a medication.FIG. 7depicts a block diagram of a vertebral facet joint implant (“implant”)160. Implant160includes a first side162, a second side164, a fastener interface166, and a substance interface168.FIGS. 8A-47Bdepict implants and fasteners according to different embodiments.

As shown inFIG. 7, implant160can be, for example, substantially disc shaped. In other embodiments, the spacer can be other shapes, e.g., square, elliptical, or any other shape. First side162and/or second side164can be, for example, convex, concave, or flat. Said another way, first side162can be concave, convex, or flat, and second side164can be concave, convex, or flat; for example, first side162can be concave and second side164can be concave, first side162can be concave and second side164can be convex, etc. In such embodiments, the shape can be determined based on a shape of a bone portion that the first side162and/or the second side164is configured to contact. Said another way, the first side162and/or the second side164can be shaped to substantially compliment the shape of a bone portion. On other words, the first side162or the second side164need not exactly match the shape of the corresponding bone portion, but instead can have a concave shape for a bone portion with a generally convex shape where the contact with the implant is to occur or can have a convex shape for a bone portion with a generally concave shape where the contact with the implant is to occur. Implant160can include any biocompatible material, e.g., stainless steel, titanium, PEEK, nylon, etc.

Implant160includes fastener interface166. Fastener interface166can be configured to retain implant160in substantially the same position. Specifically, fastener interface166can be configured to accept a fastener member (not shown) to substantially prevent movement of implant160. Fastener interface166can include an aperture and/or other opening. Fastener interface166can extend through implant160, e.g. can extend from first side162and through to second side164. In some embodiments, fastener interface166can extend through only a portion of implant160, e.g. can extend from first side162and through less than half of a width (not shown) of implant160. Fastener interface166can be disposed on and/or through first side162, second side164, and/or both first side162and second side164. Fastener interface166can be disposed through a center (not shown) of implant160. In other embodiments, fastener interface166can be disposed anywhere on and/or through implant160, e.g., offset from center. Fastener interface166can be substantially circular (cylindrical). In other embodiments, fastener interface166can be other shapes and/or can be shaped based on a shape of the fastener member, for example, rectangular (cuboid). In some embodiments, fastener interface166can be a irregular shape, based at least in part in the location of fastener interface166, see, e.g.,FIG. 48, and/or partial shapes, see, e.g.,FIG. 23B. Fastener interface166can include a substantially smooth inner surface (not shown) to allow the fastener member to easily pass through and/or into fastener interface166, and/or can include a threaded inner surface to allow the fastener member to thread into fastener interface166. While depicted inFIG. 7as including one fastener interface, implant160can include more than one fastener interface160.

Implant160includes substance interface168. Substance interface can be configured to retain, carry and/or otherwise deliver a substance to aid in fusion, such as, for example, medicines, adhesives, bone graft, and/or combinations of substances. Substance interface168can include an aperture and/or other opening. Substance interface168can extend through implant160, e.g. can extend from first side162and through to second side164. In some embodiments, fastener interface can extend through only a portion of implant160, e.g. can extend from first side162and through less than half of a width (not shown) of implant160. Substance interface168can be disposed on and/or through first side162, second side164, and/or both first side162and second side164. Substance interface168can be disposed through a center (not shown) of implant160. In other embodiments, substance interface168can be disposed anywhere on and/or through implant160, e.g., offset from center. Substance interface168can be substantially circular (cylindrical). In other embodiments, substance interface168can be other shapes and/or can be shaped based on a shape of the fastener member, for example, rectangular (cuboid). In some embodiments, substance interface168can be an irregular shape, based at least in part in the location of substance interface168. While depicted inFIG. 7as including one substance interface, implant160can include more than one substance interface160. The location, size, shape, and/or number of substance interface(s)168can be determined based on the location, size, shape, and/or number of fastener interface(s)166.

In one embodiment, a device for restoring the spacing between two facets of a facet joint is provided. As shown inFIGS. 8A and 8B, the device comprises a implant34with a least two faces, a first face36adapted to contact the articular surface of one facet of the facet joint and a second face38adapted to contact the articular surface of the other facet. In one embodiment, the implant34has a generally circular profile and is sized to fit generally within the joint capsule of the facet joint28.FIG. 8Cillustrates the implant34ofFIGS. 8A and 8Bpositioned in a facet joint. In other embodiments, the implant can have any of a variety of profiles, including but not limited to square, rectangle, oval, star, polygon or combination thereof. An octagonal implant is shown inFIGS. 9A and 9B. In one embodiment, a implant having the desired shape is selected from an array of prostheses after radiographic visualization of the articular processes and/or by radio-contrast injection into the facet joint to visualize the joint capsule. In one embodiment, the implant has a diameter of about 4 mm to about 30 mm. In another embodiment, the implant has a diameter of about 5 mm to about 25 mm. In still another embodiment, the implant has a diameter of about 10 mm to about 20 mm. In one embodiment, the implant has a cross-sectional area of about 10 mm2to about 700 mm2. In another embodiment, the implant has a cross-sectional area of about 25 mm2to about 500 mm2. In still another embodiment, the implant has a cross-sectional area of about 20 mm2to about 400 mm2, or about 25 mm2to about 100 mm2.

The implant has a thickness generally equal to about the anatomic spacing between two facets of a facet joint. The implant generally has a thickness within the range of about 0.5 mm to about 3.0 mm. In certain embodiments, the implant has a thickness of about 1 mm to about 2 mm. In one preferred embodiment, the implant has a thickness of about 0.5 mm to about 1.5 mm. In one embodiment, the thickness of the implant is nonuniform within the same implant. For example, inFIGS. 10A and 10B, the thickness of the implant42is increased around the entire outer edge44, along at least one and, as illustrated, both faces46,48. InFIGS. 11A and 11B, only a portion of the edge44on one face46of the implant42has a thickness that is greater than the thickness of a central region, and, optionally, also thicker than the typical anatomic spacing between two facets of a facet joint. An increased edge thickness may resist lateral displacement of the implant out of the facet joint.

In some embodiments, the implant is configured to provide an improved fit with the articular process and/or joint capsule. For example, inFIGS. 12A and 12B, the implant49has a bend, angle or curve50to generally match the natural shape of an articular facet.FIG. 13depicts the implant ofFIGS. 12A and 12Bpositioned in a facet joint. The implant may be rigid with a preformed bend. Alternatively, the implant may be sufficiently malleable that it will conform post implantation to the unique configuration of the adjacent facet face. Certain embodiments, such as those depicted inFIG. 8CandFIG. 13, the implant is configured to be implanted between the articular processes and/or within the joint capsule of the facet joint, without securing of the implant to any bony structures. Such embodiments can thus be used without invasion or disruption of the vertebral bone and/or structure, thereby maintaining the integrity of the vertebral bone and/or structure.

In one embodiment, at least a portion of one surface of the implant is highly polished. A highly polished portion of the implant may reduce the surface friction and/or wear in that portion of the implant as it contacts bone, cartilage or another surface of the implant. A highly polished surface on the implant may also decrease the risk of the implant wedging between the articular surfaces of the facet joint, which can cause pain and locking of the facet joint.

In one embodiment, shown inFIGS. 14A and 14B, at least a portion of one surface of the implant50has a roughened surface52. A roughened surface may be advantageous when in contact with a bone or tissue surface because it may prevent slippage of the implant50against the bone and aid in maintaining the implant50in the joint. In one embodiment, shown inFIGS. 15A and 15B, at least a portion of one surface of the implant50has a porous surface54. A porous surface54can be created in any a variety of ways known in the art, such as by applying sintered beads or spraying plasma onto the implant surface. A porous surface54can allow bone to grow into or attach to the surface of the implant50, thus securing the implant50to the bone. In one embodiment, an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate, or other adhesive known in the art, is used to bond one face of the implant to an articular surface.

In one embodiment, one surface of the implant is roughened or porous and a second surface that is highly polished. The first surface contacts or engages one facet of the facet joint and aids in maintaining the implant between the articular surfaces. The second surface of the implant is highly polished and contacts the other facet of the facet joint to provide movement at that facet joint.FIGS. 16A and 16Brepresent one embodiment of the implant comprising a curved or bent disc56with a roughened surface52on the greater face58of the disc and a highly polished surface60on the lesser face62.FIG. 17depicts the implant ofFIGS. 16A and 16Bpositioned in a facet joint. The implant generally maintains a fixed position relative to the facet contacting the roughened surface while the movement of the facet joint is preserved between the other facet and the highly polished lesser face of the implant.

FIGS. 18A and 18Bshow one embodiment, where the implant64comprises two separate discs66, each disc comprising a first face68that articulates with the complementary first face68of the other disc, and a second face70adapted to secure the disc to the adjacent bone or cartilage of one facet of the facet joint28. In one embodiment, the thickness of one disc will generally be about half of the anatomic spacing between two facets of the facet joint. In other embodiments, the implant comprises three or more discs. In one embodiment the total thickness of all the discs is generally about 25% to about 300% of the anatomic spacing between the two facets. In another embodiment, the total thickness of the discs is generally about 50% to about 150% of the anatomic spacing. In still another embodiment, the total thickness of the discs is about 75% to about 125% of the anatomic spacing. Each disc of the two-part implant can otherwise also have features similar to those of a single-disc implant, including but not limited to curved or bent configurations, highly polished or roughened surfaces, and other feature mentioned below. The two discs need not have the same size, thickness, configuration or features.FIG. 19depicts one embodiment of a two-part implant64positioned within a facet joint28.

