Expandable implants

Abstract

The expandable implant includes: a first endplate, a second endplate, a first translation member movably coupled to a first actuator, and a second translation member movably coupled to a second actuator. The first translation member can be configured to move independently of the second translation member, and the first translation member and the second translation member can be configured to change a spatial relationship between the first endplate and the second endplate. The change in spatial relationship can change the resulting height, length, width, lordosis angle, or other dimension of the expandable implant.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This patent application claims priority to U.S. Provisional Patent Application No. 63 / 170,532, filed on April 4, 2021; U.S. Provisional Patent Application No. 63 / 170,570, filed on April 5, 2021; and U.S. Provisional Patent Application No. 63 / 249,129, filed on September 28, 2021.

[0002] This disclosure generally relates to medical implants, and more specifically, to expandable implants.

Background Art

[0003] Low back pain is one of the most common and debilitating problems among people of all ethnic groups. In the United States alone, more than 500,000 spinal lumbar and cervical fixation surgeries are performed each year. One of the causes of low back pain and disability is due to the rupture or degeneration of one or more intervertebral discs in the spine.

[0004] Surgical procedures are commonly performed to correct problems of displacement, injury, or degeneration of the intervertebral disc due to trauma, disease, or aging. Generally, spinal fixation surgery involves removing part or all of a diseased or damaged intervertebral disc and inserting one or more intervertebral implants into the resulting disc space. Anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion are two of the techniques used to access the part of the spine that will be repaired or replaced by a spinal surgeon.

[0005] Replacement of damaged or deteriorated spinal vertebrae with artificial implants requires an understanding and consideration of the mechanisms of stress inherent in the spine and the biological properties of the body that respond to the device. Furthermore, the size, configuration, and placement of artificial implants require accurate positioning and handling by a skilled surgeon.

Summary of the Invention

[0006] This disclosure includes expandable implant devices and methods of using them. Expandable implant devices may be adjusted to form a specific height and / or a specific lordosis angle, in particular, to be influenced by the patient's needs or requirements and the surgeon's target procedure, and may incorporate various features to be adapted for spinal fusion.

[0007] In some embodiments, the expandable implant includes: a first end plate, a second end plate, a first translational member movably coupled to a first actuator, and a second translational member movably coupled to a second actuator. The first translational member may be configured to move independently of the second translational member, and the first and second translational members may be configured to change the spatial relationship between the first and second end plates. The spatial relationship may define the height, length, width, angle of lordosis, or any other dimension of the expandable implant.

[0008] In some embodiments, the expandable implant includes: a first end plate, a second end plate, a first translational member positioned between the first and second end plates and movably coupled to a first drive screw, and a second translational member positioned between the first and second end plates and movably coupled to a second drive screw. The first translational member is configured to move independently of the second translational member, and the first and second translational members are configured to change the spatial relationship between the first and second end plates.

[0009] In some embodiments, anti-migration features are provided to limit undesirable rotation of the lead screw. The anti-migration features provide additional rigidity and increase the amount of load that the expandable implant is configured to support.

[0010] In some embodiments, the first and second translational members may be movably coupled at the distal end of an expandable implant by a dovetail coupling. Similarly, in some embodiments, the first and second translational members may be movably coupled at the proximal end of an expandable implant by a dovetail coupling that slidably connects the first actuator housing to the second actuator housing.

[0011] In one embodiment of the method, a method is provided for treating a spinal condition using an expandable implant, the method comprising: accessing the intervertebral disc space via a substantially lateral approach; inserting an expandable implant into the intervertebral disc space, the expandable implant having a first translational member movably coupled to a first actuator and a second translational member movably coupled to a second actuator, the first and second translational members configured to change the spatial relationship between a first end plate and a second end plate as they move; and acting on at least one of the first and second actuators to change the spatial relationship between the first and second end plates to change the dimensions of the expandable implant. [Brief explanation of the drawing]

[0012] These and other features will be further understood by those skilled in the art by examining the attached drawings.

[0013] [Figure 1] A side view of an expandable implant according to the first embodiment is shown, with the expandable implant folded in the first configuration.

[0014] [Figure 2]Figure showing a side view of an expandable implant according to the first embodiment, the expandable implant being in the second configuration and expanded.

[0015] [Figure 3] Figure showing a front perspective view of an expandable implant according to the first embodiment, the expandable implant being in the second configuration and expanded.

[0016] [Figure 4] Figure showing a rear perspective view of an expandable implant according to the first embodiment, the expandable implant being in the second configuration and expanded.

[0017] [Figure 5] Figure showing a top view of an expandable implant according to the first embodiment.

[0018] [Figure 6] Figure showing a cross-sectional top view of an expandable implant according to the first embodiment.

[0019] [Figure 7] Figure showing a top view of the expansion mechanism of an expandable implant according to the first embodiment.

[0020] [Figure 8] Figure showing a perspective view of the first translation member and the second translation member of an expandable implant according to the first embodiment.

[0021] [Figure 9] Figure showing a perspective view of the actuator housing of an expandable implant according to the first embodiment.

[0022] [Figure 10] Figure showing a rear view of an expandable implant according to the first embodiment, folded in the first configuration.

[0023] [Figure 11]The second form shows a rear view of the expandable implant according to the first embodiment, which has been expanded.

[0024] [Figure 12] A front view of the expandable implant according to the first embodiment, folded in the first form, is shown.

[0025] [Figure 13] A front view of the expandable implant according to the first embodiment, expanded in the second form, is shown.

[0026] [Figure 14] A posterior view of an expandable implant according to the first embodiment, adjusted to an exemplary lordotic angle, is shown.

[0027] [Figure 15] A front view of an expandable implant according to the first embodiment, adjusted to an exemplary lordotic angle, is shown.

[0028] [Figure 16] A perspective view of an expandable implant according to a first embodiment, adjusted to an exemplary lordotic angle, is shown.

[0029] [Figure 17] A rear perspective view of an expandable implant according to a second embodiment, folded in the first form, is shown.

[0030] [Figure 18] A dorsal perspective view of an expandable implant according to a second embodiment, extended in the second form, is shown.

[0031] [Figure 19] The rear view of the expandable implant according to the second embodiment, which has been expanded in the second form, is shown.

[0032] [Figure 20]The image shows a posterior view of an expandable implant according to the second embodiment, which has been adjusted to a third form with a lordotic angle.

[0033] [Figure 21] The image shows an actuator housing for an expandable implant according to a third embodiment, which has an anti-rotation mechanism configured to limit the rotation of the drive screw.

[0034] [Figure 22] A perspective view of an expandable implant according to a third embodiment is shown.

[0035] [Figure 23] A fourth embodiment shows an expandable implant having a sliding interface.

[0036] [Figure 24] This shows an expandable implant according to a fourth embodiment, adjusted to a lordotic angle.

[0037] [Figure 25] A fourth embodiment shows an expandable implant, in which the actuator housing includes a dovetail coupling configured to move independently.

[0038] [Figure 26] A top view of an expandable implant according to a fourth embodiment is shown.

[0039] [Figure 27] A top view of the expandable implant according to the fourth embodiment in a modified form is shown.

[0040] [Figure 28] A top view of an expandable implant according to a fifth embodiment including a hinge joint is shown.

[0041] [Figure 29]A front perspective view of an expandable implant according to a fifth embodiment is shown, with the expandable implant in a folded state.

[0042] [Figure 30] A side perspective view of an expandable implant according to the fifth embodiment is shown, with the expandable implant in an expanded state.

[0043] [Figure 31] An exploded view of an expandable implant according to the fifth embodiment is shown.

[0044] [Figure 32] A top cross-sectional view of an expandable implant according to the fifth embodiment is shown.

