Fixation plates for intervertebral implants
A plate secured to the intervertebral implant with a rotating and translating fixation member locks onto the implant, addressing the challenge of maintaining its position during patient repositioning, thereby stabilizing the implant during spinal fusion procedures.
Patent Information
- Application Number
- JP2024568571
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-05-19
- Filing Date
- 2023-05-19
- Publication Date
- 2025-05-20
AI Technical Summary
The challenge is to maintain the position of a fixation device within the intervertebral disc space during patient repositioning, which is crucial for spinal fusion procedures like TLIF, PLIF, and XLIF, to prevent movement of the intervertebral implant.
A plate is secured to the intervertebral implant, featuring a bone fixation hole and a fixation member that rotates and translates to a locked configuration, capturing a retaining wall of the implant to stabilize it during patient repositioning.
The solution effectively stabilizes the intervertebral implant, preventing movement when the patient is repositioned, ensuring the implant remains in place during surgical procedures.
Smart Images

Figure 2025515964000001_ABST
Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This claims priority to U.S. Patent Application No. 63 / 343,992, filed May 19, 2022, the disclosure of which is incorporated by reference herein as if set forth in its entirety. [Background technology]
[0002] The human spinal column is composed of a series of vertebral bodies separated by intervertebral discs. A natural intervertebral disc contains a jelly-like nucleus pulposus surrounded by a fibrous annulus fibrosus. Under axial load, the nucleus pulposus is compressed and the load is transmitted radially to the annulus fibrosus. The laminated nature of the annulus fibrosus provides it with high tensile strength, thereby allowing it to expand radially in response to this transmitted load.
[0003] In healthy discs, cells within the nucleus pulposus produce an extracellular matrix (ECM) that contains a high percentage of proteoglycans. These proteoglycans contain sulfated functional groups that provide cushioning to the nucleus pulposus by retaining water. These nucleus pulposus cells can also secrete small amounts of cytokines, such as interleukin-1β and TNF-α, as well as matrix metalloproteinases ("MMPs"). These cytokines and MMPs help regulate the metabolism of the nucleus pulposus cells.
[0004] In some cases of degenerative disc disease (DDD), mechanical instability in other parts of the spine causes the gradual degeneration of the disc. In these cases, increased load and pressure on the nucleus pulposus causes cells (or invading macrophages) in the disc to release more of the above cytokines than normal. In other cases of DDD, genetic factors or apoptosis can also cause cells in the nucleus pulposus to release toxic amounts of these cytokines and MMPs. In some cases, the pumping action of the disc can be impaired (e.g., due to reduced concentrations of proteoglycans in the nucleus pulposus), which can slow the inflow of nutrients to the disc and the outflow of waste products from the disc. This reduced ability to remove waste products can lead to the accumulation of high concentrations of inflammatory cytokines and / or MMPs, which can cause nerve irritation and pain.
[0005] As DDD progresses, toxic concentrations of cytokines and MMPs present in the nucleus pulposus begin to degrade the extracellular matrix. Specifically, MMPs (mediated by cytokines) degrade the water-retaining portion of proteoglycans, thereby reducing their ability to retain water. This degradation leads to a decrease in the flexibility of the nucleus pulposus, which in turn changes the loading pattern within the disc, which can lead to delamination of the annulus fibrosus. These changes cause further mechanical instability, which causes the cells to release more cytokines, which typically lead to an increase in MMPs. As this destructive cascade continues and DDD progresses further, the disc begins to bulge ("disc herniation") and then eventually ruptures, putting the nucleus pulposus in contact with the spinal cord, causing pain.
[0006] One proposed method of addressing these problems is to remove the problematic disc from the disc space and replace it with an intervertebral implant that restores disc height and allows for bony fusion with the adjacent vertebrae. These devices are commonly referred to as fusion devices, or "interbody fusion devices." Current spinal fusion procedures include transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), and extreme lateral interbody fusion (XLIF). Once the fusion device is inserted into the disc space, the patient is often repositioned from a lateral to a prone position for implantation of a supplemental fusion. Summary of the Invention [Problem to be solved by the invention]
[0007] Therefore, what is needed is a method and apparatus for maintaining the position of a fixation device within the intervertebral disc space during repositioning of the patient. [Means for solving the problem]
[0008] In one example, the plate is configured to be secured to an intervertebral implant extending distally from the plate. The plate can include a plate body having at least one bone fixation hole configured to receive a bone fixation element extending into a vertebral body, the plate body defining a seat. The plate can further include a fixation member configured to rotate in a first rotational direction about a rotation axis from an unlocked configuration to a locked configuration. In one example, the fixation member can be configured to be driven to translate in a fixed direction along the rotation axis to a locked position until a retaining wall of the intervertebral implant is captured between the seat and the fixation member when the fixation member is in the locked configuration. [Brief description of the drawings]
[0009] The foregoing summary, as well as the following detailed description of exemplary embodiments of the intervertebral implant of the present application, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the intervertebral implant of the present application, there are shown in the drawings exemplary embodiments. It should be understood, however, that the present application is not limited to the precise arrangements and instrumentalities shown. The drawings are as follows: [Figure 1A] FIG. 1 is a perspective view of a bone fixation system including an intervertebral implant and a plate secured to the intervertebral implant, showing screws inserted through screw holes in the plate. [Figure 1B] FIG. 1B is another perspective view of the bone fixing system of FIG. 1A, with the screws omitted. [Figure 1C] FIG. 1C is a top view of the bone fixing system of FIG. [Figure 1D] FIG. 1D is a side view of the bone fixing system of FIG. [Figure 1E] FIG. 1E is a cross-sectional view of the bone fixing system of FIG. [Figure 2A] 1A-1E, constructed in accordance with one example and shown in a locked configuration. FIG. [Figure 2B] FIG. 2B is a perspective view of a plate of the bone fixing system of FIG. 2A shown in an unlocked configuration, with a portion of the plate shown in transparency; [Figure 2C] FIG. 2C is a cross-sectional view of the plate of FIG. 2B. [Figure 3A] FIG. 2 is a plan view of a plate having a pair of screw holes. [Figure 3B] 3B is a plan view of the plate of FIG. 3A having different sizes. [Figure 3C] 3A-3B with different sizes. FIG. [Figure 4A] FIG. 2 is a top view of a plate having screw holes in a first orientation. [Figure 4B] 4B is a plan view of the plate of FIG. 4A having different sizes. [Figure 4C] 4A-4B, which are plan views of the plates of different sizes. [Figure 5A]4B is a plan view of a plate having screw holes in a second orientation different from the first orientation of FIG. 4A. FIG. [Figure 5B] 5B is a plan view of the plate of FIG. 5A having different sizes. [Figure 5C] 5A-5B, which are plan views of the plates of different sizes. [Figure 6A] FIG. 13 is a perspective view, with portions cut away for illustrative purposes, of a plate constructed in accordance with another example. [Figure 6B] FIG. 6B is a front view of the plate of FIG. 6A. [Figure 6C] FIG. 6B is a side view of the plate of FIG. 6A. [Figure 6D] FIG. 6B is a front perspective view of the plate of FIG. 6A. [Figure 6E] FIG. 6B is a rear perspective view of the frame of FIG. 6A. [Figure 6F] 13 shows an insertion tool aligned to be coupled to a plate inserted into an intervertebral implant in an unlocked