Adjustable spinal implants and associated deployment instruments

Abstract

The present disclosure provides adjustable spinal devices, instruments for deploying spinal devices, methods for adjusting the height and / or lordosis angle of spinal devices, and methods for implanting such devices. The adjustable spinal fusion device includes an upper plate having an outer surface for positioning against a first vertebral body and a lower plate having an outer surface for positioning against a second vertebral body. The device further includes a translation member configured to move longitudinally relative to the upper and lower plates to adjust the angle between the upper and lower plates, and a locking member coupled to the translation member. The locking member is movable between an unlocked position, in which the translation member is permitted to move longitudinally, and a locked position, in which the translation member is restricted from moving longitudinally.

Description

[Technical Field]

[0001] The present disclosure relates to implantable devices for stabilizing and / or promoting fusion of adjacent bony structures, and more particularly to implantable spinal fusion cages that can be adjusted in height and / or angle to accommodate spacing constraints and / or address lordosis within the intervertebral space. [Background technology]

[0002] Implantable spinal devices can be used to treat a variety of spinal abnormalities, including degenerative disc disease. For example, in one type of spinal abnormality, the intervertebral disc deteriorates or becomes damaged due to acute injury or trauma, disc disease, or simply the natural aging process. The current standard of care may involve surgical removal of part or all of the diseased or damaged disc in a procedure known as a partial or total discectomy. Discectomy is often followed by the insertion of an interbody cage or spacer to stabilize the weakened or damaged spinal region and / or restore disc height. The cage or spacer serves to reduce or inhibit mobility in the treatment area to prevent further progression of damage and / or to alleviate or relieve pain caused by the injury or damage. Furthermore, these types of cages or spacers serve as a mechanical or structural framework to restore and maintain normal disc height and, in some cases, can also provide space for the insertion of bone graft material to promote bony fusion between adjacent vertebrae.

[0003] One of the current challenges of these types of procedures is the very limited working space provided for the surgeon to manipulate and insert the cage into the intervertebral space to be treated. Access to the intervertebral space requires navigation around atrophied adjacent blood vessels and tissues, such as the aorta, vena cava, dura mater, and nerve roots, leaving a very narrow path for access. The opening into the intradiscal space itself is also relatively small. Thus, there are physical limits to the actual size of the cage that can be inserted without significantly disturbing the surrounding tissue or the vertebral bodies themselves.

[0004] Further complicating the problem is the fact that vertebral bodies are not positioned parallel to one another in a normal spine. There is a natural curvature to the spine due to the angular relationship of the vertebral bodies relative to one another. An ideal interbody fusion cage must be able to accommodate this angular relationship of the vertebral bodies, or else the cage will not seat properly when inside the disc space. An improperly fitted cage will likely either become dislodged or migrate out of position, losing effectiveness over time or, worse, further damaging an already weakened area.

[0005] Another challenge with implanting an interbody fusion cage is the need to remove at least a portion, if not all, of the intervertebral disc to make room for the cage to be inserted between adjacent vertebrae. Removal of the entire disc or a portion of the disc disrupts the normal lordotic or kyphotic curvature of the spine. Conventional fusion cages do not attempt to correct this curvature, and over time, a kyphotic deformity develops as the vertebrae settle around the implanted cage. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent Application Serial No. 17 / 865,755 [Patent Document 2] International Patent Application No. PCT / EP2022 / 069886 Summary of the Invention [Problem to be solved by the invention]

[0007] It is therefore desirable to provide an implantable spinal device that has the ability to maintain and restore the normal anatomy of a fused spinal segment. It is particularly desirable to provide an intersomatic cage or spacer that not only has the mechanical strength or structural integrity to restore disc height or vertebral alignment to the spinal segment being treated, but also can easily pass through narrow access paths into the intervertebral space to accommodate the angular constraints of this space and / or correct any lordotic or kyphotic curvatures created by disc removal. [Means for solving the problem]

[0008] The present disclosure provides adjustable spinal devices and associated instruments for their deployment. The present disclosure further provides methods for adjusting the height and / or lordosis angle of spinal devices and methods for implanting such devices to treat spinal conditions or abnormalities.

[0009] In one aspect, an adjustable spinal fusion device includes an upper plate component having an outer surface for placement against a first vertebral body and a lower plate component having an outer surface for placement against a second vertebral body. The device further includes a translation member configured to move longitudinally relative to the upper and lower plates to adjust the angle between the upper and lower plates (e.g., the lordosis angle of the implant). A locking member is coupled to the translation member and configured to fix the longitudinal position of the translation member relative to the upper and lower end plates.

[0010] The device has a first configuration for advancement through a narrow access path into the intervertebral space and a second configuration in which the angle of the device can be adjusted to accommodate the angular constraints of the space and / or to correct lordotic or kyphotic curvatures. The locking member is movable between an unlocked position, in which the translation member is permitted to move longitudinally, and a locked position, in which the translation member is restricted from moving longitudinally. This ensures that the lordotic angle can only be adjusted when the locking member is in the unlocked position. For example, the locking member can be in the locked position when the device is advanced into the intervertebral space through the narrow access path to ensure that the upper and lower end plates remain fixed relative to one another until the surgeon is ready to adjust the lordosis. At this point, the locking member can be moved into the unlocked position to allow angular adjustment of the end plates.

[0011] In some embodiments, the translation member includes a bore having one or more mating features for cooperating with an actuator shaft of a surgical instrument to longitudinally move the translation member. The locking member is rotatably coupled to the translation member within the bore for movement between locked and unlocked positions. The locking member can include one or more mating features for cooperating with an actuator shaft of the surgical instrument such that rotation of at least a portion of the surgical instrument causes rotation of the locking member within the bore.

[0012] In some embodiments, the device includes one or more engaging elements coupled to or integral with one of the upper and lower endplates. The locking member includes one or more locking members that engage the engaging elements on one of the upper and lower endplates in the locked position. In an exemplary embodiment, the locking members include a plurality of protrusions, and the engaging elements on one of the upper and lower endplates include a plurality of teeth that engage the protrusions in the locked position.

[0013] In some embodiments, rotation of the locking member into the unlocked position locks mating features on the translation member to mating features on the surgical instrument, which locks at least a portion of the surgical instrument to the translation member and allows the translation member to advance longitudinally relative to the upper and lower endplates when the locking member is in the unlocked position.

[0014] In some embodiments, the upper and lower end plates each have a proximal end and a distal end. The proximal ends are pivotally coupled to one another and the distal ends are movable relative to one another to adjust the distance therebetween. The translation member can include a sloped surface extending downward in the proximal direction from the upper end plate to the lower end plate. The device can further include a ramp for cooperating with the sloped surface of the translation member.

[0015] The device can include a hinge pivotally coupling the internal support member to the lower endplate. In certain embodiments, proximal translation of the translation member engages the ramp surface with the ramp and moves the distal end of the upper endplate away from the distal end of the lower endplate such that the proximal ends of the endplates remain substantially fixed relative to one another as the distal ends are moved apart.

[0016] In one embodiment, the upper end plate includes a ramp. In another embodiment, the device further includes an internal support member coupled to or integral with the upper end plate and pivotally coupled to the lower end plate. In this embodiment, the internal support member includes a ramp.

[0017] In certain embodiments, longitudinal translation of the translation member also adjusts the height of the endplate. In one such embodiment, the upper endplate includes proximal and distal ramps, and the translation member includes proximal and distal sloped surfaces for cooperating with the proximal and distal ramps of the upper endplate to adjust the distance between the proximal and distal ends of the endplate. That is, longitudinal movement of the translation member relative to the endplate results in adjustment of both the angle and height of the endplate.

[0018] In certain embodiments, the device can include a second translational member. Longitudinal movement of the second translational member relative to the first translational member adjusts the height between the upper and lower endplates. This allows for independent adjustment of the device height and angle after it is implanted between the cones. The second translational member can include a second movable wedge having at least one inclined surface. Each of the upper and lower endplates can include a ramp for cooperating with the inclined surface of the second movable wedge of the second translational member such that longitudinal movement of the second movable wedge adjusts the distance between the proximal ends of the upper and lower endplates.

[0019] In some embodiments, the upper and lower end plates are separate components. They may be manufactured separately or manufactured together and then separated. In embodiments, the translational member, the internal support member, and / or the lower end plate include at least one protrusion, such as a pin, that extends laterally away from the longitudinal axis. The upper end plate includes an opening or slot for receiving the protrusion. The protrusion is configured to pass through the opening and couple the end plates to one another. In certain embodiments, the protrusion is positioned on the translational member and configured to slide into the slot to stabilize the upper and lower end plates during longitudinal movement of the first translational member.

[0020] In some embodiments, the device includes a mechanism for providing discrete "steps" in the movement of the translational member relative to the endplates. These steps correlate with height and / or angular adjustment of the endplates. In one such embodiment, the translational member includes a plurality of protrusions, and one of the upper or lower endplates includes a plurality of teeth that cooperate with the protrusions. The protrusions move relative to the teeth as the translational member is moved longitudinally. The teeth can include spaces between them that provide discrete segments of angular and / or height adjustment for the endplates.

[0021] In some embodiments, the device is fabricated through additive manufacturing techniques such as 3D printing. The implant may be formed layer by layer, such as longitudinally from the proximal end to the distal end, in one example. Upon completion of fabrication, the upper and lower endplates are separated from each other and held together during use by protrusions that extend through openings in the upper endplate.

