Insertion device for spinal fixation implants

Abstract

Disclosed herein are disassemblable inserters for use in spinal fixation implant procedures, methods for engaging an implant using such inserters, methods for disengaging an implant from such inserters, and methods for disassembling such inserters, as well as systems including such inserters and corresponding implants.

Description

Technical Field

[0001] Cross - Reference to Related Applications This patent application claims priority to U.S. Provisional Patent Application No. 63 / 188,763, filed on May 14, 2021, the content of which is incorporated by reference as if fully set forth herein.

[0002] The present invention relates to an inserter for a spinal fixation implant.

Background Art

[0003] Back problems are common and debilitating medical events, and as a result, more than 500,000 spinal lumbar and cervical fusion procedures are performed annually in the United States alone. One cause of back pain and disability is due to rupture or degeneration of one or more intervertebral discs in the spine.

[0004] Surgical procedures are commonly performed to correct problems of displacement, damage, or degeneration of the intervertebral disc due to trauma, disease, or aging. Generally, spinal fixation procedures involve removing some or all of the diseased or damaged intervertebral disc and inserting one or more spinal implants into the resulting intervertebral disc space.

[0005] It is desirable to provide improved instruments for use during spinal surgery procedures, including instruments used to insert spinal fixation implants.

Summary of the Invention

[0006] A first aspect of the present disclosure provides an inserter for inserting a spinal fixation implant, the inserter comprising a housing having a proximal member and a housing shaft extending distally therefrom, and an internal shaft having a distal end and a proximal end, at least partially located within the housing shaft and configured to translate relative to the housing shaft. The distal end of the internal shaft is configured to engage releasably with the spinal fixation implant. A thumbwheel is rotatably fixed to the proximal end of the internal shaft and configured to rotate around the longitudinal axis of the inserter, thereby rotating the internal shaft. A lock engages with the internal shaft and is configured to move between a locked position and an unlocked position. In the locked position, the internal shaft is rotatably fixed to the thumbwheel, while in the unlocked position, the internal shaft and the thumbwheel are separable from each other. A soft stop is configured to provide the user with one or more audible and / or tactile feedback to indicate that the spinal fixation implant has been completely disengaged from the distal end of the internal shaft.

[0007] In certain embodiments, the distal end of the medial shaft is provided with threads configured to engage with complementary threads on a spinal fixation implant.

[0008] In certain embodiments, rotation of the thumbwheel in a first direction is configured to engage the distal end of the medial shaft with the spinal fixation implant, and rotation of the thumbwheel in a second direction is configured to disengage the distal end of the medial shaft from the spinal fixation implant.

[0009] In certain embodiments, in the unlocked position, the inner shaft is configured to move distally in parallel, disengaging its proximal end from the thumbwheel. The inner shaft is further configured to be detached from the distal end of the housing shaft to disassemble the inserter.

[0010] In certain embodiments, the thumbwheel further comprises a biasing element configured to bias the thumbwheel distally. In the unlocked position, the thumbwheel is configured to move proximal parallel to the force of the biasing element. When the proximal end of the inner shaft is disengaged from the thumbwheel, the distal end of the thumbwheel is configured to move radially outward with respect to the longitudinal axis to initiate disengagement of the thumbwheel from the inserter.

[0011] In certain embodiments, the proximal end of the inner shaft is provided with a keyed feature that provides complementary mating with a corresponding keyed feature on the thumbwheel.

[0012] In certain embodiments, the keyed feature is a male hexagonal feature, and the corresponding keyed feature is a female hexagonal feature.

[0013] In certain embodiments, the inner shaft has a first diameter, and the lock further comprises a portion of the inner shaft having a second diameter reduced from the first diameter, and a lock button positioned on the housing and movable in a direction substantially perpendicular to the longitudinal axis. The lock button includes a slot configured to engage with the portion of the inner shaft having the reduced diameter. The slot has an irregular cross-sectional shape, and as a result, in the locked position, the outer surface of the lock button is substantially coplanar with the outer surface of the housing, and the first end of the slot provides an interference fit with the reduced diameter portion of the inner shaft. In the unlocked position, the outer surface of the lock button is raised relative to the outer surface of the housing, and the second end of the slot accommodates the inner shaft in the portion without the reduced diameter, allowing the inner shaft to translate.

[0014] In certain embodiments, the lock further comprises a track extending within the lock button in a direction parallel to the direction in which the lock button is movable, a pin positioned within the track, a plunger positioned within the housing and configured to engage with the lock button in a locked position and an unlocked position, a spring configured to engage with the plunger, and a screw configured to maintain the positions of the plunger and the spring.

[0015] In certain embodiments, the housing further comprises a first through-hole configured to engage with the plunger in the unlocked position and a second through-hole configured to engage with the plunger in the locked position.

[0016] In certain embodiments, the soft stop includes a keyed distal end feature configured to rotatably engage with a complementary keyed feature on the proximal end of a thumbwheel, the keyed distal end feature being coupled to a longitudinally extending body having a plurality of threads positioned thereon. The slider body is configured to screw onto the longitudinally extending body and translate within the soft stop. A first corrugated spring and a second corrugated spring are positioned at each end of the slider body, respectively. In certain embodiments, the thumbwheel is configured to remain rotatable even after the slider body has come into contact with the first or second corrugated spring.

[0017] A second aspect of this disclosure provides a system comprising the inserter described in the first aspect above and a spinal fixation implant configured to engage with the distal end of the inserter. In certain embodiments, the spinal fixation implant may include a threaded connector configured to screw into the distal tip of the inserter.

[0018] A third aspect of the present disclosure provides an inserter for inserting a spinal fixation implant, the inserter comprising a body having an outer shaft and an inner shaft having a distal end configured to engage releasably with the spinal fixation implant and a proximal end, the inner shaft being at least partially located within the outer shaft. A thumbwheel is rotatably fixed to the inner shaft and positioned around the body, and the thumbwheel is configured to move in parallel with the body to allow rotational movement of the thumbwheel about the longitudinal axis of the inserter. The thumbwheel is configured to rotate by a first range about the longitudinal axis to move the inserter between an unlocked position in which the inner shaft is configured to engage and disengage with the spinal fixation implant and a locked position in which the inner shaft is locked in engagement with the spinal fixation implant. The thumbwheel is further configured to rotate by a second range about the longitudinal axis to allow removal of the thumbwheel from the body.

[0019] In certain embodiments, the main body further comprises an intermediate main body member connected to an outer shaft and a proximal main body member connected to the intermediate main body member.

[0020] In certain embodiments, the intermediate body member further includes an anti-torque point.

[0021] In certain embodiments, the body further comprises a backing plate and a biasing element fixed to the backing plate, the biasing element being configured to bias the thumbwheel distally. In certain embodiments, the biasing element includes a wave spring.