The implant can be manufactured from any of a variety of materials known in the art, including but not limited to a polymer such as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene, fluoropolymer, hydrogel, or elastomer; a ceramic such as zirconia, alumina, or silicon nitride; a metal such as titanium, titanium alloy, cobalt chromium or stainless steel; or any combination of the above materials.

In one embodiment, 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. In some embodiments, the shape of the implant itself is capable of resisting displacement of the implant from its position generally between the facet joint surfaces. In one embodiment, a concave or biconcave configuration resists displacement of the implant by providing an increased thickness at the periphery of the implant that requires a larger force and/or greater distraction of facet joint surfaces in order to cause displacement. In other embodiments, surface treatments or texturing are used to maintain the implant against a facet of the facet joint, as described previously. In some embodiments, a combination of disc configuration, surface texturing and existing body tissue or structures are used to maintain the position of the implant.

Bone growth facilitators, electrical current, or other known techniques may be used to accelerate osteoincorporation of textured or microporous anchoring surfaces.

The implant may be configured with a fastener interface to engage (“secure”) a fastener member that facilitates retention of the implant within the joint capsule of the facet joint. Use of a fastener member may be advantageous for preventing migration of the implant over time use or with the extreme ranges of vertebral movement that may distract the articular surfaces sufficiently to allow the implant to slip out.

In one embodiment, shown inFIGS. 20 to 21B, the fastener member comprises a wire or cable72with a portion74that engages the implant76at a fastener interface78, and at least one other portion80that engages or anchors to the bone or soft tissue surrounding the facet joint. The wire or cable may be solid, braided or multi-filamented. The fastener member in this embodiment will be described primarily as a cable or wire, but it is to be understood that any of a variety of elongate structures capable of extending through a central aperture will also work, including pins, screws, and single strand or multistrand polymeric strings or weaves, polymeric meshes and fabric and other structures that will be apparent to those of skill in the art in view of the disclosure herein.

The cross-sectional shape of the fastener member can be any of a variety of shapes, including but not limited to circles, ovals, squares, rectangles, other polygons or any other shape. The wire or cable generally has a diameter of about 0.5 mm to about 2 mm and a length of about 5 mm to about 60 mm. In other embodiments, wire or cable has a diameter of about 0.25 mm to about 1 mm, or about 0.75 mm to about 1.25 mm. The diameter of the wire or cable may vary along the length of the wire or cable. In one embodiment, the wire or cable has a length of about 10 mm to about 40 mm. In another embodiment, the wire or cable has a length of about 20 mm to about 30 mm.

In one embodiment, shown inFIGS. 21A and 21B, the fastener interface78of the implant76is a conduit between the two faces82,84of the implant76, forming an aperture78. In one embodiment, the aperture78has a diameter larger than the diameter of the wire or cable72, to provide the implant76with a range of motion as the facet joint moves. The aperture78inside diameter may be at least about 110%, often at least about 150% and in certain embodiments at least about 200% or 300% or greater of the outside diameter or corresponding dimension of the fastener member in the vicinity of the engagement portion78. The cross-sectional shape of the aperture78can match or not match the cross sectional shape of the wire or cable used.

In another embodiment, the fastener interface78extends only partially through the implant72. The fastener interface78may be located generally in the center of the implant, or it may be located eccentrically, as depicted inFIGS. 22A and 22B. In one embodiment, shown inFIGS. 23A and 23B, the fastener interface78is located at the edge86of the implant76such that the interior surface of the hole78is contiguous with the outer edge of the implant. This configuration of the fastener interface78does not require the cable72to be threaded through the fastener interface78and may facilitate engagement of the fastener member with the implant.FIGS. 24A and 24Bdepict an embodiment comprising a two-part implant88. Either a single cable or two separate cables may be used retain both discs within the facet joint.FIGS. 25A and 25Bdepict another embodiment comprising a curved implant90with a fastener interface78adapted to accept a cable.

InFIG. 26, the wire or cable72is secured to the articular processes20,22by tying one or more knots92in the cable72that can resist pulling of the wire or cable through the articular process. In another embodiment, one or both ends of the wire or cable are provided with an anchor to resist migration of the implants. As shown inFIGS. 27A and 27B, one or both ends of the wire or cable72may be threaded such that a nut94can be tightened on the wire or cable72to secure the wire or cable to the articular processes20,22.FIG. 28depicts the attachment of a nut onto a threaded end of a cable. The threaded portion96of the wire or cable can be secured to the cable by pressing, crimping or twisting the threaded96portion onto the cable72. In one embodiment, the threaded portion96is made from titanium, titanium alloy, cobalt chromium, stainless steel, or any combination thereof.

In one embodiment, the wire or cable has two threaded ends96for engaging the bony or cartilaginous tissue, one portion for each facet of the facet joint.

In another embodiment, shown inFIG. 29, the wire or cable is secured to the articular process with fastener rings98. As depicted inFIGS. 30A and 30B, the fastener rings98comprise a ring100with a central lumen102and a locking element to facilitate locking the ring100to a fastener member. The central lumen102is adapted to accept insertion of a wire or cable through it. The illustrated locking element is in the form of a side lumen104which is threaded and configured to accept a rotatable screw106with a proximal end108, a threaded body110and a distal end112. The threaded body110is complementary to the threads of the side lumen104so that when the screw106is rotated at its distal end112, the proximal end108of the screw106moves further into the central lumen102and is capable of applying increasing force to a wire or cable inserted through the central lumen102. In one embodiment, the force on the wire or cable is capable of creating a friction fit or a mechanical interfit to resist movement between the wire or cable and the fastener ring98, thereby securing the wire or cable to the articular process20or22. As shown inFIGS. 31 to 33, the distal end112of the screw106can be configured to engage the wire or cable in any of a variety designs, including but no limited to a blunt tip114, curved tip116and piercing tip118.

In another embodiment, depicted inFIGS. 34A and 34B, the wire or cable is securable to the articular process with a fastener ring120have radially inward biased projections122defining a central lumen124. The central lumen has a cross-sectional shape smaller than that of the wire or cable but is capable of enlargement when the inward projections122are bent away, as shown inFIGS. 35A and 35B. The inward projections122apply increasing force to the wire or cable within the central lumen124as the projections122are bent, thereby creating a friction fit.

In one embodiment, one end of the wire or cable fastener member is preformed with a retainer for engaging the articular process. The retainer may be a preformed ring, bulb, flared end, T-bar end, or any of a variety of shapes having a greater cross sectional area than the other portions of the wire or cable fastener member. This configuration of the wire or cable fastener member is adapted to engage an articular process by passing the free end of a wire or cable fastener member through an articular process such that the end with the preformed retainer can engage the articular process.

In one embodiment, the wire or cable fastener member is secured to the articular processes with sufficient laxity or length between the secured ends or between the implant and one secured end so that the two articular processes are not fixed in position relative to each other and remain capable of performing movements such as flexion, extension, lateral flexion and/or rotation. In one embodiment, the fastener member comprises a cable of braided polymer, including but not limited to a braided polymer such as PEEK or PEKK, or a braided metal, such as braided cobalt chromium or titanium. The cable can be selected with different degrees of flexibility to provide different degrees of movement at that facet joint. The cable has a first segment capable of engaging the implant at its fastener interface to limit the movement.

In one embodiment, shown inFIG. 36A, the fastener member comprises a screw or bolt126with a proximal end128, body130and distal end132. The distal end132of the screw or bolt is capable of forming a mechanical interfit with a complementary fastener interface134on the implant or spacer136. The distal end132typically comprises threads, but other configurations may be used to form a mechanical interfit. The complementary fastener interface134on the implant136could be a threaded through hole or, a close-ended hole. The proximal end128of the screw or bolt126has a hex or other type of interface known in the art, capable of engaging a rotating tool to manipulate the screw or bolt126. The body of the screw or bolt126has a length sufficient to at least span the length of the hole or conduit created through the articular process for securing the implant. InFIG. 36B, the fastener member further comprises a pivotable washer127with a pivot surface129that articulates with the proximal end128of the screw126. In one embodiment, the pivotable washer127is capable of a range of positions relative to the screw126and provides the screw126with a better surface area contact with the bone.

FIG. 37is a cross-sectional view of a facet joint28with a spacer136bolted to one articular process20of a facet joint28. The spacer136position is fixed relative to one facet24of the joint28, but provides for spacing and movement of the other facet26with respect to the spacer136. In embodiments comprising a two-part implant, shown inFIGS. 38 and 39, each disc may have its own screw or bolt fastener member.FIG. 38depicts a flat two-part implant138andFIG. 39depicts a curved two-part implant140.

In some embodiments, shown inFIGS. 40A through 41B, the fastener member is integral with or attached to the implant and comprises a projection142from the implant144that is adapted to engage the adjacent articular process or surrounding tissue. In one embodiment, the projection comprises at least one spike142or hook projecting from one face of the implant144. In one embodiment, the spike142or hook can be ribbed, barbed or threaded to resist separation after insertion into bone or tissue.FIG. 42depicts the implant144ofFIG. 40Aengaged to a facet24of the facet joint28. In one embodiment comprising a two-part implant146, shown inFIG. 43, each disc148may have its own projection-fastener member142. In some embodiments, as depicted inFIG. 44, more than one projection150is provided on the implant152.FIG. 45illustrates the implant ofFIG. 44placed in a facet joint28. The projections150may be angled with respect to the implant152to resist dislodgement by the movement at the joint.