[0022] In one such embodiment, the device further includes a support member pivotally coupled to the lower endplate, with one or more protrusions extending laterally outward from the support member. In another embodiment, the opening is a slot, and the translation member includes one or more protrusions extending laterally therefrom and through the slot to couple the translation member to the upper endplate. In yet another embodiment, the device further includes a flexible hinge coupling the upper endplate to the lower endplate. The flexible hinge can include a leaf spring having a proximal end coupled to the lower endplate and a distal end coupled to the upper endplate.

[0023] In some embodiments, at least one of the upper and lower end plates includes a surface with one or more exhaust openings for extracting metal powder from within the device, allowing for more efficient extraction of metal powder that may remain in the cage after, for example, 3D printing.

[0024] In another aspect, a spinal fusion system includes an adjustable spinal fusion device having an upper endplate with an outer surface for positioning against a first vertebral body and a lower endplate with an outer surface for positioning against a second vertebral body. The device includes a translation member configured to move longitudinally relative to the upper and lower plates to adjust the angle and / or distance between the upper and lower plates. A locking member is coupled to the translation member and configured to fix the longitudinal position of the translation member relative to the upper and lower endplates. The system further includes an instrument having a proximal handle, an elongated shaft, and a mating feature on the elongated shaft for cooperating with the locking member. An actuator on the elongated shaft is coupled to the proximal handle to move the translation member longitudinally relative to the upper and lower endplates.

[0025] In some embodiments, a mating feature on the surgical instrument is configured to rotate the locking member from an unlocked position, allowing the translational member to move longitudinally to a locked position, where the translational member is restrained from moving longitudinally.

[0026] The instrument may include a second mating feature coupled to the actuator, and the translation member includes a bore having one or more engaging elements for cooperating with the second mating feature to secure the translation member to the instrument such that longitudinal movement of the instrument causes the translation member to move longitudinally relative to the upper and lower end plates.

[0027] The locking member can be rotatably coupled to the translational member within the bore such that rotation of the locking member into the unlocked position secures the engagement feature of the translational member to the second mating feature of the surgical instrument. In one embodiment, the second mating feature comprises one or more protrusions extending from the distal end of the shaft of the surgical instrument, and the engagement feature of the translational member comprises one or more recesses in an inner surface of the bore. The first mating feature can be positioned proximal to the second mating feature on the elongate shaft.

[0028] In some embodiments, the device includes one or more engaging elements coupled to one of the upper and lower endplates. The locking member includes one or more locking members that engage the engaging elements on one of the upper and lower endplates in the locked position. In an exemplary embodiment, the locking members include a plurality of protrusions, and the engaging element on one of the upper and lower endplates includes a plurality of teeth that engage the protrusions in the locked position.

[0029] In some embodiments, the upper and lower end plates each have a proximal end and a distal end. The proximal ends are pivotally coupled to one another and the distal ends are movable relative to one another to adjust the distance therebetween. The translation member can include a sloped surface extending downward in the proximal direction from the upper end plate to the lower end plate. The device can further include a ramp for cooperating with the sloped surface of the translation member.

[0030] The device can include a hinge pivotally coupling the internal support member to the lower endplate. In certain embodiments, proximal translation of the translation member engages the ramp surface with the ramp and moves the distal end of the upper endplate away from the distal end of the lower endplate such that the proximal ends of the endplates remain substantially fixed relative to one another as the distal ends move apart.

[0031] In one embodiment, the upper end plate includes a ramp. In another embodiment, the device further includes an internal support member coupled to or integral with the upper end plate and pivotally coupled to the lower end plate. The lower internal support member includes the ramp.

[0032] In certain embodiments, longitudinal translation of the translation member also adjusts the height of the endplate. In one such embodiment, the upper endplate includes proximal and distal ramps, and the translation member includes proximal and distal sloped surfaces for cooperating with the proximal and distal ramps of the upper endplate to adjust the distance between the proximal and distal ends of the endplate. That is, longitudinal movement of the translation member relative to the endplate results in adjustment of both the angle and height of the endplate.

[0033] In certain embodiments, the device can include a second translational member. Longitudinal movement of the second translational member relative to the first translational member adjusts the height between the upper and lower endplates. This allows for independent adjustment of the device height and angle after it is implanted between the cones. The second translational member can include a second movable wedge having at least one inclined surface. Each of the upper and lower endplates can include a ramp for cooperating with the inclined surface of the second movable wedge of the second translational member such that longitudinal movement of the second movable wedge adjusts the distance between the proximal ends of the upper and lower endplates.

[0034] In another aspect, a method of implanting a spinal fusion device in a patient includes coupling a distal end of a surgical instrument to the spinal fusion device and positioning the spinal fusion device between first and second vertebrae of the patient. A first portion of the surgical instrument is actuated to unlock a translation member within the spinal fusion device. A second portion of the surgical instrument is longitudinally translated to longitudinally advance the translation member relative to upper and lower end plates of the spinal fusion device to adjust the angle between the upper and lower end plates.

[0035] In some embodiments, the first portion of the surgical instrument is rotated to rotate the locking member into a locked position, thereby locking the longitudinal position of the translation member relative to the upper and lower endplates.

[0036] In some embodiments, the method further includes longitudinally translating a second portion of the surgical instrument to adjust the height between the upper and lower endplates.

[0037] In some embodiments, the method includes inserting a distal end of a shaft of a surgical instrument through a bore in the translation member and rotating the distal end of the shaft to lock the instrument to the translation member. In an exemplary embodiment, the translation member includes one or more recesses in an inner surface of the bore and the shaft includes one or more protrusions, and the method further includes rotating the protrusions into the recesses such that the translation member is moved into an unlocked position.

[0038] In another aspect, a surgical instrument for implanting a spinal fusion device in a patient includes an elongated shaft having a proximal handle and a distal end portion, the shaft including a first mating feature for securing the shaft of the instrument to the spinal fusion device, a second mating feature on the distal end portion for engaging a translation member of the spinal fusion device, and a third mating feature on the distal end portion for engaging a locking member of the spinal fusion device.

[0039] In some embodiments, the instrument includes a rod extending through a lumen of the shaft, the first and second mating features being positioned on a distal portion of the rod. The rod can be rotatable relative to the shaft to rotate a locking member of the spinal fusion device. The rod can be configured to translate longitudinally relative to the shaft to translate a translation member of the spinal fusion device.

[0040] In some embodiments, the first mating feature includes first and second gripping arms configured to engage and secure to a proximal portion of the spinal fusion device. The second mating feature includes one or more protrusions extending from a distal portion of the rod, and the third mating feature includes one or more protrusions extending from the distal portion of the rod proximal to the second mating feature. In an exemplary embodiment, the protrusions of the second mating feature are distal to the protrusions of the first mating feature on the instrument rod. In an exemplary embodiment, the second mating feature is configured to secure to the translation member when the third mating feature moves the locking member into the unlocked position, which allows translation of the translation member.

[0041] In some embodiments, the instrument includes a rotatable knob on the proximal handle that is coupled to the rod and configured to translate the rod relative to the shaft.

[0042] In some embodiments, the instrument includes a gauge on the proximal handle coupled to the rotatable knob and configured to indicate the lordosis angle of the first and second endplates on the spinal fusion device.

[0043] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. [Brief explanation of the drawings]

[0044] [Figure 1] FIG. 1 is a perspective view of one embodiment of an adjustable implantable spinal device. [Figure 2] FIG. 2 is a partial cutaway view of the spinal device of FIG. 1. [Figure 3] FIG. 2 is an exploded view of the device of FIG. 1. [Figure 4] FIG. 2 shows the lower endplate of the device of FIG. 1. [Figure 5] FIG. 2 shows the upper endplate of the device of FIG. 1. [Figure 6]FIG. 2 shows an internal support member of the device of FIG. 1. [Figure 7A] FIG. 2 shows an angular translation member of the device of FIG. 1. [Figure 7B] FIG. 7B is an exploded view of the translation member and locking element of FIG. 7A. [Figure 8A] FIG. 1 is a perspective view of a spinal device and a distal tip of a surgical instrument. [Figure 8B] FIG. 13 is a partial cutaway view of the spinal device and distal tip of the instrument. [Figure 9A] FIG. 16 is a partial cutaway view of a spinal device with the distal tip of the instrument engaged with the locking member of the device. [Figure 9B] FIG. 16 is a partial cutaway view of a spinal device with the distal tip of the instrument engaged with the locking member of the device. [Figure 10] FIG. 10 shows the locking member in the unlocked position. [Figure 11] FIG. 10 shows the locking member in a locked position. [Figure 12] FIG. 1 is a perspective view of a surgical instrument for use with the spinal devices described herein. [Figure 13] 13A-13C illustrate various components of a surgical instrument system including the instrument of FIG. 12. [Figure 14] FIG. 13 is an exploded view of certain components of the distal portion of the surgical instrument of FIG. 12. [Figure 15] 13 shows the surgical instrument of FIG. 12 with two enlarged views of the proximal portion of the surgical instrument of FIG. 12.

