Methods and instrumentation for intervertebral cage expansion

Abstract

To provide improved instruments and methods for implanting expandable implants, such as interbody fusion spacers.SOLUTION: An instrument may be coupled to a multi-axis expandable intervertebral cage so that the cage may be inserted into an intervertebral space, expanded along multiple different directions, filled with a bone graft, and locked with a fastener. The instrument may be part of an instrument set that includes auxiliary instruments to determine implant size, insert a bone graft into the cage, and deliver the fastener.SELECTED DRAWING: Figure 90

Description

[Technical field]

[0001] The present disclosure relates to instruments and methods for implanting and expanding intervertebral implants. The instruments and methods described herein can be used to expand intervertebral implants or spacers that can be expanded in one or more directions, i.e., horizontally (laterally) and / or vertically (cranial-caudal). More specifically, the embodiments of the instruments and methods described herein can be used to implant and expand intervertebral cages as described in pending US Patent Application Publication No. 2016 / 0133934, entitled "EXPANDABLE INTERVERTEBRAL IMPLANTS," filed on August 23, 2016, which is incorporated by reference as if set forth in its entirety. [Background technology]

[0002] There is a need for an instrument that can be coupled to a multi-axis expandable intervertebral cage so that the cage can be inserted into the intervertebral space, expanded along multiple different directions, filled with bone graft, and / or locked with fasteners. There is also a need for an instrument set that includes an implant insertion instrument and auxiliary instruments for determining implant size, inserting bone graft into the cage, and delivering fasteners.

[0003] The implant insertion instruments disclosed herein address the particular characteristics of expandable intervertebral cages. The cage expands horizontally and / or vertically as the first and second implant ends are pulled together along the longitudinal instrument axis. Each of the implant insertion instruments includes a connector that couples to the first implant end and a drawbar that couples to the second implant end. The drawbar can be rotatable about the instrument axis to couple and uncouple from the second implant end, but the drawbar does not rotate about the axis during implant expansion. In some cases, to expand the implant, the implant insertion instrument can be actuated first to lock the drawbar to prevent axial rotation, and then actuated to achieve implant expansion. These actuations can be coupled together to occur together.

[0004] In some cases, the implant insertion instrument disclosed herein also addresses the specific characteristics of specific access to the intervertebral space in the spine. For example, in transforaminal lumbar interbody fusion (TLIF), the patient can be in a prone position (face down) and the approach trajectory can be located in the transverse plane of the operative intervertebral space, tilted about 30 degrees from the sagittal plane (vertical) or 60 degrees from the coronal plane (horizontal). The weight of the implant insertion instrument therefore induces a non-small force moment on the implant, which tends to rotate the implant laterally and dislodge it. The disclosed implant insertion instrument has a removable handle assembly to reduce the weight of the instrument and therefore the force moment on the implant.

[0005] In some instances, the implant insertion instruments disclosed herein also provide the useful and advantageous associated function of a graft funnel, where the funnel can be used to loosen the implant retainer shaft after the bone graft has been delivered to the surgical site. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent Application Serial No. 15 / 244446 Summary of the Invention [Means for solving the problem]

[0007] The various systems and methods of the present technology have been developed in response to the state of the art, and in particular in response to problems and needs in the art that have not yet been fully addressed by currently available expandable implants and related instrumentation. The systems and methods of the present technology can provide improved instrumentation and methods for implanting expandable implants, such as interbody fusion spacers.

[0008] To achieve the foregoing, and in accordance with the technology incorporated and broadly described herein, in an aspect of the technology, an instrument includes a first instrument portion removably connectable to a first implant portion of an implant and a second instrument portion removably connectable to a second implant portion of the implant, wherein the first instrument portion is connected to the first implant portion and the second instrument portion is connected to the second implant portion, and when the instrument is actuated, the first instrument portion and the first implant portion translate relative to the second instrument portion and the second implant portion along a central longitudinal first axis of the instrument without rotating about the first axis during instrument actuation for implant expansion.

[0009] Embodiments of this aspect may include any or all of the following features: the first instrument portion includes a drawbar, the drawbar being removably coupleable to the first implant portion by rotation of the drawbar about a first axis, the instrument further includes an actuator and a rotation lock, instrument actuation includes movement of the actuator engaging the drawbar and translating the drawbar along the first axis relative to the second instrument portion and the second implant portion, when the rotation lock is engaged the drawbar is not permitted to rotate about the first axis and when the rotation lock is disengaged the drawbar is free to rotate about the first axis, the instrument includes a first state in which the actuator is disengaged from the drawbar and the rotation lock is disengaged and the drawbar is free to translate along the first axis and rotate about the first axis, and the instrument includes a second state in which the actuator is engaged with the drawbar and the rotation lock is engaged and the drawbar is prevented from rotating about the first axis. The rotation lock includes a rotation lock ring and a splined insert, where the rotation lock ring and the drawbar are fixed together for rotation about a first axis, the splined insert is fixed in translation along and rotation about the first axis, the splined insert is removably couplable to the rotation lock ring, where when the rotation lock is engaged the splined insert is coupled to the rotation lock ring such that the rotation lock ring cannot rotate about the first axis and when the rotation lock is disengaged the splined insert is disengaged from the rotation lock ring such that the rotation lock ring is free to rotate about the first axis, and the actuator and the rotation lock are coupled together such that when the rotation lock is engaged the actuator engages the drawbar and when the rotation lock is disengaged the actuator disengages from the drawbar. The drawbar includes a threaded portion, the actuator includes a threaded slider, the threaded slider includes a threaded portion that engages with the threaded portion of the drawbar, and the instrument actuation includes rotating the threaded portion of the threaded slider which engages with the threaded portion of the drawbar to translate the drawbar along the first axis relative to the second instrument portion and the second implant portion.6. The instrument of claim 5, wherein the first instrument portion includes a drawbar, the drawbar being removably connectable to the first implant portion by rotation of the drawbar about a first axis, the instrument further includes a shuttle and an actuator, the shuttle is fixed in rotation about the first axis, the shuttle and the drawbar are fixed together for translation along the first axis, and instrument actuation includes movement of the actuator that engages the shuttle to translate the shuttle and the drawbar relative to the second instrument portion and the second implant portion along the first axis. 7. The instrument of claim 5, wherein the shuttle includes a threaded portion and the actuator includes a threaded driver, the threaded driver includes a threaded portion that engages with the threaded portion of the shuttle, and instrument actuation includes rotation of a threaded portion of the threaded driver that engages with the threaded portion of the shuttle to translate the shuttle and the drawbar relative to the second instrument portion and the second implant portion along the first axis. The shuttle includes a series of transverse grooves, the actuator includes a ratchet mechanism including a drive link that engages with the series of transverse grooves, and instrument actuation includes translation of the drive link that engages with the series of transverse grooves to translate the shuttle and pull bar along the first axis relative to the second instrument portion and the second implant portion.

[0010] In another aspect of the present technology, an instrument includes a first instrument portion removably connectable to a first implant portion of an implant by rotating the first instrument portion relative to the first implant portion about a central longitudinal axis of the instrument, and a second instrument portion removably connectable to a second implant portion of the implant, wherein the first instrument portion is connected to the first implant portion and the second instrument portion is connected to the second implant portion, and when the instrument is actuated, the first instrument portion and the first implant portion translate relative to the second instrument portion and the second implant portion along the central longitudinal axis of the instrument such that the first implant portion approaches the second implant portion, and the first instrument portion is prevented from rotating about the central longitudinal axis while the first instrument portion and the first implant portion are translated.

[0011] Embodiments of this aspect may include any or all of the following features: the instrument further includes an actuator and a rotation lock, instrument actuation includes movement of the actuator engaging the first instrument portion to translate the first instrument portion along a first axis relative to the second instrument portion and the second implant portion, when the rotation lock is engaged the first instrument portion is prevented from rotating about the central longitudinal axis and when the rotation lock is disengaged the first instrument portion is free to rotate about the first axis, the instrument includes a first state in which the actuator is disengaged from the first instrument portion and the rotation lock is disengaged and the first instrument portion is free to translate along and rotate about the first axis, and the instrument includes a second state in which the actuator is engaged with the first instrument portion and the rotation lock is engaged and the first instrument portion is prevented from rotating about the first axis. The rotation lock includes a rotation lock ring and a splined insert, where the rotation lock ring and the first instrument portion are fixed together for rotation about the first axis, the splined insert is fixed in translation along and rotation about the first axis, the splined insert is removably couplable to the rotation lock ring, where when the rotation lock is engaged the splined insert is coupled to the rotation lock ring such that the rotation lock ring cannot rotate about the first axis and when the rotation lock is disengaged the splined insert is disconnected from the rotation lock ring such that the rotation lock ring is free to rotate about the first axis, and the actuator and rotation lock are coupled together whereby the actuator engages the first instrument portion when the rotation lock is engaged and disengages from the first instrument portion when the rotation lock is disengaged. The first instrument portion includes a threaded portion, the actuator includes a threaded slider including a threaded portion that engages with the threaded portion of the first instrument portion, and instrument actuation includes rotation of the threaded portion of the threaded slider that engages with the threaded portion of the first instrument portion to translate the first instrument portion relative to the second instrument portion and the second implant portion along a first axis.The instrument further includes a shuttle and an actuator, the shuttle fixed in rotation about a first axis, the shuttle and the first instrument portion fixed together for translation along the first axis, and instrument actuation includes movement of the actuator that engages the shuttle to translate the shuttle and the first instrument portion relative to the second instrument portion and the second implant portion along the first axis. The shuttle includes a threaded portion, the actuator includes a threaded driver, the threaded driver includes a threaded portion that engages with the shuttle threaded portion, and instrument actuation includes rotation of the threaded portion of the threaded driver that engages with the shuttle threaded portion to translate the shuttle and the first instrument portion relative to the second instrument portion and the second implant portion along the first axis. The shuttle includes a series of transverse grooves, the actuator includes a ratchet mechanism including a drive link that engages with the series of transverse grooves, and instrument actuation includes translation of the drive link that engages with the series of transverse grooves to translate the shuttle and first instrument portion relative to the second instrument portion and second implant portion along a first axis.

[0012] In yet another aspect of the present technology, an instrument includes a drawbar carried on a first end of a first shaft and releasably connectable to a first implant portion of the implant by rotating the drawbar relative to the first implant portion about a central longitudinal axis of the instrument, and a second instrument portion carried on a first end of the second shaft and releasably connectable to a second implant portion of the implant, the second instrument portion being operable to translate the drawbar along the central longitudinal axis toward the second instrument portion such that the drawbar does not rotate about the central longitudinal axis during instrument actuation.

[0013] Embodiments of this aspect may include any or all of the following features: the instrument further includes an actuator and a rotation lock, instrument actuation includes movement of the actuator engaging the drawbar to translate the drawbar along a first axis relative to the second instrument portion and the second implant portion, when the rotation lock is engaged the drawbar is not permitted to rotate about the first axis and when the rotation lock is disengaged the drawbar is free to rotate about the first axis, the instrument includes a first state in which the actuator is disengaged from the drawbar and the rotation lock is disengaged and the drawbar is free to translate along and rotate about the first axis, and the instrument includes a second state in which the actuator is engaged with the drawbar and the rotation lock is engaged and the drawbar is prevented from rotating about the first axis. The rotation lock includes a rotation lock ring and a splined insert, where the rotation lock ring and the drawbar are fixed together for rotation about a first axis, the splined insert is fixed in translation along and rotation about the first axis, the splined insert is removably couplable to the rotation lock ring, where when the rotation lock is engaged the splined insert is coupled to the rotation lock ring such that the rotation lock ring cannot rotate about the first axis and when the rotation lock is disengaged the splined insert is disengaged from the rotation lock ring such that the rotation lock ring is free to rotate about the first axis, and the actuator and the rotation lock are coupled together such that when the rotation lock is engaged the actuator engages the drawbar and when the rotation lock is disengaged the actuator disengages from the drawbar. The drawbar includes a threaded portion, the actuator includes a threaded slider, the threaded slider includes a threaded portion that engages with the threaded portion of the drawbar, and the instrument actuation includes rotation of the threaded portion of the threaded slider that engages with the threaded portion of the drawbar and translates the drawbar along a first axis relative to the second instrument portion and the second implant portion.The instrument further includes a shuttle and an actuator, the shuttle fixed in rotation about a first axis, the shuttle and the drawbar fixed together for translation along the first axis, and instrument actuation includes movement of the actuator that engages the shuttle to translate the shuttle and the drawbar relative to the second instrument portion and the second implant portion along the first axis. The shuttle includes a threaded portion, and the actuator includes a threaded driver, the threaded driver includes a threaded portion that engages with the threaded portion of the shuttle, and instrument actuation includes rotation of the threaded portion of the threaded driver that engages with the threaded portion of the shuttle to translate the shuttle and the drawbar relative to the second instrument portion and the second implant portion along the first axis. The shuttle includes a series of transverse grooves, and the actuator includes a ratchet mechanism, the ratchet mechanism includes a drive link that engages with the series of transverse grooves, and instrument actuation includes translation of the drive link that engages with the series of transverse grooves to translate the shuttle and the drawbar relative to the second instrument portion and the second implant portion along the first axis.

[0014] These and other features and advantages of the present technology will become more fully apparent from the following description and appended claims, or may be learned by the practice of the technology as set forth hereinafter. [Brief description of the drawings]

[0015] Exemplary embodiments of the present technology will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which: Exemplary embodiments are described with additional specificity and detail using the accompanying drawings, with the understanding that these drawings represent exemplary embodiments only, and therefore should not be considered limiting of the scope of the present technology.

[0016] [Figure 1] FIG. 13 is a top view of the insertion and expansion instrument. [Diagram 2] 2 is a side view of the device of FIG. 1 with a drawbar assembly inserted into the device and an expandable intervertebral implant coupled to a distal end of the device. [Diagram 3] 3 is a cross-sectional view of the instrument and implant of FIG. 2 taken along line 3-3 of FIG. 2. [Figure 4] FIG. 4 is a detailed distal cross-sectional view of the instrument and implant of FIG. 3. [Diagram 5] FIG. 4 is a proximal detail cross-sectional view of the device of FIG. [Figure 6] FIG. 2 is a top view of the device of FIG. 1 in a first partially assembled state. [Figure 7] FIG. 2 is a top view of the device of FIG. 1 in a second partially assembled state. [Figure 8] FIG. 2 is a top view of the device of FIG. 1 in a fully assembled state. [Figure 9] FIG. 2 is an exploded perspective view of the device of FIG. 1; [Figure 10] 2 is another exploded perspective view of the device of FIG. 1 from a different direction. [Figure 11] FIG. 2 is an exploded perspective view of the shuttle assembly of the instrument of FIG. 1. [Figure 12] FIG. 12 is another exploded perspective view of the shuttle assembly of FIG. 11 from a different direction. [Figure 13] FIG. 10 is a proximal end view of the inserter handle of the instrument of FIG. [Figure 14] FIG. 10 is a distal end view of the inserter handle of the instrument of FIG. [Figure 15] 10 is a proximal end view of the selector ring of the device of FIG. 9. [Figure 16] FIG. 10 is a proximal end view of the expansion knob of the instrument of FIG. [Figure 17] FIG. 10 is a distal end view of the expansion knob of the instrument of FIG. [Figure 18] FIG. 10 is a proximal end view of the threaded driver of the instrument of FIG. [Figure 19] FIG. 10 is a distal end view of the screw driver of the instrument of FIG. [Figure 20] FIG. 25 is a proximal end view of the locking tube coupling of the locking tube assembly of FIG. [Figure 21] FIG. 25 is a distal end view of the locking tube coupling of the locking tube assembly of FIG. [Figure 22]FIG. 2 is an exploded perspective view of the shaft assembly of the instrument of FIG. 1. [Figure 23] FIG. 23 is another exploded perspective view of the shaft assembly of FIG. 22 from a different direction. [Figure 24] FIG. 2 is an exploded perspective view of the locking tube assembly of the instrument of FIG. 1. [Diagram 25] FIG. 25 is another exploded perspective view of the locking tube assembly of FIG. 24 from a different direction. [Figure 26] FIG. 3 is a top view of the drawbar assembly of FIG. [Figure 27] FIG. 2 is a top view of the tamp assembly. [Figure 28] FIG. 2 is a top view of the funnel. [Figure 29] FIG. 13 is a top view of a driver assembly coupled to a lockout screw. [Diagram 30] FIG. 30 is a distal detail view of the driver assembly and lockout screw of FIG. 29. [Diagram 31] FIG. 27 is an exploded perspective view of the drawbar assembly of FIG. 26. [Diagram 32] FIG. 27 is another exploded perspective view of the drawbar assembly of FIG. 26 from a different direction. [Diagram 33] FIG. 29 is a perspective view of the funnel of FIG. 28. [Diagram 34] FIG. 29 is another perspective view of the funnel of FIG. 28 from a different direction. [Diagram 35] FIG. 28 is an exploded perspective view of the tamp assembly of FIG. 27. [Diagram 36] FIG. 28 is another exploded perspective view of the tamp assembly of FIG. 27 from a different direction. [Figure 37] FIG. 30 is an exploded perspective view of the driver assembly of FIG. 29. [Figure 38] FIG. 30 is another exploded perspective view of the driver assembly of FIG. 29 from a different direction. [Figure 39] FIG. 30 is a perspective view of a screw holder and a screw holder catch of the driver assembly of FIG. 29; [Diagram 40] 30 is another perspective view of the screw holder and screw holder catch of the driver assembly of FIG. 29 from a different direction. [Diagram 41]FIG. 41 is a proximal end view of the screw holder of FIG. 40. [Diagram 42] FIG. 41 is a distal end view of the screw holder of FIG. 40. [Diagram 43] FIG. 30 is a perspective view of the lockout screw of FIG. 29. [Diagram 44] FIG. 30 is another perspective view of the lockout screw of FIG. 29 from a different direction. [Diagram 45] FIG. 3 is a rear or second end view of the implant of FIG. 2 in a collapsed configuration. [Figure 46] FIG. 3 is a top view of the implant of FIG. 2. [Figure 47] FIG. 3 is a side view of the implant of FIG. 2. [Figure 48] FIG. 2 is an isometric view of the device of FIG. 1 in an unlocked configuration. [Figure 49] FIG. 49 is an enlarged view of the distal end of the device of FIG. 48. [Figure 50] 3 is an isometric view of the instrument of FIG. 1 with the implant of FIG. 2 coupled to a distal end of the instrument. [Figure 51] FIG. 51 is an enlarged view of the distal end of the instrument and implant of FIG. 50. [Figure 52] FIG. 51 is an isometric view of the instrument and implant of FIG. 50, with the implant adjacent to a vertebral body and in a laterally expanded configuration. [Diagram 53] FIG. 53 is an enlarged view of the instrument, implant, and distal end of the vertebra of FIG. 52. [Figure 54] FIG. 53 is an isometric view of the instrument and implant of FIG. 52, with the implant adjacent to a vertebral body end and in a laterally and vertically expanded configuration. [Figure 55] FIG. 55 is an enlarged view of the instrument, implant, and distal end of the vertebrae of FIG. 54. [Figure 56] FIG. 55 is an isometric view of the instrument and implant of FIG. 54, with the implant adjacent to a vertebral body end and in a laterally and vertically expanded configuration, and the funnel of FIG. 28 coupled to the proximal end of the instrument. [Figure 57] FIG. 57 is an enlarged view of the instrument, implant, and distal end of the vertebrae of FIG. 56. [Figure 58] FIG. 57 is an isometric view of the instrument and implant of FIG. 56, with the implant adjacent to a vertebral end and in a laterally and vertically expanded configuration, with the lockout screw of FIG. 29 extending through the implant and the driver assembly of FIG. 29 inserted through the instrument. [Figure 59] FIG. 59 is an enlarged view of the instrument, implant, and distal end of the vertebrae of FIG. 58. [Figure 60] FIG. 59 is a top view of the implant and vertebrae of FIG. 58. [Figure 61] FIG. 59 is an anterior view of the implant and vertebrae of FIG. 58. [Figure 62] FIG. 59 is a right lateral view of the implant and vertebrae of FIG. 58. [Figure 63] FIG. 59 is a left lateral view of the implant and vertebrae of FIG. 58. [Figure 64] FIG. 13 is a top view of another insertion and expansion instrument. [Figure 65] 65 is a cross-sectional view of the device of FIG. 64 taken along line 65-65 of FIG. 64. [Figure 66] FIG. 66 is a proximal detail cross-sectional view of the device of FIG. [Figure 67] FIG. 66 is a detailed distal cross-sectional view of the device of FIG. 65. [Figure 68] FIG. 65 is a perspective view of the device of FIG. [Figure 69] FIG. 65 is another perspective view of the device of FIG. 64 from a different direction. [Figure 70] FIG. 65 is an exploded perspective view of the device of FIG. [Figure 71] FIG. 65 is another exploded perspective view of the device of FIG. 64 from a different orientation. [Figure 72] FIG. 65 is an exploded perspective view of the ratchet mechanism of the instrument of FIG. [Figure 73] FIG. 73 is another exploded perspective view of the ratchet mechanism of FIG. 72 from a different direction. [Figure 74] FIG. 65 is an exploded perspective view of the shaft assembly of the instrument of FIG. [Figure 75] FIG. 75 is another exploded perspective view of the shaft assembly of FIG. 74 from a different direction. [Figure 76] FIG. 65 is an exploded perspective view of the locking tube assembly of the instrument of FIG. [Figure 77] FIG. 77 is another exploded perspective view of the locking tube assembly of FIG. 76 from a different direction. [Figure 78] FIG. 65 is an exploded perspective view of the drawbar assembly of the device of FIG. [Figure 79] FIG. 79 is another exploded perspective view of the drawbar assembly of FIG. 78 from a different direction. [Figure 80] FIG. 65 is an exploded perspective view of the handle, lock lever, set screw, and release ring of the instrument of FIG. [Figure 81] FIG. 81 is another exploded perspective view of the handle, lock lever, set screw, and release ring of FIG. 80 from a different direction. [Figure 82] FIG. 71 is a proximal end view of the inserter handle of the instrument of FIG. 70. [Figure 83] FIG. 71 is a distal end view of the inserter handle of the instrument of FIG. 70. [Figure 84] FIG. 71 is a right side view of the inserter handle of the instrument of FIG. 70. [Figure 85] FIG. 71 is a left side view of the inserter handle of the instrument of FIG. 70. [Figure 86] 13 is a top view of another insertion and expansion instrument coupled to another expandable intervertebral implant. FIG. [Figure 87] FIG. 87 is a side view of the instrument and implant of FIG. 86. [Figure 88] 88 is a cross-sectional view of the instrument and implant of FIG. 87 taken along line 88-88 of FIG. 87. [Figure 89] 89 is a cross-sectional view of the instrument and implant of FIG. 86 taken along line 89-89 of FIG. 86. [Figure 90] FIG. 87 is a perspective view of the device of FIG. 86. [Figure 91] FIG. 87 is another perspective view of the device of FIG. 86 from a different direction. [Figure 92] FIG. 87 is a perspective view of the inserter connector of the device of FIG. 86. [Figure 93] 93 is another perspective view of the inserter connector of FIG. 92 from a different direction. [Figure 94] FIG. 87 is a perspective view of a connector plate of the device of FIG. 86. [Figure 95] FIG. 95 is another perspective view of the connector plate of FIG. 94 from a different direction. [Figure 96] FIG. 87 is a perspective view of the inserter shaft of the instrument of FIG. 86. [Figure 97] 97 is another perspective view of the inserter shaft of FIG. 96 from a different direction. [Figure 98] FIG. 87 is a perspective view of an implant holder shaft of the instrument of FIG. 86. [Figure 99] 99 is another perspective view of the implant holder shaft of FIG. 98 from a different direction. [Figure 100] FIG. 87 is a perspective view of a connector button of the device of FIG. 86. [Figure 101] 101 is another perspective view of the connector button of FIG. 100 from a different direction. [Figure 102] FIG. 87 is a perspective view of a thumbwheel of the instrument of FIG. 86; [Figure 103] FIG. 103 is another perspective view of the thumbwheel of FIG. 102 from a different direction. [Figure 104] FIG. 87 is a perspective view of a wheel axle of the instrument of FIG. 86; [Figure 105] FIG. 105 is another perspective view of the wheel axle of FIG. 104 from a different direction. [Fig. 106] FIG. 87 is a perspective view of the inserter handle of the instrument of FIG. 86; [Figure 107] FIG. 107 is another perspective view of the inserter handle of FIG. 106 from a different direction. [Figure 108] [Figure 109] FIG. 87 is a perspective view of the backing plate of the instrument of FIG. 86; [Figure 110] FIG. 111 is another perspective view of the backing plate of FIG. 109 from a different direction. [Figure 111] FIG. 87 is a perspective view of a splined insert of the instrument of FIG. 86; [Figure 112] 112 is another perspective view of the splined insert of FIG. 111 from a different direction. [Figure 113]FIG. 87 is a perspective view of a rotation lock ring of the device of FIG. 86. [Fig. 114] FIG. 114 is another perspective view of the rotational lock ring of FIG. 113 from a different direction. [Fig. 115] FIG. 87 is a perspective view of a cam lever of the instrument of FIG. 86. [Fig. 116] FIG. 116 is another perspective view of the cam lever of FIG. 115 from a different direction. [Figure 117] FIG. 87 is a perspective view of a slider button of the device of FIG. 86. [Figure 118] 118 is another perspective view of the slider button of FIG. 117 from a different direction. [Figure 119] FIG. 118 is a side view of the slider button of FIG. [Figure 120] FIG. 87 is a perspective view of a threaded slider of the device of FIG. 86. [Figure 121] FIG. 121 is another perspective view of the threaded slider of FIG. 120 from a different direction. [Figure 122] FIG. 87 is a perspective view of the top of the knob of the instrument of FIG. 86; [Figure 123] 123 is another perspective view of the knob top of FIG. 122 from a different direction. [Figure 124] FIG. 87 is a perspective view of the bottom of the knob of the instrument of FIG. 86. [Fig. 125] 125 is another perspective view of the knob bottom of FIG. 124 from a different direction. [Fig. 126] FIG. 87 is a perspective view of a drawbar assembly for use with the instrument of FIG. 86; [Figure 127] FIG. 127 is another perspective view of the drawbar assembly of FIG. 126 from a different direction. [Figure 128] FIG. 127 is an exploded perspective view of the drawbar assembly of FIG. 126; [Figure 129] FIG. 127 is another exploded perspective view of the drawbar assembly of FIG. 126 from a different direction. [Fig. 130] FIG. 87 is a perspective view of a test assembly for use with the instrument of FIG. 86. [Fig. 131] FIG. 131 is another perspective view of the test assembly of FIG. 130 from a different orientation. [Fig. 132]FIG. 131 is an exploded perspective view of the test assembly of FIG. 130. [Fig. 133] FIG. 131 is another exploded perspective view of the test assembly of FIG. 130 from a different orientation. [Fig. 134] FIG. 87 is a perspective view of a funnel for use with the device of FIG. 86; [Fig. 135] FIG. 135 is another perspective view of the funnel of FIG. 134 from a different direction. [Fig. 136] FIG. 87 is a perspective view of a driver assembly for use with the instrument of FIG. 86; [Fig. 137] FIG. 137 is another perspective view of the driver assembly of FIG. 136 from a different direction. [Figure 138] FIG. 137 is an exploded perspective view of the driver assembly of FIG. 136; [Figure 139] FIG. 137 is another exploded perspective view of the driver assembly of FIG. 136 from a different direction. [Fig. 140] FIG. 87 is a rear or second end view of the implant of FIG. 86 in a collapsed configuration. [Fig. 141] FIG. 87 is a top view of the implant of FIG. 86. [Fig. 142] FIG. 87 is a side view of the implant of FIG. 86. [Fig. 143] FIG. 131 is a perspective view of the trial assembly of FIG. 130 adjacent a vertebral body. [Fig. 144] FIG. 144 is a distal detail perspective view of the trial assembly and vertebral body of FIG. 143. [Fig. 145] 127 is a perspective view of the instrument and implant of FIG. 86 coupled to the drawbar assembly of FIG. 126, with the slider button of the instrument in a proximal position. [Fig. 146] FIG. 146 is a distal detail perspective view of the instrument and implant of FIG. 145. [Fig. 147] FIG. 146 is a perspective view of the instrument, drawbar assembly, and implant of FIG. 145, with the slider button of the instrument in a distal position. [Fig. 148] FIG. 148 is a distal detail perspective view of the instrument and implant of FIG. 147. [Figure 149]FIG. 145 is a perspective view of the instrumentation, drawbar assembly, and implant of FIG. 144, the implant adjacent to a vertebral body and in a laterally expanded configuration. [Fig. 150] FIG. 150 is a detailed distal perspective view of the instrument, implant, and vertebrae of FIG. 149. [Fig. 151] FIG. 150 is a perspective view of the instrumentation, drawbar assembly, and implant of FIG. 149, with the implant adjacent to a vertebral body and in a laterally and vertically expanded configuration. [Fig. 152] FIG. 152 is a detailed distal perspective view of the instrument, implant, and vertebrae of FIG. 151 . [Fig. 153] FIG. 152 is a perspective view of the instrument, drawbar assembly, and implant of FIG. 151 , with the implant adjacent to a vertebral body and in a laterally and vertically expanded configuration, and with the slider button of the instrument released. [Fig. 154] FIG. 154 is a detailed distal perspective view of the instrument, implant, and vertebrae of FIG. 153. [Fig. 155] FIG. 154 is a perspective view of the instrument, drawbar assembly, and implant of FIG. 153, with the implant adjacent to a vertebral body and in a laterally and vertically expanded configuration, with the slider button in a proximal position. [Fig. 156] FIG. 156 is a distal detailed perspective view of the instrument, implant, and vertebrae of FIG. 155. [Fig. 157] FIG. 156 is a perspective view of the instrument and implant of FIG. 155, with the implant in a laterally and vertically expanded configuration and the instrument handle assembly partially removed from the instrument shaft assembly. [Fig. 158] FIG. 157 is a perspective view of the shaft assembly and implant of FIG. 157, the implant adjacent to a vertebral body and in a laterally and vertically expanded configuration, with the funnel of FIG. 134 and the tamp assembly of FIG. 27 coupled to the shaft assembly. [Fig. 159]FIG. 158 is a perspective view of the shaft assembly, implant, and funnel of FIG. 158 with the implant adjacent to the vertebral body and in a laterally and vertically expanded configuration with the driver assembly of FIG. 136 coupled to the lockout screw of FIG. 43 and oriented for insertion into the shaft assembly. [Fig. 160] FIG. 159 is a perspective view of the implant and lockout screw of FIG. 159 adjacent to a vertebral body and in a laterally and vertically expanded configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Exemplary embodiments of the present technology are best understood by reference to the drawings, in which like parts are designated by like numerals throughout. It will be readily understood that the components of the present technology, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of embodiments of devices, systems and methods is not intended to limit the scope of the invention as claimed, but is merely representative of exemplary embodiments of the present technology.