configuration. [Figure 6G] 13 illustrates a driver instrument inserted through the inserter instrument after the driver instrument drives the fixation members of the plate from the unlocked configuration to the locked configuration. [Figure 6H] 13 is another cross-sectional view of the driver shown coupled to a stationary member. [Figure 7A] 1 is a perspective view, with portions cut away for illustrative purposes, of a plate constructed in accordance with yet another example. [Figure 7B] 7B is a side cross-sectional view of the plate of FIG. 7A shown inserted into an intervertebral implant. [Figure 7C] FIG. 7B is another cross-sectional view of the plate of FIG. 7A. [Figure 8] 1 illustrates a number of bone screws that may be included in the kit. [Figure 9A] FIG. 13 is a side view of the plate inserter. [Figure 9B] FIG. 9B is a side cross-sectional view of the plate inserter of FIG. 9A, shown with portions removed. [Figure 10A] FIG. 9C is a side view of a driver configured to be inserted into the inserter of FIGS. 9A-9B. [Figure 10B] 10B is a side cross-sectional view of a portion of the driver of FIG. 10A shown operably coupled to a plate. [Figure 11A] FIG. 13 is a side view of the driver and inserter coupled to a plate, showing the plate secured to the implant prior to inserting the implant into the intervertebral space. [Figure 11B] 13 is a side view of a driver and inserter coupled to the plate and configured to couple the plate to the implant after the implant has been inserted into the intervertebral space. FIG. [Figure 12A] 1 shows a kit including a trial plate attached to a trial implant and a trial inserter attached to the trial plate in one of a number of angular positions. [Figure 12B] 1 shows a kit including a number of different sized trial plates attached to respective trial inserters. [Figure 13A] 1 illustrates a kit including a trial plate attached to a trial implant and a trial inserter attached to the trial plate in one of a plurality of angular positions, the trial plate including insertion depth markings. [Figure 13B] FIG. 13B is a top view of the trial implant of FIG. 13A. [Figure 13C] FIG. 13C is a side view of the trial implant of FIG. 13B inserted into the intervertebral space. [Figure 14A] 1 illustrates a trial implant inserter coupled to a trial implant and a trial insertion member coupled to a trial plate, the trial insertion member partially surrounding the trial implant inserter. [Figure 14B] 14B illustrates the assembly of FIG. 14A, with the trial implant shown disassembled from the trial implant inserter. [Figure 14C] FIG. 14D is an enlarged view of a portion of the trial implant, trial plate, and trial insert member shown in FIG. 14C. [Figure 14D]14C, showing the trial implant coupled to the trial implant inserter. [Figure 15A] 1 shows the guide sleeve inserted into the fixation hole of the trial plate at an angle. [Figure 15B] 13 shows the guide sleeve inserted at variable angles into the fixation holes of the trial plate. [Figure 15C] FIG. 15B is a perspective view of the interlocking end of the guide sleeve shown in FIG. 15A. [Figure 15D] FIG. 15C is a perspective view showing the articular surface of the guide sleeve of FIG. 15B. [Figure 15E] 1 illustrates an example of an opening device configured as a drill. [Figure 15F] 13 shows an opening device configured as an awl in another example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0010] 1A-1E, the intervertebral implant 20 is configured to be inserted into an intervertebral space. As shown in FIGS. 11A-11B, the intervertebral space 51 can be defined by an upper vertebral body 53 and an adjacent lower vertebral body 55 of a human spine. The upper vertebral body 53 defines an upper vertebral surface. The lower vertebral body 55 defines an lower vertebral surface. The lower and upper vertebral surfaces can cooperate to define the intervertebral space 51. The vertebral body 53 and the vertebral body 55 can be anatomically adjacent to one another. However, it should be understood that the intervertebral implant 20 can alternatively be configured to fit into an intervertebral space defined by the upper and lower vertebral bodies remaining after a corpectomy has been performed to remove one or more vertebral bodies between the upper and lower vertebral bodies. The intervertebral implant can be inserted into the intervertebral space after a discectomy has been performed, whereby disc material has been removed, or at least partially removed, to prepare the intervertebral space for receiving the intervertebral implant. The intervertebral space may be defined in the lumbar region of the spine, or alternatively, in the cervical or thoracic region of the spine.
[0011] As will be appreciated from the following description, the intervertebral implant 20 is configured to be inserted into the intervertebral space along a lateral anatomical approach (referred to as a lateral intervertebral implant). However, it will be understood that the present invention is not limited to lateral intervertebral implants unless otherwise indicated, and may be, for example, a TLIF implant, a PLIF implant, or an XLIF implant.
[0012] 1A-1E, the intervertebral implant 20 is described herein as extending horizontally along a longitudinal direction "L" and a lateral direction "A" and transversely along a transverse direction "T". Unless otherwise noted herein, the terms "longitudinal", "lateral" and "transverse" are used to describe various implant components and orthogonal components of the implant component axes. The longitudinal direction L may be perpendicular to the transverse direction T. The lateral direction A may be perpendicular to the longitudinal direction L and the transverse direction T. Although the longitudinal and lateral directions are shown as extending along a horizontal direction and the transverse direction T is shown as extending along a vertical direction, it should be understood that these directions may vary depending on the orientation of the implant during use. For example, when implant 20 is inserted into the intervertebral space, the transverse direction T extends generally along a superior-inferior (or caudal-cephalad) direction, while the horizontal plane defined by the longitudinal direction L and the lateral direction A generally lies in an anatomical plane defined by the anterior-posterior direction and the medial-lateral direction. For example, the lateral direction A can extend generally along an anterior-posterior direction. The longitudinal direction L can extend generally along a medial-lateral direction.
[0013] The intervertebral implant 20 defines an anterior end 22 and a posterior end 24 opposite the anterior end 22 along a longitudinal direction L. The longitudinal direction L may generally extend along a direction of insertion into the intervertebral space. Thus, the longitudinal direction L may be said to extend along an anatomical medial-lateral direction after the intervertebral implant 20 is inserted into the intervertebral space along the insertion direction. In particular, the anterior end 22 may be said to be spaced apart from the posterior end 24 in the insertion direction. The anterior end 22 may be tapered to facilitate insertion into the intervertebral space. The posterior end 24 is spaced apart from the anterior end 22 in a direction opposite the insertion direction. The anterior end 22 may also be said to define a distal end, and the posterior end 24 may be said to define a proximal end opposite the distal end. Thus, the implant 20 may be said to define a distal direction from the posterior end 24 to the anterior end 22 along the longitudinal direction L. The implant 20 can also be said to define a proximal direction from the leading end 22 to the trailing end 24 along the longitudinal direction L. Thus, the distal direction can coincide with the insertion direction. The proximal direction can coincide with the direction opposite to the insertion direction.
[0014] The intervertebral implant 20 may further define a first opposing side 26 and a second opposing side 28 opposed to one another along a lateral direction A. If the intervertebral implant 20 is a lateral implant, the first side 26 may define an anterior side and the second side 28 may define a posterior side. The lateral direction A may be oriented perpendicular to each of the longitudinal direction L and the transverse direction T. The lateral direction A may be said to define a width of the implant. If the intervertebral implant 20 is a lateral implant, the width may be measured along the anatomical anterior-posterior direction.