[0032] FIG. [Figure 16] FIG. 13 shows the surgical instrument of FIG. 12 with a close-up view of the instrument attached to a spinal device. [Figure 17] FIG. 10 shows the surgical instrument with a close-up view of the closed locking bar for securing the instrument to the spinal device. [Figure 18] FIG. 10 shows the surgical instrument in an enlarged view showing tightening of the cage fixation screws on the surgical instrument. [Figure 19] FIG. 10 illustrates the surgical instrument in an enlarged view showing the grasper interface when in the closed, locked position. [Figure 20]1A-1D illustrate the steps of inserting a spinal device between two adjacent vertebrae in the spine. [Figure 21] FIG. 13 shows the instrumentation and spinal device before lordotic expansion. [Figure 22] FIG. 10 shows lordosis expansion using surgical instruments. [Figure 23] FIG. 10 illustrates removal of the proximal portion of the surgical instrument in preparation for bone graft backfill. [Figure 24] FIG. 1 shows the surgical instruments used for bone graft backfilling. [Figure 25] FIG. 1 shows the surgical instruments used for bone graft backfilling. [Figure 26] FIG. 12 is a perspective view of another embodiment of a spinal device. [Figure 27] FIG. 27 is a partial cutaway view of the device of FIG. 26. [Figure 28] FIG. 27 is an exploded view of the device of FIG. 26. [Figure 29] FIG. 12 is a perspective view of another embodiment of a spinal device. [Figure 30] FIG. 30 is a partial cutaway view of the device of FIG. 29. [Figure 31] FIG. 30 is an exploded view of the device of FIG. 29. [Figure 32] FIG. 30 shows the upper endplate of the device of FIG. 29. [Figure 33] FIG. 30 shows the lower endplate of the device of FIG. 29. [Figure 34] FIG. 10 is a partial cutaway view of another embodiment of a spinal device. [Figure 35] FIG. 35 is another view of the spinal device of FIG. 34. DETAILED DESCRIPTION OF THE INVENTION

[0045] The present specification and the accompanying drawings illustrate exemplary embodiments and should not be construed as limiting, with the claims defining the scope of the present disclosure, including equivalents. Various mechanical, compositional, structural, and operational changes may be made without departing from the scope of the present specification and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the present disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and related aspects described in detail with respect to one embodiment may, to the extent practical, be included in other embodiments without being specifically shown or described. For example, an element may be described in detail with respect to one embodiment but not with respect to a second embodiment, yet the element can be claimed as being included in the second embodiment. Furthermore, the description herein is for illustrative purposes only and may not necessarily reflect the actual shape, size, or dimensions of the systems or illustrated components.

[0046] It should be noted that, as used throughout this specification and claims, the singular forms "a," "an," and "the," as well as any use of the singular form of either word, include plural referents unless expressly and unambiguously limited to one referent. As used herein, the term "comprises" and its grammatical variations are intended to be open-ended, and thus the recitation of items in a list does not exclude other similar items that may be substituted for or added to the listed items.

[0047] 1-7, one embodiment of a spinal implant 100 in accordance with the present disclosure is configured for placement between two vertebral bodies. In some embodiments, implant 100 is particularly advantageous for placement via a posterior approach from outside the facet joint (transforaminal lumbar interbody fusion or TLIF), although it will be appreciated that the implants disclosed herein can be employed in a variety of different surgical approaches, such as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), and / or lateral lumbar interbody fusion (LLIF).

[0048] As shown, implant 100 includes upper and lower end plates 112, 114, an internal support member 118, and a translation member 116. In this embodiment, the lordotic angle between upper end plate 112 and lower end plate 114 is adjustable; however, the overall height or distance between the end plates is not adjustable. More specifically, the distance between distal end 122 of end plate 112 and distal end 124 of end plate 114 is adjustable, while the distance between proximal ends 126 and 128 generally remains substantially fixed.

[0049] Each of the upper and lower end plates 112, 114 includes an outer surface 119, 120 for contacting the surface of a vertebral body. Preferably, the outer surfaces 119, 120 are roughened with a surface treatment to facilitate attachment to the vertebral body. The surface treatment preferably creates a diamond structure (e.g., diamond 20-1.5), although other patterns can be used. The upper and lower end plates 112, 114 can further include one or more openings 121, 123 that extend entirely through the end plates and, in one embodiment, are substantially aligned with one another (see FIGS. 4 and 8A). Similarly, the internal support member 118, in one embodiment, includes a central opening or bore 125 that can, in one embodiment, be substantially aligned with the end plate openings 121, 123 (see FIG. 6). These openings create space for the addition of bone graft or other material into the implant and to allow bone ingrowth through the implant 100.

[0050] The upper and lower endplates 112, 114 have substantially open proximal ends 126, 128 and tapered distal ends 122, 124 so as to form a closed wedge-shaped nose 154 at the distal end of the implant when in the closed position. The upper endplate 112 includes two sidewalls 156 that extend downwardly toward and at least partially overlap the sidewalls 142, 144 of the lower endplate 14.

[0051] The internal support member 118 can be coupled to or integral with the upper end plate 112 and / or the lower end plate 114. In one embodiment, the internal support member 118 is coupled to the upper end plate 112 so that the internal support member 118 and the upper end plate 112 move together. In an exemplary embodiment, the support member 118 includes one or more protrusions (discussed in more detail below), such as conical pins 190, that extend through openings 192 in the upper end plate 112 (see FIGS. 3 and 5 ) to couple the support member 118 to the upper end plate 112. The support member 118 is pivotally coupled to the lower end plate 114 by hinges positioned near the proximal ends 126, 128 of the end plates 112, 114. The hinge allows the inner support member 118 and upper endplate 112 to pivot relative to the lower endplate 114 about an axis substantially perpendicular to the longitudinal axis of the implant 100, thereby moving the distal ends 122 and 124 of the endplates toward and away from each other. This adjusts the lordotic angle of the implant 100 between the patient's two vertebral bodies, as discussed in more detail below.

[0052] In the exemplary embodiment, support member 118 includes first and second proximal arms 130, 132 spaced laterally from one another and each having an opening 134 therethrough (see FIG. 6 ). Lower end plate 114 includes a central main body 140 and side walls 142, 144 (see FIG. 4 ). Main body 140 is spaced from side walls 142, 144, forming first and second channels or gaps 146, 148 therebetween for receiving first and second arms 130, 132 of support member 118. Lower end plate 114 further includes first and second protrusions 150, 152 extending inwardly from walls 142, 144 toward main body 140 and into gaps 146, 148. The protrusions 150, 152 also extend into the openings 134 in the arms 130, 132 of the support member 118 and are designed to cooperate with these openings in the support member 118 to form a hinge.

[0053] As shown in FIG. 4 , the lower endplate 114 includes a central channel 160 for receiving the translation member 116. The translation member 116 is longitudinally movable within the channel 160 relative to the endplates 112, 114 and the support member 118. The translation member 116 includes one or more inclined surfaces or wedges 164 designed to cooperate with inclined surfaces or ramps 147 (see FIG. 6 ) on the support member 118. Longitudinal movement of the translation member 116 relative to the endplates moves these wedges 164 along the ramps 147 of the support member 118, thereby moving the support member 118 toward or away from the lower endplate (pivoting about a hinge at the proximal end of the implant 100). Additionally, the support member 118 moves the distal end 122 of the upper endplate 112 toward or away from the distal end 124 of the lower endplate 114.

[0054] 7A and 7B, translation member 116 includes a locking member 168 rotatably coupled to translation member 116 such that translation member 116 can rotate about a longitudinal axis relative thereto. Locking member 168 includes a central bore 170 for receiving an actuator shaft 220 (see FIGS. 8A-11 ) of surgical instrument 200 that causes longitudinal movement of translation member 116. To this end, bore 170 includes a first annular mating feature 177 configured to receive and couple to a first mating feature 222 of rod 202. Note that first mating feature 177 can be formed in locking member 168 and / or in translation member 116 (i.e., distal to locking member 168). When first mating feature 177 is formed in translation member 116 , bore 170 extends completely through locking member 168 and into a distal portion of translation member 116 .

[0055] In the exemplary embodiment, this mating feature 177 includes a cavity or notch sized to receive a first mating feature 222 (discussed in more detail below) of the rod 202. The cavity may include a proximal rim or protrusion (not shown) that extends toward the longitudinal axis and has an inner diameter smaller than the inner diameter of the cavity. When the actuator shaft 220 is coupled to the translation member 116, longitudinal translation of the actuator shaft 220 moves the proximal translation member 116 longitudinally relative to the end plates 112, 114, thereby moving the end plates toward or away from each other.

[0056] Locking member 168 further includes a second mating feature 176 configured to cooperate with a second mating feature 224 (see FIGS. 8A-11 ) of surgical instrument 200. As discussed in more detail below, second mating feature 176 is configured to cooperate with second mating feature 224 to rotate locking member 168 relative to translation member 116.

[0057] The lower end plate 114 may also include a central bore 172 at its proximal end for receiving an actuator shaft 220 that passes through the bore 172 and central channel 160 of the lower end plate 114 to cooperate with mating features in the locking member 168 and / or translation member 116 (discussed in more detail below).

[0058] The implant 100 can include a system for providing discrete steps when moving the translation member 116 relative to the endplates 112, 114. These steps correlate with angular adjustments of the endplates. In one embodiment, the system includes a lordosis gauge 244 on the surgical instrument 200 (see FIG. 15). The lordosis gauge 2444 provides discrete steps that indicate the lordosis angle of the implant 100.

