Devices and methods for reinforcing small articular surfaces
The device and method for reinforcing intervertebral joints using fastener members and small articular surface reinforcement devices address the need for quick and effective stabilization and fusion of vertebrae, reducing pain and deterioration.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- SPINAL ELEMENTS INC
- Filing Date
- 2021-10-28
- Publication Date
- 2026-05-08
AI Technical Summary
Current treatments for degenerative diseases of the spine, such as facet joint arthritis, often involve time-consuming and complex procedures to fuse adjacent vertebrae, and there is a need for devices and methods to stabilize and/or fix bones quickly and easily.
A device for reinforcing intervertebral joints is provided, comprising fixation portions with lumens for receiving fastener members, and methods involving the use of small articular surface reinforcement devices and fasteners to stabilize and fuse vertebrae, which can include implants with engaging members and lumens for securing to the spinous process.
The solution allows for rapid and efficient stabilization and fusion of vertebrae, reducing pain and preventing further deterioration, while preserving bone integrity and enabling medication delivery.
Smart Images

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Abstract
Description
Technical Field
[0001] This application is a continuation of U.S. Patent Application No. 14 / 274,575, filed on May 9, 2014, and claims priority based on U.S. Provisional Patent Application No. 61 / 883,960, filed on September 27, 2013, the content of which is hereby incorporated by reference in its entirety.
[0002] Some embodiments described herein generally relate to methods and implants for fusing bone, such as methods and implants for fusing vertebrae by fixing the articular processes of the vertebrae.
Background Art
[0003] Traumatic, inflammatory, and degenerative diseases of the spine can cause severe pain and loss of mobility. One cause of back and spine pain is related to degeneration of the facet joints of the spine or facet joint arthritis. When bone contacts or rubs against the degenerated intervertebral joint surface, it can contribute to some pain syndromes. In many technical advancements, while the focus has been on the intervertebral disc and its artificial replacement or repair, little progress has been made in the repair of the facet joints. Degeneration of the intervertebral joints and the intervertebral disc often occur simultaneously. Therefore, it is necessary to address the clinical problems caused by degeneration of the intervertebral joints.
[0004] The current standard treatment for dealing with the problem of degeneration associated with the intervertebral joints is to fuse two adjacent vertebrae. By performing this surgical procedure, the relative movement between two adjacent vertebrae is stopped, and thus the movement of the facet joints and the resulting pain are stopped. The procedure for fusing two adjacent vertebrae often involves fixation and / or stabilization of the two adjacent vertebrae until they fuse. Furthermore, in cases of other bone injuries and / or surgical procedures, as well as injuries and / or surgical procedures affecting other bones, such as stabilizing the sternum after cardiac surgery or stabilizing ribs after fractures, it may be desirable to fix and / or stabilize the bone until the bone or bone segment can fuse. Current procedures for fixing and / or stabilizing adjacent vertebrae and / or other bones can be time-consuming and / or complex. [Prior art documents] [Patent Documents]
[0006] [Patent Document 1] U.S. Patent Application No. 12 / 859,009 [Non-patent literature]
[0007] [Non-Patent Document 1] King et al., “Mechanism of Spinal Injury Due to Caudocephalad Acceleration,” Orthop. Clin. North Am., 6:19, 1975. [Overview of the Initiative] [Problems that the invention aims to solve]
[0008] Therefore, there is a need for devices and procedures to stabilize and / or fix bones quickly and / or easily. [Means for solving the problem]
[0009] In some embodiments, a device for reinforcing an intervertebral joint implant is provided. The device comprises a first fixation portion including a proximal surface and a distal surface. The first fixation portion comprises a first lumen located between the proximal and distal surfaces. The first lumen is suitable for receiving a fastener member. The device comprises a second fixation portion including a proximal and distal surface. The second fixation portion comprises a second lumen. The device comprises a central portion between the first and second fixation portions.
[0010] In some embodiments, the longitudinal axis of the first fixing portion is positioned at an angle to the longitudinal axis of the second fixing portion. In some embodiments, the plane of the distal surface of the first fixing portion is not parallel to the plane of the distal surface of the second fixing portion. In some embodiments, the distal surface of the microarticular surface reinforcement device is configured to engage with the bone surface of the microarticular surface. In some embodiments, the distal surface of the microarticular surface reinforcement device includes a sharp engaging member.
[0011] In some embodiments, a kit for treating the spine is provided. The kit comprises a fastener member. The kit comprises a small articular surface reinforcement device. The small articular surface reinforcement device includes a proximal surface and a distal surface. The small articular surface reinforcement device comprises a lumen located between the proximal surface and the distal surface. The lumen is suitable for receiving the fastener member.
[0012] In some embodiments, the articular surface reinforcement device further comprises a second portion adapted to attach to the spinous process of a vertebra. In embodiments, the second portion of the articular surface reinforcement device comprises at least one lumen. Some embodiments of the kit further comprises a fastener for securing the articular surface reinforcement device to the vertebra. In some embodiments, the fastener secures the articular surface reinforcement device to the spinous process of the superior vertebra. In some embodiments, the fastener is a screw or bolt.
[0013] In some embodiments, methods for treating the spine are provided. The method may include placing a small articular surface reinforcement device having a lumen adjacent to a first vertebra. The method may include passing a fastener member through the lumen. The method may include passing the fastener member through the first articular process of the facet joint. The method may include passing the fastener member through the second articular process of the facet joint. The method may include holding the small articular surface reinforcement device by fixing one end of the fastener member to the other end of the fastener member.
[0014] In some embodiments, methods for treating the spine are provided. The method may include a step of preparing the facet joint for fixation. The method may include passing a fastener member through the first articular process of the facet joint. The method may include passing a fastener member through the second articular process of the facet joint. The method may include placing a microarticular surface reinforcement device having a lumen for receiving a flexible fastening band against the surface of the first articular process. The method may include passing the fastener member through the lumen. The method may include fixing the fastener member. The method may include fastening the microarticular surface reinforcement device to the spinous process with a fastener. The method may further include inserting a microarticular surface implant having a joint configured to receive a fastener member into the facet joint. The method may further include passing the fastener member through the joint of the microarticular surface implant.
[0015] In some embodiments, methods for treating the spine are provided. The method may further include preparing a second facet joint at the same level of the spine for fixation. The method may include placing a second articular surface reinforcement device against the first articular process of the second facet joint. The method may include passing a second fastener member through the first articular process of the second facet joint. The method may include passing a second fastener member through the second articular process of the second facet joint. The method may include fixing the second fastener member. The method may include fastening the second articular surface reinforcement device to the spinous process with a fastener. The method may further include inserting a second articular surface implant having a joint configured to receive a fastener member into the facet joint. The method may further include passing the second fastener member through the joint of the second articular surface implant.
[0016] In some embodiments, a device is provided for placement in the facet joint, the purpose of which is to provide reinforcement to the bone when a fastener member is used to fix the facet joint. The device may have a sharp engaging member on the bone contact side to prevent movement. The device may have a through-opening for receiving a main articular surface fixation device. In some embodiments, the device for placement in the facet joint has a second through-opening for receiving at least one additional fastener. In some embodiments, a screw may be provided for placement through the second through-opening. [Brief explanation of the drawing]
[0017] [Figure 1] This is a lateral elevation view of a portion of the spine. [Figure 2A] This is a schematic diagram of the separated thoracic vertebrae. [Figure 2B] This is a schematic lateral view of a separated thoracic vertebra. [Figure 3A] This is a schematic posterior elevation view of a portion of the spine. [Figure 3B] It is a rear oblique elevation view of a part of the spine. [Figure 4A] It is a schematic side view of an intervertebral joint within the cervical vertebrae. [Figure 4B] It is a schematic top view of an intervertebral joint within the cervical vertebrae. [Figure 5A] It is a schematic side view of an intervertebral joint within the thoracic vertebrae. [Figure 5B] It is a schematic top view of an intervertebral joint within the thoracic vertebrae. [Figure 6A] It is a schematic side view of an intervertebral joint within the lumbar vertebrae. [Figure 6B] It is a schematic top view of an intervertebral joint within the lumbar vertebrae. [Figure 7] It is a block diagram of an implant according to one embodiment. [Figure 8A] It is a schematic diagram of one embodiment of an intervertebral joint implant including a disc. <000 [Figure 13] This is a schematic diagram of the implant from Figure 12A that was transplanted into the facet joint. [Figure 14A] This is a schematic diagram of one embodiment of an intervertebral joint implant including a disc having a rough surface on one side. [Figure 14B] This is a schematic diagram of one embodiment of an intervertebral joint implant including a disc having a rough surface on one side. [Figure 15A] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes a disc having a porous surface on one side. [Figure 15B] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes a disc having a porous surface on one side. [Figure 16A] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes a curved disc having a rough surface on its larger side. [Figure 16B] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes a curved disc having a rough surface on its larger side. [Figure 17] This is a schematic diagram of the implant from Figure 16A that was transplanted into the facet joint. [Figure 18A] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes two discs, each having a rough surface on one side. [Figure 18B] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes two discs, each having a rough surface on one side. [Figure 19] This is a schematic diagram of the implant from Figure 18A that was transplanted into the facet joint. [Figure 20] This is a schematic diagram of a fastener component including a braided cable. [Figure 21A] This is a schematic diagram of one embodiment of an intervertebral joint implant having a fastener connection portion including a centrally located hole. [Figure 21B] This is a schematic diagram of one embodiment of an intervertebral joint implant having a fastener connection portion including a centrally located hole. [Figure 22A] This is a schematic diagram of one embodiment of an intervertebral joint implant having a fastener connection portion that includes an off-center hole. [Figure 22B] This is a schematic diagram of one embodiment of an intervertebral joint implant having a fastener connection portion that includes an off-center hole. [Figure 23A] This is a schematic diagram of one embodiment of an intervertebral joint implant having a fastener connection portion that includes a hole adjacent to the edge. [Figure 23B] This is a schematic diagram of one embodiment of an intervertebral joint implant having a fastener connection portion that includes a hole adjacent to the edge. [Figure 24A] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes two discs, each having an off-center hole. [Figure 24B] This is a schematic diagram of one embodiment of an intervertebral joint implant, which includes two discs, each having an off-center hole. [Figure 25A] This is a schematic diagram of one embodiment of an intervertebral joint implant including a curved disc with a fastener connection portion. [Figure 25B] This is a schematic diagram of one embodiment of an intervertebral joint implant including a curved disc with a fastener connection portion. [Figure 26] This figure shows one embodiment in which a cable is engaged with an articular projection using a cable knot. [Figure 27A] This figure shows another embodiment of a fastener member, including a braided cable whose threaded end is adapted to receive a threaded nut. [Figure 27B] This figure shows another embodiment of a fastener member, including a braided cable whose threaded end is adapted to receive a threaded nut. [Figure 28] This figure shows one embodiment in which a cable is engaged with an articulated projection using a threaded nut on the cable. [Figure 29] This figure shows a preferred embodiment including a curved implant, cable, and two set screw-type fastener rings. [Figure 30A] This is an elevation view of one embodiment of a set screw type fastener ring. [Figure 30B]This is a cross-sectional view of one embodiment of a set screw type fastener ring. [Figure 31] These are elevation views of various embodiments of screws in a set screw type fastener ring. [Figure 32] These are elevation views of various embodiments of screws in a set screw type fastener ring. [Figure 33] These are elevation views of various embodiments of screws in a set screw type fastener ring. [Figure 34A] This is a diagram of one embodiment including a friction-fit fastener ring in a reduced state. [Figure 34B] This is a diagram of one embodiment including a friction-fit fastener ring in a reduced state. [Figure 35A] This is a diagram of one embodiment including a friction-fit fastener ring in an enlarged state. [Figure 35B] This is a diagram of one embodiment including a friction-fit fastener ring in an enlarged state. [Figure 36A] This figure shows an embodiment including an implant having a threaded fastener joint portion with closed ends and a threaded fastener member. [Figure 36B] This figure shows an embodiment including an implant having a threaded fastener joint portion with closed ends and a threaded fastener member having a pivotable washer. [Figure 36C] This figure shows an embodiment including an implant having a threaded fastener joint portion with closed ends and a threaded fastener member having a pivotable washer. [Figure 37A] This is a cross-sectional view of the implant shown in Figure 36A, which was transplanted into the facet joint. [Figure 37B] This is a cross-sectional view of the implant shown in Figure 36B, which was transplanted into the facet joint. [Figure 38] This is a transverse cross-sectional view of a two-part implant containing a flat disc transplanted into the facet joint. [Figure 39] This is a transverse cross-sectional view of a two-part implant containing a curved disc transplanted into the facet joint. [Figure 40A]This is a schematic diagram of one embodiment of an intervertebral joint implant having an integrated fastener member including a centrally located reverse-barbed nail. [Figure 40B] This is a schematic diagram of one embodiment of an intervertebral joint implant having an integrated fastener member including a centrally located reverse-barbed nail. [Figure 41A] This is a schematic diagram of one embodiment of an intervertebral joint implant having an integrated fastener member including an off-center, barbed nail. [Figure 41B] This is a schematic diagram of one embodiment of an intervertebral joint implant having an integrated fastener member including an off-center, barbed nail. [Figure 42] This figure shows the implant (Figure 41A) transplanted into the facet joint. [Figure 43] This diagram shows a two-part implant transplanted into the facet joint. [Figure 44] This figure shows one embodiment of an implant having multiple mooring protrusions. [Figure 45] This figure shows the implant (Figure 44) transplanted into the facet joint. [Figure 46A] This figure shows one embodiment of an implant having a rigid, soft tissue lateral anchor. [Figure 46B] This figure shows one embodiment of an implant having a rigid, soft tissue lateral anchor. [Figure 47A] This figure shows one embodiment including an implant having an embedded, flexible, soft tissue lateral anchor. [Figure 47B] This figure shows one embodiment including an implant having an embedded, flexible, soft tissue lateral anchor. [Figure 48A] This is a perspective view of an implant according to one embodiment. [Figure 48B] Figure 48A is a side view of the implant. [Figure 48C] Figure 48A is a cross-sectional and lateral view of the implant. [Figure 49]This is a posterior perspective view of a portion of the spine showing a method for stabilizing a vertebra using implants and fastener members according to one embodiment. [Figure 50] This is a posterior perspective view of a portion of the spine showing a method for stabilizing a vertebra using implants and fastener members according to one embodiment. [Figure 51] This is a posterior perspective view of a portion of the spine showing a method for stabilizing a vertebra using implants and fastener members according to one embodiment. [Figure 52] Figures 49-51 are flowcharts illustrating the method of using the implant and fastener components shown. [Figure 53] This is a perspective view of a flexible clamping band according to one embodiment. [Figure 54] Figure 53 is a perspective view of a portion of the flexible clamping band shown. [Figure 55] This is a side view of a flexible clamping band according to one embodiment. [Figure 56] Figure 55 is a top view of the flexible clamping band. [Figure 57] This is a side view of a flexible clamping band according to one embodiment. [Figure 58] This is a perspective view of a flexible clamping band according to one embodiment. [Figure 59] Figure 58 is a cross-sectional side view of the flexible clamping band. [Figure 60] This is a cross-sectional view taken along line XXIII of the flexible clamping band shown in Figure 58. [Figure 61] Figure 58 is a top cross view showing the flexible clamping band in the first configuration. [Figure 62] Figure 58 is a top cross view showing the flexible clamping band in the second configuration. [Figure 63] This is an exploded view of a flexible clamping band according to one embodiment. [Figure 64] Figure 63 is a perspective view of the flexible clamping band shown. [Figure 65]Figure 64 is a cross-sectional view of the flexible clamping band. [Figure 66] This is a front perspective view of an implant according to one embodiment. [Figure 67] Figure 66 is a posterior perspective view of the implant. [Figure 68] Figure 66 is a side view of the implant. [Figure 69] Figure 66 is a cross-sectional and lateral view of the implant. [Figure 70] This is a front perspective view of an implant according to one embodiment. [Figure 71] Figure 70 is a posterior perspective view of the implant. [Figure 72] Figure 70 is a side view of the implant. [Figure 73] Figure 70 is a cross-sectional and lateral view of the implant. [Figure 74] This is a front perspective view of an implant according to one embodiment. [Figure 75] Figure 74 is a posterior perspective view of the implant. [Figure 76] Figure 74 is a side view of the implant. [Figure 77] Figure 74 is a cross-sectional and lateral view of the implant. [Figure 78] This is a front perspective view of an implant according to one embodiment. [Figure 79] Figure 78 is a posterior perspective view of the implant. [Figure 80] Figure 78 is a side view of the implant. [Figure 81] Figure 78 is a cross-sectional and lateral view of the implant. [Figure 82] This is a front perspective view of a small joint surface reinforcement device according to one embodiment. [Figure 83] Figure 82 is a posterior perspective view of a portion of the spine showing a method for stabilizing a vertebra using the small articular surface reinforcement device and a fastener member according to one embodiment. [Figure 84]Figure 82 is a posterior perspective view of a portion of the spine showing a method for stabilizing a vertebra using the small articular surface reinforcement device and a fastener member according to one embodiment. [Figure 85] This is a front perspective view of a small joint surface reinforcement device according to one embodiment. [Figure 86] Figure 85 is a posterior perspective view of a portion of the spine showing a method for stabilizing a vertebra using the small articular surface reinforcement device and a fastener member according to one embodiment. [Figure 87] Figure 85 is a posterior perspective view of a portion of the spine showing a method for stabilizing a vertebra using the small articular surface reinforcement device and a fastener member according to one embodiment. [Figure 88] This is a front perspective view of a small joint surface reinforcement device according to one embodiment. [Figure 89] Figure 88 is a perspective view of a portion of the spine showing a method for stabilizing a vertebra using a first small articular surface reinforcement device, a second small articular surface reinforcement device, and one or more fastener members according to one embodiment. [Figure 90] Figure 88 is a perspective view of a portion of the spine showing a method for stabilizing a vertebra using a first small articular surface reinforcement device, a second small articular surface reinforcement device, and one or more fastener members according to one embodiment. [Figure 91] Figure 88 is a perspective view of a portion of the spine showing a method for stabilizing a vertebra using a first small articular surface reinforcement device, a second small articular surface reinforcement device, and one or more fastener members according to one embodiment. [Modes for carrying out the invention]
[0018] In this specification, the singular forms “a,” “an,” and “the” refer to multiple objects unless otherwise specified in the context. Thus, for example, the term “a ratchet” refers to a single ratchet or a combination of multiple ratchets. In this specification, substance may include, but is not limited to, any biological and / or chemical substance, including pharmaceuticals, adhesives, etc., and / or, but is not limited to, bone grafts, including autografts, allografts, xenografts, animate material grafts, synthetic grafts, and / or combinations of grafts, pharmaceuticals, and / or adhesives. While vertebrae are used illustratively, in some embodiments other bones may be involved. While specific vertebrae and / or subsets and / or classifications of vertebrae may be specifically referred to, it is understood that any vertebrae and / or subsets and / or classifications or combinations of vertebrae may be used.