[0015] The intervertebral implant 20 may define an upper surface 30 configured to engage and contact an upper vertebral surface of the upper vertebra and an lower surface 32 configured to engage and contact an inferior vertebral surface of the inferior vertebra. Thus, the upper surface 30 may be referred to as the upper or upper vertebral contact surface, and the lower surface 32 may be referred to as the lower or lower vertebral contact surface. The upper surface 30 and the lower surface 32 are spaced apart from one another along a transverse direction T that is oriented perpendicular to each of the longitudinal direction L and the lateral direction A. The transverse direction T may define a height of the intervertebral implant 20. The height may be measured along an anatomical caudal-cephalad direction. The height of the intervertebral implant 20 may be measured along the transverse direction T from the upper surface 30 to the lower surface 32. As used herein, the term "upper" and its derivatives refer to a direction from the lower surface 32 toward the upper surface 30. As used herein, the term "lower" and its derivatives refer to a direction from the upper surface 30 toward the lower surface 32.
[0016] In one example, the intervertebral implant 20 can be configured to define a lordotic or kyphotic profile as desired. Thus, the anterior side 26 can define a height along the transverse direction T equal to the height of the posterior side 28 along the transverse direction T. Alternatively, the anterior side 26 can define a height along the transverse direction T greater than the height of the posterior side 28 along the transverse direction T. For example, one or both of the superior and inferior surfaces 30 and 32 can be inclined relative to one another in a direction from the anterior side 26 to the posterior side 28. The inclination of either or both of the superior and inferior surfaces 30 and 32 can be defined in a plane oriented along the transverse direction T and the lateral direction A. In one example, the inferior surface 32 can be inclined, and the superior surface 30 can be oriented generally along a plane defined by the longitudinal direction L and the lateral direction A. Alternatively, the superior surface 30 can be inclined, and the inferior surface 32 can be oriented generally along a plane defined by the longitudinal direction L and the lateral direction A. Alternatively or further, each of the upper surface 30 and the lower surface 32 can be inclined. The upper surface 30 and the lower surface 32 can define any suitable angle in the plane defined by the lateral direction A and the transverse direction T, as desired. The angle can be substantially 8 degrees, substantially 16 degrees, or any other angle, as desired. Alternatively, the upper surface 30 and the lower surface 32 can be substantially parallel to one another, as desired. The implant 20 can be 3D printed or otherwise constructed, as desired. Additionally, the implant 20 can be non-expandable or expandable along the transverse direction T, as desired.
[0017] 1A-1E, the bone fixation system 38 can include an intervertebral implant 20 and a plate 40 configured to be secured to the implant 20 and further configured to be coupled to at least one or both of the vertebrae that define the intervertebral disc space. The implant 20 can extend distally from the plate 40 into the intervertebral disc space. Advantageously, the plate 40 can stabilize the implant 20 to limit or prevent movement of the implant 20 when the patient is repositioned during a surgical procedure. For example, the plate 40 can be secured to the implant 20 and coupled to at least one of the vertebrae while the patient is in a lateral decubitus position. Thus, when the patient is repositioned to a prone position, the plate 40 limits or prevents movement of the implant 20 within the intervertebral space.
[0018] The plate 40 may include a plate body 41 defining an anterior surface 42 that faces the intervertebral implant 20 and the vertebrae, and a posterior surface 44 opposite the anterior surface 42. The anterior surface 42 may be said to be spaced apart from the posterior surface 44 in an anterior direction, which may also be the direction of insertion of the intervertebral implant 20. The anterior direction may therefore define a distal direction. Conversely, the posterior surface 44 may be said to be spaced apart from the anterior surface 42 in a posterior direction opposite the anterior direction. The posterior direction may therefore be referred to as the proximal direction.
[0019] The plate 40 may include at least one bone fixation hole 46 extending through the plate body 41 from the anterior surface 42 to the posterior surface 44. When the plate 40 is secured to the intervertebral implant 20 when the intervertebral implant 20 is implanted, the bone fixation hole 46 may receive a bone fixation element 48 inserted through the hole 46 into one of the intervertebral bodies. In one example, the plate 40 may include two fixation holes defined by a first fixation hole 46a and a second fixation hole 46b, which are positioned such that the first bone fixation element 48a may be driven through the first fixation hole 46a into the superior vertebra. The second bone fixation element 48b may be driven through the second fixation hole 46b into the inferior vertebra. In one example, the bone fixation element may be configured as a bone screw. Thus, the first fixation hole 46a may be referred to as a superior fixation hole and the second fixation hole 46b may be referred to as an inferior fixation hole. Thus, the plate 40 may have no more than two fixation holes in one example. As will be appreciated from the description below, in other examples, the plate 40 may only include a single bone fixation hole.
[0020] As described herein, the plate 40 is configured to be secured to the intervertebral implant 20. In particular, referring now to FIGS. 2A-2C, the plate 40 can include a fixation member 50 supported by the plate body 41. The fixation member 50 is rotatable relative to the plate body 41 about a rotation axis 43 and translatable relative to the plate body 41 along the rotation axis 43. The rotation axis 43 can be defined by a longitudinal direction L and can be defined by a central axis of the fixation shaft. The fixation member 50 can include a fixation shaft 52 supported within the plate body 41 and an enlarged fixation head 54 extending outwardly from the fixation shaft 52 along a direction perpendicular to the longitudinal direction L. The fixation head 54 can be oval and in a first orientation in the unlocked configuration and in a second orientation different from the first orientation in the locked configuration. For example, the fixation head 43 can extend in an opposite direction from the fixation shaft, particularly from the distal end of the fixation shaft 52. Thus, the fixation member 50 can be substantially T-shaped. The fixation head 54 can be disposed distal to the plate body 41 when the fixation shaft 52 is supported by the plate body 41. A distal portion of the fixation shaft 52 can extend out of the plate body 41 and can terminate in the fixation head 54.
[0021] The fixation member 50 is configured to rotate in a first rotational direction about the axis of rotation 43 from the unlocked configuration to the locked configuration. The fixation head 54 can be in a first orientation in the unlocked configuration (FIGS. 2B-2C) and in a second orientation different from the first orientation in the locked configuration (FIG. 2A). In particular, the fixation member 50 can be further rotated in a second rotational direction opposite to the first rotational direction from the locked configuration to the unlocked configuration. In the unlocked configuration, the fixation member 50 can be removed from the intervertebral implant 20 by translating the plate 40 proximally away from the implant 20. When the fixation member is in the locked configuration, the fixation member 50, and in particular the fixation head 54, are longitudinally aligned with the retaining wall 56 of the implant 20 along the longitudinal direction L, as shown in FIG. 2A. Furthermore, the fixation head 54 is positioned distal to the retaining wall 56. Thus, movement of plate 40 proximally relative to implant 20 causes fixation head 54 to abut retention wall 56, thereby preventing removal of plate 40 from implant 20. When fixation member 50 is in the unlocked configuration shown in Figures 2B-2C, fixation head 54 is not aligned with the retention wall along longitudinal direction L. The first and second orientations of fixation head 54 can be angularly offset from one another by any amount as desired, such as about 90 degrees.