[0018] The phrases "coupled," "coupled," and "in communication" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components can be operatively coupled to one another even if they are not in direct contact with one another. The term "abutting" refers to articles that are in direct physical contact with one another, although the articles do not necessarily have to be attached together. The phrase "fluid communication" refers to two elements that are coupled such that fluid in one element can pass into the other element.

[0019] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While various aspects of the embodiments are presented in figures, the figures are not necessarily drawn to scale unless otherwise indicated.

[0020] Standard medical reference planes and descriptive terms are used herein. The sagittal plane divides the body into bilateral portions. The midsagittal plane divides the body into symmetrical right and left halves. The coronal plane divides the body into anterior and posterior portions. The transverse plane divides the body into superior and inferior portions. Anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward the central axis of the body. Dorsal means away from the central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. Proximal means located toward the center of the body or toward the user. Distal means located away from the center of the body or away from the user. These descriptive terms may be applied to sexual or asexual bodies.

[0021] Standard spinal descriptive terms are used herein with their usual and customary meaning.

[0022] 1 and 2, an instrument 100 for the insertion and expansion of an intervertebral implant is disclosed. The instrument 100 extends along a longitudinal instrument axis 102 from a proximal end 105 to a distal end 107. The instrument 100 includes a handle portion 108 and a shaft portion 110. In FIG. 2, an expandable intervertebral implant 1000 is coupled to the instrument distal end 107 and a drawbar assembly 160 is received within the instrument 100 for expansion of the implant.

[0023] With reference to Figures 3-8, components and features of instrument 100 are disclosed. As seen in Figures 3 and 6, instrument 100 includes a locking collar 120 attachable to shuttle 122. A proximal locking tube 124 extends distally from shuttle 122, and a distal locking tube 126 extends distally from the proximal locking tube. A locking tube coupling 128 couples proximal locking tube 124 and distal locking tube 126 to one another. Locking collar 120, shuttle 122, and proximal locking tube 124 and distal locking tube 126 are cannulated around longitudinal instrument bore 112 that extends along longitudinal instrument axis 102. As seen in Figures 3 and 7, a threaded driver 130, standoff 132, and standoff nut 134 are coupled to shuttle 122. An inserter shaft 136 extends distally from the locking tube coupling 128, with an inserter connector 138 at the distal end of the inserter shaft 136. The outer inserter shaft 136 may include one or more openings to aid in cleaning of the instrument. As seen in FIGS. 3 and 8, the fully assembled instrument further includes an expansion knob 140, an inserter handle 142, a selector ring 144, and an inset cap 146. Markings or indicia 248 on the shuttle 122 or another component may provide an indication of when a particular step of implant expansion has been reached. In one example, the terms "collapsed," "lateral," and "vertical" may be displayed when the implant is in a collapsed, laterally expanded, and vertically expanded configuration, respectively. In other embodiments, letters, numbers, symbols, or other markings may be used to indicate the stage of insertion and / or expansion.

[0024] 9 and 10, the instrument 100 may include a shuttle assembly 114, a standoff nut 134, an inserter handle 142, a selector ring 144, an extension knob 140, a threaded driver 130, a shaft assembly 116, a standoff 132, and a locking tube assembly 118.

[0025] 11 and 12, the shuttle assembly 114 may include a shuttle 122 and a locking collar 120 .

[0026] The shuttle 122 extends between a proximal end 184 and a distal end 186. The proximal end may include a head 188. A shaft 192 may extend from the head 188 toward the distal end 186. The head 188 may be wider than the shaft 192, as shown.

[0027] The head 188 can include, from proximal to distal, a first level 194, a second level 196, a third (FIG. 6) level 198, and a fourth level 202. The first level 194 can have a generally rectangular cross-section and can protrude from the shaft 192 on three sides as shown. The first level 194 can include a tab 204 that protrudes from a first side of the first level. On either side of the tab 204 can be opposing teeth 206, 208 that can also protrude from the first side of the first level. The teeth 206, 208 can be smaller and / or shorter than the tab 204. Opposite recesses 210, 212 can be present between the tab 204 and the teeth 206, 208. The second protruding side 214 and the third protruding side 216 of the first level 194 can be flat. A hole 234 can extend through the tab 204 and can be parallel to the shaft 192. Two opposing holes 236 and 238 can extend into the first level 194 on opposite sides of the tab 204. The hole 236 can be seen in FIG. 12. The hole 238 is hidden by the second level 196. The second level 196 can have a generally rectangular cross-section and can protrude from the shaft 192 all around. The second level 196 can include the tab 204, the teeth 206, 208, and the recesses 210, 212 disposed on a first protruding side of the second level. The second protruding side 218 and the third protruding side 220 can be flat and can be parallel to the sides 214, 216. The side 218 can be recessed relative to the side 214 to form a ledge 222. The side 220 may be recessed relative to the side 216 to form a ledge 224. The fourth protruding side 226 may include a shallow central recess 228 opposite the tab 204. The third level 198 (FIG. 6) may have a circular cross-section and may include a circumferential groove 230. The fourth level 202 may have a circular cross-section and may include a circumferential flange 232.

[0028] The shaft 192 can include, from proximal to distal, a first outer portion 240, a second outer portion 242, a third outer portion 244, and a fourth outer portion 246. The first outer portion 240 can have a circular cross-section and can include indicia 248, such as lines and / or letters (FIG. 6), to indicate various implant configurations, such as collapsed, laterally expanded, and / or vertically expanded. The outer diameter of the first outer portion 240 can be equal to the minor diameter in the groove 230. The second outer portion 242 can include male threads 250. The major diameter of the threads 250 can be equal to the outer diameter of the first outer portion 240. The third outer portion 244 can have a circular cross-section. The outer diameter of the third outer portion 244 can be smaller than the minor diameter of the threads 250. The fourth outer portion 246 can have a generally rectangular cross-section. The cross section can be square with rounded corners as shown. The two opposing flat sides of the fourth outer portion 246 can be parallel to the sides 214, 216 and / or sides 218, 220. The width between the flat sides can be equal to the outer diameter of the third outer portion 244. The width between the rounded corners can be greater than the outer diameter of the third outer portion 244 and less than the outer diameter of the first outer portion 240.

[0029] The shuttle 122 may include a central longitudinal bore 252 extending through the shuttle between the proximal end 184 and the distal end 186. The bore 252 may include, from proximal to distal, a first inner portion 254, a second inner portion 256, a third inner portion 258, a fourth inner portion 260 (FIG. 5), and a fifth inner portion 262. Each of these inner portions may have a circular cross section. The first inner portion 254 may extend through the first level 194 into the proximal end 184 and may terminate at the second level 196. The first inner portion 254 may be referred to as a counterbore associated with the second inner portion 256. The first inner portion 254 may extend through the first level 194 on the opposite side from the tab 204. The second inner portion 256 may extend through the second level 196. The diameter of the second inner portion 256 can be smaller than the diameter of the first inner portion 254. The third inner portion 258 can extend through the third level 198 and the fourth level 202 and through a majority of the first outer portion 240 and can terminate just proximal to the second outer portion 242. There can be a short conically tapered transition between the second inner portion 256 and the third inner portion 258. The diameter of the third inner portion 258 can be smaller than the diameter of the first inner portion 254 and can be larger than the diameter of the second inner portion 256. The fourth inner portion 260 (FIG. 5) can extend between the third inner portion 258 and the fifth inner portion 262. The fourth inner portion 260 can begin just proximal to the second outer portion 242 and can terminate just distal to the first outer portion 240. There can be a short conically tapered transition between the third inner portion 258 and the fourth inner portion 260. The diameter of the fourth inner portion 260 can be smaller than the diameter of the second inner portion 256. The fifth inner portion 262 can extend through the fourth outer portion 246 and the third outer portion 244 and a majority of the second outer portion 242 into the distal end 186 and can terminate just distal to the first outer portion 240. The diameter of the fifth inner portion 262 can be smaller than the diameter of the first inner portion 254 and larger than the diameter of the second inner portion 256.The diameter of the fifth inner portion 262 can be equal to the diameter of the third inner portion 258 .

[0030] The locking collar 120 extends between a proximal side 264 and a distal side 266. The locking collar 120 can have a generally D-shaped profile in a proximal view, having a curved side 268 and three substantially flat sides 270, 272, 274. The proximal side 264 can be flat. A central bore 276 can extend through the locking collar 120 between the proximal side 264 and the distal side 266. The bore 276 can be non-circular in a proximal view. The bore 276 can include a first curved side 278, flat tapered sides 280, 282, flat parallel sides 284, 286, and a second curved side 288. A transitional fillet surface may be present between some or all of the sides 278, 280, 282, 284, 286, 288. A conical surface 290 may be associated with the first curved side 278 and may taper from the proximal side 264 into the bore 276. A slot 292 may extend through the locking collar 120 from the proximal side 264 to the distal side 266. The slot 292 may be located between the curved side 268 and the first curved side 278 and may elongate from the curved side 268 in a direction toward the flat side 272. The distal side 266 may include opposing feet 294, 296 that project distally on either side of the bore 276. The foot 294 may be associated with the flat side 270. The foot 296 may be associated with the flat side 274. Looking distally, the outer profile of the curved side 268 can be concentric with the outer profile of the feet 294, 296. The inner profiles of the feet 294, 296 can be flat and parallel to each other and to the flat sides 270, 274. The feet 294, 296 can be undercut. A undercut groove 298 can extend along the inner profile of the foot 294, and a undercut groove 346 can extend along the inner profile of the foot 296. Taken together, the feet 294, 296 and undercut grooves 298, 346 can form a T-slot that sandwiches the distal side 266. The distal side 266 can include a first surface 348 proximal to the distal faces of the feet 294, 296.The first surface 348 can be at the same level as or similar to the distal most surface of the undercut grooves 298, 346. The distal side 266 can include a second surface 350 proximal to the first surface 348. The second surface 350 can be at the same level as or similar to the proximal most surface of the undercut grooves 298, 346. Bilateral holes 352, 354 (not shown) can extend into the locking collar between the first surface 348 and the second surface 350 along a direction from the curved side 268 to the flat side 272. The bilateral holes 352, 354 can be complementary to the bilateral holes 236, 238 in the head 188 of the shuttle 122. The flat side 272 can include friction elements 356, such as alternating ridges and grooves, knurling, grit blasting, and the like.

[0031] The shuttle assembly 114 may be assembled by orienting the locking collar 120 relative to the head 188 of the shuttle 122 so that the proximal end 184 and proximal side 264 face the same side, the side 226 and side 272 face the same side, and the sides 218, 220 are aligned between the feet 294, 296, and sliding the locking collar 120 along the direction from the flat side 272 to the curved side 268 so that the first level 194 is received in the undercut grooves 298, 346 and the second level 196 is received between the feet 294, 296. A pin or compression spring (not shown) may be inserted into the holes 236, 238 and 352, 354 on both sides. A pin (not shown) may be inserted through the slot 292 into the hole 234. When a compression spring is inserted into holes 236, 238 and 352, 354 and a pin is inserted through slot 292 into hole 234, the spring biases locking collar 120 toward a position where the pin contacts the end of slot 292 closest to outer curved side 268.

[0032] 9 and 10, the standoff nut 134 extends between a proximal side 358 and a distal side 360. The standoff nut 134 may be a generally cylindrical section. The proximal side 358 may include a circumferential outer chamfer 362 and / or opposing cutouts 364, 366. Each cutout may include a longitudinal surface 368 and a transverse surface 370. The distal side 360 ​​may include a circumferential outer chamfer 372. A central bore 374 may extend through the standoff nut 134 between the proximal side 358 and the distal side 360. The bore 374 may include, from proximally to distally, a first inner portion 376, a second inner portion 378, and a third inner portion 380. The first inner portion 376 may have a circular cross-section. The second inner portion 378 can have a circular cross section and can have a larger diameter than the first portion 376. The second inner portion 378 can have a flat proximal end. The third inner portion 380 can have an internal thread that can have a larger diameter the same as or similar to the diameter of the second portion 378. The hole 374 can include an inner chamfer 382 at the distal side 360.

[0033] 5, 9, 10, 13, and 14, the inserter handle 142 extends between a proximal end 384 and a distal end 386. The inserter handle 142 can be generally circular in cross section. The inserter handle 142 can include, from proximal to distal, a first outer portion 388, a second outer portion 390, a third outer portion 392, a fourth outer portion 394, a fifth outer portion 396, and a sixth outer portion 398. The first outer portion 388 can be cylindrical with external threads. The second outer portion 390 can be cylindrical with a diameter that can be the same as or similar to the minor diameter of the external threads of the first outer portion 388. The third outer portion 392 can be cylindrical with a diameter that can be larger than the major diameter of the external threads of the first outer portion 388. The fourth outer portion 394 may be generally hourglass shaped and may include friction elements 400, such as longitudinal grooves, alternating ridges and grooves, knurling, grit blasting, etc. The fifth outer portion 396 may be cylindrical with a diameter that may be larger than the diameter of the third outer portion 392. The fifth outer portion 396 may include indicia 402, such as a distally pointing arrow as shown, and / or an outer chamfer 404. The sixth outer portion 398 may be cylindrical with a diameter that may be the same as or similar to the diameter of the second outer portion 390. The sixth outer portion 398 may include a short base portion 406, which may be immediately adjacent the fifth outer portion 396, and a collar portion 408 at the distal end 386. The collar portion 408 may be horseshoe shaped or C shaped in cross section, with an open side facing the distally pointing arrow 402. Opposite holes 410, 412 may extend proximally into the ends (C-shaped ends) of collar portion 408.

[0034] The inserter handle 142 can include a central longitudinal bore 414 extending through the inserter handle between the proximal end 384 and the distal end 386. The bore 414 can include, from proximal to distal, a first inner portion 416, a second inner portion 418, a third inner portion 420, a fourth inner portion 422, and a fifth inner portion 424. The first inner portion 416 can have a circular cross-section and can extend distally through the first outer portion 388 and the second outer portion 390 and a majority of the third outer portion 392, and can terminate proximally at the fourth outer portion 394. The second inner portion 418 can have a generally rectangular cross-section. The cross-section can be square with rounded corners as shown, and the open side of the collar portion 408 can face one of the flat sides. The width across the flat side and the width across the rounded corner can each be smaller than the diameter of the first inner portion 416. The second inner portion 418 can extend to a location near the center of the entire proximal-distal length of the inserter handle 142. The third inner portion 420 can have a circular cross-section. The diameter of the third inner portion 420 can be the same as or similar to the width across the flat side of the second inner portion 418. The third inner portion 420 can terminate just proximal to the sixth outer portion 398. The fourth inner portion 422 can have a circular cross-section. The diameter of the fourth inner portion 422 can be smaller than the width across the flat side of the second inner portion 418 or the diameter of the third inner portion 420. Opposite longitudinal grooves 426, 428 can extend along the fourth inner portion 422. The width of the grooves 426, 428 can be the same as or similar to the width of the flat side of the second inner portion 418 or the diameter of the third inner portion 420. The grooves 428 can point into the open side of the collar portion 408 near the end with the hole 412. The grooves 426, 428 can point into a rounded corner of the second inner portion 418. The fourth inner portion 422 can terminate just distal to the fifth outer portion 396 or near the middle of the entire proximal-distal length of the base portion 406. The fifth inner portion 424 can have a circular cross-section and can be continuous with the inner wall of the collar portion 408.The diameter of the fifth inner portion 424 can be less than the width across the rounded corners of the second inner portion 418, greater than the width across the flat sides of the second inner portion or the diameter of the third inner portion 420, and greater than the width across the grooves 426, 428. The fifth inner portion 424 can be referred to as a shallow counterbore associated with the fourth inner portion 422.

[0035] 9, 10, and 15, the selector ring 144 extends between a proximal side 430 and a distal side 432. The selector ring 144 can include an outer ring 434, an inner ring 436 within the outer ring, and an arm 438 connecting the inner ring and the outer ring. The outer ring 434 can be a generally cylindrical section with flat proximal and distal sides 430 and 432. The outer surface of the outer ring 434 can include a longitudinal groove 440 and a longitudinal rib 442. The illustrated example includes four longitudinal grooves 440, 444, 446, 448 and three longitudinal ribs 442, 450, 452. The outer surface of the outer ring 434 can also include indicia 454, such as lines, letters, and / or icons as shown, to indicate various settings, such as a locked setting, an unlocked setting, and a setting for cleaning. The inner surface of the outer ring 434 can be cylindrical. The inner ring 436 can be a generally cylindrical portion with flat proximal and distal sides 456, 458. The proximal side 456 can be recessed relative to the proximal side 430, and the distal side 458 can be recessed relative to the distal side 432. The outer surface of the inner ring 436 can be cylindrical as shown. The inner surface of the inner ring 436 can be cylindrical with longitudinal rectangular grooves 460, 462 on either side. The arms 438 can extend between the inner surface of the outer ring 434 and the outer surface of the inner ring 436. The arms 438 can be aligned with the grooves 462. The arms 438 can have a longitudinal hole 464 extending between the proximal side 456 and the distal side 458.

[0036] 9, 10, 16, and 17, the expansion knob 140 extends between a proximal end 466 and a distal end 468. The expansion knob 140 can be generally circular in cross section. The expansion knob 140 can be wider toward the proximal end 466 and narrower toward the distal end 468. The expansion knob 140 can include friction elements 470, such as longitudinal grooves, alternating ridges and grooves, knurling, grit blasting, and the like. Opposite tabs 472, 474 can extend proximally. The tabs 472, 474 can have circular outer and inner profiles. The outer portions of the tabs 472, 474 can include indicia 476, such as a transverse line as shown. Opposite holes 478, 480 can extend distally into the expansion knob 140 and can be located between the tabs 472, 474 (i.e., rotated 90 degrees away from the tabs). The holes 478, 480 may include proximal counterbores.

[0037] The expansion knob 140 may include a central longitudinal bore 482 extending through the expansion knob between a proximal end 466 and a distal end 468. The bore 482 may include, from proximal to distal, a first inner portion 484, a second inner portion 486, a third inner portion 488, and a fourth inner portion 490. The first inner portion 484 may have a circular cross-section. The first inner portion 484 may extend distally approximately one-third of the total proximal-distal length of the expansion knob 140. The second inner portion 486 may have a generally rectangular cross-section. The cross-section may be square with rounded corners as shown. The width encompassing the flat side and the width encompassing the rounded corners may each be greater than the diameter of the first inner portion 484. The second inner portion 486 can extend distally approximately one-third of the entire proximal-distal length of the expansion knob 140, in other words, the second inner portion can occupy the middle third of the entire proximal-distal length of the expansion knob. The third inner portion 488 can have a circular cross-section. The diameter of the third inner portion 488 can be greater than the width of the rounded corner of the second inner portion 486. The third inner portion 488 can terminate just proximal to the distal end 468. The fourth inner portion 490 can have a circular cross-section. The diameter of the fourth inner portion 490 can be the same as, similar to, or greater than the width of the rounded corner of the second inner portion 486 and less than the diameter of the third inner portion 488. The fourth inner portion 490 can form a shallow undercut surface with the third inner portion 488.