FIGS. 46A to 47Billustrate embodiments where the fastener member comprises a projection154extending laterally such as from the side of the implant156, and adapted to engage the soft tissue surrounding the facet joint, rather than a bony or cartilaginous articular process. In one example, the implant ofFIG. 46could be inserted into a facet joint through an incision made in the joint capsule, but the integrity of the joint capsule opposite the incision site is maintained and used as an anchoring site for the implant. The orientation of the projection can be fixed as inFIG. 44, or flexible.FIG. 47depicts a flexible tether such as a wire158with its proximal end160embedded in or otherwise attached to the implant and one or more barbs which may be attached to its distal end162. A flexible projection may provide greater selection of soft tissue anchoring sites for the implant.

In one embodiment, the joint capsule is closed after placement of the implant. Closure may be performed using adhesives, suturing, stapling or any of a variety of closure mechanisms known in the art.

FIGS. 48A-48Cdepict an implant260according to an embodiment. Specifically,FIG. 48Ais a front perspective view of implant260,FIG. 48Bis a side view of implant260, andFIG. 48Cis a cross-sectional side view of implant260. Implant260can be similar to, and have similar elements and uses as implant160described above. By way of example, a fastener interface266of implant260can be similar to fastener interface166of implant160. Implant260includes a concave first face262, a convex second face264, a centrally disposed circular fastener interface266, and four irregular shaped substance interfaces268.

FIGS. 49-51show posterior perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using an implant260according to an embodiment. As shown inFIG. 49, implant260and a fastener member280can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. Any fastener member can include any biocompatible material, e.g., stainless steel, titanium, PEEK, nylon, etc. Also as shown inFIG. 49, an implant360and a fastener member380are used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2. In some embodiments, vertebra V1 and/or vertebra V2 are fused using only one of implant260or implant360. In some such embodiments, one of implant260and fastener member280or implant360and fastener member380can be used to stabilize vertebra V1 and/or vertebra V2 via one of via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2, or, via the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2. In other such embodiments, one of fastener member280or fastener member380can be used to stabilize vertebra V1 and/or vertebra V2 via both of the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2 (for example, in combination with implant260), and, the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2 (for example, in combination with implant360).

FIG. 52depicts a flow chart illustrating a method6000of using implant260with fastener member280and/or implant360with fastener member380. Prior to use of implant260and/or implant360, a patient can be prepared for surgery, at6002. Some examples of preparations for surgery are described in U.S. patent application Ser. No. 12/859,009; filed Aug. 18, 2010, and titled “Vertebral Facet Joint Drill and Method of Use” (referred to as “the '009 application”), and is incorporated herein by reference in its entirety. In addition to those procedures described in the '009 application, in some embodiments, the surgical procedure can include direct visualization of the vertebra(e) to be stabilized. Said another way, the medical practitioner can perform the operation without the use of fluoroscopy. This direct visualization can be possible due to the small incision necessary for implantation of the implant, for example, less than about 25 mm, and due to the ease of implanting and deploying the implant. In some embodiments, the surgical procedure used can include forming an opening in body tissue substantially equidistant between a first articular process of the first vertebra and a second articular process of the first vertebra. A cannula (not shown) can be inserted through the opening and a proximal end of the cannula can be positioned near the superior articular process SAP2A of vertebra V2. In some embodiments, the surgical procedure can include preparing the area near and/or around the vertebra V2 by, for example, removing all or a portion of ligaments, cartilage, and/or other tissue. For example, the area near and/or around a facet joint can be prepared by removing all or a portion of the facet joint capsule.

A drill or other device can be used to form a lumen in superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1, at6004. Specifically, the drill can be used to form the lumen in a facet of superior articular process SAP2A of vertebra V2 and to form the lumen in a facet of inferior articular process IAP1A of vertebra V1. Methods and devices for forming lumens in vertebra are described in the '009 application. A portion of the surface of the facet of SAP2A and IAP1A can be prepared for fusion, at6006. Specifically, a portion of the surface of the facet can be ground, scored, roughened, sanded, etc, such that the surface of the facet can better adhere to any substances to aid in fusion and/or otherwise fuse more readily to the implant. The fastener member280can be positioned within the cannula and can be advanced through the cannula until a proximal end portion282of fastener member280is positioned near the lumen of superior articular process SAP2A of vertebra V2. In some embodiments, the proximal end of the cannula can have a bend to direct the proximal end portion282of fastener member280into the lumen of superior articular process SAP2A of vertebra V2. The proximal end portion282of fastener member280is inserted into the lumen of superior articular process SAP2A of vertebra V2, at6008. A substance can be disposed in a substance interface268of implant260, at6010. In some embodiments, implant260can have a substance disposed in substance interface268prior to a surgical procedure, for example, during manufacturing of implant260, post-manufacturing, and/or as part of a kit. Implant260is inserted between the superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1, at6012.

The proximal end portion282of fastener member280is inserted into the lumen of inferior articular process IAP1A of vertebra V1, at6014. The fastener member can be secured, at6016. Securing the fastener member280can be based on the type of fastener member used. By way of example, securing a fastener member similar to a flexible fastener band as depicted inFIGS. 49-51, can include inserting the proximal end portion282into a fastening mechanism of a distal end portion284of the fastener member280, and advancing the proximal end portion282through the fastening mechanism to secure the fastening mechanism. In other embodiments, fastener member can be secured by tying a first portion the fastener member to a second portion of the fastener member, by screwing the fastener member into a threaded fastener interface, threading a fastener onto a threaded end of a fastener member disposed through a fastener interface, combinations of above, etc. In some embodiments, implant260can be disposed prior to inserting the proximal end portion of the fastener member280into the lumen of superior articular process SAP2A of vertebra V2. The cannula can be removed and/or reinserted at various points during the method6000, including, for example, after the proximal end portion282of fastener member280is inserted into the lumen formed within the superior articular process SAP2A of vertebra V2, after vertebra V1 and/or Vertebra V2 has been stabilized, or at other points during method6000.

After the fastener member is secured, superior articular process SAP2A of vertebra V2 can fuse to inferior articular process IAP of vertebra V1. Fusing can include one or more of bone material from superior articular process SAP2A of vertebra V2, bone material from inferior articular process IAP1A of vertebra V1, and the substance that fuses articular process SAP2A of vertebra V2 to inferior articular process IAP of vertebra V1 through substance interface268. In some embodiments, after superior articular process SAP2A of vertebra V2 is fused to inferior articular process IAP1A of vertebra V1, the fastener member280is not removed. In some other embodiments, after superior articular process SAP2A of vertebra V2 is fused to inferior articular process IAP1A of vertebra V1, all or a portion of the fastener member280can be removed. In other embodiments, fastener member280can be removed after fusion of superior articular process SAP2A of vertebra V2 to inferior articular process IAP1A of vertebra V1 has started, but has not finished.

In addition to the fastener members shown above, such as, for example, fastener member260,FIGS. 53-65show fastener members according to other embodiments.

FIG. 53depicts views of a fastener member480. Fastener member480can be a flexible fastening band (“band”)480,FIG. 54depicts a view of a portion of band480can be similar to band280described above and can include similar components. By way of example, band480includes a proximal end portion482, a first portion484, a second portion486, and a distal end portion488including a fastening mechanism490. In contrast to band280, band480includes a cylindrical second portion486and each includes a third portion489. As depicted inFIGS. 53-54, third portion489is substantially the same shape as first portion482. As shown inFIGS. 53 and 54, band480includes a gear rack487and gears494. Each of gears494can be wedge shaped to allow each of gears494to displace the ratchet of fastening mechanism490in only one direction. In some embodiments, gears494can be other shapes, such as blocks, etc.

FIG. 55is a side view andFIG. 56is a top view of a fastener member840. Fastener member840can be a flexible fastening band (“band”)580according to another embodiment. Band840can be similar to band280and band480described above and can include similar components. By way of example, band840includes a proximal end portion842, a first portion844including a gear rack847, a second portion846, and a distal end portion848including a fastening mechanism850and a ratchet862. In contrast to gear rack487, a cross sectional area of each gear864of gear rack847is rectangular in shape instead of wedge shaped. Furthermore, in contrast to first portion282, first portion844is cylindrical in shape instead of cuboidal in shape. In this manner, the lumen866of the fastening mechanism850is cylindrical in shape. A band according to this embodiment may be particularly useful in deployments where a single band in used to stabilize adjacent vertebrae. In this manner, the second portion can be disposed within the lumen of the first articular process of the first vertebra and a portion of the first portion can be disposed within the lumen of the second articular process of the first vertebra. In these embodiments the portion of the band within the first articular process of the first vertebra and the portion of the band within in the second articular process of the first vertebra can both have substantially the same shape as the lumen in the first articular process of the first vertebra and the lumen in the second articular process of the first vertebra. In this manner, and as described above regarding band480, the amount of open space within the lumens can be minimized, the amount of surface area of the first portion and/or second portion of the band in contact with the lumens can increase, and subsequently the movement of the first vertebra and/or the second vertebra can be reduced or minimized. Furthermore, when movement of the first vertebra and/or the second vertebra does occur, forces acting against the band can be more equally distributed throughout the first portion and/or the second portion, due at least to the increased surface area of the band in contact with the lumens.