[0022] In certain embodiments, the body further comprises a locking button located thereon, which is configured to extend radially outward relative to the body and to be pressed radially inward. The thumbwheel further comprises a first notch located on the inner bore of the thumbwheel and configured to accommodate the locking button in the unlocked position.

[0023] In certain embodiments, the thumbwheel further comprises a relief disposed on its distal end surface, the relief being configured to receive the lock button when the thumbwheel is rotated about its longitudinal axis through a second range.

[0024] In certain embodiments, the body further comprises a fixed tab disposed thereon, and the thumbwheel further comprises a second cutout disposed on its inner bore and configured to receive the fixed tab in the unlocked position.

[0025] In certain embodiments, the first notch is further configured to receive the fixed tab in the locked position, and the second notch is further configured to receive the lock button in the locked position.

[0026] In certain embodiments, the first notch and the second notch are disposed opposite one another on the inner bore of the thumbwheel such that the first notch and the second notch are disposed approximately 180° from one another.

[0027] In certain embodiments, the thumbwheel further comprises a radial track disposed on its inner bore, the radial track being in communication with and distally disposed relative to the first cutout and the second cutout, the radial track being configured to allow the thumbwheel to rotate about the body as the thumbwheel is translated proximally such that the fixed tab and the lock button are received within the radial track.

[0028] In certain embodiments, the inserter further comprises a rotatable tab coupled to the inner shaft at its proximal end, the rotatable tab being rotatable relative to the body and extending through a portion of the body. The tab is rotatably fixed relative to the inner shaft. The first channel extends axially along the inner bore of the thumbwheel and is configured to receive the rotatable tab, the rotatable tab being configured to rotate about the longitudinal axis of the inserter and within the first channel in response to rotation of the thumbwheel about the longitudinal axis of the inserter. The inner shaft is configured to rotate in response to rotation of the rotatable tab.

[0029] In certain embodiments, the first channel is open at its distal end to a first notch.

[0030] In certain embodiments, the inserter further comprises a second channel extending axially along the inner bore of the thumbwheel and configured to receive a fixed tab when the thumbwheel is rotated in a second range, thereby enabling the thumbwheel to translate distally away from the end of the body for removal.

[0031] In certain embodiments, the first range is about 180° and the second range is about 90°.

[0032] In certain embodiments, the inserter further comprises a cam disposed at the distal end of the inner shaft and configured to engage a cam surface on the spinal fixation implant.

[0033] A fourth aspect of the present disclosure provides a system comprising the inserter described in the third aspect above and a spinal fixation implant configured to be engaged by the distal end of the inserter. In certain embodiments, the inserter includes a cam disposed on the distal end of the inner shaft and configured to engage a cam surface on the spinal fixation implant.

[0034] A fifth aspect of the present disclosure provides a method of engaging an implant using an inserter according to the first or third aspect above.

[0035] A sixth aspect of this disclosure provides a method for disengaging an implant from an inserter according to the first or third aspect described above.

[0036] A seventh aspect of this disclosure provides a method for disassembling an inserter according to the first or third aspect described above. [Brief explanation of the drawing]

[0037] These and other aspects, advantages and notable features of the present invention will become apparent from the following detailed description disclosing embodiments of the invention, when considered in conjunction with the accompanying drawings.

[0038] [Figure 1] This is a side cross-sectional view of an inserter according to the first embodiment of the present invention. [Figure 2A] Figure 1 shows a side cross-sectional view of a portion of the housing inside box A, including a lock according to an embodiment of the present invention. [Figure 2B] Figure 1 shows a side cross-sectional view of a portion of the housing inside box A, including a lock according to an embodiment of the present invention. [Figure 2C] This is a cross-sectional view of the slot profile of a lock button along line CC in Figure 2A, according to one embodiment of the present invention. [Figure 3A] Figure 1 shows a side cross-sectional view of a portion of the housing within box B, including a thumbwheel according to an embodiment of the present invention. [Figure 3B] Figure 1 shows a side cross-sectional view of a portion of the housing within box B, including a thumbwheel according to an embodiment of the present invention. [Figure 4A] Figure 1 shows a side cross-sectional view of a portion of the housing within box C, including a soft stop according to an embodiment of the present invention. [Figure 4B] Figure 1 shows a side cross-sectional view of a portion of the housing within box C, including a soft stop according to an embodiment of the present invention. [Figure 5] Figure 1 shows an exploded perspective view of the inserter according to an embodiment of the present invention. [Figure 6]A side view of an inserter according to a second embodiment of the present invention is shown. [Figure 7] Figure 6 shows a perspective view of the inserter according to the embodiment. [Figure 8] Figure 6 shows a top view of the distal portion of the inserter according to the embodiment. [Figure 9A] Figure 6 shows a perspective view of a portion of the thumbwheel of the inserter. In particular, the cylindrical inner member of the thumbwheel is shown. [Figure 9B] Figure 6 shows a perspective view of a portion of the thumbwheel of the inserter. In particular, the cylindrical inner member of the thumbwheel is shown. [Figure 9C] Figure 6 shows a perspective view of a portion of the thumbwheel of the inserter. In particular, it shows a sleeve or grip configured to cover the cylindrical inner member. [Figure 9D] Figure 6 shows a perspective view of a portion of the thumbwheel of the inserter. In particular, it shows the sleeve or grip positioned to cover the cylindrical inner member. [Figure 10A] Figure 6 shows a perspective view of a part of the main body of the inserter according to the embodiment. [Figure 10B] Figure 6 shows a perspective view of a part of the main body of the inserter according to the embodiment. [Figure 11A] Figure 6 shows a perspective view of the proximal end of the inner shaft of the inserter according to the embodiment. [Figure 11B] Figure 6 shows a cross-sectional view of a part of the inserter according to the embodiment. [Figure 12A] Figure 6 shows a rear view of a portion of the inserter according to the embodiment. In particular, it shows the portion of the inserter where the thumbwheel is absent. [Figure 12B] Figure 6 shows a rear view of a portion of the inserter according to the embodiment. In particular, it shows the portion of the inserter in which only the cylindrical inner member of the thumbwheel exists. [Figure 12C] Figure 6 shows a rear view of a portion of the inserter according to the embodiment. In particular, it shows the portion of the inserter where the thumbwheel is located. [Figure 13] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 14] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 15] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 16] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 17] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 18] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 19] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 20] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 21] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 22] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for locking and unlocking the inserter as described herein. [Figure 23A] Figure 6 shows a flowchart illustrating the steps for locking and unlocking the inserter according to the embodiment. [Figure 23B]Figure 6 shows a flowchart illustrating the steps for locking and unlocking the inserter according to the embodiment. [Figure 24] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for disassembling the inserter as described herein. [Figure 25] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for disassembling the inserter as described herein. [Figure 26] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for disassembling the inserter as described herein. [Figure 27] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for disassembling the inserter as described herein. [Figure 28] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for disassembling the inserter as described herein. [Figure 29] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for disassembling the inserter as described herein. [Figure 30] Figure 6 shows a perspective view of a portion of the inserter according to an embodiment, further illustrating the steps in a method for disassembling the inserter as described herein. [Figure 31A] Figure 6 shows a flowchart illustrating the steps for disassembling and reassembling the inserter according to the embodiment. [Figure 31B] Figure 6 shows a flowchart illustrating the steps for disassembling and reassembling the inserter according to the embodiment.

