Expandable intervertebral fusion device
Patent Information
- Application Number
- JP2025142991
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2017-04-04
- Filing Date
- 2025-08-29
- Publication Date
- 2026-02-12
AI Technical Summary
Conventional intervertebral fusion devices face challenges in being inserted through minimal surgical corridors and maintaining intervertebral height without causing neural pressure, often requiring distracting vertebral bodies and having a larger footprint to resist subsidence.
A deployable fusion device that can be inserted with minimal distraction and expanded to a larger footprint, featuring a wedge and ramp assembly actuated by a drive mechanism to increase width and height, reducing neural pressure and maintaining spinal alignment.
The device effectively maintains intervertebral height and alignment while minimizing surgical trauma and preventing subsidence, facilitating efficient fusion through a small surgical corridor.
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Abstract
Description
[Technical Field]
[0001] cross reference This application claims the benefit of U.S. Provisional Application No. 62 / 444,663, filed January 10, 2017 (Attorney Docket No. 51624-703.101), U.S. Provisional Application No. 62 / 471,206, filed March 14, 2017 (Attorney Docket No. 51624-703.102), and U.S. Provisional Application No. 62 / 481,565, filed April 4, 2017 (Attorney Docket No. 51624-703.103), the entire contents of which are incorporated herein by reference. [Background technology]
[0002] background The present disclosure relates to medical devices and methods, more preferably to instruments and methods for promoting intervertebral fusion, and more particularly to deployable fusion devices that can be inserted between adjacent vertebrae to facilitate the fusion process.
[0003] A common treatment for pain associated with degenerated discs due to various factors, such as trauma or aging, is the use of intervertebral fusion devices to fuse one or more adjacent vertebral bodies. Generally, to fuse the adjacent vertebral bodies, the disc is first partially or completely removed. A fusion device is then typically inserted between the neighboring vertebrae to maintain normal disc spacing and restore spinal stability, thereby facilitating fusion.
[0004] There are several conventional fusion devices and methodologies known in the art for achieving intervertebral fusion. These include screw and rod arrangements, solid bone implants, and fusion devices that typically include cages or other implant mechanisms loaded with bone and / or bone growth inducers. These devices are implanted between adjacent vertebral bodies to fuse them together and alleviate associated pain.
[0005] However, there are challenges associated with known conventional fusion devices and methodologies. For example, current methods for placing conventional fusion devices may require distracting adjacent vertebral bodies to return a diseased disc space to its normal or healthy height prior to implantation of the fusion device. To maintain this height once the fusion device is inserted, the fusion device is typically sized to be taller than the initial distraction height. This height difference can make it difficult for a surgeon to place the fusion device into the distracted disc space.
[0006] Thus, there is a need for a fusion device that can be placed at a minimal, unobtrusive height within the disc space and that can maintain the normal distance between adjacent vertebral bodies when implanted.
[0007] One of the most common postoperative complications of intervertebral fusion surgery is subsidence of the intervertebral graft or cage, which can be minimized or mitigated by using a larger footprint intervertebral cage or graft. To minimize the trauma and morbidity associated with spinal surgery, it is often advantageous to utilize the smallest surgical access corridor possible to accomplish the surgical objectives, which is often difficult. Therefore, there is a need for a fusion device that can be inserted through a relatively small surgical corridor and then expanded to a larger footprint suitable for resisting subsidence.
[0008] The present device preferably meets both of these criteria, being inserted with minimal or no intervertebral distraction and minimal width through a relatively small surgical channel, and then deployed and maintained at a larger footprint suitable for resisting subsidence and at a higher height suitable for the purposes of reducing pressure on neural elements and maintaining intervertebral height, as well as maintaining desired alignment of adjacent vertebral bodies. At least some of these objectives will be achieved by the exemplary embodiments disclosed herein.
[0009] Description of the Background Art 8,568,481;8,926,704;9,474,625;9,138,328;9,445,918;2016 / 0317315;2016 / 0324654;US20170056200A1;US9801734;US9795493;US9 717601;US6821298;US20110035011A1;US9445918;US9480574;US6176882;US8105382;US8568481;US20160302940;US9561116;US927800. Summary of the Invention
[0010] overview Optionally, in any aspect, the present disclosure provides a deployable fusion device that can be inserted with minimal or no intervertebral distraction and with minimal width through a relatively small surgical channel, and then deployed with a larger footprint suitable for resisting subsidence, reducing pressure on neural elements and maintaining intervertebral height, as well as maintaining desired alignment of adjacent vertebral bodies.
[0011] In one embodiment, the fusion device includes a proximal wedge, a distal wedge, a first ramp, a second ramp, a third ramp, a fourth ramp, a first endplate, a second endplate, a third endplate, a fourth endplate, an actuator, and a retention member designed to constrain linear movement of the actuator relative to the proximal wedge. The actuator can pull the proximal and distal wedges together or away from each other and force the first ramp away from the fourth ramp, the second ramp away from the third ramp, the first ramp away from or toward the second ramp, and the third ramp away from or toward the fourth ramp, resulting in the first endplate, second endplate, third endplate, and fourth endplate moving outward from each other to a deployed configuration.
[0012] A first aspect provided herein is a deployable fusion device for implantation between two adjacent vertebrae, the device including: an actuator including a drive mechanism and a longitudinal shaft; a wedge assembly coupled to the actuator; a ramp assembly slidably coupled to the wedge assembly; an upper endplate assembly slidably coupled to the ramp assembly; and a lower endplate assembly slidably coupled to the ramp assembly.
[0013] Optionally, in any embodiment, the device has a width that includes an external width of at least one of the upper end plate assembly and the lower end plate assembly. Optionally, in any embodiment, the device has a height that includes an external distance between the upper end plate assembly and the lower end plate assembly. Optionally, in any embodiment, actuation of the drive mechanism a first number of actuations in a first actuation direction increases the width without increasing the height. Optionally, in any embodiment, actuation of the drive mechanism a second number of actuations greater than the first number of actuations in the first actuation direction increases at least one of the height and the width.
[0014] Optionally, in any embodiment, the first actuation number is from about 0.5 actuation to about 10 actuations. Optionally, in any embodiment, the first actuation number is at least about 0.5 actuations. Optionally, in any embodiment, the first actuation number is at most about 10 actuations. Optionally, in any embodiment, the first actuation number is from about 0.5 actuation to about 1 actuation, from about 0.5 actuation to about 1.5 actuations, from about 0.5 actuation to about 2 actuations, from about 0.5 actuation to about 2.5 actuations, from about 0.5 actuation to about 3 actuations, from about 0.5 actuation to about 3.5 actuations, from about 0.5 actuation to about 4 actuations, from about 0.5 actuation to about 5 actuations, from about 0.5 actuation to about 6 actuations, from about 0.5 actuation to about 8 actuations, from about 0.5 actuation to about 10 actuations, from about 1 actuation to about 1.5 actuations, from about 1 actuation to about 2 actuations, from about 1 actuation to about 2.5 actuations, 1 actuation to about 3 acts, about 1 actuation to about 3.5 acts, about 1 actuation to about 4 acts, about 1 actuation to about 5 acts, about 1 actuation to about 6 acts, about 1 actuation to about 8 acts, about 1 actuation to about 10 acts, about 1.5 acts to about 2 acts, about 1.5 acts to about 2.5 acts, about 1.5 acts to about 3 acts, about 1.5 acts to about 3.5 acts, about 1.5 acts to about 4 acts, about 1.5 acts to about 5 acts, about 1.5 acts to about 6 acts, about 1.5 acts to about 8 acts, about 1.5 acts to about 10 acts, about 2 acts to about 2.5 acts, Approximately 2 acts to approximately 3 acts, approximately 2 acts to approximately 3.5 acts, approximately 2 acts to approximately 4 acts, approximately 2 acts to approximately 5 acts, approximately 2 acts to approximately 6 acts, approximately 2 acts to approximately 8 acts, approximately 2 acts to approximately 10 acts, approximately 2.5 acts to approximately 3 acts, approximately 2.5 acts to approximately 3.5 acts, approximately 2.5 acts to approximately 4 acts, approximately 2.5 acts to approximately 5 acts, approximately 2.5 acts to approximately 6 acts, approximately 2.5 acts to approximately 8 acts, approximately 2.5 acts to approximately 10 acts, approximately 3 acts to approximately 3.5 acts, approximately 3 acts to approximately 4 acts, approximately 3 acts to approximately 5 acts, approximately 3 acts to The first actuation number is about 6 actuation, about 3 actuation to about 8 actuation, about 3 actuation to about 10 actuation, about 3.5 actuation to about 4 actuation, about 3.5 actuation to about 5 actuation, about 3.5 actuation to about 6 actuation, about 3.5 actuation to about 8 actuation, about 3.5 actuation to about 10 actuation, about 4 actuation to about 5 actuation, about 4 actuation to about 6 actuation, about 4 actuation to about 8 actuation, about 4 actuation to about 10 actuation, about 5 actuation to about 6 actuation, about 5 actuation to about 8 actuation, about 5 actuation to about 10 actuation, about 6 actuation to about 8 actuation, about 6 actuation to about 10 actuation, or about 8 actuation to about 10 actuation. Optionally, in any embodiment, the first actuation number is about 0.5 actuation, about 1 actuation, about 1.5 actuation, about 2 actuation, about 2.5 actuation, about 3 actuation, about 3.5 actuation, about 4 actuation, about 5 actuation, about 6 actuation, about 8 actuation, or about 10 actuation.
[0015] Optionally, in any embodiment, the second actuation number is from about 0.5 actuation to about 10 actuations. Optionally, in any embodiment, the second actuation number is at least about 0.5 actuations. Optionally, in any embodiment, the second actuation number is at most about 10 actuations. Optionally, in any embodiment, the second actuation number is from about 0.5 actuation to about 1 actuation, from about 0.5 actuation to about 1.5 actuations, from about 0.5 actuation to about 2 actuations, from about 0.5 actuation to about 2.5 actuations, from about 0.5 actuation to about 3 actuations, from about 0.5 actuation to about 3.5 actuations, from about 0.5 actuation to about 4 actuations, from about 0.5 actuation to about 5 actuations, from about 0.5 actuation to about 6 actuations, from about 0.5 actuation to about 8 actuations, from about 0.5 actuation to about 10 actuations, from about 1 actuation to about 1.5 actuations, from about 1 actuation to about 2 actuations, from about 1 actuation to about 2.5 actuations, 1 actuation to about 3 acts, about 1 actuation to about 3.5 acts, about 1 actuation to about 4 acts, about 1 actuation to about 5 acts, about 1 actuation to about 6 acts, about 1 actuation to about 8 acts, about 1 actuation to about 10 acts, about 1.5 acts to about 2 acts, about 1.5 acts to about 2.5 acts, about 1.5 acts to about 3 acts, about 1.5 acts to about 3.5 acts, about 1.5 acts to about 4 acts, about 1.5 acts to about 5 acts, about 1.5 acts to about 6 acts, about 1.5 acts to about 8 acts, about 1.5 acts to about 10 acts, about 2 acts to about 2.5 acts, Approximately 2 acts to approximately 3 acts, approximately 2 acts to approximately 3.5 acts, approximately 2 acts to approximately 4 acts, approximately 2 acts to approximately 5 acts, approximately 2 acts to approximately 6 acts, approximately 2 acts to approximately 8 acts, approximately 2 acts to approximately 10 acts, approximately 2.5 acts to approximately 3 acts, approximately 2.5 acts to approximately 3.5 acts, approximately 2.5 acts to approximately 4 acts, approximately 2.5 acts to approximately 5 acts, approximately 2.5 acts to approximately 6 acts, approximately 2.5 acts to approximately 8 acts, approximately 2.5 acts to approximately 10 acts, approximately 3 acts to approximately 3.5 acts, approximately 3 acts to approximately 4 acts, approximately 3 acts to approximately 5 acts, approximately 3 acts to The second actuation number is about 6 actuation, about 3 actuation to about 8 actuation, about 3 actuation to about 10 actuation, about 3.5 actuation to about 4 actuation, about 3.5 actuation to about 5 actuation, about 3.5 actuation to about 6 actuation, about 3.5 actuation to about 8 actuation, about 3.5 actuation to about 10 actuation, about 4 actuation to about 5 actuation, about 4 actuation to about 6 actuation, about 4 actuation to about 8 actuation, about 4 actuation to about 10 actuation, about 5 actuation to about 6 actuation, about 5 actuation to about 8 actuation, about 5 actuation to about 10 actuation, about 6 actuation to about 8 actuation, about 6 actuation to about 10 actuation, or about 8 actuation to about 10 actuation. Optionally, in any embodiment, the second actuation number is about 0.5 actuation, about 1 actuation, about 1.5 actuation, about 2 actuation, about 2.5 actuation, about 3 actuation, about 3.5 actuation, about 4 actuation, about 5 actuation, about 6 actuation, about 8 actuation, or about 10 actuation.
[0016] Optionally, in any embodiment, actuation of the drive mechanism a second number of actuations in a first actuation direction beyond the first number of actuations increases both the height and the width. Optionally, in any embodiment, actuation of the drive mechanism a third number of actuations in a first actuation direction beyond the first and second numbers of actuations increases the height without increasing the width.
[0017] Optionally, in any embodiment, the width of the device is maximized when the drive mechanism is actuated by at least the first number of actuations. Optionally, in any embodiment, the height of the device is maximized when the drive mechanism is actuated by at least the first and second number of actuations.
[0018] Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by about 30% to about 400%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by at least about 30%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by up to about 400%.Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first number of actuations increases the height of the device by about 30% to about 50%, about 30% to about 75%, about 30% to about 100%, about 30% to about 125%, about 30% to about 150%, about 30% to about 175%, about 30% to about 200%, about 30% to about 250%, about 30% to about 300%, about 30% to about 350%, about 30% to about 400%, about 50% to about 75%, about 50% to about 100%, about 50% to about 1 25%, about 50% to about 150%, about 50% to about 175%, about 50% to about 200%, about 50% to about 250%, about 50% to about 300%, about 50% to about 350%, about 50% to about 400%, about 75% to about 100%, about 75% to about 125%, about 75% to about 150%, about 75% to about 175%, about 75% to about 200%, about 75% to about 250%, about 75% to about 300%, about 75% to about 350%, about 75% to about 400%, about 100% to about 125%, about 100% to about 150%, about 1 00% to approximately 175%, approximately 100% to approximately 200%, approximately 100% to approximately 250%, approximately 100% to approximately 300%, approximately 100% to approximately 350%, approximately 100% to approximately 400%, approximately 125% to approximately 150%, approximately 125% to approximately 175%, approximately 125% to approximately 200%, approximately 125% to approximately 250%, approximately 125% to approximately 300%, approximately 125% to approximately 350%, approximately 125% to approximately 400%, approximately 150% to approximately 175%, approximately 150% to approximately 200%, approximately 150% to approximately 250%, approximately 150% to approximately 300%, approximately 150 % to about 350%, about 150% to about 400%, about 175% to about 200%, about 175% to about 250%, about 175% to about 300%, about 175% to about 350%, about 175% to about 400%, about 200% to about 250%, about 200% to about 300%, about 200% to about 350%, about 200% to about 400%, about 250% to about 300%, about 250% to about 350%, about 250% to about 400%, about 300% to about 350%, about 300% to about 400%, or about 350% to about 400%. Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first number of actuations increases the height of the device by about 30%, about 50%, about 75%, about 100%, about 125%, about 150%, about 175%, about 200%, about 250%, about 300%, about 350%, or about 400%.
[0019] Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by about 14% to about 150%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by at least about 14%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by up to about 150%.Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first and second actuation numbers can increase the width of the device by about 14% to about 20%, about 14% to about 30%, about 14% to about 40%, about 14% to about 50%, about 14% to about 60%, about 14% to about 70%, about 14% to about 80%, about 14% to about 100%, about 14% to about 120%, about 14% to about 140%, about 14% to about 150%, about 20% to about 30%, about 20% to about 40%, about 20% to about 50%, about 20% to about 60%, about 20% to about 70%, about 20% to about 80%, about 20% to about 100%, about 20% to about 120%, about 20% to about 140%, about 20% to about 150%, about 30% to about 40%, about 30% to about 50%, about 30% to about 60%, about 30% to about 70%, about 30% to about 80%, about 30% to about 100%, about 30% to about 120%, about 30% to about 140%, about 30% to about 150%, about 40% to about 50%, about 4 0% to approximately 60%, approximately 40% to approximately 70%, approximately 40% to approximately 80%, approximately 40% to approximately 100%, approximately 40% to approximately 120%, approximately 40% to approximately 140%, approximately 40% to approximately 150%, approximately 50% to approximately 60%, approximately 50% to approximately 70%, approximately 50% to approximately 80%, approximately 50% to approximately 100%, approximately 50% to approximately 120%, approximately 50% to approximately 140%, approximately 50% to approximately 150%, approximately 60% to approximately 70%, approximately 60% to approximately 80%, approximately 60% to approximately 100%, approximately 60% to approximately 120%, approximately 60% to An increase of about 140%, about 60% to about 150%, about 70% to about 80%, about 70% to about 100%, about 70% to about 120%, about 70% to about 140%, about 70% to about 150%, about 80% to about 100%, about 80% to about 120%, about 80% to about 140%, about 80% to about 150%, about 100% to about 120%, about 100% to about 140%, about 100% to about 150%, about 120% to about 140%, about 120% to about 150%, or about 140% to about 150%. Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first and second actuation numbers increases the width of the device by about 14%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 100%, about 120%, about 140%, or about 150%.
[0020] Optionally, in any embodiment, the actuator has a distal end and a proximal end. Optionally, in any embodiment, at least a portion of the distal end includes a first thread mechanism. Optionally, in any embodiment, at least a portion of the proximal end includes a second thread mechanism. Optionally, in any embodiment, the proximal end includes a drive mechanism. Optionally, in any embodiment, at least one of the first thread mechanism and the second thread mechanism includes threads disposed outside the periphery of the actuator. Optionally, in any embodiment, the first thread mechanism and the second thread mechanism have opposite threading directions.