FIG. 57is a side view a fastener member940. Fastener member940can be a flexible fastening band (“band”)940according to an embodiment. Band940can be similar to band280, band480, and band840described above and can include similar components. By way of example, band840includes a proximal end portion942, a first portion944including a gear rack947, a second portion946, and a distal end portion948including a fastening mechanism950. Similar to gear rack847, a cross sectional area of each gear964of gear rack947is rectangular in shape. In contrast to gear rack847, each of gears964extend the entire circumference of first portion944instead of only a portion of the circumference of first portion944. Furthermore, in contrast to first portion282, but similar to first portion844, first portion944is cylindrical in shape instead of cuboidal in shape. In this manner, the lumen966of the fastening mechanism950is cylindrical in shape. A band according to this embodiment may be particularly useful in deployments where the movement and repositioning of the band after implantation may be difficult. In this manner, because each of the gears can be the entire circumference of the first portion and/or the second portion, the first portion and/or the second portion can enter the fastening mechanism in any radial orientation and still engage the ratchet.

FIGS. 58-62are views of a fastener member780. Fastener member780can be a flexible fastening band (“band”)780according to another embodiment.FIG. 58is a perspective view andFIG. 59is a cross-sectional side view of band780.FIG. 60is a cross-sectional view of band780taken along line XXIIIFIG. 61is a cross-sectional top view of band780in a first configuration andFIG. 62is a cross-sectional top view of band780in a second configuration. Band780can be similar to band280and band480described above and can include similar components. By way of example, band780includes a proximal end portion (not shown), a first portion784including a gear rack787(seeFIG. 59), a second portion786, and a distal end portion788including a fastening mechanism790and a ratchet792. In contrast to band280and band480, band780includes a reinforcement piece772.

Reinforcement piece772can include any of the materials described above for a fastener member. In some embodiments, reinforcement piece772can include a material stronger than second portion786and/or first portion784, for example, first portion784and second portion786can include PEEK and reinforcement piece772can include titanium. As shown inFIG. 59, reinforcement piece772can be disposed within band780approximately along the entire length of second portion786, and a portion of reinforcement piece772can be disposed within the distal end portion788. In some embodiments, reinforcement piece can include a length along at least a portion of the length of second portion786and/or first portion784but not the distal end portion. In some embodiments, reinforcement piece772can be disposed only within second portion786. Reinforcement piece772can have a length in first dimension (length), a length in a second dimension (width), and a length in a third dimension (height). As described herein, a reinforcement piece be different shapes that can include more or fewer dimensions.

The reinforcement piece can be molded within the band. Said another way, in embodiments where the first portion, the second portion, and or the distal end portion are moldable materials, the reinforcement piece can be placed in the mold and the moldable materials can be injected or otherwise put in the mold around the reinforcement piece. In other embodiments, each portion of the band (for example, the proximal end portion, the first portion, the second portion, the third portion, and/or the distal end portion) around the reinforcement piece can have a top half and a bottom half, and each of the top half and the bottom half can be placed around the reinforcement piece, and sealed. As shown inFIG. 61, reinforcement piece772includes support members774. WhileFIG. 61shows reinforcement piece772including four support members774, in some embodiments, more or fewer support members774can be used. Support members774can maintain the position of reinforcement piece772during the molding and/or assembly process of band780. As shown inFIG. 62, support members774are removed before band780is used.

As shown inFIG. 60, reinforcement piece772can has a substantially uniform cuboidal shape. In other embodiments, reinforcement piece772can have other shapes. The shape of the reinforcement piece can be selected depending on the desired bending and/or torsion characteristics of the material chosen. By way of example, a substantially planar cuboidal shape can provide a greater increase in bending strength while providing a lesser increase in torsion strength, a cylindrical shape can provide an increase in bending strength while providing very little increase in torsion strength, a substantially square and/or tubular cuboidal shape can provide similar bending and torsion increases. Any shape can be selected to achieve the desired bending and torsion strength. Combinations of materials and shapes can also be considered. For example, a material having higher torsion strength may be combined with a shape having a lower torsion strength to combine for the desired torsion strength. As shown inFIGS. 61 and 62, reinforcement piece772includes holes776distributed along the length of the first dimension. WhileFIGS. 61 and 62shows band780including many holes776, in some embodiments, more or fewer holes776can be used.FIGS. 61 and 62depict holes776distributed substantially equally along the length of the first dimension, in some embodiments, the holes can be distributed differently or along different dimensions depending on the shape and/or material chosen, and/or whether the reinforcement piece is solid or hollow. Holes776can be configured to reduce the weight of reinforcement piece772while still provided band780additional strength. Holes776can be round, oval, square, or any other shape.

FIG. 63is an exploded view,FIG. 64is a perspective view, andFIG. 65is a cross-sectional view of a fastener member880. Fastener member880can be a flexible fastening band (“band”)880according to another embodiment. Band880can be similar to band280and band480described above and can include similar components. By way of example, band880includes a proximal end portion882, a first portion884, a second portion886including a gear rack887, a distal end portion888, a fastening mechanism890and a ratchet892. In contrast to band280and band480, the fastening mechanism890of band880is separately formed from distal portion888of band880. While second portion886of band880is shown inFIGS. 63-65as having a substantially cuboidal shape, in some embodiments, second portion886can be substantially cylindrical in shape or any other appropriate shape discussed herein. As shown inFIGS. 64 and 65, band880includes a gear rack887and gears894. Each of gears894can be wedge shaped to allow each of gears894to displace a ratchet892of fastening mechanism890in only one direction. In some embodiments, gears894can be other shapes, such as blocks, or any other appropriate shape discussed herein. As shown inFIGS. 63-65, distal end portion888can be substantially circular in shape and can have a diameter greater than a width of second portion886. In other embodiments, distal portion888can have other shapes, for example, oval, rectangular, square, etc.

In addition to the implants shown above, such as, for example, implant160,FIGS. 66-81show implants according to other embodiments.

FIGS. 66-69depict an implant1060according to an embodiment. Specifically,FIG. 66is a front perspective view of implant1060,FIG. 67is a rear perspective view of implant1060,FIG. 68is a side view of implant1060, andFIG. 69is a cross-sectional side view of implant1060. Implant1060can be similar to, and have similar elements and uses as implant160and implant260described above. By way of example, a fastener interface1066of implant1060can be similar to fastener interface166of implant160, and similar to fastener interface266of implant260Implant1060includes a concave first face1062, a convex second face1064, a centrally-disposed substantially-circular fastener interface1066, and six substantially-circular shaped substance interfaces1068.

FIGS. 70-73depict an implant1160according to an embodiment. Specifically,FIG. 70is a front perspective view of implant1160,FIG. 71is a rear perspective view of implant1160,FIG. 72is a side view of implant1160, andFIG. 73is a cross-sectional side view of implant1160. Implant1160can be similar to, and have similar elements and uses as implant160and implant260described above. By way of example, a fastener interface1166of implant1160can be similar to fastener interface166of implant160, and similar to fastener interface266of implant260. Implant1160includes a concave first face1162, a convex second face1164, a centrally-disposed substantially-circular fastener interface1166, and five rounded rectangular shaped substance interfaces1168.

FIGS. 74-77depict an implant1260according to an embodiment. Specifically,FIG. 74is a front perspective view of implant1260,FIG. 75is a rear perspective view of implant1260,FIG. 76is a side view of implant1260, andFIG. 77is a cross-sectional side view of implant1260. Implant1260can be similar to, and have similar elements and uses as implant160and implant260described above. By way of example, a fastener interface1266of implant1260can be similar to fastener interface166of implant160, and similar to fastener interface266of implant260. Implant1260includes a concave first face1262, a convex second face1264, a centrally-disposed substantially-circular fastener interface1266, and several substantially-circular shaped and variably-sized substance interfaces1268.

FIGS. 78-81depict an implant1360according to an embodiment. Specifically,FIG. 78is a front perspective view of implant1360,FIG. 79is a rear perspective view of implant1360,FIG. 80is a side view of implant1360, andFIG. 81is a cross-sectional side view of implant1360. Implant1360can be similar to, and have similar elements and uses as implant160and implant260described above. By way of example, a fastener interface1366of implant1360can be similar to fastener interface166of implant160, and similar to fastener interface266of implant260. Implant1360includes a concave first face1362, a convex second face1364, a centrally-disposed substantially-circular fastener interface1166, four irregular shaped substance interfaces1368, and four projections1369. Each of the four projections1369can engage, or other wise dig, latch, lock, or hook into or onto, a bone portion to prevent or reduce movement of the implant1360, such as, for example, rotation of implant1360, longitudinal movement of implant1360, and/or lateral movement of implant1360. In this manner, the projections1369can secure implant1360to a bone portion during a fusion procedure. In some embodiments, projections1369can substantially maintain a position of implant1369after a fastener member is removed.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, not limitation, and various changes in form and details may be made. For example, while the descriptions given are with reference to stabilizing vertebra, another bone(s), such as, for example, a sternum and/or a rib(s) could be stabilized using the fastener members and implants described herein. In another example, a fastener member can be used to stabilize and/or fixate an intramedullary (IM) rod or nail. For example, the fastener member can be used at different longitudinal locations along an IM rod or nail, and used to couple adjacent bone portions to the IM rod or nail. In such situations, a given fastener member can fix a first bone portion, the IM rod or nail, and a second bone portion, all of which are positioned between the distal portion and the proximal portion of the fastener member. In yet another example, a fastener member can be used to stabilize and/or fixate a bone fragment. While various embodiments have been described above with regard to natural bone spaces, (e.g., the space between an inferior articulate process and a superior articulate process), in other embodiments, the bone spacing can be man-made (e.g., sternum split during a heart procedure), and/or due to an injury (e.g., broken bone).