[0039] Please note that the drawings in this disclosure are not necessarily to a uniform scale. The drawings are intended to illustrate only typical aspects of this disclosure and should not be considered to limit the scope of this disclosure. In the drawings, similar numbers represent similar elements across drawings. [Modes for carrying out the invention]

[0040] As described above, aspects of the present invention provide an inserter for inserting a spinal fixation implant, a method for engaging an implant using the inserter, a method for disengaging an implant from the inserter, a method for disassembling the inserter, and a system comprising such an inserter and a corresponding implant. Such instruments can offer improvements over conventional instruments. For example, the instruments may relate to the ease of engagement and disengagement between the implant and the inserter, ease of operation, and the ability to disassemble the inserter to facilitate cleaning and sterilization of the inserter (e.g., before and / or after such procedures).

[0041] As used herein, the term proximal refers to the direction away from the attachment of the element to the object, as shown as direction P in Figure 1, while the term distal refers to the direction opposite to the proximal direction, towards the attachment of the element to the object, as shown as direction D in Figure 1.

[0042] Referring to Figures 1 to 5 in general, a first exemplary inserter 100 is provided for use in inserting a spinal fusion implant 10 into the intervertebral space of a patient's spine.

[0043] As shown in Figures 1 and 5, the inserter 100 may include a housing 110. The housing 110 may include a proximal member 114 and a housing shaft 112 extending distally from the proximal member to a distal end 116. In various embodiments, the proximal member 114 may be substantially "C" shaped, or otherwise adapted to accommodate a thumbwheel 140. The housing shaft 112 and the proximal member 114 may be a single, integrated structure, or may include two or more members joined together to form the housing 110.

[0044] As shown in Figure 1, the inner shaft 120, having a distal end 122 and a proximal end 124, is configured to be at least partially located within the housing shaft 112 when assembled for use. The distal end 122 is configured to releasably engage with the spinal fixation implant 10. In certain embodiments, the distal end 122 of the inner shaft 120 may be threaded and configured to engage with complementary threads on the spinal fixation implant 10. For example, the distal end 122 may include a male thread feature, and the spinal fixation implant 10 may include a female thread feature. Thus, rotation of the inner shaft 120 in a first direction (e.g., clockwise or counterclockwise) may result in engagement (e.g., screwing) of the distal end 122 of the inner shaft 120 with the implant 10, while rotation of the inner shaft 120 in another direction may result in disengagement of the distal end 122 of the inner shaft 120 from the implant 10. In addition to rotating within the housing shaft 112, the inner shaft 120 is configured to translate relative to the housing shaft 112.

[0045] The thumbwheel 140 is configured to be rotatably fixed to the inner shaft 120, for example, the thumbwheel 140 may be rotatably fixed to the proximal end 124 of the inner shaft 120. The thumbwheel 140 is configured to provide a user (e.g., a surgeon, medical professional, or operating room technician) with an easily accessible means to operate the rotation of the inner shaft 120. The thumbwheel 140 is configured to rotate around the longitudinal axis of the inserter 100, thereby rotating the inner shaft 120. As described above, rotation of the thumbwheel 140 in a first direction is configured to engage the distal end 122 of the inner shaft 120 with the spinal fixation implant 10, and rotation of the thumbwheel 140 in a second direction is configured to disengage the distal end 122 of the inner shaft 120 from the spinal fixation implant 10. The rotation of the inner shaft 120 may directly correspond to the degree of rotation of the thumbwheel 140.

[0046] The lock 130 can engage with the inner shaft 120 (for example, at its proximal end 124). The lock 130 is configured to move between a locked position and an unlocked position. In the locked position, the inner shaft 120 (for example, the proximal end 124 of the inner shaft 120) is positioned within the thumbwheel 140 and rotatably fixed to the thumbwheel 210. In the unlocked position, the inner shaft 120 and the thumbwheel 140 are separable from each other (for example, they can be disassembled). In particular, in the unlocked position, the lock 130 is configured to disengage from the inner shaft 120, allowing the inner shaft 120 to move distally in translation within the housing shaft 112, disengaging the proximal end 124 of the inner shaft 120 from the thumbwheel 140. In this state, the inner shaft 120 is configured to translate distally and eventually be removed from the housing shaft 112 by its distal end 116.

[0047] The soft stop 150 is configured to provide the user with one or more audible and / or tactile feedback to indicate that the spinal fixation implant 10 has been completely disengaged from the distal end of the medial shaft 120, while still allowing further rotation of the thumbwheel 140.

[0048] Referring to Figures 3A and 3B, embodiments of the thumbwheel 140 of the inserter 100 are shown. As shown, the proximal end 124 of the inner shaft 120 may include a keyed feature 126, and the distal end thumbwheel 140 may include a corresponding keyed feature 142. The keyed feature 142 may provide a complementary mating with the corresponding keyed feature 126 on the inner shaft 120 (e.g., on its proximal end 124) so ​​that the rotation of the thumbwheel 140 drives the rotation of the inner shaft 120. In various examples, the keyed feature 126 and the keyed feature 142 may mate with each other in a male / female relationship. The keyed feature 126 may have a cross-sectional shape of any non-circular geometric shape, such as a rectangle, square, pentagon, hexagon, octagon, or star, having any number of points configured to transmit torque between the thumbwheel 140 and the inner shaft 120. In the example shown in Figure 3A, the keyed feature 126 has a hexagonal cross-sectional shape, and the keyed feature 142 includes an axially extending channel that opens at the distal end of the thumbwheel 140, the axially extending channel having a hexagonal cross-sectional shape. The keyed feature 142 may have a cross-sectional shape that is complementary to the keyed feature 126 and is configured to receive the keyed feature 210 in an interference fit, providing rotational fixation and torque transmission between the inner shaft 120 and the thumbwheel 140.

[0049] The thumbwheel 140 may include a biasing element 144 located within the thumbwheel, which may be configured to bias the thumbwheel 140 distally. In the locked position, when the housing 110, the inner shaft 120, and the thumbwheel 140 are locked together, this bias of the thumbwheel 140 distally (e.g., toward the inner shaft 120) contributes to maintaining the locked position and to contact between the thumbwheel 140 and the inner shaft 120 at the keyed features 142, 126.