[0019] As shown in Figure 1, the spine 2 comprises a series of alternating vertebrae 4 and fibrous discs 6, providing axial support and movement to the upper part of the body. The spine 2 typically contains 33 vertebrae 4, consisting of 7 cervical vertebrae (C1-C7), 12 thoracic vertebrae (T1-T12), 5 lumbar vertebrae (L1-L5), 5 fused sacral vertebrae (S1-S5), and 4 fused coccygeal vertebrae. Figures 2A and 2B show a typical thoracic vertebra. Each vertebra includes an anterior part 8 and a posterior arch 10. The posterior arch 10 includes two pedicles 12 and two lamina plates 14, which connect posteriorly to form a spinous process 16. From each side of the posterior arch 10 project the transverse process 18, the superior articular process 20, and the inferior articular process 22. The articular surfaces 24 and 26 of the superior and inferior articular processes 20 and 22 form facet joints 28 with the articular processes of the adjacent vertebrae (see Figures 3A and 3B). Facet joints are typical synovial joints with cartilaginous surfaces and joint capsules.
[0020] The orientation of the facet joints varies depending on the level of the spine. For example, in the C1 and C2 vertebrae, the facet joints are parallel to the transverse plane. Figures 4A–6B show examples of facet joint orientations at different levels of the spine. In the examples of the C3–C7 vertebrae shown in Figures 4A and 4B, the articular surfaces are oriented at a 45-degree angle to the transverse plane 30 and parallel to the anterior surface 32. This orientation allows the cervical facet joints to contract, extend, laterally contract, and rotate. When oriented at a 45-degree angle to the transverse plane 30, the cervical facet joints can guide the movement of the cervical vertebrae without restricting it. Figures 5A and 5B show examples of the thoracic vertebrae, where the articular surfaces are oriented at a 60-degree angle to the transverse plane 30 and a 20-degree angle to the anterior surface 32, respectively. This orientation allows for lateral contraction and rotation, but contraction and extension are restricted. Figures 6A and 6B show examples of the lumbar spine region, where the facet joints are oriented at angles of 90 degrees to the transverse plane 30 and 45 degrees to the anterior surface 32, respectively. The lumbar spine is capable of contraction, extension, and lateral contraction, but rotation, if any, is minimal due to the 90-degree orientation of the facet joints relative to the transverse plane. The actual range of motion along the spine can vary considerably from one vertebra to another.
[0021] In addition to guiding the movement of the vertebrae, the facet joints also contribute to the load-bearing capacity of the spine. A study by King et al., "Mechanism of Spinal Injury Due to Caudocephalad Acceleration," Orthop. Clin. North Am. 6:19, 1975, found that the load-bearing capacity of the facet joints is 30% higher at several locations in the spine. The facet joints can also play a role in withstanding shear stress between the vertebrae. Over time, these forces acting on the facet joints can cause degeneration and arthritis.
[0022] In some embodiments described herein, facet joint implants can be used to stabilize, fix, and / or fuse a first vertebra to a second vertebra to reduce pain, to reduce further deterioration of the spine or specific vertebrae of the spine, and / or until the first and second vertebrae fuse. In some embodiments, facet joint implants can be implanted and introduced to restore the space between the articular surfaces of the superior articular process of the first vertebra and the inferior articular process of the adjacent vertebra. In some embodiments, facet joint implants can be implanted and introduced to help stabilize adjacent vertebrae with adhesive and / or to deliver medication. Figure 7 shows a block diagram of a facet joint implant ("implant") 160. The implant 160 includes a first side 162, a second side 164, a fastener joint portion 166, and a material joint portion 168. Figures 8A–47B show implants and fasteners according to different embodiments.
[0023] As shown in Figure 7, the implant 160 can be substantially disc-shaped, for example. In other embodiments, the spacer can be of other shapes, such as square, oval, or any other shape. The first side 162 and / or the second side 164 can be convex, concave, or flat, for example. In other words, the first side 162 can be concave, convex, or flat, and the second side 164 can be concave, convex, or flat. For example, the first side 162 can be concave and the second side 164 can be concave, the first side 162 can be concave and the second side 164 can be convex, and so on. In such embodiments, this shape can be determined based on the shape of the bone portion to which the first side 162 and / or the second side 164 are configured to contact. In other words, the first side 162 and / or the second side 164 can be shaped to substantially complement the shape of the bone portion. In other words, the first side 162 or the second side 164 does not need to perfectly match the shape of the corresponding bone portion, and can have a concave shape relative to a bone portion that has a generally convex shape in contact with the implant, or a convex shape relative to a bone portion that has a generally concave shape in contact with the implant. The implant 160 may include any biocompatible material, such as stainless steel, titanium, PEEK, nylon, etc.
[0024] The implant 160 includes a fastener joint 166. The fastener joint 166 can be configured to hold the implant 160 in substantially the same position. Specifically, the fastener joint 166 can be configured to receive a fastener member (not shown) and substantially prevent movement of the implant 160. The fastener joint 166 can include openings and / or other openings. The fastener joint 166 can extend through the implant 160, for example, from a first side 162 to a second side 164. In some embodiments, the fastener joint 166 can extend through only a portion of the implant 160, for example, from a first side 162 to less than half the width (not shown) of the implant 160. The fastener joint 166 can be positioned on and / or within the first side 162, the second side 164, and / or both the first side 162 and the second side 164. The fastener joint 166 can be positioned to pass through the center (not shown) of the implant 160. In other embodiments, the fastener joint portion 166 can be positioned at any location on and / or within the implant 160, for example, off-center. The fastener joint portion 166 can be substantially circular (cylindrical). In other embodiments, the fastener joint portion 166 can have other shapes and / or shapes based on the shape of the fastener member, for example, square (cubic). In some embodiments, the fastener joint portion 166 can have an irregular shape (see, for example, Figure 48) at least partially based on the position of the fastener joint portion 166, and / or a partial shape (see, for example, Figure 23B). The fastener joint portion 166 may include a substantially smooth inner surface (not shown) so that the fastener member can easily penetrate and / or enter the fastener joint portion 166, and / or include a threaded inner surface so that the fastener member can be screwed into the fastener joint portion 166.Although Figure 7 shows that it includes one fastener connection portion, the implant 160 may also include two or more fastener connection portions 166.
[0025] The implant 160 includes a material bonding portion 168. The material bonding portion may be configured to hold, transport, and / or otherwise deliver a material to aid in the fusion of, for example, a drug, adhesive, bone graft, and / or combination of materials. The material bonding portion 168 may include openings and / or other openings. The material bonding portion 168 may extend through the implant 160, for example, from a first side 162 to a second side 164. In some embodiments, the fastener bonding portion may extend through only a portion of the implant 160, for example, from a first side 162 to less than half the width (not shown) of the implant 160. The material bonding portion 168 may be positioned on and / or within the first side 162, the second side 164, and / or both the first side 162 and the second side 164. The material bonding portion 168 may be positioned to pass through the center (not shown) of the implant 160. In other embodiments, the material joining portion 168 can be positioned at any location on and / or within the implant 160, for example, off-center. The material joining portion 168 can be substantially circular (cylindrical). In other embodiments, the material joining portion 168 can have other shapes and / or shapes based on the shape of the fastener member, for example, square (cubic). In some embodiments, the material joining portion 168 can have an irregular shape, at least partially based on the position of the material joining portion 168. Although Figure 7 shows one material joining portion, the implant 160 may also include two or more material joining portions 168. The position, dimensions, shape, and / or number of the material joining portions 168 can be determined based on the position, dimensions, shape, and / or number of the fastener joining portions 166.
[0026] In one embodiment, a device is provided for restoring the space between the two articular surfaces of an intervertebral joint. As shown in Figures 8A and 8B, the device comprises an implant 34 having at least two surfaces, the first surface 36 being fitted to contact the articular surface of one articular surface of the intervertebral joint, and the second surface 38 being fitted to contact the articular surface of the other articular surface. In one embodiment, the implant 34 has a generally circular profile and is dimensioned to fit generally into the joint capsule of the intervertebral joint 28. Figure 8C shows the implant 34 of Figures 8A and 8B positioned within the intervertebral joint. In other embodiments, the implant can have any of a variety of profiles, including, but not limited to, square, rectangular, elliptical, star-shaped, polygonal, or a combination thereof. Figures 9A and 9B show an octagonal implant. In one embodiment, an implant having the desired shape is selected from many prostheses by visualizing the articular process by radiography and / or by injecting a contrast agent into the intervertebral joint to visualize the joint capsule. In one embodiment, the implant has a diameter of approximately 4 mm to approximately 30 mm. In another embodiment, the implant has a diameter of approximately 5 mm to approximately 25 mm. In yet another embodiment, the implant has a diameter of approximately 10 mm to approximately 20 mm. In one embodiment, the implant is approximately 10 mm 2 From approximately 700mm 2 It has a cross-sectional area of approximately 25 mm. In another embodiment, the implant has a cross-sectional area of approximately 25 mm. 2 From approximately 500mm 2 It has a cross-sectional area of approximately 20 mm. In yet another embodiment, the implant has a cross-sectional area of approximately 20 mm. 2 From approximately 400mm 2 or approximately 25mm 2 From approximately 100mm 2 It has the following cross-sectional area.
[0027] The implant has a thickness that is roughly equal to the approximate anatomical distance between the two small articular surfaces of the facet joint. Implants typically have a thickness ranging from 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 non-uniform within the same implant. For example, in Figures 10A and 10B, the thickness of the implant 42 increases along at least one of the surfaces 46, 48, or both as shown, along the entire outer edge 44. In Figures 11A and 11B, only a portion of the edge 44 on one side 46 of the implant 42 is greater than the thickness of the central region and optionally thicker than the typical anatomical distance between the two small articular surfaces of the facet joint. Increasing the edge thickness allows the implant to withstand lateral displacement and attempt to exit the facet joint.
[0028] In some embodiments, the implant is configured to provide an improved mating with the articular process and / or joint capsule. For example, in Figures 12A and 12B, the implant 49 has a bend, angle, or curve 50 to substantially match the natural shape of the articular surface of the joint. Figure 13 shows the implants of Figures 12A and 12B positioned within the facet joint. The implant can be rigid with a pre-formed bend. Alternatively, the implant can be malleable enough to conform to the intrinsic configuration of the adjacent articular surface after implantation. In certain embodiments, such as those shown in Figures 8C and 13, the implant is configured to be implanted within the interarticular and / or facet joint capsule without being fixed to any bone structure. Thus, such embodiments can be used without intrusion or destruction of the bone and / or structure of the vertebra, thereby preserving the integrity of the bone and / or structure of the vertebra.