[0022] When the fixation member 50 is in the locked configuration, the fixation member 50 is configured to be driven to translate in a fixed direction along the axis of rotation 43 such that the fixation head 54 moves toward the plate 40, and in particular the seat 58 of the plate body 41. The fixation direction may be defined by a proximal direction in some examples. The seat 58 may be defined by the front surface 42 of the plate body 41. The fixation member 50 moves in the fixed direction until the fixation member 50 reaches a fixed position, whereby the retaining wall 56 is captured between the seat 58 and the fixation member 50. In particular, the fixation member 50 is configured to translate in the fixed direction until the retaining wall 56 is captured between the seat 58 and the fixation head 54. When the retaining wall 56 is captured, the plate 40 and the implant 20 may define a rigid structure.
[0023] 2A-2C, the plate 40 may further include an actuator 60 threadedly coupled to the fixed shaft 52. In this regard, the actuator 60 may be threadedly coupled to a proximal end portion of the fixed shaft 52. The actuator 60 may define a cap disposed on and threadedly coupled to the proximal end portion of the fixed shaft 52. The actuator 60 may be configured to rotate in a first rotational direction during a first rotational stroke to rotate the fixed member 50 in the first rotational direction to a locked configuration. Thus, during the first stroke of rotation of the actuator 60, the actuator 60 and the fixed member 50 are rotatably coupled. The actuator 60 may then be further rotated in the first rotational direction during a second rotational stroke in which the actuator 60 rotates relative to the fixed shaft 52. Thus, the actuator 60 and the fixed shaft 52 are rotatably decoupled during the second rotational stroke. It should be appreciated that the second rotational stroke may be consecutive to the first rotational stroke. The actuator 60 is threadedly coupled to the fixed shaft 52 so that rotation of the actuator during the second rotational stroke translates or otherwise moves the fixed shaft 52 in a fixed direction relative to the plate body 41 and implant 20.
[0024] The plate 40 may further include an auxiliary shaft 62 that is positionally fixed to the plate body 41 and may provide a locking member configured to interlock with the fixed shaft 52 during rotation and translation of the fixed shaft 52. In particular, the auxiliary shaft 62 may extend into a slot 64 of the fixed member 50, in particular the fixed shaft 52. The slot 64 may extend circumferentially around the axis of rotation 43 along a portion of the circumference of the fixed shaft 52. The slot 64 may be defined by a first end and a second end that respectively define a first stop surface 66 and a second stop surface 68 against which the auxiliary shaft 62 may abut in use. For example, when the fixed shaft 52 is in an unlocked configuration, the auxiliary shaft 62 may abut against the second stop surface 68.
[0025] During a first rotational stroke of the actuator 60, the actuator 60 and the fixing member 50 rotate together relative to the plate until the first stop surface 66 abuts the auxiliary shaft 62. As the actuator 60 rotates during the first rotational stroke, the fixing member 50 likewise rotates from the unlocked configuration to the locked configuration. The abutment between the auxiliary shaft 62 and the first stop surface prevents the fixing member 50 from continuing to rotate in the first direction relative to the plate 40. Thus, continued rotation of the actuator 60 in the first rotational direction is relative to the fixing member 50. The threaded connection between the actuator 60 and the fixing member 50 causes the fixing member 50 to move in the locked direction during a second rotational stroke of the actuator 60. The slot 64 of the fixing member 50 may define a longitudinal opening 70 adjacent the first stop surface 66. The longitudinal opening 70 can extend distally such that the auxiliary shaft 62 moves into the longitudinal opening when the fixation member moves proximally in the fixed direction relative to the plate body 41 and the auxiliary shaft 62. It should be appreciated that in one example, the actuator 60 drives the fixation member 50 to move in the fixed direction only when the fixation member 50 is in the locked configuration.
[0026] When it is desired to separate the plate 40 from the implant 20, the actuator 60 can be rotated in a second rotational direction, opposite to the first rotational direction, relative to the plate body 41. Rotation of the actuator 60 in the second rotational direction causes the auxiliary shaft 62 to abut against a surface of the fixing member 50, particularly the fixing shaft 52, that partially defines the longitudinal opening 70. Thus, the fixing member 50 cannot rotate in the second rotational direction relative to the plate body 41, and thus the actuator 60 rotates relative to the fixing member 50. Relative rotation of the actuator 60 in the second rotational direction relative to the fixing member 50 moves the fixing member 50 distally in a disengagement direction, thereby moving the fixing head 54 away from the retaining wall 56 of the implant 20 and the seat 58 of the plate body 41. The fixing member 50 continues to move distally until the auxiliary shaft 62 is disposed in the slot 64, after which the auxiliary shaft 62 rotatably couples the fixing member 50 and the actuator 60 in the second rotational direction. The actuator 60 rotates together with the fixed member 50 in the second rotational direction to the unlocked configuration whereby the auxiliary shaft 62 seats against the second stop member 68, preventing further rotation of the actuator 60 and fixed member 50 in the second rotational direction.
[0027] The plate body 41 may further include first and second stop members, such as a pair of first and second stop members that abut against the fixed head 54 when the fixed member 50 is in the locked and unlocked configurations, respectively. Thus, the abutment between the fixed head 54 and the stop members, in combination with the abutment between the auxiliary shaft 62 and the stop surfaces 66 and 68, may distribute the load preventing over-rotation of the fixed member 50.
[0028] In operation, the fixation member 50 may be in its unlocked configuration. The plate 40 may be moved toward the proximal end of the implant 20 until the fixation head 52 is inserted through the opening 72 and into an interior void 74 of the implant 20 defined in part by the retaining wall 56. The opening 72 may be large enough to receive the fixation head 52 when the fixation member 50 is in the unlocked configuration, but not large enough to receive the fixation head 52 when the fixation member 50 is in the locked configuration. Once the fixation head 52 is positioned within the void 74, the fixation member 50 may be cycled to the locked configuration in which the fixation head 52 is aligned with the retaining wall 56 in the manner described above. The fixation member 50 is then biased to move in the locked direction until the retaining wall 56 is captured between the fixation head 52 and the seat 58 in the manner described above.
[0029] As shown in FIGS. 2A-2C, the auxiliary shaft 62 can extend from the plate body 41 into the slot 64 of the fixed member 50. Thus, the auxiliary shaft 62 extends into the fixed shaft 52 but does not pass through the fixed shaft 52. Furthermore, the auxiliary shaft 62 terminates without intersecting the rotation axis 43. The auxiliary shaft 62 can be screwed into the plate body 41 to positionally fix the auxiliary shaft 62 relative to the plate body 41. Alternatively, as shown in FIGS. 7A-7C, the auxiliary shaft 62 can be configured as a pin that extends across the rotation axis 43 and can intersect with the rotation axis 43. In particular, the auxiliary shaft 62 can extend completely through the fixed member 50, particularly through the fixed shaft 52. Both ends of the auxiliary shaft 62 can be fixed to the plate body 41. The auxiliary shaft can be described as extending at least into the fixed member 50, which should be understood to mean extending into or through the fixed member 50. The auxiliary shaft 62 may be oriented substantially perpendicular to the axis of rotation 43 .