[0045] [Figure 33] This shows a top view of the expandable implant according to the fifth embodiment with the upper plate removed.

[0046] [Figure 34] Figure 33 shows an enlarged view of box A.

[0047] [Figure 35] A rear perspective view of an expandable implant according to a fifth embodiment is shown, the expandable implant having an improved surface structure.

[0048] [Figure 36] A rear-view perspective of an expandable implant according to the sixth embodiment is shown, and the expandable implant is fixed in place.

[0049] [Figure 37] A perspective side view of an expandable implant according to the seventh embodiment is shown, and the expandable implant is fixed.

[0050] [Figure 38] An enlarged perspective view of a fixed opening according to one embodiment of the present disclosure is shown.

[0051] [Figure 39] Figure 38 shows a cross-sectional view of the fixed opening.

[0052] [Figure 40] A perspective view of a fixed element according to one embodiment of the present disclosure is shown, including an enlarged view of the head portion of the fixed element.

[0053] [Figure 41] A perspective top view of a fixed opening according to another embodiment is shown.

[0054] [Figure 42] A perspective top view of a fixed opening according to another embodiment is shown.

[0055] [Figure 43] A side view of a fixed element according to another embodiment is shown.

[0056] [Figure 44] Figure 43 shows a cross-sectional view of the head portion of the fixed element according to the embodiment.

[0057] [Figure 45] Figure 43 shows a top view of the fixed element according to the embodiment.

[0058] [Figure 46] A rear view of an expandable implant according to the eighth embodiment is shown.

[0059] [Figure 47] A perspective side view of the modular plate design for an expandable implant according to the ninth embodiment is shown.

[0060] [Figure 48] This shows a perspective side view of a module plate coupled to a housing according to the ninth embodiment.

[0061] [Figure 49]An exploded view of the module plate according to the ninth embodiment, along with the housing, is shown.

[0062] [Figure 50] This shows a cross-sectional top view of a module plate coupled to a housing according to the ninth embodiment.

[0063] [Figure 51] This shows a cross-sectional side view of a module plate coupled to a housing according to the ninth embodiment. [Modes for carrying out the invention]

[0064] Details and descriptions of certain preferred embodiments are provided below, not as limitations but for illustrative purposes, so that those skilled in the art may manufacture and use the invention. These details and descriptions represent only certain preferred embodiments. However, countless other embodiments not expressly described will be readily apparent to those skilled in the art if this specification is thoroughly examined. Accordingly, any reviewer of this disclosure should interpret the scope of the invention by the claims, and such scope is not limited by the embodiments described and illustrated herein.

[0065] This disclosure includes expandable implant devices and methods of using them. Expandable implant devices may be adjusted to form a specific height and a specific lordosis angle, influenced by the patient's needs or requirements, the surgeon's target procedure, etc., and expandable implants may further incorporate various features to adapt to and / or facilitate spinal fusion.

[0066] In a typical embodiment, the expandable implant includes: a first end plate, a second end plate, a first translational member, and a second translational member, wherein the first translational member is configured to move independently of the second translational member, and the movement of at least one of the first and second translational members is configured to change the dimensions of the expandable implant.

[0067] In some embodiments, the expandable implant includes: a first end plate, a second end plate, a first actuator having a first translational member movably coupled to a first actuator, and a second actuator having a second translational member movably coupled to a second actuator, wherein the first translational member is configured to move independently of the second translational member, and the first and second translational members are configured to change the spatial relationship between the first and second end plates. The spatial relationship may include the dimensions of the expandable implant, and may include the height, width, length, curvature, and at least one of the other dimensions of the expandable implant.

[0068] Next, looking at the drawings, Figure 1-13 shows various diagrams of the expandable implant 100 according to the first embodiment.

[0069] Figure 1 shows an expandable implant 100 folded in a first embodiment. The expandable implant 100 is shown to include a second actuator having a first end plate 110, a second end plate 120, a first translational member 130 (Figure 5-8), and a second translational member 140 (Figure 5-8). The first translational member 130 may be configured to move independently of the second translational member 140, and the first translational member 130 and the second translational member 140 may be configured to change the spatial relationship between the first end plate 110 and the second end plate 120.

[0070] The expandable implant 100 may be inserted through an access incision in a folded form to reduce the insertion profile of the expandable implant 100. The first end plate 110 and the second end plate 120 further include fusion openings 113 (Figure 3-5), 123 (Figure 3) and bone contact surfaces 112 (Figure 3-5), 122 (Figure 3). After the expandable implant 100 is placed in the patient's prepared intervertebral disc space and adjusted to the desired lordosis height and angle, the bone contact surfaces 112, 122 of the first end plate 110 and the second end plate 120 are configured to contact the inferior and superior vertebral bodies, respectively. As such, the bone contact surfaces 112, 122 may further include an anti-movement mechanism configured to prevent the expandable implant 100 from sliding within the patient's intervertebral disc space. The bone contact surfaces 112, 122 may further include porous bone contact surfaces to promote fusion.

[0071] Figure 2 shows a side view of the expandable implant 100 extended to a height H in the second embodiment. Here, as described above, the threaded portion of the first drive screw 153 (Figures 6 and 9) and the threaded portion of the second drive screw 154 (Figures 6 and 9) are driven into the threaded holes of the first translational member 130 and the second translational member 140, respectively. The first threaded portion moves toward the actuator housing 150 due to the communication between the threaded portion 153a of the first drive screw 153 (Figures 6 and 9) and the threaded hole of the first translational member 130 (Figures 6-7 and 9). Similarly, the second threaded portion moves toward the actuator housing 150 due to the communication between the threaded portion 154a of the second drive screw 154 and the threaded hole of the second translational member 140.

[0072] Figure 3 shows a front perspective view of the expandable implant 100 according to the first embodiment, where the expandable implant 100 is shown in a second expanded form. Rotation of the first drive screw 153 can drive the threaded portion 153a of the first drive screw 153 into the threaded hole of the first translational member 130. The position of the first drive screw 153 relative to the actuator housing 150 can be fixed in a state in which the drive screw 153 is captured but rotatably positioned around the actuator housing 150. Driving the threaded portion 153a of the first drive screw 153 into the translational member 130 effectively moves the translational member 130 toward the actuator housing 150 along the length of the first drive screw 153, thereby changing the dimensions of the expandable implant 100.

[0073] Figure 4 shows a rear perspective view of an expandable implant 100 according to a first embodiment, which has a first actuator including a first drive screw 153 (Figures 6 and 9) and a second actuator including a second drive screw 154 (Figures 6 and 9). The actuator housing 150 includes one or more openings configured to receive at least portions of the first drive screw 153 and the second drive screw 154. The actuator housing 150 is movably connected to a first end plate 110 and a second end plate 120, allowing movement of the first end plate 110 and the second end plate 120 when the first drive screw 153 and the second drive screw 154 are actuated.

[0074] The actuator housing 150 further includes an insertion cavity 156 and a graft opening 155. The insertion cavity 156 is configured to removably secure the expandable implant 100 to the tip of the insertor. After the expandable implant 100 is placed in the patient's prepared intervertebral disc space and adjusted to the desired lordosis height and angle, a bone graft or bone graft substitute material may be loaded into the internal volume of the expandable implant 100. In some embodiments, the bone graft or bone graft substitute material is delivered to the expandable implant 100 by the insertor and loaded into the internal volume of the expandable implant 100 through the graft opening 155.

[0075] The bone fusion openings 113, 123 of the first end plate 110 and the second end plate 120 are configured to allow bone grafts or bone graft substitutes filled within the internal volume of the expandable implant to communicate with the patient's vertebral body to assist the bone fusion process.