[0029] In one embodiment, at least a portion of one surface of the implant is highly polished. Using a highly polished portion of the implant can reduce surface friction and / or wear of that portion of the implant when it comes into contact with bone, cartilage, or another surface. The highly polished surface on the implant can also reduce the risk of the implant becoming lodged between the articular surfaces of the facet joint. If the implant becomes lodged, it can cause pain in the facet joint or immobility of the facet joint.
[0030] In one embodiment shown in Figures 14A and 14B, at least a portion of one surface of the implant 50 has a rough surface 52. The rough surface can be advantageous when in contact with a bone or tissue surface because it can prevent the implant 50 from sliding against the bone and can help maintain the implant 50 within the joint. In one embodiment shown in Figures 15A and 15B, at least a portion of one surface of the implant 50 has a porous surface 54. The porous surface 54 can be made by any variety of methods known in the art, such as applying sintered beads or spraying plasma onto the surface of the implant. The porous surface 54 allows bone to grow into or adhere to the surface of the implant 50, and thus the implant 50 can be fixed to the bone. In one embodiment, an adhesive or sealant, such as cyanoacrylate, polymethyl methacrylate, or other adhesives known in the art, is used to bond one side of the implant to the joint surface.
[0031] In one embodiment, one surface of the implant is rough or porous, and the second surface is highly polished. The first surface contacts or engages with one articular surface of the facet joint, helping to maintain the implant between the articular surfaces. The second surface of the implant is highly polished and contacts the other articular surface of the facet joint, providing movement in that facet joint. Figures 16A and 16B show one embodiment of an implant comprising a curved or bent disc 56, the disc 56 having a rough surface 52 on the larger surface 58 of the disc and a highly polished surface 60 on the smaller surface 62. Figure 17 shows the implant of Figures 16A and 16B positioned within the facet joint. The implant typically maintains a fixed position relative to the articular surface that contacts the rough surface, while movement of the facet joint is maintained between the other articular surface and the smaller, highly polished surface of the implant.
[0032] Figures 18A and 18B show one embodiment in which the implant 64 includes two separate discs 66, each disc including a first surface 68 that articulates with a complementary first surface 68 of the other disc, and a second surface 70 adapted to fix the disc to the adjacent bone or cartilage of one articular surface of the facet joint 28. In one embodiment, the thickness of one disc is approximately half the anatomical distance between the two articular surfaces of the facet joint. In other embodiments, the implant includes three or more discs. In one embodiment, the overall thickness of all discs is approximately 25% to 300% of the anatomical distance between the two articular surfaces. In another embodiment, the overall thickness of these discs is approximately 50% to 150% of the anatomical distance. In yet another embodiment, the overall thickness of these discs is approximately 75% to 125% of the anatomical distance. Each disc of a two-part implant may also have features similar to those of a single-disc implant, including, but not limited to, a curved or bent configuration, a highly polished or rough surface, and other features described below. The two discs do not need to have the same dimensions, thickness, configuration, or features. Figure 19 shows one embodiment of a two-part implant 64 positioned within an intervertebral joint 28.
[0033] Implants can be manufactured from any of the various materials known in the art, including, but not limited to, polymers such as polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polyethylene, fluorinated polymers, hydrogels, or elastomers; ceramics such as zirconia, alumina, or silicon nitride; metals such as titanium, titanium alloys, cobalt-chromium, or stainless steel; or any combination of the above materials.
[0034] In one embodiment, the implant is maintained between the two articular surfaces of the facet joint by utilizing the joint capsule and / or other body tissues surrounding the facet joint to restrict the movement of the implant away from the facet joint. In some embodiments, the shape of the implant itself is generally sufficient to withstand displacement of the implant from its position between the facet joint surfaces. In one embodiment, a concave or biconcave configuration is used to withstand implant displacement by increasing the thickness around the periphery of the implant, thus requiring greater force and / or further disturbance of the facet joint surface to cause displacement. In other embodiments, as described above, surface treatment or texture application is used to maintain the implant in contact with the articular surfaces of the facet joint. In some embodiments, a combination of disc configurations, surface texture application, and existing body tissues or structures is used to maintain the position of the implant.
[0035] Bone growth promoters, electrical currents, or other known techniques can be used to accelerate the uptake of textured or microporous anchoring surfaces into bone.
[0036] The implant may be configured with a fastener connection to engage with ("fix") a fastener component that facilitates the retention of the implant within the joint capsule of the facet joint. The use of a fastener component can be advantageous in preventing implant migration over time or during the maximum range of motion of the vertebra that could disturb the joint surface sufficiently to cause the implant to slip out.
[0037] In one embodiment shown in Figures 20-21B, the fastener member includes a wire or cable 72, the wire or cable 72 having a portion 74 that engages with the implant 76 at the fastener joint portion 78 and at least one other portion 80 that engages with or anchors to the bone or soft tissue surrounding the facet joint. The wire or cable may be single-strand, braided, or multi-fiber. In this embodiment, the fastener member is described primarily as a cable or wire, but it should be understood that any of the various elongated structures that can extend through the central opening may function, including pins, screws, and single-strand or multi-strand polymer cords or fabrics, polymer meshes and cloths, as well as other structures that will be apparent to those skilled in the art upon viewing the disclosure herein.
[0038] The cross-sectional shape of the fastener component is not limited to these, but can be any of a variety of shapes, including circular, elliptical, square, rectangular, other polygons, or any other shape. The wire or cable typically 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, the 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 can 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.
[0039] In one embodiment shown in Figures 21A and 21B, the fastener connection portion 78 of the implant 76 is a conduit between two faces 82, 84 of the implant 76, forming an opening 78. In one embodiment, the diameter of the opening 78 is larger than the diameter of the wire or cable 72, thereby allowing the implant 76 to move in conjunction with the movement of the facet joint. The inner diameter of the opening 78 can be at least about 110%, often at least about 150%, and in certain embodiments at least about 200% or 300% or more, of the outer diameter or corresponding dimension of the fastener member near the engagement portion 78. The cross-sectional shape of the opening 78 may or may not match the cross-sectional shape of the wire or cable used.
[0040] In another embodiment, the fastener portion 78 extends through only a portion of the implant 76. The fastener portion 78 can be located approximately in the center of the implant, or it can be located off-center, as shown in Figures 22A and 22B. In one embodiment shown in Figures 23A and 23B, the fastener portion 78 is located on the edge 86 of the implant 76 such that the inner surface of the hole 78 is continuous with the outer edge of the implant. In this configuration of the fastener portion 78, it is not necessary to insert the cable 72 into the fastener portion 78, and the fastener member and the implant can be easily engaged. Figures 24A and 24B show one embodiment including a two-part implant 88. Both discs can be held within the facet joint using either a single cable or two separate cables. Figures 25A and 25B show another embodiment including a curved implant 90 having a fastener portion 78 adapted to receive a cable.
[0041] In Figure 26, the wire or cable 72 is secured to the articular processes 20, 22 by creating one or more knots 92 in the cable 72 that can withstand the pulling of the wire or cable by the articular processes. In another embodiment, one or both ends of the wire or cable are equipped with anchors that can withstand the movement of the implant. As shown in Figures 27A and 27B, one or both ends of the wire or cable 72 can be threaded, and as a result, a nut 94 can be tightened onto the wire or cable 72 to secure the wire or cable to the articular processes 20, 22. Figure 28 shows the attachment of a nut onto the threaded end of the cable. The threaded portion 96 of the wire or cable can be secured to the cable by pushing, crimping, or twisting the threaded portion 96 onto the cable 72. In one embodiment, the threaded portion 96 is made of titanium, titanium alloy, cobalt-chromium, stainless steel, or any combination thereof.
[0042] In one embodiment, the wire or cable has two threaded ends 96 for engaging with bone or cartilaginous tissue, i.e., one portion for each small articular surface of the facet joint.
[0043] In another embodiment shown in Figure 29, the wire or cable is secured to the articular process by a fastener ring 98. As shown in Figures 30A and 30B, the fastener ring 98 includes a ring 100, which has a central lumen 102 and a locking element that easily locks the ring 100 to the fastener member. The central lumen 102 is adapted to receive the insertion of a wire or cable into the central lumen 102. The illustrated locking element is in the form of a threaded lateral lumen 104 configured to receive a rotatable screw 106 at its proximal end 108, a threaded body 110, and a distal end 112. The threaded body 110 is complementary to the thread of the lateral lumen 104, so that as the screw 106 rotates at the distal end 112, the proximal end 108 of the screw 106 can move further into the central lumen 102, allowing further force to be applied to the wire or cable inserted through the central lumen 102. In one embodiment, applying force to the wire or cable can create a friction fit or mechanical engagement that withstands movement between the wire or cable and the fastener ring 98, thereby securing the wire or cable to the articulated projection 20 or 22. As shown in Figures 31-33, the distal end 112 of the screw 106 can be configured to engage with the wire or cable in any of a variety of designs, including, but not limited to, a blunt tip 114, a curved tip 116, and a perforating tip 118.
[0044] In another embodiment shown in Figures 34A and 34B, the wire or cable can be secured to the articular process by a fastener ring 120 in which radially inwardly biased projections 122 define a central lumen 124. The central lumen has a smaller cross-sectional shape than the cross-sectional shape of the wire or cable, but can be expanded when the inwardly biased projections 122 are bent away from each other, as shown in Figures 35A and 35B. The inwardly biased projections 122 apply additional force to the wire or cable within the central lumen 124 when the projections 122 are bent, thereby achieving a friction fit.
[0045] In one embodiment, a retaining portion is pre-formed at one end of the wire or cable fastener member to engage with an articular projection. The retaining portion can be a pre-formed ring, sphere, flared end, T-shaped end, or any of various shapes having a larger cross-sectional area than the rest of the wire or cable fastener member. The wire or cable fastener member in this configuration is adapted to engage with the articular projection by passing the free end of the wire or cable fastener member through the articular projection, thereby allowing the end with the pre-formed retaining portion to engage with the articular projection.
[0046] In one embodiment, a wire or cable fastener member is fixed to the articular processes with sufficient slack or length between the fixed ends or between the implant and one fixed end, so that the two articular processes are not fixed in a fixed position relative to each other and remain capable of performing movements such as contraction, extension, lateral contraction, and / or rotation. In one embodiment, the fastener member includes, but is not limited to, a cable of a braided polymer including a braided polymer such as PEEK or PEKK, or a cable of 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 motion in its facet joint. The cable has a first portion capable of engaging with the implant at the fastener joint portion to restrict movement.
[0047] In one embodiment shown in Figure 36A, the fastener member comprises a screw or bolt 126 having a proximal end 128, a body 130, and a distal end 132. The distal end 132 of the screw or bolt is capable of forming a mechanical mating with a complementary fastener joint 134 on the implant or spacer 136. Typically, the distal end 132 has threads, but other configurations may be used to form the mechanical mating. The complementary fastener joint 134 on the implant 136 may be a threaded through-hole or a hole with a closed end. The proximal end 128 of the screw or bolt 126 has a hexagonal or other type of joint known in the art, into which a rotary tool can be engaged to operate the screw or bolt 126. The body of the screw or bolt 126 is long enough to span at least the length of the hole or conduit made through the articular projection to secure the implant. In Figure 36B, the fastener member further comprises a pivotable washer 127 having a pivot surface 129 that articulates with the proximal end 128 of the screw 126. In one embodiment, the pivotable washer 127 can be positioned in various locations relative to the screw 126, providing better surface area contact between the screw 126 and the bone.
[0048] Figure 37 is a cross-sectional view of an intervertebral joint 28 in which a spacer 136 is bolted to one articular process 20 of the intervertebral joint 28. The position of the spacer 136 is fixed relative to one articular surface 24 of the joint 28, but spacing and movement are achieved on the other articular surface 26 relative to the spacer 136. In embodiments including the two-part implant shown in Figures 38 and 39, each disc may have its own screw or bolt fastener member. Figure 38 shows a flat two-part implant 138, and Figure 39 shows a curved two-part implant 140.
[0049] In some embodiments shown in Figures 40A to 41B, the fastener member is integrated with or attached to the implant and includes a projection 142 adapted to engage with an adjacent articular process or surrounding tissue from the implant 144. In one embodiment, the projection includes at least one nail 142 or hook protruding from one side of the implant 144. In one embodiment, the nail 142 or hook may be ribbed, barbed, or threaded to withstand separation after insertion into bone or tissue. Figure 42 shows the implant 144 of Figure 40A engaged with the articular surface 24 of the facet joint 28. In one embodiment, including the two-part implant 146 shown in Figure 43, each disc 148 may have its own projection fastener member 142. In some embodiments shown in Figure 44, the implant 152 is provided with two or more projections 150. Figure 45 shows the implant of Figure 44 positioned within the facet joint 28. The projection 150 can be angled relative to the implant 152 to withstand removal due to joint movement.
[0050] Figures 46A–47B show embodiments in which the fastener member includes a projection 154 extending laterally from the side of the implant 156, and is adapted to engage with the soft tissue surrounding the facet joint rather than a bony or cartilaginous articular process. In one example, the implant in Figure 46 may also be inserted into the facet joint through an incision made in the joint capsule, but the integrity of the joint capsule on the opposite side of the incision is maintained and used as an anchoring site for the implant. The orientation of the projection can be fixed as in Figure 44 or it can be flexible. Figure 47 shows a flexible tether, such as a wire 158, whose proximal end 160 is embedded in the implant or otherwise attached to the implant, and which can have one or more antiprongs attached to its distal end 162. The flexible projection can provide further choice of soft tissue anchoring sites for the implant.
[0051] In one embodiment, the joint capsule is closed after the placement of the implant. Closure can be performed using adhesive, sutures, stapling, or any of the various closure mechanisms known in the art.
[0052] Figures 48A to 48C show an implant 260 according to one embodiment. Specifically, Figure 48A is a front perspective view of the implant 260, Figure 48B is a side view of the implant 260, and Figure 48C is a cross-sectional side view of the implant 260. The implant 260 can be similar to the implant 160 described above and may have similar elements and applications. For example, the fastener joint portion 266 of the implant 260 can be similar to the fastener joint portion 166 of the implant 160. The implant 260 includes a concave first surface 262, a convex second surface 264, a centrally located circular fastener joint portion 266, and four irregularly shaped material joining portions 268.