Where methods described above indicate certain events occurring in certain order, the ordering of certain events can be modified. Additionally, certain of the events can be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components and/or features of the different embodiments described. For example,FIGS. 54 and 56depict band580including a single ratchet592, andFIG. 57depicts band680including a single ratchet692, however, in some embodiments, any of the fastener members can include any number of ratchets. Similarly, any of fastener members can include a reinforcement piece and/or a implant. Furthermore, while one embodiment of an implant may be shown in use with one embodiment of a fastener member, in other embodiments, implants and fastener member can be used with other implants and fastener members. For example, whileFIG. 28depicts an implant being secured with a threaded wire, in some embodiments, a flexible fastening band can be used.

Facet Reinforcement Device

Although the flexible fastening band may be used alone or with an embodiment of facet implant as described above, in some applications it may be desirable to reinforce the fixation of the band as it exits the bone of the articular process. This may prevent cut out by relieving pressure on the surface of the articular process and hold in the bone from the fastener band and/or fastening mechanism. The facet reinforcement may also anchor the flexible facet band to the vertebra using a fastener. This may prevent migration of the band and restrict motion at the facet joint to improve fusion.

FIG. 82depicts one arrangement of facet reinforcement device1400. The facet reinforcement device1400of the illustrated arrangement can include a proximal surface1402, a distal surface1406, an ablumenal surface1404extending from the proximal surface1402to the distal surface1406. In certain arrangements, the proximal surface1402and/or distal surface1406can be curved and/or malleable to conform to the shape of the facet. The facet reinforcement device1400can include a luminal surface1410surrounding a central lumen1420. The luminal surface1410can extend from the proximal surface1402to the distal surface1406. The central lumen1420can be centrally disposed within the device1400. As described below, the luminal surface1410can include a fastener interface (not illustrated) in certain embodiments.

As will be explained below, the facet reinforcement devices described herein can be used in combination with the implants depicted inFIGS. 8A-81Aand/or other implants described herein. The facet reinforcement device1400can also be used in combination with the fastener members depicted inFIGS. 20-65, and/or other fastener members described herein. Accordingly, the fastener member1480depicted inFIG. 84can refer to any fastener member described herein; and the fastener member1580depicted inFIG. 87can refer to any fastener member described herein; and the fastener members1680,1680A depicted inFIG. 89can refer to any fastener member described herein.

As shown inFIG. 82, at least a portion of one surface of the facet reinforcement device1400can include a roughened surface. A roughened surface may be advantageous when in contact with a bone or tissue surface because it may prevent slippage or migration of the facet reinforcement device1400against the bone. A roughened surface may aid in maintaining the facet reinforcement device1400and the fastener member1480(seeFig. 84) engaged with tissue or bone.

The roughened surface can include at least one projection1416. As shown inFIG. 82, the facet reinforcement device1400can comprise a plurality of projections1416. The projections1416can extend from the distal surface1406and can include a sharp edge or tip. The projections1416can also extend between the ablumenal surface1404and the luminal surface1410or in certain embodiments only extend along a portion of said area. In some embodiments, the projections1416comprise at least one spike, barb, wedge, or hook projecting from at least a portion of one surface of the facet reinforcement device1400. In some embodiments, the projections1416can be ribbed, barbed, or threaded to resist separation after insertion into bone or tissue. The projections1416may have different shapes from one another or they may have a uniform shape. A portion of the surface of the projections1416can be porous. A porous surface can be created in any of a variety of ways known in the art, such as by applying sintered beads or spraying plasma onto the surface of the projection1416. A porous surface can allow bone to grow into or attach to the surface of the projection1416, thus securing the projection1416and the facet reinforcement device1400to the bone. In certain embodiments, other surfaces of the facet reinforcement device1400can be porous. In one embodiment, an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate, or other adhesive known in the art, is used to bond at least one surface of the facet reinforcement device1400to a bone or tissue surface. In some embodiments, an adhesive or sealant is used to bond the distal surface1406of the facet reinforcement device1400to the surface of the facet.

The facet reinforcement device1400may include one row of projections1416or may include multiple rows of projections1416. The facet reinforcement device1400may include projections1416arranged in a random order or orientation.

The ablumenal surface1404of the facet reinforcement device1400can include a substantially circular cross-section (cylindrical), as shown inFIG. 82. The ablumenal surface1404can have other cross-sectional shapes including, but not limited to, circular (cylindrical), hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. In certain embodiments, the ablumenal surface1404may conform to the shape of an insertion tool.

In the illustrated embodiment ofFIG. 82, the central lumen1420and the luminal surface1410can be circular (cylindrical). The central lumen1420and the luminal surface1410can have other cross-sectional shapes including, but not limited to, hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The central lumen1420and the luminal surface1410may conform to the shape of an insertion tool. In certain embodiments, the central lumen1420and the luminal surface1410can be shaped based on a shape of the fastener member (not shown) (e.g., the central lumen and luminal surface can have a similar cross-sectional shape as the fastener member extending through the central lumen). In certain embodiments, the central lumen1420and the luminal surface1410can include a substantially smooth inner surface to allow the fastener member1480to easily pass through. In other embodiments, the central lumen1420and the luminal surface1410can include a threaded inner surface to allow the fastener member1480to thread into central lumen1420.

The central lumen1420and the luminal surface1410may be configured to match the shape of a lumen formed in the articular process, during a method of use. The central lumen1420and the luminal surface1410may be smaller than a lumen formed in the articular process, during a method of use. In this configuration, the facet reinforcement device1400may reduce stress at the outer aspect of the lumen in the bone. The central lumen1420and the luminal surface1410may be larger than a lumen formed in the articular process, during a method of use. In this configuration, the facet reinforcement device1400may be in contact with a larger surface area of the facet, thereby distributing the forces of the fastener member.

The proximal surface1402may have a feature to mechanically interfit with an insertion tool, including grooves and/or protrusions configured to mate with a corresponding groove and/or protrusion of the insertion tool. The proximal surface1402may have a feature (e.g., a groove or recess) to mechanically interfit with a portion of the fastener member1480(shown inFIG. 84). The feature to mechanically interfit with a portion of the fastener member may increase stability of the system and resistance to migration of components of the system.

The diameter of the facet reinforcement device1400may be in the range of 2 mm-20 mm or in the range of 4 mm-15 mm. The diameter of the central lumen1420may be in the range of 0.5 mm-10 mm or range of 1-7 mm.

FIGS. 83-84show posterior perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using the embodiment of the facet reinforcement device1400shown inFIG. 82. The method can include using an implant deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra.

In one method of use, a drill or other device can be used to form a lumen in superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1. A portion of the surface of the facet of SAP2A and a portion of the surface of the facet of IAP1A can be prepared for fusion. For example, a portion of the surface of the facet can be ground, scored, roughened, sanded, etc., such that the surface of the facet can better adhere to any substances to aid in fusion and/or otherwise fuse more readily to an implant positioned within the facet joint.

FIG. 83illustrates the facet reinforcement device1400placed on the outer, posterior facing surface of the left inferior articular process IAP1A of the superior vertebra V1. In other embodiments and/or in addition, the facet reinforcement device can be placed on the surface of the facet of SAP2A. A lumen is formed in the articular process. The facet reinforcement device1400can be placed after a lumen is formed in the articular process. In another arrangement, the facet reinforcement device1400can be placed prior to forming a lumen in the articular process. In this method, the facet reinforcement device1400may serve as a guide for drilling the lumen. The facet reinforcement device1400can be placed after or prior preparation for fusion. An insertion tool may remain on the facet reinforcement device1400during the steps of forming the lumen and/or during the step of preparing for fusion.

As shown inFIG. 84, a facet reinforcement device1400and a fastener member1480can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. In some embodiments, at least one implant (not shown inFIG. 84) is used with the fastener member1480to fuse a vertebra V1 and vertebra V2.FIG. 84depicts fusing the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. However, the inferior articular process IAP1B of vertebra V1 can be fused to the superior articular process SAP2B of vertebra V2.

In one method of use, the fastener member1480can be positioned within a cannula and can be advanced through the cannula. The proximal end portion of fastener member1480can then be inserted into the central lumen1420of the facet reinforcement device1400. The proximal end portion of the fastener member1480can be adjacent and/or abut the luminal surface1410. The proximal end portion of fastener member1480can then be inserted into the lumen of inferior articular process IAP of vertebra V1. The proximal end portion of fastener member1480can be advanced until a proximal end portion of fastener member is positioned near the lumen of superior articular process SAP2A of vertebra V2. In some embodiments, the proximal end of the cannula can have a bend to direct the proximal end portion of fastener member1480into the lumen of superior articular process SAP2A of vertebra V2. The proximal end portion of fastener member1480can be inserted into the lumen of superior articular process SAP2A of vertebra V2. An implant can be inserted between the superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1. In some embodiments, the implant can be disposed prior to inserting the proximal end portion of the fastener member1480into the lumen of superior articular process SAP2A of vertebra V2. The cannula can be removed and/or reinserted at various points during the method, including, for example, after the proximal end portion of fastener member1480is inserted into the lumen formed within the superior articular process SAP2A of vertebra V2, after vertebra V1 and/or vertebra V2 have been stabilized, or at any other point during the method.