[0076] The first drive screw 153 and the second drive screw 154 each include threaded portions 153a and 154a configured to be nested within the threaded holes 132 and 142 (Figure 8) of the first translational member 130 and the second translational member 140, respectively. For example, the threaded portion 153a of the first drive screw 153 is configured to communicate with the threaded hole 132 of the first translational member 130, and the threaded portion 154a of the second drive screw 154 is configured to communicate with the threaded hole 142 of the second translational member 140.

[0077] At least portions of the first translational member 130 and the second translational member 140 may be positioned between the first end plate 110 and the second end plate 120. Each of the first translational member 130 and the second translational member 140 may include one or more wedges 131,141 (Figure 8) configured to communicate with at least one wedge 111,121 (Figure 1-4) of the first end plate 110 and the second end plate 120 as the translational members 130,140 move. In some embodiments, one or more of the first end plate 110 and the second end plate 120 may include at least one wedge 111,121 configured to communicate with one or more wedges 131,141 of at least one translational member 130,140.

[0078] The first translational member 130 and the second translational member 140 are slidably coupled at the distal end of the expandable implant 100, allowing the first translational member 130 to move independently of the second translational member 140. When the first translational member 130 is moved simultaneously in substantially the same direction and by substantially the same distance as the second translational member 140, one or more wedges 111,121 of the first end plate 110 and the second end plate 120 slide one or more wedges 131,141 of the first translational member 130 and the second translational member 140 upward, changing the height of the expandable implant 100. To selectively change the height, simultaneous rotation of the first drive screw 153 and the second drive screw 154 is not required; however, the magnitude of the travel distance of the first translational member 130 and the second translational member 140 relative to the drive screws 153 and 154 should be substantially equal in order to minimize the amount of angular actuation of the first end plate 110 relative to the second end plate 120.

[0079] When one of the first translational member 130 and the second translational member 140 is moved, and both the first and second translational members 130 and 140 are moved in opposite directions, and the orientation of the first end plate 110 relative to the second end plate 120 changes, angular movement of the expandable implant 100 can be achieved. The change in orientation corresponds to a change in the lordosis angle of the expandable implant 100 (see Figures 17 and 21).

[0080] As those skilled in the art will understand, a patient's condition or other spinal deformities may require an implant of height H. However, the larger the implant, the larger the incision required to position the implant in the patient's intervertebral space during surgery. By providing an expandable implant 100, the surgeon can insert the expandable implant 100 in its initial folded and lowered form, and then expand the expandable implant to height H while the implant is positioned in the patient's intervertebral space, thereby requiring only the smallest possible incision.

[0081] In some embodiments, at least one of the first translational member 130 and the second translational member 140 may include at least one wedge 131,141. Each wedge 131,141 may be configured to connect to at least one wedge 111 of the first end plate 110 and at least one wedge 121 of the second end plate 120. As the first translational member 130 moves toward the actuator housing 150, at least one wedge 131 of the first translational member 130 is configured to connect to at least one of the first end plate 110 and the second end plate 120. Similarly, as the second translational member 140 moves toward the actuator housing 150, at least one wedge 141 of the second translational member 140 is configured to connect to at least one of the first end plate 110 and the second end plate 120.

[0082] In this embodiment, substantially equal and simultaneous movement of the first translational member 130 and the second translational member 140 in the same direction changes the height and slightly changes the length of the expandable implant 100. The first translational member 130 and the second translational member 140 in this embodiment each include three wedges 131, 141 configured to connect with the opposing wedges 111, 121 of the first end plate 110 and the second end plate 120 as the first translational member 130 and the second translational member 140 move toward the actuator housing 150.

[0083] As those skilled in the art will understand, one or more of the simultaneous movement of the first translational member 130 and the second translational member 140 in opposite directions, and the movement of only one of the first translational member 130 and the second translational member 140, can change the height of each end of the expandable implant 100, thereby effectively changing the angle of the first end plate 110 relative to the second end plate 120. In some embodiments, the adjusted angle between the first end plate 110 and the second end plate 120 may include a lordotic angle.

[0084] Figure 5 shows a top view of an expandable implant 100 according to a first embodiment. The first end plate 110 and the second end plate 120 are shown to include fusion openings 113, 123 (Figure 6). The fusion openings 113 are configured to assist the bone fusion process and allow bone grafts or bone graft material deposited within the internal volume of the expandable implant to communicate with the patient's vertebral body. Offsetting the first translational member 130 and the second translational member 140 so that they extend along opposing ends, for example, the first and second ends of the expandable implant, forms a cavity within the internal volume of the expandable implant 100. This cavity may be filled with bone grafts or bone graft substitute material to assist the fusion process.

[0085] Figure 6 shows a cross-sectional top view of the expandable implant 100 taken across plane A (see Figure 2). Here, the threaded portion 153b of the first drive screw 153 and the threaded portion 154b of the second drive screw 154 are shown nested within the threaded holes of the first translational member 130 and the second translational member 140, respectively. In this embodiment, the first drive screw 153 and the second drive screw 154 are rotatably incorporated within the actuator housing 150. This arrangement allows rotational movement of the first drive screw 153 and the second drive screw 154, but prevents translational movement of the first drive screw 153 and the second drive screw 154.

[0086] Figure 7 shows a top view of the expansion mechanism of an expandable implant 100 according to the first embodiment. The expansion mechanism includes an actuator housing 150, a first drive screw 153, a first translational member 130, a second drive screw 154, and a second translational member 140.

[0087] As will be described in more detail below, this embodiment also includes an anti-rotation mechanism configured to restrict undesirable rotation of the drive screws. In this embodiment, the anti-rotation mechanism includes a plurality of flexible members 157, at least a portion of which are configured to be nested within a plurality of divots of the first drive screw 153 and the second drive screw 154.

[0088] Figure 8 shows perspective views of the first translational member 130 and the second translational member 140 of the expandable implant 100. The first translational member 130 and the second translational member 140 include screw holes 132 and 142 configured to connect to the threaded portions 153a and 154a of the drive screws 153 and 154. The translational members 130 and 140 each further include a number of wedges 131 and 141 configured to connect to wedges 111 and 121 of the first end plate 110 and the second end plate 120, and configured to move the first end plate 110 relative to the second end plate 120.

[0089] Figure 9 shows a perspective view of the actuator housing 150 of an expandable implant 100 having a first drive screw 153 and a second drive screw 154 nested inside. The illustrated actuator housing 150 includes a plurality of flexible members 157 configured to restrict undesirable movement of the first drive screw 153 and the second drive screw 154.

[0090] Figures 10-15 show two perspective views of the expandable implant 100, front and rear, as it is adjusted from a first folded form to a second extended form. Figure 10 shows a rear view of the folded expandable implant 100 in its first form. Note the relative positions of the first end plate 110 and the second end plate 120. Figure 11 shows a rear view of the extended expandable implant 100 in its second form. Note the movement of the first end plate 110 relative to the second end plate 120 and the change in the height of the expandable implant 100.

[0091] From a different perspective, Figure 12 shows a front view of the expandable implant 100 folded in the first embodiment, and Figure 13 shows a front view of the expandable implant 100 expanded in the second embodiment.

[0092] To illustrate the angle adjustment of the expandable implant 100, Figure 14 shows a rear view of the expandable implant 100 according to the first embodiment, adjusted to an exemplary lordotic angle. Figure 15 shows a front view of the expandable implant 100 according to the first embodiment, adjusted to an exemplary lordotic angle. By comparing this form with the first and second forms described above, it can be seen that the first end plate 110 is positioned at a certain angle relative to the second end plate 120, corresponding to the exemplary lordotic angle.