[0030] 6A-6H , in yet another example, the fixation member 50 can define an angled recess 76 that receives the auxiliary shaft 62 as the fixation member 50 rotates 50 about the rotation axis 43, which drives the fixation member 50 to selectively move proximally in the fixation direction and distally in the disengagement direction. In particular, the recess 76 can extend along a longitudinal direction such that it extends circumferentially around at least a portion of the circumference of the fixation member 50, in particular the fixation shaft 52. The auxiliary shaft 62 is in communication with the fixation shaft 52 to drive the fixation member 50 to selectively move in the fixation direction and the disengagement direction during rotation of the fixation member 50.
[0031] In operation, the fixation member 50 may be in an unlocked configuration such that the fixation head 54 may be inserted into the implant 20 in the manner described above. The fixation member 50 is then rotated in a first rotational direction, causing the auxiliary shaft 62 to ride in the recess 76. The auxiliary shaft 62 then drives the fixation member 50 to translate along the rotation axis 43. In particular, when the fixation member 50 is rotated in a first rotational direction, the auxiliary shaft 62 drives the fixation member 50 to translate in a proximal fixation direction until the retaining wall 56 is captured between the fixation head 54 and the seat 58, as described above. It will be appreciated that because the retaining wall 56 is aligned with the auxiliary head 54 along the longitudinal direction L, the fixation head 54 may be said to be in a locked configuration. Conversely, when the fixation member 50 is rotated in a second rotational direction, the auxiliary shaft 62 drives the fixation member 50 to translate in a distal disengagement direction, thereby moving the fixation head 54 away from the retaining wall 56 until the fixation member 50 is in the unlocked configuration, thereby allowing the fixation head 54 to be removed from the implant 20 by moving the plate 40 in a proximal direction relative to the implant 20.
[0032] In one example, the auxiliary shaft 62 rides within the recess 76, although it should be understood that the recess 76 is merely one example of any suitable track that may be coupled to the auxiliary shaft 62. The auxiliary shaft 62 may ride along the track while positionally fixed to the plate body 41, thereby driving the locking member 50 to rotate into the locked and unlocked configurations as the locking member 50 moves in the locked and disengaged directions, respectively. In one example, the track may be a helical track, or may have any suitable alternative shape desired that causes the locking member to move along the axis of rotation 43 as the locking member rotates about the axis of rotation 43.
[0033] 1A and 2A, the plate 40 may be angularly and translationally adjustable along an adjustment surface 25 located at the proximal or posterior end 24 of the intervertebral implant 20 between a plurality of positions at which the plate 40 is configured to be fixed to the implant 20. The positions may be translationally offset from one another along a horizontal plane and may also be angularly offset relative to one another along the horizontal plane. The horizontal plane may be perpendicular to the transverse direction T and may thus be defined by the longitudinal direction L and the lateral direction A. The adjustment surface 25 may be generally convex in the horizontal plane. The plate 40 may define a complementary concave adjustment surface 45 configured to engage the adjustment surface 25 of the implant 20. Each of the adjustment surface 25 and the adjustment surface 45 may be corrugated to interlock with one another when the plate 40 is positioned in one of the plurality of positions. The adjustment surface 25 is curved so that the angle of the plate 40 is adjusted as the plate translates along the adjustment surface 25. It should be appreciated that the plate 40 may be secured to the implant as described above to releasably lock the plate in one of a number of positions. The different angles at the various positions may be up to 45 degrees, including up to a 30 degree position. In one example, the plate 40 is configured to be secured at any desired angle, such as about 0 degrees, about 15 degrees, and about 30 degrees, as defined by the axis of rotation 43 and the insertion direction of the implant 20.
[0034] 3-5, the kit 35 can include multiple plates 40 as described above, but with different numbers of bone fixation holes 46 and / or bone fixation holes 46 located in different relative locations. For example, as shown in FIGS. 3A-3C and described above, the plates can include a first bone fixation hole 46a and a second bone fixation hole 46b. In other examples shown in FIGS. 4A-4C and 5A-5C, the plates 40 can each include only a single bone fixation hole 46. The plates 40 can be oriented in a first orientation such that the fixation hole 46 is aligned with the superior vertebral body and secured to the implant 20. Alternatively, the plates 40 can be oriented in a second orientation such that the fixation hole is aligned with the superior vertebral body and secured to the implant 20.
[0035] The first plate or plates 40 of the kit 35 may include a respective single bone fixation hole 46 at a first location, as shown in Figures 4A-4C, and the second plate or plates 40 of the kit may include a respective single bone fixation hole at a second location different from the first location, as shown in Figures 5A-5C. Thus, when the first plate and the second plate 40 are stacked on top of each other such that their respective peripheries are aligned, the respective bone fixation holes 48 are not aligned. In one example, the first plate 40 may be a mirror image relative to the second plate. The kit may include a third plate or plates 40 having a first bone fixation hole 46a and a second bone fixation hole 46b as described above. Additionally, the kit may include the plates 40 of Figures 3, 4, and 5 of different sizes. Now referring to FIG. 8 , the kit may further include bone fixation elements 48, which may be configured as bone screws of different lengths configured to be inserted through the bone fixation holes 46 of the plate 40 of the kit and into the underlying bone.
[0036] 1A and 3A-5C, each of the plates 40 described herein can include a cam member 78 associated with each bone fixation hole 46 and movable from a first position spaced apart from the head of the bone fixation element to a second position in which the cam member interferes with the head to prevent backout of the bone fixation element. Thus, the bone fixation element 48 can be inserted through the fixation hole 46 while the cam member 78 is in the first position, and then the cam member 78 can be moved to the second position. In one example, the cam member 78 can rotate from the first position to the second position. For example, the cam member 78 can rotate about an axis oriented along the longitudinal direction L. When the cam member 78 moves to the second position, an inner surface of the cam member 78 can move toward the head of the bone fixation element 48 until the inner surface overlaps the head of the bone fixation element 48. Additionally, the cam member 78 can exert a retaining force against the head of the bone fixation element 48 when the cam member is in the second position, which urges the bone fixation element 48 toward the underlying bone in the direction of insertion into the bone.
[0037] It should be appreciated that the bone fixation system 38 can include a plate 40 and an implant 20. Additionally, a kit can include multiple implants 20 of different sizes and lordotic profiles. Now referring to FIGS. 9A-9B, the bone fixation system 38 can further include an inserter 80 configured to couple to the plate 40. The inserter 80 can include an inner sleeve 82 having a plate-engaging end 84 and an outer sleeve 86 surrounding the inner sleeve and coupled to an engagement member 88 that is movable in a posterior direction to correspondingly move the outer sleeve 86 posteriorly from the plate-engaging end 84 of the inner sleeve 82. The engagement member 88 can, in some instances, be manually moved in a posterior direction to expose the plate-engaging end 84 of the inner sleeve 82. The plate engaging end 84 is configured to be inserted into the groove of the plate body 41 along the insertion direction, and then rotated along the rotation direction to a position where the plate engaging end 84 interferes with one or more flanges of the plate body 41 to prevent the inner sleeve 82 from retracting from the plate body 41 along a direction opposite to the insertion direction, thereby coupling the inserter 80 to the plate body 41. The rotation direction may be centered around the insertion direction. Then, by releasing the engaging member 88, the outer sleeve 86 can be moved forward to engage with the plate body 41 and prevent relative rotation between the inserter 80 and the plate body 41. Since the outer sleeve 86 can be spring-loaded, moving the engaging member 88 in a rearward direction counters the spring force of the spring 90 that biases the outer sleeve 86 in a forward direction. Thus, when the engaging member 88 is released, the outer sleeve 86 moves in a forward direction under the force of the spring 90. An actuator 92, configured as an end cap in one example, can be rotated to tighten the interfaces between the plate body 41 and the inner and outer sleeves 82, 86. In one example, the forward direction can be defined by the distal direction and the rearward direction can be defined by the proximal direction.