[0053] Figures 49-51 show posterior perspective views of a portion of the spine in a method for fusing adjacent vertebrae using implant 260 according to one embodiment. As shown in Figure 49, implant 260 and fastener member 280 can be used to fuse vertebrae V1 and vertebrae V2 via the inferior articular process IAP1A of vertebrae V1 and the superior articular process SAP2A of vertebrae V2. Any fastener member can include any biocompatible material, such as stainless steel, titanium, PEEK, nylon, etc. Also as shown in Figure 49, implant 360 and fastener member 380 are used to fuse vertebrae V1 and vertebrae V2 via the inferior articular process IAP1B of vertebrae V1 and the superior articular process SAP2B of vertebrae V2. In some embodiments, vertebrae V1 and / or vertebrae V2 are fused using only one of implant 260 or implant 360. In some such embodiments, one of the implants 260 and fastener member 280 or implant 360 and fastener member 380 can be used to stabilize vertebrae V1 and / or vertebrae V2 via one of the inferior articular process IAP1A of vertebrae V1 and superior articular process SAP2A of vertebrae V2 or inferior articular process IAP1B of vertebrae V1 and superior articular process SAP2B of vertebrae V2. In other such embodiments, one of the fastener members 280 or fastener member 380 can be used to stabilize vertebrae V1 and / or vertebrae V2 via both the inferior articular process IAP1A of vertebrae V1 and superior articular process SAP2A of vertebrae V2 (for example, in combination with implant 260) and the inferior articular process IAP1B of vertebrae V1 and superior articular process SAP2B of vertebrae V2 (for example, in combination with implant 360).
[0054] Figure 52 shows a flowchart illustrating a method 6000 of using implant 260 having a fastener member 280 and / or implant 360 having a fastener member 380. Before using implant 260 and / or implant 360, the patient can be prepared for surgery in 6002. Several examples of preparation for surgery are described in U.S. Patent Application No. 12 / 859,009, “Vertebral Facet Joint Drill and Method of Use” (referred to as the “'009 Application”), filed August 18, 2010. That Application is incorporated herein by reference in its entirety. In addition to those procedures described in the '009 Application, in some embodiments, the surgical procedure may include direct visualization of the vertebra to be stabilized. In other words, the physician can perform the procedure without using fluoroscopy. This direct visualization is possible because the incision required for implant placement is small, for example less than about 25 mm, and the implant can be easily placed and introduced. In some embodiments, the surgical procedure used may include creating an opening in body tissue substantially equidistant between the first articular process of the first vertebra and the second articular process of the first vertebra. A cannula (not shown) can be inserted into this opening, and the proximal end of the cannula can be positioned near the superior articular process SAP2A of vertebra V2. In some embodiments, the surgical procedure may include preparing a region near and / or around vertebra V2 by removing all or part of ligaments, cartilage, and / or other tissues, for example. For example, a region near and / or around the facet joint may be prepared by removing all or part of the facet joint capsule.
[0055] In 6004, a drill or other device can be used to form lumens in the superior articular process SAP2A of vertebra V2 and the inferior articular process IAP1A of vertebra V1. Specifically, a drill can be used to form lumens in the articular surface of the superior articular process SAP2A of vertebra V2 and the articular surface of the inferior articular process IAP1A of vertebra V1. Methods and devices for forming lumens within vertebrae are described in application '009. In 6006, portions of the surface of the articular surfaces of SAP2A and IAP1A can be prepared for fusion. Specifically, portions of the surface of the articular surfaces can be ground, scratched, roughened, polished, etc., so that the surface of the articular surface adheres better to any material to aid in fusion and / or so that it fuses more easily with the implant in other ways. The fastener member 280 can be positioned within the cannula and advanced through the cannula until the proximal end 282 of the fastener member 280 is positioned near the lumen of the superior articular process SAP2A of vertebra V2. In some embodiments, the proximal end of the cannula may have a bend that directs the proximal end 282 of the fastener member 280 into the lumen of the superior articular process SAP2A of vertebra V2. 6008 The proximal end 282 of the fastener member 280 is inserted into the lumen of the superior articular process SAP2A of vertebra V2. 6010 Material can be placed in the material bonding portion 268 of the implant 260. In some embodiments, the implant 260 may have material placed in the material bonding portion 268 before the surgical procedure, for example, during the manufacture of the implant 260, after the manufacture, and / or as part of a kit. 6012 The implant 260 is inserted between the superior articular process SAP2A of vertebra V2 and the inferior articular process IAP1A of vertebra V1.
[0056] In 6014, the proximal end 282 of the fastener member 280 is inserted into the lumen of the inferior articular process IAP1A of vertebra V1. In 6016, the fastener member can be secured. The fastener member 280 can be secured based on the type of fastener member used. For example, securing a fastener member similar to a flexible fastening band, as shown in Figures 49-51, may include inserting the proximal end 282 into the fastening mechanism of the distal end 284 of the fastener member 280, and advancing the proximal end 282 through the fastening mechanism to secure the fastening mechanism. In other embodiments, the fastener member can be secured by tying a first part of the fastener member to a second part of the fastener member, screwing the fastener member into a threaded fastener joint, screwing the fastener onto the threaded end of the fastener member positioned through the fastener joint, or a combination of the above. In some embodiments, the implant 260 can be positioned before inserting the proximal end of the fastener member 280 into the lumen of the superior articular process SAP2A of vertebra V2. The cannula can be removed and / or reinserted at various points in Method 6000, including, for example, after inserting the proximal end 282 of the fastener member 280 into the lumen formed in the superior articular process SAP2A of vertebra V2, after stabilizing vertebra V1 and / or vertebra V2, or at other points in Method 6000.
[0057] After the fastener member is fixed, the superior articular process SAP2A of vertebra V2 can fuse with the inferior articular process IAP1A of vertebra V1. The fusion may include bone material from the superior articular process SAP2A of vertebra V2, bone material from the inferior articular process IAP1A of vertebra V1, and one or more materials that fuse the superior articular process SAP2A of vertebra V2 to the inferior articular process IAP1A of vertebra V1 through the material bonding portion 268. In some embodiments, the fastener member 280 is not removed after the superior articular process SAP2A of vertebra V2 fuses with the inferior articular process IAP1A of vertebra V1. In some other embodiments, all or part of the fastener member 280 may be removed after the superior articular process SAP2A of vertebra V2 fuses with the inferior articular process IAP1A of vertebra V1. In other embodiments, the fastener member 280 may be removed after the fusion of the superior articular process SAP2A of vertebra V2 and the inferior articular process IAP1A of vertebra V1 has begun but before it has ended.
[0058] For example, in addition to the fastener members described above, such as fastener member 280, Figures 53 to 65 show fastener members according to other embodiments.
[0059] Figure 53 shows a diagram of a fastener member 480. The fastener member 480 can be a flexible fastening band ("band") 480. Figure 54 shows a diagram of a portion of the band 480, and the band 480 can be similar to the band 280 described above and may include similar components. For example, the band 480 includes a proximal end 482, a first portion 484, a second portion 486, and a distal end 488 including a fastening mechanism 490. In contrast to the band 280, the band 480 includes a cylindrical second portion 486, each including a third portion 489. As shown in Figures 53-54, the third portion 489 is substantially the same shape as the first portion 482. As shown in Figures 53 and 54, the band 480 includes a rack gear 487 and a gear 494. Each gear 494 can be wedge-shaped so as to allow the ratchet of the fastening mechanism 490 to be displaced in only one direction. In some embodiments, the gear 494 may also be of other shapes, such as a block.
[0060] Figure 55 is a side view of the fastener member 840, and Figure 56 is a top view. According to another embodiment, the fastener member 840 may be a flexible fastening band ("band") 580. The band 840 may be similar to the bands 280 and 480 described above and may include similar components. For example, the band 840 includes a proximal end 842, a first part 844 including a rack gear 847, a second part 846, and a distal end 848 including a fastening mechanism 850 and a ratchet 862. In contrast to the rack gear 487, the cross-sectional area of each gear 864 of the rack gear 847 is rectangular rather than wedge-shaped. Furthermore, in contrast to the first part 282, the first part 844 is cylindrical rather than cubic. Thus, the lumen 866 of the fastening mechanism 850 is cylindrical. The band according to this embodiment may be particularly useful in introducing a single band to stabilize adjacent vertebrae. In this way, the second portion can be positioned within the lumen of the first articular process of the first vertebra, and a portion of the first portion can be positioned within the lumen of the second articular process of the first vertebra. In these embodiments, both the band portion within the first articular process of the first vertebra and the band portion within the second articular process of the first vertebra can have substantially the same shape as the lumen within the first articular process of the first vertebra and the lumen within the second articular process of the first vertebra. In this way, as described above in relation to the band 480, the amount of open space within the lumen can be minimized, the amount of surface area of the first and / or second portions of the band in contact with the lumen can be increased, and the movement of the first and / or second vertebra can be reduced or minimized. Furthermore, when movement of the first and / or second vertebra occurs, the force acting on the band can be more evenly distributed across the entire first and / or second portion because at least the surface area of the band in contact with the lumen is increased.
[0061] Figure 57 is a side view of the fastener member 940. According to one embodiment, the fastener member 940 can be a flexible fastening band ("band") 940. The band 940 can be similar to the bands 280, 480, and 840 described above and may include similar components. For example, the band 840 includes a proximal end 942, a first portion 944 including a rack gear 947, a second portion 946, and a distal end 948 including a fastening mechanism 950. Similar to the rack gear 847, the cross-sectional area of each gear 964 of the rack gear 947 is rectangular. In contrast to the rack gear 847, each gear 964 extends not only to a portion of the circumference of the first portion 944, but to the entire circumference of the first portion 944. Furthermore, similar to the first portion 844, but in contrast to the first portion 282, the first portion 944 is cylindrical rather than cubic. Thus, the lumen 966 of the clamping mechanism 950 is cylindrical in shape. Bands according to this embodiment can be particularly useful for introductions where movement and repositioning of the band after transplantation may be difficult. In this way, since the gears are located around the entire circumference of the first and / or second parts, the first and / or second parts can enter the clamping mechanism in any radial orientation and still engage with the ratchet.
[0062] Figures 58-62 are diagrams of the fastener member 780. According to another embodiment, the fastener member 780 may be a flexible fastening band ("band") 780. Figure 58 is a perspective view of the band 780, and Figure 59 is a cross-sectional side view. Figure 60 is a cross-sectional view of the band 780 cut along line XXIII. Figure 61 is a cross-sectional top view of the band 780 in a first configuration, and Figure 62 is a cross-sectional top view of the band 780 in a second configuration. The band 780 may be similar to the bands 280 and 480 described above and may include similar components. For example, the band 780 includes a proximal end (not shown), a first portion 784 (see Figure 59) including a rack gear 787, a second portion 786, and a distal end 788 including a fastening mechanism 790 and a ratchet 792. In contrast to bands 280 and 480, band 780 includes a reinforcing piece 772.
[0063] The reinforcing piece 772 may include any of the materials described above with respect to the fastener member. In some embodiments, the reinforcing piece 772 may include a material stronger than the second portion 786 and / or the first portion 784, for example, the first portion 784 and the second portion 786 may include PEEK and the reinforcing piece 772 may include titanium. As shown in Figure 59, the reinforcing piece 772 may be positioned along substantially the entire length of the second portion 786 within the band 780, and a portion of the reinforcing piece 772 may be positioned within the distal end 788. In some embodiments, the length of the reinforcing piece may be along at least a portion of the length of the second portion 786 and / or the first portion 784, but may not reach the distal end. In some embodiments, the reinforcing piece 772 may be positioned only within the second portion 786. The reinforcing piece 772 may have a length of a first dimension (length), a length of a second dimension (width), and a length of a third dimension (height). As described herein, the reinforcing piece may have different shapes, thereby changing the number of dimensions it includes.
[0064] The reinforcing piece can be molded within the band. In other words, in embodiments where the first portion, second portion, and / or distal end are made of a moldable material, the reinforcing piece can be placed in a mold, and the moldable material can be injected around the reinforcing piece in the mold, or otherwise placed. In other embodiments, each portion of the band around the reinforcing piece (e.g., the proximal end, first portion, second portion, third portion, and / or distal end) can have an upper half and a lower half, and the upper and lower halves can be positioned around the reinforcing piece and sealed, respectively. As shown in Figure 61, the reinforcing piece 772 includes support members 774. Figure 61 shows a reinforcing piece 772 including four support members 774, but in some embodiments, the number of support members 774 used can also be changed. The support members 774 can maintain the position of the reinforcing piece 772 during the molding and / or assembly process of the band 780. As shown in Figure 62, the support members 774 are removed before the band 780 is used.
[0065] As shown in Figure 60, the reinforcing piece 772 can have a substantially uniform cubic shape. In other embodiments, the reinforcing piece 772 can have other shapes. The shape of the reinforcing piece can be selected depending on the desired bending and / or torsional properties of the material selected. For example, using a substantially planar cubic shape can further increase bending strength but not much torsional strength; using a cylindrical shape can increase bending strength but not much torsional strength; and using a substantially square and / or tubular cubic shape can increase both bending and torsion. Any shape can be selected to achieve the desired bending and torsional strength. Combinations of material and shape can also be considered. For example, the desired torsional strength can be obtained by combining a material with higher torsional strength with a shape with lower torsional strength. As shown in Figures 61 and 62, the reinforcing piece 772 includes holes 776 distributed along the length of a first dimension. Figures 61 and 62 show a band 780 with many holes 776, but in some embodiments, the number of holes 776 used can also be changed. Figures 61 and 62 show holes 776 distributed substantially equally along the length of a first dimension, but in some embodiments, these holes can be distributed in different shapes or along different dimensions, depending on the shape and / or material selected, and / or whether the reinforcing piece is solid or hollow. The holes 776 can be configured to provide additional strength to the band 780 while reducing the weight of the reinforcing piece 772. The holes 776 can be circular, elliptical, square, or any other shape.
[0066] Figure 63 is an exploded view of the fastener member 880, Figure 64 is a perspective view, and Figure 65 is a cross-sectional view. According to another embodiment, the fastener member 880 may be a flexible fastening band ("band") 880. The band 880 may be similar to the bands 280 and 480 described above and may include similar components. For example, the band 880 includes a proximal end 882, a first portion 884, a second portion 886 including a rack gear 887, a distal end 888, a fastening mechanism 890, and a ratchet 892. In contrast to the bands 280 and 480, the fastening mechanism 890 of the band 880 is formed separately from the distal portion 888 of the band 880. Figures 63-65 show the second portion 886 of the band 880 having a substantially cubic shape, but in some embodiments, the second portion 886 may be substantially cylindrical or any other suitable shape discussed herein. As shown in Figures 64 and 65, the band 880 includes a rack gear 887 and a gear 894. Each gear 894 can be wedge-shaped so as to allow the ratchet 892 of the clamping mechanism 890 to be displaced in only one direction. In some embodiments, the gears 894 can also be other shapes such as blocks or any other suitable shapes discussed herein. As shown in Figures 63-65, the distal end 888 can be substantially circular in shape and may have a diameter greater than the width of the second portion 886. In other embodiments, the distal portion 888 can have other shapes, such as elliptical, square, or the like.