[0021] Optionally, in any embodiment, the wedge assembly includes a distal wedge and a proximal wedge. Optionally, in any embodiment, actuation of the drive mechanism in a first direction moves the distal wedge and the proximal wedge toward each other. Optionally, in any embodiment, the distal wedge includes a third thread mechanism, the third thread mechanism threadably coupled to the first thread mechanism. Optionally, in any embodiment, the proximal wedge includes a fourth thread mechanism, the fourth thread mechanism threadably coupled to the second thread mechanism. Optionally, in any embodiment, the third thread mechanism includes threads disposed on the interior of the distal wedge. Optionally, in any embodiment, the fourth thread mechanism includes threads disposed on the interior of the proximal wedge.
[0022] Optionally, in any embodiment, the lamp assembly includes a first distal lamp, a second distal lamp, a first proximal lamp, and a second proximal lamp. Optionally, in any embodiment, the slidable connection between at least one of the wedge assembly and the lamp assembly, the lamp assembly and the upper end plate assembly, and the lamp assembly and the lower end plate assembly is at an angular position transverse to the longitudinal axis.
[0023] Optionally, in any embodiment, the angle across the longitudinal axis is from about 0° to about 90°. Optionally, in any embodiment, the angle across the longitudinal axis is at least about 0°. Optionally, in any embodiment, the angle across the vertical axis is at most about 90°. Optionally, in any embodiment, the angle across the vertical axis is at most about 0° to about 1°, about 0° to about 5°, about 0° to about 10°, about 0° to about 20°, about 0° to about 30°, about 0° to about 40°, about 0° to about 50°, about 0° to about 60°, about 0° to about 70°, about 0° to about 80°, about 0° to about 90°, about 1° to about 5°, about 1° to about 10°, about 1° to about 20°, about 1° to about 30°, or about 1° to about 40°. , about 1° to about 50°, about 1° to about 60°, about 1° to about 70°, about 1° to about 80°, about 1° to about 90°, about 5° to about 10°, about 5° to about 20°, about 5° to about 30°, about 5° to about 40°, about 5° to about 50°, about 5° to about 60°, about 5° to about 70°, about 5° to about 80°, about 5° to about 90°, about 10° to about 20°, about 10° to about 30°, about 10° to about 40°, about 10° to about 5 0°, approximately 10° to approximately 60°, approximately 10° to approximately 70°, approximately 10° to approximately 80°, approximately 10° to approximately 90°, approximately 20° to approximately 30°, approximately 20° to approximately 40°, approximately 20° to approximately 50°, approximately 20° to approximately 60°, approximately 20° to approximately 70°, approximately 20° to approximately 80°, approximately 20° to approximately 90°, approximately 30° to approximately 40°, approximately 30° to approximately 50°, approximately 30° to approximately 60°, approximately 30° to approximately 70°, approximately 30° to approximately 80°, approximately The angle is 30° to about 90°, about 40° to about 50°, about 40° to about 60°, about 40° to about 70°, about 40° to about 80°, about 40° to about 90°, about 50° to about 60°, about 50° to about 70°, about 50° to about 80°, about 50° to about 90°, about 60° to about 70°, about 60° to about 80°, about 60° to about 90°, about 70° to about 80°, about 70° to about 90°, or about 80° to about 90°. Optionally, in any embodiment, the angle across the longitudinal axis is about 0°, about 1°, about 5°, about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, or about 90°.
[0024] Optionally, in any embodiment, the slidable connection between at least one of the wedge assembly and the lamp assembly, the lamp assembly and the upper end plate assembly, and the lamp assembly and the lower end plate assembly includes a protrusion and a slot. Optionally, in any embodiment, the protrusion extends from at least one of the wedge assembly, the lamp assembly, the upper end plate assembly, and the lower end plate assembly, and the slot is disposed in at least one of the upper end plate assembly and the lower end plate assembly. Optionally, in any embodiment, the protrusion comprises a pin, a ridge, a dimple, a bolt, a screw, a bearing, or any combination thereof. Optionally, in any embodiment, the slot comprises a through slot, a blind slot, a t-slot, a v-slot, a groove, or any combination thereof.
[0025] Optionally, in any embodiment, the drive mechanism includes a recessed area configured to receive a drive instrument. Optionally, in any embodiment, the recessed area includes a slot, Phillips, Pozidriv, Frearson, Robertson, 12-point flange, hex socket, security hex socket, star drive, security Torx®, ta, three-point, three-wing, spanner head, clutch, one-way, double square, triple square, Polydrive, spline drive, double hex, bristles, threaded, friction fit, or pentalobe recess. Optionally, in any embodiment, a protuberance extends from the drive mechanism and is configured to couple to the drive instrument. Optionally, in any embodiment, the protuberance includes a hex, hexalobular, threaded, or square protuberance.
[0026] Optionally, in any embodiment, the upper endplate assembly includes a first endplate and a second endplate, and the lower endplate assembly includes a third endplate and a fourth endplate. Optionally, in any embodiment, at least one of the first endplate and the second endplate, the third endplate and the fourth endplate, the first proximal ramp and the second proximal ramp, and the first distal ramp and the second distal ramp have mirror equivalents. Optionally, in any embodiment, at least one of the second endplate and the fourth endplate is larger than at least one of the first endplate and the third endplate. Optionally, in any embodiment, the outer surface of at least one of the first endplate, the second endplate, the third endplate, and the fourth endplate includes a texture configured to grip a vertebra. Optionally, in any embodiment, the texturing includes teeth, protuberances, roughened areas, metal coatings, ceramic coatings, keels, spikes, protrusions, grooves, or any combination thereof.
[0027] Optionally, in any embodiment, at least one of the actuator, wedge assembly, ramp assembly, upper end plate assembly, and lower end plate assembly comprises titanium, cobalt, stainless steel, tantalum, platinum, PEEK, PEKK, carbon fiber, barium sulfate, hydroxyapatite, ceramic, zirconium oxide, silicon nitride, carbon, bone implant pieces, demineralized bone matrix products, synthetic bone substitutes, bone forming agents, bone growth inducing materials, or any combination thereof.
[0028] A second aspect provided herein is an expandable fusion system for implantation between two adjacent vertebrae, the system including an inserter and an expandable fusion device, the device including: an actuator including a drive mechanism and a longitudinal axis; a wedge assembly; a ramp assembly; an upper endplate assembly; and a lower endplate assembly; wherein the device has a width including an external distance between at least one of a first endplate and a third endplate, and a second endplate and a fourth endplate; the device has a height including an external distance between at least one of a first endplate and a second endplate, and a third endplate and a fourth endplate; actuating the drive mechanism a first number of actuations in a first actuation direction increases the width without increasing the height; and actuating the drive mechanism a second number of actuations greater than the first number of actuations in the first actuation direction increases at least one of the height and the width.
[0029] Optionally, in any embodiment, actuation of the drive mechanism a second number of actuations in a first actuation direction greater than the first number of actuations increases both the height and the width. Optionally, in any embodiment, actuation of the drive mechanism a second number of actuations in a first actuation direction greater than the first number of actuations increases the height without increasing the width.
[0030] Optionally, in any embodiment, the width of the device is maximized when the drive mechanism is actuated by at least the first number of actuations. Optionally, in any embodiment, the height of the device is maximized when the drive mechanism is actuated by at least the first and second number of actuations.
[0031] Optionally, in any embodiment, the first actuation number is from about 0.5 actuation to about 10 actuations. Optionally, in any embodiment, the first actuation number is at least about 0.5 actuations. Optionally, in any embodiment, the first actuation number is at most about 10 actuations. Optionally, in any embodiment, the first actuation number is from about 0.5 actuation to about 1 actuation, from about 0.5 actuation to about 1.5 actuations, from about 0.5 actuation to about 2 actuations, from about 0.5 actuation to about 2.5 actuations, from about 0.5 actuation to about 3 actuations, from about 0.5 actuation to about 3.5 actuations, from about 0.5 actuation to about 4 actuations, from about 0.5 actuation to about 5 actuations, from about 0.5 actuation to about 6 actuations, from about 0.5 actuation to about 8 actuations, from about 0.5 actuation to about 10 actuations, from about 1 actuation to about 1.5 actuations, from about 1 actuation to about 2 actuations, from about 1 actuation to about 2.5 actuations, 1 actuation to about 3 acts, about 1 actuation to about 3.5 acts, about 1 actuation to about 4 acts, about 1 actuation to about 5 acts, about 1 actuation to about 6 acts, about 1 actuation to about 8 acts, about 1 actuation to about 10 acts, about 1.5 acts to about 2 acts, about 1.5 acts to about 2.5 acts, about 1.5 acts to about 3 acts, about 1.5 acts to about 3.5 acts, about 1.5 acts to about 4 acts, about 1.5 acts to about 5 acts, about 1.5 acts to about 6 acts, about 1.5 acts to about 8 acts, about 1.5 acts to about 10 acts, about 2 acts to about 2.5 acts, Approximately 2 acts to approximately 3 acts, approximately 2 acts to approximately 3.5 acts, approximately 2 acts to approximately 4 acts, approximately 2 acts to approximately 5 acts, approximately 2 acts to approximately 6 acts, approximately 2 acts to approximately 8 acts, approximately 2 acts to approximately 10 acts, approximately 2.5 acts to approximately 3 acts, approximately 2.5 acts to approximately 3.5 acts, approximately 2.5 acts to approximately 4 acts, approximately 2.5 acts to approximately 5 acts, approximately 2.5 acts to approximately 6 acts, approximately 2.5 acts to approximately 8 acts, approximately 2.5 acts to approximately 10 acts, approximately 3 acts to approximately 3.5 acts, approximately 3 acts to approximately 4 acts, approximately 3 acts to approximately 5 acts, approximately 3 acts to The first actuation number is about 6 actuation, about 3 actuation to about 8 actuation, about 3 actuation to about 10 actuation, about 3.5 actuation to about 4 actuation, about 3.5 actuation to about 5 actuation, about 3.5 actuation to about 6 actuation, about 3.5 actuation to about 8 actuation, about 3.5 actuation to about 10 actuation, about 4 actuation to about 5 actuation, about 4 actuation to about 6 actuation, about 4 actuation to about 8 actuation, about 4 actuation to about 10 actuation, about 5 actuation to about 6 actuation, about 5 actuation to about 8 actuation, about 5 actuation to about 10 actuation, about 6 actuation to about 8 actuation, about 6 actuation to about 10 actuation, or about 8 actuation to about 10 actuation. Optionally, in any embodiment, the first actuation number is about 0.5 actuation, about 1 actuation, about 1.5 actuation, about 2 actuation, about 2.5 actuation, about 3 actuation, about 3.5 actuation, about 4 actuation, about 5 actuation, about 6 actuation, about 8 actuation, or about 10 actuation.
[0032] Optionally, in any embodiment, the second actuation number is from about 0.5 actuation to about 10 actuations. Optionally, in any embodiment, the second actuation number is at least about 0.5 actuations. Optionally, in any embodiment, the second actuation number is at most about 10 actuations. Optionally, in any embodiment, the second actuation number is from about 0.5 actuation to about 1 actuation, from about 0.5 actuation to about 1.5 actuations, from about 0.5 actuation to about 2 actuations, from about 0.5 actuation to about 2.5 actuations, from about 0.5 actuation to about 3 actuations, from about 0.5 actuation to about 3.5 actuations, from about 0.5 actuation to about 4 actuations, from about 0.5 actuation to about 5 actuations, from about 0.5 actuation to about 6 actuations, from about 0.5 actuation to about 8 actuations, from about 0.5 actuation to about 10 actuations, from about 1 actuation to about 1.5 actuations, from about 1 actuation to about 2 actuations, from about 1 actuation to about 2.5 actuations, 1 actuation to about 3 acts, about 1 actuation to about 3.5 acts, about 1 actuation to about 4 acts, about 1 actuation to about 5 acts, about 1 actuation to about 6 acts, about 1 actuation to about 8 acts, about 1 actuation to about 10 acts, about 1.5 acts to about 2 acts, about 1.5 acts to about 2.5 acts, about 1.5 acts to about 3 acts, about 1.5 acts to about 3.5 acts, about 1.5 acts to about 4 acts, about 1.5 acts to about 5 acts, about 1.5 acts to about 6 acts, about 1.5 acts to about 8 acts, about 1.5 acts to about 10 acts, about 2 acts to about 2.5 acts, Approximately 2 acts to approximately 3 acts, approximately 2 acts to approximately 3.5 acts, approximately 2 acts to approximately 4 acts, approximately 2 acts to approximately 5 acts, approximately 2 acts to approximately 6 acts, approximately 2 acts to approximately 8 acts, approximately 2 acts to approximately 10 acts, approximately 2.5 acts to approximately 3 acts, approximately 2.5 acts to approximately 3.5 acts, approximately 2.5 acts to approximately 4 acts, approximately 2.5 acts to approximately 5 acts, approximately 2.5 acts to approximately 6 acts, approximately 2.5 acts to approximately 8 acts, approximately 2.5 acts to approximately 10 acts, approximately 3 acts to approximately 3.5 acts, approximately 3 acts to approximately 4 acts, approximately 3 acts to approximately 5 acts, approximately 3 acts to The second actuation number is about 6 actuation, about 3 actuation to about 8 actuation, about 3 actuation to about 10 actuation, about 3.5 actuation to about 4 actuation, about 3.5 actuation to about 5 actuation, about 3.5 actuation to about 6 actuation, about 3.5 actuation to about 8 actuation, about 3.5 actuation to about 10 actuation, about 4 actuation to about 5 actuation, about 4 actuation to about 6 actuation, about 4 actuation to about 8 actuation, about 4 actuation to about 10 actuation, about 5 actuation to about 6 actuation, about 5 actuation to about 8 actuation, about 5 actuation to about 10 actuation, about 6 actuation to about 8 actuation, about 6 actuation to about 10 actuation, or about 8 actuation to about 10 actuation. Optionally, in any embodiment, the second actuation number is about 0.5 actuation, about 1 actuation, about 1.5 actuation, about 2 actuation, about 2.5 actuation, about 3 actuation, about 3.5 actuation, about 4 actuation, about 5 actuation, about 6 actuation, about 8 actuation, or about 10 actuation.
[0033] Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by about 30% to about 400%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by at least about 30%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by up to about 400%.Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first number of actuations increases the height of the device by about 30% to about 50%, about 30% to about 75%, about 30% to about 100%, about 30% to about 125%, about 30% to about 150%, about 30% to about 175%, about 30% to about 200%, about 30% to about 250%, about 30% to about 300%, about 30% to about 350%, about 30% to about 400%, about 50% to about 75%, about 50% to about 100%, about 50% to about 1 25%, about 50% to about 150%, about 50% to about 175%, about 50% to about 200%, about 50% to about 250%, about 50% to about 300%, about 50% to about 350%, about 50% to about 400%, about 75% to about 100%, about 75% to about 125%, about 75% to about 150%, about 75% to about 175%, about 75% to about 200%, about 75% to about 250%, about 75% to about 300%, about 75% to about 350%, about 75% to about 400%, about 100% to about 125%, about 100% to about 150%, about 1 00% to approximately 175%, approximately 100% to approximately 200%, approximately 100% to approximately 250%, approximately 100% to approximately 300%, approximately 100% to approximately 350%, approximately 100% to approximately 400%, approximately 125% to approximately 150%, approximately 125% to approximately 175%, approximately 125% to approximately 200%, approximately 125% to approximately 250%, approximately 125% to approximately 300%, approximately 125% to approximately 350%, approximately 125% to approximately 400%, approximately 150% to approximately 175%, approximately 150% to approximately 200%, approximately 150% to approximately 250%, approximately 150% to approximately 300%, approximately 150 % to about 350%, about 150% to about 400%, about 175% to about 200%, about 175% to about 250%, about 175% to about 300%, about 175% to about 350%, about 175% to about 400%, about 200% to about 250%, about 200% to about 300%, about 200% to about 350%, about 200% to about 400%, about 250% to about 300%, about 250% to about 350%, about 250% to about 400%, about 300% to about 350%, about 300% to about 400%, or about 350% to about 400%. Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first number of actuations increases the height of the device by about 30%, about 50%, about 75%, about 100%, about 125%, about 150%, about 175%, about 200%, about 250%, about 300%, about 350%, or about 400%.
[0034] Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by about 14% to about 150%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by at least about 14%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by up to about 150%. Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first and second actuation numbers may result in the width of the device decreasing by about 14% to about 20%, about 14% to about 30%, about 14% to about 40%, about 14% to about 50%, about 14% to about 60%, about 14% to about 70%, about 14% to about 80%, about 14% to about 90%, about 14% to about 100%, about 14% to about 120%, about 14% to about 150%, about 20% to about 30%, about 20% to about About 40%, about 20% to about 50%, about 20% to about 60%, about 20% to about 70%, about 20% to about 80%, about 20% to about 90%, about 20% to about 100%, about 20% to about 120%, about 20% to about 150%, about 30% to about 40%, about 30% to about 50%, about 30% to about 60%, about 30% to about 70%, about 30% to about 80%, about 30% to about 90%, about 30% to about 100%, about 30% to about 120%, about 30% to about 150%, about 40% to about 50%, About 40% to about 60%, about 40% to about 70%, about 40% to about 80%, about 40% to about 90%, about 40% to about 100%, about 40% to about 120%, about 40% to about 150%, about 50% to about 60%, about 50% to about 70%, about 50% to about 80%, about 50% to about 90%, about 50% to about 100%, about 50% to about 120%, about 50% to about 150%, about 60% to about 70%, about 60% to about 80%, about 60% to about 90%, about 60% to about 100%, about 60 % to about 120%, about 60% to about 150%, about 70% to about 80%, about 70% to about 90%, about 70% to about 100%, about 70% to about 120%, about 70% to about 150%, about 80% to about 90%, about 80% to about 100%, about 80% to about 120%, about 80% to about 150%, about 90% to about 100%, about 90% to about 120%, about 90% to about 150%, about 100% to about 120%, about 100% to about 150%, or about 120% to about 150% increase.Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first and second actuation numbers increases the width of the device by about 14%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, about 120%, or about 150%.
[0035] Optionally, in any embodiment, the actuator has a distal end and a proximal end. Optionally, in any embodiment, at least a portion of the distal end includes a first thread mechanism. Optionally, in any embodiment, at least a portion of the proximal end includes a second thread mechanism, wherein the proximal end includes a drive mechanism. Optionally, in any embodiment, at least one of the first thread mechanism and the second thread mechanism includes threads disposed outside the periphery of the actuator. Optionally, in any embodiment, the first thread mechanism and the second thread mechanism have opposite threading directions.