[0038] 9, 10, 18, and 19, the threaded driver 130 extends between a proximal end 492 and a distal end 494. The threaded driver 130 may be referred to as an actuator. The threaded driver 130 may be a rectangular solid or a cube. With reference to FIGS. 18 and 19, the threaded driver 130 may have rounded corners when viewed proximally or distally. Side holes 496, 498 may extend into the proximal end 492 about one-third of the entire proximal-distal length of the threaded driver 130. The holes 496, 498 may be located at opposite corners of the proximal end 492. The proximal ends of the holes 496, 498 may include shallow countersinks. The threaded driver 130 may include a central longitudinal hole 500 extending through the threaded driver between the proximal end 492 and the distal end 494. The bore 500 may include, from proximal to distal, a first inner portion 502, a second inner portion 504, a third inner portion 506, a fourth inner portion 508, and a fifth inner portion 510. The first inner portion 502 may be a shallow conical countersink about the bore 500 in the proximal end 492. The second inner portion 504 may be a shallow cylindrical countersink. The third inner portion 506 may include internal threads 512 that receive the external threads 250 of the shuttle 122. With reference to FIGS. 18 and 19 , the cross-sectional shape of the third inner portion 506 may be a superposition of a circle and a rectangle that defines a minor diameter of the internal threads 512. The minor diameter of the internal threads 512 may be smaller than the diameter of the second inner portion 504. The major diameter of the internal threads 512 may be larger than the diameter of the second inner portion 504. The rectangle may be a square and may have rounded corners. The width across the flat side may be slightly less than the minor diameter of the female threads 512. The width across the corner may be slightly less than the major diameter of the female threads 512. The fourth inner portion 508 may be a shallow cylindrical counterbore and has a diameter greater than the minor diameter of the female threads 512 and less than the major diameter of the female threads 512. The diameter of the fourth inner portion 508 may be equal to or similar to the diameter of the second inner portion 504.The fifth inner portion 510 may be a shallow countersink around the hole 500 in the distal end 494 and has a diameter larger than the major diameter of the internal threads 512 .

[0039] 9, 10, 22, and 23, the shaft assembly 116 can include an insert cap 146, an inserter connector 138, and an inserter shaft 136.

[0040] The fitting cap 146 extends between a proximal side 514 and a distal side 516. The fitting cap 146 can be circular in a proximal or distal view. The fitting cap 146 can include, from proximal to distal, a first outer portion 518, a second outer portion 520, and a third outer portion 522. The first outer portion 518 can be cylindrical. The second outer portion 520 can be conical and can be referred to as a chamfer. The third outer portion 522 can be cylindrical and can have a diameter larger than the diameter of the first outer portion 518. The outer distal edge of the third outer portion 522 can be rounded. Indicia 524, such as the mark 524 shown in FIG. 22, can be included on the third outer portion 522. One or more indentations 526 can be included in the proximal side. Three evenly spaced indentations 526, 528, 530 are shown. The central indentation 528 may be aligned with the mark 524. Side holes 532, 534 may extend through the fitting cap 146 between the proximal side 514 and the distal side 516. The holes 532, 534 may be symmetrically located with respect to the mark 524. Referring to FIG. 23, each hole 532, 534 may include a conical distal countersink. A central hole 536 may extend through the fitting cap 146 between the proximal side 514 and the distal side 516.

[0041] The inserter connector 138 extends between a proximal end 538 and a distal end 540. The proximal end 538 can be circular in a proximal view. A notch 542 can be present in an outer proximal edge of the proximal end 538. The notch 542 can be rounded or semicircular in a side view. The distal end 540 can be rectangular in a distal view. The distal end 540 can have rounded corners in a distal view. The major dimension (length) of the rectangle can be aligned with the notch 542. The inserter connector 138 can include a central longitudinal bore 544 extending through the inserter connector between the proximal end 538 and the distal end 540. The bore 544 can include, from proximal to distal, a first inner portion 546, a second inner portion 548, and a third inner portion 550. The first inner portion 546 can have a circular cross-section and can extend distally about one-third of the entire proximal-distal length of the inserter connector 138. The first inner portion 546 can have a flat distal end. The second inner portion 548 can have a circular cross-section with a smaller diameter than the first inner portion 546. The second inner portion 548 can extend distally about one-third of the entire proximal-distal length of the inserter connector 138. With reference to FIG. 23, the cross-sectional shape of the third inner portion 550 can be a superposition of a circle and a rectangle. The diameter of the circle can be smaller than the diameter of the first inner portion 546 and larger than the diameter of the second inner portion 548. The major dimension (length) of the rectangle can be larger than the diameter of the first inner portion 546 and can be aligned with the major dimension (length) of the rectangle of the distal end 540. The minor dimension (width) of the rectangle can be less than the diameter of the circle and less than the diameter of the second inner portion 548. The rectangle can have rounded corners. The third inner portion 550 can have a flat proximal end. The inner distal edge of the rectangle can be chamfered.

[0042] The inserter shaft 136 extends between a proximal end 552 and a distal end 554. The inserter shaft 136 may be a tubular portion with a circular outer cross-sectional shape and an inner cross-sectional shape. The inserter shaft 136 may include, from proximal to distal, a first outer portion 556, a second outer portion 558, and a third outer portion 560. The first outer portion 556 may include a pair of shaped slots 562, 564, each including a substantially 90 degree bend. The slots 562, 564 may extend longitudinally into the proximal end 552 before making the substantially 90 degree bend. Each slot 562, 564 may extend through one wall of the first outer portion 556. The outer diameter of the second outer portion 558 may be greater than the outer diameter of the first outer portion 556. The second outer portion 558 can occupy a majority of the entire proximal-distal length of the inserter shaft 136. The second outer portion 558 can include one or more openings 566. Four openings 566 are shown evenly spaced along the length of the second outer portion 558. Each opening 566 can extend through one wall of the second outer portion 558, or through both walls as shown. The second outer portion 558 can include one or more indicia or markings. Three indicia are shown from proximal to distal: a transverse "8" 568, a longitudinal line 570, and a set of numbers and transverse lines 572. The indicia can be repeated on the opposite side of the second outer portion 558 as shown in FIGS. 22 and 23. The outer diameter of the third outer portion 560 can be smaller than the outer diameter of the first outer portion 556. The inserter shaft 136 can include a central longitudinal bore 574 extending through the inserter shaft between the proximal end 552 and the distal end 554. The bore 574 can be chamfered around its proximal inner edge. The diameter of the bore 574 can be the same as or similar to the diameter of the second inner portion 548 of the inserter connector.

[0043] The shaft assembly 116 may be assembled by inserting the first outer portion 556 of the inserter shaft 136 into the central hole 536 of the fitting cap 146 such that the proximal side 514 and the proximal end 552 face the same direction, the distal side 516 abuts the proximal end of the second outer portion 558, and the mark 524 is aligned with the transverse "8" 568 and / or the longitudinal line 570, and inserting the third outer portion 560 of the inserter shaft 136 into the first inner portion 546 of the inserter connector 138 such that the major dimension of the rectangle of the distal end 540 is transverse or perpendicular to the transverse "8" 568 and / or the longitudinal line 570. The shaft assembly 116 may be a weldment. Alternatively, the fitting cap 146, the inserter connector 138, and / or the inserter shaft 136 may be combined into a single piece.

[0044] 9 and 10, the standoff 132 extends between a proximal end 576 and a distal end 578. The standoff 132 may be a tubular portion with a circular outer cross-sectional shape and an inner cross-sectional shape. The standoff 132 may include, from proximal to distal, a first outer portion 580 and a second outer portion 582. The first outer portion 580 may extend over a majority of the entire proximal-distal length of the standoff 132. The outer diameter of the second outer portion 580 may be larger than the outer diameter of the first outer portion 580 such that the second outer portion 580 forms a flange around the distal end 578. The standoff 132 may include a central longitudinal hole 584 extending through the standoff between the proximal end 576 and the distal end 578.

[0045] 9, 10, 24, and 25, the locking tube assembly 118 may include a proximal locking tube 124, a proximal locking tube terminus 148, a distal locking tube 126, and a locking tube coupling 128.

[0046] The proximal locking tube 124 extends between a proximal end 586 and a distal end 588. The proximal locking tube 124 may be a tubular portion with a circular outer cross-sectional shape and an inner cross-sectional shape. The proximal locking tube 124 may include, from proximally to distally, a first outer portion 590 and a second outer portion 592. The first outer portion 590 may extend distally a short distance. The diameter of the second outer portion 592 may be greater than the diameter of the first outer portion 590. The second outer portion 592 may extend over a majority of the entire proximal-distal length of the proximal locking tube 124. The proximal locking tube 124 may include a central longitudinal bore 594 extending through the proximal locking tube between the proximal end 586 and the distal end 588. The bore 594 may be chamfered around its proximal inner edge.

[0047] The proximal locking tube termination 148 extends between a proximal end 596 and a distal end 598. The proximal locking tube termination 148 may be a tubular portion with a circular outer cross-sectional shape and an inner cross-sectional shape. The proximal locking tube termination 148 may include, from proximal to distal, a first outer portion 600, a second outer portion 602, and a third outer portion 604. The first outer portion 600 may extend distally a short distance and may include a chamfer around its proximal outer edge. The diameter of the second outer portion 602 may be smaller than the diameter of the first outer portion 600. The second outer portion 602 may also extend distally a short distance. The diameter of the third outer portion 604 may be larger than the diameter of the second outer portion 602 and may be equal to the diameter of the first outer portion 600. Thus, the second outer portion 602 may be referred to as an exterior groove about the proximal end 596. There may be a short tapered transition between the distal end of the second outer portion 602 and the proximal end of the third outer portion 604. The proximal locking tube termination 148 may include a central longitudinal bore 606 that extends through the proximal locking tube termination between the proximal end 596 and the distal end 598. The bore 606 may include a chamfer 608 around its proximal inner edge and may include a distal counterbore 610. The inner diameter of the bore 606 may be the same as or similar to the inner diameter of the bore 594.

[0048] The distal locking tube 126 extends between a proximal end 612 and a distal end 614. The distal locking tube 126 may be a tubular portion with circular exterior and interior cross-sectional shapes. The proximal end 612 may include a transverse notch 616 extending through both walls of the distal locking tube 126. The notch 616 may include a rounded distal end. The notch 616 may divide the proximal end 612 into a pair of tabs 618, 620. The notch 616 may gradually increase in width proximally and, correspondingly, each tab 618, 620 may gradually decrease in width proximally to form fingers 622, 624. The distal end 614 may be chamfered around its outer distal edge. With brief reference to FIG. 49, the distal end 614 may include a pair of molded slots 152, each including an approximately 90° bend. The slots 152 can extend longitudinally into the distal end 614 before making an approximately 90° bend. Each slot 152 can extend through one wall of the distal locking tube 126. The distal locking tube 126 can include a central longitudinal bore 626 extending through the distal locking tube between the proximal end 612 and the distal end 614. The inner diameter of the bore 626 can be the same as or similar to the inner diameter of the bore 594.

[0049] 24, 25, 20 and 21, the locking tube coupling 128 extends between a proximal end 628 and a distal end 630. The locking tube coupling 128 may be a tubular portion. The locking tube coupling 128 may include a proximal body 632, which may have a circular cross-sectional outer shape and may extend distally approximately one-half or three-fifths of the entire proximal-distal length of the locking tube coupling 128. Opposite tabs 634, 636 may protrude distally from opposite sides of the body 632. The tabs 634, 636 may be inboard relative to the outer diameter of the body 632. The distal portions of the tabs 634, 636 may include posts 638, 640, respectively. The posts 638, 640 may protrude outwardly from the outer sides of the tabs 634, 636 and may protrude beyond the outer diameter of the body 632, as shown in FIGS. 20 and 21. The locking tube coupling 128 can include a central longitudinal bore 642 extending through the locking tube coupling between the proximal end 628 and the distal end 630. The bore 642 can include, from proximal to distal, a first inner portion 644, a second inner portion 646, and a third inner portion 648. The first inner portion 644 can have a circular cross-section and can extend distally about one-third of the entire proximal-distal length of the locking tube coupling 128 or about half the length of the body 632. The second inner portion 646 can have a circular cross-section with a diameter smaller than that of the first inner portion 644. The diameter of the second inner portion 646 can be the same as or similar to the inner diameter of the bore 594. The second inner portion 646 can extend distally a full diameter for a short distance, but a section can extend past the distal end to form the inner portions of the tabs 634, 636. The third inner portion 648 can have a non-circular cross-section that includes opposing alcoves 650, 652 between the tabs 634, 636 in the distal wall of the body 632 (in other words, the alcoves 650, 652 are located 90° away from the tabs 634, 636).

[0050] The locking tube assembly 118 may be assembled by inserting the first outer portion 590 of the proximal locking tube 124 into the distal counterbore 610 of the proximal locking tube termination 148, inserting the distal end 588 of the proximal locking tube 124 into the first inner portion 644 of the locking tube coupling 128, and inserting the proximal end 612 of the distal locking tube 126 into the third inner portion 648 of the locking tube coupling 128 such that the fingers 622, 624 are received in the alcoves 650, 652 and the tabs 634, 636 are received in the notches 616. The bore 594 of the proximal locking tube 124, the bore 606 of the proximal locking tube termination 148, the bore 626 of the distal locking tube 126, and the second inner portion 646 of the bore 642 of the locking tube coupling 128 may together form the longitudinal instrument bore 112. The proximal locking tube 124, the proximal locking tube terminal end 148, the distal locking tube 126, and the locking tube coupling 128 may be permanently connected, for example by welding, or the proximal locking tube 124, the proximal locking tube terminal end 148, the distal locking tube 126, and / or the locking tube coupling 128 may be combined into a single piece.

[0051] The instrument 100 may be assembled by coupling the shaft assembly 116 to the locking tube assembly 118, coupling the selector ring 144 to the shaft assembly 116 and the locking tube assembly 118, coupling the inserter handle 142 to the shaft assembly 116, the locking tube assembly 118, and the selector ring 144, coupling the standoff 132 and standoff nut 134 to the shaft assembly 116, the locking tube assembly 118, the selector ring 144, and the inserter handle 142, coupling the threaded driver 130 and shuttle assembly 114 to the extension knob 140, and coupling the shuttle assembly, threaded driver, and extension knob 140 to the shaft assembly 116, the locking tube assembly 118, the selector ring 144, and the inserter handle 142.

[0052] Coupling the shaft assembly 116 to the locking tube assembly 118 may include inserting the distal end 614 of the distal locking tube 126 into the hole 574 in the proximal end 552 of the inserter shaft 136, advancing the locking tube assembly 118 distally until the posts 638, 640 enter the molded slots 562, 564, and twisting the locking tube assembly 118 counterclockwise so that the posts 638, 640 are captured within the molded slots 562, 564.

[0053] Coupling the selector ring 144 to the shaft assembly 116 and the locking tube assembly 118 may include inserting the proximal end 596 of the proximal locking tube termination 148 into the inner ring 436 of the selector ring 144 and advancing the locking tube assembly 118 proximally until the posts 638, 640 enter the grooves 460, 462 and the hole 464 is aligned with the central indentation 528. A compression spring or ball detent may be received within the hole 464 to engage the indentations 526, 528, 530.

[0054] Coupling the inserter handle 142 to the shaft assembly 116, the locking tube assembly 118, and the selector ring 144 may include inserting the proximal end 596 of the proximal locking tube terminus 148 into the hole 414 in the distal end 386 of the inserter handle 142, advancing the locking tube assembly 118 proximally until the collar portion 408 enters the space between the outer ring 434 and the inner ring 436, and inserting fasteners, such as screws, through the holes 532, 410 and the holes 534, 412.

[0055] Coupling the standoff 132 and standoff nut 134 to the shaft assembly 116, the locking tube assembly 118, the selector ring 144, and the inserter handle 142 can include inserting a proximal end 596 of the proximal locking tube termination 148 into a hole 584 in the distal end 578 of the standoff 132, advancing the locking tube assembly 118 proximally until the distal end 578 abuts the proximal end 384 of the inserter handle 142, inserting the proximal end 596 into a hole 374 in the distal side 360 ​​of the standoff nut 134, advancing the locking tube assembly 118 proximally until the distal side 360 ​​abuts the proximal end 384, and engaging the female threads of the third inner portion 380 with the male threads of the first outer portion 388 to provide a tight coupling. The notches 364, 366 can facilitate tightening.

[0056] Coupling the threaded driver 130 and shuttle assembly 114 to the expansion knob 140 includes inserting a proximal end 492 of the threaded driver 130 into the hole 482 in the distal end 468 of the expansion knob 140, aligning the holes 478 and 496, advancing the threaded driver 130 proximally into the second inner portion until the proximal end 492 abuts the proximal end of the second inner portion 486, inserting a distal end 186 of the shuttle 122 into the hole 482 in the proximal end 466 of the expansion knob 140, and advancing the distal end 186 of the shuttle 122 to the hole 482 in the proximal end 466 of the expansion knob 140 until the distal end 186 is threaded. This may include advancing the shuttle assembly 114 distally until it abuts the proximal end 492 of the driver 130, aligning the fourth outer portion 246 and the third inner portion 506, further advancing the shuttle assembly 114 distally until the distal end of the second outer portion 242 abuts the proximal end 492, and engaging the male threads 250 of the second outer portion 242 with the female threads 512 of the third inner portion 506 until the shuttle assembly 114, the extension knob 140, and the threaded driver 130 are snugly coupled.

[0057] Coupling the shuttle assembly 114, threaded driver 130, and extension knob 140 to the shaft assembly 116, locking tube assembly 118, selector ring 144, and inserter handle 142 includes inserting the proximal end 596 of the proximal locking tube termination 148 into the bore 252 in the distal end 186 of the shuttle and engaging the fifth inner portion 510 of the threaded driver 130 with the proximal end 576 of the standoff 132 and the third inner portion 488 of the extension knob 140 with the standoff nut 146. The method may include advancing the locking tube assembly 118 proximally until the locking tube assembly 118 receives the fourth outer portion 246 of the inserter handle 142, the fourth inner portion 490 of the extension knob 140 receives the third outer portion 392 of the inserter handle 142, the distal end 468 of the extension knob 140 abuts the distal end of the third outer portion 392, and the second inner portion 418 of the hole 414 of the inserter handle 142 receives the fourth outer portion 246 of the inserter handle 142, and inserting fasteners, such as screws, through the holes 478, 496 and the holes 480, 498.

[0058] The instrument 100 can be actuated by sliding the locking collar 120 , rotating the selector ring 144 , or rotating the extension knob 140 .

[0059] 11 and 12, the locking collar 120 is coupled to the shuttle 122 such that it can slide relative to the shuttle 122 along a direction established by the undercut grooves 298, 346, the feet 294, 296, and the slot 292. The travel of the locking collar 120 may be limited by the presence of a pin within the slot 292 and the bore 234 of the shuttle 122. In this arrangement, the locking collar 120 may slide between a first position and a second position. In the first position, the pin may contact the end of the slot 292 closest to the first curved side 278 of the bore 276. The first position may be referred to as an open or unlocked position. In the second position, the pin may contact the end of the slot 292 closest to the outer curved side 268. The second position may be referred to as a closed or locked position. The locking collar 120 may be biased toward the second position.

[0060] 9, 10, and 15, the selector ring 144 is coupled to posts 638, 640 of the locking tube coupling 128 such that rotation of the selector ring 144 rotates the locking tube assembly 118 relative to the remainder of the instrument 100. With reference to Figures 14 and 15, rotation of the selector ring 144 is limited by the presence of the collar portion 408 in the space between the outer ring 434 and the inner ring 436. In the illustrated example, the selector ring 144 is rotatable between a first position and a third position. In the first position, arm 438 may contact the end of collar portion 408 including hole 412, hole 464 may align with indentation 530, indicia for the cleaning setting 454 may align with distally pointing arrow 402, posts 638, 640 may be positioned within molded slots 562, 564 to be free to slide axially out of the slots, and posts 638, 640 may align with grooves 426, 428. The first position may be referred to as the cleaning position because locking tube assembly 118 and / or other portions of instrument 100 are positioned for disassembly for cleaning or reassembly after cleaning. In the third position, the arm 438 contacts the end of the collar portion 408 including the hole 410, the hole 464 can be aligned with the indentation 526, the indicia for the locked setting 454 can be aligned with the distally pointing arrow 402, the posts 638, 640 can be positioned within the molded slots 562, 564 to be captured within the slots, the posts 638, 640 can be rotated out of alignment with the grooves 426, 428, and the molded slots 152 can be positioned with their distal openings toward the corners of the third inner portion 550 of the hole 544 of the inserter connector 138. The third position can be referred to as a locked position because the members of the instrument 100 are positioned to lock the implant 1000 to the instrument. The selector ring 144 can be rotatable to a second position that is between the first and third positions.In the second position, the arm 438 can be centered within the open side of the collar portion 408, the hole 464 can be aligned with the indentation 528, the indicia for the unlocked setting 454 can be aligned with the distally pointing arrow 402, the posts 638, 640 can be positioned within the molded slots 562, 564 so as to be captured within the slots, the posts 638, 640 can be rotated out of alignment with the grooves 426, 428, and the molded slots 152 can be positioned with their distal openings directed along the major dimension (length) of the third inner portion 550 of the hole 544 of the inserter connector 138. The second position can be referred to as an unlocked position because the members of the instrument 100 are positioned such that the implant 1000 can be coupled or uncoupled from the instrument 100.

[0061] 9-12, 13, 14 and 16-19, the expansion knob 140 is coupled to the shuttle assembly 114, the threaded driver 130, and the inserter handle 142 such that rotation of the expansion knob 140 linearly translates the shuttle assembly 114 along the longitudinal instrument axis 102 without rotating the shuttle assembly 114 about the axis 102. The threaded driver 130 is received within the second inner portion 486 of the bore 482 of the expansion knob 140 such that rotation of the expansion knob 140 rotates the threaded driver 130. The external threads 250 of the second outer portion 242 of the shuttle 122 are received by the internal threads 512 of the third inner portion 506 of the threaded driver 130 and the fourth outer portion 246 of the shuttle 122 is received within the second inner portion 418 of the bore 414 of the inserter handle 142 such that rotation of the threaded driver 130 causes the shuttle assembly 114 to linearly translate along the longitudinal instrument axis 102. In the illustrated example, the shuttle assembly 114 is movable between a first position and a third position. In the first position, the distal side of the flange 232 of the shuttle 122 can abut the proximal end 466 (tabs 472, 474) of the expansion knob 140, the proximal end of the male threads 250 of the second outer portion of the shuttle 122 can be flush with or close to the proximal end 492 of the threaded driver 130, and the indicia 248 of the shuttle 122 for the collapsed configuration can be aligned with the indicia 476 of the expansion knob 140. For this reason, the first position can be referred to as the collapsed position. In the third position, the distal end of the male threads 250 can be flush with or close to the distal end 494 of the threaded driver 130, and the indicia 248 of the shuttle 122 for the vertically expanded configuration can be aligned with the indicia 476 of the expansion knob 140. For this reason, the third position can be referred to as the vertically expanded position. The shuttle assembly 114 can be movable to a second position between the first and third positions. In the second position, the distal end of the male threads 250 can be flush with or near the proximal end 358 of the standoff nut 134 and the indicia 248 of the shuttle 122 for the laterally expanded configuration can be aligned with the indicia 476 of the extension knob 140.For this reason, the second position may be referred to as a laterally extended position. The shuttle assembly 114 may be movable to any number of positions between the first and third positions by the threaded interconnection between the shuttle 122 and the threaded driver 130.

[0062] A variety of additional tools may be used with the instrument 100 to implant and expand intervertebral implants. The instrument 100 and selected additional tools may be provided as a kit and may collectively be referred to as an instrument system 115. FIGS. 26-30 disclose the additional tools of the instrument system 115, including a drawbar assembly 160, a graft funnel 170, a tamp assembly 180, and a driver assembly 190. The drawbar assembly 160 may include a threaded tip 162 and a handle 164. The driver assembly 190 may be assembled with a screw holder 200 to hold a lockout screw 654 and be driven into an implant, such as the implant 1000, to lock the implant in an expanded configuration. The instrument system 115 may be used to implant and / or expand other expandable implants.

[0063] 26, 31, and 32, the drawbar assembly 160 may include a drawbar 156 and a drawbar knob or handle 164.