[0067] For example, in addition to the above-mentioned implants such as implant 160, Figures 66 to 81 show implants according to other embodiments.
[0068] Figures 66-69 show an implant 1060 according to one embodiment. Specifically, Figure 66 is a front perspective view of implant 1060, Figure 67 is a rear perspective view of implant 1060, Figure 68 is a side view of implant 1060, and Figure 69 is a cross-sectional side view of implant 1060. Implant 1060 can be similar to implants 160 and 260 described above and may have similar elements and applications. For example, the fastener joint portion 1066 of implant 1060 can be similar to the fastener joint portion 166 of implant 160 and can be similar to the fastener joint portion 266 of implant 260. Implant 1060 includes a concave first surface 1062, a convex second surface 1064, a substantially circular fastener joint portion 1066 located in the center, and six substantially circular material joint portions 1068.
[0069] Figures 70-73 show an implant 1160 according to one embodiment. Specifically, Figure 70 is a front perspective view of implant 1160, Figure 71 is a rear perspective view of implant 1160, Figure 72 is a side view of implant 1160, and Figure 73 is a cross-sectional side view of implant 1160. Implant 1160 can be similar to implants 160 and 260 described above and may have similar elements and applications. For example, the fastener joint portion 1166 of implant 1160 can be similar to the fastener joint portion 166 of implant 160 and can be similar to the fastener joint portion 266 of implant 260. Implant 1160 includes a concave first surface 1162, a convex second surface 1164, a substantially circular fastener joint portion 1166 located in the center, and a material joint portion 1168 in the shape of a five-cornered square.
[0070] Figures 74-77 show an implant 1260 according to one embodiment. Specifically, Figure 74 is a front perspective view of implant 1260, Figure 75 is a rear perspective view of implant 1260, Figure 76 is a side view of implant 1260, and Figure 77 is a cross-sectional side view of implant 1260. Implant 1260 can be similar to implants 160 and 260 described above and may have similar elements and applications. For example, the fastener joint portion 1266 of implant 1260 can be similar to the fastener joint portion 166 of implant 160 and can be similar to the fastener joint portion 266 of implant 260. Implant 1260 includes a concave first surface 1262, a convex second surface 1264, a substantially circular fastener joint portion 1266 located in the center, and several substantially circular material joint portions 1268 of varying dimensions.
[0071] Figures 78-81 show an implant 1360 according to one embodiment. Specifically, Figure 78 is a front perspective view of implant 1360, Figure 79 is a rear perspective view of implant 1360, Figure 80 is a side view of implant 1360, and Figure 81 is a cross-sectional side view of implant 1360. Implant 1360 can be similar to implants 160 and 260 described above and may have similar elements and applications. For example, the fastener joint portion 1366 of implant 1360 can be similar to the fastener joint portion 166 of implant 160 and can be similar to the fastener joint portion 266 of implant 260. Implant 1360 includes a concave first surface 1362, a convex second surface 1364, a substantially circular fastener joint portion 1366 located in the center, four irregularly shaped material joining portions 1368, and four protrusions 1369. Each of the four projections 1369 can engage with the bone portion to prevent or reduce movement of the implant 1360, such as rotation of the implant 1360, longitudinal movement of the implant 1360, and / or lateral movement of the implant 1360, or can be otherwise drilled, latched, locked, or hooked into or on the bone portion. In this way, the projections 1369 can fix the implant 1360 to the bone portion during the fusion procedure. In some embodiments, the projections 1369 can substantially maintain the position of the implant 1360 after the fastener member has been removed.
[0072] While various embodiments have been described above, it should be understood that these embodiments are presented for illustrative purposes only and not limiting, and that various modifications can be made to the shape and details. For example, although the above description refers to the stabilization of a vertebra, the fastener members and implants described herein can also be used to stabilize other bones, such as the sternum and / or ribs. In another example, the fastener member can be used to stabilize and / or fix an intramedullary (IM) nail or nail. For example, the fastener member can be used at different longitudinal positions along the IM nail or nail, and the fastener member can be used to connect adjacent bone portions to the IM nail or nail. In such a situation, a given fastener member can fix a first bone portion, an IM nail or nail, and a second bone portion, all of which are positioned between the distal and proximal portions of the fastener member. In yet another example, the fastener member can be used to stabilize and / or fix a bone fragment. While various embodiments have been described in relation to natural bone spaces (e.g., the space between the inferior and superior articular processes), in other embodiments, the bone spaces may be artificial (e.g., sternal incision during cardiac procedures) and / or due to injury (e.g., fracture).
[0073] While the above methods demonstrate that certain events occur in a specific order, the order of these events can be modified. Furthermore, these specific events can be performed simultaneously in parallel processing, where possible, as well as sequentially, as described above. Any part of the apparatus and / or method described herein can be combined in any combination, except for mutually exclusive combinations. Embodiments described herein may include various combinations and / or subcombinations of the functions, components, and / or features of the different embodiments described. For example, Figures 54 and 56 show a band 580 including a single ratchet 592, and Figure 57 shows a band 680 including a single ratchet 692, but in some embodiments, any of these fastener members may include any number of ratchets. Similarly, any of the fastener members may include a reinforcing piece and / or implant. Furthermore, even if one embodiment of an implant is shown to be used with one embodiment of a fastener member, in other embodiments, the implant and fastener member may be used with other implants and fastener members. For example, Figure 28 shows that the implant is secured with a threaded wire, but in some embodiments, a flexible fastening band may be used.
[0074] Small articular surface reinforcement device
[0075] The flexible clamping band can be used alone or in conjunction with the embodiments of the articular surface implant described above, but in some applications, it is desirable to reinforce the band's fixation where it emerges from the bone of the articular process. This prevents tearing by relieving pressure on the surface of the articular process and allows the clamping band and / or clamping mechanism to retain it in place of the bone. Alternatively, the articular surface reinforcement can be secured to the vertebra using a fastener, which prevents the band from moving and restricts movement at the facet joint, thereby improving fusion.
[0076] Figure 82 shows one configuration of the microarticular surface reinforcement device 1400. The microarticular surface reinforcement device 1400 in the illustrated configuration may include a proximal surface 1402, a distal surface 1406, and an anti-luminal surface 1404 extending from the proximal surface 1402 to the distal surface 1406. In a particular configuration, the proximal surface 1402 and / or the distal surface 1406 may be curved and / or malleable to conform to the shape of the microarticular surface. The microarticular surface reinforcement device 1400 may include a luminal surface 1410 surrounding a central lumen 1420. The luminal surface 1410 may extend from the proximal surface 1402 to the distal surface 1406. The central lumen 1420 may be located in the center of the device 1400. As will be described later, the luminal surface 1410 may include a fastener joint portion (not shown) in a particular embodiment.
[0077] As described below, the articular surface reinforcement devices described herein can be used in combination with the implants shown in Figures 8A to 81A and / or other implants described herein. The articular surface reinforcement device 1400 can also be used in combination with the fastener members shown in Figures 20 to 65 and / or other fastener members described herein. Therefore, the fastener member 1480 shown in Figure 84 can refer to any fastener member described herein, the fastener member 1580 shown in Figure 87 can refer to any fastener member described herein, and the fastener members 1680 and 1680A shown in Figure 89 can refer to any fastener member described herein.
[0078] As shown in Figure 82, at least a portion of one surface of the articular surface reinforcement device 1400 may include a rough surface. The rough surface can be advantageous when in contact with a bone or tissue surface because it can prevent the articular surface reinforcement device 1400 from sliding or moving relative to the bone. The rough surface can help maintain the articular surface reinforcement device 1400 and the fastener member 1480 (see Figure 83) when engaged with the tissue or bone.
[0079] The rough surface may include at least one projection 1416. As shown in Figure 82, the microarticular surface reinforcement device 1400 may have multiple projections 1416. The multiple projections 1416 may extend from the distal surface 1406 and may include sharp edges or tips. The multiple projections 1416 may also extend between the anti-luminal surface 1404 and the luminal surface 1410, or, in certain embodiments, may extend only along a portion of that region. In some embodiments, the multiple projections 1416 include at least one nail, barb, wedge, or hook protruding from at least a portion of one surface of the microarticular surface reinforcement device 1400. In some embodiments, the multiple projections 1416 may be ribbed, barbed, or threaded to withstand separation after insertion into bone or tissue. The multiple projections 1416 may have different shapes from each other or may have a uniform shape. A portion of the surface of the multiple projections 1416 may be porous. The porous surface can be created by any of the various methods known in the art, such as applying sintered beads or spraying plasma onto the surface of the multiple protrusions 1416. The porous surface allows bone to grow into or adhere to the surface of the multiple protrusions 1416, thereby enabling the multiple protrusions 1416 and the articular surface reinforcement device 1400 to be fixed to the bone. In certain embodiments, other surfaces of the articular surface reinforcement device 1400 can be made porous. In certain embodiments, an adhesive or sealant, such as cyanoacrylate, polymethyl methacrylate, or other adhesives known in the art, is used to bond at least one surface of the articular surface reinforcement device 1400 to the surface of bone or tissue. In some embodiments, an adhesive or sealant is used to bond the distal surface 1406 of the articular surface reinforcement device 1400 to the surface of the articular surface.
[0080] The small articular surface reinforcement device 1400 may include a row of multiple protrusions 1416, or it may include multiple rows of multiple protrusions 1416. The small articular surface reinforcement device 1400 may also include multiple protrusions 1416 arranged in an irregular order or orientation.
[0081] The anti-luminal surface 1404 of the small articular surface reinforcement device 1400 may include a substantially circular cross-section (cylindrical), as shown in Figure 82. The anti-luminal surface 1404 may have other cross-sectional shapes, including but not limited to circular (cylindrical), hexagonal, rectangular (cubic), square, and elliptical, and / or a combination of curved surfaces, flat surfaces, and / or partial shapes. In certain embodiments, the anti-luminal surface 1404 may be made to match the shape of the insertion device.
[0082] In the illustrated embodiment of Figure 82, the central lumen 1420 and the lumen surface 1410 can be circular (cylindrical). The central lumen 1420 and the lumen surface 1410 can have other cross-sectional shapes, including but not limited to hexagonal, rectangular (cubic), square, and elliptical, and / or curved surfaces, flat surfaces, and / or combinations of partial shapes. The central lumen 1420 and the lumen surface 1410 may be shaped to match the shape of the insertion device. In certain embodiments, the central lumen 1420 and the lumen surface 1410 can be shaped based on the shape of a fastener member (not shown) (for example, the central lumen and the lumen surface can have a cross-sectional shape similar to that of a fastener member extending through the central lumen). In certain embodiments, the central lumen 1420 and the lumen surface 1410 may include a substantially smooth inner surface so that the fastener member 1480 can easily pass through. In other embodiments, the central lumen 1420 and the lumen surface 1410 may include a threaded inner surface so that the fastener member 1480 can be screwed into the central lumen 1420.
[0083] The central lumen 1420 and lumen surface 1410 may be configured to conform to the shape of the lumen formed in the articular process during use. The central lumen 1420 and lumen surface 1410 may be smaller than the lumen formed in the articular process during use. In this embodiment, the small articular surface reinforcement device 1400 can reduce stress on the outer surface of the bone lumen. The central lumen 1420 and lumen surface 1410 may be larger than the lumen formed in the articular process during use. In this embodiment, the small articular surface reinforcement device 1400 can contact a larger surface area of the small articular surface, thereby distributing the force of the fastener member.
[0084] The proximal surface 1402 may have a functional portion for mechanically mating with an insertion device, the functional portion may include grooves and / or projections configured to mating with corresponding grooves and / or projections of the insertion device. The proximal surface 1402 may also have a functional portion (e.g., a groove or recess) for mechanically mating with a portion of the fastener member 1480 (shown in Figure 84). The functional portion for mechanically mating with a portion of the fastener member can increase the stability of the system and the resistance to movement of the system's components.
[0085] The diameter of the small articular surface reinforcement device 1400 can be in the range of 2 mm to 20 mm, or in the range of 4 mm to 15 mm. The diameter of the central lumen 1420 can be in the range of 0.5 mm to 10 mm, or in the range of 1 mm to 7 mm.
[0086] Figures 83 to 84 show a posterior perspective view of a portion of the spine in a method of fusing adjacent vertebrae using an embodiment of the articular surface reinforcement device 1400 shown in Figure 82. The method may include using an implant introduced to restore the space between the articular surfaces of the superior articular process of the first vertebra and the inferior articular process of the adjacent vertebra.
[0087] In one method of use, a drill or other device can be used to form lumens in the superior articular process SAP2A of vertebra V2 and the inferior articular process IAP1A of vertebra V1. A portion of the surface of the articular surface of SAP2A and a portion of the surface of the articular surface of IAP1A can be prepared for fusion. For example, a portion of the surface of the articular surface can be ground, scratched, roughened, polished, etc., so that the surface of the articular surface adheres better to any material to aid in fusion, and / or otherwise fuses more easily with an implant located within the facet joint.
[0088] Figure 83 illustrates a microarticular surface reinforcement device 1400 placed on the posterior-facing outer surface of the inferior articular process IAP1A on the left side of the superior vertebra V1. In other embodiments, and / or additionally, the microarticular surface reinforcement device may be placed on the surface of the microarticular surface of SAP2A. The microarticular surface reinforcement device 1400 may be placed after the lumen has been formed in the articular process. In another configuration, the microarticular surface reinforcement device 1400 may be placed before the lumen is formed in the articular process. In this method, the microarticular surface reinforcement device 1400 can function as a guide for perforating the lumen. The microarticular surface reinforcement device 1400 may be placed after or before preparation for fusion. The insertion device may be left on the microarticular surface reinforcement device 1400 during the step of forming the lumen and / or the step of preparing for fusion.
[0089] As shown in Figure 84, the small articular surface reinforcement device 1400 and the fastener member 1480 can be used to fuse vertebrae V1 and vertebrae V2 via the inferior articular process IAP1A of vertebrae V1 and the superior articular process SAP2A of vertebrae V2. In some embodiments, at least one implant (not shown in Figure 84) is used together with the fastener member 1480 to fuse vertebrae V1 and vertebrae V2. Figure 84 shows the fusion of the inferior articular process IAP1A of vertebrae V1 and the superior articular process SAP2A of vertebrae V2. However, the inferior articular process IAP1B of vertebrae V1 can also be fused to the superior articular process SAP2B of vertebrae V2.