[0036] Optionally, in any embodiment, the wedge assembly includes a distal wedge and a proximal wedge. Optionally, in any embodiment, actuation of the drive mechanism in a first direction moves the distal wedge and the proximal wedge toward each other. Optionally, in any embodiment, the distal wedge includes a third thread mechanism, the third thread mechanism threadedly engaged with the first thread mechanism. Optionally, in any embodiment, the proximal wedge includes a fourth thread mechanism, the fourth thread mechanism communicatively coupled to the second thread mechanism. Optionally, in any embodiment, the third thread mechanism includes threads disposed on the interior of the distal wedge. Optionally, in any embodiment, the fourth thread mechanism includes threads disposed on the interior of the proximal wedge.
[0037] Optionally, in any embodiment, the lamp assembly includes a first distal lamp, a second distal lamp, a first proximal lamp, and a second proximal lamp. Optionally, in any embodiment, the slidable connection between at least one of the wedge assembly and the lamp assembly, the lamp assembly and the upper end plate assembly, and the lamp assembly and the lower end plate assembly is at an angle transverse to the longitudinal axis. Optionally, in any embodiment, the angle transverse to the longitudinal axis is between about 0° and about 90°. Optionally, in any embodiment, the slidable connection between at least one of the wedge assembly and the lamp assembly, the lamp assembly and the upper end plate assembly, and the lamp assembly and the lower end plate assembly includes a protrusion and a slot. Optionally, in any embodiment, the protrusion extends from at least one of the wedge assembly, the lamp assembly, the upper end plate assembly, and the lower end plate assembly, and the slot is disposed in at least one of the upper end plate assembly and the lower end plate assembly. Optionally, in any embodiment, the protrusion includes a pin, a ridge, a dimple, a bolt, a thread, a bearing, or any combination thereof. Optionally, in any embodiment, the slot comprises a through slot, a blind slot, a t-slot, a v-slot, a groove, or any combination thereof.
[0038] Optionally, in any embodiment, the drive mechanism includes a recessed area configured to receive a drive instrument. Optionally, in any embodiment, the recessed area includes a slot, Phillips, Pozidriv, Frearson, Robertson, 12-point flange, hex socket, security hex socket, star drive, hexalobe, security Torx®, ta, three-point, three-wing, spanner head, clutch, one-way, double square, triple square, Polydrive, spline drive, double hex, bristles, threaded, friction fit, or pentalobe recess, or any other shape of recess. Optionally, in any embodiment, a protuberance extends from the drive mechanism and is configured to couple to the drive instrument. Optionally, in any embodiment, the protuberance includes a hex, hexalobular, threaded, or square protuberance, or any other shape of protuberance.
[0039] Optionally, in any embodiment, the upper endplate assembly includes a first endplate and a second endplate, and the lower endplate assembly includes a third endplate and a fourth endplate. Optionally, in any embodiment, at least one of the first endplate and the second endplate, the third endplate and the fourth endplate, the first proximal ramp and the second proximal ramp, and the first distal ramp and the second distal ramp have mirror equivalents. Optionally, in any embodiment, at least one of the second endplate and the fourth endplate is larger than at least one of the first endplate and the third endplate. Optionally, in any embodiment, the outer surface of at least one of the first endplate, the second endplate, the third endplate, and the fourth endplate includes a texture configured to grip a vertebra. Optionally, in any embodiment, the texturing includes teeth, ridges, roughened areas, metal coatings, ceramic coatings, keels, spikes, protrusions, grooves, or any combination thereof.
[0040] Optionally, in any embodiment, at least one of the actuator, wedge assembly, upper end plate assembly, and lower end plate assembly comprises titanium, cobalt, stainless steel, tantalum, platinum, PEEK, PEKK, PEI, PET, carbon fiber, barium sulfate, hydroxyapatite, ceramic, zirconium oxide, silicon nitride, carbon, bone implant pieces, demineralized bone matrix products, synthetic bone substitutes, bone forming agents, bone growth inducing materials, or any combination thereof.
[0041] A third aspect provided herein is a method for implanting a deployable fusion device between two adjacent vertebrae, the method including: inserting a device having a width and a height between the two adjacent vertebrae; actuating the drive mechanism a first number of actuations in a first actuation to increase the width without increasing the height; and actuating the drive mechanism a second number of actuations greater than the first number of actuations in a first actuation direction to increase at least one of the height and the width; and attaching an inserter to the deployable fusion device, wherein the device has a width and a height and includes the drive mechanism.
[0042] Optionally, in any embodiment, actuation of the drive mechanism a second number of actuations in a first actuation direction greater than the first number of actuations increases both the height and the width. Optionally, in any embodiment, actuation of the drive mechanism a second number of actuations in a first actuation direction greater than the first number of actuations increases the height without increasing the width.
[0043] Optionally, in any embodiment, the width of the device is maximized when the drive mechanism is actuated by at least the first number of actuations. Optionally, in any embodiment, the height of the device is maximized when the drive mechanism is actuated by at least the first and second number of actuations.
[0044] Optionally, in any embodiment, the first actuation number is from about 0.5 actuation to about 10 actuations. Optionally, in any embodiment, the first actuation number is at least about 0.5 actuations. Optionally, in any embodiment, the first actuation number is at most about 10 actuations. Optionally, in any embodiment, the first actuation number is from about 0.5 actuation to about 1 actuation, from about 0.5 actuation to about 1.5 actuations, from about 0.5 actuation to about 2 actuations, from about 0.5 actuation to about 2.5 actuations, from about 0.5 actuation to about 3 actuations, from about 0.5 actuation to about 3.5 actuations, from about 0.5 actuation to about 4 actuations, from about 0.5 actuation to about 5 actuations, from about 0.5 actuation to about 6 actuations, from about 0.5 actuation to about 8 actuations, from about 0.5 actuation to about 10 actuations, from about 1 actuation to about 1.5 actuations, from about 1 actuation to about 2 actuations, from about 1 actuation to about 2.5 actuations, 1 actuation to about 3 acts, about 1 actuation to about 3.5 acts, about 1 actuation to about 4 acts, about 1 actuation to about 5 acts, about 1 actuation to about 6 acts, about 1 actuation to about 8 acts, about 1 actuation to about 10 acts, about 1.5 acts to about 2 acts, about 1.5 acts to about 2.5 acts, about 1.5 acts to about 3 acts, about 1.5 acts to about 3.5 acts, about 1.5 acts to about 4 acts, about 1.5 acts to about 5 acts, about 1.5 acts to about 6 acts, about 1.5 acts to about 8 acts, about 1.5 acts to about 10 acts, about 2 acts to about 2.5 acts, Approximately 2 acts to approximately 3 acts, approximately 2 acts to approximately 3.5 acts, approximately 2 acts to approximately 4 acts, approximately 2 acts to approximately 5 acts, approximately 2 acts to approximately 6 acts, approximately 2 acts to approximately 8 acts, approximately 2 acts to approximately 10 acts, approximately 2.5 acts to approximately 3 acts, approximately 2.5 acts to approximately 3.5 acts, approximately 2.5 acts to approximately 4 acts, approximately 2.5 acts to approximately 5 acts, approximately 2.5 acts to approximately 6 acts, approximately 2.5 acts to approximately 8 acts, approximately 2.5 acts to approximately 10 acts, approximately 3 acts to approximately 3.5 acts, approximately 3 acts to approximately 4 acts, approximately 3 acts to approximately 5 acts, approximately 3 acts to The first actuation number is about 6 actuation, about 3 actuation to about 8 actuation, about 3 actuation to about 10 actuation, about 3.5 actuation to about 4 actuation, about 3.5 actuation to about 5 actuation, about 3.5 actuation to about 6 actuation, about 3.5 actuation to about 8 actuation, about 3.5 actuation to about 10 actuation, about 4 actuation to about 5 actuation, about 4 actuation to about 6 actuation, about 4 actuation to about 8 actuation, about 4 actuation to about 10 actuation, about 5 actuation to about 6 actuation, about 5 actuation to about 8 actuation, about 5 actuation to about 10 actuation, about 6 actuation to about 8 actuation, about 6 actuation to about 10 actuation, or about 8 actuation to about 10 actuation. Optionally, in any embodiment, the first actuation number is about 0.5 actuation, about 1 actuation, about 1.5 actuation, about 2 actuation, about 2.5 actuation, about 3 actuation, about 3.5 actuation, about 4 actuation, about 5 actuation, about 6 actuation, about 8 actuation, or about 10 actuation.
[0045] Optionally, in any embodiment, the second actuation number is from about 0.5 actuation to about 10 actuations. Optionally, in any embodiment, the second actuation number is at least about 0.5 actuations. Optionally, in any embodiment, the second actuation number is at most about 10 actuations. Optionally, in any embodiment, the second actuation number is from about 0.5 actuation to about 1 actuation, from about 0.5 actuation to about 1.5 actuations, from about 0.5 actuation to about 2 actuations, from about 0.5 actuation to about 2.5 actuations, from about 0.5 actuation to about 3 actuations, from about 0.5 actuation to about 3.5 actuations, from about 0.5 actuation to about 4 actuations, from about 0.5 actuation to about 5 actuations, from about 0.5 actuation to about 6 actuations, from about 0.5 actuation to about 8 actuations, from about 0.5 actuation to about 10 actuations, from about 1 actuation to about 1.5 actuations, from about 1 actuation to about 2 actuations, from about 1 actuation to about 2.5 actuations, 1 actuation to about 3 acts, about 1 actuation to about 3.5 acts, about 1 actuation to about 4 acts, about 1 actuation to about 5 acts, about 1 actuation to about 6 acts, about 1 actuation to about 8 acts, about 1 actuation to about 10 acts, about 1.5 acts to about 2 acts, about 1.5 acts to about 2.5 acts, about 1.5 acts to about 3 acts, about 1.5 acts to about 3.5 acts, about 1.5 acts to about 4 acts, about 1.5 acts to about 5 acts, about 1.5 acts to about 6 acts, about 1.5 acts to about 8 acts, about 1.5 acts to about 10 acts, about 2 acts to about 2.5 acts, Approximately 2 acts to approximately 3 acts, approximately 2 acts to approximately 3.5 acts, approximately 2 acts to approximately 4 acts, approximately 2 acts to approximately 5 acts, approximately 2 acts to approximately 6 acts, approximately 2 acts to approximately 8 acts, approximately 2 acts to approximately 10 acts, approximately 2.5 acts to approximately 3 acts, approximately 2.5 acts to approximately 3.5 acts, approximately 2.5 acts to approximately 4 acts, approximately 2.5 acts to approximately 5 acts, approximately 2.5 acts to approximately 6 acts, approximately 2.5 acts to approximately 8 acts, approximately 2.5 acts to approximately 10 acts, approximately 3 acts to approximately 3.5 acts, approximately 3 acts to approximately 4 acts, approximately 3 acts to approximately 5 acts, approximately 3 acts to about 6 actuates, about 3 actuates to about 8 actuates, about 3 actuates to about 10 actuates, about 3.5 actuates to about 4 actuates, about 3.5 actuates to about 5 actuates, about 3.5 actuates to about 6 actuates, about 3.5 actuates to about 8 actuates, about 3.5 actuates to about 10 actuates, about 4 actuates to about 5 actuates, about 4 actuates to about 6 actuates, about 4 actuates to about 8 actuates, about 4 actuates to about 10 actuates, about 5 actuates to about 6 actuates, about 5 actuates to about 8 actuates, about 5 actuates to about 10 actuates, about 6 actuates to about 8 actuates, about 6 actuates to about 10 actuates, or about 8 actuates to about 10 actuates.Optionally, in any embodiment, the second actuation number is about 0.5 actuation, about 1 actuation, about 1.5 actuation, about 2 actuation, about 2.5 actuation, about 3 actuation, about 3.5 actuation, about 4 actuation, about 5 actuation, about 6 actuation, about 8 actuation, or about 10 actuation.
[0046] Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by about 30% to about 400%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by at least about 30%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least the first number of actuations increases the height of the device by up to about 400%.Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least a first number of actuations increases the height of the device by about 30% to about 50%, about 30% to about 75%, about 30% to about 100%, about 30% to about 125%, about 30% to about 150%, about 30% to about 175%, about 30% to about 200%, about 30% to about 250%, about 30% to about 300%, about 30% to about 350%, about 30% to about 400%, about 50% to about 75%, about 50% to about 100%, about 5 ... 5%, about 50% to about 150%, about 50% to about 175%, about 50% to about 200%, about 50% to about 250%, about 50% to about 300%, about 50% to about 350%, about 50% to about 400%, about 75% to about 100%, about 75% to about 125%, about 75% to about 150%, about 75% to about 175%, about 75% to about 200%, about 75% to about 250%, about 75% to about 300%, about 75% to about 350%, about 75% to about 400%, about 100% to about 125%, about 100% to about 150%, about 10 0% to approximately 175%, approximately 100% to approximately 200%, approximately 100% to approximately 250%, approximately 100% to approximately 300%, approximately 100% to approximately 350%, approximately 100% to approximately 400%, approximately 125% to approximately 150%, approximately 125% to approximately 175%, approximately 125% to approximately 200%, approximately 125% to approximately 250%, approximately 125% to approximately 300%, approximately 125% to approximately 350%, approximately 125% to approximately 400%, approximately 150% to approximately 175%, approximately 150% to approximately 200%, approximately 150% to approximately 250%, approximately 150% to approximately 300%, approximately 150% to about 350%, about 150% to about 400%, about 175% to about 200%, about 175% to about 250%, about 175% to about 300%, about 175% to about 350%, about 175% to about 400%, about 200% to about 250%, about 200% to about 300%, about 200% to about 350%, about 200% to about 400%, about 250% to about 300%, about 250% to about 350%, about 250% to about 400%, about 300% to about 350%, about 300% to about 400%, or about 350% to about 400%. Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first number of actuations increases the height of the device by about 30%, about 50%, about 75%, about 100%, about 125%, about 150%, about 175%, about 200%, about 250%, about 300%, about 350%, or about 400%.
[0047] Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by about 14% to about 150%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by at least about 14%. Optionally, in any embodiment, actuating the drive mechanism in a first actuation direction by at least a first and second number of actuations increases the width of the device by up to about 150%.Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first and second actuation numbers can increase the width of the device by about 14% to about 20%, about 14% to about 30%, about 14% to about 40%, about 14% to about 50%, about 14% to about 60%, about 14% to about 70%, about 14% to about 80%, about 14% to about 100%, about 14% to about 120%, about 14% to about 140%, about 14% to about 150%, about 20% to about 30%, about 20% to about 40%, about 20% to about 50%, about 20% to about 60%, about 20% to about 70%, about 20% to about 80%, about 20% to about 100%, about 20% to about 120%, about 20% to about 140%, about 20% to about 150%, about 30% to about 40%, about 30% to about 50%, about 30% to about 60%, about 30% to about 70%, about 30% to about 80%, about 30% to about 100%, about 30% to about 120%, about 30% to about 140%, about 30% to about 150%, about 40% to about 50%, about 4 0% to approximately 60%, approximately 40% to approximately 70%, approximately 40% to approximately 80%, approximately 40% to approximately 100%, approximately 40% to approximately 120%, approximately 40% to approximately 140%, approximately 40% to approximately 150%, approximately 50% to approximately 60%, approximately 50% to approximately 70%, approximately 50% to approximately 80%, approximately 50% to approximately 100%, approximately 50% to approximately 120%, approximately 50% to approximately 140%, approximately 50% to approximately 150%, approximately 60% to approximately 70%, approximately 60% to approximately 80%, approximately 60% to approximately 100%, approximately 60% to approximately 120%, approximately 60% to An increase of about 140%, about 60% to about 150%, about 70% to about 80%, about 70% to about 100%, about 70% to about 120%, about 70% to about 140%, about 70% to about 150%, about 80% to about 100%, about 80% to about 120%, about 80% to about 140%, about 80% to about 150%, about 100% to about 120%, about 100% to about 140%, about 100% to about 150%, about 120% to about 140%, about 120% to about 150%, or about 140% to about 150%. Optionally, in any embodiment, actuating the drive mechanism in the first actuation direction by at least the first and second actuation numbers increases the width of the device by about 14%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 100%, about 120%, about 140%, or about 150%.
[0048] Optionally, in any embodiment, the actuator has a distal end and a proximal end. Optionally, in any embodiment, at least a portion of the distal end includes a first thread mechanism. Optionally, in any embodiment, at least a portion of the proximal end includes a second thread mechanism, wherein the proximal end includes a drive mechanism. Optionally, in any embodiment, at least one of the first thread mechanism and the second thread mechanism includes threads disposed outside the periphery of the actuator. Optionally, in any embodiment, the first thread mechanism and the second thread mechanism have opposite threading directions.
[0049] Optionally, in any embodiment, the wedge assembly includes a distal wedge and a proximal wedge. Optionally, in any embodiment, actuation of the drive mechanism in a first direction moves the distal wedge and the proximal wedge toward each other. Optionally, in any embodiment, the distal wedge includes a third thread mechanism, the third thread mechanism being threadedly engaged with the first thread mechanism. Optionally, in any embodiment, the proximal wedge includes a fourth thread mechanism, the fourth thread mechanism being threadedly engaged with the second thread mechanism. Optionally, in any embodiment, the third thread mechanism includes threads disposed on the interior of the distal wedge. Optionally, in any embodiment, the fourth thread mechanism includes threads disposed on the interior of the proximal wedge.