[0059] In an alternative embodiment, the system includes a series of protrusions or teeth 180 in the channel 160 of the lower endplate 114 that cooperate with a series of protrusions 182 on the locking member 168. As the translation member 116 moves longitudinally, the protrusions 182 are configured to move from the space between two teeth 180 to the space between adjacent teeth or ratchets. These spaces provide discrete steps or segments. Additionally, the teeth 180 can help hold the translation member 116 in a fixed position relative to the endplate 112 to maintain a particular angle between the upper and lower endplates. These protrusions can prevent reverse (i.e., distal) movement of the translation member 116 relative to the endplate.

[0060] In another alternative embodiment, the upper end plate 112 can include a clicker arm (not shown), and the translation member 116 can include an upwardly extending protrusion or tooth (not shown) for the clicker arm on the upper end plate 112. Alternatively, both the upper end plate 112 and the lower end plate 114 can include clicker arms.

[0061] The implant 100 can include several features that couple the components together and / or stabilize the implant during angular adjustment. In the exemplary embodiment, the support member 118 includes one or more protrusions, such as conical pins 190, that extend through openings 192 in the upper endplate 112 (see FIGS. 3 and 5). The lower endplate 114 can further include protrusions 194 for coupling to one or more openings or slots 196 in the upper endplate 112 (see FIGS. 4 and 5). These protrusions help stabilize the endplates during angular adjustment.

[0062] In other embodiments, the upper and lower end plates 112, 114 can further include first and second flexible hinges or leaf springs (not shown) on either side of them that couple and further stabilize them to one another. These end plates are separate components coupled to one another only by the leaf springs and the connection created by the various conical pins (discussed above) that span slots in the upper end plate. Each of the leaf springs is formed as an elongated component extending from a proximal portion of the lower end plate to a distal portion of the lower end plate. The elongated components have a relatively small cross-sectional area, which provides flexibility to the elongated components as the end plates move relative to one another. This flexibility allows the elongated components to flex with this movement and remain coupled to the end plates. This provides positional stability to the end plates during height and angle adjustment.

[0063] 8A-11, surgical instrument 200 (described in more detail below with respect to FIGS. 12-15) includes an actuator rod 220 having first and second mating features 222, 224 at its distal end. Actuator rod 220 is configured to pass through central bore 172 in end plates 112, 114 and into bore 170 in locking member 168 to couple rod 220 to translation member 116 (see FIG. 9A). As discussed above, first mating feature 222 cooperates with an internal cavity or internal notch 177 in locking member 168 and / or translation member 116 to couple rod 220 to translation member 116 (see FIGS. 7B and 9B). Additionally, the second mating feature 224 cooperates with the second mating feature 176 on the locking member 168 to lock or unlock the translational member 116 relative to the end plates 112, 114. More specifically, the second mating feature 224 can be oriented to unlock the translational member 116 so that the translational member 116 can move longitudinally relative to the end plates 112, 114.

[0064] 9B, 10, and 11, actuation of the actuation rod 220 and translational member 116 will now be discussed. When the actuation rod 220 is advanced into the bore 170 of the locking member 168, the first and second mating features 222, 224 are oriented relative to the translational member 116 in a locked position (see FIG. 9B). In the locked position, the protrusion 182 of the translational member 116 engages the protrusion or tooth 180 in the channel 160 of the lower end plate 114 to prevent longitudinal movement of the translational member 116. In this locked position, the first mating feature 222 does not engage the internal cavity or internal notch 177 in the translational member 116, and thus the rod 220 is not yet secured to the translational member 116.

[0065] 10 , rotation of the actuator rod 220 rotates both mating features 222, 224. The second mating feature 224 rotates the locking member 168 such that the protrusion 182 rotates away from the tooth 180 of the end plate 114, unlocking the translation member 116 (i.e., the translation member 116 is no longer secured to the lower end plate 114). At the same time, the first mating feature 222 engages the internal notch 177 in the translation member 116 such that the rod 220 is secured to the translation member 116. At this point, as discussed above, longitudinal movement of the rod 220 moves the translation member 116 longitudinally relative to the end plates 112, 114, adjusting the angle of the distal ends 126 and 128.

[0066] In the exemplary embodiment, rod 220 is rotated approximately 90 degrees in a clockwise direction to move locking member 168 from the locked position into the unlocked position. In other embodiments, rod 220 can be rotated counterclockwise to unlock translation member 116. Similarly, it should be noted that the device is not limited to a 90-degree rotation of rod 220. In certain embodiments, rod 220 can be rotated less than or more than 90 degrees to move locking member 168 between the locked and unlocked positions.

[0067] 11 , to lock the translation member 116, the rod 220 is pivoted approximately 90 degrees in a counterclockwise direction, causing the first and second mating features 222, 224 to rotate relative to the translation member 116. As a result, the protrusion 182 rotates into engagement with the tooth 180. This rotation also disengages the first mating feature 222 from engagement with the cavity 177 of the translation member 116, thereby allowing the rod 220 to be removed from the implant 100.

[0068] 12-15 , an insertion tool 200 for use with the implants described herein includes an elongated shaft 210 having a proximal handle 212 and a distal gripping element 214 for removably coupling the tool 200 to the spinal implant 10. The elongated shaft 210 includes inner and outer concentric rods 220, 230 that surround an inner shaft 238. The inner rod 220 can extend through a bore 172 in the end plates 112, 114 and into the bore 170 of the locking member 168, as discussed above. The outer rod 230 can be coupled to the gripping element 214 and extend to the proximal end of the end plates 112, 114 for coupling the shaft 210 to the implant 100.

[0069] In one embodiment, the distal gripping element 214 includes first and second gripping arms 216, 218 for coupling to proximal mating features 219 (see also FIG. 1 ) on either side of the upper and / or lower endplates 112, 114. The distal gripping arms 216, 218 are coupled to an actuator rod 230 for moving them substantially laterally relative to the longitudinal axis of the shaft 210. The arms 216, 218 can move toward each other to hold the endplates and move apart to release the lower endplate. In certain embodiments, the distal gripping element 214 can further include a sheath 236 extending over a proximal portion thereof.

[0070] The instrument 200 includes a locking bar 242, a cage locking screw 246, a lordosis gauge 244, and a torque limiting knob 270 on a proximal handle 212 coupled to the proximal end of the inner rod 220. Rotating the locking bar 242 rotates the inner rod 220 and the locking member 168, as discussed below. The knob 270 is also coupled to the inner rod 220 such that rotation of the torque limiting knob 270 causes longitudinal translation of the inner rod 220 to move the translation member 116 relative to the endplates 112, 114 to adjust lordosis. The cage locking screw 246 is coupled to the proximal end of the outer rod 230 and can be used to attach and detach the gripping arms 216, 218 to the implant 100.

[0071] 13, the instrument assembly 201 may further include an implantation set 250 and a reversal tool 260. The function and operation of these components are described in more detail below. The instrument 200 may further include a lateral handle 240 coupled to a lateral extension 248 on the proximal handle 212 of the instrument 200. The lateral handle 240 forms a grasping element for the surgeon to manipulate and control the instrument 200.

[0072] 16-25, a method of positioning implant 100 within the intervertebral space between adjacent intervertebral bodies 280, 282 will now be described. As shown in FIG. 16, instrument 100 is inserted in a folded configuration such that endplates 112, 114 are substantially parallel relative to one another and translation member 116 is positioned in a distal-most location within implant 100 (see FIG. 8B). Locking bar 242 is configured such that, in the open position, mating features 222, 224 on inner rod 220 can extend through bore 170 of locking member 168. Cage locking screw 246 is also configured such that, in the open position, gripping arms 216, 218 open, allowing them to be positioned around the proximal interface 219 (see FIG. 1) of endplates 112, 114.

[0073] As shown in FIG. 17 , the inner rod 220 of the instrument 100 is advanced through the bore 172 in the end plates 112, 114 and the bore 170 in the locking member 168. The locking bar 242 is then rotated to rotate the inner rod 220 relative to the implant 100. As discussed above, this results in rotation of both mating features 222, 224. The second mating feature 224 rotates the locking member 168 such that the protrusion 182 rotates away from the tooth 180 of the end plate 114, unlocking the translation member 116 (i.e., the translation member 116 is no longer secured to the lower end plate 114). At the same time, the first mating feature 222 engages an internal notch in the translation member 116 such that the rod 220 is secured to the translation member 116.

[0074] 18 and 19, the cage locking screw 246 is then tightened so that the gripping arms 216, 218 close and engage the interface 219, thereby further securing the instrument 200 to the implant 100. The implant 100 may then be advanced into the intervertebral space between adjacent vertebral bodies 280 and 281 (see FIG. 20).

[0075] 21 and 22, to increase the lordotic angle of the implant 100, the distal ends 122 and 124 of the endplates 12, 14 are moved away from one another. To this end, the torque limit knob 270 can be rotated to translate the inner rod 220 proximally. This, as discussed above, moves the translation member 116 proximally, engaging its wedge with the ramp of the support member 118, thereby moving the distal ends of endplates 112 and 114 away from one another.