[0093] Figure 16 shows a perspective view of an expandable implant 100 according to a first embodiment, adjusted to an exemplary lordosis angle. Depending on the patient's needs, the individual components of the expandable implant can be sized to provide the required amount of lordosis.

[0094] The expandable implant 100 includes a sliding interface 170 (Figures 6-7 and 10-16) located at the distal end of the expandable implant 100. The distal end of the expandable implant 100, particularly the distal ends of the first translational member 130 and the second translational member 140, is configured with tapered edges having a sliding interface 170 that movably connects the first translational member 130 to the second translational member 140. The tapered edges are configured to assist in the insertion of the expandable implant into the patient's intervertebral disc space, and the sliding interface 170 is configured to enhance the stability and load-bearing properties of the expandable implant 100.

[0095] In this embodiment, the slidable interface 170 includes a dovetail coupling, which includes an extension of the first translational member 130 nested within a channel of the second translational member. As those skilled in the art will understand, in this embodiment, the extension is part of the first translational member 130 and the channel is located in the second translational member 140. In some embodiments, the extension is part of the second translational member 140 and communicates with the channel of the first translational member 130. Similarly, in this embodiment, the slidable interface 170 is a dovetail coupling and has a substantially triangular geometric shape, but those skilled in the art will understand that other shapes may be provided.

[0096] Figure 17-20 shows a second embodiment of an expandable implant 200, which includes a first end plate 210, a second end plate 220, a first translational member 230 positioned between the first end plate 210 and the second end plate 220 and movably coupled to a first drive screw 253, and a second translational member 240 positioned between the first end plate 210 and the second end plate 220 and movably coupled to a second drive screw 254. The first translational member 230 is configured to move independently of the second translational member 240, and the first and second translational members 230 and 240 are configured to change the spatial relationship between the first end plate 210 and the second end plate 220. The first and second translational members 230 and 240 are mirror images of each other and therefore have corresponding features.

[0097] In this embodiment, the first end plate 210 and the second end plate 220 include porous bone contact surfaces 211, 221. The first end plate 210, the second end plate 220, and any other components of the expandable implant 200 may be manufactured using additive manufacturing techniques. The porous bone contact surfaces 211, 221 may be printed using additive manufacturing techniques. In some embodiments, the first end plate 210, the second end plate 220, and any other components of the expandable implant 200 may include polyetherketone (PEEK). As such, the porous bone contact surfaces 211, 221 may be manufactured using any known process for manufacturing porous PEEK implants. In some embodiments, the expandable implant 200 may be manufactured from titanium and other materials commonly used in the manufacture of medical implants.

[0098] Figure 17 shows the expandable implant 200 in a first folded configuration. The expandable implant 200 includes: a first end plate 210, a second end plate 220, a first translational member 230, a second translational member 240, and an actuator housing 250. The actuator housing 250 includes a first drive screw 253 having a first threaded portion communicating with a threaded hole in the first translational member 230, and a second drive screw 254 communicating with a first threaded hole in the second translational member 240.

[0099] When at least one of the first drive screw 253 and the second drive screw 254 is rotated, the threaded portion (not shown in Figure 17, but similar to 153a, 154a (Figure 6) relating to implant 100) communicates with the first threaded holes 232, 242 of the first translational member 230 and the second translational member 240, thereby translating the first translational member 230 and / or the second translational member 240.

[0100] Each of the first translational member 230 and the second translational member 240 may include at least one wedge 231,241, each wedge 231,241 configured to connect with wedges 211,221 of the first end plate 210 and the second end plate 220. During one or more translations of the first translational member 230 and the second translational member 240, one or more wedges 231,241 of the translational members 230,240 are configured to connect with one or more wedges 211,221 of the end plates 210,220, thereby changing the dimensions of the expandable implant 200. Although not shown in Figure 17-18, it is understood that the second translational member 240 includes a wedge 241, since the translational member 240 is a mirror image of the translational member 230.

[0101] In this embodiment, the wedges 211, 221 of the end plates 210, 220 include keyed portions configured to move within the tracks of the wedges 231, 241 of the translational members 230, 240. The keyed portions that move within the tracks are configured to provide the expandable implant with further stability and load-bearing properties.

[0102] Figure 18 shows a rear perspective view of the expandable implant 200 in a second extended form. When the first drive screws 253 and 254 are rotated so that the first translational member 230 and the second translational member 240 move by substantially equal amounts, the wedges 231, 241 of the first translational member 230 and the second translational member 240 connect with the wedges 211, 221 of the first end plate 210 and the second end plate 220, displacing the first end plate 210 and the second end plate 220 relative to the actuator housing 250. In this embodiment, this movement extends the expandable implant 200 and changes the height of the expandable implant 200.

[0103] Here, in some embodiments, the expandable implant 200 is also configured to be adjustable in terms of lordosis angle. For reference, Figure 19 shows a rear view of the expandable implant 200 in the same second expanded form as in Figure 18. As will be understood by those skilled in the art, the angle between the first end plate 210 and the second end plate 220 is changed by rotating one of the first drive screws 253 and the second drive screws 254, or by rotating both the first drive screw 253 and the second drive screw 254 in opposite directions.

[0104] Figure 20 shows a rear view of the expandable implant 200 adjusted to a third form having a selected lordosis angle. As those skilled in the art will understand, selecting the dimensions of the wedges 211, 221 of the end plates 210, 220 and the wedges 231, 241 of the translation members 230, 240 determines the range of lordosis angles that the expandable implant 200 is configured to provide.

[0105] As those skilled in the art will understand, the first embodiment 100, the second embodiment 200, and all embodiments illustrated and described herein are adjustable in both height and lordosis angle. Any number of height and lordosis configurations may be provided by expandable implants, but are not expressly shown herein. In this sense, the entire range of possible adjustments should be considered encompassed by this disclosure, and the disclosure is not limited by the configurations expressly shown herein.

[0106] Some embodiments may include an anti-rotation mechanism to restrict undesirable rotation of the lead screws. The anti-rotation mechanism provides additional rigidity and increases the amount of load that the expandable implant can support. For example, Figures 21 and 22 show an actuator housing 350 of an expandable implant 300 according to a third embodiment, the actuator housing 350 including an anti-rotation mechanism 357 configured to restrict undesirable rotation of a first drive screw 353 and a second drive screw 354. In this embodiment, the anti-rotation mechanism 357 includes a plurality of flexible members 357 extending from the actuator housing 350. The first drive screw 353 and the second drive screw 354 in this embodiment include a plurality of divots 353b, 354b, each configured to accept at least a portion of each of the plurality of flexible members 357, and the anti-rotation mechanism is configured to have a ratchet function to prevent undesirable rotation of the drive screws 353, 354.

[0107] As those skilled in the art will understand, the connections of at least some of the multiple flexible members 357 nested within the multiple divots 353b, 354b increase the force requirements necessary to rotate the drive screws 353, 354. However, the ratchet mechanism of the multiple flexible members 357 connected to the divots 353b, 354b of the drive screws 353, 354 functions to prevent undesirable rotation of the drive screws 353, 354 and helps to prevent the folding of the expandable implant 300.

[0108] In some embodiments, the actuator housing 350 may be manufactured using additive manufacturing technology, and the multiple flexible members 357 may be manufactured such that the actuator housing 350 and the multiple flexible members 357 form a monolithic piece. In some embodiments, this single monolithic piece may be 3D printed directly around the drive screw to reduce the number of components and assist in the assembly process. In some embodiments, the drive screw is inserted through its respective cavity and secured in place by friction fitting.