[0064] The drawbar 156 extends between a proximal end 656 and a distal end 658. The drawbar 156 may be a cylindrical shaft as shown. The drawbar 156 may include, from proximal to distal, a first outer portion 660, a second outer portion 662, and a third outer portion 664. The first outer portion 660 may extend distally the majority of the entire proximal-distal length of the drawbar 156 and may be chamfered around its proximal outer edge. The diameter of the second outer portion 662 may be smaller than the diameter of the first outer portion 660. A tapered shoulder 668 may be included between the first outer portion 660 and the second outer portion 662. The third outer portion 664 may include a threaded tip 162 with male threads. The major diameter of the threads may be smaller than the diameter of the second outer portion 662.

[0065] The drawbar handle 164 extends between a proximal end 670 and a distal end 672. The drawbar handle 164 may include, from proximal to distal, a knob body 674 and a shaft 676. The knob body 674 may be generally disk-shaped with an outer diameter greater than its proximal-distal length. The knob body 674 may include one or more gripping elements 678, such as the six rim scallops shown. The outer diameter of the shaft 676 may be less than the outer diameter of the knob body 674, and the proximal-distal length of the shaft may be greater than the proximal-distal length of the knob body 674. The shaft 676 may include a flange 680 (annular portion 166) extending circumferentially around a central portion of the shaft. The flange 680 may include a distal chamfer 682. The shaft 676 may include one or more holes 684 extending transversely into or through the shaft. Two through holes 684 are shown just distal to the distal side of the knob body 674. The two through holes 684 are at right angles to each other. The drawbar handle 164 can include a central longitudinal bore 686 that extends through the drawbar handle between the proximal end 670 and the distal end 672. The bore 686 can include, from proximal to distal, a first inner portion 688, a second inner portion 690, a third inner portion 692, and a fourth inner portion 694. The first inner portion 688 can have a circular cross section and can extend distally about half, or a majority of, the proximal-distal length of the knob body 674. The first inner portion 688 can have a flat distal end. A circumferential fillet radius can be present around a proximal inner edge of the first inner portion 688. A circumferential fillet radius can be present in the distal inner corner of the first inner portion 688. The second inner portion 690 can be conical. The second inner portion 690 can be referred to as a countersink, or a circumferential chamfer, associated with the third inner portion 692. The major diameter of the second inner portion 690 can be less than the diameter of the first inner portion 688. The third inner portion 692 can have a circular cross section and can extend distally to a level at or similar to the distal side of the knob body 674.The diameter of the third inner portion 692 can be smaller than the diameter of the first inner portion 688. The fourth inner portion 694 can have a circular cross-section and can extend distally through the distal end 672 of the drawbar handle 164. The diameter of the fourth inner portion 694 can be smaller than the diameter of the first inner portion 688 and larger than the larger diameter of the second inner portion 690 and the diameter of the third inner portion 692. The fourth inner portion 694 can have a flat proximal end. A bore 684 can extend into the proximal end of the fourth inner portion 694.

[0066] The drawbar assembly 160 may be assembled by inserting the proximal end 656 of the drawbar 156 into the hole 686 of the drawbar handle 164 such that the first portion 660 is received within the third inner portion 692 and the proximal end 656 is at the same or similar level as the distal end of the first inner portion 688. A circumferential gap 696 may exist between the outer surface of the first portion 660 and the inner surface of the fourth inner portion 694. See FIG. 5. The drawbar 156 and the drawbar handle 164 may be permanently connected, for example, by welding. Alternatively, the drawbar 156 and the drawbar handle 164 may be combined into a single part.

[0067] The drawbar 156 may be received within the locking tube assembly 118, more specifically within the bore 606 of the proximal locking tube terminus 148, the bore 594 of the proximal locking tube 124, the second inner portion 646 of the bore 642 of the locking tube coupling 128, and the bore 626 of the distal locking tube 126.

[0068] 28, 33, and 34, the graft funnel 170 extends between a proximal end 698 and a distal end 700. The graft funnel 170 may include a proximal mouth 702 and a distal stem 704. The mouth 702 and stem 704 may have a circular cross-section. The mouth 702 may be conically or otherwise tapered. The diameter of the stem 704 may be significantly smaller than the diameter of the mouth 702. The graft funnel 170 may include a central longitudinal bore 706 extending through the graft funnel between the proximal end 698 and the distal end 700. The bore 706 may include, from proximally to distally, a first inner portion 708, a second inner portion 710, a third inner portion 712, and a fourth inner portion 714. Each of these inner portions may have a circular cross-section. The first inner portion 708 may be conically or otherwise tapered and may be shaped like the mouth 702. The second inner portion 710 may be described as a fillet radius transition or throat between the first inner portion 708 and the third inner portion 712. The second inner portion 710 may be at the same or similar level as the transition between the mouth 702 and the stem 704. The diameter of the third inner portion 712 may be smaller than the minor diameter of the first inner portion 708. The fourth inner portion 714 may extend proximally about half or more of the proximal-distal length of the stem 704. The diameter of the fourth inner portion 714 may be larger than the diameter of the third inner portion 712. The proximal end of the fourth inner portion 714 may be flat and a circumferential chamfer may be present at the inner edge between the third inner portion 712 and the fourth inner portion 714.

[0069] The stem 704 may be received by the second inner portion 256 of the bore 252 of the shuttle 122 of the shuttle assembly 114. The fourth inner portion 714 may receive the proximal end 596 of the proximal locking tube termination 148 of the locking tube assembly 118. The diameter of the third inner portion 712 may be the same as or similar to the diameter of the bore 606.

[0070] 27, 35 and 36, the tamp assembly 180 can include a tamp shaft 158, a tamp shaft upper portion 168, a tamp handle 172, and a tamp shaft tip portion 174.

[0071] The tamp shaft 158 ​​extends between a proximal end 716 and a distal end 718. The tamp shaft 158 ​​may be a cylindrical shaft as shown. The tamp shaft 158 ​​may include a proximal, externally threaded portion 720 and a distal, smooth portion 722. The diameter of the distal, smooth portion 722 may be larger than the larger diameter of the proximal, externally threaded portion 720. The tamp shaft 158 ​​may include a central, longitudinal, internally threaded bore 724 extending proximally into the distal end 718.

[0072] The tamp shaft upper portion 168 extends between a proximal end 726 and a distal end 728. The tamp shaft upper portion 168 can include a proximal male threaded portion 730, a central smooth cylindrical portion 732, and a distal torque coupling 734, such as the hex key shown. The diameter of the central smooth cylindrical portion 732 can be larger than the major diameter of the proximal male threaded portion 730. The outer diameter of the distal torque coupling 734 can be smaller than the diameter of the central smooth cylindrical portion 732. The tamp shaft upper portion 168 can include a central longitudinal female threaded bore 736 extending proximally into the distal end 728.

[0073] The tamp handle 172 extends between a proximal end 738 and a distal end 740. The tamp handle 172 may be a cylindrical portion with rounded proximal and distal ends 738, 740 as shown. The tamp handle 172 may include one or more friction elements 742, such as a series of shallow circumferential grooves as shown. The tamp handle 172 may include a central longitudinal bore 744 extending proximally into the distal end 740. The bore 744 may extend proximally approximately half, or a majority, of the entire proximal-distal length of the tamp handle 172. The bore 744 may include, from proximal to distal, a first inner portion 746, a second inner portion 748, and a third inner portion 750 of approximately equal proximal-distal lengths. Each of the inner portions may have a circular cross section. The first inner portion 746 is not visible in FIG. The first inner portion 746 may be a blind hole included to facilitate manufacturing of the second inner portion 748 having female threads. The minor diameter of the threads may be equal to or similar to the diameter of the first inner portion 750. The diameter of the third inner portion 750 may be larger than the major diameter of the threads. The third inner portion 750 may be referred to as a counterbore about the second inner portion 748. The proximal end of the third inner portion 750 may be flat.

[0074] The tamp shaft tip 174 extends between a proximal end 752 and a distal end 754. The tamp shaft tip 174 may be a cylindrical shaft as shown. The tamp shaft tip 174 may include a proximal male threaded portion 756 and a distal smooth portion 758. The diameter of the distal smooth portion 758 may be greater than the larger diameter of the proximal male threaded portion 756. The distal end 754 may have a concave surface 760.

[0075] The tamp assembly 180 may be assembled by threading the proximal externally threaded portion 730 of the tamp shaft top 168 into the second inner portion 748 of the bore 744 of the tamp handle 172, threading the proximal externally threaded portion 720 of the tamp shaft 158 ​​into the bore 736 of the tamp shaft top 168, and threading the proximal externally threaded portion 756 of the tamp shaft tip 174 into the bore 724 of the tamp shaft 158, such that the central smooth cylindrical portion 732 is received within the third inner portion 750. The tamp assembly 180 may be a weldment. Alternatively, the tamp shaft 158, the tamp shaft top 168, the tamp handle 172, and / or the tamp shaft tip 174 may be combined into a single piece.

[0076] The outer diameter of the distal smooth portion 722 of the tamp shaft 158 ​​and the distal smooth portion 758 of the tamp shaft tip 174 may be received within the inner diameter of the third inner portion 712 of the bore 706 of the graft funnel 170, and within the locking tube assembly 118, more specifically, the bore 606 of the proximal locking tube terminus 148, the bore 594 of the proximal locking tube 124, the second inner portion 646 of the bore 642 of the locking tube coupling 128, and the bore 626 of the distal locking tube 126.

[0077] 29, 30, 37 and 38, the driver assembly 190 may include a handle 176, a shaft 178, a screw holder 200, and a screw holder catch 182.

[0078] The handle 176 extends between a proximal end 762 and a distal end 764. The handle 176 can include a proximal gripping portion 766 with one or more friction elements 768, such as the four generally pear-shaped indentations shown, and a distal shaft 770. The shaft 770 can include a proximal first portion 772 and a distal second portion 774. The first portion 772 can include one or more friction elements 776, such as a series of shallow circumferential grooves shown. The first portion 772 can be a sleeve that is longitudinally movable relative to the second portion 774. A central longitudinal D-shaped hole 778 can extend proximally into the distal end 764. One or more balls (not shown) may be captured between the first portion 772 and the second portion 774 and may protrude at least partially into the D-shaped hole 778 when the first portion 772 is in a first position relative to the second portion 774. The balls are free to move radially away from the hole 778 when the first portion 772 is in a second position relative to the second portion 774. The first portion 772 may be biased toward the first position.

[0079] The shaft 178 extends between a proximal end 780 and a distal end 782. The shaft 178 can be generally cylindrical as shown. The shaft 178 can include, from proximal to distal, a first outer portion 784, a second outer portion 786, a third outer portion 788, a fourth outer portion 790, and a fifth outer portion 792. The first outer portion 784 can have a generally circular cross section and can include a longitudinal flat 794 on only one side such that the first outer portion 784 is complementary to a D-shaped hole 778 in the shaft 770 of the handle 176. A circumferential groove 796 can extend around the circular side of the first outer portion 784 to engage a ball in the shaft 770 of the handle 176. The diameter of the second outer portion 786 can be greater than the diameter of the first outer portion 784. The second outer portion 786 can extend over a majority of the proximal-distal length of the shaft 178. The third outer portion 788 can include male threads. The major diameter of the threads can be smaller than the diameter of the second outer portion 786. The fourth outer portion 790 can have a circular cross-section and can be smooth. The diameter of the fourth outer portion 790 can be the same as or similar to the minor diameter of the threads of the third outer portion 788. The fifth outer portion 792 can include a torque coupling 798, such as a hex key as shown.

[0080] 39-42, the screw holder 200 extends between a proximal end 800 and a distal end 802. The screw holder 200 may be a tubular portion with a generally circular exterior and interior cross-sectional shape. The screw holder 200 may include, from proximal to distal, a first outer portion 804 and a second outer portion 806. The first outer portion 804 may have a generally circular cross-section and may extend distally over a majority of the proximal-distal length of the screw holder 200. Opposite flats 808, 810 may be included at or near the middle of the proximal-distal length of the first outer portion. A longitudinal slot 812 may extend through one wall of the first outer portion 804 and may be located between the flats 808, 810. The proximal end of the slot 812 can be at the same or similar level as the proximal ends of the flats 808, 810. The proximal end of the slot 812 can include a circular counterbore 814. The distal end of the slot 812 can extend distally approximately twice as far as the distal ends of the flats 808, 810. The slot 812 can be rectangular or elliptical. The second outer portion 806 can taper inwardly toward the distal end 802. The second outer portion 806 can be conical. The second outer portion 806 can include a notch 816 that extends proximally from the distal end 802 through one wall of the second outer portion 806. The notch 816 can be rectangular or square and can have rounded corners. The notch 816 can be in line with the slot 812. The screw holder 200 can include a central longitudinal bore 818 extending through the screw holder between the proximal end 800 and the distal end 802. The bore 818 can include, from proximal to distal, a first inner portion 820, a second inner portion 822, and a third inner portion 824. The first inner portion 820 can include female threads. The diameter of the second inner portion 822 can be less than, equal to, or similar to the minor diameter of the threads. The proximal end of the second inner portion 822 can be proximal to the proximal ends of the flats 808, 810.The distal end of the second inner portion 822 can be distal to the proximal end of the notch 816 and can be at or near the middle of the proximal-distal length of the notch 816. A short tapered surface can be included at the transition between the second inner portion 822 and the third inner portion 824. The second inner portion 822 can include a longitudinal alcove 826 on only one side that extends into one wall of the second inner portion 822. The alcove 826 can be in alignment with the slot 812 and the notch 816. The diameter of the third inner portion 824 can be smaller than the major diameter of the threads of the first inner portion 820 and larger than the minor diameter of the threads.

[0081] The screw holder catch 182 extends between a proximal end 828 and a distal end 830. The screw holder catch 182 may be a generally plate-like portion and may include, from proximal to distal, a first portion 832, a second portion 834, and a third portion 836. The first portion 832 may have a size and shape that is complementary to the slot 812 of the screw holder 200. The proximal end of the first portion 832 may include a circular shelf 838 that is complementary to the counterbore 814. The second portion 834 may be offset from the first portion 832 in a direction opposite the shelf 838 and may be substantially parallel to the first portion 832. The second portion 834 may include a longitudinal arcuate groove 840 that faces in the same direction as the shelf 838. The third portion 836 may have a size and shape that is complementary to the notch 816 of the screw holder 200. The third portion 836 can be aligned with the first portion 832 (and thus offset from the second portion in a direction toward the ledge 838). The third portion 836 can include distal teeth 842 that face in the same direction as the ledge 838.

[0082] The screwdriver assembly 190 may be assembled by coupling the screw holder catch 182 to the screw holder 200 such that the ledge 838 is in the counterbore 814, the second portion 834 is in the alcove 826, the third portion 836 is in the notch 816, and the groove 840 faces the interior of the screw holder 200, threading the first inner portion 820 of the hole 818 of the screw holder 200 onto the third outer portion 788 of the shaft 178, and inserting the first outer portion 784 of the shaft 178 into the D-shaped hole 778 of the handle 176 such that the ball engages the groove 796. Alternatively, the handle 176, shaft 178, screw holder 200, and / or screw holder catch 182 may be combined into a single piece.

[0083] The outer diameter of the first outer portion 804 of the screw holder 200 and the second outer portion 786 of the shaft 178 may be received within the inner diameter of the third inner portion 712 of the bore 706 of the graft funnel 170 and within the locking tube assembly 118, more specifically, within the bore 606 of the proximal locking tube terminus 148, the bore 594 of the proximal locking tube 124, the second inner portion 646 of the bore 642 of the locking tube coupling 128, and the bore 626 of the distal locking tube 126.

[0084] 43 and 44, the lockout screw 654 extends between a proximal end 844 and a distal end 846. The lockout screw 654 can include, from proximal to distal, a first portion 848, a second portion 850, a third portion 852, a fourth portion 854, a fifth portion 856, and a sixth portion 858, each having a circular cross section. The first portion 848 can include a rounded outer proximal circumferential edge and can extend a short distance in the proximal-distal direction. The first portion 848 can form a circumferential lip or flange around the proximal end of the lockout screw 654. The diameter of the second portion 850 can be smaller than the diameter of the first portion 848. There can be a 90 degree corner between the first portion 848 and the second portion 850. The diameter of the third portion 852 can be larger than the diameter of the first portion 848. There can be a 90 degree corner between the second portion 850 and the third portion 852, such that the second portion 850 forms a circumferential groove between the first portion 848 and the third portion 852. The third portion 852 can have a rounded outer proximal circumferential edge. The diameter of the fourth portion 854 can be the same as or similar to the diameter of the first portion 848, larger than the diameter of the second portion 850, and smaller than the diameter of the third portion 852. There can be a shoulder 655 between the third portion 852 and the fourth portion 854. The shoulder 655 can be tapered and can be conical. The fourth portion 854 can extend distally to about the middle of the proximal-distal length of the lockout screw 654. The fifth portion 856 can include an externally threaded portion 653. The major diameter of the threads can be the same as or similar to the diameter of the fourth portion 854. There can be a tapered transition between the fourth portion 854 and the fifth portion 856. The diameter of the sixth portion 858 can be the same as or similar to the minor diameter of the threaded portion 653. The sixth portion 858 can have a smooth shaft and can include a rounded outer distal circumferential edge. The lockout screw 654 can include a torque coupling 860 in or on the proximal end 844, such as the hex socket shown.The lockout screw 654 is described in pending US Pat. No. 5,399,623.

[0085] The outer diameter of the third portion 852 of the lockout screw 654 may be received within the inner diameter of the third inner portion 712 of the hole 706 of the graft funnel 170 and within the locking tube assembly 118, more specifically, within the hole 606 of the proximal locking tube terminal end 148, the hole 594 of the proximal locking tube 124, the second inner portion 646 of the hole 642 of the locking tube coupling 128, and the hole 626 of the distal locking tube 126.

[0086] The lockout screw 654 can be coupled to the screwdriver assembly 190 by coupling the torque coupling 798 of the shaft 178 to the torque coupling 860 of the lockout screw 654, inserting the first portion 848 of the lockout screw 654 into the third inner portion 824 of the screw holder 200, and engaging the teeth 842 of the screw holder catch 182 within the second portion 850 of the lockout screw 654. Alternatively, the lockout screw 654 may be coupled to the driver assembly 190 by inserting a first portion 848 of the lockout screw 654 into the third inner portion 824 of the screw holder 200, engaging the teeth 842 of the screw holder catch 182 into the second portion 850 of the lockout screw 654, coupling the torque coupling 798 of the shaft 178 to the torque coupling 860 of the lockout screw 654, and threading the first inner portion 820 of the bore 818 of the screw holder 200 onto the third outer portion 788 of the shaft 178. The lockout screw 654 may be uncoupled from the driver assembly 190 by reversing these steps.

[0087] 45-47, the implant 1000 is expandable along a horizontal or lateral or transverse or medial-lateral axis 104 and a vertical or cranio-caudal axis 106. The implant 1000 includes a first support member 1040 and a second support member 1030, the support members being connected by a first end 1050 and a second end 1052. The first support member 1040 may include an upper support 1042 and a lower support 1044. A pair of linking pins 1055 protrude from the second end 1052. A plurality of link members 1060, 1062, 1064, 1066 pivotally connect each of the first end 1050 and the second end 1052 to each of the support members 1030, 1040. The lower support 1044 includes angled expansion slots 1114, 1124, and the upper support includes angled expansion slots 1154, 1164. The implant 1000 represents the intervertebral cage described in pending US Pat. No. 6,399,323.

[0088] 48-59, a method for inserting and expanding an expandable intervertebral implant with an instrument system 115 is shown. The instrument 100 as seen in FIGS. 48 and 49 includes a bayonet receiver 150 at the distal end 107 of the distal locking tube 126. The bayonet receiver 150 includes a pair of molded slots 152, each including an approximately 90° bend. The slots are in the distal end 614 of the distal locking tube 126 of the locking tube assembly 118. The bayonet receiver 150 may also include the inserter connector 138 of the shaft assembly 116. In one step of the method, an implant 1000 is attached to the distal end 107 of the instrument 100. A link pin 1055 is received in the molded slot 152 of the bayonet receiver 150, thereby causing the implant 1000 to extend distally from the instrument 100. The distal locking tube 126 is rotated so that the pin 1055 traverses the 90° bend in the molded slot 152 to form the bayonet connection 154, locking the implant 1000 to the instrument 100. The second end 1052 of the implant may be stabilized against rotation by mating it within the third inner portion 550 of the inserter connector 138. Other embodiments within the scope of the present disclosure may include a threaded connection between the implant 1000 and the instrument 100 rather than a bayonet connection. In one embodiment, the distal locking tube 126 may be rotated by rotation of the selector ring 144. In one embodiment, the locking tube is rotated 30° to complete the bayonet connection. The locking tube assembly (distal locking tube 126, locking tube coupling 128, proximal locking tube 124) may additionally be unlocked from the inserter shaft 136 and removed from the instrument 100 for cleaning.

[0089] 26, 50, and 51, another step of the method can include inserting the drawbar assembly 160 distally through the instrument bore 112. The distal threaded tip 162 of the drawbar assembly 160 passes through the second end body 1052 of the implant and is threadably engaged with the first end body 1050 of the implant. The instrument locking collar 120 can be actuated to engage the instrument shuttle 122 with the annulus 166 near the proximal end of the drawbar assembly 160. The locking collar 120 can be moved to its first position, the drawbar assembly 160 can be advanced within the instrument bore 112 until the annulus is distal to the locking collar 120, and the locking collar 120 can be moved to its second position. Once the drawbar assembly 160 is inserted to couple with the implant 1000, but prior to expanding the implant, the indicia 248 or markings can indicate that the implant is in its collapsed configuration.

[0090] 52 and 53, in another step of the method, the instrument 100 can be used to insert an implant 1000 into a prepared intervertebral space between a first vertebra 2 and a second vertebra (not shown for clarity). The implant 1000 can be positioned in the intervertebral space before or after inserting the drawbar assembly 160 into the instrument 100.

[0091] When the implant is properly positioned within the intervertebral space and the drawbar assembly 160 is inserted into the instrument 100, in another step of the method, the expansion knob 140 is rotated while turning the threaded driver 130. The knob 140, threaded driver 130, and shuttle 122 form a motion conversion mechanism to convert rotational motion into linear or axial motion along the longitudinal instrument axis 102. The interaction of the threaded driver 130 and shuttle 122 translates the shuttle 122 and drawbar assembly 160 proximally providing an axial force in a first direction along the axis 102 pulling the first end 1050 of the implant proximally toward the second end 1052 of the implant and laterally expanding the implant along the axis 104 in a second direction perpendicular to the first direction. When an axial force is applied to the implant, the link members 1060, 1062, 1064, 1066 pivot outwardly away from the central longitudinal axis 102, carrying the first support member 1040 and the second support member 1030 away from each other along the axis 104, causing the implant to expand laterally. Stop surfaces on the implant ends and support members can interact to limit the lateral expansion. When the lateral expansion is reached, indicia 248 or markings on the instrument can indicate that the implant is in a laterally expanded configuration.

[0092] In another step of the method, the implant 1000 is vertically expanded. With reference to FIGS. 54 and 55, the expansion knob 140 is further rotated to continue translating the drawbar assembly 160 proximally along the longitudinal instrument axis 102. Continued axial force along the first direction causes the link members 1064, 1066 in the implant 1000 to advance along the expansion slots 1114, 1124, 1154, 1164 in the upper and lower supports 1042, 1044, urging the upper and lower supports away from one another and causing the first support member 1040 to expand vertically along a third direction, indicated by axis 106, perpendicular to the first and second directions. When vertical expansion is reached, indicia 248 or markings on the instrument can indicate that the implant is in a vertically expanded configuration.

[0093] It is understood that the expansion knobs may be actuated in separate steps to expand the implant first laterally and then vertically, or the expansion knobs may be actuated in a continuous motion to expand the implant first laterally and then vertically. It is also understood that in another embodiment, vertical expansion of the implant may occur before horizontal expansion. In the illustrated embodiment, only the first support member 1040 expands vertically, and the height of the second support member 1030 is fixed. This may provide lordosis correction between the first and second vertebrae. In other embodiments, the first support member 1040 may be fixed and the second support member 1030 may be vertically expandable, or both the first support member 1040 and the second support member 1030 may be vertically expandable. When expansion is complete, the drawbar assembly 160 may be disengaged from the shuttle 122 by actuating the locking collar 120, loosened from the implant 1000, and removed from the instrument 100.

[0094] In another step of the method, graft tissue material may be inserted through the instrument and into the expanded implant 1000. With reference to Figures 27, 28, 56, and 57, a funnel 170 may be coupled to the proximal end of the instrument bore 112. Graft tissue material may be inserted axially through the funnel 170 and bore 112 and deposited within the implant inner chamber 1120. A tamp assembly 180 may be deployed through the instrument 100 to push and pack the graft tissue through the bore 112 and into the chamber 1120.