[0076] As shown in Figure 21, the lordosis gauge 244 initially indicates a lordosis angle of 0 degrees when the implant 100 is positioned within the intervertebral space. As this angle increases, the arrow on the lordosis gauge 244 rotates within the gauge to indicate the lordosis angle of the implant 100 (see Figure 22).

[0077] Once the appropriate lordosis angle is set, the locking bar 242 is rotated to a locked position (see FIG. 23 ), thereby rotating the locking member 168 within the translation member 116. As discussed above, this rotation rotates the protrusions 182 into engagement with the teeth 180 so that the translation member 116 cannot subsequently move relative to the end plates 112, 114. Additionally, this rotation disengages the first mating feature 222 from engagement with the cavity 192 of the translation member 116 so that the rod 220 can be removed from the implant 100. This ensures that the implant 100 remains fixed at the lordosis angle selected by the surgeon when the instrument 200 is disengaged, particularly from the first.

[0078] In certain embodiments, the instrument 200 can include a proximal actuation unit 286 that can be detached from the remainder of the instrument 200 to allow for bone graft backfilling of the implant 100. As shown in FIGS. 23 and 24 , once the locking bar 242 is rotated into the locked position, the proximal actuation unit 286 can be retracted proximally to allow for coupling of a graft funnel 294 to the proximal end 288 of the instrument. Bone graft can then be introduced through the shaft 210 and into the implant 100, for example, by a syringe 290 or other suitable method known to those skilled in the art. The bone graft can be advanced into the implant 100 using a graft pusher 292 or other component. Once the physician has completed the lordosis angle adjustment and / or graft loading phases, the physician loosens the cage locking screw 246 and opens the gripping arms 216, 218 so that the instrument can be extracted from the patient.

[0079] The process of angular adjustment is reversible. For example, the process described above can be reversed so that the inner rod is moved distally to move the translation member 116 distally and bring the distal ends of the endplates closer together.

[0080] 26-28, another embodiment of a spinal implant 300 will now be described. Spinal implant 300 has substantially similar features to spinal implant 100, except as described below. As shown, implant 300 includes upper and lower endplates 312, 314, an internal support member 320, and first and second translation members 316, 318. In this embodiment, the lordotic angle between upper endplate 312 and lower endplate 314 is adjustable; however, the height or distance between the proximal ends of these endplates is not adjustable. More specifically, the distance between distal end 322 of endplate 312 and distal end 324 of endplate 314 is adjustable, while the distance between proximal ends 325 and 328 generally remains substantially fixed.

[0081] The internal support member 320 can be coupled to or integral with the lower endplate 314. The second translational member 316 can be coupled to or integral with the upper endplate 314. The second translational member 316 is pivotally coupled to the support member 320 by a hinge positioned near the proximal ends 326, 328 of the endplates 312, 314. The hinge allows the support member 320 and upper endplate 312 to rotate relative to the second translational member 316 and lower endplate 314 about an axis substantially perpendicular to the longitudinal axis of the implant 300. In the exemplary embodiment, the translational member 316 includes protrusions 340 on each side that are designed to cooperate with openings or channels (not shown) in the support member 320 to form hinges. That is, the support member 320 includes first and second proximal arms 342, 344 designed to be attached to opposite sides of the translation member 316 so that the protrusions 340 extend into openings or channels on the arms 342, 344.

[0082] The lower endplate 314 includes a central channel 330 for receiving the translation members 316, 318. The first translation member 318 is longitudinally movable relative to the support member 320, the endplates 312, 314, and the second translation member 316. As with the previous embodiment, the first translation member 316 includes one or more inclined surfaces or wedges 332 designed to cooperate with inclined surfaces or ramps 334 on the support member 320. Longitudinal movement of the first translation member 318 moves the distal end of the support member 320 upward and away from the lower endplate 314 (pivoting about a hinge at the proximal end of the implant 10). Additionally, the first translation member 318 moves the distal end 322 of the upper endplate 312 toward or away from the distal end 324 of the lower endplate 314.

[0083] As with the previous embodiment, the second translational member 318 includes a locking member 368 rotatably coupled to the second translational member 318 such that the second translational member 318 can rotate about the longitudinal axis relative thereto. The locking member 368 includes a central bore 350 for receiving an actuator shaft 220 (see FIGS. 8A-11 ) of the surgical instrument 200, which causes longitudinal movement of the translational member 318. To cause this longitudinal movement, the bore 350 includes a first annular mating feature configured to receive and couple to a first mating feature 222 of the rod 202. In the exemplary embodiment, this mating feature includes a cavity or notch sized to receive the first mating feature 222 of the rod 202 (discussed in more detail below). The cavity can include a proximal rim or protrusion (not shown) extending toward the longitudinal axis and having an inner diameter smaller than the inner diameter of the cavity. With the actuator shaft 220 coupled to the translation member 318, longitudinal translation of the actuator shaft 220 causes the translation member 318 to move longitudinally relative to the end plates 212, 314, thereby moving the end plates toward or away from each other.

[0084] Locking member 368 further includes a second mating feature (not shown) configured to cooperate with second mating feature 224 (see FIGS. 8A-11 ) of surgical instrument 200. This second mating feature is configured to cooperate with second mating feature 224 to rotate locking member 368 relative to translation member 318, as discussed above with respect to implant 100.

[0085] Also, as with the previous embodiment, the implant 300 can include a clicker system to provide discrete steps or increments of angular adjustment. In the exemplary embodiment, the clicker system includes a series of protrusions or teeth 352 on the support member 316 that cooperate with a series of protrusions 354 on the translation member 318. As the translation member 318 moves longitudinally, the protrusions 354 are configured to move from the space between two teeth 352 to the space between adjacent teeth. These spaces provide discrete steps or increments. Additionally, the teeth 352 hold the translation member 318 in a fixed position relative to the end plates 312 to maintain a particular angle between the upper and lower end plates. The protrusions also prevent reverse (i.e., distal) movement of the translation member 318 relative to the end plates.

[0086] As with the previous embodiments, implant 300 can include several features to couple components together and / or stabilize the implant during angulation. In the exemplary embodiment, support member 320 includes one or more protrusions, such as conical pins 360, that extend through openings 362 in upper endplate 312. Lower endplate 314 can also include openings or protrusions for coupling to one or more of the components of implant 300.

[0087] Referring now to Figures 29-33, another embodiment of a spinal implant 400 will now be described. Implant 400 is similar in many features to implants 300 and 100. As shown, implant 400 includes upper and lower endplates 412, 414 and a translation member 416. In this embodiment, there are no additional support members. The upper endplate 412 incorporates features of the support member 318 of the immediately preceding embodiment. As with the immediately preceding implant 300, the angle between the upper and lower endplates 412, 414 is adjustable; however, the height or distance between the endplates is not adjustable. More specifically, the distance between the distal end 422 of endplate 412 and the distal end 424 of endplate 414 is adjustable, while the distance between the proximal ends 426, 428 remains substantially fixed.

[0088] The upper endplate 412 is pivotally coupled to the lower endplate 414 by a hinge positioned near the proximal ends of the endplates 412, 414. The hinge allows the upper endplate 412 to rotate relative to the lower endplate 414 about an axis substantially perpendicular to the longitudinal axis of the implant 400. In the exemplary embodiment, the upper endplate 414 includes a first proximal arm 430 and a second proximal arm 432 spaced laterally from each other and each having an opening 434 therethrough (see FIG. 32). The lower endplate 414 includes a main body 440 and sidewalls 442, 444 (see FIG. 33). The main body 440 is spaced from side walls 442, 444 to form first and second channels or gaps 446, 448 therebetween for receiving the first and second arms 430, 432 of the support member 418. The lower end plate 414 further includes first and second protrusions 450, 452 that extend outward from the main body 440 toward the side walls 442, 444 and into the gaps 446, 448. The protrusions 450, 452 also extend into openings 434 in the arms 430, 432 of the upper end plate 412 and are designed to cooperate with these openings to form hinges.

[0089] 33 , the lower endplate 414 includes a central channel 460 for receiving a translational member 416. The translational member 416 is longitudinally movable within the channel 460 relative to the endplates 412, 414. As with the previous embodiment, the translational member 416 includes one or more inclined surfaces or wedges 464 designed to cooperate with inclined surfaces or ramps 466 on the upper endplate 412. Longitudinal movement of the translational member 416 moves the distal end of the upper endplate 412 toward or away from the lower endplate 414 (pivoting about a hinge at the proximal end of the implant 400).

[0090] 32 , the translation member 416 includes a main body 418 and a locking member 468 that is rotatably coupled to the main body 418 such that the locking member 468 can rotate about a longitudinal axis relative to the translation member 416. The locking member 468 functions in a manner similar to the previous embodiment. The lower end plate 414 can also include a central bore 472 at its proximal end for receiving an actuator shaft that passes through the bore 472 and central channel 460 of the lower end plate 414 and cooperates with mating features in the bore 470 of the locking member 468. These mating features can be similar to those described above.