[0090] In one method of use, the fastener member 1480 can be positioned within the cannula and advanced through the cannula. The proximal end of the fastener member 1480 can then be inserted into the central lumen 1420 of the articular surface reinforcement device 1400. The proximal end of the fastener member 1480 can be adjacent to and / or abut against the lumen surface 1410. The proximal end of the fastener member 1480 can then be inserted into the lumen of the inferior articular process IAP1A of vertebra V1. The proximal end of the fastener member 1480 can be advanced until it is positioned near the lumen of the superior articular process SAP2A of vertebra V2. In some embodiments, the proximal end of the cannula may have a bend to direct the proximal end of the fastener member 1480 into the lumen of the superior articular process SAP2A of vertebra V2. The proximal end of the fastener member 1480 can then be inserted into the lumen of the superior articular process SAP2A of vertebra V2. The implant can be inserted between the superior articular process SAP2A of vertebra V2 and the inferior articular process IAP1A of vertebra V1. In some embodiments, the implant can be positioned before inserting the proximal end of the fastener member 1480 into the lumen of the superior articular process SAP2A of vertebra V2. The cannula can be removed and / or reinserted at various points in the procedure, including, for example, after inserting the proximal end of the fastener member 1480 into the lumen formed in the superior articular process SAP2A of vertebra V2, after stabilizing vertebra V1 and / or vertebra V2, or at other points in the procedure.
[0091] The fastener member 1480 can be fixed in place. The fastener member 1480 can be fixed in place depending on the type of fastener member used. For example, fixing a fastener member 1480 having the characteristics of the fastener member shown in Figures 49-51 may involve several steps, namely, inserting the proximal end of the fastener member 1480 into a fastening mechanism 1484 located at the distal end of the fastener member 1480; fixing one end of the fastener member 1480 to the opposite end of the fastener member 1480; fixing the proximal end of the fastener member 1480 to the distal end of the fastener member 1480; and / or advancing the proximal end of the fastener member 1480 through the fastening mechanism 1484. In other embodiments, the fastener member 1480 can be fixed by tying a first portion of the fastener member to a second portion of the fastener member, by forming knots at the first and second ends, by screwing the fastener member into a threaded central cavity, by screwing a fastener onto a threaded end of the fastener member positioned through a threaded central cavity, by including an elongated portion at the end of the fastener member, and / or by a combination of the above. The fastener member 1480 can be fixed to hold a small articular surface reinforcement device 1400. The small articular surface reinforcement device 1400 is held in a loop of the fastener member 1480 or other defined portion. The small articular surface reinforcement device 1400 may remain movable along a portion of the defined portion after the fastener member 1480 is fixed. In some embodiments, the small articular surface reinforcement device 1400 is fixed so that it cannot move along a portion of the defined portion after the fastener member 1480 is fixed.
[0092] Figure 84 illustrates an assembly system including a small articular surface reinforcement device 1400 and a fastener member 1480. The assembly system is implanted on the left facet joint 1490 between the upper vertebra V1 and the lower vertebra V2. The left facet joint 1490 can be compressed by the assembly system, thereby bringing the two small articular surfaces closer together and juxtaposing them. This compression is in contrast to the unfixed right facet joint 1492.
[0093] A second articular surface reinforcement device 1400 with or without a second implant, and a second fastener member 1480, may be implanted in the right facet joint 1492 in accordance with the method described above with respect to the left facet joint 1490. Implantation of the second articular surface reinforcement device 1400 and the second fastener can improve stability. The second articular surface reinforcement device 1400 with or without a second implant and the second fastener member 1480 may also be implanted at other levels of the spine. Multiple articular surface reinforcement devices 1400 with or without implants and multiple fastener members 1480 may also be implanted at other levels of the spine at various locations on the spine. In some embodiments, the same and / or similar fixation methods, the same fastener member 1480, the same implant, and / or the same articular surface reinforcement device 1400 may be used at different locations. In other embodiments, different fixation methods, different fastener members 1480, different implants, and / or different articular surface reinforcement devices 1400 may be used at different locations.
[0094] Figure 85 shows another embodiment of the small articular surface reinforcement device 1500. In the illustrated configuration, the small articular surface reinforcement device 1500 has a lower end 1502 and an upper end 1504. The small articular surface reinforcement device 1500 has a first fixing portion 1530 located toward the lower end 1502 and a second fixing portion 1540 located toward the upper end 1504. The first fixing portion 1530 and the second fixing portion 1540 can be connected to each other by a central portion 1510.
[0095] The first fixing portion 1530 can be configured for placement on the outer surface of the articular surface. The first fixing portion 1530 may include a lumen 1506 surrounded by a lumen surface 1511. The lumen 1506 and lumen surface 1511 can be substantially circular (cylindrical), as shown in the illustrated embodiment. The lumen 1506 can have other cross-sectional shapes, including but not limited to circular (cylindrical), hexagonal, rectangular (cubic), square, and elliptical, and / or a combination of curved surfaces, flat surfaces and / or partial shapes. The lumen 1506 and lumen surface 1511 can be shaped based on the shape of the fastener member 1580 (for example, having a shape complementary to or similar to the outer shape of the portion of the fastener member 1580 extending through it). The lumen 1506 and lumen surface 1511 can also be matched to the shape of the insertion device. The lumen 1506 and the lumen surface 1511 may include a substantially smooth inner surface so that the fastener member 1580 can easily pass through. In other embodiments, the lumen 1506 and the lumen surface 1511 may include a threaded surface so that the fastener member can be screwed into the lumen 1506.
[0096] The first fixing portion 1530 may include one, two, three, or more lumens 1506 (as shown). One or more lumens 1506 may be the same shape or different shapes. The first fixing portion 1530 may include a row of lumens 1506, for example, the lumens 1506 may be aligned along an axis. In other arrangement configurations, the first fixing portion 1530 may include multiple rows of lumens 1506. The first fixing portion 1530 may include multiple lumens 1506 arranged in an irregular order or orientation. As described below, one or more lumens 1506 may be configured to receive one or more fastener members 1580 and / or one or more fasteners 1590.
[0097] The second fixation part 1540 can be configured for placement on a vertebral structure. The vertebral structure can be positioned away from or spaced apart from the outer surface of the articular surface. For example, in one placement configuration, the second fixation part 1540 can be configured for placement on the outer surface or base of the spinous process 1570: for a translaminar position, and / or for placement on the outer surface of the arch (i.e., the base of the spinous process).
[0098] The second fixing portion 1540 may include a lumen 1508 surrounded by a lumen surface 1521. The lumen 1508 and lumen surface 1521 can be circular (cylindrical). The lumen 1508 may have other cross-sectional shapes, including but not limited to hexagonal, rectangular (cubic), square, and elliptical, and / or a combination of curved surfaces, flat surfaces, and / or partial shapes. The lumen 1508 may be shaped based on the shape of the fastener member 1580 and / or fastener 1590. The lumen 1508 and lumen surface 1521 can be circular, hexagonal, rectangular (cubic), square, and elliptical, and / or a combination of curved surfaces, flat surfaces, and / or partial shapes. The lumen 1508 and lumen surface 1521 may also be shaped to match the shape of the insertion device. The lumen 1508 and the lumen surface 1521 may include a substantially smooth inner surface so that the fastener members 1580 and / or fastener 1590 can easily pass through, or the lumen 1508 may include a threaded surface so that the fastener members 1580 and / or fastener 1590 can be screwed into the lumen 1508.
[0099] The second fixation portion 1540 may include one, two (as shown), three, or more lumens 1508. Additional lumens 1508 can increase fixation security and reduce torsional forces.
[0100] The lumen 1508 can be the same or different in shape. The two lumen 1508 shown in Figure 85 are substantially the same in shape. The second fixing part 1540 includes a row of multiple lumen 1508, for example, the multiple lumen 1508 can be aligned along an axis. The row of multiple lumen 1508 can be aligned along the longitudinal axis of the second fixing part 1540. The second fixing part 1540 can include multiple rows of multiple lumen 1508. The second fixing part 1540 can include multiple lumen 1508 arranged in an irregular order or orientation. One or more lumen 1508 can be configured to receive one or more fastener members 1580 and / or one or more fasteners 1590. One or more lumen 1508 can be oriented to facilitate the arrangement of the fastener members 1580 and / or fasteners 1590. The fastener 1590 may be positioned transvertebral. The fastener 1590 may be positioned on the spinous process or at the base of the spinous process. The fastener 1590 may be positioned across the spinous process of the vertebra.
[0101] At least one surface of the small articular surface reinforcement device 1500 may have a functional portion for mechanically mating with an insertion device (not shown), the functional portion may include grooves and / or projections configured to mating with corresponding grooves and / or projections of the insertion device. At least one surface of the small articular surface reinforcement device 1500 may have a functional portion (e.g., a groove or recess) for mechanically mating with fastener members 1580 and / or fasteners 1590. The functional portion for mechanically mating with fastener members 1580 and / or fasteners 1590 can increase the stability of the system and the resistance of the system's components to movement.
[0102] The diameter of the first fixing part 1530 may be in the range of 2 mm to 20 mm, or its diameter may be in the range of 4 mm to 15 mm. The diameter of the lumen 1506 may be in the range of 0.5 mm to 10 mm, or in the range of 1 mm to 7 mm. The diameter of the lumen 1508 may be in the range of 0.5 mm to 10 mm, or in the range of 1 mm to 7 mm.
[0103] In some embodiments, at least a portion of one surface of the articular surface reinforcement device 1500 has a rough and / or porous surface, as described above with respect to Figure 82. The rough surface may include at least one projection 1516. In one embodiment, the projection 1516 may comprise at least one nail, barb, wedge, or hook protruding from one surface of the articular surface reinforcement device 1500. The first fixing portion 1530, the second fixing portion 1540, the central portion 1510, and / or any combination of these portions may include a rough and / or porous surface. In some embodiments, an adhesive or sealant, such as cyanoacrylate, polymethyl methacrylate, or other adhesives known in the art, is used to bond one surface of the articular surface reinforcement device 1500 to a bone or tissue surface. In some embodiments, at least a portion of one surface of the articular surface reinforcement device 1500 may be curved or malleable. A portion of one surface of the small articular surface reinforcement device 1500 can be shaped to match the shape of an anatomical structure, such as a small articular surface or a spinous process.
[0104] As shown in Figure 85, the first fixation part 1530 and the second fixation part 1540 can be located on different planes. The first fixation part 1530 is located on plane P1, as shown in Figure 85. The first fixation part 1530 may include a lumen 1506. The lumen 1506 has a central longitudinal axis (axis 1) extending through the lumen 1506. Plane P1 can be located perpendicular to axis 1 of the lumen 1506 of the first fixation part 1530. Plane P1 can be located adjacent to the distal surface 1531 of the first fixation part 1530. Plane P1 can be located adjacent to the surface of the first fixation part 1530 configured to engage with bone or tissue.
[0105] The second fixation portion 1540 can be located on a plane P2. The second fixation portion 1540 may include at least one lumen 1508. The lumen 1508 has a central longitudinal axis (axis 2) extending through the lumen 1508. The plane P2 can be located parallel to axis 2 of the lumen 1508 of the second fixation portion 1540. The plane P2 can be located adjacent to the distal surface 1541 of the second fixation portion 1540. The plane P2 can be located adjacent to the surface of the second fixation portion 1540 configured to engage with bone or tissue.
[0106] Plane P1 can be angled with respect to plane P2, forming an angle A (see Figure 85) between planes P1 and P2. Angle A can be between 30 and 150 degrees. In one configuration, angle A can be between 60 and 105 degrees. Axis 1 and axis 2 are not parallel in such configurations. In one embodiment, axis 1 and axis 2 can be perpendicular. In other embodiments, axis 1 can be angled with respect to axis 2.
[0107] In certain configurations, the first fixing part 1530 can be offset in multiple dimensions from the second fixing part 1540. The first fixing part 1530 can be offset from the second fixing part 1540 along the longitudinal axis of the small joint surface reinforcement device 1500. The longitudinal axis of the first fixing part 1530 can be offset from, angled, or otherwise not aligned with the longitudinal axis of the second fixing part 1540.
[0108] For example, as illustrated in Figure 86, the second fixation part 1540 may be located intermediate and / or posterior to the first fixation part 1530. The second fixation part 1540 may be located above the first fixation part 1530. The proximal and posterior terms referred herein refer to the portion of the articular surface reinforcement device configured to be implanted in the vertebra or vertebra, toward the tip of the spinous process. The distal and anterior terms refer to the portion of the articular surface reinforcement device configured to be implanted in the vertebra or vertebra, toward the vertebral body. The intermediate term refers toward the midline (center of the spinous process), and the transverse term refers toward the direction away from the midline (towards the tip of the transverse process). The superior term refers toward the direction toward the head, or a portion of the articular surface reinforcement device configured to face toward the head when installed, and the inferior term refers to a structure or portion of the articular surface reinforcement device that faces toward the foot or is positioned toward the foot. The central portion 1510 can be bent and / or twisted to result in a displacement and / or angle of the first fixing portion 1530 relative to the second fixing portion 1540.
[0109] Figures 86 and 87 show perspective views of a portion of the spine in a method for fusing adjacent vertebrae using a microarticular surface reinforcement device 1500. The method involves using an implanted device to restore the space between the microarticular surfaces of the superior articular process of the first vertebra and the inferior articular process of the adjacent vertebra.
[0110] In one method of use, a drill or other device can be used to form lumens in the superior articular process SAP2A of vertebra V2 and the inferior articular process IAP1A of vertebra V1. A portion of the surface of the articular surface of SAP2A and a portion of the surface of the articular surface of IAP1A can be prepared for fusion. Specifically, a portion of the surface of the articular surface can be ground, scratched, roughened, polished, etc., so that the surface of the articular surface adheres better to any material to aid in fusion, and / or otherwise fuses more easily with the implant when used.
[0111] Figure 86 illustrates a small articular surface reinforcement device 1500 placed on the outer surface of the upper vertebra V1. The first fixation part 1530 is placed on the posterior-facing outer surface of the left inferior articular process IAP1A of the upper vertebra V1. The second fixation part 1540 is placed on the outer surface of the spinous process near the base of the spinous process of V1.
[0112] In one method of use, the lumen is formed in the articular process. The small articular surface reinforcement device 1500 can be placed after the lumen has been formed in the articular process. The small articular surface reinforcement device 1500 can be placed before the lumen is formed in the articular process. In this method, the small articular surface reinforcement device 1500 can function as a guide for perforating the lumen. The small articular surface reinforcement device 1500 can be placed after preparation for fusion. The small articular surface reinforcement device 1500 can be placed before preparation for fusion. The insertion device may be left on the small articular surface reinforcement device 1500 during the step of forming the lumen and / or during the step of preparing for fusion.