[0050] The thumbwheel 140 is configured to translate proximal to the force of the biasing element 144. Such translation in the proximal direction causes compression of the biasing element 144, allowing the thumbwheel 140 to translate proximal to the inner shaft 120. When the thumbwheel 140 has translated a sufficient distance in the proximal direction, the proximal end 124 of the inner shaft 120 is no longer constrained within the keyed feature 142 of the thumbwheel 140. The proximal end 124 of the inner shaft 120 may then disengage from the thumbwheel 140. When the proximal end 124 of the inner shaft 120 exits the keyed feature 142 at the distal end of the thumbwheel 140, the distal end of the thumbwheel 140 is configured to move radially outward with respect to the longitudinal axis of the inserter 100. Next, subject to the operation of the lock 130, the inserter 100 can be disassembled, the inner shaft 120 can be removed via the distal end 116 of the housing shaft 112, and the thumbwheel 140 can be removed by pulling the thumbwheel 140 away from the housing 110, starting with the distal end, so as to move it away from the longitudinal axis of the inserter.

[0051] Referring to Figures 2A and 2B, as described above, the inserter 100 may further include a lock 130 configured to lock and hold the axial position of the inner shaft 120 relative to the housing 110.

[0052] As shown in Figures 2B and 5, the inner shaft 120 may have a first diameter 127 along a portion of the shaft. The inner shaft 120 may further include a portion having a second diameter 128 smaller than the first diameter 127. The portion with the reduced diameter 128 may be positioned between the portions with the first diameter 127 in both the proximal and distal directions. This portion with the reduced diameter 128 may be configured to interact with the lock button 132 to form a lock 130.

[0053] The lock button 132 may be located on the housing 110 and may be movable in a direction substantially perpendicular to the longitudinal axis of the inserter 100. The lock button 132 may include a slot 134 located therein, through which the inner shaft 120 passes or extends. The slot 134 may be configured to engage with a portion of the inner shaft 120 having a second smaller diameter 128. For this purpose, the slot 134 may include an irregular cross-sectional shape (Figure 2C) configured to accommodate a first diameter 127 at one end and a second reduced diameter 128 at the other end. When the lock 130 is in the locked position, the lock button 132 is pressed down (for example, the outer surface of the lock button is substantially coplanar with the outer surface of the housing 110), and the first end 131 of the slot 134 provides an interference fit with the portion of the inner shaft having the reduced diameter 128. Therefore, when the lock button 132 is pressed down, the first end 131 of the slot 134, which has a diameter configured to provide an interlocking fit around the second reduced diameter portion 128 of the inner shaft 120, is pressed down onto the inner shaft 120, and the slot 134 engages with the portion of the inner shaft 120 having the reduced diameter 128. In this way, the narrower first end 131 of the slot 134 engages with the reduced diameter portion 128 of the inner shaft 120, preventing translation in either the proximal or distal direction. In this position, the portions of the inner shaft 120 having the first diameter 127 on both the proximal and distal sides of the reduced diameter portion 128 are not accommodated within the first end 131 of the slot 134 through which the inner shaft 120 passes.

[0054] When the lock 132 is in the unlocked position shown in Figures 2A and 2B, the outer surface of the lock button 132 is raised relative to the outer surface of the housing 110, thus translating the lock button 132 and the slot 134 upward. In this position, the second end 133 of the slot 134 is aligned with the inner shaft 120. The second end 133 of the slot 134 is molded and dimensioned to accommodate the larger diameter 127 of the inner shaft 120. Thus, when the lock button 132 is raised, the inner shaft 120 is accommodated through the slot 134 along its entire length, including the portion having the first larger diameter 127. In this position, the inner shaft 120 can be translated without restriction.

[0055] The lock 130 may further include a track 136 extending within the lock button 132 in a direction parallel to the direction in which the lock button 132 is movable. A pin 138 may be located within the track 136. The track 136 and pin 138 may be configured to further define and restrict the movement of the lock button 132. A plunger 135 may further be located within the housing 110 and may be configured to engage with the lock button 132 in the locked and unlocked positions. A spring 137 may be configured to engage with the plunger 135, and a screw 139 may further be configured to maintain the position of the plunger and spring. The housing 110 may further include a first through-hole 118a configured to engage with the plunger 135 in the unlocked position, and a second through-hole 118b configured to engage with the plunger 135 in the locked position. The inserter 100 can be moved manually or automatically from the locked position (e.g., the lock button is pressed down) to the unlocked position (e.g., the lock button is lifted). For example, the user can manually change the inserter 100 from the locked position to the unlocked position.

[0056] Referring next to Figures 4A and 4B, the inserter 100 may further include a soft stop 150. As previously mentioned, the soft stop 150 may be configured to provide the user with auditory and / or tactile feedback when the inner shaft 120 is completely disengaged from the implant 10 (Figure 1). The thumbwheel 140 may include a keyed feature 146 located on its proximal end, which may be configured to rotatably engage with a complementary keyed feature 152 on the distal end of the soft stop 150. For example, the keyed features 146 and 152 may engage with each other in a female / male correspondence. The keyed feature 152 may have a cross-sectional shape of any non-circular geometric shape, such as a rectangle, square, pentagon, hexagon, octagon, or star with any number of points, configured to transmit torque between the thumbwheel 140 and the body 154 of the soft stop 150. The keyed mechanism 152 may be connected to the body 154 which extends axially in the proximal direction. The main body 154 may include a plurality of threads 156 arranged on its outer surface. The slider body 158 may be located within the soft stop 150 and may include a threaded opening 157 configured to screw into the threads 156 on the longitudinally extending body 154. A pair of biasing members 159 may be located on both sides of the slider body 158 and at both ends of the soft stop 150.

[0057] When in use, the thumbwheel 140, including the keyed feature 146, rotates in a second direction to disengage the distal tip 122 from the implant 10, and the body 154 rotates in response to the rotation of the thumbwheel 140. The body 154 is fixed in its axial position but rotates relative to the slider body 158. As a result of the thread engagement between the threads 156 of the body 154 and the threaded opening 157 of the slider body 158, the slider body is configured to translate along the internal bore of the soft stop 150, driven by the rotating threads of the body 154. As the thumbwheel 140 rotates, the slider body 158 is configured to translate either proximal or distal, depending on the direction in which the thumbwheel 140 rotates. Finally, the slider body 158 translates to the proximal or distal end of the soft stop 150 and contacts the biasing member 159. Each biasing member 159 may be, for example, a corrugated spring. This contact between the slider body 158 and the biasing member 159 is configured to provide the user with tactile and / or audible feedback.

[0058] The axial length of the soft stop 150 is configured such that the user can understand that the inner shaft 120 has been completely disengaged from the implant 10 when the thumbwheel has been rotated a sufficient number of times to generate audible and / or tactile feedback as described above. This feedback allows the user to withdraw the injector 100 from the patient with confidence, for example, that the implant 10 is not yet engaged and will not be inadvertently moved from its position by the withdrawal of the injector 100. This feedback also allows the user to quickly withdraw the injector 100 from the patient after disengaging from the implant 10 without rotating the thumbwheel 140 an unnecessary additional number of times beyond the point of disengagement from the implant 10, in order to avoid inadvertent repositioning of the implant 10. The soft stop 150 may be configured such that the thumbwheel 140 remains rotatable even after the slider body 158 has contacted and / or abutted against one of the biasing members 159.