[0109] Figure 23 shows an expandable implant 400 according to a fourth embodiment, adjusted to a selected height and lordosis angle. The expandable implant 400 includes a sliding interface 460 formed at the respective interfaces (boundaries) of the ends of the end plates 410, 420 and the translational members 430, 440. There is an enlarged view of the sliding interface 460 of the first end plate 410 and the second translational member 440. This sliding interface 460 between the end plates 410, 420 and the translational members 430, 440 helps the expandable implant 400 achieve an increased amount of lordosis.

[0110] In this embodiment, the sliding interface 460 is formed by providing at least one groove along the length of the translational members 430, 440 and a plurality of notches extending along at least a portion of the length of the end plates 410, 420. When the expandable implant is adjusted to a specific lordotic angle, the pivot points of the first end plate 410 and the second end plate 420 change. As the pivot points move toward the ends of the end plates 410, 420, the translational members 430, 440 can contact the end plates 410, 420 and effectively restrict their movement. However, by providing the sliding interface 460, the end plates are given an increased range of motion.

[0111] In some embodiments, the first translational member 430 and the second translational member 440 may be movably coupled at the distal end of the expandable implant by a sliding interface 470. The sliding interface 470 may be configured to allow the first translational member 430 and the second translational member 440 to move independently. Figure 24 shows the distal end of the expandable implant 400, and the sliding interface 470 (Figure 25) has a dovetail coupling that slidably connects the first translational member 430 and the second translational member 440. The dovetail coupling is configured to allow the first translational member 430 and the second translational member 440 to move independently. Similarly, in some embodiments, the first translational member 430 and the second translational member 440 may be movably coupled at the proximal end of the expandable implant by a sliding interface configured to allow the first translational member 430 and the second translational member 440 to move independently.

[0112] In some embodiments, a slidable interface 470 at the proximal end of the expandable implant 400 may be formed between the first actuator housing 450a and the second actuator housing 450b (Figures 25-27). Figure 25 shows the proximal end of the expandable implant 400 having a slidable interface 470 configured to provide a movable coupling between the first actuator housing 450a and the second actuator housing 450b. The slidable interface 470 includes a dovetail coupling configured to allow the first actuator housing 450a and the second actuator housing 450b to move independently.

[0113] Providing sliding couplings at both the proximal and distal ends of an expandable implant provides the expandable implant with enhanced stability and load-bearing properties. Furthermore, providing sliding couplings at both the proximal and distal ends of an expandable implant allows for length expansion and length contraction of the expandable implant at either end. For example, Figures 26-27 show a top view of an expandable implant 400 according to a fourth embodiment. In Figure 26, the expandable implant 400 is positioned in a first folded configuration. In Figure 27, a first drive screw is rotated to adjust the lordosis angle of the expandable implant 400. In this manner, the first actuator housing 450a moves toward the first translational member 430, causing the first end plate 410 and the second end plate 420 to pivot.

[0114] Referring to Figure 28, in some embodiments, one or more hinge joints may be provided. The hinge joints may be configured to provide further stability to the expandable implant. The hinge joints may movably connect the first end plate 510 to the second end plate 520. In some embodiments, the first end plate 510 and the second end plate 520 may be connected at the rear or front end. In some embodiments, the first end plate 510 and the second end plate 520 may be movably connected by linkages. For example, Figure 28 shows an expandable implant 500 according to a fifth embodiment, in which the first end plate 510 has a linkage 514 movably connected to a linkage 524 of the second end plate 520. The linkage 514 of the first end plate 510 is movably connected to the linkage 524 of the second end plate 520 by a coupling pin. These connecting parts 514 and 524 movably connect the first end plate 510 to the second end plate 520, improving the stability and load-bearing characteristics of the expandable implant 500.

[0115] A method for treating spinal disorders using an expandable implant is further provided. This method includes the steps of accessing the intervertebral disc space via a substantially lateral approach, and inserting an expandable implant into the intervertebral disc space, the expandable implant having a first translational member movably coupled to a first actuator and a second translational member movably coupled to a second actuator. The first and second translational members may be configured to change the spatial relationship between a first end plate and a second end plate as they move. This method may further include the step of acting on at least one of the first and second actuators to change the dimensions of the expandable implant by changing the spatial relationship between the first and second end plates.

[0116] In some embodiments, this method may include the step of adjusting an expandable implant in situ within the patient's intervertebral disc space.

[0117] In some embodiments, this method may include the step of filling the expandable implant with a bone graft or bone graft substitute. This step may be performed by using a special inserter to provide the bone graft or bone graft substitute to the expandable implant in situ, either before inserting the implant into the intervertebral disc space or after placing the implant in the intervertebral disc space.

[0118] In some embodiments, this method may include the step of adjusting the expandable implant to a desired height, and additionally or alternatively, the step of adjusting the expandable implant to a desired lordotic angle. Figure 29 shows an expandable fusion intervertebral implant device 600 according to another embodiment. As shown in Figure 29, the expandable fusion intervertebral implant device 600 is in a folded insertion configuration. Figure 30 shows the expandable fusion intervertebral implant device 600 of Figure 29 in a fully expanded configuration. According to this exemplary embodiment, the expandable fusion device 600 is configured to have independently expandable first and second lateral portions so that the user can choose to expand only the first or second lateral portion of the implant (i.e., increase the height / distance between the first end plate 610 and the second end plate 620). Expanding only the first or second lateral portion of the implant results in a so-called lordotic implant. In other words, the height of the extended side is greater than the height of the unextended side, creating an angle (i.e., a lordosis or lordosis angle) between the first end plate 610 and the second end plate 620.

[0119] According to the exemplary embodiment shown in Figures 29-35, the expandable fusion intervertebral implant device 600 is dimensioned to span the width of the end plate of the vertebral body, from the ipsilateral side of the vertebral body to the contralateral side of the vertebral body. For example, the length of the expandable fusion intervertebral implant device 600 from the tip 602 to the posterior end 604 may range from about 40 mm to about 60 mm. The expandable fusion intervertebral implant device 600 is dimensioned to be positioned in the intervertebral cavity from a lateral approach, e.g., a direct lateral / transpsoas approach or an anterolateral / anterior psoas approach. For example, the width of the expandable fusion intervertebral implant device 600 may range from about 18 mm to about 28 mm from the first side to the second side of the expandable fusion intervertebral implant device 600. Furthermore, the expandable fusion intervertebral implant device 600 in its folded form may have parallel or substantially parallel end plates, i.e., with about 0° of lordosis. Furthermore, the expandable fusion intervertebral implant device 600 in its folded state may have a lordotic angle between the end plates 610 and 620. For example, the angle between the first end plate 610 and the second end plate 620 in the folded form may range from 0° to 15°.

[0120] Figure 31 is an exploded view of the expandable fusion intervertebral implant device 600 according to this embodiment. As best shown in Figure 31, the expandable fusion intervertebral implant device 600 comprises a first end plate 610, a second end plate 620, a first expansion member 630, a second expansion member 640, a first actuator 653, a second actuator 654, and a housing 650.

[0121] The first end plate 610 has an upper surface (or bone contact surface) 612, an inner surface 614 opposite to the upper surface 612, a first side portion 615a, a second side portion 615b, a plurality of extensions 611a extending from the first side portion 615a along the edge of the end plate 610 (Figure 29), and a plurality of extensions 611b extending from the second side portion 615b and offset from the edge of the end plate 610 (Figures 30-31). The second end plate 620 has a bottom surface (or bone contact surface) 622, an inner surface 624 opposite to the bottom surface 622, a first side 625a, a second side 625b, a plurality of extensions 621a (Figure 31) extending from the first side 625a and offset along the edge of the end plate 620, and a plurality of extensions 611b (Figures 30-31) extending from the second side 625b and extending along the edge of the end plate 620.