[0050] Optionally, in any embodiment, the lamp assembly includes a first distal lamp, a second distal lamp, a first proximal lamp, and a second proximal lamp. Optionally, in any embodiment, the slidable connection between at least one of the wedge assembly and the lamp assembly, the lamp assembly and the upper end plate assembly, and the lamp assembly and the lower end plate assembly is at an angle transverse to the longitudinal axis. Optionally, in any embodiment, the angle transverse to the longitudinal axis is between about 30° and about 90°. Optionally, in any embodiment, the slidable connection between at least one of the wedge assembly and the lamp assembly, the lamp assembly and the upper end plate assembly, and the lamp assembly and the lower end plate assembly includes a protrusion and a slot. Optionally, in any embodiment, the protrusion extends from at least one of the wedge assembly, the lamp assembly, the upper end plate assembly, and the lower end plate assembly, and the slot is disposed in at least one of the upper end plate assembly and the lower end plate assembly. Optionally, in any embodiment, the protrusion includes a pin, a ridge, a dimple, a bolt, a thread, a bearing, or any combination thereof. Optionally, in any embodiment, the slot comprises a through slot, a blind slot, a t-slot, a v-slot, a groove, or any combination thereof.
[0051] Optionally, in any embodiment, the drive mechanism includes a recessed area configured to receive a drive instrument. Optionally, in any embodiment, the recessed area includes a slot, Phillips, Pozidriv, Frearson, Robertson, 12-point flange, hex socket, security hex socket, star drive, security Torx®, ta, three-point, three-wing, spanner head, clutch, one-way, double square, triple square, Polydrive, spline drive, double hex, bristles, threaded, friction fit, or pentalobe recess. Optionally, in any embodiment, a protuberance extends from the drive mechanism and is configured to couple to the drive instrument. Optionally, in any embodiment, the protuberance includes a hex, hexalobular, threaded, or square protuberance.
[0052] Optionally, in any embodiment, the upper endplate assembly includes a first endplate and a second endplate, and the lower endplate assembly includes a third endplate and a fourth endplate. Optionally, in any embodiment, at least one of the first endplate and the second endplate, the third endplate and the fourth endplate, the first proximal ramp and the second proximal ramp, and the first distal ramp and the second distal ramp have mirror equivalents. Optionally, in any embodiment, at least one of the second endplate and the fourth endplate is larger than at least one of the first endplate and the third endplate. Optionally, in any embodiment, the outer surface of at least one of the first endplate, the second endplate, the third endplate, and the fourth endplate includes a texture configured to grip a vertebra. Optionally, in any embodiment, the texturing includes teeth, ridges, roughened areas, metal coatings, ceramic coatings, keels, spikes, protrusions, grooves, or any combination thereof.
[0053] Optionally, in any embodiment, at least one of the actuator, wedge assembly, upper end plate assembly, and lower end plate assembly comprises titanium, cobalt, stainless steel, tantalum, platinum, PEEK, PEKK, carbon fiber, barium sulfate, hydroxyapatite, ceramic, zirconium oxide, silicon nitride, carbon, bone implant pieces, demineralized bone matrix products, synthetic bone substitutes, bone forming agents, bone growth inducing materials, or any combination thereof.
[0054] Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating preferred or exemplary aspects of the disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure. [Brief explanation of the drawings]
[0055] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments in which the principles of the disclosure are utilized, and the accompanying drawings:
[0056] [Figure 1] FIG. 1 shows an exemplary first deployable fusion device implanted between two vertebral bodies in an initial, collapsed state.
[0057] [Figure 2] FIG. 2 shows an exemplary first deployable fusion device in a fully deployed state and implanted between two vertebral bodies.
[0058] [Figure 3] FIG. 3 shows a perspective view of an exemplary first deployable fusion device in an initial, folded state.
[0059] [Figure 4] FIG. 4 shows a perspective view of an exemplary first deployable fusion device in a fully deployed state.
[0060] [Figure 5] FIG. 5 shows an exploded view of an exemplary first deployable fusion device.
[0061] [Figures 6A-6F] FIG. 6A shows a top plan view of an exemplary first deployable fusion device in an initial, folded state.
[0062] FIG. 6B shows a plan end view of an exemplary first deployable fusion device in an initial, folded state.
[0063] FIG. 6C shows a planar top view of an exemplary first deployable fusion device in its fully width-deployed state.
[0064] FIG. 6D shows a planar end view of an exemplary first deployable fusion device in its fully width-deployed state.
[0065] FIG. 6E shows a planar top view of an exemplary first deployable fusion device in a fully deployed state in both width and height.
[0066] FIG. 6F shows a planar end view of an exemplary first deployable fusion device in both a fully deployed width and height state.
[0067] [Figure 7A-7C] FIG. 7A shows a detailed view of an exemplary first deployable fusion device in an initial collapsed state, illustrating articulation that causes delayed height deployment.
[0068] FIG. 7B shows a detailed view of the exemplary first deployable fusion device, particularly in its width-deployed state.
[0069] FIG. 7C shows a detailed view of the exemplary first deployable fusion device, particularly in its deployed width and height state.
[0070] [Figure 8A] FIG. 8A shows a bottom view of an exemplary end plate.
[0071] [Figure 8B] FIG. 8B shows a top view of an exemplary endplate.
[0072] [Figures 9A-9D] FIG. 9A shows an exemplary end plate having a T-shaped slot.
[0073] FIG. 9B shows an exemplary end plate having an L-shaped slot.
[0074] FIG. 9C shows an exemplary end plate with a Y-shaped slot.
[0075] FIG. 9D shows an exemplary end plate with an F-shaped slot.
[0076] [Figure 9E] FIG. 9E shows an exemplary end plate with straight slots.
[0077] [Figure 10A] FIG. 10A shows a perspective top view of an exemplary endplate.
[0078] [Figure 10B] FIG. 10B shows a bottom view of an exemplary end plate.
[0079] [Figure 10C] FIG. 10C shows a perspective view of an exemplary first deployable fusion device in a fully deployed state.
[0080] [Figures 10D1-10D3] FIG. 10D1 shows a perspective view of an exemplary first deployable fusion device in an initial, folded state.
[0081] FIG. 10D2 shows a perspective view of an exemplary first deployable fusion device in a fully deployed state.
[0082] FIG. 10D3 shows a perspective view of the exemplary first deployable fusion device in a fully deployed state with bone fasteners assembled.
[0083] [Figures 11A-11I] FIG. 11A shows an end view of an exemplary first deployable fusion device with all flat endplates.
[0084] FIG. 11B shows an end view of an exemplary first deployable fusion device with a generally convex endplate.
[0085] FIG. 11C shows an end view of an exemplary first deployable fusion device with all individually convex endplates.
[0086] FIG. 11D shows an end view of an exemplary first deployable fusion device with all flat endplates, some of which have different heights.
[0087] FIG. 11E shows an end view of an exemplary first deployable fusion device in which the top and bottom plates are generally convex and lordotic.
[0088] FIG. 11F shows an end view of an exemplary first deployable fusion device with all convex endplates, some of which have different heights.
[0089] FIG. 11G shows an end view of an exemplary first deployable fusion device with flat and lordotic endplates.
[0090] FIG. 11H shows an end view of an exemplary first deployable fusion device with a flat bottom end plate and a top end plate with distinct convex edges.
[0091] FIG. 11I shows an end view of an exemplary first deployable fusion device with two generally convex top end plates and two flat bottom end plates.
[0092] [Figures 12A-12D] FIG. 12A shows a side view of an exemplary first deployable fusion device with all flat endplates.
[0093] FIG. 12B shows a side view of an exemplary first deployable fusion device with all dome-shaped endplates.
[0094] FIG. 12C shows a side view of an exemplary first deployable fusion device with all flat and angled endplates.
[0095] FIG. 12D shows an end view of an exemplary first deployable fusion device with all flat and dome-shaped endplates.
[0096] [Figures 13A-13D] FIG. 13A shows a top view of an exemplary first deployable fusion device in an initial, collapsed state with all endplates of the same length.
[0097] FIG. 13B shows a top view of an exemplary first deployable fusion device in an initial, folded state with endplates of different lengths.
[0098] FIG. 13C shows a top view of an exemplary first expandable fusion device in a fully width-deployed state with all endplates of the same length.
[0099] FIG. 13D shows a top view of an exemplary first expandable fusion device in a fully width-deployed state with endplates of different lengths.
[0100] [Figure 14A] FIG. 14A shows a side view of height deployment of an exemplary first deployable fusion device.
[0101] [Figure 14B1]FIG. 14B1 shows a top view of an exemplary first deployable fusion device in a collapsed state, configured for uneven deployment at both ends.
[0102] [Figure 14B2] FIG. 14B2 shows a top view of a fully deployed exemplary first deployable fusion device with an alternative deployment mechanism and designed for uneven deployment at both ends.
[0103] [Figure 15A] FIG. 15A shows a side view of a width deployment of an exemplary first deployable fusion device.
[0104] [Figures 15B-15C] FIG. 15B shows a top view of an exemplary first expandable fusion device with endplates of different lengths designed to expand more width on one side than the other.
[0105] FIG. 15C shows a top view of an exemplary first expandable fusion device in its fully expanded state, with endplates of different lengths designed to expand more width on one side than the other.
[0106] [Figure 15D] FIG. 15D shows a perspective view of an exemplary first expandable fusion device in a fully deployed state with endplates of different lengths designed to expand more width on one side than the other.
[0107] [Figures 15E-15G] FIG. 15E shows a perspective view of an exemplary distal wedge with a non-uniform ramp.
[0108] FIG. 15F shows a perspective view of an exemplary proximal wedge with a non-uniform ramp.
[0109] FIG. 15G shows a perspective view of an exemplary lamp.
[0110] [Figure 16] FIG. 16 shows an end view of height deployment of an exemplary first deployable fusion device.
[0111] [Figures 17A-17B] FIG. 17A shows an inside perspective view of an exemplary lamp.
[0112] FIG. 17B shows an exterior perspective view of an exemplary lamp.
[0113] [Figures 18A-18C] FIG. 18A shows an inner perspective view of an exemplary lamp with L-shaped branches.
[0114] FIG. 18B shows an inner perspective view of an exemplary lamp with C-shaped branches.
[0115] FIG. 18C shows an inner perspective view of an exemplary lamp with T-shaped branches and T-shaped channels.
[0116] [Figure 18D-18E] FIG. 18D shows an inside perspective view of an exemplary lamp with Y-shaped branches and Y-shaped channels.
[0117] FIG. 18E shows an inside perspective view of an exemplary lamp with an inner T-shaped branch and a Y-shaped channel.
[0118] [Figures 19A-19B] FIG. 19A shows an inside perspective view of an exemplary lamp having cylindrical branches with a straight cross section.
[0119] FIG. 19B shows an exterior perspective view of an exemplary lamp having cylindrical branches with a straight cross section.
[0120] [Figures 19C-19D] FIG. 19C shows an inside perspective view of an exemplary lamp having cylindrical branches with an L-shaped cross section.
[0121] FIG. 19D shows an exterior perspective view of an exemplary lamp having cylindrical branches with an L-shaped cross section.
[0122] [Figures 19E-19F] FIG. 19E shows an inside perspective view of an exemplary lamp having cylindrical branches with a T-shaped cross section.
[0123] FIG. 19F shows an exterior perspective view of an exemplary lamp having cylindrical branches with a T-shaped cross section.
[0124] [Figures 19G1-19G3] FIG. 19G1 shows a detailed cross-sectional view of the articulation between an exemplary ramp and an exemplary endplate in an unassembled state.
[0125] FIG. 19G2 shows a detailed cross-sectional view of the articulation between an exemplary ramp and an exemplary endplate in a partially assembled state.
[0126] FIG. 19G3 shows a detailed cross-sectional view of the articulation between an exemplary ramp and an exemplary endplate in a fully assembled state, with the ramp's range of motion limited.
[0127] [Figure 19H1-19H2] FIG. 19H1 shows a detailed cross-sectional view of the articulation between an exemplary ramp, an exemplary endplate, and an exemplary fastener, where the range of motion of the ramp is limited.
[0128] FIG. 19H2 shows a detailed exploded view of the articulation between an exemplary ramp, an exemplary end plate, and an exemplary fastener, limiting the range of motion of the ramp.
[0129] [Figure 20] FIG. 20 shows a perspective view of an exemplary actuator embodiment.
[0130] [Figure 21A] FIG. 21A shows a perspective view of an exemplary actuator.
[0131] [Figure 21B] FIG. 21B shows a perspective view of an exemplary actuator.
[0132] [Figure 22-23] FIG. 22 shows a perspective view of an exemplary retaining pin.
[0133] FIG. 23 shows a perspective view of an exemplary retention set screw.
[0134] [Figure 24-25] FIG. 24 shows a perspective view of an exemplary retention c-clip.
[0135] FIG. 25 shows a cross-sectional view of the articulation between an exemplary proximal wedge, an exemplary actuator, and an exemplary retaining c-clip.
[0136] [Figure 26A] FIG. 26A shows a rear perspective view of an exemplary proximal wedge.
[0137] [Figure 26B] FIG. 26B shows a front perspective view of an exemplary proximal wedge.
[0138] [Figure 27A] FIG. 27A shows a perspective view of an exemplary proximal wedge with a T-shaped protrusion.
[0139] [Figure 27B] FIG. 27B shows a perspective view of an exemplary proximal wedge with a threaded central opening and an alternative instrument attachment mechanism.
[0140] [Figure 27C] FIG. 27C shows a perspective view of an exemplary proximal wedge with a T-shaped protrusion and an alternative instrument attachment mechanism.
[0141] [Figure 27D]FIG. 27D shows a perspective view of an exemplary proximal wedge with a T-shaped protrusion, an alternative instrument attachment mechanism, and an alternative side opening shape.
[0142] [Figure 28A] FIG. 28A shows a front perspective view of an exemplary distal wedge.
[0143] [Figure 28B] FIG. 28B shows a front perspective view of an exemplary distal wedge with a T-shaped protrusion and no side opening. FIG.
[0144] [Figure 29A] FIG. 29A shows a front perspective view of an exemplary distal wedge with a T-shaped protrusion.
[0145] [Figure 29B] FIG. 29B shows a front perspective view of an exemplary distal wedge with a T-shaped protrusion and no side opening.
[0146] [Figure 30] FIG. 30 shows a perspective view of an exemplary insertion instrument.
[0147] [Figure 31] FIG. 31 shows a perspective view of an exemplary insertion instrument.
[0148] [Figure 32] FIG. 32 shows a detailed perspective view of the distal end of an exemplary insertion instrument.
[0149] [Figure 33] FIG. 33 shows a perspective view of an exemplary deployment drive instrument.
[0150] [Figure 34] FIG. 34 shows a perspective view of an exemplary first deployable fusion device attached to an exemplary insertion instrument.
[0151] [Figure 35] FIG. 35 shows an exemplary first deployable fusion device in an initial folded state implanted between two vertebral bodies, with an exemplary insertion instrument attached.
[0152] [Figure 36] FIG. 36 shows a perspective view of an exemplary first deployable fusion device attached to an exemplary insertion instrument with an exemplary deployment driver instrument.
[0153] [Figure 37] FIG. 37 shows a detailed perspective view of an exemplary first deployable fusion device attached to an exemplary insertion instrument.
[0154] [Figure 38] FIG. 38 shows a detailed perspective view of an exemplary first deployable fusion device in a partially deployed width state attached to an exemplary insertion instrument.
[0155] [Figure 39] FIG. 39 is a detailed perspective view of an exemplary first deployable fusion device in a full width deployed state attached to an exemplary insertion instrument.
[0156] [Figure 40] FIG. 40 shows a detailed perspective view of the first exemplary deployable fusion device in a fully width and height deployed state attached to an exemplary insertion instrument.
[0157] [Figure 41] FIG. 41 shows a perspective view of an exemplary first deployable fusion device in a fully width and height deployed state, filled with graft material and attached to an exemplary insertion instrument.
[0158] [Figure 42] FIG. 42 shows an exemplary first deployable fusion device implanted between two vertebral bodies in a fully deployed state and filled with graft material.
[0159] [Figure 43] FIG. 43 shows an exemplary insertion instrument
[0160] [Figure 44] FIG. 44 shows a detailed cross-sectional view of an exemplary actuation mechanism of an exemplary insertion instrument.
[0161] [Figure 45] FIG. 45 shows a detailed view of the distal end of the main shaft of an exemplary insertion instrument.
[0162] [Figure 46] FIG. 46 shows a detailed view of the distal end of an exemplary insertion instrument.
[0163] [Figure 47] FIG. 47 shows a detailed cross-sectional view of the articulation between an exemplary first deployable fusion device and an exemplary insertion instrument.
[0164] [Figure 48] FIG. 48 shows a detailed perspective view of the first exemplary deployable fusion device in an initial, folded state attached to an exemplary insertion instrument in an unlocked state.
[0165] [Figure 49] FIG. 49 shows a detailed perspective view of an exemplary first deployable fusion device in an initial, folded state attached to an exemplary insertion instrument in a locked state.
[0166] [Figure 50] FIG. 50 shows a perspective view of an exemplary first deployable fusion device attached to an exemplary insertion instrument including an exemplary deployment driver instrument.
[0167] [Figure 51] FIG. 51 shows a perspective view of an exemplary first deployable fusion device in a fully width-deployed state attached to an exemplary insertion instrument.
[0168] [Figure 52] FIG. 52 shows a perspective view of an exemplary first deployable fusion device in a fully width and height deployed state and attached to an exemplary insertion instrument.
[0169] [Figure 53] FIG. 53 shows a perspective view of an exemplary first expandable fusion device in a fully width and height deployed state, filled with graft material and attached to an exemplary insertion instrument.
[0170] [Figure 54A] FIG. 54A shows a perspective view of an exemplary second deployable fusion device in an initial, folded state.
[0171] [Figure 54B] FIG. 54B shows a perspective view of the exemplary second deployable fusion device of FIG. 54A in a fully deployed state.
[0172] [Figure 54C] FIG. 54C shows an exploded view of an exemplary second deployable fusion device.
[0173] [Figure 55A] FIG. 55A shows a front view of an exemplary proximal wedge used in the second exemplary deployable fusion device of FIGS. 54A-54C.
[0174] [Figure 55B] FIG. 55B shows a rear view of an exemplary proximal wedge used in the second exemplary deployable fusion device of FIGS. 54A-54C.
[0175] [Figure 56A] FIG. 56A shows a perspective view of an exemplary third deployable fusion device in an initial, folded state.
[0176] [Figure 56B]FIG. 56B shows a perspective view of an exemplary third deployable coaptation in a fully deployed state.
[0177] [Figure 56C] FIG. 56C shows an exploded view of an exemplary third deployable fusion device.