[0059] In addition to the inserter 100 described above, another embodiment may provide a system for use in spinal fusion procedures. The system may include the inserter 100 substantially described herein, together with a spinal fusion implant 10 (Figure 1). Suitable spinal fusion implants are known in the art. Examples of spinal implants that can benefit from the devices described herein include the implants described in U.S. Patent No. 10,675,158 (filing June 16, 2018, application number 16 / 010,405), U.S. Patent No. 10,390,960 (filing June 27, 2017, application number 15 / 635,087), U.S. Patent No. 9,730,802 (filing January 14, 2015, application number 14 / 597,085), and U.S. Patent No. 9,180,021 (filing June 25, 2014, application number 14 / 314,823), the contents of which are incorporated herein by reference in their entirety for all purposes.

[0060] Furthermore, this specification provides exemplary methods of using the inserter 100. According to the first step, the inserter 100 is provided. The inserter 100 may be in a disassembled state, and if so, may be assembled. Such assembly may include positioning the keyed feature 146 of the thumbwheel 140 on the keyed feature 152 of the soft stop 150 and aligning the thumbwheel 140 with the longitudinal axis of the inserter 100. The inner shaft 120 may then be inserted proximal into the housing shaft 112 such that its proximal end 124 engages with the thumbwheel 140. In the second step, the thumbwheel 140 may be rotated in the first direction to engage with the implant 10. In the third step, the lock button can be pressed to lock the axial position of the inner shaft 120, as well as the rotational positions of the inner shaft 120 and the thumbwheel 140. In the fourth step, the implant 10 may be inserted through an incision and placed in a desired location in the patient, for example, in the intervertebral space. In the fifth step, the inserter 100 is unlocked, extending the lock button upward so that it is no longer coplanar with the housing surface. In the sixth step, the thumbwheel 140 may be rotated in a second direction opposite to the first direction, disengaging the distal end 122 of the inner shaft 120 from the implant 10. In the seventh step, the rotation may be interrupted after the user receives feedback from the soft stop 150. In the eighth step, the inserter 100 may be withdrawn from the patient. In the ninth step, the inner shaft may be removed distally from the inserter 100. Finally, in the tenth step, the thumbwheel, which is no longer constrained by the proximal end of the inner shaft, may be removed from the housing 110. The inserter 100 can then be cleaned or sterilized in its disassembled state.

[0061] Further embodiments of the inserter 200 are described herein with reference to Figures 6 to 31. As shown in Figure 6, an inserter 200 for inserting a spinal fixation implant 10 (Figure 8) is disclosed. The inserter 200 may include a body 210 comprising an outer shaft 212 and an inner shaft 220 at least partially disposed within the outer shaft 212. The inner shaft 220 may include a distal end 222, the details of which are illustrated in Figure 8. The distal end 222 of the inner shaft 220 may extend from the distal end 216 of the outer shaft 212 and may be configured to releasably engage with the spinal fixation implant 10 (see Figure 8). In certain embodiments, the inner shaft 220 may include a cam located at its distal end 222, the cam being configured to engage with a cam surface of the spinal fixation implant 10. The inner shaft 220 may further include a proximal end 224 (see Figures 11A to 11B).

[0062] Continuing to refer to Figure 6, the body 210 of the inserter 200 may include two or more body members. As described above, the body 210 may include a distal body member including an outer shaft 212. The body 210 may further include an intermediate body member 213 connected to the proximal end of the outer shaft 212. The intermediate body member 213 may be coupled to the proximal body member 214 at its proximal end. In certain embodiments, features of the body 210 may be located on certain body members, for example, as further described herein, a reverse torque point 283 may be provided on the intermediate body member 213 (Figure 7), and a biasing member 282 (Figure 13) may be provided on the proximal body member 214.

[0063] The inserter 200 may further include a thumbwheel 240, which may be rotatably fixed to the inner shaft 220 at its proximal end 224 and positioned around the body 210. The thumbwheel 240 may provide the user with means for acting on the rotation and / or translation of the inner shaft 220, which is easily accessible and operable.

[0064] The thumbwheel 240 may include a plurality of relief features on its inner bore surface 267, which may be configured to interact with the features of the body 210 to provide the inserter 200 with some of the functionalities described herein. For example, the thumbwheel 240 may be configured to translate relative to the body 210 to enable, or allow, rotational motion of the thumbwheel 240 around the longitudinal axis 202 of the inserter 200, as facilitated by the features of the inner bore surface 267 of the thumbwheel 240 and the body 210. In particular, the thumbwheel 240 may be translated proximal to enable rotational motion of the thumbwheel 240 around the longitudinal axis 202 of the inserter 200.

[0065] The thumbwheel 240 may further be configured to rotate about the longitudinal axis 202 in order to move the inserter 200 between an unlocked position in which the inner shaft 220 is configured to engage with and disengage from the spinal fixation implant 10, and a locked position in which the inner shaft 220 is locked engaged with the spinal fixation implant, and the inner shaft 220 and the thumbwheel 240 are locked in the rotational direction. In particular, the translation of the thumbwheel 240 in the proximal direction, as described above, for example, may allow the thumbwheel 240 to rotate to a first extent, for example, about 180° about the longitudinal axis 202, in order to move the inserter 200 from the unlocked position to the locked position or vice versa. In other embodiments (for example, embodiments having a double cam located at the distal end 222 of the inner shaft 220), the first range may be about 90°. In the latter embodiments, other angles and spatial relationships, such as those disclosed herein, may be adjusted for adaptation.

[0066] When translated in the proximal direction, the thumbwheel 240 may be further configured to rotate approximately 90° around the longitudinal axis 202, for example, from the unlocked position to a detachment position configured to remove the thumbwheel 240 from the body 210. For example, the thumbwheel 240 may be removed from the body 210 by sliding the thumbwheel 240 away from the distal end of the body 210.

[0067] As described above, the thumbwheel 240 may include a plurality of relief features on its inner bore surface 267, which are configured to interact with corresponding features on the body 210, as further described herein, to provide specific functions of the thumbwheel 240 and the inserter 200. Referring to Figures 9A to 9D, for example, these features of the thumbwheel 240, including a first notch 260, a second notch 262, a relief 264, a radial track 266, a channel 268, and a channel 269, may include reliefs cut through a partial thickness of the integrally formed thumbwheel body, or alternatively, full-thickness or partial-thickness features cut through a cylindrical inner member 261, which is positioned within a sleeve or grip member 263 and configured to collectively form the thumbwheel 240. In one embodiment shown in Figures 9A-9D, Figures 9A-9B show a cylindrical inner member 261 having various features described herein, and Figure 9C shows a sleeve or grip 263 configured to be positioned on the cylindrical inner sleeve 261. Figure 9D shows a sleeve or grip 263 positioned on the cylindrical inner member 261 to collectively form a thumbwheel 240.