[0095] In another step of the method, a locking fastener, such as a lockout screw 654, can be inserted through the instrument into fixed engagement with the expanded implant 1000 to lock the implant in the horizontally and vertically expanded configuration. With reference to FIGS. 29, 30, 58, and 59, the screw 654 can be loaded into the screw holder 200 and coupled to a distal end of the driver assembly 190. The distal tip of the driver assembly 190 can include a tip 792 shaped to complementarily engage the proximal end of the screw 654. The driver assembly 190 with the screw holder 200 and screw 654 attached can be inserted longitudinally through the bore 112 of the instrument 100. The driver assembly 190 can be actuated to engage the threaded portion 653 of the screw 654 with the threaded first end 1050 of the implant 1000. When the screw is driven distally, the proximal shoulder 655 of the screw 654 abuts a surface of the second end 1052 to rigidly lock the cage in the expanded configuration. The screw holder 200 can include a release element or mechanism to release the screw 654 from the holder 200 after the screw is engaged with the implant 1000. For example, the screw holder catch 182 can be biased to disengage the tooth 842 from the second portion 850 of the screw 654 when the screw is engaged with the implant 1000. When deployment and release of the screw 654 is complete, the driver assembly 190 and attached screw holder 200 can be removed from the instrument 100.

[0096] 60-63, the implant 1000 is shown in vivo after insertion between the first vertebral body 2 and the second vertebral body. In the depicted embodiment, the support members 1040 and 1030 are expanded horizontally along the anterior-posterior direction to provide support between the first and second vertebral bodies. The support member 1040 is expanded vertically along the cranio-caudal direction to provide lordosis correction between the first and second vertebrae. It is understood that in other embodiments of the invention, both support members can be expanded vertically or only the support member 1030 can be expanded vertically to provide kyphosis correction. One or more implants 1000 can be implanted between the first and second vertebrae. Other approaches, including lateral, transforaminal, and anterior, may be used within the scope of the present disclosure. One or more implants can be inserted in any orientation relative to the first and second vertebrae.

[0097] 64-71, another insertion and expansion instrument is shown. The instrument 300 can be deployed to insert and expand the implant 1000 or another expandable intervertebral implant. The instrument 300 can include a bayonet or other connection to releasably couple the implant 1000 to the instrument. The instrument 300 includes a ratchet mechanism 310 operable by a lever 312 to axially translate the shuttle 322 and the drawbar assembly 328 proximally. The ratchet mechanism 310 can be referred to as an actuator. As with the instrument 100, translation of the drawbar assembly 328 provides an axial force to laterally and / or vertically expand the coupled implant. Other tools, such as the funnel 170, tamp assembly 180, and driver assembly 190 disclosed herein, can be used with the instrument 300 or adapted for use with the instrument 300 to deposit graft material into the implant and secure a locking fastener, such as the screw 654.

[0098] The instrument 300 extends along a longitudinal instrument axis 866 between a proximal end 862 and a distal end 864. The instrument 300 includes a ratchet mechanism 310, a lever 312, a shuttle 322 that may be similar to the shuttle 122, an inserter handle 302 that may be similar to the inserter handle 142, a shaft assembly 304 that may be similar to the shaft assembly 116, an inserter shaft 306 that may be similar to the inserter shaft 136, a distal tip 308 that may be similar to the inserter connector 138, a locking lever 314, a set screw 316, a locking tube assembly 318 that may be similar to the locking tube assembly 118, a locking tube coupling 318 that may be similar to the locking tube coupling 128, and a locking lever 314 that may be similar to the locking tube coupling 128. The locking tube 320 may include a locking tube coupling 320 which may be similar to the proximal locking tube 124, a proximal locking tube 324 which may be similar to the proximal locking tube 124, a distal locking tube 326 which may be similar to the distal locking tube 126, a drawbar assembly 328 which may be similar to the drawbar assembly 160, a drawbar knob 330 which may be similar to the handle 164, a drawbar tip 332, a drawbar 334 which may be similar to the drawbar 156, a spring plunger 336, a ratchet 338, a lever link 340, a return link 342, and / or a release ring 344.

[0099] 70-73, the ratchet mechanism 310 may include a lever 312, a spring plunger 336, a ratchet 338, a lever link 340, and a return link 342. The ratchet mechanism 310 may include a shuttle 322.

[0100] The lever 312 extends between a proximal end 868 and a distal end 870. The lever 312 can include a body 872 and an arm 874. The arm 874 can extend proximally at an angle away from an outer portion 876 of the body 872. An opposing inner portion 878 of the body can include a pair of outer arms 880, 882 forming an outer clevis and a pair of inner arms 884, 886 forming an inner clevis. The inner arms 884, 886 can be located between the outer arms 880, 882. The inner arms 884, 886 can be shorter than the outer arms 880, 882 and can extend from the inner portion 878 about one-third of the outer arms. The arms 880, 882, 884, 886 can all be parallel as shown and perpendicular to the inner portion 878. A first hole 888 can extend through the arms 880, 882, 884, 886 near the inner portion 878. A second hole 890 can extend through the outer arms 880, 882 near the free ends of the outer arms. The first hole 888 and the second hole 890 can be parallel to the inner portion 878. A third hole 892 can extend into the inner portion 878 between the inner arms 884, 886. The third hole 892 can be parallel to the arms 880, 882, 884, 886.

[0101] The spring plunger 336 extends between a proximal end 892 and a distal end 894. The spring plunger 336 may be a generally cylindrical shaft with a circular cross-section as shown. The spring plunger 336 may include, from proximal to distal, a first outer portion 896 and a second outer portion 898. The first outer portion 896 may extend distally the majority of the proximal-distal length of the spring plunger 336. The diameter of the second outer portion 898 may be smaller than the diameter of the first outer portion 896. There may be a tapered transition between the first outer portion 896 and the second outer portion 898. The second outer portion 898 may include a rounded distal outer edge. A central longitudinal bore 900 may extend distally into the proximal end of the spring plunger 336. The hole 900 can extend distally through most of the first outer portion 896 .

[0102] A ratchet 338 extends between the proximal end 902 and the distal end 904. The ratchet 338 can have a rectangular or square cross-section as shown. Teeth 906 can protrude from an inner side 908 of the ratchet 338. The teeth 906 can be located along an inner proximal edge of the ratchet 338. A first hole 910 can extend through the ratchet 338 near the distal end 904 and can be parallel to the teeth 906. A second hole 912 can extend into the inner side 908 near the distal end 904 and can be perpendicular to the first hole 910. The second hole 912 can be between the first hole 910 and the distal end 904.

[0103] The lever link 340 extends between a proximal end 914 and a distal end 916. The lever link 340 may have a rectangular or square cross section as shown. Teeth 918 may protrude from an inner side 920 of the lever link 340. The teeth 918 may be located along an inner proximal edge of the lever link 340. A one-sided notch 922 may extend along the lever link 340 to intersect a proximal portion of the inner side 920 and an inner portion of the proximal end 916, such that the teeth 918 are narrower than the distal end 916. A first hole 924 may extend through the lever link 340 near the distal end 916 and may be parallel to the teeth 918. A second hole 926 may extend into an outer side 928 of the lever link 340 opposite the inner side 920, near the distal end 916, and may be perpendicular to the first hole 924. The first hole 924 can be between the second hole 926 and the distal end 916 .

[0104] The return link 342 extends between a proximal end 930 and a distal end 932. The return link 342 can have a rectangular or square cross-section as shown. A foot 934 can protrude from a first side 936 of the return link 342. The foot 934 can be located at the proximal end 930 of the return link 342. The foot 934 can extend perpendicular to the proximal-distal length of the return link 342. A one-sided notch 938 can extend along the return link 342 to intersect with a proximal portion of the inner portion 940 of the return link and an inner portion of the proximal end 930. A first hole 942 can extend distally into the proximal end 930 and the foot 934. A second hole 944 can extend through the return link 342 near the distal end 932 and can be parallel to the foot 934.

[0105] The shuttle 322 extends between a proximal end 946 and a distal end 948. The shuttle 322 can include, from proximal to distal, a first outer portion 950, a second outer portion 952, a third outer portion 954, and a fourth outer portion 956. The first outer portion 950 can have a circular cross-section and rounded proximal and distal outer circumferential edges. The proximal-distal length of the first outer portion 950 can be less than its diameter. The second outer portion 952 can have a circular cross-section with a diameter less than the diameter of the first outer portion 950. The second outer portion 952 can form a square (90 degree) inner corner with the first outer portion 950. The proximal-distal length of the second outer portion 952 can be the same as or similar to the length of the first outer portion 950. The third outer portion 954 can have a circular cross section with a diameter smaller than that of the second outer portion 952. The third outer portion 952 can form a square inner corner with the second outer portion 952. The third outer portion 954 can extend over a majority of the proximal-distal length of the shuttle 322. The fourth outer portion 956 can have a circular cross section that tapers to a decreasing diameter toward the distal end 948. The fourth outer portion 956 can be conical. A one-sided longitudinal groove 958 can extend along the second outer portion 952 and the third outer portion 954 and can terminate within the fourth outer portion 956. The groove 958 can have a rectangular or square cross section with a rounded proximal end at the proximal end of the second outer portion 952. A first series of transverse grooves 960 may extend across the third outer portion 954 and may be located 90 degrees from the longitudinal grooves 958. There may be ten grooves 960 as shown, or another number. The size and shape of the grooves 960 may be complementary to the teeth 918 of the lever link 340. A second series of transverse grooves 962 may extend across the third outer portion 954 and may be located 90 degrees from the longitudinal grooves 958 and 180 degrees from the first series of transverse grooves 960. There may be fifty-four grooves 962 as shown, or another number.The size and shape of the grooves 960 can be complementary to the teeth 906 of the ratchet 338. Indicia 964 can be included along the third outer portion 954 opposite the longitudinal grooves 958. The indicia 964 can include transverse lines and numbers as shown, or other markings or etchings. A one-sided molded slot 966 can extend proximally into the distal end of the third outer portion 954 and can terminate in the fourth outer portion 956. The proximal end of the slot 966 can make a 90 degree bend toward the longitudinal grooves 958. The slot 966 can have a rectangular or square cross-section. The slot 966 and other similarly shaped slots disclosed herein can be referred to as bayonet slots.

[0106] The shuttle 322 can include a central longitudinal bore 968 extending through the shuttle between a proximal end 946 and a distal end 948. The bore 968 can include, from proximal to distal, a first inner portion 970, a second inner portion 972, a third inner portion 974, and a fourth inner portion 976, each having a circular cross section. The first inner portion 970 can be a shallow countersink around the proximal end of the bore 968. The second inner portion 972 can have internal threads. The minor diameter of the threads can be the same as or similar to the minor diameter of the first inner portion 970. The third inner portion 974 can be smooth and have a smaller diameter than the minor diameter of the threads of the second inner portion 972. See FIG. 66. The distal end of the third inner portion 974 can have a square (90 degree) inner corner. The fourth inner portion 976 may be smooth and has a diameter smaller than the diameter of the third inner portion 974 .

[0107] 70, 71, 74 and 75, the shaft assembly 304 can include an inserter shaft 306 and a distal tip 308.

[0108] The inserter shaft 306 extends between a proximal end 978 and a distal end 980. The inserter shaft 306 may be a tubular portion with a circular exterior and interior cross-sectional shape. The inserter shaft 306 may include a pair of molded slots 982, 984, each including a substantially 90 degree bend. The slots 982, 984 may extend longitudinally into the proximal end 978 before making the bend. Each slot 982, 984 may extend through one wall of the inserter shaft 306. The inserter shaft 306 may include bilateral transverse grooves 986, 988, which may be located 90 degrees distal from the slots 982, 984. The inserter shaft 306 may include one or more openings 990. Three openings 990 are shown spaced distal to the transverse grooves 986, 988 along the inserter shaft 306. Each opening 990 can extend through one wall of the inserter shaft 306, or through both walls as shown. The inserter shaft 306 can include a central longitudinal bore 992 extending through the inserter shaft between the proximal end 978 and the distal end 980. The bore 992 can include a proximal countersink 994 and / or a distal counterbore 996.

[0109] The distal tip 308 extends between a proximal end 1200 and a distal end 1202. The proximal end 1200 can be circular in a proximal view. The distal end 1202 can be rectangular in a distal view. The distal end 1202 can have rounded corners in a distal view. The distal tip 308 can include, from proximal to distal, a first outer portion 1204, a second outer portion 1206, and a third outer portion 1208. The first outer portion 1204 can have a circular cross-section and can extend distally about one-quarter of the proximal-distal length of the distal tip 308. The second outer portion 1206 can have a circular cross-section and can have a diameter larger than the diameter of the first outer portion 1204. The second outer portion 1206 can form a square (90 degree) inner corner with the first outer portion 1204. The third outer portion 1208 can include a rectangular distal end 1202 and can also include a curved transition surface that blends with the second outer portion 1206. The distal tip 308 can include a central longitudinal bore 1210 that extends through the distal tip between the proximal end 1200 and the distal end 1202. The bore 1210 can include, from proximal to distal, a first inner portion 1212 and a second inner portion 1214. The first inner portion 1212 can have a circular cross-section and can extend distally about two-thirds to three-quarters of the entire proximal-distal length of the distal tip 308. The cross-sectional shape of the second inner portion 1214 can be rectangular or square. The rectangle or square can have rounded corners. The major dimension (length) of the rectangle can be greater than the diameter of the first inner portion 1212 and can be aligned with the major dimension (length) of the rectangle at the distal end 1202. The minor dimension (width) of the rectangle can be greater than the diameter of the first inner portion 1212. The second inner portion 1214 can have a flat proximal end.

[0110] The shaft assembly 304 may be assembled by inserting the first outer portion 1204 of the distal tip 308 into the counterbore 996 of the inserter shaft 306 and aligning the rectangular length of the third outer portion 1208 to extend over the transverse grooves 986, 988. The inserter shaft 306 and the distal tip 308 may be permanently connected, for example by welding. Alternatively, the inserter shaft 306 and the distal tip 308 may be combined into a single piece. The inner diameters of the bore 992 of the inserter shaft 306 and the first inner portion 1212 of the bore 1210 of the distal tip 308 may be the same or similar, and together they may form the shaft assembly bore 1434. See Figures 70 and 71.

[0111] 70, 71, 76, and 77, the locking tube assembly 318 can include a locking tube coupling 320, a proximal locking tube 324, and a distal locking tube 326.

[0112] The locking tube coupling 320 extends between a proximal end 1216 and a distal end 1218. The locking tube coupling 320 may be a tubular portion. The locking tube coupling 320 may include a proximal body 1220, which may have a circular cross-sectional outer shape and may extend distally approximately one-half or three-fifths of the entire proximal-distal length of the locking tube coupling 320. A first lateral post 1222 may extend radially outward from the distal end of the body 1220. A tab 1224 on only one side may project distally from the body 1220 and may be aligned with the first lateral post 1222. An outer surface of the tab 1224 is radially inward relative to an outer diameter of the body 1220. A second lateral post 1226 may project radially outward from the tab 1224. The second lateral post 1226 can protrude radially beyond the outer diameter of the body 1220 as shown. The second lateral post 1226 can be distal to and in alignment with the first lateral post 1222. The first hole 1228 and the second hole 1230 can extend through one wall of the body 1220 on either side of a location opposite the first lateral post 1222, or in other words, each hole can be located approximately 135 degrees away from the first lateral post 1222. The locking tube coupling 320 can include a central longitudinal hole 1232 extending through the locking tube coupling between the proximal end 1216 and the distal end 1218. The hole 1232 can include, from proximal to distal, a first inner portion 1234, a second inner portion 1236, and a third inner portion 1238. The first inner portion 1234 can have a circular cross-section and can extend distally about one-third of the entire proximal-distal length of the locking tube coupling 320 or about half the length of the body 1220. The second inner portion 1236 can have a circular cross-section with a diameter smaller than the diameter of the first inner portion 1234. The second inner portion 1236 can extend distally a full diameter only a short distance, but a section of it can extend through the distal end 1218 to form the inner portion of the tab 1224.The third inner portion 1238 can have a non-circular cross-section that is a C-shaped alcove in the distal wall of the body 1220 opposite the tab 1224. The alcove can extend around an arc of greater than 180 degrees.

[0113] The proximal locking tube 324 extends between a proximal end 1240 and a distal end 1242. The proximal locking tube 324 may be a tubular section with circular outer and inner cross-sectional shapes and constant outer and inner diameters.

[0114] The distal locking tube 326 extends between a proximal end 1244 and a distal end 1246. The distal locking tube 326 can be a tubular portion with a circular outer cross-sectional shape and an inner cross-sectional shape. The proximal end 1244 can include a one-sided cutout 1248 that extends distally into one side of the distal locking tube 326. The cutout 1248 can extend around an arc of less than 180°. The cutout 1248 can include, from proximal to distal, a first portion 1250 and a second portion 1252. The first portion 1250 can have a flat distal end with square corners. The second portion 1252 can be narrower than the first portion 1250. The second portion 1252 can have a flat distal end with rounded corners. The distal end 1246 can include a pair of molded slots 1254, 1256, each including an approximately 90° bend. The slots 1254, 1256 can extend longitudinally into the distal end 1246 before making the approximate 90° bend. Each slot 1254, 1256 can extend through one wall of the distal locking tube 326. The distal locking tube 326 can include a central longitudinal bore 1258 extending through the distal locking tube between the proximal end 612 and the distal end 614. The bore 1258 can include, from proximal to distal, a first inner portion 1260 and a second inner portion 1262. The first inner portion 1260 can extend distally for a majority of the proximal-distal length of the distal locking tube 326 and can have a flat distal end. The diameter of the second inner portion 1262 can be smaller than the diameter of the first inner portion 1260 .

[0115] The locking tube assembly 318 may be assembled by inserting the distal end 1242 of the proximal locking tube 324 into the first inner portion 1234 of the locking tube coupling 320 and inserting the proximal end 1244 of the distal locking tube 326 into the third inner portion 1238 of the locking tube coupling 320 such that the tab 1224 is received within the second portion 1252 of the notch 1248. The locking tube coupling 320, the proximal locking tube 324, and the distal locking tube 326 may be permanently connected, for example, by welding. Alternatively, the locking tube coupling 320, the proximal locking tube 324, and / or the distal locking tube 326 may be combined into a single piece. The inner diameters of the second inner portion 1236 of the bore 1232 of the locking tube coupling 320, the proximal locking tube 324, and the first inner portion 1260 of the bore 1258 of the distal locking tube 326 can all be the same or similar, and together they can form a longitudinal instrument bore 1260. See FIGS. 64, 70, and 71. The distal locking tube 326 and the body 1220 of the locking tube coupling 320 can fit within the bore 1434 of the shaft assembly 304. The post 1226 of the locking tube coupling 320 can fit within either of the slots 982, 984 of the inserter shaft 306 of the shaft assembly 304.

[0116] 70, 71, 78, and 79, the drawbar assembly 328 may include a drawbar knob 330, a drawbar tip 332, and a drawbar 334.

[0117] The drawbar knob 330 extends between a proximal end 1262 and a distal end 1264 .

[0118] The drawbar handle 330 extends between a proximal end 1262 and a distal end 1264. The drawbar handle 330 can include, from proximal to distal, a knob body 1266 and a shaft 1268. The knob body 1266 can be generally disk-shaped with an outer diameter greater than its proximal-distal length. The knob body 1266 can include one or more gripping elements 1270, such as the six rim scallops shown. The outer diameter of the shaft 1268 can be less than the outer diameter of the knob body 1266, and the proximal-distal length of the shaft can be greater than the proximal-distal length of the knob body 1266. The shaft 1268 can include a flange 1272 or annulus extending circumferentially around a central portion of the shaft. The flange 1272 can have square proximal and distal outer circumferential edges. The shaft 1268 may include one or more holes 1274 extending transversely into or through the shaft. Two through holes 1274 are shown between the distal side of the knob body 1266 and the proximal side of the flange 1272. The two through holes 1274 are at right angles to each other. The distal portion of the shaft 1268 may include male threads 1276. The outer diameter of the flange 1272 may be larger than the major diameter of the threaded portion 1276. The minor diameter of the threaded portion 1276 may be larger than the outer diameter of the remaining smooth portion of the shaft 1268. The drawbar handle 330 may include a central longitudinal hole 1278 extending through the drawbar handle between the proximal and distal ends 1262 and 1264. The hole 1278 may include, from proximal to distal, a first inner portion 1280, a second inner portion 1282, and a third inner portion 1284. The first inner portion 1280 can have a circular cross-section and can extend distally about half or a majority of the proximal-distal length of the knob body 1266. The first inner portion 1280 can have a flat distal end. A circumferential fillet radius can be present around a proximal inner edge of the first inner portion 1280. A circumferential fillet radius can be present in a distal inner corner of the first inner portion 1280. The second inner portion 1282 can have a circular cross-section and can extend distally between the distal side of the knob body 1266 and the bore 1274.The diameter of the second inner portion 1282 can be smaller than the diameter of the first inner portion 1280. The third inner portion 1284 can have a circular cross-section and can extend distally through the distal end of 1264 of the drawbar handle 330. The diameter of the third inner portion 1284 can be smaller than the diameter of the first inner portion 1280 and larger than the diameter of the second inner portion 1282. The third inner portion 1284 can have a flat proximal end. The bore 1274 can extend into the proximal end of the third inner portion 1284.

[0119] The drawbar tip 332 extends between a proximal end 1286 and a distal end 1288. The drawbar tip 332 may include, from proximal to distal, a first outer portion 1290, a second outer portion 1292, a third outer portion 1294, and a fourth outer portion 1296. The first outer portion 1290 may have a circular cross section and may extend distally about one-third to one-half of the entire proximal-distal length of the drawbar tip 332. An outer proximal edge of the first outer portion 1290 may include a circumferential chamfer. The second outer portion 1292 may have a circular cross section and may extend distally a short distance. The diameter of the second outer portion 1292 may be greater than the diameter of the first outer portion 1290. The second outer portion 1292 may be referred to as a flange or annulus around a central portion of the drawbar tip 332. The third outer portion 1294 can have a circular cross-section. The diameter of the third outer portion 1294 can be greater than the diameter of the first outer portion 1290 and less than the diameter of the second outer portion 1292. The fourth outer portion 1296 can be a torque coupling, such as a hex key as shown. An outer distal edge of the fourth outer portion 1296 can include a circumferential chamfer. The drawbar tip 332 can include a central longitudinal bore 1298 extending through the drawbar tip between the proximal end 1286 and the distal end 1288. The bore 1298 can include, from proximal to distal, a first inner portion 1300, a second inner portion 1302, and a third inner portion 1304. The first inner portion 1300 can have a circular cross-section. A distal end of the first inner portion 1300 can be proximal to the second outer portion 1292. The second inner portion 1302 can include an internal thread. A major diameter of the threads can be smaller than a diameter of the first inner portion 1300. The third inner portion 1304 can have a circular cross-section. A diameter of the third inner portion 1304 can be smaller than a diameter of the first inner portion 1300 and larger than a major diameter of the threads of the second inner portion 1302.

[0120] The drawbar 334 extends between the proximal end 1306 and the distal end 1308. The drawbar 334 may be a cylindrical shaft as shown. The drawbar 334 may include a central longitudinal bore 1310 extending proximally into the distal end 1308 of the drawbar 334. The bore 1310 may include, from proximal to distal, a first inner portion 1312 and a second inner portion 1314. The first inner portion 1312 may have a circular cross-section. The second inner portion 1314 may have a circular cross-section with a diameter greater than the diameter of the first inner portion 1312.

[0121] The drawbar assembly 328 may be assembled by inserting the proximal end 1306 of the drawbar 334 into the second inner portion 1282 of the bore 1278 of the drawbar handle 330 and the first outer portion 1290 of the drawbar tip 332 into the second inner portion 1314 of the bore 1310 of the drawbar 334 such that the proximal end 1306 is at the same or similar level as the distal end of the first inner portion 1280. A circumferential gap 1316 may exist between the outer surface of the drawbar 334 and the inner surface of the third inner portion 1284. See FIG. 66. The drawbar knob 330, the drawbar tip 332, and the drawbar 334 may be permanently connected, for example, by welding. Alternatively, the drawbar knob 330, the drawbar tip 332, and / or the drawbar 334 may be combined into a single piece. The drawbar tip 332 and the drawbar 334 may fit within a bore 1260 of the locking tube assembly 318. The proximal end 1240 of the proximal locking tube 324 may fit within the cavity 1316.