[0113] As shown in Figure 87, the small articular surface reinforcement device 1500 and the fastener member 1580 can be used to fuse vertebrae V1 and vertebrae V2 via the inferior articular process IAP1A of vertebrae V1 and the superior articular process SAP2A of vertebrae V2. In some embodiments, at least one implant is used together with the fastener member 1580 to fuse vertebrae V1 and vertebrae V2. Figure 87 shows the fusion of the inferior articular process IAP1A of vertebrae V1 and the superior articular process SAP2A of vertebrae V2. However, the inferior articular process IAP1B of vertebrae V1 can also be fused to the superior articular process SAP2B of vertebrae V2.
[0114] The fastener member 1580 can be fixed in place. The fastener member 1580 can be fixed in place depending on the type of fastener member used. For example, fixing a fastener member 1580 having the characteristics of the fastener member shown in Figures 49-51 may involve several steps, namely, inserting the proximal end of the fastener member 1580 into the fastening mechanism 1584 located at the distal end of the fastener member 1580; fixing one end of the fastener member 1580 to the opposite end of the fastener member 1580; fixing the proximal end of the fastener member 1580 to the distal end of the fastener member 1580; and / or advancing the proximal end of the fastener member 1580 through the fastening mechanism 1584. In other embodiments, the fastener member 1580 can be fixed by tying a first portion of the fastener member to a second portion of the fastener member, by forming knots at the first and second ends, by screwing the fastener member into a threaded central cavity, by screwing a fastener onto the threaded end of the fastener member positioned through the threaded central cavity, by including it at the end of the fastener member, and / or by a combination of the above. The fastener member 1580 can be fixed to hold a small articular surface reinforcement device 1500. The small articular surface reinforcement device 1500 is held in a loop of the fastener member 1580 or other defined portion. The small articular surface reinforcement device 1500 may remain movable along a portion of the defined portion after the fastener member 1580 is fixed. In some embodiments, the small articular surface reinforcement device 1500 is fixed so that it cannot move along a portion of the defined portion after the fastener member 1580 is fixed. The fastener member 1580 can be fixed in place to hold the first fixing portion 1530.
[0115] The lumen is formed in the spinous process. The small articular surface reinforcement device 1500 can be installed after the lumen has been formed in the spinous process. The small articular surface reinforcement device 1500 can be installed before the lumen has been formed in the spinous process. In this method, the small articular surface reinforcement device 1500 can function as a guide for perforating the lumen. The second fixation portion 1540 can be fixed to V1 using the fastener member 1580 and / or other fasteners 1590. The fasteners 1590 can be screws, bolts, dual-head screws, pedicle screws, transpedicular screws, posts, plugs, tethers, artificial ligaments, rods, or other devices for fixing plates to bone, as will be known to those skilled in the art. The fasteners 1590 can pass translaminally through the base of the spinous process 1570 or penetrate through the base of the spinous process 1570. In some embodiments, the fastener 1590 is threaded, and the lumen 1508 is threaded. The corresponding threading between the lumen 1508 and the fastener 1590 facilitates the fastener 1590's attachment and / or locking to the small articular surface reinforcement device 1500. Figure 86 shows two lumen 1508s within the second fastening portion 1540. The fastener 1590 associated with the lumen 1508s can be the same fastener, different fasteners, or a combination of similar and different fasteners for three or more lumen 1508s.
[0116] Figure 87 illustrates an assembly system including a small articular surface reinforcement device 1500 and a fastener member 1580. The assembly system is implanted on the left facet joint 1490 between the upper vertebra V1 and the lower vertebra V2. The left facet joint can be compressed by the assembly system, thereby bringing the two small articular surfaces closer together and juxtaposing them. This compression is in contrast to the unfixed right facet joint.
[0117] Figure 88 shows an embodiment of the microarticular surface reinforcement device 1600. The microarticular surface reinforcement device 1600 has features similar to the microarticular surface reinforcement device 1500 described herein. The microarticular surface reinforcement device 1600 includes a first fixing portion 1630 located toward the lower end 1602 and a second fixing portion 1640 located toward the upper end 1604. A central portion 1610 connects the first fixing portion 1630 and the second fixing portion 1640. The first fixing portion 1630 may include a lumen 1606 surrounded by a tubular surface 1611. The first fixing portion 1630 may be configured for placement on the microarticular surface outside the microarticular surface. In some embodiments, at least a portion of one surface of the microarticular surface reinforcement device 1600 has a rough and / or porous surface, which may include at least one projection 1616.
[0118] The second fixation part 1640 can be configured for placement on a vertebral structure. The vertebral structure can be positioned away from the outer surface of the articular surface. The second fixation part 1640 can be configured for placement on the outer surface of the spinous process 1670.
[0119] The second fixation portion 1640 may include a lumen 1608 surrounded by a tubular surface 1621. The second fixation portion 1640 may include two lumen 1608. The two lumen 1608 can be in a different configuration from the lumen 1508 shown in Figure 85. For example, the two lumen 1608 may be oriented vertically along the spinous process in the second fixation portion 1640. The two lumen 1508 may be oriented horizontally along the base of the spinous process in the second fixation portion 1540. The orientation of the two lumen 1608 of the microarticular surface reinforcement device 1600 is generally perpendicular to the lumen 1508 of the microarticular surface reinforcement device 1500. The orientation shown in Figure 89 may be advantageous in terms of resisting forces on the microarticular surface reinforcement device 1600. The orientation shown in Figure 89 may allow for further visualization of posterior vertebral structures such as the V1 arch. The orientation of the lumen 1608 allows for the placement of the fastener 1690A across the spinous process 1670.
[0120] The first fixing portion 1630 and the second fixing portion 1640 can be located on different planes. The first fixing portion 1630 is located on plane P3, as shown in Figure 88. The lumen 1606 has a central longitudinal axis (axis 1) extending through the lumen 1606. Plane P3 is located perpendicular to axis 1 of the lumen 1606 of the first fixing portion 1630. Plane P3 can be located adjacent to the distal surface 1631 of the first fixing portion 1630.
[0121] The second fixation part 1640 is located on a plane P4. The second fixation part 1640 may include at least one lumen 1608. The lumen 1608 has a central longitudinal axis (axis 2) extending through the lumen 1608. The plane P4 is located parallel to axis 2 of the lumen 1608 of the second fixation part 1640. The plane P4 may be located adjacent to the distal surface 1641 of the second fixation part 1640. The plane P3 may be angled with respect to the plane P4. An angle A is formed between the plane P3 and the plane P4. Angle A can be between 30 and 150 degrees. Angle A can be between 60 and 105 degrees. The first fixation part 1630 may be shifted in multiple dimensions from the second fixation part 1640.
[0122] Figures 89 to 91 show perspective views of a portion of the spine in a method for fusing adjacent vertebrae using articular surface reinforcement devices 1600 and 1600A. Implantation of articular surface reinforcement devices 1600 and 1600A can be substantially the same as implantation of articular surface reinforcement device 1500.
[0123] Figure 90 illustrates the small articular surface reinforcement devices 1600 and 1600A placed on the outer surface of the upper vertebra V1. The first fixation part 1630 is placed on the posterior-facing outer surface of the left inferior articular process IAP1A of the upper vertebra V1. The second fixation part 1640 is placed on the outer surface of the spinous process 1670. The first fixation part 1630A is placed on the posterior-facing outer surface of the right inferior articular process IAP1B of the upper vertebra V1. The second fixation part 1640A is placed on the outer surface of the spinous process 1670.
[0124] The second fixation portion 1640 may include two lumens 1608, which are oriented vertically along the spinous process in the second fixation portion 1640. The second fixation portion 1640A may include two lumens 1608A, which are oriented vertically along the spinous process in the second fixation portion 1640A. The orientation of the lumens 1608,1608A allows for the placement of the fastener 1690A across the spinous process 1670.
[0125] Luminous cavities can be formed in the superior articular process SAP2A of vertebra V2 and the inferior articular process IAP1A of vertebra V1. Luminous cavities can be formed in the superior articular process SAP2B of vertebra V2 and the inferior articular process IAP1B of vertebra V1. Fastener members 1680 and 1680A can be inserted as described above. The proximal end of fastener member 1680 can be inserted into the lumen 1606 of the first fixation part 1630, into the lumen of the inferior articular process SAP1A of vertebra V1, and into the lumen of the superior articular process SAP2A of vertebra V2. The proximal end of fastener member 1680A can be inserted into the lumen of the first fixation part 1630A, into the lumen of the inferior articular process SAP1B of vertebra V1, and into the lumen of the superior articular process SAP2B of vertebra V2. The implant can be inserted between the superior and inferior articular processes.
[0126] Fastener members 1680 and 1680A can have the characteristics of fastener member 1580 and can be fixed in the same way as fastener member 1580. The proximal ends of fastener members 1680 and 1680A can be inserted into the tightening mechanisms 1684 and 1684A. The tightening mechanisms 1684 and 1684A can be positioned at the distal ends of fastener members 1680 and 1680A. As shown in Figure 90, the small articular surface reinforcement device 1600 and fastener member 1680 can be used to fuse vertebrae V1 and vertebrae V2 via the inferior articular process IAP1A of vertebrae V1 and the superior articular process SAP2A of vertebrae V2. The small articular surface reinforcement device 1600A and fastener member 1680A can be used to fuse vertebrae V1 and vertebrae V2 via the inferior articular process IAP1B of vertebrae V1 and the superior articular process SAP2B of vertebrae V2. The small articular surface reinforcement device 1600 can be substantially similar to the small articular surface reinforcement device 1600A. The small articular surface reinforcement device 1600 can be a mirror image of the small articular surface reinforcement device 1600A.
[0127] The lumen is formed in the spinous process 1670. The second fixation parts 1640, 1640A can be fixed to V1 using fastener members 1680, fastener 1690, and / or fastener 1690A. Fastener members 1680 and fastener 1690 can be inserted as described above with respect to fastener members 1580 and fastener 1590. Fastener 1690 can be a screw, bolt, dual-head screw, pedicle screw, transpedicular screw, post, plug, tether, artificial ligament, rod, or other means for fixing a plate to bone, as will be known to those skilled in the art. In some embodiments, fastener 1690 is threaded and the lumen 1608 is threaded. The corresponding threading between the lumen 1608 and fastener 1690 can facilitate the fixation and / or locking of fastener 1690 to the small articular surface reinforcement device 1600. Figure 89 shows two lumens 1608 within the second fixing portion 1640. The fastener 1690 associated with the lumens 1608 can be the same fastener, different fasteners, or a combination of similar and different fasteners for three or more lumens 1608.
[0128] The fastener 1690A can pass through or penetrate the spinous process 1670 transarctiformally. The fastener 1690A is located between the lumen 1608 and the lumen 1608A. The fastener 1690A is located between the second fixation part 1640 and the second fixation part 1640A. Referring to Figures 90 and 91, the fastener 1690A is illustrated together with the head 1694, the shaft 1696, and the nut 1692. The shaft 1696 may be threaded or smooth. The fastener 1690A may take the form of a screw, bolt, dual-head screw, pedicle screw, transpedicular screw, post, plug, tether, artificial ligament, rod, or other form known in the art. Additional security is provided by fixing the two small articular surface reinforcement devices 1600 and 1600A to each other through the spinous process.
[0129] Figures 89 to 91 illustrate the assembly system including the small articular surface reinforcement devices 1600 and 1600A. Figure 91 illustrates the system as seen from above on V1. Figure 90 clearly shows that the fastener 1690A penetrates the lumen 1608 and spinous process 1670 of the small articular surface reinforcement device 1600, and the lumen 1608A of the small articular surface reinforcement device 1600A.
[0130] The assembly system is implanted on the left and right facet joints between the upper vertebra V1 and the lower vertebra V2. These facet joints can be compressed by the assembly system, thereby bringing the two small articular surfaces closer together and juxtaposing them. The implantation of the second small articular surface reinforcement device 1600A and the second fastener member 1680A can improve stability.
[0131] The small articular surface reinforcement devices 1400, 1500, 1600, 1600A and fasteners 1580, 1590, 1680, 1690, 1690A can be made from any of the various materials known in the art, including, but not limited to, polymers such as polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polyethylene, fluorinated polymers, hydrogels, or elastomers; ceramics such as zirconia, alumina, or silicon nitride; metals such as titanium, titanium alloys, cobalt-chromium, or stainless steel; or any combination of the above materials. The small articular surface reinforcement devices 1400, 1500, 1600, 1600A can be made from a combination of multiple materials. For example, the anti-luminal surface 1404 may contain polymers such as PEEK or polyethylene, and the luminal surface 1410 may contain metal or ceramic. For example, the proximal surface 1402 may contain a polymer, and the distal surface 1406 and / or projection 1416 may contain metal or ceramic. The material of the small articular surface reinforcement device 1400 may be the same as the material of the fastener member and / or implant. The material of the small articular surface reinforcement device 1400 may be different from the material of the fastener member and / or implant.
[0132] Kits may be provided to facilitate spinal fusion procedures. A kit may include, for example, one or more articular surface reinforcement devices, such as those described herein. Multiple articular surface reinforcement devices of different sizes and shapes may be provided in a single kit. Various kits having multiple articular surface reinforcement devices of different sizes and shapes are available. A kit may include, for example, one or more fastener components, such as those described herein. A kit may include, for example, one or more fasteners, such as those described herein. These fasteners may be screws, bolts, nuts, tethers, plugs, posts, or other forms of fasteners, as will be known to those skilled in the art. A kit may include, for example, one or more articular surface implants, such as those described herein.
[0133] The kit may include a drill or drill bit for creating a lumen in the articular process of the facet joint. The kit may include a drill or drill bit for creating a lumen in the spinous process. The kit may include a drill or drill bit for creating a fastener lumen in the bone. The kit may include several tools for preparing the surface of the small articular surface. The kit may include one or more tools for implantation.
[0134] The method of use may include some of the following steps: The method steps may include using an implanted implant to restore the space between the articular surfaces of the superior articular process of the first vertebra and the inferior articular process of the adjacent vertebra; forming a lumen in the superior articular process of the vertebra; forming a lumen in the inferior articular process of the vertebra; forming a lumen in the superior articular process of the vertebra; forming a lumen in the second superior articular process of the vertebra; forming a lumen in the second inferior articular process of the vertebra; and / or preparing the surfaces of the articular surfaces for fusion.
[0135] The method steps may include placing the small articular surface reinforcement device on the outer surface of the superior vertebra, placing the first fixation part on the inferior articular process, and / or placing the second fixation part on the outer surface of the spinous process.
[0136] The method steps may include steps of fusing the vertebrae with a fastener member, positioning the fastener member in a first fixation part, inserting the fastener member into the lumen of the first fixation part, advancing the fastener member, and / or inserting the fastener member into the lumen of the superior articular process of the vertebra.