[0178] [Figure 57A] FIG. 57A shows a right side view of an exemplary ramp of an exemplary third deployable fusion device.
[0179] [Figure 57B] FIG. 57B shows a left side view of an exemplary ramp of an exemplary third deployable fusion device.
[0180] [Figure 58] FIG. 58 shows a bottom view of an exemplary endplate of an exemplary third deployable fusion device.
[0181] [Figure 59A] FIG. 59A shows a perspective view of an exemplary fourth deployable fusion device in an initial, folded state.
[0182] [Figure 59B] FIG. 59B shows a perspective view of the exemplary fourth deployable fusion device of FIG. 59A in a fully deployed state.
[0183] [Figure 59C] FIG. 59C shows a top view of the exemplary fourth deployable fusion device of FIG. 59A in an initial, fully collapsed state.
[0184] [Figure 59D] FIG. 59D shows a perspective view of a partial assembly of an exemplary fourth deployable fusion device including two opposing endplates.
[0185] [Figure 60A]FIG. 60A shows a perspective view of an exemplary fifth deployable fusion device in a fully deployed state.
[0186] [Figure 60B] FIG. 60B shows a side view of the exemplary fifth deployable fusion device of FIG. 60A in a fully deployed state.
[0187] [Figure 61A] FIG. 61A shows a perspective view of an exemplary sixth deployable fusion device in a fully deployed state.
[0188] [Figure 61B] FIG. 61B shows an exploded view of an exemplary sixth deployable fusion device.
[0189] [Figure 62A] FIG. 62A shows a perspective view of an exemplary seventh deployable fusion device in a fully deployed state.
[0190] [Figure 62B] FIG. 62B shows an exploded view of an exemplary seventh deployable fusion device.
[0191] [Figure 63A-63B] FIG. 63A shows a perspective view of an exemplary eighth deployable fusion device in an initial, folded state.
[0192] FIG. 63B shows a perspective view of an exemplary eighth expandable fusion device in a fully width-deployed state.
[0193] [Figure 63C] FIG. 63C shows a perspective view of an exemplary eighth deployable fusion device in a fully deployed state.
[0194] [Figure 63D] FIG. 63D shows an exploded view of an exemplary eighth deployable fusion.
[0195] [Figure 64] FIG. 64 shows a perspective view of an exemplary eighth proximal wedge used in an exemplary deployable fusion device.
[0196] [Figure 65A] FIG. 65A shows a perspective view of an exemplary ninth deployable fusion device in an initial, folded state.
[0197] [Figure 65B] FIG. 65B shows a perspective view of an exemplary ninth deployable fusion device in a fully deployed state.
[0198] [Figure 65C] FIG. 65C shows a partially assembled perspective view of an exemplary ninth deployable fusion device in an initial, folded state.
[0199] [Figure 65D] FIG. 65D shows a partially assembled perspective view of an exemplary ninth expandable fusion device in a partial width-deployed state (linear width-deployed only).
[0200] [Figure 65E] FIG. 65E shows a partially assembled perspective view of an exemplary ninth deployable fusion device in a fully width-deployed state (both linear and angular deployment completed).
[0201] [Figure 66A] FIG. 66A shows a perspective view of an exemplary tenth deployable fusion device in a fully deployed state.
[0202] [Figure 66B] FIG. 66B shows a perspective view of an exemplary tenth deployable fusion device in an initial, folded state.
[0203] [Figure 66C] FIG. 66C shows a perspective view of an exemplary tenth expandable fusion device in a fully width-deployed state.
[0204] [Figure 66D] FIG. 66D shows a top perspective view of an exemplary tenth compound endplate used in an exemplary deployable fusion device.
[0205] [Figure 67A] FIG. 67A shows a perspective view of an exemplary eleventh deployable fusion device in a fully deployed state.
[0206] [Figure 67B] FIG. 67B shows a perspective view of an exemplary eleventh endplate complex used in an exemplary deployable fusion device.
[0207] [Figure 67C] FIG. 67C shows a perspective view of the exemplary eleventh deployable fusion device of FIG. 67A in an initial, folded state.
[0208] [Figure 67D] FIG. 67D shows a perspective view of the exemplary eleventh expandable fusion device of FIG. 67A in a fully width-deployed state.
[0209] [Figure 68] FIG. 68 shows a perspective view of an exemplary twelfth deployable fusion device in an initial, folded state.
[0210] [Figure 69A-69B] FIG. 69A shows a rear perspective view of an exemplary twelfth proximal wedge used in an exemplary deployable fusion device.
[0211] FIG. 69B shows a cross-sectional view of an exemplary twelfth proximal wedge used in an exemplary deployable fusion device.
[0212] [Figure 70A-70B]FIG. 70A shows a front view of an exemplary twelfth distal wedge used in an exemplary deployable fusion device.
[0213] FIG. 70B shows a cross-sectional view of an exemplary twelfth distal wedge used in an exemplary deployable fusion device.
[0214] [Figure 71] FIG. 71 shows a perspective view of an exemplary twelfth deployable fusion device in an initial folded state and assembled with a tensioning instrument.
[0215] [Figure 72A] FIG. 72A shows a cross-sectional view of an exemplary twelfth deployable fusion device in an initial, folded state assembled with a tensioning instrument.
[0216] [Figure 72B] FIG. 72B shows a cross-sectional view of an exemplary twelfth deployable fusion device in a deployed state assembled with a tensioning instrument.
[0217] [Figure 72C] FIG. 72C shows a cross-sectional view of an exemplary twelfth deployable fusion device in a deployed state with the tension members locked in place.
[0218] [Figures 73A-73C] FIG. 73A shows a top view of an exemplary thirteenth deployable fusion device in an initial, folded state.
[0219] FIG. 73B shows a top view of the thirteenth exemplary deployable fusion device in a fully width-deployed state.
[0220] FIG. 73C shows a perspective view of the exemplary thirteenth deployable fusion device in a fully height deployed state.
[0221] [Figure 73D]FIG. 73D shows an exploded view of an exemplary thirteenth deployable fusion device.
[0222] [Figure 74A] FIG. 74A shows a perspective view of an exemplary thirteenth deployable fusion device attached to an exemplary insertion-deployment instrument in an initial, folded state.
[0223] [Figure 74B] FIG. 74B shows a perspective view of an exemplary thirteenth deployable fusion device attached to an exemplary insertion-deployment instrument in a fully width-deployed state.
[0224] [Figure 75A-75B] FIG. 75A shows a top view of an exemplary fourteenth deployable fusion device in an initial, folded state.
[0225] FIG. 75B shows a top view of the exemplary fourteenth expandable fusion device in a fully width-deployed state.
[0226] [Figure 75C-75D] FIG. 75C shows a perspective view of the exemplary fourteenth expandable fusion device in a fully height deployed state.
[0227] FIG. 75D shows a perspective view of an exemplary fourteenth expandable fusion device in a fully width and height deployed state.
[0228] [Figure 75E] FIG. 75E shows an exploded view of an exemplary fourteenth deployable fusion device.
[0229] [Figures 76A-76C] FIG. 76A shows a top view of an exemplary fifteenth deployable fusion device in an initial, folded state.
[0230] FIG. 76B shows a top view of the exemplary fifteenth expandable fusion device in a fully width-deployed state.
[0231] FIG. 76C shows a perspective view of an exemplary fifteenth expandable fusion device in a fully width and height deployed state.
[0232] [Figure 76D] FIG. 76D shows an exploded view of an exemplary fifteenth deployable fusion device.
[0233] [Figures 77A-78] FIG. 77A shows a perspective view of an exemplary fifteenth deployable fusion device attached to an insertion-deployment instrument in an initial, folded state.
[0234] FIG. 77B shows a perspective view of an exemplary fifteenth deployable fusion device attached to an insertion-deployment instrument in a fully width-deployed state.
[0235] FIG. 78 shows a perspective view of an exemplary sixteenth deployable fusion device in an initial, folded state.
[0236] [Figure 79A-79B] FIG. 79A shows a perspective view of an exemplary sixteenth deployable fusion device attached to an insertion-deployment instrument in an initial, folded state.
[0237] FIG. 79B shows a perspective view of an exemplary sixteenth deployable fusion device attached to an insertion-deployment instrument in a fully width-deployed state.
[0238] [Figure 80] FIG. 80 shows a top schematic view of the exemplary seventeenth deployable fusion device, outlining its initial, wide-deployed configuration.
[0239] [Figure 81A-81B] FIG. 81A shows a perspective view of an exemplary eighteenth deployable fusion device in its deployed state.
[0240] FIG. 81B shows a perspective view of an exemplary eighteenth deployable fusion device in its collapsed state.
[0241] [Figure 81C] FIG. 81C shows a perspective view of an exemplary eighteenth deployable fusion device in a disassembled state.
[0242] [Figure 82] FIG. 82 shows a perspective view of an exemplary actuator of the eighteenth deployable fusion device.
[0243] [Figure 83A-83B] FIG. 83A shows a perspective view of an exemplary proximal wedge of the eighteenth deployable fusion device.
[0244] FIG. 83B shows a perspective view of an exemplary distal wedge of the eighteenth deployable fusion device.
[0245] [Figure 84A-84B] FIG. 84A shows a first perspective view of an exemplary proximal ramp of the eighteenth deployable fusion device.
[0246] FIG. 84B shows a second perspective view of an exemplary proximal ramp of the eighteenth deployable fusion device.
[0247] [Figure 85] FIG. 85 shows a perspective view of an exemplary distal ramp of the eighteenth deployable fusion device.
[0248] [Figure 86] FIG. 86 shows a perspective view of an exemplary endplate of the eighteenth deployable fusion device.
[0249] [Figure 87A-87B] FIG. 87A shows a perspective view of an exemplary nineteenth deployable fusion device in its deployed state.
[0250] FIG. 87B shows a perspective view of an exemplary nineteenth deployable fusion device in its collapsed state.
[0251] [Figure 87C] FIG. 87C shows a perspective view of an exemplary nineteenth deployable fusion device in a disassembled state.
[0252] [Figure 88] FIG. 88 shows a perspective view of an exemplary actuator of the nineteenth deployable fusion device.
[0253] [Figure 89A-89B] FIG. 89A shows a perspective view of an exemplary distal wedge of an exemplary nineteenth deployable fusion device.
[0254] FIG. 89B shows a perspective view of an exemplary distal wedge of an exemplary nineteenth deployable fusion device.
[0255] [Figure 90A-90B] FIG. 90A shows a perspective view of an exemplary first ramp of an exemplary nineteenth deployable fusion device.
[0256] FIG. 90B shows a perspective view of an exemplary first ramp of an exemplary nineteenth deployable fusion device.
[0257] [Figure 91A-91B] FIG. 91A shows a perspective view of an exemplary second ramp of an exemplary nineteenth deployable fusion device.
[0258] FIG. 91B shows a perspective view of an exemplary second ramp of an exemplary nineteenth deployable fusion device.
[0259] [Figure 92A-92B] FIG. 92A shows a perspective view of an exemplary first endplate of an exemplary nineteenth deployable fusion device.
[0260] FIG. 92B shows a perspective view of an exemplary first endplate of an exemplary nineteenth deployable fusion device.
[0261] [Figure 93A] FIG. 93A shows a perspective view of an exemplary second endplate of an exemplary nineteenth deployable fusion device.
[0262] [Figure 93B] FIG. 93B shows a perspective view of an exemplary second endplate of an exemplary nineteenth deployable fusion device.
[0263] [Figure 94A-94B] FIG. 94A shows a perspective view of an exemplary third endplate of an exemplary nineteenth deployable fusion device.
[0264] FIG. 94B shows a perspective view of an exemplary third endplate of an exemplary nineteenth deployable fusion device.
[0265] [Figure 95A] FIG. 95A shows a perspective view of an exemplary fourth endplate of an exemplary nineteenth deployable fusion device.
[0266] [Figure 95B] FIG. 95B shows a perspective view of an exemplary fourth endplate of an exemplary nineteenth deployable fusion device.
[0267] [Figure 96A-96B] FIG. 96A shows a perspective view of an exemplary nineteenth deployable fusion device and an exemplary separation inserter tool.
[0268] FIG. 96B shows a perspective view of an exemplary nineteenth deployable fusion device and an exemplary connector inserter tool.
[0269] [Figure 97] FIG. 97 shows a cross-sectional view of an exemplary nineteenth deployable fusion device and an exemplary connector inserter tool.
[0270] [Figure 98A] FIG. 98A shows a perspective view of an exemplary twentieth deployable fusion device in its collapsed state.
[0271] [Figure 98B] FIG. 98B shows a perspective view of an exemplary twentieth deployable fusion device in a disassembled state.
[0272] [Figure 99] FIG. 99 shows a top view of an exemplary twenty-first deployable fusion device. DETAILED DESCRIPTION OF THE INVENTION
[0273] Detailed Description The following descriptions of various embodiments are merely exemplary in nature and are not intended to teach, limit, or in any way limit their application or use. While the following description is generally directed to embodiments of a deployable fusion device and methods for its implantation into the spine between two adjacent lumbar vertebrae using lateral, posterior, and transforaminal approaches, it will be understood that similar mechanisms and arrangements thereof are also used to treat cervical, thoracic, and spinal segments utilizing other surgical approaches, including, but not limited to, pedicle, transiliac, anterior, and anterior-lateral approaches, and are configured to accommodate the respective anatomical structures and approach angles. Similarly, while the following description is generally directed to embodiments of a deployable fusion device in which an actuator pulls wedges together to cause deployment, it will be understood that in other embodiments, the same functionality can be readily achieved by an actuator that forces the wedges apart. Spinal fusion is typically employed to relieve pain caused by the movement of degenerated disc material. Upon successful fusion, the fusion device is permanently fixed within the disc space.
[0274] First deployable fusion device An exemplary embodiment of a first deployable fusion device 1000 is shown as FIG. 1 in an initial, collapsed state implanted between endplates 6 and 8 of adjacent vertebral bodies 2 and 4 via a surgical corridor 5. Implanting the first deployable fusion device 1000 in the initial, collapsed state can reduce the impaction force required for implantation and the size of the surgical corridor 5. As shown in FIG. 2, the first deployable fusion device 1000 is shown in an expanded state (expanded in both width and height) implanted between adjacent vertebral bodies 2 and 4 via a surgical corridor 5 and engaging endplates 6 and 8. The first deployable fusion device 1000 deploys in height from about 8 mm to about 13 mm, or more preferably from 8 mm to 16 mm, or most preferably from 7 mm to 14 mm, and in width from about 10 mm to about 18 mm, and more preferably from about 11 mm to about 20 mm, and more preferably from about 14 mm to about 24 mm, or most preferably from about 15 mm to about 26 mm. The first deployable fusion device 1000 will preferably be longer than its width in its initial folded state, and the endplates will preferably be longer than their width. Deploying fusion device 1000 while implanted between vertebral bodies 2 and 4 allows for an increase in the width of fusion device 1000 and the spacing or contact area (or footprint) between fusion device 1000 and the end plates 6 and 8 beyond it, which would otherwise be permitted by the application of distraction forces to surgical corridor 5 and end plates 6 and 8 to increase and maintain the distance and / or angle between vertebral bodies 2 and 4, preferably by increasing and maintaining the height of the implant and / or the angular orientation of its components.
[0275] The components of the first deployable fusion device 1000 may be made from a variety of materials, including, but not limited to, metals and alloys (e.g., chemically pure titanium, titanium alloys including Ti-6Al-4V based alloys, cobalt alloys including CoCrMo alloys, stainless steel, tantalum and its alloys, platinum and its alloys, etc.), polymers (e.g., PEEK, PEKK, PEKEK, PEI, PET, PETG, UHMWPE, PPSU, acetal, polyacetal, etc., including carbon fiber reinforced varieties and other filled varieties, including, for example, carbon fiber, carbon nanotubes, graphene, barium sulfate, or hydroxyapatite), ceramics (e.g., aluminum oxide, zirconium oxide, silicon nitride, diamond-like carbon, etc., as well as various metallized ceramics and metal-ceramic compositions). Optionally, in any embodiment, the components of fusion device 1000 may be fabricated from titanium alloys (including but not limited to Ti-6Al-4V alloy) or cobalt alloys, including but not limited to CoCrMo alloys. Optionally, in any embodiment, fabricating some of the threaded components of fusion device 1000 from a CoCr-based alloy allows for increased strength, reduced size, and other performance considerations.
[0276] Optionally, in any embodiment, bone allograft, bone autograft, xenograft, demineralized bone matrix product, synthetic bone substitute, osteogenic agent, or other bone growth inducing material is introduced into and / or around fusion device 1000 to further promote or facilitate intervertebral fusion. In one embodiment, fusion device 1000 is packed or injected with bone graft, demineralized bone matrix product, synthetic bone substitute, osteogenic agent, or other bone growth inducing material, preferably after it is deployed, while in other embodiments, graft material may be introduced into the space in and / or around fusion device 1000 prior to implantation or after implantation but prior to deployment.
[0277] An exemplary fusion device 1000 is shown with reference to Figures 3-5. Figure 3 shows the fusion device 1000 in a fully folded state. Figure 4 shows the fusion device 1000 in an unfolded state. Figure 5 shows an exploded view of the fusion device 1000. Optionally, in any embodiment, the fusion device 1000 includes a first endplate 100, a second endplate 150, a third endplate 200, a fourth endplate 250, a proximal wedge 550, a distal wedge 650, an actuator 500, a first ramp 300, a second ramp 350, a third ramp 400, a fourth ramp 450, a retaining pin 600 (best seen in Figure 5), and a retaining set screw 700. Optionally, in any embodiment, first end plate 100, second end plate 150, third end plate 200, and fourth end plate 250 are substantially identical, although all four have the same set of features, the particular size and angular orientation of these features need not be identical in all embodiments or within any particular embodiment. Optionally, in any embodiment, first lamp 300, second lamp 350, third lamp 400, and fourth lamp 450 are substantially identical (note that the lamps, while identical in some embodiments, may or may need to be suitably rotated or mirror-flipped for assembly into the arrangements shown in FIGS. 3-5 ), but all four have the same set of features, the particular size and angular orientation of these features need not be identical in all embodiments or within any particular embodiment. Additionally, the effect of endplates, ramps, and wedges having their ramp surfaces angled at different angles on the deployment characteristics of fusion device 1000 is illustrated in more detail below.