[0091] Also, as with the previous embodiment, the implant 400 can include a clicker system to provide discrete steps or increments of angular adjustment. In the exemplary embodiment, the clicker system includes a series of protrusions or teeth 480 within the channel 460 of the lower endplate 414 that cooperate with a series of protrusions 482 on the translation member 416. As the translation member 416 moves longitudinally, the protrusions 482 are configured to move from the space between two teeth 480 to the space between adjacent teeth. These spaces provide discrete steps or increments. Furthermore, the teeth 480 hold the translation member 416 in a fixed position relative to the endplate 412 to maintain a particular angle between the upper and lower endplates. These protrusions can prevent reverse movement (i.e., distal movement) of the translation member 416 relative to the endplate.

[0092] As with the previous embodiments, the implant 400 can include several features that couple the components together and / or stabilize the implant during angulation.

[0093] 34 and 35, another embodiment of a spinal implant 500 includes upper and lower endplates 512, 514 and a translation member 516. The implant 500 has many features and elements similar to the previous embodiments. However, in this embodiment, the translation member 516 is configured to adjust both the angle and height of the endplates 512, 514 when the translation member 516 is moved longitudinally relative to the endplates 512, 514.

[0094] 35 , the translation member 516 includes first and second distal angled surfaces or wedges 520 and first and second proximal angled surfaces or wedges 522. The distal and proximal wedges 520, 522 extend proximally downward from the upper endplate 512 and are spaced apart relative to the longitudinal axis of the implant 500 (note that only one distal wedge 520 and one proximal wedge 522 are shown). The upper endplate 514 also includes first and second distal angled surfaces or ramps 524 and first and second distal angled surfaces or ramps 526 (again, only one of each of these ramps is shown). As with the previous embodiment, longitudinal movement of the translation member 516 brings the wedges into contact with the ramps, moving the upper endplate 512 toward and away from the lower endplate 514.

[0095] The translation member 516 further includes two lower distal wedges 528 extending proximally toward the upper endplate 512 and spaced laterally from one another. Similarly, the lower endplate 514 includes two distal angled surfaces or ramps 530 extending proximally toward the upper endplate 514 (only one of the ramps and wedges is shown). Longitudinal movement of the translation member 516 brings the wedges 528 into contact with the ramps 530 such that a distal end 532 of the upper endplate 512 and a distal end 534 of the lower endplate 514 move toward and away from one another. Because the proximal end 536 of the endplate 512 and the proximal end 538 of the endplate 514 do not move relative to one another in conjunction with the distal ends 532, 534, such movement changes the overall angle of the endplates 512 and 514. Note that while proximal ends 536, 538 do move upward with an increase in overall height, this movement is coordinated with the movement of distal ends 532, 534. However, distal ends 532 and 534 move further apart than proximal ends 536 and 538, resulting in an adjustment of the angle between end plates 512 and 514.

[0096] As with the previous embodiment, the translation member 516 includes a locking member (not shown) having an internal bore 540 for receiving and mating with a shaft actuator (not shown) of the instrument shaft. The shaft actuator causes longitudinal movement of the translation member 516. As with the previous embodiment, the implant 500 can include several features that couple the components together and / or stabilize the implant during angulation.

[0097] Also, as with the previous embodiment, the translation member 516 includes a ratchet shaft 442 that cooperates with protrusions or teeth 544 on the lower end plate 514 to provide discrete steps or segments of height and / or angular adjustment.

[0098] The entire implant can be fabricated using additive manufacturing techniques such as 3D printing. The implant is built layer by layer in a direction, such as a longitudinal direction from the proximal end to the distal end. Upon completion of fabrication, the upper and lower end plates are substantially separated from each other except for their distal end portions. These portions are separated using wire EDM by cutting a substantially vertical line through the portions to form two separate components. Within the spring component, the end plates remain coupled to each other only by the leaf spring. The end plates maintain their relative positional stability during use through a conical knob in the proximal translation member that slides through an angled slot in the end plate, while a conical knob in the lower end plate slides through a vertical slot in the upper end plate and leaf spring.

[0099] In an exemplary embodiment, the implant is manufactured by selective laser melting (SLM). For example, a substrate plate is fastened to an indexing table inside a chamber with a controlled inert gas (e.g., argon or nitrogen) atmosphere. Metal powder is applied evenly to the substrate plate in layers. The metal powder is preferably a titanium alloy, e.g., Ti-6Al-4V, to provide biocompatible functionality. Each 2D slice of the cage is melted by selectively melting the metal powder with a laser. The laser has enough energy to completely melt, or rather weld, the metal particles to form a solid metal. The substrate plate is then lowered (in the z-direction) by the layer thickness. New metal powder is added, and the process described above is repeated layer by layer until the part is complete. The finished part is then removed from the substrate plate by cutting or sectioning.

[0100] Preferably, all components of the cage are printed nested within each other. This allows for a higher utilization rate compared to printing adjacent components separately. This means that a higher melting rate and a lower residual metal powder rate can be achieved during 3D printing. This significantly reduces production time and costs.

[0101] After 3D printing, the areas connecting the individual components of the cage are cut by electrical discharge machining (EDM) to allow for the individual movement of these components. Furthermore, EDM can be used to achieve smooth surfaces, for example, to allow for low-friction sliding of two components relative to each other. EDM can also be used to remove the cage from the substrate plate.

[0102] To reduce manufacturing costs, several cages can be printed on one substrate plate, and then all cages placed on the substrate plate can be simultaneously cut using EDM before being removed.

[0103] The implant can include one or more drain openings in the upper and lower end plates to allow extraction of metal powder remaining in the cage after 3D printing. Preferably, the drain openings are positioned on the lateral surfaces of the moving plate. It is also possible to position the drain openings on the horizontal surfaces of the cage, preferably on the base plate or the moving plate. Preferably, the cage includes multiple drain openings. This means that more of the area inside the cage is accessible, and the metal powder can be extracted more efficiently. Similarly, the external sliding means, preferably a conical groove, can be configured to be used as an additional drain opening. Therefore, the conical groove is dug until a passage to the outside is created.

[0104] Additional embodiments of adjustable spinal fusion cages are described in related and commonly owned U.S. Patent Application No. 17 / 865,755, filed July 15, 2022, and International Patent Application No. PCT / EP2022 / 069886, filed July 15, 2022, the entire contents of which are incorporated herein by reference. It is understood that features present in these patent applications may be incorporated into the adjustable spinal fusion cages described herein.

[0105] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the embodiments being indicated by the following claims.

[0106] For example, in a first aspect, a first embodiment is an adjustable spinal fusion device that includes an upper endplate having an outer surface for placement against a first vertebral body, a lower endplate having an outer surface for placement against a second vertebral body, a translation member configured to move longitudinally relative to the upper and lower endplates to adjust the angle between the upper and lower endplates, and a locking member coupled to the translation member and configured to fix the longitudinal position of the translation member relative to the upper and lower endplates.

[0107] The second embodiment is the first embodiment in which the translation member includes a bore having one or more mating features for cooperating with an actuator shaft of a surgical instrument to longitudinally move the translation member.

[0108] A third embodiment is a combination of either of the first two embodiments in which the locking member is rotatably coupled to the translation member within the bore so as to be rotatable from an unlocked position, in which the translation member is permitted to move longitudinally, to a locked position, in which the translation member is restricted from moving longitudinally.

[0109] A fourth embodiment is a combination of any of the first three embodiments in which the locking member includes one or more mating features for cooperating with an actuator shaft of a surgical instrument such that rotation of at least a portion of the surgical instrument causes rotation of the locking member within the bore.

[0110] A fifth embodiment is a combination of any of the first four embodiments in which rotation of the locking member into an unlocked position secures the mating features of the translating member to the mating features of the surgical instrument.

[0111] A sixth embodiment is a combination of any of the first five embodiments, further including one or more engagement elements coupled to one of the upper and lower end plates, wherein the locking member includes one or more locking elements that engage the engagement elements on one of the upper and lower end plates in the locked position.

[0112] A seventh embodiment is a combination of any of the first six embodiments, wherein the locking element of the locking member includes a plurality of protrusions, and the engagement element of one of the upper and lower end plates includes a plurality of teeth that engage the protrusions in the locked position.

[0113] An eighth embodiment is a combination of any of the first seven embodiments in which the upper and lower end plates each have a proximal end and a distal end, the proximal ends being pivotally coupled to one another and the distal ends being movable relative to one another to adjust the distance therebetween.

[0114] A ninth embodiment is a combination of any of the first eight embodiments, wherein the translation member includes a sloping surface extending downwardly in the proximal direction from the upper endplate to the lower endplate, and the device further includes a ramp for cooperating with the sloping surface of the translation member.

[0115] A tenth embodiment is a combination of any of the first nine embodiments where the lamp is on the upper end plate.

[0116] An eleventh embodiment is a combination of any of the first ten embodiments, further including an internal support member coupled to or integral with the upper end plate and a hinge pivotally coupling the internal support member to the lower end plate, and wherein the lamp is on the internal support member.

[0117] A twelfth embodiment is a combination of any of the first eleven embodiments, in which proximal translation of the translation member engages the inclined surface with the ramp, moving the distal end of the upper endplate away from the distal end of the lower endplate.

[0118] A thirteenth embodiment is a combination of any of the first twelve embodiments in which the proximal ends of the endplates remain substantially fixed relative to one another as the distal ends move apart.

[0119] A fourteenth embodiment is a combination of any of the first thirteen embodiments in which longitudinal translation of the translation member adjusts the distance between the proximal and distal ends of the endplates.