[0068] Referring back to Figure 9A, the thumbwheel 240 may include a first cutout 260 located on the inner bore 267 of the thumbwheel 240. The first notch 260 may have a depth and width configured to accommodate the size and dimensions of a lock button 286 (see Figures 13-14) when the inserter 200 is in the unlocked position. The lock button 286 may be located on the body 210, for example, on a central body member 213, as further described herein. As shown in Figure 9B, the thumbwheel 240 may further include a second cutout 262 similarly located on the inner bore 267 of the thumbwheel 240. The second notch 262 may have a depth and width configured to accommodate the size and dimensions of a fixing tab 284 located on the body 210, for example, on an intermediate body member 213, when the inserter 200 is in the unlocked position (see Figure 15). The first cutout 260 and the second cutout 262 may have substantially similar dimensions and shapes and may be spaced approximately 180° apart along the circumference of the thumbwheel 240 in a common axial position. This arrangement allows the first notch 260 to accommodate the locking tab 284 and the second notch 262 to accommodate the lock button 286 when the thumbwheel 240 is rotated 180° from the unlocked position to the locked position (see, for example, Figures 22-23).

[0069] As described above, the lock button 286 (see, for example, Figures 11A and 12A) may be positioned on the body 210 (e.g., the intermediate body 213) and may extend radially outward from there. The lock button 286 is configured to interact with the inner shaft 220 to hold the axial position of the inner shaft 220 relative to the body 210, and the axial position of the thumbwheel 240 relative to the body 210. The lock button 286 may be movable in and out of the recess 215 of the body 210 (e.g., the intermediate body member 213) in a direction substantially perpendicular to the longitudinal axis 202 of the inserter 200.

[0070] The lock button 286 is further configured to prevent rotation of the thumbwheel 240 in a certain configuration through interaction with the first and second cutouts 260, 262. A retaining tab 284 may be further positioned on the body 210 (for example, on the intermediate body 213). The retaining tab 284 (see Figure 11B) may also extend radially outward from the body 210 and may have substantially the same shape and dimensions as the lock button 286.

[0071] The thumbwheel 240 may further include a relief 264 (see Figures 9B and 9D) positioned on its distal end surface. The relief 264 may be in the form of a recess or depression within the distal end surface of the thumbwheel 240. The relief 264 may be configured to accommodate a lock button 286 when the thumbwheel 240 is rotated within a second range, for example, about 90°, around the longitudinal axis 202 (see Figure 24). When the lock button 286 is housed within the relief 264, rotation of the thumbwheel 240 is prevented by the interaction between the raised lock button 286 and the edge of the relief 264.

[0072] The thumbwheel 240 may further include a radial track 266 shown in Figures 9A and 9B, the radial track 910 may be in the form of a radially oriented track or channel extending circumferentially around the inner surface 267 of the thumbwheel 240. The radial track 266 may communicate with both the first and second cutouts 260 and 262, providing a continuous passage between the first and second cutouts 260 and 262, along which the fixing tab 284 and lock button 286 may advance as the thumbwheel 240 is rotated. The radial track 266 may be positioned distal to the first and second cutouts 260 and 262. As a result, features such as the fixing tab 284 and lock button 286, which are located within the notches 260, 262 when stationary, are configured to enter the radial track 266, thus giving the thumbwheel 240 the freedom to rotate when it is translated proximally. Thus, the radial track 266 allows the thumbwheel 240 to rotate around the body 210 when it is translated proximally, and as a result, the fixing tab 284 and lock button 286 are housed within the radial track 266.

[0073] Continuing to refer to Figures 9A and 9B, the first channel 268 extends axially along the inner bore 267 of the thumbwheel 240. The first channel 268 may be oriented and positioned such that it opens at its distal end to a base surface defining the depth of the first notch 260. The first channel 268 may extend proximal therefrom. Thus, the first notch 260 and the first channel 268 may communicate with each other. The first channel 268 is configured to accommodate a rotatable tab 288 (see Figures 11A and 11B) located on the body 210, for example, on the intermediate body 213.

[0074] As shown in detail in Figures 11A and 11B, the rotatable tab 288 may be coupled to the proximal end 224 of the inner shaft 220 so that the rotatable tab 288 is rotatably fixed to the inner shaft 220. The rotatable tab 288 may extend radially outward from the inner shaft 220, and the rotation of the tab 288 around the inner shaft 220 may be configured to rotate the inner shaft 220 to a corresponding degree. As shown in Figure 12A, the body 210, for example, the central body member 213, may be positioned to cover the proximal end 224 of the inner shaft 220 and also cover the rotatable tab 288. The central body member 213 may include a track 217 (see Figures 10A, 10B, and 12A), through which the rotatable tab 288 extends, enabling engagement with the thumbwheel 240. The track 217 may extend over a partial extent around the circumference of the intermediate body 213. For example, the track 217 may extend approximately 180° around the circumference of the intermediate body, thereby providing the tab 288 with a range of motion of approximately 180° while constraining the tab 288 in the axial direction.

[0075] As shown in Figure 12B, the rotatable tab 288 may be housed within the first channel 268 of the thumbwheel 240. The interaction between the first channel 268 and the tab 288 provides a rotational connection between the thumbwheel 240 and the inner shaft 220. The rotatable tab 288 is constrained within the first channel 268 and rotatably fixed with respect to the first channel 310. The rotatable tab 288 is therefore configured to rotate within the track 217 about the longitudinal axis 202 of the body 210 in response to the rotation of the thumbwheel 240 about the longitudinal axis 202. In this way, the rotation of the thumbwheel 240 results in the rotation of the rotatable tab 288, which in turn causes the rotation of the inner shaft 220. Figure 12C shows an inserter in the same position as shown in Figure 12B, with a sleeve or grip 263 positioned on top of a cylindrical inner member 261.

[0076] Referring back to Figures 9A and 9B, the thumbwheel 240 may further include a second channel 269 extending axially along the inner bore 267 of the thumbwheel 240. The second channel 269 may be sized and dimensioned to accommodate the fixing tab 284 when the thumbwheel is rotated over a second range, for example, about 90°, thereby allowing translation of the thumbwheel 240. In particular, the accommodation of the fixing tab 284 by the second channel 269 is configured to allow the thumbwheel 240 to translate distally from the end of the body 210 for removal without being obstructed by any collision between the fixing tab 284 and the proximal edge of the radial track 266 or the proximal edge of the cutouts 260, 262 (as described in Figure 30 and further herein). In particular, the second channel 269 may be oriented and arranged to extend in a direction parallel to the first channel 268 and spaced about 90° apart from the first channel 268 around the circumference of the thumbwheel 240.