[0038] 10A-10B, the bone fixing system 38 may further include a driver instrument 94 configured to be received by or otherwise coupled to the inserter 80. In particular, the inner sleeve 82 of the inserter 80 may be cannulated such that the fixation member 50 or actuator 60 is exposed within the cannula. The fixation member 50 or actuator may include a rearward-facing interface configured to receive the driver instrument 94, which is configured to drive the fixation member 50 or actuator 60 to rotate between the unlocked and locked configurations as described above. The driver instrument 94 may include a handle 95 and a shaft 97 extending distally from the handle 95 and configured to be inserted within the inner sleeve 82 and driven distally until an engagement end 99 of the driver instrument couples with the fixation member 50 or actuator 60. The engagement end 99 may be defined by the shaft 97, in particular as a distal-most portion of the shaft 97. In one example, the engagement end 99 of the driver instrument 94 may be received within an appropriately shaped socket 69 of the fixation member 50 or actuator 60. The inserter 80 may provide a counter torque to the plate body 41 while the driver instrument 94 drives and rotates the fixation member 50 or actuator 60.
[0039] 11A-11B, the inserter 80 can be coupled to the plate 40 and the driver instrument 94 can secure the plate 40 to the implant 20 to create a rigid structure prior to inserting the implant 20 into the intervertebral space 51. Alternatively, the implant 20 can be inserted into the intervertebral space 51 first, and then the inserter 80 can be coupled to the plate 40, and then the driver instrument 94 can secure the plate 40 to the implant 20 in the manner described herein.
[0040] 12A-15, a trial kit 37 can include a trial plate 100 corresponding to each of the plates 40 described herein with respect to FIGS. 3-5 and one or more trial implants 102 corresponding to the intervertebral implants 20 described above. The trial kit 37 including the trial plate 100 and trial implants 102 can be included in the kit 35 described above or can be a separate kit as desired. The trial plate 100 can be abutted against the trial implant 102 or a permanent implant to determine the appropriate size plate 40 to be secured to the implant. The trial plate 100 can be coupled to or integral with a trial insert member 104 configured to be received within an internal cavity of the trial implant to simulate the fixation member 50 in an unlocked configuration. The trial insert member 104 can be further positioned at one of the multiple different angles described above to determine the appropriate plate 40 and the appropriate angle to couple the appropriate plate 40 to the implant 20 within a range of angles. For example, as shown in Figure 12A, the insertion member 104 can be oriented at any suitable angle as desired along a plane defined by the anterior-posterior and medial-lateral directions. As shown in Figure 12B, the trial plate 100 can include first and second fixation holes 146a, 146b, respectively, which can be different sizes and spaced apart by different distances that can positionally correspond to the fixation holes 46a and 46b of the final plate 40 to be implanted.
[0041] 13A-13C, the trial implant 102 may include insertion depth markings 106. The depth markings 106 indicate the insertion depth of the trial implant when the trial implant 102 is inserted and fully seated in the intervertebral space 51. Thus, an appropriately sized final implant 20 may be selected having an insertion depth that is the measured insertion depth of the trial implant or that otherwise corresponds to the measured insertion depth of the trial implant.
[0042] 14A-14D , the trial kit 37 may further include a trial implant inserter 108, which may be removably attachable to the trial implants 102 or may be integral with each of the trial implants 102. The trial implant inserter 108 may deliver the trial implants 102 into the intervertebral space 51. The trial insertion member 104 may be configured as a sleeve 106 that at least partially surrounds the trial implant inserter 108 to position the trial plate 100 relative to the trial implants 102 as desired. In this manner, the desired size and configuration of the final intervertebral implant 20 and the final plate 40 may be determined.
[0043] 15A-15F, any suitable opening instrument 110 can be driven through the fixation holes 146a and 146b of the trial plane 100 to create pilot holes in the underlying bone for later insertion of bone screws through the fixation holes 46a and 46b of the final plate 40 in the manner described above. The trial kit 37 can further include one or more guide sleeves 112 configured to be inserted into either or both of the fixation holes 146a and 146b. Each of the guide sleeves 112 can define an outer wall having an inner surface that defines a through hole 113 and an outer surface opposite the inner surface. The opening instrument 110 can be driven through the through hole 113 such that the inner surface guides the opening instrument 110 into the underlying bone to create pilot holes in the underlying bone. The guide sleeves 112 can define an insertion end 114 configured to be selectively driven into the fixation holes 146a and 146b. The insertion end 114 may define an interlock 116 that may be inserted into the fixation hole to positionally lock the guide sleeve 112 in the fixation hole, as shown in FIG. 15C. The opening instrument 110 thus creates a pilot hole along a fixed trajectory defined by the fixed angle of the guide sleeve 112. Alternatively, the insertion end 114 may define an articular surface 118 that may be rounded or otherwise shaped to articulate along an inner surface of the trial plate 110 that defines the fixation hole. It will be appreciated that as the articular surface 118 articulates, the guide sleeve 112 angles in the fixation hole relative to the trial plate 100, thereby correspondingly adjusting the trajectory of the pilot hole created in the underlying bone. As shown in FIGS. 15E-15F, the opening instrument 110 may be configured, in one example, as a drill 120 having cutting flutes 122. Alternatively, the opening instrument 110 may be configured as an awl 124 having a smooth outer surface 126 and a tapered tip 128. It should be understood that the opening appliance 110 may be alternatively configured as desired.
[0044] It is recognized that the plates described herein can provide stability to the intervertebral implant to resist or prevent migration of the implant when the patient is repositioned during a surgical procedure, for example, from a lateral to a prone position. It is understood that additional posterior fixation, such as pedicle screws and one or more spinal rods, can be implanted when the patient is in the prone position.
[0045] Although the present disclosure has been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention as defined by the appended claims. Moreover, the scope of the present disclosure is not intended to be limited to the specific embodiments described herein. As one skilled in the art would readily appreciate, any currently existing or later developed process, machine, manufacture, composition of matter, means, method, or step that performs substantially the same function or achieves substantially the same result as the corresponding embodiments described herein can be utilized in accordance with the present disclosure.