The fastener member1480can be secured. Securing the fastener member1480can be based on the type of fastener member used. By way of example, securing a fastener member1480having the characteristics of the fastener member depicted inFIGS. 49-51, can include the following steps: inserting the proximal end portion of the fastener member1480into a fastening mechanism1484; the fastener mechanism located at a distal end portion of the fastener member1480; securing an end of the fastener member1480to the opposite end of the fastener member1480; securing the proximal end portion of the fastener member1480to the distal end portion of the fastener member1480; and/or advancing the proximal end portion of the fastener member1480through the fastening mechanism1484. In other embodiments, fastener member1480can be secured by tying a first portion the fastener member to a second portion of the fastener member, by forming a knot in a first end and second end; by screwing the fastener member into a threaded central lumen, by threading a fastener onto a threaded end of a fastener member disposed through a threaded central lumen, by including enlarged portion at the end of the fastener member, and/or combinations of above. The fastener member1480can be secured in order to retain the facet reinforcement device1400. The facet reinforcement device1400is retained within a loop or other defined segment of the fastener member1480. The reinforcement device1400can remain freely movable along a portion of the defined segment after the fastener member1480is secured. In some embodiments, the reinforcement device1400is immobile or otherwise secured along a portion of the defined segment after the fastener member1480is secured.

FIG. 84illustrates the assembled system, including the facet reinforcement device1400and the fastener member1480. The assembled system is implanted on the left facet joint1490between the superior vertebra V1 and the inferior vertebra V2. The left facet joint1490may be compressed by the assembled system, thereby bringing the two facet surfaces in close apposition. This compression is in contrast with the unsecured right facet joint1492.

A second facet reinforcement device1400, a second fastener member1480with or without a second implant may be implanted in the right facet joint1492, according to the method described above with respect to the left facet joint1490. The implantation of a second facet reinforcement device1400and a second fastener may improve stabilization. A second facet reinforcement device1400and a second fastener member1480with or without a second implant may be implanted on other levels of the spine. A plurality of reinforcement devices1400and a plurality of fastener members1480with or without a plurality of implants may be implanted on other levels of the spine, and at various locations on the spine. In some embodiments, the same and/or similar method of fixation, the same fastener members1480, the same implants and/or the same facet reinforcement devices1400may be used at different locations. In other embodiments, a different method of fixation, different fastener members1480, different implants and/or different facet reinforcement devices1400may be used at different locations.

FIG. 85shows another embodiment of a facet reinforcement device1500. In the illustrated arrangement, the facet reinforcement device1500has an inferior end1502and a superior end1504. The facet reinforcement device1500has a first securing portion1530toward the inferior end1502and a second securing portion1540toward the superior end1504. The first securing portion1530and second securing portion1540can be connected to each other by a central portion1510.

The first securing portion1530can be configured for placement on an outer facet surface of a facet. The first securing portion1530can include a lumen1506surrounded by a luminal surface1511. The lumen1506and the luminal surface1511can be substantially circular (cylindrical) as shown in the illustrated embodiment. The lumen1506can have other cross-sectional shapes including, but not limited to, circular (cylindrical), hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The lumen1506and the luminal surface1511can be shaped based on a shape of a fastener member1580(e.g., having a shape complimentary or similar to the outer shape of the portion of the fastener member1580extending there-through). The lumen1506and the luminal surface1511may conform to the shape of an insertion tool. The lumen1506and the luminal surface1511can include a substantially smooth inner surface to allow the fastener member1580to easily pass through. In other embodiments, the lumen1506and the luminal surface1511can include a threaded surface to allow the fastener member to thread into the lumen1506.

The first securing portion1530can include one (as illustrated), two, three or a plurality of lumens1506. The one or more lumens1506can have the same shape or different shape. The first securing portion1530may include one row of lumen1506, for example, the lumens1506can be aligned along an axis. In other arrangements, the first securing portion1530may include multiple rows of lumens1506. The first securing portion1530may include lumens1506arranged in a random order or orientation. As will be described below, the one or more lumens1506can be configured to accept one or more fastener members1580and/or one or more fasteners1590.

The second securing portion1540can be configured for placement on a vertebral structure. The vertebral structure can be remote or distanced from the outer facet surface of a facet. For example, in one arrangement, the second securing portion1540can be configured for placement on an outer surface or base of the spinous process1570; a translaminar position, and/or for placement on an outer surface of the lamina (e.g., base of spinous process).

The second securing portion1540can include a lumen1508surrounded by a luminal surface1521. The lumen1508and the luminal surface1521can be circular (cylindrical). The lumen1508can have other cross-sectional shapes including, but not limited to, hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The lumen1508can be shaped based on a shape of the fastener member1580and/or the fastener1590. The lumen1508and the luminal surface1521may be circular, hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The lumen1508and the luminal surface1521may conform to the shape of an insertion tool. The lumen1508and the luminal surface1521can include a substantially smooth surface to allow the fastener member1580and/or the fastener1590to easily pass through, or the lumen1508can include a threaded surface to allow the fastener member1580and/or the fastener1590to thread into the lumen1508.

The second securing portion1540can include one, two (as illustrated), three or a plurality of lumens1508. Additional lumens1508may increase fixation security and reduce torsional forces.

The one or more lumens1508can have the same shape or different shape. The two lumens1508depicted inFIG. 85have substantially the same shape. The second securing portion1540may include one row of lumens1508, for example, the lumens1508can be aligned along an axis. The row of lumens1508may be aligned along a longitudinal axis of the second securing portion1540. The second securing portion1540may include multiple rows of lumens1508. The second securing portion1540may include lumens1508arranged in a random order or orientation. The one or more lumens1508can be configured to accept one or more fastener members1580and/or one or more fasteners1590. The one or more lumens1508can be oriented in order to facilitate placement of the fastener members1580and/or the fasteners1590. The fastener1590may be placed in a translaminar position. The fastener1590may be placed in the spinous process, or the base of the spinous process. The fastener1590may be placed across the spinous process of a vertebra.

At least one surface of the facet reinforcement device1500may have a feature to mechanically interfit with an insertion tool (not shown), including grooves and/or protrusions configured to mate with a corresponding groove and/or protrusion of the insertion tool. At least one surface of the facet reinforcement device1500can have a feature (e.g., a recess or groove) to mechanically interfit with the fastener member1580and/or fastener1590. The feature to mechanically interfit with the fastener member1580and/or fastener1590member may increase stability of the system and resistance to migration of components of the system.

The diameter of the first securing portion1530may be in the range of 2 mm-20 mm or the diameter may be in the range of 4 mm-15 mm. The diameter of the lumen1506may be in the range of 0.5 mm-10 mm or in the range of 1-7 mm. The diameter of the lumen1508may be in the range of 0.5 mm-10 mm or 1-7 mm.

In some embodiments, at least a portion of one surface of the facet reinforcement device1500has a roughened surface and/or a porous surface, as described above with respect toFIG. 82. The roughened surface can comprise at least one projection1516. In one embodiment, the projection1516can comprise at least one spike, barb, wedge, or hook projecting from one surface of the facet reinforcement device1500. The first securing portion1530, the second securing portion1540, the central portion1510, and/or any combination of these portions may include a roughened surface and/or a porous surface. In some embodiment, an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate, or other adhesive known in the art, is used to bond one surface of the facet reinforcement device1500to a bone or tissue surface. In some embodiments, at least a portion of one surface of the facet reinforcement device1500may be curved or malleable. The portion of one surface of the facet reinforcement device1500may be shaped to conform to a shape of an anatomic structure, such as a facet or spinous process.

As shown the first securing portion1530and the second securing portion1540may lie on different planes as shown inFIG. 85. The first securing portion1530can lie on a plane P1, as shown inFIG. 85. The first securing portion1530can include the lumen1506. The lumen1506has a central, longitudinal axis, Axis1, extending through the lumen1506. The plane P1can lie perpendicular to the Axis1of the lumen1506of the first securing portion1530. The plane P1can lie adjacent to a distal surface1531of the first securing portion1530. The plane P1can lie adjacent to a surface of the first securing portion1530configured to engage a bone or tissue.

The second securing portion1540can lie on a plane P2. The second securing portion1540can include at least one lumen1508. The lumen1508has a central, longitudinal axis, Axis2, extending through the lumen1508. The plane P2can lie parallel to the Axis2of the lumen1508of the second securing portion1540. The plane P2can lie adjacent to a distal surface1541of the second securing portion1540. The plane P2can lie adjacent to a surface of the second securing portion1540configured to engage a bone or tissue.

The plane P1may be angled relative to the plane P2to form an angle A (seeFIG. 85) between the plane P1and the plane P2. The angle A may be between 30-150 degrees. The angle A may be 60-105 degrees in one arrangement. The Axis1and the Axis2may not be parallel in such arrangements. In one embodiment, the Axis1and the Axis2may be perpendicular. In other embodiments, the Axis1may be angled relative to the Axis2.

In certain arrangements, the first securing portion1530may be offset in multiple dimensions from the second securing portion1540. The first securing portion1530may be offset along a longitudinal axis of the facet replacement device1500from the second securing portion1540. The longitudinal axis of the first securing portion1530may be offset, angled, or otherwise not aligned with the longitudinal axis of the second securing portion1540.

For example, as illustrated inFIG. 86, the second securing portion1540may lie medial and/or posterior to the first securing portion1530. The second securing portion1540may lie superior to the first securing portion1530. Proximal or posterior, as referred to here, refers to the part of the vertebra or the facet reinforcement device that is configured to be implanted in a vertebra toward the tip of the spinous process. Distal and anterior refer to the part of the vertebra or the facet reinforcement device that is configured to be implanted in a vertebra toward the vertebral body. Medial refers to toward the midline (center of spinous process), lateral refers to a direction away from the midline (toward the tip of the transverse processes). Superior refers to a direction toward the head, or to a part of the facet reinforcement device that configured to face toward the head on placement, and inferior to a structure or part of the facet reinforcement device which faces or is positioned toward the feet. The central portion1510may be bent and/or twisted to provide the offset and/or angulation of the first securing portion1530relative to the second securing portion1540.