[0077] Referring to Figure 13, the body 210 (for example, the proximal body member 214) may further include a flange or backing plate 280 and a biasing element 282 attached thereto. The biasing element 282 may be positioned distal to the backing plate 280 and may be fixed to the backing plate, for example, by welding or by other means, so that the biasing element 282 can engage with the thumbwheel 240. The biasing element 282 may be configured to interact with a proximal contact on the inner bore 267 of the thumbwheel 240, the proximal contact may be, for example, the proximal end surface 265 of the cylindrical inner member 261. The biasing element 282 may be configured to bias the thumbwheel 240 distally. In certain embodiments, the biasing element 282 may include a corrugated spring. The biasing element 282 may provide a resistance force that can cause the thumbwheel 240 to be translated proximally in order to actuate rotation, and otherwise contribute to maintaining the position of the inserter 200 until the user specifically chooses to actuate the thumbwheel proximally, and unless such a choice is made.

[0078] Furthermore, a method for using the intubator 200 during a surgical procedure is disclosed herein, which includes a method for connecting an implant to the intubator (see Figure 23A) and a method for separating the implant from the intubator after the implant has been placed in the patient (see Figure 23B).

[0079] Referring to the flowcharts in Figures 13–22 and 23A, a method for coupling the implant 10 to the inserter 200 is provided. In step 1.1, the inserter 200 may be provided in a disengaged configuration in which the distal end 222 of the inner shaft 220 is ready to receive and couple to the implant 10 (see Figure 8). Referring to Figure 13, the inserter 200 may include a visible indicator 281 on the body 210, for example on the intermediate body member 213, which is visible within a ridge 264 when the inserter 200 is in the disengaged position. The visible indicator 281 may be, for example, a green button or dot, or other marking that is easily understood by the user to correspond to the disengaged position. As shown in Figures 14–15, in the disengaged position, the lock button 286 and the retaining tab 284 may be located in or recessed within first and second notches 260, 262, respectively. The rotation of the thumbwheel 240 is prevented by rotational constraints on the lock button 286 and fixing tab 284, provided by cutouts 260, 262.

[0080] To release the thumbwheel 240 from the unlocked position, in step 1.2, the thumbwheel 240 is translated proximally relative to the force of the biasing member 282, as shown in Figures 16-17. In particular, the proximal end 265 of the cylindrical inner member 261 of the thumbwheel 240 may contact the biasing member 282. This proximal translation of the thumbwheel 240 is configured to bring the lock button 286 and the retaining tab 284 out of the cutouts 260, 262 and align them axially with the radial track 266, as shown in Figures 18-19. Once translated in this manner, the thumbwheel 240 rotates freely relative to the body 210.

[0081] In step 1.3, the thumbwheel 240 may then be rotated in a first direction, for example, clockwise or counterclockwise. In the embodiments shown herein, the first direction may be counterclockwise, but the orientation of the feature may be configured such that the first direction is instead clockwise, using the same feature. The radial track 266 provides sufficient axial clearance for the lock button 286 and the fixing tab 284, thus allowing the thumbwheel 240 to rotate without further translation in either the proximal or distal direction. The rotation of the thumbwheel 240 may be configured to directly correspond to the rotation of the inner shaft 220 by the connection between the thumbwheel 240 and the inner shaft 220 provided by the rotating tab 288, as described above and shown in Figure 20. In certain embodiments, the inserter 200 moves from the unlocked position to the locked position by rotating the thumbwheel 240 180° counterclockwise from the unlocked position (see Figure 13), while the lock button 286 is exposed for disassembly by rotating the thumbwheel 240 90° counterclockwise from the unlocked position, as further described herein.

[0082] As shown in Figures 21-22, after rotating 180° counterclockwise from the unlocked position as described above, in step 1.4, the inserter 200 is configured in a locked position where the implant 10 (see Figure 8) is connected to the distal end of the inserter 200. In the locked position, the lock button 286 and the fixing tab 284 are positioned in the second and first notches 262, 260, respectively; that is, the lock button 286 and the fixing tab 284 are positioned in the notches 260, 262 opposite to where their respective features were located when the inserter 200 was in the unlocked position. This is due to the 180° rotation of the thumbwheel 240. The thumbwheel 240 is biased by the biasing member 282 and can be translated distally, and further rotation is prevented when the second notch 262 and the first notch 260 restrain the lock button 286 and the fixing tab 284, respectively.

[0083] Further reference to the flowcharts in Figures 13–22 and Figure 23B provides a method for separating the implant 10 from the insertor after the implant 10 has been placed in the patient's body. The steps of such a method are substantially the reverse of the steps described above. In step 2.1, the process begins with the insertor in a locked configuration. This may be done, for example, immediately after the implant 10 has been placed in the patient's intervertebral space. In step 2.2, the thumbwheel is translated proximal to allow rotation of the thumbwheel. In step 2.3, the thumbwheel 240 may be rotated 180° in the opposite direction to the rotation in step 1.3. For example, the thumbwheel 240 may rotate clockwise to return to the unlocked position, and the rotation required to achieve the locked configuration was counterclockwise. The opposite configuration is also obviously possible. In step 2.4, the unlocked configuration is achieved, and the thumbwheel is able to be translated distally, biased by the biasing member 282 to prevent further rotation.

[0084] Referring to the flowcharts in Figures 24 to 30 and Figure 31A, this specification also discloses a method for disassembling or taking apart the insertor 200, which may be useful, for example, after use during surgical procedures or for cleaning or sterilizing the instrument.

[0085] In disassembly step 3.1, the inserter 200 is provided in an unlocked configuration. In step 3.2, the thumbwheel 240 is rotated 90° from its unlocked position, and as a result, the lock button 286 is fully visible within the relief 264, as shown in Figure 24. In step 3.3, the lock button 286 is fully pressed down so that it is located below the inner bore 267 of the thumbwheel 240 (Figure 25). The lock button 286 is therefore substantially coplanar with the surface of the body 210, for example, the central body member 213 (Figure 26). Once the lock button 286 no longer restrains the thumbwheel 240, the thumbwheel 240 is released and translates distally in step 3.4 (Figure 27). As shown in Figure 28, the biasing member 282 may be attached to the backing plate 280 on the proximal body member 214 and therefore does not have to translate with the thumbwheel 240. In step 3.4, the thumbwheel 240 is translated distally away from the body 210 of the inserter 200. When this happens, channels 268 and 269 allow the rotating tab 288 and the fixed tab 284 to remain in place, respectively (Figure 29), even as the thumbwheel 240 is translated distally (Figure 30).

[0086] Referring to the flowcharts in Figures 24–30 and Figure 31B, this specification also discloses a method for assembling the inserter 200, which may be useful, for example, before use during a surgical procedure or after cleaning or sterilization of the instrument. The steps of such a method are substantially the reverse of the steps described above with respect to Figure 31A, and may be performed before, after, or independently.