[0120] A fifteenth embodiment is a combination of any of the first fourteen embodiments, further including a second translation member configured to move longitudinally relative to the upper and lower end plates to adjust the height between the upper and lower end plates.

[0121] A sixteenth embodiment is a combination of any of the first fifteen embodiments in which the upper and lower end plates each have a proximal and a distal end, and the proximal ends are movable relative to each other to adjust the distance therebetween.

[0122] A seventeenth embodiment is a combination of any of the first sixteen embodiments, wherein the second translation member includes one or more sloping surfaces extending downwardly in the proximal direction from the upper endplate toward the lower endplate, and the device further includes a ramp for cooperating with the sloping surfaces of the second translation member to adjust the distance between the proximal ends of the endplates upon longitudinal translation of the second translation member.

[0123] An eighteenth embodiment is a combination of any of the first seventeen embodiments in which the second translational member is integral with the first translational member.

[0124] In another aspect, a first embodiment is a spinal fusion system including an adjustable spinal fusion device and an instrument. The fusion device includes an upper endplate having an outer surface for placement against a first vertebral body, a lower endplate having an outer surface for placement against a second vertebral body, a translation member configured to move longitudinally relative to the upper and lower endplates to adjust the angle between the upper and lower endplates, and a locking member coupled to the translation member and configured to fix the longitudinal position of the translation member relative to the upper and lower endplates. The instrument includes a proximal handle, an elongated shaft, and a mating feature on the elongated shaft for cooperation with the locking member.

[0125] The second embodiment is the first embodiment in which the mating feature on the surgical instrument is configured to rotate the locking member from an unlocked position, in which the translation member is allowed to move longitudinally, to a locked position, in which the translation member is restrained from moving longitudinally.

[0126] A third embodiment is a combination of any of the first two embodiments, wherein the mating feature is a first mating feature, the instrument includes a second mating feature, and the translation member includes a bore having one or more engaging elements for cooperating with the second mating feature to secure the translation member to the instrument such that longitudinal movement of the instrument moves the translation member longitudinally relative to the upper and lower end plates.

[0127] A fourth embodiment is a combination of any of the first three embodiments in which the locking member is rotatably coupled to the translating member within the bore.

[0128] A fifth embodiment is a combination of any of the first four embodiments in which rotation of the locking member into an unlocked position secures a mating feature of the translating member to a second mating feature of the surgical instrument.

[0129] A sixth embodiment is a combination of any of the first five embodiments, wherein the second mating feature includes one or more protrusions extending from the distal end of the shaft of the surgical instrument and the mating feature of the translation member includes one or more recesses within the interior surface of the bore.

[0130] A seventh embodiment is a combination of any of the first six embodiments, wherein the first mating feature includes one or more protrusions extending from the distal end of the shaft of the surgical instrument, and the first mating feature is positioned proximal to a second mating feature on the elongate shaft.

[0131] An eighth embodiment is a combination of any of the first seven embodiments, further including one or more engagement elements coupled to one of the upper and lower end plates, wherein the locking member includes one or more locking elements that engage the engagement elements on one of the upper and lower end plates in the locked position.

[0132] A ninth embodiment is a combination of any of the first eight embodiments, wherein the locking element of the locking member includes a plurality of protrusions, and the engagement element of one of the upper and lower end plates includes a plurality of teeth that engage the protrusions in the locked position.

[0133] A tenth embodiment is a combination of any of the first nine embodiments, in which the upper and lower end plates each have a proximal end and a distal end, the proximal ends are pivotally coupled to each other at the proximal end, and the distal ends are movable relative to each other to adjust the distance therebetween.

[0134] An eleventh embodiment is a combination of any of the first ten embodiments, wherein the translation member includes a sloping surface extending downwardly in the proximal direction from the upper endplate toward the lower endplate, and the device further includes a ramp for cooperating with the sloping surface of the translation member.

[0135] A twelfth embodiment is a combination of any of the first eleven embodiments, in which proximal translation of the translation member engages an inclined surface with a ramp to move the distal end of the upper endplate away from the distal end of the lower endplate.

[0136] A thirteenth embodiment is a combination of any of the first twelve embodiments in which the proximal ends of the endplates remain substantially fixed relative to one another as the distal ends move apart.

[0137] A fourteenth embodiment is a combination of any of the first thirteen embodiments in which longitudinal translation of the translation member adjusts the distance between the proximal and distal ends of the endplates.

[0138] A fifteenth embodiment is a combination of any of the first fourteen embodiments, further including a second translation member configured to move longitudinally relative to the upper and lower end plates to adjust the height between the upper and lower end plates.

[0139] In another aspect, a first embodiment is a method of implanting a spinal fusion device in a patient, comprising coupling a distal end of a surgical instrument to a spinal fusion device, positioning the spinal fusion device between first and second vertebrae of the patient, rotating a first portion of the surgical instrument to unlock a translation member in the spinal fusion device, and translating a second portion of the surgical instrument to longitudinally advance the translation member relative to the upper and lower end plates of the spinal fusion device to adjust the angle between the upper and lower end plates.

[0140] The second embodiment is the first embodiment, further including rotating the first portion of the instrument to lock the longitudinal position of the translation member relative to the upper and lower endplates.

[0141] A third embodiment is a combination of any of the first two embodiments, further comprising longitudinally translating a second portion of the surgical instrument to adjust the height between the upper and lower end plates.

[0142] A fourth embodiment is a combination of any of the first three embodiments, further comprising inserting the distal end of a shaft of a surgical instrument through a bore in the translation member and rotating the distal end of the shaft to lock the instrument to the translation member.

[0143] A fifth embodiment is a combination of any of the first four embodiments, wherein the translation member includes one or more recesses in the inner surface of the bore, the shaft includes one or more protrusions, and the method further includes rotating the protrusions into the recesses.

[0144] A sixth embodiment is a combination of any of the first five embodiments in which the locking member is moved into the unlocked position when the protrusion is rotated into the recess.

[0145] A seventh embodiment is a combination of any of the first six embodiments, wherein the one or more protrusions are a first set of protrusions, and the shaft includes a second set of one or more protrusions positioned proximally of the first set, and wherein when the instrument shaft is rotated, the second set of protrusions engages an inner surface of the bore of the locking member to rotate the locking member.

[0146] In another aspect, a first embodiment is a surgical instrument for implanting a spinal fusion device in a patient. The instrument includes an elongated shaft having a proximal handle and a distal end portion, a first mating feature for securing the instrument shaft to the spinal fusion device, a second mating feature on the distal end portion for engaging a translation member of the spinal fusion device, and a third mating feature on the distal end portion for engaging a locking member of the spinal fusion device.

[0147] The second embodiment is the first embodiment further including a rod extending through the lumen of the shaft, the second and third mating features being positioned on a distal portion of the rod.

[0148] A third embodiment is a combination of either of the first two embodiments in which the rod is rotatable relative to the shaft to rotate the locking member of the spinal fusion device.

[0149] A fourth embodiment is a combination of any of the first three embodiments in which the rod is configured to translate longitudinally relative to the shaft to translate the translation member of the spinal fusion device.

[0150] A fifth embodiment is a combination of any of the first four embodiments, wherein the first mating feature includes first and second gripping arms configured to engage and secure to a proximal portion of a spinal fusion device.

[0151] A sixth embodiment is a combination of any of the first five embodiments, wherein the second mating feature includes one or more protrusions extending from the distal portion of the rod.

[0152] A seventh embodiment is a combination of any of the first six embodiments, wherein the third mating feature includes one or more protrusions extending from a distal portion of the rod proximal to the second mating feature.

[0153] An eighth embodiment is a combination of any of the first seven embodiments, wherein the second mating feature is configured to secure the translation member when the third mating feature moves the locking member to an unlocked position, which allows translation of the translation member.

[0154] A ninth embodiment is a combination of any of the first eight embodiments, further including a rotatable knob on the proximal handle coupled to the rod and configured to translate the rod relative to the shaft.

[0155] A tenth embodiment is a combination of any of the first nine embodiments, further including a gauge on the proximal handle coupled to the rotatable knob and configured to indicate the lordosis angle of the first and second endplates on the spinal fusion device. [Explanation of symbols]

[0156] 100 implants 112 Upper end plate 114 Lower end plate 116 Translational Member 118 Support member 219 Proximal Mating Feature

Claims

1. an upper endplate having an outer surface for placement against the first vertebral body; a lower endplate having an outer surface for placement against the second vertebral body; a translation member configured to move longitudinally relative to the upper and lower end plates to adjust the angle between the upper and lower end plates; a locking member coupled to the translational member and configured to fix the longitudinal position of the translational member relative to the upper and lower end plates; an adjustable spinal fusion device, including:

2. 10. The adjustable spinal fusion device of claim 1, wherein the translation member includes a bore having one or more mating features for cooperating with an actuator shaft of a surgical instrument to longitudinally move the translation member.

3. 3. The adjustable spinal fusion device of claim 2, wherein the locking member is rotatably coupled to the translation member within the bore from an unlocked position, in which the translation member is allowed to move in the longitudinal direction, to a locked position, in which the translation member is restrained from moving in the longitudinal direction.

4. 4. The adjustable spinal fusion device of claim 3, wherein the locking member includes one or more mating features for cooperating with the actuator shaft of the surgical instrument such that rotation of at least a portion of the surgical instrument causes rotation of the locking member within the bore.