[0122] 66, 70, 71, and 80-85, the inserter handle 302 extends between a proximal end 1318 and a distal end 1320. The inserter handle 302 may include, from proximal to distal, a first outer portion 1322, a second outer portion 1324, and a third outer portion 1326. The first outer portion 1322 may be cylindrical with a circumferential groove 1328 centrally located along the proximal-distal length of the first outer portion 1322. The groove 1328 may have square inner corners. The second outer portion 1324 may extend distally over a majority of the entire proximal-distal length of the inserter handle 302. The second outer portion 1324 may be generally hourglass shaped or otherwise contoured to be comfortably and ergonomically grasped by a user's hand. The third outer portion 1326 can extend over approximately one-quarter of the entire proximal-distal length of the inserter handle 302. The third outer portion 1326 can include a flat front surface 1330 and a rear surface 1332 that can extend proximally from the distal end 1320 over the majority of the proximal-distal length of the third outer portion 1326 and the second outer portion 1324. The third outer portion 1326 can include a rectangular or square boss 1374 that protrudes from a right side 1376 of the third outer portion. The boss 1374 can extend from a central portion of the proximal-distal length of the third outer portion 1326. A left side 1378 of the third outer portion 1326 can be a portion of a cylinder.

[0123] The inserter handle 302 can include a recess 1334 on only one side extending distally into the second outer portion. The recess 1334 can be on the same side as the front surface 1330. The recess 1334 can be arcuate and can extend around an arc of less than 180 degrees. The recess 1334 can include ridges 1336, 1338 on both sides as best seen in FIG. 82. The ridges 1336, 1338 can extend proximally a short distance from the distal end of the recess 1334. A pocket 1340 can be located in the proximal region of the front surface 1330. A window 1342 can be located in the pocket 1340. The window 1342 can extend through the front side of the inserter handle 302. The pocket 1340 can include indicia 1344, such as the transverse lines shown, that bracket the window 1342. The hole 1380 can extend through the inserter handle 302 between the front and rear sides and can be located within the proximal right portion of the third outer portion 1326 .

[0124] A longitudinal slot 1346 can extend into the right side 1348 of the second outer portion 1324 of the inserter handle 302. The slot 1346 can be rectangular with rounded corners. The proximal end of the slot 1346 can be proximal to the pocket 1340 and the distal end of the slot can be distal to the pocket. The distal portion 1350 of the slot 1346 can be shallow with a flat bottom and the proximal portion 1352 of the slot can be deep. The distal portion 1350 can extend over the distal third of the entire proximal-distal length of the slot 1346. The distal portion 1350 can include a hole 1354 in the bottom near the distal end. A transverse hole 1356 can extend through the inserter handle 302 between the front and rear sides, thereby intersecting a sidewall of the distal portion 1350 proximal to the hole 1354. A hole 1358 can extend into the right side 1348 of the second outer portion 1324 of the inserter handle 302 distal to the slot 1346. The hole 1358 can include internal threads and a counterbore that complements the set screw 316. A transverse slot 1382 can extend into the right side 1376 of the third outer portion 1326. The slot 1382 can extend into a distal portion of the boss 1374. The slot 1382 can be transversely tapered, narrowing as the slot extends into the third outer portion 1326. See FIG.

[0125] A longitudinal slot 1360 can extend into the left side 1362 of the second outer portion 1324 and the third outer portion 1326 of the inserter handle 302. The proximal end of the slot 1360 can be at the same or similar level as the proximal end of the slot 1346, and the distal end of the slot can extend approximately half the entire proximal-distal length of the third outer portion 1326. The proximal portion 1364 of the slot 1360 can be narrower than the distal portion 1366 of the slot. Each of the proximal portion 1364 and the distal portion 1366 can be rectangular with rounded corners. The distal end of the proximal portion 1364 can be distal to the hole 1358 and proximal to the third outer portion 1326. A narrow ledge 1368 on only one side can extend along the proximal rear sidewall in the proximal portion 1364. A platform 1370 can extend between the side walls of the proximal portion 1364 and the distal portion 1366. The proximal end of the platform 1370 can be distal to the hole 1358 and proximal to the distal end of the proximal portion 1364, and the distal end of the platform can be located about one-third of the overall proximal-distal length of the third outer portion 1326 or about one-half of the overall proximal-distal length of the distal portion 1366. The platform 1370 can be deeper within the inserter handle 302 than the ledge 1368. A longitudinal hole 1372 can extend proximally into the distal end 1320 of the inserter handle 302 and into the proximal end wall of the proximal portion 1364 of the slot 1360. See FIG. 66.

[0126] The inserter handle 302 can include a central longitudinal bore 1384 extending through the inserter handle between the proximal end 1318 and the distal end 1320. The bore 1384 can include, from proximal to distal, a first inner portion 1386, a second inner portion 1388, and a third inner portion 1389. Each of these inner portions can have a circular cross-section. The first inner portion 1386 can extend distally to the proximal end of the platform 1370. The diameter of the second inner portion 1388 can be smaller than the diameter of the first inner portion 1386. The second inner portion 1388 can extend distally to intersect with the slot 1382. The diameter of the third inner portion 1389 can be smaller than the diameter of the second inner portion 1388. The window 1342, the proximal portion 1352 of the slot 1346, the hole 1358, and the proximal portion 1364 of the slot 1360 can open into the first inner portion 1386. The distal portion 1366 of the slot 1360 distal to the platform 1370 and the slot 1382 can open into the second inner portion 1388. Side holes 1390, 1392 can extend through the inserter handle 302 between the right and left sides near the distal end 1320. The holes 1390, 1392 can intersect the third inner portion 1389.

[0127] The lock lever 314 extends between a proximal side 1394 and a distal side 1395. The lock lever 314 can include a ring 1398, a stem 1400, and a cap 1402. The stem 1400 can extend from one side of the ring 1398. The cap 1402 can be an enlarged portion at a free end of the stem 1400. A central longitudinal hole 1404 can extend through the lock lever 314 between the proximal side 1394 and the distal side 1396. A keyway 1406 can also extend through the lock lever 314 at the base of the stem 1400, between the proximal side 1394 and the distal side 1396, along an inner wall of the hole 1404. A hole 1408 can extend into the stem 1400 near the ring 1398.

[0128] The set screw 316 may be a bar head thread that is complementary to the hole 1358. The set screw 316 may have a pan head or a cheese head.

[0129] A release ring 344 extends between the proximal end 1410 and the distal end 1412. The release ring 344 can include one or more friction elements 1414, such as the twelve rim scallops shown. The release ring 344 can include a one-sided tab 1416 that can extend distally. The interior of the tab 1416 can include two longitudinal grooves 1418, 1420 that extend through the distal end 1412. A central longitudinal hole 1422 can extend through the release ring 344 between the proximal side 1410 and the distal side 1412. The hole 1422 can include, from proximal to distal, a first inner portion 1424 and a second inner portion 1426. The first inner portion 1424 can have a generally circular cross-section with a one-sided key 1428 that extends radially into the hole 1422 at the proximal end 1410. The key 1428 can be generally opposite the tab 1416, but can be offset from directly opposite the tab by a few degrees. For example, the key 1428 can be 155 degrees away from the tab 1416. The second inner portion 1426 can have a circular cross-section with a diameter larger than the diameter of the first inner portion 1424. The proximal end of the second inner portion 1426 can be flat. The inner side of the tab 1416 can be radially offset outward from the second inner portion 1426. Opposite transverse holes 1430, 1432 can extend through the release ring 344. The holes 1430, 1432 can intersect the second inner portion 1426.

[0130] The instrument 300 may be assembled by coupling the release ring 344, ratchet 338, set screw 316, and spring plunger 336 to the inserter handle 302, coupling the lever link 340 and return link 342 to the lever 312, coupling the subassembly of the lever link 340, return link 342, and lever 312 to the inserter handle 302 (with the spring plunger 336), coupling the shaft assembly 304 and lock lever 314 to the inserter handle 302, inserting the locking tube assembly 318 into the shaft assembly 304, coupling the shuttle 322 to the inserter handle 302 (with the set screw 316 and release ring 344), inserting the draw bar assembly 328 into the locking tube assembly 318, and coupling the draw bar assembly 328 to the shuttle 322. These steps may be performed in any order.

[0131] Coupling the release ring 344 to the inserter handle 302 may include inserting the first outer portion 1322 of the inserter handle 302 into the second inner portion 1426 of the hole 1422 of the release ring 344 so that the tab 1416 is within the recess 1334 between the ridges 1336, 1338, aligning the holes 1430, 1432 with the groove 1328, and inserting a pin into the holes 1430, 1432 and the groove 1328.

[0132] Coupling the ratchet 338 to the inserter handle 302 can include inserting a compression spring (not shown) into the holes 912, 1354, inserting the ratchet 338 into the slot 1346 with the teeth 906 facing into the first inner portion 1386 of the hole 1384, aligning the holes 1356, 910, and inserting a pin (not shown) through the holes 1356, 910. The spring can bias the ratchet 338 to protrude into the first inner portion 1386.

[0133] Coupling the set screw 316 to the inserter handle 302 can include inserting the tip of the screw into the hole 1358, engaging the complementary threads, and tightening the screw into the hole 1358.

[0134] Coupling the spring plunger 336 to the inserter handle 302 may include inserting a compression spring (not shown) into the hole 900 of the spring plunger 336 and inserting the proximal end 892 of the spring plunger 336 into the proximal portion of the hole 1372 of the inserter handle 302 such that the second outer portion 898 protrudes distally into the proximal portion 1364 of the slot 1360.

[0135] Coupling the lever link 340 and the return link 342 to the lever 312 can include positioning the distal end 916 of the lever link 340 between and next to the inner arms 884, 886 of the lever 312 with the hole 924 aligned with the hole 888 and the tooth 918 facing away from the arm 874, positioning the distal end 932 of the return link 342 between and next to the inner arms 884, 886 with the hole 944 aligned with the hole 888 and the foot 934 facing the proximal end 914 of the lever link, and inserting a pin (not shown) through the holes 888, 924, 944 to hingeably couple the lever link 340 and the return link 342 to the lever 312. The pin can extend only through the inner arms 884, 886, the lever link 340, and the return link 342. A compression spring (not shown) may be inserted into holes 892 , 926 to bias the lever link 340 away from the lever 312 .

[0136] Coupling the subassembly of lever link 340, return link 342, and lever 312 to the inserter handle 302 (with spring plunger 336) can include inserting inner arms 884, 886 of lever 312 into distal portion 1366 of slot 1360 of inserter handle 302 such that inserter handle 302 is between outer arms 880, 882 and lever link 340 and return link 342 extend into proximal portion 1364 of slot 1360, inserting second outer portion 898 of spring plunger 336 into hole 942 of return link 342, and inserting a pin (not shown) into holes 890, 1380. The spring plunger 336 and associated compression spring can bias the lever 312 away from the inserter handle 302. The ledge 1368 fits within the notch 922 to control the depth that the tooth 918 extends into the first inner portion 1386 of the hole 1384 .

[0137] Coupling the shaft assembly 304 and the lock lever 314 to the inserter handle 302 can include inserting the ring 1398 of the lock lever 314 into the slot 1382 of the inserter handle 302 such that the stem 1400 and the cap 1402 extend laterally outside the slot 1382 and the hole 1408 faces the front surface 1330, inserting the proximal end 978 of the inserter shaft 306 into the third inner portion 1389 of the hole 1384 in the distal end 1320 of the inserter handle 302 and into the hole 1404 of the lock lever 314, aligning the grooves 986, 988 with the holes 1390, 1392, and inserting a pin (not shown) into the holes 1390, 1392 and the grooves 986, 988. A compression spring (not shown) can be inserted into the hole 1408 to bear against the front wall of the slot 1382. The spring can bias the lock lever 314 towards the rear surface 1332 .

[0138] Inserting the locking tube assembly 318 into the shaft assembly 304 may include inserting the distal end 1246 of the distal locking tube 326 into the hole 992 in the proximal end 978 of the inserter shaft 306, advancing the locking tube assembly 318 into the shaft assembly 304 until the body 1220 of the locking tube coupling 320 enters the hole 992 and the post 1226 enters the slot 982 or the slot 984, and twisting the locking tube assembly 318 relative to the shaft assembly 304 to move the post 1226 past the slot bend. When the shaft assembly 304, lock lever 314, inserter handle 302, and lock tube assembly 318 are operably assembled, the body 1220 of the lock tube coupling 320 can fit within the hole 1404 of the lock lever 314, and the posts 1222, 1226 of the lock tube coupling 320 can fit within the keyway 1406 of the lock lever 314.

[0139] Coupling the shuttle 322 to the inserter handle 302 (including the set screw 316 and release ring 344) can include inserting the proximal end 1240 of the proximal locking tube 324 into the fourth inner portion 976 of the hole 968 at the distal end 948 of the shuttle 322, inserting the key 1428 of the release ring 344 into the groove 958 at the distal end 948 of the shuttle 322, sliding the shuttle 322 into the first inner portion 1386 of the hole 1384 until the tip of the set screw 316 slides into the slot 966, and twisting the release ring 344 and shuttle 322 relative to the inserter handle 302 to move the tip past the bend in the slot.

[0140] When the instrument 300 is operatively assembled as described in the previous step, the proximal locking tube 324 is within the hole 968 of the shuttle 322, the teeth 918 of the lever link can engage with the groove 960 of the shuttle 322, the teeth 906 of the ratchet 338 can engage with the groove 962 of the shuttle 322, and a portion of the markings 964 of the shuttle 322 can be exposed through the window 1342 of the inserter handle 302.

[0141] Inserting the drawbar assembly 328 into the locking tube assembly 318 may include inserting the distal end 1288 of the drawbar tip 332 into an inner diameter of the proximal end 1240 of the proximal locking tube 324 and advancing the drawbar assembly 328 into the locking tube assembly 318 until the proximal end 1240 enters the gap 1316.

[0142] Coupling the drawbar assembly 328 to the shuttle 322 may include engaging the female threads of the second inner portion 972 of the hole 968 of the shuttle 322 with the male threads 1276 of the drawbar handle 330 and tightening the threads until the flange 1272 abuts the proximal end 946 of the shuttle 322.

[0143] The instrument 300 can be actuated by rotating the release ring 344 , pivoting the lock lever 314 , and pivoting the lever 312 .

[0144] The release ring 344 can be coupled to the shuttle 322 by placing the key 1428 in the groove 958, such that the shuttle is free to slide axially relative to the release ring, and the shuttle is rotationally coupled to the release ring such that rotation of the release ring causes rotation of the shuttle. When the release ring 344 is rotated such that the groove 1420 engages the ridge 1338, the slot 966 of the shuttle 322 can be free to slide axially relative to the set screw 316, and the grooves 960, 962 can rotate out of engagement with the teeth 918, 906, respectively. When the release ring 344 is rotated such that the groove 1418 engages the ridge 1336, the slot 966 can capture the set screw 316 past the slot turn. Thus, the release ring 344 and the set screw 316 cooperate to couple or decouple the shuttle 322 and the inserter handle 302.

[0145] The lock lever 314 can be coupled to the lock tube coupling 320 by receiving the posts 1222, 1226 in the keyways 1406, such that the lock tube coupling is free to slide axially relative to the lock lever, and the lock tube coupling is rotationally coupled to the lock lever such that rotation of the lock lever 314 causes rotation of the lock tube coupling. When the lock lever 314 is rotated toward the front surface 1330 of the inserter handle 302, the posts 1222, 1226 can be free to slide axially relative to the keyways 1406 and the slots 982 or 984 of the inserter shaft 306. When the lock lever 314 is rotated toward the rear surface 1332, the slots 982 or 984 can capture the post 1226 past the slot bend. The lock lever 314 can be biased toward the rear surface 1332. The lock lever 314 thus couples or decouples the lock tube assembly 318 and the shaft assembly 304.

[0146] The lever 312 and associated ratchet mechanism 310 can be coupled to other portions of the instrument 300 such that actuation of the lever axially translates the shuttle 322 proximally relative to the inserter handle 302. Pivoting the lever 312 away from the inserter handle 302 can move the lever link 340 distally relative to the shuttle 322. Pivoting the lever 312 toward the inserter handle 302 can move the lever link 340 proximally. When the tooth 918 is engaged within the groove 960, pivoting the lever 312 toward the inserter handle 302 can also linearly translate the shuttle 322 proximally along the longitudinal instrument axis 866 without rotating the shuttle 322 about the axis 866. Thus, the lever link 340 can be referred to as the drive link of the ratchet mechanism 310. The tooth 906 of the ratchet 338 can engage the groove 962 to prevent the shuttle 322 from moving distally.

[0147] 86-91, another insertion and expansion instrument is shown. Instrument 1500 may be deployed to insert and expand implant 1000, implant 1100 as shown, or another expandable intervertebral implant. Other tools, such as drawbar assembly 160, funnel 170, tamp assembly 180, and driver assembly 190 disclosed herein, may be used or adapted for use with instrument 1500 to deploy the implant, deposit graft material within the implant, and secure locking fasteners, such as screws 654.

[0148] The instrument 1500 can differ from the instruments 100 and 300 in at least the following attributes: The drawbar may be engaged by a slider button / lever that can prevent it from rotating and can engage with a rotating portion of the inserter handle to allow expansion. The slider button / lever can reduce the possibility of erroneous user input, i.e., poka-yoke. The drawbar length can be adjustable so that one drawbar is compatible with multiple implant lengths. The handle can be detachable from the tube portion of the instrument 1500 to minimize the mass attached to the implant during bone graft insertion or other steps of the method of use. By minimizing the instrument mass attached to the implant and the associated moment arm through the center of gravity of the instrument mass, unintended movement or misalignment of the implant during steps in the method of use can be minimized. The funnel can be used to loosen the inserter shaft (implant retainer shaft) from the implant, for example after installation of the lockout screw 654.

[0149] The instrument 1500 can include an inserter connector 1502, which may be similar to the inserter connector 138 or the distal tip 308, a connector plate 1504, which may be similar to the fitting cap 146, an inserter shaft 1506, which may be similar to the inserter shaft 136 or 306, an implant retainer shaft 1508, which may function similar to the locking tube assembly 118 or 318, a connector button 1510, a thumb wheel 1514, a wheel axle 1516, an inserter handle 1518, a knob backing plate 1520, a splined insert 1522, a rotating lock ring 1524, a cam lever 1526, a slider button 1528, a threaded slider 1530, a top knob portion 1532, a bottom knob portion 1534, and a drawbar assembly 1536, which may be similar to the drawbar assembly 160 or 328. The instrument 1500 may also include various pins, screws, and / or bolts, springs, ball detents, etc. These parts may be basic components available anywhere, which are generally not shown in this disclosure. The instrument 1500 extends along a longitudinal instrument axis 1542 from a proximal end 1538 to a distal end 1540.

[0150] 92 and 93, the inserter connector 1502 extends between a proximal end 1544 and a distal end 1546. The proximal end 1544 can be circular in a proximal view. The distal end 1546 can be rectangular in a distal view. The distal end 1546 can have rounded corners in a distal view. The inserter connector 1502 can include, from proximal to distal, a first outer portion 1548, a second outer portion 1550, and a third outer portion 1552. The first outer portion 1548 can have a circular cross-section and can extend distally about one-quarter to one-third of the proximal-distal length of the inserter connector 1502. The second outer portion 1550 can be a curved transition surface blending between the first outer portion 1548 and the third outer portion 1552. The third outer portion 1552 can include a rectangular distal end 1546. The rectangular outer distal edge can be chamfered. The inserter connector 1502 can include a central longitudinal bore 1554 extending through the distal tip between the proximal end 1544 and the distal end 1546. The bore 1554 can include, from proximal to distal, a first inner portion 1556, a second inner portion 1558, and a third inner portion 1560. The first inner portion 1556 can have a circular cross-section and can extend distally about one-quarter to one-third of the entire proximal-distal length of the inserter connector 1502. The second inner portion 1558 can have a circular cross-section with a diameter smaller than that of the first inner portion 1556. The cross-sectional shape of the third inner portion 1560 can be a superposition of a circle and a rectangle. The diameter of the circle can be smaller than the diameter of the first inner portion 1556 and the same as or similar to the diameter of the second inner portion 1558. The major dimension (length) of the rectangle can be larger than the diameter of the first inner portion 1556 and can be aligned with the major dimension (length) of the rectangle of the third outer portion 1552. The minor dimension (width) of the rectangle can be smaller than the diameter of the circle and smaller than the diameter of the second inner portion 1558. The rectangle can have rounded corners. The third inner portion 1560 can have a flat proximal end.

[0151] 94 and 95, the connector plate 1504 extends between a proximal side 1562 and a distal side 1564. The connector plate 1504 can be circular in a proximal or distal view. The connector plate 1504 can include, from proximal to distal, a first outer portion 1566 and a second outer portion 1568. The first outer portion 1566 can taper inwardly from proximal to distal and can be conical. The first outer portion 1566 can have a flat distal end. The second outer portion 1568 can be cylindrical and have a diameter smaller than the minor diameter of the first outer portion 1566. Bilateral holes 1570, 1572 can extend through the connector plate 1504 between the proximal side 1562 and the distal side 1564. A central longitudinal bore 1574 can extend through the connector plate 1504 between the proximal side 1562 and the distal side 1564. The bore can include, from proximal to distal, a first inner portion 1576, a second inner portion 1578, a third inner portion 1580, a fourth inner portion 1582, and a fifth inner portion 1584. Each inner portion can have a circular cross section. The first inner portion 1576 can have a short proximal-distal length and a circumferential chamfer around the inner proximal edge. The second inner portion 1578 can have a diameter larger than the diameter of the first inner portion 1576. The third inner portion 1580 can have a diameter the same as or similar to the diameter of the first inner portion 1576 and smaller than the diameter of the second inner portion 1578. There can be a tapered transition between the second inner portion 1578 and the third inner portion 1580. The distal end of the third inner portion 1580 can be flat and can be proximal to the distal end of the first outer portion 1566. The fourth inner portion 1582 can have a diameter smaller than the diameter of the first inner portion 1576. The fifth inner portion 1584 can have a diameter smaller than the diameter of the first inner portion 1576 and larger than the diameter of the fourth inner portion 1582.

[0152] 96 and 97, the inserter shaft 1506 extends between a proximal end 1586 and a distal end 1588. The inserter shaft 1506 may be a tubular portion with a circular outer cross-sectional shape and an inner cross-sectional shape. The inserter shaft 1506 may include, from proximal to distal, a first outer portion 1590, a second outer portion 1592, and a third outer portion 1594. The first outer portion 1590 may have a short proximal-distal length. The outer diameter of the second outer portion 1592 may be larger than the outer diameter of the first outer portion 1590. The second outer portion 1592 may occupy a majority of the entire proximal-distal length of the inserter shaft 1506. The second outer portion 1592 may include one or more openings 1596. Four openings 1596 are shown evenly spaced along the length of the second outer portion 1592. Each opening 1596 can extend through one wall of the second outer portion 1592, or through both walls as shown. The outer diameter of the third outer portion 1594 can be the same as or similar to the outer diameter of the first outer portion 1590 and smaller than the outer diameter of the second outer portion 1592. The inserter shaft 1506 can include a central longitudinal bore 1598 extending therethrough between the proximal and distal ends 1586, 1588.

[0153] The inserter connector 1502, connector plate 1504, and inserter shaft 1506 may be coupled together in a shaft assembly 1600, such as shaft assembly 116 or 304. See FIGS. 86 and 87. The shaft assembly 1600 may also include two pins (not shown) protruding proximally from holes 1570, 1572 in the connector plate 1504. The shaft assembly 1600 may be assembled by inserting the first outer portion 1590 of the inserter shaft 1506 into the fourth inner portion 1582 of the connector plate 1504 and inserting the third outer portion 1594 into the first inner portion 1556 of the inserter connector 1502. The holes 1570, 1572 may be aligned adjacent to the rectangular long sides of the third outer portion 1552. The shaft assembly 1600 may be a weldment. The diameters of the second inner portion 1558 of the inserter connector 1502, the fourth inner portion 1582 of the connector plate 1504, and the hole 1598 in the inserter shaft 1506 can be the same or similar, and together they can form a shaft assembly hole.

[0154] 96 and 97, the implant holder shaft 1508 extends between a proximal end 1602 and a distal end 1604. The implant holder shaft 1508 can include, from proximal to distal, a first outer portion 1606, a second outer portion 1608, and a third outer portion 1610. The first outer portion 1606 can be an elongated torque coupling such as the hex key shown. The second outer portion 1608 can extend over a majority of the proximal-distal length of the implant holder shaft 1508 and can have a circular cross-section with a diameter smaller than the minor diameter of the first outer portion 1606. The third outer portion 1610 can include male threads. The major diameter of the threads can be the same as or similar to the diameter of the second outer portion 1608. A central longitudinal bore 1612 can extend through the implant retainer shaft 1508 between the proximal and distal ends 1602, 1604.

[0155] 100 and 101, the connector button 1510 extends between a proximal end 1614 and a distal end 1616. The connector button 1510 can have a flat inner portion 1618 and an opposing outer portion 1620. A hole 1622 can extend into the inner portion 1618. A transverse groove 1624 can extend across the outer portion 1620 near the proximal end 1614, thereby forming a corresponding ledge 1626 along the outer proximal edge of the connector button 1510. Opposite thinned ears 1628, 1630 can be located on either end of the ledge 1626 to form inner proximal corners of the connector button 1510. An indentation 1632 can be present in the outer portion 1620. Opposite slots 1634, 1636 may extend through the connector button 1510 parallel to the inner portion 1618 and through the ledge 1626. The slots 1634, 1636 may intersect the groove 1624. A second connector button 1512 is shown. The connector button 1512 may be a mirror image of the connector button 1510.