[0137] The method steps may include steps of securing the fastener member, inserting the fastener member into the fastening mechanism, advancing the fastener member through the fastening mechanism, holding the small joint surface reinforcement device, and / or holding the first fixing portion.
[0138] The method steps may include forming a lumen in the spinous process, positioning the fastener member to the second fixation part, positioning the fastener to the second fixation part, positioning the fastener to the second fixation part and passing it transarctic, and / or positioning the fastener between the second fixation part of the first articular surface reinforcement device and the second fixation part of the second articular surface reinforcement device.
[0139] The method steps may include preparing the facet joint, positioning the small articular surface reinforcement device, installing a fastener member through the small articular surface reinforcement device, installing the fastener member through the first articular process of the facet joint, installing the fastener member through the second articular process of the facet joint, and / or fixing the fastener member onto the small articular surface reinforcement device. Positioning the small articular surface reinforcement device may be performed before or after the step of preparing the facet joint. The step of preparing the facet joint may include perforating the lumen through both articular processes of the facet joint. The step of preparing the facet joint may include roughening, perforating, burring, or otherwise preparing the articular surface of the facet joint.
[0140] The method may include passing the fastener member through the opening of the implant. The method may include some of the following steps in the following order: namely, the step of placing the fastener member through the small articular surface reinforcement device, then the step of placing the fastener member through the first articular process of the facet joint, then the step of placing the fastener member through the implant, and then the step of placing the fastener member through the second articular process of the facet joint.
[0141] The method may include securing the fastener member. The method may include passing the end of the fastener member through a fastening mechanism, inserting the proximal end of the fastener member 1480 into a fastening mechanism 1484 located at the distal end of the fastener member 1480, securing one end of the fastener member 1480 to the opposite end of the fastener member 1480, securing the proximal end of the fastener member 1480 to the distal end of the fastener member 1480, and / or advancing the proximal end of the fastener member 1480 through the fastening mechanism 1484. The method may include tying a first portion of the fastener member to a second portion of the fastener member, forming a knot between the first and second ends, screwing the fastener member into a threaded central lumen, screwing a fastener onto a threaded end of the fastener member positioned through a threaded central lumen, and / or including an elongated portion at the end of the fastener member. The method may include using a fastener member to secure a small joint surface reinforcement device, and / or using a fastener member to secure a first fixing portion of the small joint surface.
[0142] The method may include fastening the fastener. The method may include passing the end of the fastener through the second fastening portion, passing the end of the fastener through the second fastening portion of the first articular surface reinforcement device, and / or passing the end of the fastener through the second fastening portion of the second articular surface reinforcement device. The step of using the fastener may be performed following the step of positioning the articular surface reinforcement device. The method may include using the fastener to fasten the articular surface 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 the fastener may include installing one or more fasteners.
[0143] The method may include installing a second articular surface reinforcement device at a contralateral facet joint by repeating several steps. The method may include installing a second articular surface reinforcement device at another facet joint by repeating several steps. The method may include installing a second articular surface reinforcement device at another vertebral level by repeating several steps. The method may include fastening the articular surface reinforcement device to the vertebral structure using fasteners. The method may include installing one or more fasteners through the lumen of the first articular surface reinforcement device and through the lumen of the second articular surface reinforcement device. The fasteners may also be installed through the vertebral structure. The fasteners may also be installed through the spinous process. The fasteners may also be secured with nuts or other fastening elements. The fasteners may be screwed into the lumen of the first articular surface reinforcement device and / or into the lumen of the second articular surface reinforcement device.
[0144] In the embodiments described above, it should be understood that fastener members similar to any of those described above, for example, reference numerals 72, 280, 380, 480, 580, 680, 780, and 880, can be used with any embodiment of the articular surface reinforcement device described herein. Furthermore, the articular surface reinforcement device can be used with various articular surface implants described herein, such as those having wires or cables to hold the device. Although the articular surface reinforcement device is primarily described in relation to reinforcing the inferior articular process, it should be understood that embodiments can also be used to reinforce the superior articular process. For example, for use on the surface of the superior articular surface, an embodiment of the articular surface reinforcement device similar to 1500 can be shaped and sized such that the second fixation portion 1540 conforms to the vertebra. The articular surface reinforcement device 1500 can, for example, allow the placement of one or more fasteners 1590 through the pedicle or into the vertebral body.
[0145] Similarly, while the illustration of the small articular surface reinforcement device shows a small articular surface reinforcement device applied to the lumbar spine, it will be understood that multiple sizes and shapes can be provided to suit placement on the small articular surface in the cervical and thoracic spine.
[0146] As used herein, the terms “approximately,” “nearly,” “about,” and “substantially” refer to quantities or characteristics that are close to the stated quantity or characteristic, yet still perform the desired function or achieve the desired result. For example, the terms “nearly,” “nearly,” “about,” and “substantially” may refer to quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% of the stated quantity or characteristic.
[0147] As used herein, the term “approximately up to…” has its usual meaning as known to those skilled in the art and may include 0% by weight, minimum or slight %, a given %, and all % by weight in between.
[0148] Although the present invention has been described in relation to various exemplary embodiments, various additional embodiments and modifications to the described embodiments are intended to be within the scope of the invention. Therefore, nothing in the foregoing description should be construed as limiting the scope of the invention as described in the following claims. In all of the embodiments described above, the steps of the method do not need to be performed sequentially.
[0149] Further features of the present invention are given in the numbered items below.
[0150] [Section 1] The first fixed part and The central part, The second fixed part, A device for reinforcing facet joint implants, comprising: The first fixing portion includes a proximal surface, a distal surface, and a lumen positioned between the proximal surface and the distal surface, wherein the lumen is suitable for receiving a flexible clamping band. A device in which the second fixing portion includes a proximal surface, a distal surface, and at least one fastener lumen.
[0151] [Section 2] The device described in item 1 above, wherein the longitudinal axis of the first fixed portion is positioned at an angle to the longitudinal axis of the second fixed portion.
[0152] [Section 3] The device according to item 1 above, wherein the plane of the lumen of the first fixed portion is not parallel to the plane of the lumen of the second fixed portion.
[0153] [Section 4] The device according to item 1 above, wherein the second fixing portion includes at least the lumen of the second fastener.
[0154] [Section 5] The device described in item 4 above, wherein the second fixing portion is adapted to be fixed to the spinous process of a vertebra.
[0155] [Section 6] Flexible clamping band, A small articular surface reinforcement device including a proximal surface, a distal surface, an anti-luminal surface, a luminal surface, and a lumen for receiving the flexible clamping band, A kit for treating the spine, equipped with [specific features / equipment].
[0156] [Section 7] The kit according to item 6 above, wherein the distal surface of the small articular surface reinforcement device is configured to engage with the bone surface of the small articular surface.
[0157] [Section 8] The kit according to item 6 above, wherein the distal surface of the small joint surface reinforcement device is provided with a sharp engaging member.
[0158] [Section 9] The kit according to item 6 above, further comprising a second portion of the articular surface reinforcement device adapted to attach to a vertebra.
[0159] [Section 10] The kit described in item 9 above, wherein the second portion of the small articular surface reinforcement device is adapted to attach to a spinous process.
[0160] [Section 11] The kit described in item 9 above, wherein the second portion of the small articular surface reinforcement device is adapted to attach to the vertebral arch.
[0161] [Section 12] The kit according to item 9 above, wherein the second portion of the small articular surface reinforcement device includes at least one fastener lumen.
[0162] [Section 13] The kit described in item 9 above, further comprising fasteners for fixing the aforementioned small articular surface reinforcement device to a vertebra.
[0163] [Section 14] The kit described in item 13 above, wherein the fastener is a screw or a bolt.
[0164] [Section 15] The kit according to item 6 above further comprises an implant having a joint portion configured to receive the aforementioned flexible clamping band.
[0165] [Section 16] Steps to prepare for stabilization of the facet joints, The steps include: passing a flexible clamping band through the first and second articular processes of the facet joints; A step of placing a small articular surface reinforcement device having a lumen for receiving the flexible clamping band against the surface of the first articular process, wherein the flexible clamping band passes through the lumen; The steps of fixing the flexible fastening band and Methods for treating the spine, including [specific treatments].
[0166] [Section 17] The method described in item 16 above, further comprising the step of fixing the small articular surface reinforcement device to the vertebra with a fastener.
[0167] [Section 18] The method according to item 17 above, wherein the step of fixing the articular surface reinforcement device to the vertebra with a fastener includes fixing the articular surface reinforcement device to the spinous process, the base of the spinous process, or the vertebral arch of the vertebra.
[0168] [Section 19] Steps to prepare the second facet joint for fixation at the same level of the spine, The steps include: placing the second small articular surface reinforcement device against the first articular process of the second facet joint; The steps include passing a second flexible clamping band through the first and second articular processes of the second facet joint, The steps of securing the second flexible clamping band and The methods described in item 16 above, further including the following:
[0169] [Section 20] The step further includes inserting a small articular surface implant having a joint portion configured to receive the flexible clamping band into the facet joint, The method according to item 16 above, wherein the step of passing the flexible clamping band through the first and second articular processes of the facet joint also includes passing the flexible clamping band through the joint portion of the small articular surface implant.
[0170] [Section 21] A device for placement in an intervertebral joint, intended to provide bone reinforcement when a fastener member is used to fix the intervertebral joint, the device having, on the bone contact side, a sharp engaging member for preventing movement and a through-opening for receiving a main small articular surface fixation device.
[0171] [Section 22] The device described in item 21 above, further comprising a second through-opening for receiving at least one additional fastener.
[0172] [Section 23] The device described in item 21 above, further comprising screws for arrangement through the second through-opening. [Explanation of symbols]
[0173] 1400 Small articular surface reinforcement device (Second small articular surface reinforcement device) 1402 Proximal surface 1404 Abluminal surface 1406 Distal surface 1410 Luminal surface 1416 Protrusion 1420 Central lumen 1480 Fastener component (second fastener component) 1484 Tightening mechanism 1490 Left facet joint 1492 Right facet joint 1500 Small Articular Surface Reinforcement Devices 1502 Bottom end 1504 Top 1506 Lumen 1508 Lumen 1510 Central part 1511 Luminal surface 1516 Protrusion 1521 Luminal surface 1530 First fixing part 1531 Distal surface 1540 Second fixing part 1541 Distal surface 1570 spinous process 1580 Fastener components 1584 Tightening mechanism 1590 Zipper 1600 Small Articular Surface Reinforcement Device 1600A Small Articular Surface Reinforcement Device (Second Small Articular Surface Reinforcement Device) 1602 Bottom end 1604 Top 1606 Lumen 1608 Lumen 1608A lumen 1610 Central part 1611 Luminal surface 1616 Protrusion 1621 Luminal surface 1630 First fixing part 1630A First fixing part 1631 Distal surface 1640 Second fixing part 1640A Second fixing part 1641 Distal surface 1670 spinous process 1680 Fastener components 1680A Fastener component (second fastener component) 1684 Tightening mechanism 1684A Tightening mechanism 1690 Zipper 1690A Fastener 1692 Nut 1694 head 1696 Shaft
Claims
1. A small articular surface reinforcement device comprising a proximal surface, a distal surface, an anti-luminal surface extending between the proximal surface and the distal surface, and a lumen extending between the proximal surface and the distal surface, The small articular surface reinforcement device is positioned only on the outer surface facing the posterior side of the articular process and is configured not to come into contact with other articular processes that form the facet joint, the anti-luminal side of the small articular surface reinforcement device is cylindrical, and the purpose of the small articular surface reinforcement device is to provide reinforcement to the bone when a flexible clamping band is used to fix the facet joint. The flexible clamping band is fixed by fixing one end of the flexible clamping band to the opposite end of the flexible clamping band to form a continuous closed loop of the flexible clamping band, and the small joint surface reinforcement device is held within the continuous closed loop of the flexible clamping band.
2. The small joint surface reinforcement device according to claim 1, wherein the lumen is cylindrical.
3. The small articular surface reinforcement device according to claim 1, wherein the lumen is located in the center of the small articular surface reinforcement device.
4. The small articular surface reinforcement device according to claim 1, wherein the lumen includes a substantially smooth inner surface.
5. The small articular surface reinforcement device according to claim 1, wherein the lumen is configured to match the shape of the articular lumen formed in the articular process.
6. The small articular surface reinforcement device according to claim 5, wherein the lumen is smaller than the articular lumen.
7. The small articular surface reinforcement device according to claim 5, wherein the lumen is larger than the articular lumen.
8. The small articular surface reinforcement device according to claim 1, wherein at least one surface is malleable.
9. The small articular surface reinforcement device according to claim 1, wherein the small articular surface reinforcement device is used in conjunction with an implant configured to restore the space between the small articular surface of an articular process and an adjacent articular process.
10. The small articular surface reinforcement device according to claim 1, wherein at least a portion of one surface of the small articular surface reinforcement device includes a rough surface.
11. The small joint surface reinforcement device according to claim 10, wherein the rough surface includes at least one projection.
12. The small joint surface reinforcement device according to claim 1, wherein at least a portion of one surface of the small joint surface reinforcement device is porous.
13. The small joint surface reinforcement device according to claim 1, wherein the small joint surface reinforcement device is used together with an adhesive or a sealant.
14. The small joint surface reinforcement device according to claim 1, wherein the flexible clamping band is fixed by advancing the end of the flexible clamping band through a clamping mechanism located at the opposite end of the flexible clamping band.
15. The small joint surface reinforcing device according to claim 1, wherein the flexible clamping band comprises a gear configured to displace the ratchet of the flexible clamping band in only one direction.
16. A small articular surface reinforcement device including a proximal surface, a distal surface, an anti-luminal surface extending between the proximal and distal surfaces, and a lumen extending between the proximal and distal surfaces, A flexible clamping band, wherein the lumen is configured to receive the flexible clamping band, A kit that includes, The small articular surface reinforcement device is positioned only on the outer surface facing the posterior side of the articular process and is configured not to come into contact with other articular processes that form the facet joint. The side of the small articular surface reinforcement device that is not luminal is cylindrical. The purpose of the small articular surface reinforcement device is to reinforce the fixation of the flexible tightening band where it emerges from the articular process. The flexible clamping band is secured by fixing one end of the flexible clamping band to the opposite end of the flexible clamping band to form a continuous closed loop of the flexible clamping band, and the small articular surface reinforcement device is held within the continuous closed loop of the flexible clamping band, in a kit.
17. The kit according to claim 16, further comprising an implant.
18. The kit according to claim 16, wherein the flexible clamping band includes a ratchet and rack gear.
19. The kit according to claim 16, wherein the flexible clamping band is secured by advancing its end through the clamping mechanism.
20. The kit according to claim 16, wherein at least a portion of one surface of the small joint surface reinforcement device is roughened or porous.
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