5. 5. The adjustable spinal fusion device of claim 4, wherein rotation of the locking member into the unlocked position causes the mating feature of the translation member to lock into a mating feature of the surgical instrument.

6. 5. The adjustable spinal fusion device of claim 4, further comprising one or more engaging elements coupled to one of the upper and lower endplates, wherein the locking member comprises one or more locking elements that engage the engaging elements on one of the upper and lower endplates in the locked position.

7. 7. The adjustable spinal fusion device of claim 6, wherein the locking element of the locking member includes a plurality of protrusions, and the engaging element of one of the upper and lower endplates includes a plurality of teeth that engage the protrusions in the locked position.

8. 10. The adjustable spinal fusion device of claim 1, wherein the upper and lower endplates each have a proximal end and a distal end, the proximal ends pivotally coupled to one another and the distal ends movable relative to one another to adjust the distance therebetween.

9. 10. The adjustable spinal fusion device of claim 1, wherein the translation member includes a sloped surface extending downwardly in a proximal direction from the upper endplate to the lower endplate, the device further including a ramp for cooperating with the sloped surface of the translation member.

10. 10. The adjustable spinal fusion device of claim 9, wherein the ramp is on the upper endplate.

11. 10. The adjustable spinal fusion device of claim 9, further comprising an internal support member coupled to or integral with said upper endplate and a hinge pivotally coupling said internal support member to said lower endplate, said ramp being on said internal support member.

12. 10. The adjustable spinal fusion device of claim 9, wherein proximal translation of the translation member engages the angled surface with the ramp and moves the distal end of the upper endplate away from the distal end of the lower endplate.

13. 13. The adjustable spinal fusion device of claim 12, wherein the proximal ends of the endplates remain substantially fixed relative to one another as the distal ends move apart.

14. 10. The adjustable spinal fusion device of claim 9, wherein longitudinal translation of the translation member adjusts the distance between the proximal and distal ends of the endplates.

15. 10. The adjustable spinal fusion device of claim 1, further comprising a second translation member configured to move longitudinally relative to the upper and lower endplates to adjust the height between the upper and lower endplates.

16. 16. The adjustable spinal fusion device of claim 15, wherein the upper and lower endplates each have a proximal end and a distal end, the proximal ends being movable relative to one another to adjust the distance therebetween.

17. 17. The adjustable spinal fusion device of claim 16, wherein the second translation member includes one or more angled surfaces extending downwardly in a proximal direction from the upper endplate to the lower endplate, the device further including ramps that cooperate with the angled surfaces of the second translation member to adjust the distance between the proximal ends of the endplates upon longitudinal translation of the second translation member.

18. 16. The adjustable spinal fusion device of claim 15, wherein the second translation member is integral with the first translation member.

19. an upper endplate having an outer surface for placement against the first vertebral body; a lower endplate having an outer surface for placement against the second vertebral body; a translation member configured to move longitudinally relative to the upper and lower end plates to adjust the angle between the upper and lower end plates; and a locking member coupled to the translational member and configured to fix the longitudinal position of the translational member relative to the upper and lower end plates; an adjustable spinal fusion device comprising: an instrument having a proximal handle, an elongated shaft, and a mating feature on the elongated shaft for cooperating with the locking member; Spinal fusion systems, including:

20. 20. The spinal fusion system of claim 19, wherein the mating feature on the surgical instrument is configured to rotate the locking member from an unlocked position, in which the translation member is allowed to move in the longitudinal direction, to a locked position, in which the translation member is restrained from moving in the longitudinal direction.

21. 21. The spinal fusion system of claim 20, wherein the mating feature is a first mating feature, the instrument includes a second mating feature, and the translation member includes a bore having one or more engaging elements for cooperating with the second mating feature to secure the translation member to the instrument such that longitudinal movement of the instrument moves the translation member longitudinally relative to the upper and lower endplates.

22. 22. The spinal fusion system of claim 21, wherein the locking member is rotatably coupled to the translation member within the bore.

23. 23. The spinal fusion system of claim 22, wherein rotation of the locking member into the unlocked position causes an engagement feature of the translation member to lock into the second mating feature of the surgical instrument.

24. 24. The spinal fusion system of claim 23, wherein the second mating feature comprises one or more protrusions extending from a distal end of the shaft of the surgical instrument, and the engagement feature of the translation member comprises one or more recesses on an interior surface of the bore.

25. 25. The spinal fusion system of claim 24, wherein the first mating feature comprises one or more protrusions extending from a distal end of the shaft of the surgical instrument, the first mating feature being positioned proximal to the second mating feature on the elongate shaft.

26. 20. The spinal fusion system of claim 19, further comprising one or more engaging elements coupled to one of the upper and lower endplates, wherein the locking member comprises one or more locking elements that engage the engaging elements on one of the upper and lower endplates in the locked position.

27. 27. The spinal fusion system of claim 26, wherein the locking element of the locking member includes a plurality of protrusions, and the engaging element of one of the upper and lower endplates includes a plurality of teeth that engage the protrusions in the locked position.

28. each of the upper and lower end plates having a proximal end and a distal end, the proximal ends pivotally coupled to one another at the proximal ends and the distal ends movable relative to one another to adjust the distance therebetween; 20. The spinal fusion system of claim 19.

29. 30. The spinal fusion system of claim 28, wherein the translation member includes a sloped surface extending downwardly in a proximal direction from the upper endplate to the lower endplate, the device further including a ramp for cooperating with the sloped surface of the translation member.

30. 30. The spinal fusion system of claim 29, wherein proximal translation of the translation member engages the angled surface with the ramp and moves the distal end of the upper endplate away from the distal end of the lower endplate.

31. 31. The spinal fusion system of claim 30, wherein the proximal ends of the endplates remain substantially fixed relative to one another as the distal ends move apart.

32. 32. The spinal fusion system of claim 31, wherein longitudinal translation of the translation member adjusts the distance between the proximal and distal ends of the endplates.

33. 20. The spinal fusion system of claim 19, further comprising a second translation member configured to move longitudinally relative to the upper and lower endplates to adjust the height between the upper and lower endplates.

34. 1. A method of implanting a spinal fusion device in a patient, comprising: coupling a distal end of a surgical instrument to the spinal fusion device; positioning the spinal fusion device between first and second vertebrae of the patient; rotating a first portion of the surgical instrument to unlock a translation member in the spinal fusion device; longitudinally translating a second portion of the surgical instrument to longitudinally advance the translation member relative to the upper and lower endplates of the spinal fusion device to adjust the angle between the upper and lower endplates; A method comprising:

35. 35. The method of claim 34, further comprising rotating the first portion of the instrument to lock the longitudinal position of the translation member relative to the upper and lower endplates.

36. 36. The method of claim 35, further comprising longitudinally translating the second portion of the surgical instrument to adjust the height between the upper and lower endplates.

37. 35. The method of claim 34, further comprising inserting a distal end of a shaft of the surgical instrument through a bore in the translation member and rotating the distal end of the shaft to lock the instrument to the translation member.

38. 38. The method of claim 37, wherein the translation member includes one or more recesses in an inner surface of the bore and the shaft includes one or more protrusions, the method further comprising rotating the protrusions into the recesses.

39. 39. The method of claim 38, wherein the locking member is moved into the unlocked position when the protrusion is rotated into the recess.

40. the one or more protrusions are a first set of protrusions, and the shaft includes a second set of one or more protrusions positioned proximally of the first set; the second set of protrusions engage an inner surface of a bore of the locking member to rotate the locking member when the shaft of the instrument is rotated.

40. The method of claim 39.

41. 1. A surgical instrument for implanting a spinal fusion device in a patient, comprising: an elongated shaft having a proximal handle and a distal end portion; a first mating feature for securing the shaft of the instrument to the spinal fusion device; a second mating feature on the distal end portion for engaging a translation member of the spinal fusion device; a third mating feature on the distal end portion for engaging a locking member of the spinal fusion device; and An appliance including:

42. 42. The instrument of claim 41, further comprising a rod extending through the lumen of the shaft, the second and third mating features being positioned on a distal portion of the rod.

43. 43. The instrument of claim 42, wherein the rod is rotatable relative to the shaft to rotate the locking member of the spinal fusion device.

44. 44. The instrument of claim 43, wherein the rod is configured to translate longitudinally relative to the shaft to translate the translation member of the spinal fusion device.

45. 42. The instrument of claim 41, wherein the first mating feature includes first and second gripping arms configured to engage and secure a proximal portion of the spinal fusion device.

46. 43. The instrument of claim 42, wherein the second mating feature comprises one or more protrusions extending from the distal portion of the rod.

47. 47. The instrument of claim 46, wherein the third mating feature comprises one or more protrusions extending from the distal portion of the rod proximal to the second mating feature.

48. 43. The instrument of claim 42, wherein the second mating feature is configured to secure to the translation member when the third mating feature moves the locking member into an unlocked position to allow translation of the translation member.

49. 43. The instrument of claim 42, further comprising a rotatable knob on the proximal handle coupled to the rod and configured to translate the rod relative to the shaft.

50. 42. The instrument of claim 41, further comprising a gauge on the proximal handle coupled to the rotatable knob and configured to indicate a lordosis angle of first and second endplates on the spinal fusion device.

Images