[0087] In assembly step 4.1, the inserter is provided in a disassembled configuration, for example, before use or after a sterilization or cleaning procedure. In assembly step 4.2, the thumbwheel 240 slides proximal from its distal end along the body, for example, along the outer shaft 212. When the proximal end of the thumbwheel 240 reaches the lock button 286, in step 4.3, the lock button 286 is pressed to allow the thumbwheel 240 to slide over the lock button 286. In step 4.4, the thumbwheel 240 moves proximal parallel to the lock button 286, covering it until it contacts, for example, the biasing member 282. In step 4.5, the thumbwheel 240 may then be rotated 90° in a second direction from its disassembled position (Figure 24) to its unlocked position. The inserter 200 is then ready for use in coupling to an implant, for example, as described above with respect to the drawing and flowchart in Figure 23A.

[0088] In addition to the inserter 200 and method described above, another embodiment may provide a system for use in spinal fusion procedures, which substantially includes the inserter 200 as described above, together with a spinal fusion implant 10 (see Figure 8). Suitable spinal fusion implants are known in the art.

[0089] Where used herein, terms such as “first,” “second,” etc., do not indicate any order, quantity, or importance, but rather are used to distinguish one element from another, and the terms “a” and “an” herein do not indicate a limitation of quantity, but rather indicate the presence of at least one of the items mentioned. The modifier “about” used in relation to quantity includes the stated value and has meaning determined by the context (e.g., including the degree of error relating to the measurement of a particular quantity). The suffix “(s)” used herein is intended to include both singular and plural of the term it modifies, thereby including one or more of that term (e.g., metal(s) includes one or more metals). The scope disclosed herein is inclusive and can be combined independently (e.g., the range “up to about 25 mm, or more specifically, about 5 mm to about 20 mm” includes the endpoints and all intermediate values ​​of the range “about 5 mm to about 25 mm,” etc.).

[0090] While various embodiments are described herein, it will be understood from this specification that various combinations, modifications, or improvements of elements may be made by those skilled in the art, and these will remain within the scope of the present invention. Furthermore, many modifications can be made to adapt the teachings of the present invention to specific situations or materials without departing from the essential scope of the present invention. Thus, the present invention is not limited to the specific embodiments disclosed as the best mode intended to carry out the present invention, and the present invention is intended to include all embodiments that fall within the scope of the appended claims.

Claims

1. An inserter for inserting a spinal fixation implant, wherein the inserter is A housing having a proximal member and a housing shaft extending distally therefrom, An internal shaft having a distal end and a proximal end, wherein the internal shaft is at least partially positioned within the housing shaft and configured to move parallel to the housing shaft, and the distal end is configured to engage releasably with the spinal fixation implant, A thumbwheel is rotatably fixed to the proximal end of the inner shaft and configured to rotate around the longitudinal axis of the inserter, thereby causing the inner shaft to rotate. A lock that engages with the inner shaft, wherein the lock is configured to move between a locked position and an unlocked position, in the locked position the inner shaft is rotatably fixed to the thumbwheel, and in the unlocked position the inner shaft and the thumbwheel are separable from each other, Softstop, and The aforementioned soft stop is A main body portion extending in the axial direction having screw threads on its outer surface, A slider body having a screw hole configured to engage with the aforementioned screw threads, The slider body includes one or more biasing members configured to provide audible and / or tactile feedback when it comes into contact with the slider body, An inserter wherein the soft stop is configured to provide the user with one or more audible and / or tactile feedback to indicate that the spinal fixation implant has been completely disengaged from the distal end of the medial shaft.

2. The inserter according to claim 1, wherein the distal end of the inner shaft is provided with a thread configured to engage with a complementary thread on the spinal fixation implant.

3. The inserter according to claim 1, wherein the rotation of the thumbwheel in a first direction is configured to engage the distal end of the inner shaft with the spinal fixation implant, and the rotation of the thumbwheel in a second direction is configured to engage and disengage the distal end of the inner shaft from the spinal fixation implant.

4. In the unlocked position, The inner shaft is configured to translate distally and to engage and disengage its proximal end from the thumbwheel. The inserter according to claim 1, wherein the inner shaft is further configured to be removable from the distal end of the housing shaft.

5. The thumbwheel further comprises a biasing element configured to bias the thumbwheel distally, In the unlocked position, the thumbwheel is configured to translate proximal to the force of the biasing element. The inserter according to claim 4, wherein when the proximal end of the inner shaft is disengaged from the thumbwheel, the distal end of the thumbwheel is configured to move radially outward with respect to the longitudinal axis, thereby initiating the disassembly of the thumbwheel from the inserter.

6. The inserter according to claim 1, wherein the proximal end of the inner shaft is provided with a keyed feature that provides complementary engagement with a corresponding keyed feature on the thumbwheel.

7. The inserter according to claim 6, wherein the keyed feature portion is a male hexagonal feature portion, and the corresponding keyed feature portion is a female hexagonal feature portion.

8. An inserter according to claim 1, The inner shaft has a first diameter and includes a portion in its middle section having a reduced diameter. The aforementioned lock, A lock button is provided, which is disposed on the housing and movable in a direction perpendicular to the longitudinal axis, wherein the lock button has a slot configured to engage with the portion of the inner shaft having the reduced diameter, The aforementioned slot has a non-circular cross-sectional shape, and therefore, In the locked position, the outer surface of the lock button is coplanar with the outer surface of the housing, and the first end of the slot provides an interlocking fit with the portion of the inner shaft having the reduced diameter. The inserter according to claim 1, wherein in the unlocked position, the outer surface of the lock button is raised relative to the outer surface of the housing, and the second end of the slot accommodates the inner shaft in the portion of the inner shaft that does not have the reduced diameter, thereby allowing the inner shaft to translate.

9. The aforementioned lock, A track extending within the lock button in a direction parallel to the direction in which the lock button is movable, A pin placed within the aforementioned track, A plunger disposed within the housing and configured to engage with the lock button in the locked position and the unlocked position, A spring configured to engage with the plunger, The inserter according to claim 8, further comprising a screw configured to maintain the positions of the plunger and the spring.

10. The inserter according to claim 9, wherein the housing further comprises a first through hole configured to engage with the plunger in the unlocked position and a second through hole configured to engage with the plunger in the locked position.

11. The aforementioned soft stop, A keyed distal end feature configured to rotatably engage with a complementary keyed feature on the proximal end of the thumbwheel, wherein the keyed distal end feature is coupled to a longitudinally extending body having a plurality of threads positioned thereon, A slider body is configured to be screwed into the longitudinally extending body and to translate within the soft stop, The inserter according to claim 1, further comprising a first wave spring and a second wave spring, respectively, positioned at both ends of the slider body.

12. The inserter according to claim 11, wherein the thumbwheel is configured to be rotatable after the slider body comes into contact with the first wave spring or the second wave spring.

13. The inserter according to claim 1, A system comprising the aforementioned spinal fixation implant.

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