FIGS. 86-87show perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using the facet reinforcement device1500. The method may include using an implant deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra.

In one method of use, a drill or other device can be used to form a lumen in superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1. A portion of the surface of the facet of SAP2A and a portion of the surface of the facet of IAP1A can be prepared for fusion. Specifically, a portion of the surface of the facet can be ground, scored, roughened, sanded, etc., such that the surface of the facet can better adhere to any substances to aid in fusion and/or otherwise fuse more readily to the implant if used.

FIG. 86illustrates the facet reinforcement device1500placed on an outer surface of the superior vertebra V1. The first securing portion1530is placed on outer, posterior facing surface of the left inferior articular process IAP1A of the superior vertebra V1. The second securing portion1540is placed on outer surface of the spinous process, near the base of the spinous process of V1.

In one method of use, a lumen is formed in the articular process. The facet reinforcement device1500can be placed after a lumen is formed in the articular process. The facet reinforcement device1500can be placed prior to forming a lumen in the articular process. In this method, the facet reinforcement device1500may serve as a guide for drilling the lumen. The facet reinforcement device1500can be placed after preparation for fusion. The facet reinforcement device1500can be placed before preparation for fusion. An insertion tool may remain on the facet reinforcement device1500during the steps of forming the lumen and/or during the step of preparing for fusion.

As shown inFIG. 87, a facet reinforcement device1500and a fastener member1580can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. In some embodiments, at least one implant is used with the fastener member1580to fuse a vertebra V1 and vertebra V2.FIG. 87depicts fusing the inferior articular process IAP1A of vertebra V1 and the superior articular process SAP2A of vertebra V2. However, the inferior articular process IAP1B of vertebra V1 can be fused to the superior articular process SAP2B of vertebra V2.

The fastener member1580can be secured. Securing the fastener member1580can be based on the type of fastener member used. By way of example, securing a fastener member1580having the characteristics of the fastener member depicted inFIGS. 49-51, can include the following steps: inserting the proximal end portion of the fastener member1580into a fastening mechanism1584; the fastener mechanism located at a distal end portion of the fastener member1580; securing an end of the fastener member1580to the opposite end of the fastener member1580; securing the proximal end portion of the fastener member1580to the distal end portion of the fastener member1580; and/or advancing the proximal end portion of the fastener member1580through the fastening mechanism1584. In other embodiments, fastener member1580can be secured by tying a first portion the fastener member to a second portion of the fastener member, by forming a knot in a first end and second end; by screwing the fastener member into a threaded central lumen, by threading a fastener onto a threaded end of a fastener member disposed through a threaded central lumen, by include at the end of the fastener member, and/or combinations of above. The fastener member1580can be secured in order to retain the facet reinforcement device1500. The facet reinforcement device1500is retained within a loop or other defined segment of the fastener member1580. The reinforcement device1500can remain freely movable along a portion of the defined segment after the fastener member1580is secured. In some embodiments, the reinforcement device1500is immobile or otherwise secured along a portion of the defined segment after the fastener member1580is secured. The fastener member1580can be secured in order to retain the first securing portion1530.

A lumen is formed in the spinous process. The facet reinforcement device1500can be placed after a lumen is formed in the spinous process. The facet reinforcement device1500can be placed prior to forming a lumen in the spinous process. In this method, the facet reinforcement device1500may serve as a guide for drilling the lumen. The second securing portion1540can be secured to V1 using fastener member1580and/or other fastener1590. The fastener1590may be a screw, a bolt, a dual headed screw, a pedicle screw, a transpedicular screw, a post, a plug, a tether, artificial ligament, a rod or any other device of securing a plate to bone, which would be known to one skilled in the art. The fasteners1590may pass translaminally or through the base of the spinous process1570. In some embodiments, the fastener1590is threaded and the lumen1508is threaded. The corresponding threading between lumen1508and fastener1590may facilitate the securing and/or locking of the fastener1590to the facet reinforcement device1500.FIG. 86depicts two lumens1508in the second securing portion1540. The fasteners1590associated with the lumens1508may be the same or different, or a combination of similar and different fasteners for three or more lumens1508.

FIG. 87illustrates the assembled system, including the facet reinforcement device1500and the fastener member1580. The assembled system is implanted on the left facet joint between a superior vertebra V1 and an inferior vertebra V2. The left facet joint may be compressed by the assembled system, thereby bringing the two facet surfaces in close apposition. This compression is in contrasts with the unsecured right facet joint.

FIG. 88shows an embodiment of a facet reinforcement device1600. The facet reinforcement device1600has similar features to the facet reinforcement device1500, described herein. The facet reinforcement device1600includes a first securing portion1630toward an inferior end1602and a second securing portion1640toward a superior end1604. A central portion1610connects the first securing portion1630and the second securing portion1640. The first securing portion1630can include at least one lumen1606surrounded by a luminal surface1611. The first securing portion1630can be configured for placement on an outer facet surface of a facet. In some embodiments, at least a portion of one surface of the facet reinforcement device1600has a roughened surface and/or a porous surface, which may include at least one projection1616.

The second securing portion1640can be configured for placement on a vertebral structure. The vertebral structure can be remote from the outer facet surface of a facet. The second securing portion1640can be configured for placement on an outer surface of the spinous process1670.

The second securing portion1640can include at least one lumen1608surrounded by a luminal surface1621. The second securing portion1640can include two lumens1608. The two lumens1608may be in a different configuration than lumens1508, shown inFIG. 85. For example, the two lumens1608are oriented vertically along the spinous process in the second securing portion1640. The two lumens1508are oriented horizontally along the base of the spinous process in the second securing portion1540. The orientation of the two lumens1608of the facet reinforcement device1600is generally perpendicular to the lumens1508of the facet reinforcement device1500. The orientation shown inFIG. 89may be advantageous in countering forces on the facet reinforcement device1600. The orientation shown inFIG. 89may permit increased visualization of posterior vertebral structures such as the V1 lamina. The orientation of the lumens1608permits placement of fasteners1690A across the spinous process1670.

The first securing portion1630and the second securing portion1640may lie on different planes. The first securing portion1630lies on a plane P3, as shown inFIG. 88. The lumen1606has a central, longitudinal axis, Axis1, extending through the lumen1606. The plane P3lies perpendicular to the Axis1of the lumen1606of the first securing portion1630. The plane P3can lie adjacent to a distal surface1631of the first securing portion1630.

The second securing portion1640lies on a plane P4. The second securing portion1640can include at least one lumen1608. The lumen1608has a central, longitudinal axis, Axis2, extending through the lumen1608. The plane P4lies parallel to the Axis2of the lumen1608of the second securing portion1640. The plane P4can lie adjacent to a distal surface1641of the second securing portion1640. The plane P3may be angled relative to the plane P4. An angle A may be formed between the plane P3and the plane P4. The angle A may be between 30-150 degrees. The angle A may be 60-105 degrees. The first securing portion1630may be offset in multiple dimensions from the second securing portion1640.

FIGS. 89-91show perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using a facet reinforcement device1600and a facet reinforcement device1600A. The implantation of the facet reinforcement devices1600,1600A can be substantially similar to the implantation of the facet reinforcement device1500.

FIG. 90illustrates the facet reinforcement devices1600and1600A placed on an outer surface of the superior vertebra V1. A first securing portion1630is placed on outer, posterior facing surface of the left inferior articular process IAP1A of the superior vertebra V1. A second securing portion1640is placed on outer surface of the spinous process1670. A first securing portion1630A is placed on outer, posterior facing surface of the right inferior articular process IAP1B of the superior vertebra V1. A second securing portion1640A is placed on outer surface of the spinous process1670.

The second securing portion1640can include two lumens1608. The two lumens1608are oriented vertically along the spinous process in the second securing portion1640. The second securing portion1640A can include two lumens1608A. The two lumens1608A are oriented vertically along the spinous process in the second securing portion1640A. The orientation of the lumens1608,1608A permits placement of fasteners1690A across the spinous process1670.

A lumen can be formed in superior articular process SAP2A of vertebra V2 and inferior articular process IAP of vertebra V1. A lumen can be formed in superior articular process SAP2B of vertebra V2 and inferior articular process IAP1B of vertebra V1. A fastener member1680and a fastener member1680A can be inserted in a manner as described above. The proximal end portion of a fastener member1680can be inserted into the lumen1606of the first securing portion1630, the lumen of inferior articular process IAP1A of vertebra V1, and the lumen of superior articular process SAP2A of vertebra V2. The proximal end portion of a fastener member1680A can be inserted into a lumen in the first securing portion1630A, the lumen of inferior articular process IAP1B of vertebra V1, and the lumen of superior articular process SAP2B of vertebra V2. An implant can be inserted between the superior articular process and the inferior articular process.

The fastener members1680,1680A can have the characteristics of the fastener member1580and can be secured in a similar manner to securing fastener member1580. The proximal end portion of the fastener member1680,1680A can be inserted into a fastening mechanism1684,1684A. The fastener mechanism1684,1684A can be located at a distal end portion of the fastener member1680,1680A. As shown inFIG. 90, the facet reinforcement device1600and the fastener member1680can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. The facet reinforcement device1600A and a fastener member1680A can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2. The facet reinforcement device1600can be substantially similar to the facet reinforcement device1600A. The facet reinforcement device1600can be a mirror image of the facet reinforcement device1600A.