[0122] According to an exemplary embodiment, the first and second end plates 610, 620 are identical in size and shape to each other and are arranged opposite each other. According to an alternative embodiment, the first end plate 610 may have a first side 615a height greater than the height of the second side 615b of the first end plate 610 and / or greater than the maximum height of the second end plate 620. Each of the first and second end plates 610, 620 may further have openings 613, 623 (Figure 31) extending from the top or bottom surface 612, 622 through the inner surface 614, 624 of the end plates 610, 620. According to one exemplary embodiment, each of the first and second end plates 610, 620 includes at least one central fusion opening 613, 623 that is sized and configured to allow bone growth, passing through the first end plate 610, through the central region of the implant device 600, and through the second end plate 620. According to one embodiment best shown in Figure 35, each of the first and second end plates 610, 620 has a porous bone contact layer adjacent to the upper surface 612 and the bottom surface 622, respectively.

[0123] The first expansion member 630 has a length comparable to the lengths of the first and second end plates 610, 620. The first expansion member 630 has a tip 632, a rear end 634, a plurality of curved surfaces 631, and an opening 636 in the rear end 634 that extends for at least a portion of the length of the first expansion member 630. The tip 632 of the first expansion member 630 is inclined or tapered to assist in the insertion of the expandable fusion intervertebral implant device 600 into the intervertebral cavity. The tip 632 of the first expansion member 630 extends beyond the tip 602 of the first and second end plates 610, 620, forming the tip of the entire expandable fusion intervertebral implant device 600. The tip 632 of the first expansion member 630 may also have dovetail or tongue and groove features that mate with corresponding features on the first end plate 610. The dovetail or tongue and groove feature is configured to engage with at least one corresponding feature of the first and second end plates 610, 620 to actively pull the first end plate 610 toward the second end plate 620, thereby "actively folding" the expandable fusion intervertebral implant device 600.

[0124] According to an exemplary embodiment, the first extension member 630 has a plurality of curved surfaces 631 spaced apart from each other and configured to engage with a plurality of extensions 611a of the first side 615a of the first end plate 610 and a plurality of extensions 611a offset from the edge of the first side 625a of the second end plate 620. The first extension member 630 may also have a cleat 638 (Figure 31-33) extending substantially perpendicular to the longitudinal axis of the first extension member 630 and configured to connect to a corresponding cleat 648 (Figure 31-33) on the second extension member 640, enabling the first and second extension members 630, 640 to be slidably engaged with each other.

[0125] The second expansion member 640 includes features corresponding to those of the first expansion member 630 described above. Specifically, the second expansion member 640 has a tip 642, a rear end 644, a plurality of curved surfaces 641, an opening 646 in the rear end 644 that extends into at least a portion of the length of the second expansion member 640, and a cleat 648. The tip 642 of the second expansion member 640 is inclined or tapered to assist in the insertion of the expandable fusion intervertebral implant device 600 into the intervertebral cavity. The tip 642 of the second expansion member 640 extends beyond the tip 602 of the first and second end plates 610, 620, forming the tip of the entire expandable fusion intervertebral implant device 600. The tip 642 of the second expansion member 640 may also have a dovetail or tongue and groove feature 633 (Figure 35) that engages with corresponding feature portions on the first end plate 610 and the second end plate 620. The dovetail or tongue and groove feature 633 is configured to engage with a feature portion corresponding to at least one of the first and second end plates 610, 620, to actively pull the first end plate 610 toward the second end plate 620, thereby "actively folding" the expandable fusion intervertebral implant device 600.

[0126] The shape, geometry and / or configuration of one or more wedges 631,641 of the extension members 630,640 and the wedges 611,621 of the end plates 610,620 may be customized to enhance extension and folding. For example, another active folded feature 605 is shown as shown in Figure 35. Specifically, the first and second end plates 610,620 may include at least one extension 611c,621c configured to interact with the wedge 641c of the extension members 630,640 during the folding of the implant 600, such that the interaction of the extensions 611c,621c of the first and second end plates 610,620 with the wedge 641c of the extension members 630,640 directs and assists in the folding of the implant 600. It should be understood that the end plates 610, 620 and the extension members 630, 640 may include any number of active folding mechanisms without departing from the embodiments of the disclosure.

[0127] The curved surface 641 of the second extension member 640 is configured to engage with an extension 611b offset from the edge of the second side portion 615b of the first end plate 610, and an extension 621b along the edge of the second side portion 621b of the second end plate 620. According to one embodiment, the first and second extension members 630, 640 are identical in size and shape, and their front ends 632, 642 and rear ends 634, 644 are aligned, but the second extension member 640 may be positioned opposite to each other so as to be reversed around the longitudinal axis of the extension members. According to an exemplary embodiment, the openings 636, 646 of the rear ends 634, 644 of the first and second extension members 630, 640 are dimensioned to receive the first portions 653a, 654a of the first and second actuators 653, 654, respectively. The openings 636, 646 may be threaded to correspond to the thread shape of the first portions 653a, 654a of the first and second actuators 653, 654.

[0128] The first and second actuators 653, 654 each have first portions 653a, 654a, second portions 653b, 654b, and intermediate regions 653c, 654c (Figure 32) between the first portions 653a, 654a and the second portions (653b, 654b). According to an exemplary embodiment, the first and second actuators 653, 654 are identical to each other in size and shape. The first portions 653a, 654a of each of the first and second actuators 653, 654 are configured to engage with the first and second extension members 630, 640. For example, when the first actuator 653 rotates in a first direction, the first extension member 630 translates toward the housing 650, and when the first actuator 653 rotates in a second direction, the first extension member 630 translates toward the housing 650. Similarly, when the second actuator 654 rotates in the first direction, the second extension member 640 translates toward the housing 650, and when the second actuator 654 rotates in the second direction, the second extension member 640 translates toward the housing 650. The second portions 653b, 654b of the first and second actuators 653, 654, respectively, are substantially or completely contained within the first and second openings 652a, 652b (Figure 31) in the housing 650. The rear ends of the second portions of the first and second actuators 653, 654, respectively, have engaging features 653d, 654d (Figure 32) configured to receive the distal tip of an extension driver that engages with the first and second actuators 653, 654 to rotate them in the first or second direction. The engagement features 653d, 654d at the rear ends of the first and second actuators 653, 654, respectively, are exposed through corresponding openings 652s, 652b within the housing 650 on the proximal surface of the housing 650, which is also the rear end surface of the entire expandable fusion intervertebral implant device 600. Each of the actuators 653, 654 and the corresponding expansion members 630, 640 may be completely independent of the others. The actuator 653, 654 and expansion member 630, 640 assemblies are configured to actuate and translate independently, thereby increasing the height of only the first or second lateral portion of the expandable fusion intervertebral implant device 600.Alternatively, actuators 653, 654 can both be engaged and rotated simultaneously, causing parallel expansion of the expandable fusion intervertebral implant device 600. For example, the second portions 653b, 654b of each of the first and second actuators 653, 654 may include lips or flanges 656, 658 having a larger circumference than the rest of the second portions 653b, 654b of actuators 653, 654, which are held in corresponding pockets or channels within the first and second openings 652a, 652b of the housing 650. Also, each of the first and second actuators 653, 654 includes intermediate or central regions 653c, 654c. The central regions 653c, 654c may have multiple recessed channels around the periphery of the central regions 653c, 654c of actuators 653, 654.