[0156] 102 and 103, the thumbwheel 1514 extends between a proximal side 1638 and a distal side 1640. The thumbwheel 1514 may be a generally disk or ring shaped piece with one or more friction elements 1642, such as the ten scallops shown, disposed around its outer periphery. A central longitudinal bore 1644 may extend through the thumbwheel 1514 between the proximal side 1638 and the distal side 1640. The bore 1644 may include, from proximal to distal, a first inner portion 1646 and a second inner portion 1648. The first inner portion 1646 may have a circular cross section and may extend distally about two-fifths to one-half of the entire proximal-distal length of the thumbwheel 1514. The second inner portion 1648 may be a torque coupling, such as the hexagonal socket shown. The major dimension of the second inner portion 1648 can be smaller than the diameter of the first inner portion 1646 .

[0157] 104 and 105, the wheel axle 1516 extends between a proximal end 1650 and a distal end 1652. The wheel axle 1516 may be a funnel-shaped piece with a wide proximal mouth 1654 and a narrow distal stem 1656 or shaft. The mouth 1654 may taper toward the stem 1656. A central longitudinal bore 1658 may extend through the wheel axle 1516 between the proximal end 1650 and the distal end 1652. The bore 1658 may include, from proximal to distal, a first inner portion 1660, a second inner portion 1662, and a third inner portion 1664. The first inner portion 1660 may have a rounded cross-sectional shape and may correspond to the outer shape of the mouth 1654. The second inner portion 1662 can have a circular cross-sectional shape and can extend distally into the stem 1656. The third inner portion 1664 can have a circular cross-section with a diameter larger than the diameter of the second inner portion 1662.

[0158] 106-108, the inserter handle 1518 extends between a proximal end 1668 and a distal end 1670. The inserter handle 1518 may include, from proximal to distal, a first outer portion 1672, a second outer portion 1674, a third outer portion 1676, and a fourth outer portion 1678. The first outer portion 1672 may have a circular cross-section and a short proximal-distal length. The second outer portion 1674 may have a circular cross-section with a diameter smaller than that of the first outer portion 1672. The third outer portion 1676 may be generally hourglass shaped or otherwise contoured to be comfortably and ergonomically grasped by a user's hand. The proximal diameter of the third outer portion 1676 can be greater than the diameter of the first outer portion 1672, such that the second outer portion 1674 forms a circumferential groove between the first outer portion 1672 and the third outer portion 1676. The fourth outer portion 1678 can have a circular cross-section with a diameter smaller than the diameter of the second outer portion 1674 and the distal diameter of the third outer portion 1676. A transverse hole 1680 can extend through the inserter handle 1518 into the third outer portion 1676 along a first direction, referred to as the anterior-posterior direction. The hole 1680 can be rectangular or square and can have rounded corners. A pocket 1682 can extend transversely into the inserter handle 1518 along a second direction, referred to as the lateral direction, that is 90 degrees from the first direction. A pocket 1682 can extend proximally into the third outer portion 1674 and distally into the fourth outer portion 1678. The pocket can be D-shaped with a flat distal side and a curved proximal side. A second pocket 1684 can extend into the inserter handle 1518 opposite the pocket 1682 and can be a mirror image of the pocket 1682. A central longitudinal bore 1686 can extend through the inserter handle 1518 between the proximal and distal ends 1668, 1670. The bore 1686 can include, from proximal to distal, a first inner portion 1688, a second inner portion 1690, a third inner portion 1692, and a fourth inner portion 1694.The first inner portion 1688 can have a cross-section that includes a circular portion that is concentric with the second inner portion 1690, the third inner portion 1692, and the fourth inner portion 1694, and an alcove portion 1696 that extends radially away from the circular portion toward a first side of the inserter handle 1518, referred to as the front side. The distal end of the first inner portion 1688 can be flat. A hole 1698 can extend distally within the alcove portion 1696 and can be centered within the alcove portion. The hole 1698 can include a counterbore 1700. The second inner portion 1690 can taper inwardly as it extends distally. The second inner portion 1690 can be conical. The major diameter of the second inner portion can be smaller than the diameter of the circular portion of the first inner portion 1688. The third inner portion 1692 can have a circular cross-section and can extend distally into the bore 1680. The fourth inner portion 1694 can have a circular cross-section with a diameter the same as or similar to that of the third inner portion 1692. Opposite holes 1702, 1704 can extend proximally into the distal end 1670 of the inserter handle 1518. The holes 1702, 1704 can be located towards the front and rear. Opposite holes 1706, 1708 can extend proximally into the distal end 1670 and into the proximal wall of the pocket 1682. Opposite holes 1710, 1712 can extend proximally into the distal end 1670 and into the proximal wall of the pocket 1684.

[0159] 109 and 110, the knob receiver 1520 extends between a proximal end 1714 and a distal end 1716. The knob receiver 1520 can have a flat left side 1718 and a right side 1720 and can have an hourglass shape when viewed from side to side. The knob receiver 1520 can include one or more openings 1722. Two openings 1722 are shown extending along the anterior-posterior direction. Each opening 1722 can extend through one wall of the knob receiver 1520 or through both walls as shown. A central longitudinal hole 1724 can extend through the knob receiver 1520 between the proximal and distal ends 1716. The hole 1724 can include, from proximal to distal, a first inner portion 1726, a second inner portion 1728, and a third inner portion 1730. The first inner portion 1726 can include a generally circular central portion with opposing longitudinal grooves 1732, 1734 extending along the front-to-rear direction such that the first inner portion 1726 has a generally non-circular cross-section. The first inner portion 1726 can extend distally over a majority of the proximal-distal length of the knob backplate 1520 and can have a flat distal end. The second inner portion 1728 can have a circular cross-section with a diameter smaller than the diameter of the circular central portion of the first inner portion 1726. The second inner portion 1728 can have a short proximal-distal length. Opposite holes 1736, 1738 can extend distally through the second inner portion 1728 and can be aligned with the grooves 1732, 1734. The holes 176, 1738 can be countersinks. The third inner portion 1730 can have a generally rectangular cross-section and can have rounded corners. The major dimension (length) of the rectangle can be greater than the diameter of the circular central portion of the first inner portion 1726 and can extend along the front-to-rear direction. The third inner portion 1730 can extend through the front side of the knob receiving plate 1520, such that the front side has a distal notch. The minor dimension (width) of the rectangle can be less than the diameter of the circular central portion of the first inner portion 1726 and greater than the diameter of the second inner portion 1728. The teeth 1740, 1742 on both sides can protrude toward each other from the left and right walls of the third inner portion 1730 near the front side.

[0160] 111 and 112, the splined insert 1522 extends between a proximal end 1744 and a distal end 1746. The splined insert 1522 can have a cylindrical body 1748 with a tab 1750 on only one side extending radially outward from the proximal end 1744. A longitudinal hole 1752 can extend through the tab 1750. The hole 1752 can be a countersink on the distal side of the tab 1750. The central longitudinal hole 1754 can include, from proximal to distal, a first inner portion 1756 and a second inner portion 1758. The first inner portion 1756 can have a circular cross section and can include a shallow countersink or chamfer around an inner proximal edge. The second inner portion 1758 can include a torque coupling, such as an internal spline as shown.

[0161] 113 and 114, the rotating lock ring 1524 extends between a proximal end 1760 and a distal end 1762. The rotating lock ring 1524 can include, from proximal to distal, a first outer portion 1764, a second outer portion 1766, a third outer portion 1768, and a fourth outer portion 1770. The first outer portion 1764 can have a circular cross section and can include a rounded outer proximal edge. The second outer portion 1766 can have a circular cross section with a diameter smaller than the diameter of the first outer portion 1764. The third outer portion 1768 can have a circular cross section with a diameter the same as or similar to the diameter of the first outer portion 1764. The distal outer edge of the third outer portion can include a circumferential chamfer. The fourth outer portion 1770 can include a torque coupling, such as the external spline shown. The fourth outer portion 1770 can be complementary to the second inner portion 1758 of the splined insert 1522. A central longitudinal torque coupling 1772 can extend through the rotation lock ring 1524 between the proximal end 1760 and the distal end 1762. The torque coupling 1772 can be a hexagonal hole as shown. The proximal end 1760 of the rotation lock ring can be concave. The splined insert 1522 and the rotation lock ring 1524 together can be referred to as a rotation locking mechanism.

[0162] 115 and 116, the cam lever 1526 extends between a proximal end 1774 and a distal end 1776. The cam lever 1526 can include, from proximal to distal, a first portion 1778 and a second portion 1780. The first portion 1778 can include a hole 1782, a first notch 1784, a protrusion 1786, a second notch 1788, and a tooth 1790. The hole 1782 can extend transversely through the cam lever 1526. The hole 1782 can be near the proximal end 1774. A proximal / outer bearing surface 1783 can be located adjacent the hole 1782. The surface 1783 can be referred to as a first fulcrum of the cam lever 1526. The first notch 1784 and protrusion 1786 can extend transversely across an outer portion of the cam lever 1526 distal to the hole 1782. The protrusion 1786 can be immediately adjacent a distal or outer side of the first notch 1784. The protrusion 1786 can be referred to as a second fulcrum of the cam lever 1526. The second notch 1788 and tooth 1790 can extend transversely across an inner portion of the cam lever 1526 distal to the hole 1782. The tooth 1790 can be immediately adjacent a proximal or inner side of the second notch 1788. The second notch 1788 and tooth 1790 can be distal to the first notch 1784 and protrusion 1786. The second portion 1780 can be a distally extending arm for actuation by a user. The second portion 1780 can be larger than the first portion 1778 such that rounded shoulders 1792, 1794 are formed at the interface between the first portion 1778 and the second portion 1780. The shoulders 1792, 1794 can face proximally and inwardly.

[0163] 117-119, the slider button 1528 extends between a proximal end 1796 and a distal end 1798, and between an outer portion 1800 and an inner portion 1802. The outer portion 1800 may include an elliptical dome-shaped surface 1804 with a longitudinal central trough 1806. The trough 1806 may be generally rectangular and may extend through the distal end 1798. A window 1808 may extend through the slider button 1528 between the outer portion 1800 and the inner portion 1802. The window 1808 may be rectangular with its major dimension (length) extending along the proximal-distal direction. A flange 1810 may surround the surface 1804 and may serve as an interface between the outer portion 1800 and the inner portion 1802. The flange 1810 may be discontinuous near the window 1808. The inner portion 1802 can include, from proximal to distal, a first portion 1812, a second portion 1814, a third portion 1816, a fourth portion 1818, a fifth portion 1820, a sixth portion 1822, a seventh portion 1824, an eighth portion 1826, a ninth portion 1828, and a tenth portion 1830. The first portion 1812 can be parallel to the flange 1810 at a first distance from the inner side of the flange 1810. A hole 1832 can extend outwardly into the first portion 1812 near the proximal end 1796. The second portion 1814 can be sloped between the first portion 1812 and the third portion 1816. The third portion 1816 can be parallel to the flange 1810 at a second distance from the inner side of the flange, where the second distance is less than the first distance. The fourth portion 1818 can slope between the third portion 1816 and the fifth portion 1820. The fourth portion 1818 can be parallel to the second portion 1814. The fifth portion 1820 can be parallel to the flange 1810 at the same or similar level as the outer side of the flange. The sixth portion 1822 can slope between the fifth portion 1820 and the seventh portion 1824. The seventh portion 1824 can be parallel to the flange 1810 and at the same or similar level as the third portion 1816.The eighth portion 1826 can be curved between the seventh portion 1824 and the ninth portion 1828. The ninth portion 1828 can be parallel to the flange 1810 at a third distance from the inner side of the flange 1810, the third distance being greater than the first distance. The tenth portion 1830 can protrude a fourth distance from the inner side of the flange 1810 and can extend distally beyond the flange. The tenth portion 1830 can include a semicircular yoke 1834 that flares outwardly from the flange 1810.

[0164] 119 and 120, the threaded slider 1530 extends between a proximal end 1836 and a distal end 1838, and between an outer portion 1840 and an inner portion 1842. The threaded slider 1530 may be referred to as an actuator. The threaded slider 1530 may include a rectangular body 1844 with a post 1846 extending from the inner portion 1842. The outer portion 1840 may be angled outwardly from proximal to distal. A notch 1848 may extend into the distal outer edge of the body 1844 between the opposing prongs 1850 and 1852. A transverse hole 1854 may extend through the threaded slider 1530, through the prongs 1850, 1852, and intersect with the notch 1848. A shallow hole 1856 or recess can extend inwardly into the outer portion 1840 near the proximal end 1836, in line with the notch 1854. A longitudinal hole 1858 extends through the threaded slider 1530 between the proximal end 1836 and the distal end 1838. The hole 1858 can include a first side portion 1860 toward the outer portion 1840 and a second side portion 1862 toward the inner portion 1842. The first side portion 1860 can include female threads around an arc of approximately 180 degrees, i.e., along a semi-cylinder. The second side portion 1862 can be smooth, D-shaped, and larger than the major diameter of the female threads of the first portion 1860.

[0165] 122-123, the upper knob portion 1532 extends between a proximal end 1864 and a distal end 1866, and between an outer portion 1868 and an inner portion 1870. The outer portion 1868 may be dome-shaped. A window 1872 may extend through the upper knob portion 1532 between the outer portion 1868 and the inner portion 1870. The window 1872 may be oval or rectangular, with its major dimension (length) extending in a proximal-distal direction. The inner portion 1868 may be generally concave and may include, from proximally to distally, a first portion 1874, a second portion 1876, a third portion 1878, a fourth portion 1880, and a fifth portion 1882. The first portion 1874 may have a semicircular cross-section and a short proximal-distal length. The second portion 1876 can be elliptical or rectangular, with its major dimension extending along the proximal-distal direction. The second portion 1876 can be aligned with the window 1872 and can extend over a majority of the proximal-distal length of the upper knob portion 1532. Opposite longitudinal ledges 1884, 1886 can extend along the inner edge of the window 1872. The third portion 1878 can have a semicircular or semi-elliptical cross-section and a short proximal-distal length. The first and third portions 1878 can have the same or similar diameters (or radii), with the third portion 1878 being offset toward the outer portion 1868. The fourth portion 1880 can have a semicircular cross-section and a short proximal-distal length. The diameter of the fourth portion 1880 can be greater than the diameter of the first portion 1874. The fourth portion 1880 can be concentric with the first portion 1874. The fifth portion 1882 can have a semicircular cross-section and a short proximal-distal length. The diameter of the fifth portion 1882 can be greater than the diameter of the first portion 1874 and less than the diameter of the fourth portion 1880. The fifth portion 1882 can be concentric with the first portion 1874. Taken together, the fourth portion 1880 can be referred to as a groove or undercut, and the fifth portion 1882 can be referred to as a lip or protruding portion. Bilateral holes 1888, 1890 can extend into the medial portion 1870 on either side of the third portion 1878. The holes 1888, 1890 can include female threads.The proximal end 1864 can include a protrusion 1892 that is complementary to the third inner portion 1730 of the knob backing plate 1520. The protrusion 1892 can be generally rectangular and can include notches 1894, 1896 on either side for receiving the teeth 1740, 1742. An internally threaded bore 1898 can extend distally into the protrusion 1892 between the notches 1894, 1899 and beside the first portion 1874.

[0166] 124 and 125, a bottom knob portion 1534 extends between the proximal end 1900 and the distal end 1902 and between the outer portion 1904 and the inner portion 1906. The outer portion 1904 may be domed. One or more openings 1908 may extend through the bottom knob portion 1534 between the outer and inner portions 1902, 1904. Two openings 1908 are shown. Opposite holes 1910, 1912 may extend into the outer portion 1904 near the distal end 1902. The holes 1910, 1912 may include counterbores. A semicircular wall 1914 or shell may protrude from the inner portion 1906 near the proximal end 1900, such that the convex side of the wall 1914 faces proximally. The wall 1914 can include a distally extending internally threaded through hole 1916. A U-shaped or partially elliptical wall 1918 can project from the inner portion 1906 near the distal end 1902 such that the convex side of the wall 1918 faces distally. A hole 1920 can extend through the bottom knob portion 1534 between the outer portion 1904 and the inner portion 1906. The hole 1920 can be located between the distal end of the wall 1914 and the proximal end of the wall 1918. The hole 1920 can include, from medial to lateral, a first inner portion 1922, a second inner portion 1924, and a third inner portion 1926. The first inner portion 1922 can have a rectangular or square cross-section and can extend outwardly over a majority of the medial-lateral thickness of the bottom knob portion 1534. The first inner portion 1922 can have a flat outer end. The second inner portion 1924 can have a circular cross-section with a diameter smaller than the minor dimension of the first inner portion 1922. The second inner portion 1924 can have a flat outer end. The third inner portion 1926 can have a circular cross-section with a diameter smaller than the diameter of the second inner portion 1924. A longitudinal bore 1928 can extend through the bottom knob portion 1534 between the proximal end 1900 and the distal end 1902. The bore 1928 can include, from proximal to distal, a first inner portion 1930, a second inner portion 1932, a third inner portion 1934, and a fourth inner portion 1936.The first inner portion 1930 can have a circular cross-section and can extend distally into the proximal region of the wall 1918. The second inner portion 1932 can have the same or similar diameter (radius) as the first inner portion 1930, but can taper toward the outer portion 1904 to form an elliptical cross-section. The second inner portion 1932 can extend through the distal end of the wall 1918. The third inner portion 1934 can have a semicircular cross-section with a diameter larger than the diameter of the first inner portion 1930 and a short proximal-distal length. The fourth inner portion 1936 can have a semicircular cross-section with a diameter larger than the diameter of the first inner portion 1930 and smaller than the diameter of the third inner portion 1934 and a short proximal-distal length. Taken together, the third inner portion 1934 may be referred to as a groove or undercut, and the fourth inner portion 1936 may be referred to as a lip or protrusion.

[0167] The proximal end 1900 can include a protrusion 1938 that, when combined with the protrusion 1892 of the upper knob portion 1532, is complementary to the third inner portion 1730 of the knob backing plate 1520. The outer profile of the protrusion 1938 can be rectangular or square. An internally threaded hole 1940 can extend distally into the protrusion 1938 beside the first inner portion 1930.

[0168] The connector buttons 1510, 1512, thumb wheel 1514, wheel axle 1516, inserter handle 1518, knob backing plate 1520, splined insert 1522, rotation lock ring 1524, cam lever 1526, slider button 1528, threaded slider 1530, top knob portion 1532, and bottom knob portion 1534 may be coupled together in a handle assembly 1942. See FIG.

[0169] The handle assembly 1942 can be assembled by coupling the connector button 1510 to the inserter handle 1518, coupling the thumb wheel 1514, wheel axle 1516, and splined insert 1522 to the inserter handle 1518, coupling the cam lever 1526, slider button 1528, threaded slider 1530, rotary lock ring 1524, and top knob portion 1532 together, coupling the top knob portion 1532 and bottom knob portion 1534 to the inserter handle 1518, and coupling the knob receiving plate 1520 to the top knob portion 1532 and bottom knob portion 1534.

[0170] Coupling the connector button 1510 to the inserter handle 1518 may include inserting a compression spring (not shown) into the hole 1622, orienting the connector button 1510 and the inserter handle 1518 with the proximal ends 1614, 1668 facing the same direction and the medial portion 1618 facing into the pocket 1682, inserting the connector button 1510 into the pocket 1682, and inserting a pin (not shown) into the holes 1706, 1708 and slots 1634, 1636. Coupling the connector button 1512 to the inserter handle 1518 may include similar steps with the pocket 1684 and holes 1710, 1712.

[0171] Coupling the thumbwheel 1514, the wheel axle 1516, and the splined insert 1522 to the inserter handle 1518 may include orienting the thumbwheel 1514 and the inserter handle 1518 with the proximal ends 1638, 1668 facing the same direction, inserting the thumbwheel 1514 into the hole 1680, inserting a compression spring (not shown) into the third inner portion 1664 of the wheel axle 1516, inserting the distal end 1652 of the wheel axle 1516 into the first inner portion 1646 of the thumbwheel 1516 through the third inner portion 1692 of the inserter handle 1518, inserting the distal end 1746 of the splined insert 1522 into the first inner portion 1688 of the inserter handle 1518, inserting the tab 1750 into the alcove portion 1696, and inserting a pin (not shown) into the holes 1752, 1698.

[0172] Coupling the cam lever 1526, slider button 1528, threaded slider 1530, rotational lock ring 1524 and upper knob portion 1532 together involves inserting a ball detent (not shown) into hole 1832 in slider button 1528; inserting first portion 1778 of cam lever 1526 from outer portion 1800 through window 1808 in slider button such that second portion 1780 extends outwardly, protrusion 1786 faces proximally and teeth 1790 faces distally; and inserting first portion 1778 into protrusion 1850, so that outwardly angled outer portion 1840 abuts fourth portion 1818. 1852 into the notch 1848 of the threaded slider 1530 between the holes 1854, 1782, inserting a pin (not shown) into the holes 1854, 1782, engaging the yoke 1834 with the first outer portion 1764 and the second outer portion 1766 of the rotational lock ring 1524 so that the proximal ends 1760, 1796 face in the same direction, and inserting the second portion 1780 and the slider button 1528 from the inner portion 1870 into the window 1872 of the upper knob portion 1532 so that the flange 1810 rests against the ledges 1884, 1886 and the proximal ends 1864, 1796 face in the same direction.

[0173] Coupling the top knob portion 1532 and the bottom knob portion 1534 to the inserter handle 1518 can include engaging the first outer portion 1672, the fourth portion 1880, and the third inner portion 1934, engaging the second outer portion 1674, the fifth portion 1882, and the fourth inner portion 1936 with the inner portions 1870, 1904 facing each other, and inserting screws (not shown) into the holes 1910, 1888 and holes 1912, 1890. When this step is performed after the previous step, the post 1846 of the threaded slider 1530 is in the hole 1920 of the bottom knob portion 1534.

[0174] Joining the knob receiving plate 1520 to the top knob portion 1532 and the bottom knob portion 1534 can include abutting the inner portions 1870, 1904 so that the proximal ends 1864, 1900 face in the same direction, inserting the protrusions 1892, 1938 into the third inner portion 1730 so that the notches 1894, 1896 receive the teeth 1740, 1742, and inserting screws (not shown) into the holes 1736, 1898, 1916 and the holes 1738, 1940.

[0175] The handle assembly 1942 can be actuated by pressing the connector buttons 1510 , 1512 , rotating the thumb wheel 1514 , pivoting the cam lever 1526 , and rotating the knob backing plate 1520 , the top knob portion 1532 and the bottom knob portion 1534 .

[0176] Depressing the connector buttons 1510, 1512 of the handle assembly 1942 can disconnect the connector plate 1504 of the shaft assembly 1600 from the handle assembly and can also enable or facilitate connecting the shaft assembly to the handle assembly. The connector buttons 1510, 1512 are biased outward such that the handle assembly retains the shaft assembly.

[0177] Turning the thumbwheel 1514 rotates the implant holder shaft 1508 to couple and decouple the instrument 1500 and the implant 1100. More specifically, turning the thumbwheel 1514 engages and disengages the male threads of the third outer portion 1610 of the implant holder shaft 1508 and the female threads 1155 of the second end 1152 of the implant 1100.

[0178] Pivoting the cam lever 1526 may engage and disengage the female threads of the first side portion 1860 of the bore 1858 of the threaded slider 1530 and the male threaded portion 2036 of the shaft 2032 of the threaded shaft 1954, as discussed below. Pivoting the cam lever 1526 inward (distally) may also lock the slider button 1528 in its distal position due to the interaction of the teeth 1790 with the distal edge of the window 1808. Pivoting the cam lever 1526 outward may provide sufficient mechanical advantage to overcome residual friction and / or potential energy within the instrument 1500 following expansion of the implant 1100 to disengage the threads of the threaded slider 1530 from the threaded shaft 1954. This mechanical advantage can be due primarily to the interaction of a first fulcrum, surface 1783, with the proximal edge of window 1808, and secondly, to the interaction of a second fulcrum, protrusion 1786, with a proximal portion of trough 1806 adjacent the proximal edge of window 1808.

[0179] By rotating the knob receiving plate 1520, the top knob portion 1532, and the bottom knob portion 1534 relative to the inserter handle 1518, the threaded slider 1530 and the threaded shaft 1954 are engaged and the sixth outer portion 1974 of the handle 1944 is within the torque coupling 1772 of the rotation lock ring 1524, allowing the pull rod assembly 1536 to be linearly translated along the longitudinal instrument axis 1542 without rotating the pull rod assembly 1536 about the axis 1542.