A lumen is formed in the spinous process1670. The second securing portions1640,1640A can be secured to V1 using the fastener members1680, the fastener1690, and/or the fastener1690A. The fastener members1680and the fastener1690can be inserted in a manner as describe above with respect to fastener members1580and the fastener1590. The fastener1690may be a screw, a bolt, a dual headed screw, a pedicle screw, a transpedicular screw, a post, a plug, a tether, artificial ligament, a rod or any other means of securing a plate to bone, which would be known to one skilled in the art. In some embodiments, the fastener1690is threaded and the lumen1608is threaded. The corresponding threading between the lumen1608and the fastener1690may facilitate the securing and/or locking of the fastener1690to the facet reinforcement device1600.FIG. 89depicts two lumens1608in the second securing portion1640. The fasteners1690associated with the lumens1608may be the same or different, or a combination of similar and different fasteners for three or more lumens1608.

The fastener1690A may pass translaminally or through the spinous process1670. The fastener1690A is located between the lumen1608and the lumen1608A. The fastener1690A is located between the second securing portion1640and the second securing portion1640A. Referring toFIGS. 90 and 91, the fastener1690A is illustrated with head1694, shaft1696, and nut1692. The shaft1696may be threaded or smooth. The fastener1690A can take the form of a screw, a bolt, a dual headed screw, a pedicle screw, a transpedicular screw, a post, a plug, a tether, artificial ligament, a rod or any other form known in the art. Additional security may be provided by securing the two facet reinforcement devices1600,1600A together through the spinous process.

FIGS. 89-91illustrate the assembled system, including the facet reinforcement device1600and1600A.FIG. 91illustrates the system, viewed from superior to V1. The fasteners1690A may be seen passing through lumen1608in facet reinforcement device1600, through spinous process1670and through lumen1608A in facet reinforcement device1600A inFIG. 90.

The assembled system is implanted on the left facet joint and the right facet joint between a superior vertebra V1 and an inferior vertebra V2. The facet joints may be compressed by the assembled system, thereby bringing the two facet surfaces in close apposition. The implantation of the second facet reinforcement device1600A and the second fastener member1680A may improve stabilization.

The facet reinforcement device1400,1500,1600,1600A and fasteners1580,1590,1680,1690,1690A may be made of any of a variety of materials known in the art, including but not limited to a polymer such as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene, fluoropolymer, hydrogel, or elastomer; a ceramic such as zirconia, alumina, or silicon nitride; a metal such as titanium, titanium alloy, cobalt chromium or stainless steel; or any combination of the above materials. The facet reinforcement device1400,1500,1600,1600A may be made of multiple materials in combination. For example, the ablumenal surface1404can comprise a polymer, such as PEEK or polyethylene, and the luminal surface1410can comprise a metal or ceramic. For example, the proximal surface1402can comprise a polymer and the distal surface1406and/or the projections1416can comprise a metal or ceramic. The material of the facet reinforcement device1400can be the same as the material of the fastener member and/or the implant. The material of the facet reinforcement device1400can be different from the material of the fastener member and/or the implant.

Kits may be provided to facilitate spine fixation procedures. Kits may include one or more facet reinforcement devices, such as any of those described herein. Different sizes and configurations of facet reinforcement devices may be provided in a single kit. Different kits may be available that have different sizes and configurations of facet reinforcement devices. Kits may include one or more fastener members, such as any of those described herein. The kits may include one or more fasteners, such as any of those described herein. These fasteners may be screws, bolts and nuts, tethers, plugs, posts or other configurations of fastener that would be known to one of skill in the art. Kits may include one or more facet implants, such as any of those described herein.

Kits may include drills or drill bits for creating lumens in the articular processes of a facet joint. The kits may include drills or drill bits for creating lumens in the spinous process. Kits may include drills or drill bits for creating a fastener lumen in bone. The kits may include tools for preparing the facet joint surface. Kits may include one or more tools for implantation.

Methods of use may include any of the following steps. Method steps may include: using an implant deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra; forming a lumen in a superior articular process of a vertebra; forming a lumen in a inferior articular process of a vertebra; forming a lumen in a second superior articular process of a vertebra; forming a lumen in a second inferior articular process of a vertebra; and/or preparing the surface of the facet for fusion.

Method steps may include: placing a facet reinforcement device on an outer surface of the superior vertebra; placing the first securing portion on the inferior articular process; and/or placing second securing portion on outer surface of the spinous process.

Method steps may include: fusing the vertebra with a fastener member; positioning the fastener member in a first securing portion; inserting the fastener member into a lumen of a first securing portion; inserting the fastener member into the lumen of an inferior articular process of a vertebra; advancing the fastener member; and/or inserting the fastener member into the lumen of a superior articular process of a vertebra.

Method steps may include: securing the fastener member; inserting an end of the fastener member into a fastening mechanism; advancing the fastener member through the fastening mechanism; retaining the facet reinforcement device; and/or retaining the first securing portion.

Method steps may include: forming a lumen in the spinous process; positioning a fastener member in a second securing portion; positioning a fastener in a second securing portion; positioning a fastener in a second securing portion that passes tranlaminally; and/or positioning a fastener between the second securing portion of a first facet reinforcement device and the second securing portion of a second facet reinforcement device.

Method steps may include: preparing a facet joint; positioning a facet reinforcement device, placing a fastener member through a facet reinforcement device; placing a fastener member through a first articular process of a facet joint; placing a fastener member through a second articular process of the facet joint; and/or securing the fastener member over the facet reinforcement device. The positioning of the facet reinforcement device may be performed prior to preparing the facet joint or after preparing the facet joint. The step of preparing the facet joint may involve drilling a lumen through both articular processes of the facet joint. The step of preparing the facet joint may involve roughening up, drilling, burring, or otherwise preparing the articular surfaces of the facet joint.

The method may include passing the fastener member through an aperture in an implant. The method may include any of the following steps from the following order: placing a fastener member through the facet reinforcement device; then placing the fastener member through a first articular process of a facet joint; then placing the fastener member through an implant; then placing the fastener member through a second articular process of the facet joint.

The method may include securing the fastener member. The method may include passing an end of the fastener member through a fastening mechanism; inserting the proximal end portion of the fastener member1480into a fastening mechanism1484; the fastener mechanism located at a distal end portion of the fastener member1480; securing an end of the fastener member1480to the opposite end of the fastener member1480; securing the proximal end portion of the fastener member1480to the distal end portion of the fastener member1480; and/or advancing the proximal end portion of the fastener member1480through the fastening mechanism1484. The method may include tying a first portion the fastener member to a second portion of the fastener member; forming a knot in a first end and second end; screwing the fastener member into a threaded central lumen; threading a fastener onto a threaded end of a fastener member disposed through a threaded central lumen; and/or including enlarged portions at the end of the fastener member. The method may include using the fastener member to secure the facet reinforcement device; and/or using the fastener member to secure the facet first securing portion.

The method may include securing the fastener. The method may include passing an end of the fastener through the second securing portion; passing an end of the fastener through the second securing portion of a first facet reinforcement device; and/or passing an end of the fastener through the second securing portion of a second facet reinforcement device. The step of positioning the facet reinforcement device may be followed by the step of using a fastener. The method may include using a fastener to secure the facet reinforcement device to a vertebral structure. This vertebral structure may be a spinous process, the base of a spinous process, or other posterior structure. The step of using a fastener may include placing one or more fasteners.

The method may include repeating steps to place a second facet reinforcement device at the contralateral facet joint. The method may include repeating steps to place a second facet reinforcement device at another facet joint. The method may include repeating steps to place a second facet reinforcement device at another vertebral level. The method may include using a fastener to secure the facet reinforcement device to a vertebral structure. The method may include by placing one or more fasteners through a lumen in the first facet reinforcement device and through a lumen in the second facet reinforcement device. The fastener may be placed through a vertebral structure. The fastener may be placed through a spinous process. The fastener may be secured with a nut or other securing element. The fastener may be threaded into a lumen in the first facet reinforcement device and/or a lumen in the second facet reinforcement device.

In the above embodiments, it should be understood that fastener member similar to any of those described above, for example, at 72, 280, 380, 480, 580, 680, 780, and 880, may be used with any of the embodiments of the facet reinforcement device described herein. Furthermore, the facet reinforcement devices may be used with various of the facet implants described herein, such as those with a wire or cable retaining device. Though the facet reinforcement devices are primarily described in relation to reinforcing the inferior articular process, it is to be understood that embodiments may also be used to reinforce the superior articular process. For example, for use on a surface of a superior facet, embodiments of a facet reinforcement device similar to1500may be shaped and sized such that the second securing portion1540meets the vertebra. The facet reinforcement device1500could permit placement of one or more fasteners1590through, for example, the pedicle or into the vertebral body.

Similarly, through the illustrations of the facet reinforcement device show the facet reinforcement device applied to lumbar vertebrae, it will be understood that multiple sizes and shapes may be provided adapted for placement on facet surfaces in the cervical or thoracic region.

The terms “generally” “approximately”, “about”, and “substantially” as used herein represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “generally” “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount or characteristic.

The term “up to about” as used herein has its ordinary meaning as known to those skilled in the art and may include 0 wt. %, minimum or trace wt. %, the given wt. %, and all wt. % in between.

Although the present invention has been described in relation to various exemplary embodiments, various additional embodiments and alterations to the described embodiments are contemplated within the scope of the invention. Thus, no part of the foregoing description should be interpreted to limit the scope of the invention as set forth in the following claims. For all of the embodiments described above, the steps of the methods need not be performed sequentially.