[0129] The housing 650 is configured to be located at the rear end 604 of the expandable fusion intervertebral implant device 600. According to one embodiment, the housing 650 has a width equal to the maximum extent of the expandable fusion intervertebral implant device 600, from the first side to the second side of the expandable fusion intervertebral implant device 600. The housing 650 includes a distal surface and a proximal surface, first and second openings 652a, 652b (Figure 31) extending from the proximal surface through the distal surface of the housing 650, and a plurality of flexible extensions 657 (Figure 33) extending from the distal surface of the housing 650 adjacent to the first and second openings 652a, 652b. The first and second openings 652a, 652b are configured to hold second portions 653b, 654b of the first and second actuators 653, 654, respectively. Each of the multiple flexible extensions 657 extending from the distal surface of the housing 650 has a distal end configured to rest in one of the lobes or recessed channels 659 (Figure 34) around the central regions 653c, 654c of the actuators 653, 654. According to an exemplary embodiment, the multiple flexible extensions 657 may have different lengths so that the flexible extensions 657 engage with the recessed channels 659 of the central regions 653c, 654c of the actuators 653, 654 at different positions. According to an exemplary embodiment, the housing 650 including the multiple flexible extensions 657 may be a single structure. The flexible extensions 657 are configured to restrict undesirable movement of the first and second actuators 653, 654. The second portions 653b, 654b of the first and second actuators 653, 654 are constrained within the housing 650 without requiring the use of a secondary lock or screw mechanism.

[0130] According to an exemplary embodiment, the entire expandable fusion intervertebral implant device 600 may be manufactured using additive manufacturing technology. According to another exemplary embodiment, the expandable fusion implant may include a biocompatible metal. At least one of the end plates 610, 620 or the expansion members 630, 640 may be treated to improve the surface structure to promote intrinsic or extrinsic growth to the treated component. According to another exemplary embodiment, the entire expandable fusion intervertebral implant device 600 may be treated to improve the surface structure to promote intrinsic or extrinsic growth to the expandable fusion intervertebral implant device 600.

[0131] Referring next to Figure 36, another embodiment of the expandable fusion intervertebral implant device 700 is shown. This embodiment includes features substantially consistent with those of the expandable fusion intervertebral implant device 600 (Figures 29-35), except that the expandable fusion intervertebral implant device 700 includes a plated design. More specifically, the expandable fusion intervertebral implant device 700 includes at least one fixed opening 760 formed integrally with a first end plate 710 and at least one fixed opening 770 formed integrally with a second end plate 720. Each of the at least one fixed opening 760, 770 is configured to receive a fixing element, such as a bone screw, blade, etc., for fixing the expandable fusion intervertebral implant device 700 to an adjacent bone. A housing 750 may be positioned between the at least one fixed opening 760 formed integrally with the first end plate 710 and the at least one fixed opening 770 formed integrally with the second end plate 720. Although shown to include two fixed openings 760, 770, it is understood that each end plate 710, 720 may include any number of fixed openings without departing from the aspects of the disclosure. Furthermore, it is conceivable that only one of the first end plate 710 or the second end plate 720 may include fixed openings.

[0132] In this embodiment, each of at least one fixed opening 760,770 is shown to include a tilting coil mechanism 762,772 as an anti-back-out feature, although other types may be used to fix an expandable fusion intervertebral implant device 700 to adjacent bone once it has been positioned and sized. Further details of exemplary tilting coil locking mechanisms are described in International Patent Application PCT / US2009 / 040396, filed on 13 April 2009 and published on 15 October 2009 as WO2009 / 126968A1, which is incorporated herein by reference as if it were described in its entirety. For example, some embodiments may include polymer members for ultrasonic welding. Further details of exemplary polymer components are described in International Patent Application PCT / US2018 / 040463, filed on 29 June 2018 and published on 3 January 2019 as WO2019 / 006407A1, which is incorporated herein by reference as if it were contained herein.

[0133] Each of at least one of the fixed openings 760, 770 may be positioned around the end plates 710, 720 on the posterior end 704 of the expandable fusion intervertebral implant device 700. Furthermore, each of the at least one of the fixed openings 760, 770 may be centered or off-center around the end plates 710, 720 at the posterior end 704. Furthermore, each of the at least one of the fixed openings 760, 770 may be configured to orient the bone screw placed therein at a desired angle and direction. In one example, the fixed openings 760, 770 may be shifted to the anterior portion of the expandable fusion intervertebral implant device 700, and the bone screw trajectory may be oriented posteriorly, which allows the expandable fusion intervertebral implant device 700 to be used in an anterior posterior psoas (ATP) approach.

[0134] Next, Figure 37 shows another embodiment of the expandable fusion intervertebral implant device 800. This embodiment includes features substantially corresponding to those described in relation to the expandable fusion intervertebral implant device 600 (Figures 29-35), but the expandable fusion intervertebral implant device 800 is fixed in a similar manner to the expandable fusion intervertebral implant device 700. More specifically, the expandable fusion intervertebral implant device 800 includes at least one fixing opening 860 formed integrally with the first end plate 810 and at least one fixing opening 870 formed integrally with the second end plate 820. Each of the at least one fixing opening 860, 870 is configured to receive a fixing element, such as a bone screw, blade, etc., for fixing the expandable fusion intervertebral implant device 800 to an adjacent bone. The housing 850 may be positioned between the at least one fixing opening 860 formed integrally with the first end plate 810 and the at least one fixing opening 870 formed integrally with the second end plate 820.

[0135] In this embodiment, each of at least one fixed opening 860, 870 is shown to include at least one latch lock 862, 872 disposed therein. While the fixed openings 860, 870 are shown to include three latch locks 862, 872 per fixed opening, it should be understood that any number of latch locks 862, 872 may be included without departing from the aspects of the disclosure. Figure 38 shows an enlarged view of a fixed opening 870 having a latch lock 872 therein. Figure 39 shows an enlarged cross-sectional view of a fixed opening 870. As illustrated, each latch lock 872 includes a ratchet tab 874 for engaging with the scalloped cut portion 882 (Figure 40) of the head of the bone screw 880 (Figure 40), thereby providing a retraction prevention mechanism. The ratchet tab 874 may project inward toward the center of the fixed opening 870 and / or distally toward the opposite end of the fixed opening 870 (downward in the figure as shown in Figure 39). The latch lock 872 may be configured to allow a certain degree of flexibility, which allows the latch lock 872 to bend outward or spread during the placement of the bone screw 880. Furthermore, the fixed opening 870 is fixed opening To ensure that the fixing element 880 reaches the bottom within the opening 870, the head of the fixing element 880 includes a threaded portion 876 for engaging with a helical interface portion 884. The latch lock, ratchet tab, and threaded portion 876 are illustrated and described in relation to at least one fixing opening 870, but it should be understood that at least one fixing opening 860 may include substantially the same features, and therefore its description is omitted for brevity. The latch lock 872, ratchet tab 874, and threaded portion 876 are formed within the fixing opening 870 and, similarly, may be formed within the fixing opening 860 via 3D printing.

[0136] During use, the fixing element 880 is inserted into the fixing openings 860, 870 via a driver (not shown). Once the fixing element 880 is inserted, the latch locks 872 swerve or spread outward so that the ratchet tabs 874 of each latch lock 872 engage with the corrugated cut portions 882 of the fixing element 880, and then snap back inward toward the center of the fixing openings 860, 870, thereby providing rotational retraction resistance. Furthermore, the helical interface feature portion 884 of the fixing element 880 engages with the threaded portion 876 of the fixing openings 860, 870, thereby providing hard-stop tactile feedback and retraction resistance. Specifically, the helical interface feature portion 884 has a different pitch from the pitch of the threaded portion 876, causing cross-threading and / or engagement to provide tactile feedback and ensure that the fixing element 880 reaches the bottom within the fixing openings 860, 870.