[0180] 126-129, the drawbar assembly 1536 can include a handle 1944, a pull rod 1946, a set screw 1948, a button 1950, a button spring 1952, a threaded shaft 1954, a retainer 1956, and a retainer spring 1958.

[0181] The handle 1944 extends between a proximal end 1960 and a distal end 1962. The handle 1944 may include, from proximal to distal, a first outer portion 1964, a second outer portion 1966, a third outer portion 1968, a fourth outer portion 1970, a fifth outer portion 1972, and a sixth outer portion 1974. The first outer portion 1964 may have a maximum outer diameter of the handle 1944. A friction element 1976, such as the ten scallops shown, may be included about the first outer portion 1964. The second outer portion 1966 may have a circular cross section with a diameter smaller than the diameter of the first outer portion 1964. A transverse hole 1978 may extend through the second outer portion 1966. The bore 1978 may include, in sequence, a first inner portion 1980, a second inner portion 1982, and a third inner portion 1984. The first inner portion 1980 may be rectangular or square and may have a flat bottom. The second inner portion 1982 may have a circular cross section with a diameter smaller than the dimensions of the first inner portion 1980. The third inner portion 1984 may also have a circular cross section with a diameter smaller than the diameter of the second inner portion 1982. The third outer portion 1968 may have a circular cross section with a diameter smaller than the diameter of the second outer portion 1966 and a short proximal-distal length. The fourth outer portion 1970 may include male threads. The fifth outer portion 1972 may be a torque coupling such as the hex key shown. The dimensions of the torque coupling can be smaller than the diameters of the first outer portion 1964, the second outer portion 1966, and the third outer portion 1968. The sixth outer portion 1974 can also be a torque coupling, such as the hex key shown. The dimensions of the sixth outer portion 1974 can be smaller than the dimensions of the fifth outer portion 1972. A central longitudinal bore 1986 can extend through the handle 1944 between the proximal end 1960 and the distal end 1962. The bore 1986 can include, from proximal to distal, a first inner portion 1988, a second inner portion 1990, and a third inner portion 1992. The first inner portion 1988 can have a short proximal-distal length and can include female threads.The second inner portion 1990 can be smooth with a circular cross-section with a diameter smaller than the minor diameter of the threads of the first inner portion 1988. The third inner portion 1992 can have a circular cross-section with a diameter smaller than the diameter of the second inner portion 1990.

[0182] The pull rod 1946 extends between a proximal end 1994 and a distal end 1996. The pull rod 1946 can include, from proximal to distal, a first portion 1998, a second portion 2000, a third portion 2002, a fourth portion 2004, and a fifth portion 2006. The first portion 1998 can have a generally circular cross-section and a short proximal-distal length. The second portion 2000 can have the largest cross-sectional dimension of the pull rod 1946. Opposite longitudinal flats 2008, 2010 can extend along the first portion 1998 and the second portion 2000. The dimension between the flats 2008, 2010 can be less than the diameter of the first portion 1998. A flat 2012 on only one side can extend along the second portion 2000 without affecting the first portion 1998. A transverse notch 2014 can extend into the second portion 2000 through the side with the flat 2012. There can be a plurality of notches, for example a linear array of notches along the side with the flat 2012. The third portion 2002 can have a circular cross section with a diameter smaller than that of the first portion 1998 and can be the same as or similar to the dimension between the flats 2008, 2010. The third portion 2002 can extend over the majority of the proximal-distal length of the pull rod 1946. The fourth portion 2004 can have a circular cross section with a diameter smaller than that of the third portion 2002. The fifth portion 2006 can include male threads, with the major diameter of the threads being the same as or similar to the diameter of the fourth portion 2004. The pull rod 1946 may include indicia 2016, such as letters, icons, lines, or other markings.

[0183] The button 1950 can include a generally rectangular or square body 2018. A post 2020 can extend from the body 2018. A hole 2022 can extend through the body transversely to the post 2020. The hole 2022 can be rectangular or elliptical in cross section, with a major dimension of the rectangle or ellipse extending in a straight line with the post 2020. A rib 2024 can protrude from an inner wall of the hole adjacent the post 2020. The rib 2024 can be oriented transversely to the hole 2022.

[0184] The threaded shaft 1954 extends between a proximal end 2026 and a distal end 2028. The threaded shaft 1954 can include a proximal head 2030 and a distal shaft 2032 extending from the head. The shaft 2032 can include a proximal smooth portion 2034 and a distal externally threaded portion 2036. Opposite longitudinal troughs 2038, 2040 can extend across the junction between the head 2030 and the smooth portion 2034. The thread form of the threaded portion 2036 can be buttress threads for large axial thrust in one direction. The load bearing thread surface can be substantially perpendicular to the thread axis. The load bearing thread surface of the threaded shaft 1954 can face toward the distal end 2028. A central longitudinal bore 2042 can extend through the threaded shaft 1954 between the proximal end 2026 and the distal end 2028. The bore 2042 can be a torque coupling, such as the hexagonal bore shown.

[0185] The retainer 1956 extends between the proximal end 2044 and the distal end 2046. The retainer 1956 may be a tubular portion. Indicia 2048, such as letters, icons, graphics, lines, etc., may be present on an outer surface of the retainer. A central longitudinal bore 2050 may extend through the retainer 1956 between the proximal end 2044 and the distal end 2046. The bore 2050 may include, from proximal to distal, a first inner portion 2052, a second inner portion 2054, a third inner portion 2056, and a fourth inner portion 2058. The first inner portion 2052 may have a circular cross section. The second inner portion 2054 may include an internal thread. The major diameter of the threads may be the same as or similar to the diameter of the first inner portion 2052. The third inner portion 2056 can have a circular cross-sectional shape with a diameter the same as or similar to the minor diameter of the threads of the second inner portion 2054. The third inner portion 2056 can have a flat distal end. The fourth inner portion 2058 can have a circular cross-section with a diameter smaller than the diameter of the third inner portion 2056.

[0186] The drawbar assembly 1536 is assembled by inserting the spring 1952 into the second inner portion 1982 of the bore 1978 of the handle 1944, inserting the button 1950 into the bore 1978 of the handle 1944 such that the post 2020 is received within the third inner portion 1984 and the body 2018 is received within the first inner portion 1980, depressing the button 1950 while inserting the distal end 1996 of the pull rod 1946 into the bore 1986 in the proximal end 1960 of the handle 1944, advancing the pull rod 1946 until the notch 2014 receives the rib 2024, tightening the set screw 1948 into the first inner portion 1988, and fastening the distal end 1962 of the handle 1944 to the threaded shaft 19 1956, inserting the retainer spring 1958 into each trough 2038, 2040, inserting the distal end 2028 of the threaded shaft 1954 into the hole 2050 in the proximal end 2044 of the retainer 1956, and advancing the threaded shaft 1954 until the first inner portion 2052 of the retainer 1956 receives the third outer portion 1968 of the handle 1944, the second inner portion 2054 is threaded onto the fourth outer portion 1970, and the third inner portion 2056 receives the head 2030 of the threaded shaft 1954.

[0187] The drawbar assembly 1536 may be actuated by depressing the button 1950 while sliding the pull rod 1946 proximally or distally to engage a different notch, such as notch 2014. Different pull rods may also be substituted in the drawbar assembly 1536. Different drawbar lengths and / or configurations may be compatible with different implant lengths or configurations (in the collapsed configuration) (i.e., implants for anterior vertebral body fixation, posterior vertebral body fixation, lateral vertebral body fixation, or foraminal vertebral body fixation, etc.). The drawbar assembly 1536 may be an improvement in the art because it may be adjustable to provide a drawbar length that corresponds to any given implant length. Even if an incorrect drawbar length is initially selected, the drawbar assembly 1536 may be quickly and easily readjusted to the correct drawbar length with positive confirmation that the correct length has been selected. The drawbar assembly 1536 also reduces instrument inventory for sets of drawbars of different lengths.

[0188] The instrument 1500 may be assembled by coupling the implant holder shaft 1508 to the handle assembly 1942 , coupling the shaft assembly 1600 to the handle assembly 1942 , and coupling the drawbar assembly 1536 to the handle assembly 1942 .

[0189] Coupling the implant holder shaft 1508 to the handle assembly 1942 may include inserting the proximal end 1602 of the implant holder shaft 1508 into the fourth inner portion 1694 of the hole 1686 at the distal end 1670 of the inserter handle 1518 and advancing the implant holder shaft 1508 until the first outer portion 1606 is received within the second inner portion 1648 of the hole 1644 of the thumb wheel 1514.

[0190] Coupling the shaft assembly 1600 to the handle assembly 1942 may include inserting pins protruding proximally from holes 1570, 1572 in the connector plate 1504 into holes 1702, 1704 in the inserter handle 1518, and inserting the proximal end 1668 of the inserter handle into the hole 1574 in the proximal side 1562 of the connector plate such that the first outer portion 1672 is received within the third inner portion 1580, the ledge 1626 of the connector button 1510 is received within the second inner portion 1578, and the first inner portion 1576 is received within the groove 1624 (as well as the connector button 1512). Optionally, the connector buttons 1510, 1512 may be depressed during this step.

[0191] Coupling the pull rod assembly 1536 to the handle assembly 1942 can include rotating the cam lever 1526 outwardly and advancing the pull rod assembly 1536 so that the distal end 1996 of the pull rod 1946 is inserted into the hole 1724 in the proximal end 1714 of the knob receiver 1520, the fourth and fifth portions 2004, 2002 are received into the hole 1612 of the implant retainer shaft 1606, the sixth outer portion 1974 of the handle 1944 is received into the torque coupling 1772 of the rotation lock ring 1524 and the second inner portion 1662 of the wheel axle 1516, the threaded portion 2036 of the threaded shaft 1954 is received into the hole 1858 of the threaded slider 1530 and the hole 1928 of the bottom knob portion 1534, and the retainer 1956 is received into the hole 1724 of the knob receiver 1520. The drawbar assembly 1536 can slide into the handle assembly 1942 without rotating about the axis 1542. After the drawbar assembly 1536 is fully inserted into the handle assembly 1942, the cam lever 1526 can be rotated inwardly to engage the threads of the threaded slider 1530 and the threaded shaft 1954.

[0192] The instrument 1500 can be actuated by pressing the connector buttons 1510 , 1512 , rotating the thumb wheel 1514 , pivoting the cam lever 1526 , and rotating the knob backing plate 1520 , top knob portion 1532 , and bottom knob portion 1534 .

[0193] A variety of additional tools can be used with instrument 1500 to implant and expand the intervertebral implant. Instrument 1500 and selected additional tools can be provided in a kit, and together they can be referred to as an instrument set or system. Figures 130-139 show additional tools for use with instrument 1500, including a trial assembly 2060, a funnel 2062, and a driver assembly 2064.

[0194] 130-133, the test assembly 2060 can include a handle 2066, a block 2068, a head 2070, and a shaft 2072. A distal end 2074 of the shaft 2072 can be received within a proximal hole 2076 in the head 2070. The block 2068 can be received within a distal hole 2078 in the handle 2066. The block 2068 and hole 2078 can have a complementary rounded proximal portion 2080 and complementary rectangular or square distal portions 2082, 2084. The block 2068 can be retained within the handle 2066 by passing a pin (not shown) through the holes 2086, 2088. A proximal end 2090 of the shaft 2072 can be received within a distal hole 2092 in the block 2068. The head 2070, shaft 2072, and block 2068 may be a weldment. Alternatively, the handle 2066, block 2068, head 2070, and shaft 2072 may be combined into a single piece. The trial assembly 2060 may include various markings or other indicia 2094 to communicate the trial dimensions and corresponding implant state (e.g., expanded or collapsed).

[0195] 134 and 135, the funnel 2062 can include a wide mouth 2096 that tapers inwardly to a narrow stem 2098 or spout. The stem 2098 can include a torque coupling 2100, which in this example is a hexagonal hole in the distal end of the stem. The torque coupling 2100 can be sized and shaped to receive the first outer portion 1606 at the proximal end 1602 of the implant holder shaft 1508. This allows the funnel 2062 to be coupled to the implant holder shaft 1508 for delivery of implant tissue material, and also allows the funnel 2062 to be used to loosen the implant holder shaft 1508, for example, after the lockout screw 654 has been inserted. See FIGS. 157 and 158.

[0196] 27, 35 and 36, the tamp assembly 180 may be used with the instrument 1500 and implant 1100 as described above with respect to the instrument 100 and implant 1000.

[0197] 136-139, the driver assembly 2064 can include a handle 2102 and a shaft 2104. The handle 2102 can be the same as or similar to the handle 176 of FIGS. 29, 37 and 38. The shaft 2104 can be the same as or similar to the shaft 178. A proximal end 2118 of the shaft 2104 can be received within a distal end 2120 of the handle 2102.

[0198] 43 and 44, the lockout screw 654 may be used with the instrument 1500 and implant 1100 as described above with respect to the instrument 100 and implant 1000.

[0199] 140-142, the implant 1100 is expandable along a horizontal, or lateral, or transverse, or medial-lateral axis 104, and a vertical, or cranio-caudal axis 106. The axis 102 is an anterior-posterior axis. The implant 1100 includes a first support member 1140 and a second support member 1130, the support members being connected by a first end body 1150 and a second end body 1152. The first support member 1140 can include an upper support 1142 and a lower support 1144. The second support member 1130 can include an upper support 1132 and a lower support 1134. An internal thread 1155 is included in the second end body 1152 for connection with an implant retainer shaft 1508. A plurality of link members 1160, 1162, 1166, 1168 pivotally connect each of the first end 1150 and second end 1152 to each of the support members 1130, 1140. The lower support 1144 includes angled expansion slots 1174, 1176 and the upper support 1142 includes angled expansion slots 1170, 1172. A chamber 1122 can be present centrally between the supports 1142, 1144, 1132, 1134, at least when the implant 1100 is expanded. The implant 1100 represents an intervertebral cage as described in pending U.S. Patent Application Publication No. 2006 / 0139994.

[0200] 143-160, a method for inserting and expanding an expandable intervertebral implant using instrument 1500 and associated instruments is shown.

[0201] 143 and 144 illustrate the use of a trial assembly 2060 in the intervertebral space to determine the appropriate size for the implant 1100. The trial assembly 2060 can be inserted into the intervertebral space as shown and then rotated 90 degrees about its longitudinal axis to simulate implant vertical expansion.

[0202] 145 and 146 show the steps of coupling together the instrument 1500 and the implant 1100. Note that the cam lever 1526 has been rotated outwardly, which allows the drawbar assembly 1536 to be inserted and rotated into the instrument 1500 to engage the threads of the fifth portion 2006 of the pull rod 1946 of the drawbar assembly 1536 with the threads 1155 of the first end 1150 of the implant 1100.

[0203] 147 and 148 show the step of locking the instrument 1500 and implant 1100 together. Note that the cam lever 1526 has been rotated inward (distal). With the cam lever in this position, the external splines of the fourth outer portion 1770 of the rotation lock ring 1524 engage with the internal splines of the second inner portion 1758 of the splined insert 1522 to prevent the drawbar assembly 1536 from rotating about the axis 1542, and the female threads of the first side portion 1860 of the bore 1858 of the threaded slider 1530 engage with the male threaded portion 2036 of the threaded shaft 1954 of the drawbar assembly 1536 to prepare the instrument 1500 for actuation to expand the implant 1100.

[0204] 149 and 150 show the step of laterally expanding the implant 1100. The knob backing plate 1520, top knob portion 1532 and bottom knob portion 1534 can be rotated together in a clockwise direction relative to the inserter handle 1518 to rotate the female threads of the first side portion 1860 of the bore 1858 of the threaded slider 1530 relative to the male threaded portion 2036 of the threaded shaft 1954 of the drawbar assembly 1536 to urge the drawbar assembly proximally to expand the implant 1100.

[0205] 151 and 152 show the step of vertically expanding the implant 1100. This step can be functionally consecutive with the step of laterally expanding the implant. Note that the implant 1100 features vertical expansion on both sides of the first support member 1140 and the second support member 1130.

[0206] 153 and 154 illustrate the step of releasing the cam lever 1526 after implant expansion is complete. By releasing the cam lever 1526, the external splines of the fourth outer portion 1770 of the rotation lock ring 1524 are disengaged from the internal splines of the second inner portion 1758 of the splined insert 1522 so that the drawbar assembly 1536 can rotate about the axis 1542, and the female threads of the first side portion 1860 of the bore 1858 of the threaded slider 1530 are disengaged from the male threaded portion 2036 of the threaded shaft 1954 of the drawbar assembly 1536 by moving the threaded slider 1530 transversely relative to the axis 1542 such that the smooth second side portion 1862 of the bore 1858 approaches the male threaded portion 2036.

[0207] 155 and 156 show the step of unlocking the instrument 1500 and the implant 1100. This step may be functionally consecutive to the previous step. At this point, the drawbar assembly 1536 may be removed from the instrument 1500.

[0208] FIG. 157 shows the step of removing the handle assembly 1942 from the shaft assembly 1600 and the implant holder shaft 1508. The connector buttons 1510, 1512 are depressed to decouple the shaft assembly 1600 from the handle assembly 1942, thereby also allowing the implant holder shaft 1508 to slide off. Note that the handle assembly 1942 can be significantly heavier than the shaft assembly 1600 and the implant holder shaft 1508 together, and that the handle assembly 1942 is located at the opposite end of the shaft assembly 1600 from the implant 1100. Thus, by removing the handle assembly 1942, the force moment on the implant 1100 is greatly reduced due to the weight of the attached instrumentation apparatus. The force moment is the force times the moment arm. In this step, the force is at least the weight of the handle assembly 1942 due to gravity. The moment arm is approximately the length of the shaft assembly 1600 trigonometrically corrected to account for the angle between the shaft assembly 1600 and true vertical, e.g., in the case of a TLIF (Translumbar Interbody Fusion), the length of the shaft assembly 1600 multiplied by the cosine of 30 degrees. The true moment arm is the horizontal distance between the center of gravity of the implant 110 and the center of gravity of the handle assembly 1942. Additionally, the removable handle assembly 1942 shortens the length of the screwdriver 2064 and its associated force moment on the implant 1100.

[0209] FIG. 158 illustrates the step of coupling a funnel 2062 to the implant holder shaft 1508 (not visible in this view) and inserting the tamp assembly 180 through the funnel and onto the shaft assembly 1600.

[0210] 159 shows the step of inserting the locking screw 654 through the funnel 2062 and shaft assembly 1600 using the driver assembly 2064. The step of using the funnel 2062 to unthread the implant holder shaft 1508 from the implant 1100 is not shown.

[0211] FIG. 160 shows the implant 1100 in its final, implanted state.

[0212] The terms "upper" and "lower", "top" and "bottom", "front" and "rear" are used herein as related terms for ease of description and understanding. It is understood that in embodiments of the present disclosure, the entities of upper and lower may be reversed, as may top and bottom, front and rear.

[0213] Any method disclosed herein includes one or more steps or actions for implementing the described method. The method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified.

[0214] Throughout this specification, a reference to "one embodiment" or "the embodiment" means that a particular feature, structure, or characteristic described in connection with this embodiment is included in at least one embodiment. Thus, references to the phrase, or variations thereof, listed throughout this specification do not necessarily all refer to the same embodiment.

[0215] Similarly, in the above description of the embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. However, this method of disclosure is not to be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Instead, when the claims reflect, aspects of the invention lie in fewer than all features of any single, previously disclosed embodiment. Thus, the claims following this detailed description are expressly incorporated herein into this detailed description, with each claim standing on its own as a separate embodiment. The present disclosure includes all permutations of the independent claims with their dependent claims.

[0216] The reference in a claim to a "first" or "second" feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements referred to in a means-plus-function form are intended to be construed in accordance with 35 U.S.C. §112, paragraph 6. It will be apparent to those skilled in the art that changes may be made in the details of the embodiments described above without departing from the underlying principles of the technology.

[0217] Although specific embodiments and applications of the present technology have been illustrated and described, it should be understood that the technology is not limited to the precise configuration and components disclosed herein. Various modifications, changes and variations that will be apparent to those skilled in the art may be made in the arrangement, operation and details of the methods and systems of the present technology disclosed herein without departing from the spirit and scope of the technology.

Claims

1. Intervertebral implant and instrument set, It is an implant, The first terminal body and An implant comprising: a second end body proximal to the first end body, the second end body having a female thread; An inserter configured to insert the implant between a first vertebra and a second vertebra, the inserter is A first device portion that is detachably connectable to the first end body, The inserter comprises a second device portion having a threaded portion that can be detachably connected to the female thread of the second end body, An apparatus in which the first apparatus portion is connected to the first end body, the second apparatus portion is connected to the second end body, and when the apparatus is operated, the first apparatus portion and the first end body translate along a first longitudinal axis in the center of the apparatus, without rotating about the first axis, relative to the second apparatus portion and the second end body.

2. The first device portion comprises a tension rod, which is detachably connected to the first end body by rotation of the tension rod around the first axis, The aforementioned device further comprises an actuator and a rotation lock, The device operation includes the movement of the actuator, which engages with the tension rod and translates the tension rod along the first axis relative to the second device portion and the second end body, When the rotation lock is engaged, the tension rod cannot rotate around the first axis, and when the rotation lock is disengaged, the tension rod can rotate freely around the first axis. The device includes a first state in which the actuator is disengaged from the tension rod, the rotation lock is disengaged, and the tension rod is free to translate along the first axis and rotate around the first axis. The apparatus according to claim 1, further comprising a second state in which the actuator is engaged with the tension rod, the rotation lock is engaged, and the tension rod is prevented from rotating around the first axis.

3. The rotation lock comprises a rotation lock ring and a spline insert, wherein the rotation lock ring and the tension rod are fixed together to rotate around the first axis, the spline insert is fixed in translation along the first axis and rotation around the first axis, and the spline insert is detachably connectable to the rotation lock ring. When the rotation lock is engaged, the spline insert is connected to the rotation lock ring so that the rotation lock ring cannot rotate around the first axis, and when the rotation lock is disengaged, the spline insert is disengaged from the rotation lock ring so that the rotation lock ring can rotate freely around the first axis. The apparatus according to claim 2, wherein the actuator and the rotation lock are coupled together, so that when the rotation lock is engaged, the actuator engages with the tension rod, and when the rotation lock is disengaged, the actuator disengages from the tension rod.

4. The aforementioned tension rod is equipped with a threaded portion, The apparatus according to claim 3, wherein the actuator comprises a threaded slider, the threaded slider having a threaded portion that engages with the threaded portion of the tension rod, and the apparatus operation includes rotation of the threaded portion of the threaded slider, which engages with the threaded portion of the tension rod to translate the tension rod along the first axis relative to the second apparatus portion and the second end body.

5. The first device portion comprises a tension rod, which is detachably connected to the first end body by rotation of the tension rod around the first axis, The apparatus further comprises a shuttle and an actuator. The shuttle is fixed in rotation around the first axis, and the shuttle and the tension rod are fixed together for translation along the first axis. The apparatus according to claim 1, wherein the apparatus operation includes the movement of the actuator, which engages with the shuttle to translate the shuttle and the tension rod along the first axis relative to the second apparatus portion and the second end body.

6. The shuttle is equipped with a screw portion, The apparatus according to claim 5, wherein the actuator comprises a screwdriver, the screwdriver comprises a screw portion that engages with the screw portion of the shuttle, and the apparatus operation comprises rotation of the screw portion of the screwdriver, which engages with the screw portion of the shuttle to translate the shuttle and the tension rod along the first axis relative to the second apparatus portion and the second end body.

7. The shuttle is equipped with a series of transverse grooves, The apparatus according to claim 5, wherein the actuator comprises a ratchet mechanism, the ratchet mechanism comprises a drive link that engages with the series of transverse grooves, and the apparatus operation comprises translation of the drive link that engages with the series of transverse grooves to translate the shuttle and the tension rod along the first axis relative to the second apparatus portion and the second end body.

8. The first device portion comprises a tension rod, which is detachably connected to the first end body by rotation of the tension rod around the first axis, The device according to claim 1, wherein the second device portion is an implant retainer shaft, the implant retainer shaft being removablely connectable to the first end body by rotation of the implant retainer shaft around the first axis.

9. The first end body comprises an additional implant thread portion, The apparatus according to claim 8, wherein the tension rod further comprises an additional device thread portion configured to engage with the additional implant thread portion in accordance with the rotation of the tension rod around the first axis.

10. The device according to claim 1, wherein the implant is configured to expand laterally and vertically in response to the movement of the second end relative to the first end.

11. The device according to claim 10, wherein the implant is configured to expand laterally and vertically such that lateral expansion is completed before vertical expansion occurs.

12. The device according to claim 11, further comprising a first marking configured to indicate when lateral expansion is complete and a second marking configured to indicate when vertical expansion is complete.

Images