[0278] As discussed in more detail below, actuator 500 functions to pull proximal wedge 550 and distal wedge 650 together, forcing first ramp 300 away from third ramp 400 and second ramp 350 away from fourth ramp 450, which causes endplates 100 and 150 to be forced away from endplates 250 and 200 (resulting in width deployment of fusion device 1000). Optionally, in any embodiment, first ramp 300 and second ramp 350 are pulled toward each other and third ramp 400 and fourth ramp 450 are pulled toward each other only after width deployment is substantially complete. Movement of the first ramp 300 and the second ramp 350 toward each other forces the first endplate 100 away from the second endplate 150, and movement of the third ramp 400 toward the fourth ramp 450 forces the third endplate 200 away from the fourth endplate 250 (resulting in height deployment). The retaining pin 600 and the retaining set screw 700, in some embodiments, act to resist tension in the actuator 500 and maintain the linear position of the proximal wedge 550 relative to the actuator 500. Optionally, in any embodiment, the subassembly including the actuator, proximal wedge, distal wedge, and four ramps is collectively referred to as the actuator assembly.
[0279] Optionally, in any embodiment, after width expansion has substantially occurred, only ramps 300 and 350 and ramps 400 and 450 begin to move toward one another, with ramps 300 and 400 substantially reaching the limit of their travel relative to proximal wedge 550 and ramps 350 and 450 substantially reaching the limit of their travel relative to distal wedge 650. Optionally, in any embodiment, this delay in height expansion is achieved by end plates 100, 150, 200, 250 slidably engaging proximal wedge 550 and distal wedge 650 through the initial portion of the width expansion process. As wedges 550 and 650 move toward one another during the width expansion process, they eventually disengage from end plates 100, 150, 200, 250, allowing them to expand in height, as will be discussed below. Optionally, in any embodiment, the delay in height development is further achieved by an insertion instrument that constrains height development until width development has substantially occurred, as will be discussed below.
[0280] When fully assembled, the first deployable fusion device 1000 is most preferably a stable assembly of components that are all held in place within the assembly through a full range of motion by the use of fasteners such as "dovetail" articulations, e.g., pins, balls, screws, and set screws. Optionally, in any embodiment, the fasteners are secured to one component and travel through a mating feature (such as a track) on another component, thereby limiting the range of motion of the first component to the amount allowable by the track feature, thereby preventing disassembly of the components.
[0281] With reference to Figures 6A-6F, Figures 6A and 6B show side and end views, respectively, of fusion device 1000 in an initial, fully folded state, Figures 6C and 6D show side and end views, respectively, of fusion device 1000 in a fully width-expanded state, and Figures 6E and 6F show side and end views, respectively, of fusion device 1000 in a fully width- and height-expanded state.
[0282] 7A-7C illustrate mechanisms for delaying height deployment until width deployment is partially or substantially complete. In FIG. 7A, fusion device 1000 is shown in an initial, folded state, demonstrating, by way of example, engagement of proximal wedge 550 with mating features on endplates 100 and 150; in this state, pulling proximal wedge 550 and distal wedge 650 together results in width deployment, but not height deployment, of fusion device 1000. Optionally, in any embodiment, as in FIG. 7A, engagement between the proximal wedge and endplate prevents height deployment. Once width deployment has occurred sufficiently for the wedges to disengage from the mating features on the endplates (shown in FIG. 7B), further pulling proximal wedge 550 and distal wedge 650 together can result in either height-only deployment (shown in FIG. 7C) or simultaneous height and width deployment. Optionally, in any embodiment, FIG. 7B, disengagement of the proximal wedge from the endplate allows height expansion. Optionally, in any embodiment, the starting width is preferably 14 mm, with height expansion beginning when the width reaches approximately 20 mm. Optionally, in any embodiment, height expansion may begin when the full maximum or substantial width is achieved (as discussed above). A delay in height expansion is achieved because, for height expansion to occur, a pair of ramps on either side of the fusion device 1000 must translate toward each other relative to the endplate with which they are engaged. Because the endplate is rigid and spans the distance between the proximal wedge 550 and the distal wedge 650, this cannot occur while the ramp surfaces of the wedges simultaneously engage both the endplate and the ramp, thereby allowing only width expansion until the state shown in FIG. 3C is reached, at which point the wedges are still engaged with the ramps but no longer engage the endplate. Pulling the wedges together forward from this point allows the ramps to move toward each other relative to the endplate, resulting in height expansion. A detailed description of the components and their mechanisms is provided below.
[0283] The following discussion relates to first endplate 100, but it should be understood that because in this embodiment first endplate 100 is substantially identical to second endplate 150, third endplate 200, and fourth endplate 250, it also applies equally to second endplate 150, third endplate 200, and fourth endplate 250. (It is noted that while the endplates are identical in some embodiments, they may or may need to be suitably rotated or mirror-flipped to assemble into the arrangement shown above in the assembly shown in FIGS. 3-5.) Endplates 100 and 250 are collectively referred to as upper endplates, and endplates 150 and 200 are collectively referred to as lower endplates. While the phrase "substantially identical" refers to end plates 100, 150, 200, and 250 having the same or similar set of features, all of which perform the same or similar function in each of end plates 100, 150, 200, as described below, it should be understood that the specific size and angular orientation of these features may or may not be identical between end plates 100, 150, 200, and 250 within any particular embodiment.
[0284] 8A and 8B, which show bottom and top views, respectively, of end plate 100. Optionally, in any embodiment, first end plate 100 has first end 102 and second end 104. In the illustrated embodiment, first end plate 100 further includes an upper surface 134 connecting first end 102 and second end 104, and a lower surface 132 connecting first end 102 and second end 104. Optionally, in any embodiment, first end plate 100 further includes two tapered slots: a first tapered slot 107 extending from lower surface 132 toward upper surface 134 and proximate first end 102, and a second tapered slot 109 extending from lower surface 132 toward upper surface 134 and proximate second end 104. Optionally, in any embodiment, the slope or shape of tapered slots 107 and 109 are equal to or different from one another.
[0285] First tapered slot 107 includes a bottom surface 106 that is substantially parallel to the longitudinal axis in some embodiments, but may be angled or curved in a plane transverse to the longitudinal axis in other embodiments, a tapered surface 110 that is generally transverse to bottom surface 106, and a tapered surface 136 that is opposite tapered surface 110 and generally transverse to bottom surface 106, where tapered surfaces 110 and 136 taper from bottom surface 106 toward each other and toward inward-facing surface 130. Second tapered slot 109 includes a bottom surface 108 that is substantially parallel to the longitudinal axis in some embodiments, but may be angled or curved in a plane transverse to the longitudinal axis in other embodiments, a tapered surface 138 that is generally transverse to bottom surface 108, and a tapered surface 112 that is opposite tapered surface 138 and generally transverse to bottom surface 108, where tapered surfaces 138 and 112 taper from bottom surface 108 toward each other and toward inward-facing surface 130.
[0286] End plate 100 optionally further includes a first relief 125 forming a planar surface 126 and a second relief 127 forming a planar surface 128. First relief 125 extends from first end 102 to first tapered slot 107 and is defined by planar surface 126 substantially parallel to lower surface 132, and first relief surface 114 is substantially planar and parallel to inward-facing surface 130. Second relief 127 extends from second end 104 to second tapered slot 109 and is defined by planar surface 128 substantially parallel to lower surface 132, and second relief surface 116 is substantially planar and parallel to inward-facing surface 130. Optionally, in any embodiment, endplate 100 includes a first chamfer 142 proximate first end 102 and a second chamfer 144 proximate second end 104. Chamfers 142 and 144 preferably reduce the height of endplate 100 at first end 102 and second end 104, thereby providing tapered leading and trailing edges to facilitate introduction and removal of fusion device 1000 between adjacent vertebral bodies 2 and 4.
[0287] Optionally, in any embodiment, end plate 100 optionally further includes ramp grooves 122 and 118 proximate first end 102 and ramp grooves 124 and 120 proximate second end 104. Ramp grooves 122, 118 and 124, 120 are configured to engage the mating ramp shapes of proximal wedge 550 and distal wedge 650, causing the initial deployment of fusion device 1000 to be limited to width deployment and preventing fusion device 1000 from simultaneously expanding in width and height. The slopes of ramp grooves 122, 118, 124 and 120 are configured to mate with these wedges 550 and 650. Ramp grooves 124 and 122 are configured to mate with the trapezoidal (or in other embodiments, T-shaped, Y-shaped, etc.) protruding shape of wedges 550 and 650. Ramp grooves 118 and 120 are each preferably formed by two surfaces, one parallel to bottom surface 132 and one perpendicular thereto. Ramp grooves 118 and 120 are configured to fit into the protruding protuberances of wedges 550 and 650.
[0288] 9A-9E, while in the illustrated embodiment, slots 107 and 109 have trapezoidal cross-sections, it should be understood that they may optionally have, but are not limited to, a T-shaped cross-section (shown in FIG. 9A), an L-shaped cross-section (shown in FIG. 9B), a Y-shaped cross-section (shown in FIG. 9C), an F-shaped cross-section (shown in FIG. 9D), or preferably, any cross-section in general that results in slots 107 and 109 being narrower at the inward-facing surfaces 106 and 108 than at the bottom surfaces 106 and 108, or at any point between inward-facing surfaces 130 and bottom surfaces 106 and 108. Optionally, in any embodiment, if retention of lamp 300 within end plate 100 is desired via a "dovetail," tapered, T-shaped, or other slot shape, then while such shapes are preferred, a non-tapered, generally straight cross-section of slots 107 and 109 (as shown in FIG. 9E ) may be advantageous, for example, if an additional fastener (e.g., a pin or set screw) is used to retain lamp 300 in slot 107 or 109 to only allow translation in one dimension (while also allowing rotation in one or more planes). It should also be understood that while various alternative shapes of end plates are shown herein as separate embodiments, these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment herein. It should also be understood that substituting any of the above optional alternative features in the end plate component may or would require the mating components (e.g., end plate, ramp, and wedge) to use the inverse or complementary shapes of those features for proper engagement, and that the shape of the inverse or complementary shapes would necessarily be derived from the above optional alternative feature shapes.
[0289] 10A-10D3 illustrate alternative embodiments of end plate 100. FIGS. 10A and 10B illustrate an exemplary end plate 100 in which lower surface 132 further includes protrusion 145, which shares tapered surface 110 with first tapered slot 107, and protrusion 146, which shares tapered surface 112 with second tapered slot 109. In the embodiment of FIGS. 10A and 10B, lower surface 132 further includes recess 147 configured to receive protrusion 146 of another end plate and recess 148 configured to receive protrusion 145 of another end plate. The purpose of protrusions 145 and 146 and recesses 147 and 148 is to increase the contact area and provide additional stability between endplates 100, 150, 200, 250 and ramps 300, 350, 400, 450 as fusion device 1000 approaches its maximum height deployed state (shown in FIG. 10C below). In embodiments without protrusions 145 and 146, as fusion device 1000 deploys height, the contact area between the endplates and ramps steadily decreases as the ramps translate through tapered slots in the endplates to cause deployment. Protrusions 145 and 146 compensate for this loss of contact area, thereby improving the stability of the fusion device 1000 assembly. It should be understood that the same embodiments discussed above and shown in FIGS. 9A, 9B, 9C, and 9D would equally apply to the embodiment shown in FIGS. 10A and 10B. Optionally, in any embodiment, protrusions 145 and 146 generate additional contact areas between the endplates and the ramps in some areas. Additionally, optionally, in any embodiment, protrusions 145 and 146 and mating recesses 147 and 148, while depicted as generally triangular in some embodiments, may have other shapes that accomplish the same goal of increasing the contact area between endplates 100, 150, 200, 250 and ramps 300, 350, 400, 450 as fusion device 1000 approaches its maximum height deployed state. Figure 10C shows an exemplary fusion device 1000 in a fully deployed state, including protrusions 145 and 146 and mating recesses 147 and 148 on the endplates.Some areas where the protrusion creates additional contact area between the endplate and the ramp are indicated and labeled. Figures 10D1-10D3 show an exemplary fusion device 1000 in which the endplate 100 includes a protrusion 143 on its proximal end. The protrusion 143 further includes an opening 149 configured to receive a bone fastener 730. The angle between the central axis of aperture 149 and the longitudinal axis of endplate 100 may have any value between 0 and 90 degrees, but is most preferably between 0 and 45 degrees, and generally (but not necessarily in embodiments in which the proximal portion of bone fastener 730 that contacts projection 143 (i.e., the "head" of fastener 730) is substantially larger than that of the body of bone fastener 730 that contacts the bone (i.e., the shank of fastener 730), and in embodiments in which the body is substantially smaller than aperture 149) defines the trajectory of bone fastener 730 shown assembled with fusion device 1000 in FIG. 10D3. While various alternative forms of endplates are shown herein as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment herein. It should also be understood that substituting any of the above optional alternative features in the end plate component may or would require the mating components (e.g., end plate, ramp, and wedge) to use the inverse or complementary shapes of those features for proper engagement, and that the shape of the inverse or complementary shapes would necessarily be derived from the above optional alternative feature shapes.
[0290] 11A-12D, optionally, in any embodiment, for FIGS. 11A, 11D, and 12A, top surface 134 of first endplate 100 is generally planar, allowing top surface 134 of first endplate 100 to engage adjacent vertebral body 2. Alternatively, top surface 134 is curved in one or more planes (shown in FIGS. 11B, 11C, 11F, 11H, and 12B) to allow for greater engagement with adjacent vertebral body 2. Optionally, in any embodiment, top surface 134 includes a generally straight ramp surface (shown in FIGS. 11G and 12C) or a curved ramp surface (shown in FIGS. 11E, 11I, and 12D), but is generally planar. The ramped surfaces allow engagement with adjacent vertebral bodies 2 in a lordotic fashion, as shown, for example, in FIG. 11E, and / or in a coronal, tapered fashion, as shown, for example, in FIGS. 12C and 12D. Optionally, in any embodiment, non-ramped endplates of different heights, as well as arrangements of ramped and non-ramped endplates of different heights, also provide a shape suitable for lordotic engagement with the endplates, as seen and illustrated in FIGS. 11D, 11F, 11H, and 11I. Because FIGS. 11A-11I and 12A-12D show device 1000 at two different projections at 90 degrees from one another, it should be understood that the ramped quality of surface 134 is described as "lordotic" for FIGS. 11A-11I and as "tapered" for FIGS. 12A-12D. While in one embodiment, all endplates in fusion device 1000 have the same length, it is further contemplated that in other embodiments, some or all of the endplates may have different lengths to better accommodate the target anatomy. Figures 13A and 13C show fully folded and fully unfolded views of an exemplary fusion device 1000 in which all endplates have the same length, and Figures 13B and 13D show an exemplary fusion device 1000 in which two endplates have a shorter length than the other two, which may be advantageous in lateral and some posterior approach applications.Optionally, in any embodiment, the upper surface 134 includes texturing 140 to aid in gripping adjacent vertebral bodies. In the illustrated embodiment, the texturing 140 includes a series of parallel grooves running transverse to the long axis of the endplate 100, and the texturing may include, but is not limited to, teeth, ridges, areas of high surface roughness, metallic or ceramic coatings with relatively high surface roughness, friction-increasing elements, keels, spikes, or gripping or leveraging protrusions. Optionally, in any embodiment, one or more endplates may be shorter, longer, thinner, or wider than the others. While various alternative shapes of endplates are shown herein as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment herein. It should also be understood that replacing any of the above-described optional alternative features in the endplate components may or would require mating components (e.g., endplates, ramps, and wedges) to use the inverse and / or complementary shapes of those features for proper intended engagement between the various components of the fusion device 1000 and between those components and the surrounding anatomical structures, and that the shapes of the inverse and / or complementary shapes would necessarily be derived from the above-described optional alternative feature shapes.
[0291] The effect of changing the slope and / or orientation of tapered slots 107 and 109, or the amount of allowed movement between the ramp and tapered slots 107 and 109, is seen and illustrated in Figures 14A-14B2. Figure 14A shows the effect of changing the slope and / or orientation of slots 107 and 109 on each of the four end plates viewed from the side, where the top surface of device 1000 is represented by end plate 250 and the bottom surface of the device is represented by end plate 200. Varying the slope of slots 107 and 109 or limiting the allowable movement between the ramps and slots 107 and 109 in the respective end plates can result in first end 102 and second end 104 that deploy both the upper and lower surfaces of fusion device 1000 uniformly, deploy both the upper and lower surfaces non-uniformly, deploy the upper surface uniformly and the lower surface non-uniformly, or deploy the lower surface uniformly and the upper surface non-uniformly. Figures 14B1 and 14B2 show initial, fully folded and unfolded views, respectively, of an exemplary fusion device 1000 configured to deploy non-uniformly at its proximal and distal ends, leading to a deployed state in which the end plates taper at an angle. 14B1 and 14B2 employ an alternative embodiment of ramp 300 (discussed in detail below) that is suitable for uneven deployment between one end of the endplate and the other endplate by allowing tapered slots 107 and 109 to make contact with a circular surface instead of the flat ramp surface of other embodiments, which in turn allows the long axis of the endplate to be at an angle to the long axis of the ramp. The embodiment of FIGS. 14B1 and 14B2 further employs a mechanism, described in detail below, that independently limits the amount of travel between ramp and tapered slot 107 and ramp and tapered slot 109, for example, allowing the proximal end of the endplate to reach the end of its height deployment and therefore stop deployment before the distal end of the endplate does, which results in continued deployment at the distal end of the endplate after the proximal end stops deployment, thereby achieving greater height deployment than the proximal end in the fully deployed state.