[0046] [Embodiment] (1) A plate configured for fixation to an intervertebral implant, the intervertebral implant extending distally from the plate, the plate comprising: a plate body having at least one bone fixation hole configured to receive a bone fixation element driven into a vertebral body, the plate body defining a seat; a locking member configured to rotate in a first rotational direction about a rotation axis from an unlocked configuration to a locked configuration; A plate, wherein the fixation member is configured to be driven to translate in a fixed direction along the axis of rotation to a fixed position when the fixation member is in the locked configuration until a retaining wall of the intervertebral implant is captured between the seat and the fixation member. (2) The plate of embodiment 1, wherein the fixation member comprises a fixation shaft and a fixation head, the fixation head being configured to be inserted into the implant when the fixation member is in the unlocked configuration and then repeated into the locked configuration. (3) The plate of embodiment 2, wherein the fixing direction is defined by a proximal direction opposite to the distal direction. (4) The plate of claim 3, wherein the fixation head is aligned with the retaining wall when the fixation head is in the locked configuration and is not aligned with the retaining wall when the fixation head is in the unlocked configuration. (5) A plate as described in any one of embodiments 2 to 4, wherein the fixing head is elliptical and in the unlocked configuration is in a first orientation and in the locked configuration is in a second orientation different from the first orientation.
[0047] (6) The plate of embodiment 5, wherein the fixation heads extend in opposite directions from the fixation shaft. (7) A plate according to any one of embodiments 5 to 6, wherein the fixing heads extend in opposite directions from the ends of the fixing shaft such that the fixing members are substantially T-shaped. (8) The plate according to any one of embodiments 5 to 7, wherein the first orientation and the second orientation are offset from each other by about 90 degrees. (9) A plate as described in any one of embodiments 1 to 8, wherein when the fixing member is in the locking configuration and the retaining wall is captured, the fixing member is configured to be driven to translate in a disengagement direction opposite to the fixing direction, thereby moving the fixing head away from the seat. (10) The plate according to any one of the first to ninth embodiments, wherein the rotation axis is defined by a central axis of the fixed shaft.
[0048] (11) The plate according to any one of embodiments 1 to 10, wherein the fixing member is configured to be driven to translate in the fixed direction while the fixing member rotates in the first rotation direction. (12) The plate of claim 11, further comprising an auxiliary shaft positionally fixed relative to the plate body, the auxiliary shaft cooperating with the fixed shaft to drive the fixed member to move in the fixed direction during rotation of the fixed member. (13) The plate of embodiment 12, wherein the rotation axis is oriented along a longitudinal direction, the fixed member has a track extending along the longitudinal direction when extending circumferentially around the fixed shaft, and the auxiliary shaft is coupled to the track and positionally fixed relative to the plate body. (14) The plate of claim 13, wherein the track includes a recess extending into the fixed shaft, and the auxiliary shaft extends into the recess. (15) The plate according to any one of embodiments 13 to 14, wherein the track is a spiral track.
[0049] (16) A plate according to any one of embodiments 11 to 15, wherein the auxiliary shaft is configured to drive the fixing member to move in a disengagement direction opposite to the fixing direction when the fixing member is rotated in a second rotational direction opposite to the first rotational direction. (17) The plate of any one of claims 1 to 10, further comprising an actuator configured to rotate in the first rotational direction to drive the fixing member to rotate in the first rotational direction to the locking configuration, whereby continued rotation of the driver in the first rotational direction moves the fixing member in the fixing direction. (18) The plate of claim 17, wherein the actuator is configured to drive the fixing member to move in the fixing direction only when the fixing member is in the locked configuration. (19) A plate described in any one of embodiments 17 to 18, wherein the fixed member rotates together with the actuator in the first rotational direction until the fixed member is in the locked configuration, at which point further rotation of the actuator in the first rotational direction is performed relative to the fixed shaft. (20) The plate of embodiment 19, wherein the actuator rotates in a second direction relative to the fixed member until the fixed member moves into the slot, at which point the fixed shaft rotates with further rotation of the actuator.
[0050] (21) A plate described in any of embodiments 17 to 20, further comprising an auxiliary shaft that is positionally fixed to the plate body and abuts against a first stop surface of the fixed shaft when the fixed member is in the locking configuration, the auxiliary shaft being spaced apart from the first stop member when the fixed member is not in the locking configuration. (22) The plate of claim 21, wherein when the fixing member is in the locked configuration, rotation of the actuator in the second rotational direction opposite the first rotational direction moves the fixing shaft in a disengagement direction opposite the fixing direction until the auxiliary shaft seats against a second stop surface of the fixing member. (23) The plate of any one of embodiments 17 to 22, wherein the actuator comprises an interface configured to receive a driver tool that drives and rotates the actuator. (24) The plate of embodiment 23, wherein the actuator comprises a cap disposed around a proximal end portion of the fixed shaft. (25) The method of any one of embodiments 17 to 24, wherein the actuator is threadedly connected to the fixed shaft.
[0051] (26) The plate according to any one of embodiments 22 to 25, wherein the auxiliary shaft extends within a slot in the fixed shaft, and opposing circumferential ends of the slot define the first stop surface and the second stop surface, respectively. (27) The plate of embodiment 26, wherein the axis of rotation is oriented along a longitudinal direction, the slot defines a longitudinal opening adjacent the first stop surface, and the auxiliary shaft moves into the opening as the fixed shaft moves in the fixed direction. (28) A plate according to any one of embodiments 2 to 27, wherein the plate body defines first and second stop surfaces which abut against the fixed head when the fixed head is in the locked configuration and the unlocked configuration, respectively. (29) The plate of embodiment 28, wherein the first and second stop surfaces comprise first and second pairs of stop surfaces. (30) The plate according to any one of embodiments 20 to 29, wherein the auxiliary shaft extends within the fixed shaft but does not pass through the fixed shaft.
[0052] (31) The plate of embodiment 30, wherein the auxiliary shaft terminates without intersecting the rotation axis. (32) The plate according to any one of embodiments 20 to 29, wherein the auxiliary shaft extends through the fixed shaft across the rotation axis. (33) The plate according to any one of embodiments 20 to 32, wherein the auxiliary shaft is oriented substantially perpendicular to the rotation axis. (34) A plate according to any one of embodiments 1 to 33, wherein the plate is configured to be selectively fixed to the intervertebral implant before and after implantation of the implant into the intervertebral space. (35) The plate of any one of embodiments 1 to 34, wherein the at least one bone fixation hole comprises a first bone fixation hole configured to receive a first bone fixation element extending into a first vertebral body and a second bone fixation hole configured to receive a second bone fixation element extending into a second vertebral body, and an intervertebral space configured to receive the intervertebral implant is disposed between the first vertebral body and the second vertebral body.
[0053] (36) A plate according to any one of embodiments 1 to 35, wherein at least one bone fixation hole is the only bone fixation hole in the plate, and the bone fixation hole is in a first position. (37) The plate according to any one of embodiments 1 to 36, further comprising a cam member, the cam member being rotatable from a first position spaced apart from the head of the bone fixation element to a second position in which the cam member interferes with the head to prevent backout of the bone fixation element. (38) The plate of embodiment 37, wherein the inner surface of the cam member moves gradually toward the head of the bone fixation element as it rotates in a direction from the first position to the second position. (39) The plate of embodiment 38, wherein the inner surface of the cam member exerts a retaining force against the head of the bone fixation element when the cam member is in the second position. (40) The kit of plates described in embodiment 36, comprising a first plurality of plates having the only bone fixation hole in a first location and a second plurality of plates having the only bone fixation hole in a second location different from the first location.