[0137] Figure 41 shows another embodiment of the anti-retraction and hard-stop features of the fixed openings 860, 870. In particular, this embodiment is discussed again in relation to the fixed opening 870, but is equally applicable to the fixed opening 860. As shown, the fixed opening 870 includes a latch lock 872 as shown in Figures 38-39, but instead of a threaded portion 876, it includes a projection or ridge 878 which may be formed close to the bottom of the fixed opening 870 to mate and / or engage with a cut portion formed in the fixed element 880. The projection or ridge 878 may be formed via 3D printing. The projection or ridge 878 provides a hard stop in the form of a prominent torque spike when the bottom of the head of the fixed element 880 engages with the projection or ridge 878.

[0138] Figure 42 shows another embodiment of the projection or ridge 878. In this embodiment, the projection or ridge 878 is in the form of a micropore formed by 3D printing. The micropore provides a hard stop in the form of a prominent torque spike when the bottom of the screw head engages with the micropore.

[0139] Figures 43-45 show another embodiment of the retraction prevention mechanism in the form of a washer 886 formed to substantially surround the head of the fixation element 880 and configured to be received in a groove around the head. The washer 886 includes a helical interface feature 884. The helical interface feature of the washer 886 is configured to engage with the threaded portion 876 (Figures 38-39) of the fixation opening 870, as described in relation to Figure 40. The inner surface of the washer 886 may be keyed and dimensioned so as to provide sufficient countertorque to seat the fixation element 880 by preventing rotation. This configuration allows the fixation element 880 to be driven into the fixation opening of an expandable fusion intervertebral implant device 700,800 to achieve a hard stop, but also allows for a toggle to consider postoperative fixation of the bone screw 880. The fixation element 880 having the washer 886 may be formed via 3D printing.

[0140] Figure 46 shows one embodiment of an expandable fusion intervertebral implant device 900, which includes fixed openings 960, 970 integrally formed with end plates 910, 920, the fixed openings 960, 970 being located on the anterior posterior end 904 and configured to provide a screw trajectory to the posterior side. Such an embodiment may be used in an anterior posterior psoas (ATP) approach.

[0141] Referring next to Figures 47-51, an expandable fusion intervertebral implant device 1000 having a modular plate configuration is shown. Specifically, the implant device 1000 is shown to include a plate 1005 configured to be coupled to a housing 1050 of the expandable fusion intervertebral implant device 1000. The expandable fusion intervertebral implant device 1000 may be in any form of the embodiments discussed herein, for example, shown in Figure 1-37. The plate 1005 includes a body 1006 having at least one boss, tab, extension, and / or projection (hereinafter referred to as "boss") 1007 extending from its distal surface (Figures 49-50). The boss 1007 is configured to be received within an opening in the housing 1050. The body 1006 also includes a pair of wings, tabs, extensions, or projections (hereinafter referred to as "wings") 1004 similarly extending within an opening in the housing 1050. The body 1006 may be substantially "T-shaped" or "t-shaped," but other shapes are also possible and intended by this disclosure. The body 1006 may also have an opening 1008 that completely penetrates the body 1006 and may be configured to align with an opening in the housing 1050.

[0142] The plate 1005 may also include at least one fixing opening 1009 integrally formed with the body 1006. The fixing opening 1009 is configured to receive fixing elements, such as bone screws, blades, etc., for fixing the plate 1005, and thus the expandable fusion intervertebral implant device 1000, to adjacent bone. The fixing opening 1009 may be configured similarly to any of the fixing openings 760, 770, 860, 870, 960, 970 (Figures 36-46), such that the fixing opening 1009 includes any number of retraction prevention mechanisms and bottom-out feedback mechanisms, including tilt coil mechanisms, latch lock mechanisms, threads, projections, protrusions, and / or micropores, as described herein.

[0143] Attachment 1090 may be configured for insertion into openings 1008 (Figure 50) in the main body 1006 and in the housing 1050 to secure plate 1005 to an expandable fusion intervertebral implant device 1000. In some embodiments, attachment 1090 includes a threaded end 1092 configured to screw-engage with a complementary threaded portion in the opening of the housing 1050. In other embodiments, attachment 1090 is screwed into nuts 1092 located within and between wings 1004 of plate 1006. When attachment 1090 is screwed into opening 1008, nuts 1092 are pulled away from the housing 1050, thereby separating and / or spreading the wings 1004. As a result, an interference fit is created between the wings 1004 and the housing 1050.

[0144] The embodiment shown in Figures 47-51 is modular in that the plate 1005 is separate but connectable to and removable from the expandable fusion intervertebral implant device 1000. The plate 1005 is configured to connect to the housing 1050 after the expandable fusion intervertebral implant device 1000 has expanded to the desired configuration. As a result, the method described herein may also include connecting the plate 1005 to the implant and fixing the plate 1005 to the bone via a fixation element received within the fixation opening 1009. This modular design allows the surgeon to use a fixed implant without having to remove a non-fixed implant and replace it with a fixed implant.

[0145] While certain features and embodiments are described to enable those skilled in the art to manufacture and use the inventions described in the claims, it should be understood that some modifications, changes, or substitutions can be achieved to arrive at this disclosure. Nothing in this specification should be construed as limiting the spirit and scope of the inventions described in the following claims.

Claims

1. The first end plate and the second end plate; A first translational member movably coupled to the first actuator; A second translational member movably coupled to the second actuator; It has a mechanism to prevent movement; The first translational member is configured to move independently of the second translational member; The first translational member and the second translational member are configured to change the spatial relationship between the first end plate and the second end plate; The movement prevention mechanism has a plurality of flexible members configured to restrict the rotation of at least one of the first actuator and the second actuator. Expandable implant.

2. At least one of the first end plate and the second end plate further has a porous bone engagement surface. The expandable implant according to claim 1.

3. At least one of the first translational member and the second translational member further has at least one wedge configured to interact with at least one of the first end plate and the second end plate. The expandable implant according to claim 1.

4. The first translational member is movably coupled to the second translational member, and the first and second translational members are configured to move independently of each other. The expandable implant according to claim 1.

5. The first translational member is movably coupled to the second translational member by a dovetail coupling. The expandable implant according to claim 4.

6. The present invention further comprises a housing configured to enclose at least a portion of the first actuator and at least a portion of the second actuator. The expandable implant according to claim 1.

7. One or more of the first actuator and the second actuator further have lobes configured to receive at least a portion of the flexible member configured to restrict its movement. The expandable implant according to claim 1.

8. The first end plate and the second end plate; A first translational member positioned between the first end plate and the second end plate and movably coupled to the first drive screw; A second translational member positioned between the first end plate and the second end plate and movably connected to the second drive screw; It has a mechanism to prevent movement, The first translational member is configured to move independently of the second translational member. The first translational member and the second translational member are configured to change the spatial relationship between the first end plate and the second end plate. The movement prevention mechanism has a plurality of flexible members configured to restrict the rotation of at least one of the first drive screw and the second drive screw. Expandable implant.

9. At least one of the first end plate and the second end plate further has a porous bone engagement surface. The expandable implant according to claim 8.

10. The first translational member further comprises at least one wedge. The expandable implant according to claim 8.

11. The second translational member further comprises at least one wedge. The expandable implant according to claim 8.

12. The first translational member is movably coupled to the second translational member, and the first and second translational members are configured to move independently of each other. The expandable implant according to claim 8.

13. The first translational member is movably coupled to the second translational member by a dovetail. The expandable implant according to claim 12.

14. The device further comprises a housing configured to surround at least a portion of the first drive screw and at least a portion of the second drive screw. The expandable implant according to claim 8.

15. One or more of the first drive screw and the second drive screw further have lobes configured to receive at least a portion of the flexible member configured to restrict its rotation. The expandable implant according to claim 8.

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