[0292] Turning now to Figures 15A-15G, the effect of varying the slope and / or orientation of ramp grooves 122, 118, 124, and 120 of endplate 100, as well as the slope and / or orientation of the complementary mating features of the ramps and wedges, is shown. Figure 15A shows an end view of fusion device 1000, where the upper surface of device 1000 is represented by endplates 100 and 250, and the lower surface of the device is represented by endplates 150 and 200. Figure 15A illustrates an embodiment in which both sides of fusion device 1000 deploy evenly, and an embodiment in which the left and right sides deploy unevenly. Figures 15B, 15C, and 15D illustrate an exemplary fusion device 1000 in which the left and right sides of fusion device 1000 deploy unevenly due to variations in the mating ramp features of the endplates, wedges, and ramps. FIG. 15B shows a top view of the embodiment in a collapsed state, and FIG. 15C shows a top view of the embodiment in an expanded state, schematically illustrating the amount of width expansion achieved in each direction, which is not equal. FIG. 15D shows a perspective view of the embodiment in an expanded state, allowing a better view of the difference in slope of the ramp surfaces between the two sides of the fusion device 1000. FIG. 15E further illustrates an exemplary distal wedge 650 used in the assembly 1000 shown in FIG. 15D. FIG. 15F further illustrates an exemplary proximal wedge 550 used in the assembly 1000 shown in FIG. 15D. FIG. 15G further illustrates an exemplary ramp 300 used in the assembly 1000 shown in FIG. 15D. Turning now to FIG. 16, which shows end views of four embodiments of fusion device 1000 illustrating the effect of varying the slope of slots 107 and 109 between the endplates but keeping them the same within each individual endplate, this may result in, without limitation, all four endplates deploying at the same speed, all four endplates deploying at different speeds, any three endplates deploying at the same speed while the fourth deploys at a different speed, or any two endplates deploying at one speed while the other two deploy at different speeds.Additionally, curving slots 107 and 109 in a plane transverse to the long axis of any endplates will preferably cause those endplates to tilt during deployment as shown in FIG. 16. While the various alternative shapes of the endplates, wedges, and ramps are shown herein as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment herein. It should also be understood that substituting any of the above optional alternative features on one component may or will require mating components (e.g., endplates, ramps, and / or wedges) to use the inverse and / or complementary shapes of these features for proper intended engagement between all of the various components of fusion device 1000 and between these components and surrounding anatomical structures, and that the shapes of the inverse and / or complementary shapes will necessarily be derived from the above optional alternative feature shapes.
[0293] While the following discussion pertains to the first lamp 300, it should be understood that because, in embodiments of the present disclosure, the first lamp 300 is substantially identical to the second lamp 350, the third lamp 400, and the fourth lamp 450, it also applies equally to the second lamp 350, the third lamp 400, and the fourth lamp 450. (It is noted that the lamps, while identical in some embodiments, may or may not be suitably rotated for assembly into the arrangements shown above in the assemblies shown in FIGS. 3-5.) While the phrase "substantially identical" refers to lamps 300, 350, 400, and 450 having the same set of features, all of which perform the same or similar functions, as described below, in each of lamps 100, 150, 200, and 250, it should be understood that the specific size and angular orientation of these features may or may not be identical between lamps 300, 350, 400, and 450 within any particular embodiment.
[0294] 17A and 17B, in one embodiment, a first lamp 300 has a first end 301 and a second end 303. In the illustrated embodiment, the first lamp 300 further includes an inner surface 305 connecting the first end 301 and the second end 303, and an outer surface 307 (best seen in FIG. 17B) connecting the first end 301 and the second end 303. The first lamp 300 further includes an upper surface 309 connecting the first end 301 and the second end 303, and a lower surface 311 connecting the first end 301 and the second end 303, the two surfaces 309 and 311 preferably being, but not necessarily, parallel to one another. First ramp 300 further includes a protuberance 315 including an upper branch 321, which extends preferably but not necessarily beyond outer surface 307 and lower surface 311, and a lower branch 323, which extends preferably but not necessarily beyond outer surface 307 and lower surface 311. Upper branch 321 includes first ramp surface 302 and second ramp surface 310, which extend from inner surface 305 and taper outward toward outer surface 327, giving upper branch 321 a generally trapezoidal cross-section. Lower branch 323 includes first ramp surface 304 and second ramp surface 312, which extend from inner surface 305 and taper outward toward outer surface 327, giving lower branch 323 a generally trapezoidal cross-section. Branches 321 and 323 are intended to slidably engage tapered slots 107 and 109 in the end plates. It is contemplated that the mating cross sections of branches 321 and 323 and tapered slots 107 and 109 are configured only to allow translation in one dimension, either linear or curved (although some embodiments may allow rotation in one or more planes).
[0295] As seen in FIG. 17A , inner surface 305 includes a protrusion 319 forming ramp surface 320 and surface 325, which preferably form an angle greater than 90 degrees with inner surface 305, as FIG. 17A shows. Protrusion 319 includes first and second branches 314, 316 and a groove 322. Groove 322 extends from outer surface 307 along ramp surface 320 toward inner surface 305. Instead of terminating at surface 324, groove 322 does not extend through surface 325. As will be discussed below, the purpose of channel 322 and surface 324 is to limit the movement of proximal wedge 550 and distal wedge 650 relative to ramp 300 by causing mating features on ramp 300 to bottom out onto surface 324. Channel 322 may further include a blind bore 308 that coincides with surface 324. The purpose of bore 308 is to optionally receive a mating pin to limit the allowable amount of width expansion. Branch 314 extends from ramp surface 320 to surface 329, and branch 316 extends from ramp surface 320 to surface 330. Protrusion 319 further includes a relief 306, the axis of which is substantially parallel to the longitudinal axis. Relief 306 is configured to mate with actuator 500 and allows the ramps to be closer together than would otherwise be possible without relief 306. Relief 306 has any cross-section suitable for accomplishing the above-described functions, such as a generally rectilinear cross-section, or more preferably a partially polygonal cross-section, or most preferably a circular cross-section. Ramp surface 320 and branches 314 and 316 form a tapered channel 328 having a generally trapezoidal cross-section. The tapered channel 328 has a trapezoidal cross-section in the illustrated embodiment, but it should be understood that the cross-section may include, but is not limited to, a T-shaped cross-section (shown in FIG. 18C), a Y-shaped cross-section (shown in FIGS. 18D and 18E), an L-shaped cross-section (not shown), an F-shaped cross-section (not shown), or preferably, any cross-section in general that results in a tapered channel 328 that is narrower at surface 329 than at lamp surface 320 or at any point between surface 329 and lamp surface 327.Optionally, in any embodiment, the slope of the lamp surface 320 may or may not be the same between the lamps 350, 400, 450, 500 at the end plates.
[0296] While in the illustrated embodiment, branches 321 and 323 have trapezoidal cross-sections, it should be understood that they may have, but are not limited to, a T-shaped cross-section, a Y-shaped cross-section, an L-shaped cross-section, or, preferably, any cross-section in general that results in branches 321 and 323 being thinner at inner surface 305 than at outer surface 327 or at any point between inner surface 305 and outer surface 327. FIGS. 18A, 18B, 18C, 18D, and 18E show some cross-sections that branches 321 and 323 may take. Any of the embodiments described herein may optionally have these cross-sections in their branches. For manufacturability considerations, L-shaped ( FIG. 18A ), U-shaped ( FIG. 18B ), and T-shaped ( FIG. 18C ) cross-sections may be particularly preferred, although Y-shaped cross-sections ( FIG. 18D ) and “internal T”-shaped cross-sections ( FIG. 18E ) are also possible. Optionally, in any embodiment, the slopes of branches 321 and 323 are equal to or different from one another. Because branches 321 and 323 are intended to engage slots 107 and 109, the effect of altering their slope is the same as that discussed above for slots 107 and 109 in end plate 100. Similarly, the effect of altering the slope of ramp surfaces 320 between each of the four ramps on the deployment characteristics of device 1000 has been described above and can be seen in FIGS. 15A-15G above; however, in addition to the description of these figures, and in light of the detailed description of ramps 300 provided herein, it should be understood that because the slope of ramp surfaces 320 controls the width expansion of device 1000, altering the slope of each of the ramps (and altering the mating slope of the ramps in the wedges in a complementary manner) may result in, without limitation, all four end plates expanding at the same rate, the end plate on the right side expanding faster than the end plate on the left side, and the end plate on the left side expanding faster than the end plate on the right side, or one, some, or all end plates deploying faster than the others.While various alternative shapes of the lamp are shown herein as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment in the specification. It should also be understood that substituting the above-described optional alternative features in any lamp component will require the mating component (e.g., end plate, wedge, and / or actuator) to use the inverse or complementary shape of those features for proper engagement, and that the shape of that inverse or complementary shape will necessarily be derived from the above-described optional alternative feature shape.
[0297] 19A-19H2, FIGS. 19A and 19B show an alternative embodiment of ramp 300, in which branches 321 and 323 each have their central axes that are generally perpendicular to the longitudinal axis of ramp 300 and include generally cylindrical (in other contemplated embodiments, conical) protrusions 331 and 332. Optionally, in any embodiment, protrusions 331 and 332 further include openings 334 and 335, respectively. Openings 334 and 335 have central axes that coincide with the central axes of protrusions 331 and 332, said openings being configured to engage fastener 740, which in some embodiments is a pin (but in other embodiments is a screw) configured to engage openings 334 and 335 and track 127A (best seen in FIG. 19H2) extending into bottom surface 108 of end plate 100 and a corresponding track (not shown) extending into bottom surface 106 of end plate 100. When engaging corresponding tracks in end plate 100, fasteners 740 are intended to equally or preferentially limit the amount of translation allowed between ramp 300 and ramp slots 107 and 109 in end plate 100. It should be understood that in the illustrated embodiment, protrusions 331 and 332 have a cross section through their central axes that is not limited to a rectangular or less, but includes an L-shaped cross section (shown in FIGS. 19C and 19D), a T-shaped cross section (shown in FIGS. 19E and 19F), a trapezoidal cross section (not shown), or preferably, generally any cross section that results in protrusions 331 and 332 being thinner at inner surface 305 than at outer surface 327 or at any point between inner surface 305 and outer surface 327. The articulation between these aspects of the ramp 300 and the end plate 100 is intended to allow the ramp 300 to translate in only one dimension in the ramp slots 107 and / or 109 of the end plate 100 and to rotate within said slots in only one plane.
[0298] 19G1-19G3 show cross-sectional views of assembly of an articulation embodiment of an exemplary endplate 100 and an exemplary ramp 300, where, due to T-slot 149 being a blind slot and not breaking through bottom surface 132 of endplate 100, ramp 300 is translationally constrained within ramp slot 109 of endplate 100 at one angle formed between the long axis of ramp 300 and endplate 100, while being able to pass (e.g., and preferably during assembly of fusion device 1000) at another angle between the long axis of ramp 300 and endplate 100 (preferably outside the functional and / or useful range of exemplary fusion device 1000). FIGS. 19H1 and 19H2 show portions of an exemplary fusion device including an articulation embodiment between ramp 300 and endplate 100, where ramp slot 109 of endplate 100 has a generally T-shaped cross-section and protrusion 331 of ramp 300 has a generally T-shaped cross-section. The protrusion 331 further includes an aperture 334 generally concentric therewith, where the aperture 334 is configured to receive a fastener 740, which in this embodiment includes a pin. The ramp slot 107 of the end plate 100 further includes a track recessed in its bottom surface and configured to engage the fastener 740 for the purpose of limiting translational movement of the ramp 300 inside the slot 107 of the end plate 100. FIG. 19H1 shows a side view of the assembled articulation joint, and FIG. 19H2 shows an exploded view of the articulation joint. Both the embodiments of FIGS. 19G1-19G3 and 19H1-19H2 are contemplated as being useful for, but not limited to, creating uneven deployment of the distal and proximal ends of the fusion device 1000 shown in FIGS. 14B1 and 14B2 above. While various alternative forms of the lamp are shown herein as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment in the specification.It should also be understood that substituting the above-described optional alternative features in any one component may or would require mating components (e.g., end plates, wedges, and / or actuators) to use the inverse and / or complementary shapes of these features for proper, intended engagement between the various components of fusion device 1000 and between these components and surrounding anatomical structures, and that the shapes of the inverse and / or complementary shapes would necessarily be derived from the above-described optional alternative feature shapes.
[0299] 20 , actuator 500 includes a proximal end 504, a distal end 502, and a cylindrical surface 506 connecting proximal end 504 and distal end 502. Optionally, in any embodiment, actuator 500 further includes a drive mechanism 512 proximate proximal end 504 and threads 508 proximate distal end 502. Cylindrical surface 506 includes a groove 514 circumferentially disposed about the actuator proximate drive mechanism 512 and a ridge 510 circumferentially disposed about the actuator proximate threads 508. Ridge 510 is intended to function as a depth stop to limit the linear travel of actuator 500 by making contact with distal wedge 650 at the end of an allowable range of travel. In one embodiment, drive mechanism 512 is shown as a hexalobular protrusion (external hexalobular drive), however, optionally, in any embodiment, drive mechanism 512 may be, but is not limited to, an internal hexalobular, an external hexagonal, an internal hexagonal, an external cruciform, an internal cruciform, or any other shape. Optionally, in any embodiment shown in FIG. 21A , drive mechanism 512 is a hexagonal recess (internal hexagonal drive). Additionally, in the embodiment shown in FIG. 21A , cylindrical surface 506 of actuator 500 further includes ridges 515 circumferentially disposed around the actuator proximal end 504 but distal to grooves 514. Ridges 515 are configured to bottom out on second end 560 of proximal wedge 550 and are intended to provide resistance to actuator 500 subject to extrusion through central opening 568, retaining pin 600, retaining set screw 700, retaining c-clip 720, or some other actuator retention means against high loads. 25 shows a cross-sectional view of a subassembly including proximal wedge 550, actuator 500, and retaining c-clip 720, demonstrating the location and function of ridge 515. Optionally, in any embodiment shown in FIG. 21B, actuator 500 includes additional threads 517 proximal to proximal end 504. Threads 517 are composed of helical grooves in the opposite direction to that of threads 508 (i.e., if threads 508 are right-handed, then threads 517 are left-handed).An additional effect of the opposing threads 517 is that the actuator 500 will thread into the distal wedge 650, for example, in a clockwise fashion, while threading into the proximal wedge 550 in a counterclockwise fashion, causing the actuator 500 to also translate relative to both wedges when actuated torsionally, pulling the wedges together. The extent of movement of the actuator 500 relative to each wedge is contemplated to be controlled either by thread length, in which case the thread runout will bottom out on the respective wedge, or by dedicated ridges (e.g., 510 and 515) circumferentially disposed around the actuator and configured to bottom out on the respective wedge, thereby limiting the translation of the actuator. While various alternative forms of the actuator are shown herein as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment herein. It should also be understood that substituting any of the above optional alternative features in the actuator component would require the mating component (such as a wedge, ramp, or any auxiliary device intended to engage the actuator 500) to use the inverse or complementary shape of those features for proper engagement, and that the shape of that inverse shape would necessarily be derived from the above optional alternative feature shape.
[0300] With reference to FIG. 22 , retaining pin 600 includes a first end 604, a second end 602, and a cylindrical surface 606 connecting ends 604 and 602, where cylindrical surface 606 may have any diameter and any length suitable for a particular application, mating mechanism, or component. With reference to FIG. 23 , retaining set-screw 700 includes a first end 704, a second end 702, and a threaded surface 705 connecting ends 704 and 702. Retaining set-screw 700 further includes a drive mechanism proximate first end 704 and a cylindrical protrusion 710 extending from second end 702. With reference to FIG. 24 , retaining c-clip 720 includes an inner diameter 724, an outer diameter 722, and a split 725 intercepting both inner diameter 722 and outer diameter 724.
[0301] 26A-26B , in an exemplary embodiment, proximal wedge 550 includes a first end 562, a second end 560, an upper surface 590 connecting first end 562 and second end 560, and a lower surface 552 connecting first end 562 and second end 560. Proximal wedge further includes a first ramp surface 580 and a second ramp surface 582 located proximate second end 560. First ramp surface 580 includes a first protrusion 564 extending from first ramp surface 580 toward surface 565 and having a generally trapezoidal cross-section. Second ramp surface 582 includes a second protrusion 566 extending from second ramp surface 582 toward surface 567 and having a generally trapezoidal cross-section. Optionally, in any embodiment, first protrusion 564 includes protuberance 574 and second protrusion 566 includes protuberance 575. It is contemplated that protrusions 564 and 566 are configured to slidably engage tapered channel 328 of ramp 300 in the end plate in a manner such that ramp 300 only translates relative to proximal wedge 550 in one dimension, back and forth, either in a straight line or a curve (optionally, in any embodiment, rotation in one plane may also be allowed between ramp and wedge 550). Optionally, in any embodiment, protuberances 574 and 575 are configured to engage groove 322 on ramp 300 in the end plate, limiting the degree of translation between ramp 300 and wedge 550 by making contact with surface 324 at the limit of allowable movement. Optionally, in any embodiment, in some embodiments, top surface 590 includes protrusion 554 extending from top surface 590. Protrusion 554 includes a channel 599 that extends through first end 562 but not through second end 560. It should be understood that channel 599 is intended as a mating mechanism for auxiliary instruments used in the introduction, deployment and / or graft delivery of device 1000, and may be configured, shaped and positioned in other manners so long as it is accessible from first end 562. Proximal wedge 550 further includes central opening 568 (shown, for example, in FIG. 19) and side openings 570 and 572 (shown, for example, in FIG. 26B).Optionally, in any embodiment, central opening 568 includes undercut 571, and both side-openings 570 and 572 are threaded. Central opening 568 is configured to engage and retain actuator 500 by a retaining set screw 700 engaged in threaded recess 586 and extending into groove 514 of actuator 500, and / or a retaining pin 600 engaged in bore 584 and extending into groove 514 of actuator 500, or a retaining c-clip 720 (see FIG. 24 ) that simultaneously engages undercut 571 and groove 514 of actuator 500, or any other retention mechanism that allows actuator 500 to rotate inside central opening 568 but substantially prevents actuator 500 from translating along the axis of central opening 568.
[0302] It should be understood that in the illustrated embodiment, first protrusion 564 and second protrusion 566 have a trapezoidal cross-section, or a cross-section including, but not limited to, a T-shaped cross-section, a Y-shaped cross-section (not shown), or preferably, any cross-section in general that results in narrower protrusions 564 and 566 at lamp surfaces 580 and 582 than they are at surfaces 565 and 567. Similarly, any embodiment may have any of the cross-sections described above. Figure 27A shows an embodiment including protrusions 564 and 566 with a T-shaped cross-section, which may be particularly preferred for manufacturability and performance considerations.