[0054] (41) The kit of embodiment 40, wherein the first plurality of plates are mirror images of the second plurality of plates. (42) A kit described in any of embodiments 40 to 41, further comprising a third plurality of plates, each plate having a first bone fixation hole configured to receive a first bone fixation element extending into a first vertebral body and a second bone fixation hole configured to receive a second bone fixation element extending into a second vertebral body, and an intervertebral space configured to receive the intervertebral implant is disposed between the first vertebral body and the second vertebral body. (43) A plate as described in any one of embodiments 1 to 39, wherein the plate is configured to be selectively fixed to the intervertebral implant at a plurality of different positions, the plurality of different positions being translationally offset above and below one another and also angularly offset relative to one another. (44) The plate of embodiment 43, wherein the anterior surface of the plate is scalloped to mate with a scalloped curved surface of the intervertebral implant at each of the plurality of different locations. (45) A plate as described in any of embodiments 43 to 44, wherein the intervertebral implant defines anterior and posterior ends spaced apart from one another along a selected direction, and the rotation axis and the selected direction define a different angle in each of the plurality of different directions.
[0055] (46) The plate of embodiment 45, wherein the different angles are in the range of up to about 30 degrees. (47) A bone fixation system comprising a plate described in any one of embodiments 1 to 39 and 44 to 46 and an intervertebral implant. (48) An inserter configured to be coupled to the plate according to any one of embodiments 1 to 39 and 43 to 46, the inserter comprising: an inner sleeve having a plate engaging end; an outer sleeve surrounding the inner sleeve and coupled to an engagement member, the engagement member movable in a rearward direction to correspondingly move the outer sleeve rearward from the plate engagement end; the plate-engaging end of the inner sleeve is configured to be inserted into a groove in the plate body and then rotated to prevent backout of the inner sleeve, thereby coupling the inserter to the plate body; Thereafter, releasing the engagement member causes the outer sleeve to move forward and engage the plate body, thereby preventing relative rotation between the inserter and the plate body. (49) The inserter of embodiment 48, wherein the inner sleeve is cannulated to receive a driver instrument configured to rotate the actuator or the fixation member of the plate. (50) The inserter of claim 48, wherein the outer sleeve is spring loaded, and moving the engagement member in the rearward direction counteracts a spring force biasing the outer sleeve forward.
[0056] (51) A driver configured to cycle a fixing member of a plate described in any of embodiments 1 to 39 and 43 to 46 from an unlocked configuration to a locked configuration and a fixed position, the driver being insertable within an inner sleeve of an inserter described in any of embodiments 48 to 50, the driver being configured to drive and rotate one of the fixing member and the actuator while the inserter provides a counter torque to the plate.
Claims
1. 1. A plate configured for fixation to an intervertebral implant, the intervertebral implant extending distally from the plate, the plate comprising: a plate body having at least one bone fixation hole configured to receive a bone fixation element driven into a vertebral body, the plate body defining a seat; a locking member configured to rotate in a first rotational direction about a rotation axis from an unlocked configuration to a locked configuration; A plate, wherein the fixation member is configured to be driven to translate in a fixed direction along the axis of rotation to a fixed position when the fixation member is in the locked configuration until a retaining wall of the intervertebral implant is captured between the seat and the fixation member.
2. 2. The plate of claim 1, wherein the fixation member comprises a fixation shaft and a fixation head configured to be inserted into the implant when the fixation member is in the unlocked configuration and then cycled to the locked configuration.
3. The plate of claim 2 , wherein the fixed direction is defined by a proximal direction opposite the distal direction.
4. The plate of claim 3 , wherein the fixation head is aligned with the retaining wall when the fixation head is in the locked configuration and is out of alignment with the retaining wall when the fixation head is in the unlocked configuration.
5. The plate of any one of claims 2 to 4, wherein the fixation head is oval and is in a first orientation in the unlocked configuration and in a second orientation different from the first orientation in the locked configuration.
6. The plate of claim 5 , wherein the fixation heads extend in opposite directions from the fixation shaft.
7. The plate of claim 5 , wherein the first orientation and the second orientation are offset from each other by approximately 90 degrees.
8. The plate of claim 1 , wherein the fixed member is configured to be driven to translate in the fixed direction while the fixed member rotates in the first rotational direction.
9. 9. The plate of claim 8, further comprising an auxiliary shaft positionally fixed relative to the plate body, the auxiliary shaft cooperating with the fixed shaft to drive the fixed member to move in the fixed direction during rotation of the fixed member.
10. 10. The plate of claim 9, wherein the axis of rotation is oriented along a longitudinal direction, the stationary member comprises a track extending along the longitudinal direction when extending circumferentially around the stationary shaft, and the auxiliary shaft is coupled to the track and positionally fixed relative to the plate body.
11. The plate of claim 10 , wherein the track comprises a recess extending into the fixed shaft and the secondary shaft extends into the recess.
12. 2. The plate of claim 1, further comprising an actuator configured to rotate in the first rotational direction to drive the fastening member to rotate in the first rotational direction to the locked configuration, whereby continued rotation of a driver in the first rotational direction moves the fastener in the locked direction.
13. The plate of claim 12 , wherein the actuator is configured to drive the securing member to move in the securing direction only when the securing member is in the locked configuration.
14. 14. A plate according to any one of claims 12 to 13, wherein the fixing member rotates with the actuator in the first rotational direction until the fixing member is in the locked configuration, at which point further rotation of the actuator in the first rotational direction is effected relative to the fixed shaft.
15. 15. The plate of claim 14, wherein the actuator rotates in a second direction relative to the fixation member until the fixation member moves into the slot, at which point the fixation shaft rotates with further rotation of the actuator.
16. 13. The plate of claim 12, further comprising an auxiliary shaft positionally fixed to the plate body and abutting a first stop surface of the fixation shaft when the fixation member is in the locked configuration, the auxiliary shaft being spaced from the first stop member when the fixation member is not in the locked configuration.
17. The plate of claim 2 , wherein the plate body defines first and second stop surfaces that abut the fixation head when the fixation head is in the locked and unlocked configurations, respectively.
18. The plate of claim 15 , wherein the auxiliary shaft terminates without intersecting the axis of rotation.
19. The plate of claim 1 , wherein the plate is configured to be selectively secured to the intervertebral implant before and after implantation of the implant into an intervertebral space.
20. 2. The plate of claim 1, wherein the at least one bone fixation hole comprises a first bone fixation hole configured to receive a first bone fixation element extending into a first vertebral body and a second bone fixation hole configured to receive a second bone fixation element extending into a second vertebral body, and an intervertebral space configured to receive the intervertebral implant is disposed between the first vertebral body and the second vertebral body.
21. The plate of claim 1 , wherein the at least one bone fixation hole is the only bone fixation hole in the plate, and the bone fixation hole is in a first location.
22. 2. The plate of claim 1, further comprising a cam member, the cam member being rotatable from a first position spaced from a head of the bone fixation element to a second position in which the cam member interferes with the head to prevent backout of the bone fixation element.
23. 23. The plate of claim 22, wherein the inner surface of the cam member moves gradually toward the head of the bone fixation element as it rotates in a direction from the first position to the second position.
24. 24. The plate of claim 23, wherein the inner surface of the cam member exerts a retaining force against the head of the bone fixation element when the cam member is in the second position.
25. 10. The plate of claim 1, wherein the plate is configured to be selectively secured to the intervertebral implant at a plurality of different locations, the plurality of different locations being translationally offset above and below one another and also angularly offset relative to one another.