[0303] Side openings 570 and 572 are intended as mating features for auxiliary instruments used in the introduction and / or deployment of device 1000 and / or graft delivery to device 1000, and may be configured, shaped, and positioned in other manners so long as they are accessible from first end 562. By way of example, there may be one or two side openings, one or both side openings may be threaded or neither may be threaded, and one or both side openings may be non-circular. Additionally, central opening 568 is intended to engage an actuator and may or may not be in the geometric center of proximal wedge 550, and may or may not be threaded. 27B shows an exemplary proximal wedge 550 in which the central opening is threaded with left-handed threads (but may be threaded with right-handed threads in other embodiments), one of the side openings is threaded, and one of the side openings has a generally rectangular, or preferably generally square, shape, which is considered advantageous for graft delivery to the fusion device 1000 because it may provide a larger cross-sectional area for graft material to travel through compared to a circular opening of similar external dimensions. Other optional instrument attachment features are also contemplated, including, but not limited to, the embodiments of the proximal wedge 550 shown in FIGS. 27B, 27C, and 27D. For example, the embodiment shown in FIG. 27B does not include protrusion 554, but instead includes protrusions 587 and 588 extending from the upper surface and forming channel 591, and protrusions 589 and 590 extending from the lower surface 552 and forming channel 592. Figure 27C shows the embodiment from Figure 27B including groove 592 extending from protrusion 587 to protrusion 589. Optionally, in any embodiment, another groove (not shown) of similar dimensions may extend from protrusion 589 to protrusion 590. It is further contemplated that these grooves will function as engagement features for auxiliary instruments. The embodiment of Figure 27C further includes both side openings that are circular and threaded, and a central opening that is not threaded.FIG. 27D shows the embodiment from FIG. 27C further including stepped recesses 593 and 594 on the sides of proximal wedge 550, including deeper portions of stepped recesses 593 and 594 located proximal to second end 560. Optionally, in any embodiment, stepped recesses 593 and 594 may serve as engagement features for auxiliary instruments. The embodiment of FIG. 27D further includes one side opening that is circular and threaded, one opening that is generally rectangular or preferably square in shape, and a central opening that is not threaded. Optionally, in any embodiment, the slopes of ramp surfaces 580 and 582 (and the slopes of ramp surfaces 680 and 682, discussed below) are equal to or different from one another. Because the branches of the wedge ramp surfaces 580, 582 (and 680, 682, discussed below) are intended to mate with the ramp surfaces 320 of ramps 300, 350, 400, 450, the effect of altering their slope is the same as discussed above for ramp surface 320 in ramp 300. While the various alternative shapes of the proximal wedge are shown here as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment in the specification. It should also be understood that substituting the above-described optional alternative features in any proximal wedge component will require the mating components (e.g., end plate, ramp, actuator, and distal wedge) to use the inverse or complementary shapes of those features for proper engagement, and that the shape of the inverse shape will necessarily be derived from the above-described optional alternative feature shapes.
[0304] 28A and 28B, in the exemplary embodiment, distal wedge 650 includes a first end 662, a second end 660, an upper surface 690 connecting first end 662 and second end 660, and a lower surface 652 connecting first end 662 and second end 660. Proximal wedge further includes a planar first ramp surface 680 and a planar second ramp surface 682 located proximate second end 660. First ramp surface 680 includes a first protrusion 664 extending from first ramp surface 680 toward surface 665 and having a generally trapezoidal cross-section. Second ramp surface 682 includes a second protrusion 666 extending from second ramp surface 682 toward surface 667 and having a generally trapezoidal cross-section. Optionally, in any embodiment, first protrusion 664 includes protuberance 674 and second protrusion 666 includes protuberance 675. It is contemplated that protuberances 664 and 666 are configured to slidably engage tapered channel 328 of ramp 300 in the end plate in a manner such that ramp 300 only translates relative to proximal wedge 650 in one dimension, back and forth, in either a straight line or a curve. Optionally, in any embodiment, protuberances 674 and 675 are configured to engage groove 322 on ramp 300 and limit the degree of translation between ramp 300 and wedge 650 by making contact with surface 324 at the limit of allowable movement. Optionally, in any embodiment, upper surface 690 further includes protuberance 654 extending from upper surface 690 and protuberance 655 extending from lower surface 652. Protrusions 654 and 655 further include chamfers 688 and 689 configured to facilitate introduction of device 1000 during initial distraction of adjacent vertebrae 2 and 4. Distal wedge 650 further includes a central aperture 668 and side apertures 670 and 672. Central aperture 668 is fully threaded and both side apertures 670 and 672 are threaded. Central aperture 668 is configured to engage actuator 500.The side openings are intended as mating features for auxiliary instruments used in the introduction and / or deployment of device 1000 and / or graft delivery to device 1000 and may be configured, shaped, and positioned in other manners. Optionally, in any embodiment, there may be one or two side openings, one or both side openings 670 and 672 may be threaded, or none of side openings 670 and 672 may be threaded, and one or both side openings 670 and 672 may be non-circular. FIG. 29A shows, by way of example, an exemplary distal wedge 650 that does not include a side opening. While in the illustrated embodiment, first protrusion 664 and second protrusion 666 have trapezoidal cross-sections, it should be understood that they, or any other embodiment disclosed herein, may optionally have, without limitation, a T-shaped cross-section, a Y-shaped cross-section, an L-shaped cross-section, or generally any cross-section that preferably results in narrower protrusions 664 and 666 at ramp surfaces 680 and 682 than they are at surfaces 665 and 667. FIG. 29B shows an exemplary distal wedge including protrusions 664 and 666 with a T-shaped cross-section, which may be particularly preferred for manufacturability and performance considerations. Optionally, in any embodiment, the slopes of ramp surfaces 580 and 582 and the slopes of ramp surfaces 680 and 682 are equal to or different from one another. Because the branches of the wedge ramp surfaces 580, 582, 680, 682 are intended to mate with the ramp surfaces 320 of the ramps 300, 350, 400, 450, the effect of altering their slope is the same as that discussed above for the ramp surfaces 320 in the ramps 300. While the various alternative shapes of the distal wedge are shown herein as separate embodiments, it should be understood that these alternative embodiments have optional features that may be substituted or mixed / combined with any other embodiment herein.It should also be understood that substituting any of the above optional alternative features in the distal wedge component would require the mating components (e.g., endplate, ramp, actuator, and proximal wedge) to use the inverse or complementary shape of those features for proper engagement, and that the shape of the inverse would necessarily be derived from the above optional alternative feature shape.
[0305] Turning now to a method of implanting a fusion device between two adjacent vertebral bodies 2 and 4, FIGS. 30, 31, and 32 illustrate an embodiment of an inserter 800 configured to reversibly attach to a fusion device 1000, allow the fusion device 1000 to be implanted between adjacent vertebral bodies 2 and 4, and facilitate delivery of a graft to the fusion device 1000. Optionally, in any embodiment, the inserter 800 includes an elongated body 820 that is generally rectangular in shape, although other shapes may be used in other embodiments, and most preferably has a cross-section that is substantially the same as the transverse cross-section of the fusion device 1000 in its initial, collapsed state. The inserter 800 further includes a threaded shaft 840 slidably disposed in the body. The body 820 further includes a distal end configured to mate with the proximal wedge 550 of the fusion device 1000 and includes three openings running the entire length of the body 820. The first opening 821 allows the threaded shaft 840 to access one of the threaded side-openings in the proximal wedge 550, allowing reversible attachment of the inserter 800 to the fusion device 1000 by threading the threaded shaft 840 into the proximal wedge 550. The second opening 822 allows the deployment driver instrument 870 to access the drive mechanism 512 of the actuator 500. The deployment driver instrument 870 is shown in FIG. 33 and includes a distal end including a drive mechanism 877 that mates with the drive mechanism 512 of the actuator 500, and a proximal end including an attachment mechanism 875 for a torque handle, torque-limiting handle, or torque-indicating handle that is used to actuate the actuator 500 and achieve deployment of the fusion device 1000. A third opening 823 allows access to the side opening of the proximal wedge 550 for purposes of delivering a therapeutic agent, such as a bone graft or bone growth inducing material, to the fusion device 1000 after deployment. The distal end of the body 820 further includes flats forming ledges 825 and 827 intended to prevent height deployment of the fusion device 1000 until width deployment is substantially complete. Once the inserter 800 is attached to the fusion device 1000 by threading the threaded shaft 840 into the proximal wedge 550 (see FIG. 34), the fusion device 1000 is implanted between the adjacent vertebral bodies 2 and 4 (see FIG. 35).Once the initial implantation position of the fusion device 1000 is found to be satisfactory, a deployment driver instrument 870 is slidably introduced into the second opening 822 in the inserter 800, and the driver mechanism 877 is engaged with the driver mechanism 512 of the actuator 500 (see FIG. 36 ). Application of torque to the deployment driver instrument 870 now results in deployment of the fusion device 1000. FIG. 37 shows the inserter 800 attached to the fusion device 1000 in a fully collapsed state, with the ledge 825 partially covering the endplates, thereby preventing height deployment of the fusion device 1000 but allowing width deployment. The ledge 825 in FIG. 37 is shown covering a portion of the endplates and preventing height deployment of the fusion device 1000. Figure 38 shows the inserter 800 attached to the fusion device 1000 in a partial width-expanded state, with the ledge 825 partially covering the endplates, thereby preventing height expansion of the fusion device 1000 but allowing further width expansion. Figure 39 shows the inserter 800 attached to the fusion device 1000 in a full width-expanded state, with the ledge 825 no longer covering the endplates, thereby allowing height expansion of the fusion device 1000. Figure 40 shows the inserter 800 attached to the fusion device in a full width- and height-expanded state. Bone graft or bone growth inducing material (graft material) is then introduced, delivered, or injected into the fusion device 1000 through the third opening 823 of the inserter 800. Optionally, in any embodiment, once the fusion device 1000 is implanted and deployed, the graft material may be pre-packed into the third opening 823 using an elongated tamp (not shown) configured to fit through the third opening 823 before attaching the inserter 800 and packing it through the third opening 823 into the fusion device 1000. It is further contemplated that the graft material may be delivered to the proximal opening of the third opening 823 after the device 1000 is deployed by means including, but not limited to, a syringe, a funnel, a screw-actuated graft delivery device, or a grip-actuated graft delivery device. The elongated tamp is then used to push any graft material remaining inside the third opening 823 into the fusion device 1000.It is further contemplated that graft material may be introduced into the fusion device 1000 after it has been deployed and the insertion instrument has been removed, with the graft being introduced through any available opening in the proximal wedge 550, or through the gap between the first intervertebral endplate 6 and the proximal wedge 550, or through the gap between the second intervertebral endplate 8 and the proximal wedge 550, or through both simultaneously. FIG. 41 shows the fusion device 1000 in a fully deployed state, filled with bone graft material and still attached to the inserter 800. FIG. 42 shows the fusion device 1000 between two adjacent vertebral bodies 2 and 4 in a fully deployed state, filled with bone graft and removed from the inserter 800. Implantation of the fusion device 1000 is then complete, and the surgical scar may then be closed.
[0306] FIG. 43 shows an exemplary insertion instrument. The inserter 900 includes a main shaft 955, a sleeve 930, a wheel 945, a handle 915, and pins 970 and 971. The main shaft 955 further includes a distal end configured to mate with the proximal wedge 550 of the fusion device 1000 and external threads located proximal to the proximal end. A detailed cross-sectional view of the threaded articulation of the inserter is seen in FIG. 44. As shown in FIGS. 45 and 46, the main shaft further includes three openings running the entire length of the main shaft 955. The second opening 961 allows the deployment drive instrument 870 to access the drive mechanism 512 of the actuator 500. The first opening 961 and the third opening 963 allow access to the side openings of the proximal wedge 550 for the purpose of delivering bone graft or bone growth inducing material to the fusion device 1000 after deployment. The distal end of the main shaft 955 further includes a first tang 956 including a distal protrusion 964 and a second tang 957 including a distal protrusion 965. The tangs 956 and 957 are partially separated from the main bulk of the main shaft 955 by slits 958 and 959, which provide flexibility to the tangs. The distal ends of the tangs are configured to engage mating features of the exemplary proximal wedge 550; this articulation is shown in cross section in FIG. 47 . The sleeve 930 is configured to slide over the main shaft 955 and is advanced distally or proximally along the main shaft 955 by means of turning a wheel 945 that is communicatively engaged with the main shaft 955 and rotationally engaged with the sleeve 930 by means of pins 970 and 971, providing an articulation whereby the wheel 945 rotates relative to the sleeve 930 but does not translate relative thereto. The handle 915 is fixedly attached to the proximal end of the main shaft 955 .When sleeve 930 is in its proximal-most position (shown in FIG. 48 ), tangs 956 and 957 are allowed to elastically deform from one another to engage mating features on proximal wedge 550 of fusion device 1000, and when sleeve 930 is in its distal-most position (shown in FIG. 49 ), it prevents tangs 956 and 957 from elastically deforming from one another, resulting in positive engagement between proximal wedge 550 of fusion device 1000 and inserter 900. Furthermore, in its distal-most state, sleeve 930, and particularly its distal end, performs the same function in inserter 900 that ledges 825 and 827 do in inserter 800, which is to prevent fusion device 1000 from expanding in height until width expansion is substantially complete. Once inserter 900 is attached to fusion device 1000, fusion device 1000 is implanted between adjacent vertebral bodies 2 and 4. Once the initial implant placement of the fusion device 1000 is found to be satisfactory, the deployment drive instrument 870 is introduced into the second opening 962 in the inserter 900, and the drive mechanism 877 is engaged with the drive mechanism 512 of the actuator 500 (see FIG. 50). Application of torque to the deployment drive instrument 870 now results in expansion of the fusion device 1000, first in width (see FIG. 51), and then in both width and height (see FIG. 52). Delivery of bone graft material through the inserter 900 and into the fusion device 1000 may now be accomplished through one or both of the openings 961 and 963 in the manner discussed above. FIG. 53 shows the fusion device 1000 in a fully deployed state, filled with bone graft material and still attached to the inserter 900. The inserter 900 may then be removed from the fusion device 1000, the implantation of the fusion device 1000 may then be completed, and the surgical scar may then be closed.
[0307] Second Deployable Fusion Device Turning now to Figures 54A-54C, which illustrate an exemplary second deployable fusion device 1000a, Figure 54A illustrates the exemplary second deployable fusion device 1000a in a fully collapsed state, Figure 54B illustrates the exemplary second deployable fusion device 1000a in a fully deployed state, and Figure 54C illustrates an exploded view of the exemplary second deployable fusion device 1000a. Optionally, in any embodiment, second deployable fusion device 1000a includes embodiment 300a of first ramp 300 (as well as ramps 350a, 400a, and 450a, all of which are identical in this embodiment, and ramp 400a is used to refer to the reference number for ramp 300a in FIG. 54C) and is the same as the exemplary embodiment of first ramp 300, with the following exceptions: outer surface 327 includes ramp slot 335a that is parallel to the ramp surface of branch 323, branches 321 and 323 have an approximately C-shaped cross-section, surfaces 329 and 330 include protrusions 337a and 338a, channel 328 has an approximately T-shaped cross-section, and does not include groove 322 present in the previously discussed embodiment for ramp 300.
[0308] The second deployable fusion device 1000a further includes embodiment 100a of the first end plate 100 (as well as end plates 150a, 200a, and 250a, which are all identical in this embodiment but may need to be suitably aligned to be assembled into the arrangement of the second deployable fusion device 1000a), in which lamp slots 107 and 109 have a C-shaped cross-section configured to mate with lamp 300a, and upper surface 132 includes a protrusion 145a adjacent slot 109 and a recess 146a adjacent lamp slot 107, while protrusion 145a and recess 146a have complementary shapes such that when the two end plates are suitably rotated, one protrusion 145a overlaps the other recess 146a, allowing the lower surface of the top end plate to contact the upper surface of the bottom end plate. The outward-facing surface of the projection 145a further includes a divot 147a (shown on end plate 200a in FIG. 54C ), which, when assembled, is generally aligned with the long axis of the ramp slot 335a of the ramp 300a, but does not extend completely to the other side of the end plate. The divot 147a may be spherical, cylindrical (as shown), or have any other shape. The purpose of the divot is to create a narrowed area of material between the bottom of the divot and the inward-facing surface of the ramp slot 109, which allows for deformation (stretching) of the bottom of the divot, creating a protruding dimple 148a on the inward-facing surface of the slot 109 in the end plate. The stretching step is performed as the final step in the assembly process when the components are assembled and in a fully folded state, and is performed by means of a punch or pointed or rounded tool that applies a load to the bottom surface of the divot by impaction, pressing, or other means. As described above, the stretching creates dimples 148a on the inward surface of the end plate which, in the assembled device state, align with and engage the ramp recesses of the ramps, capturing them upon hyper-deployment and preventing disassembly of the second deployable fusion device 1000a.Optionally, in any embodiment, the divots are replaced with through openings in the end plates, and the function of the stamped dimples is performed by pins that engage ramp slots in the ramps pressed through the end plate openings. End plate 100a does not include tapered grooves 122, 118, 124, and 120 present in the previously discussed embodiment of end plate 100, but instead includes ramp surfaces 121a and 123a (shown on end plate 200a in FIG. 54C), which perform generally the same function as grooves 122, 118, 124, and 120, which is to prevent height deployment from occurring until the device is fully deployed in width. This is accomplished through ramp surfaces 121 a and 123 a in contact with the mating ramp surfaces of the wedges during most of the width expansion process; while they are in contact with the wedges, the ramps on the opposing sides of each end plate can only move along the direction of the ramp surfaces of the wedges and ramp surfaces 121 a and 123 a, remaining static relative to each other during this time; whereas, to achieve height expansion, the opposing ramps must be able to move toward each other along the long axis of the device. Once width expansion is substantially complete, and once ramp surfaces 121 a and 123 a are no longer in contact with the wedges, the ramps are allowed to move toward each other, resulting in height expansion. The top surface 132 further includes a protrusion 115a adjacent to the lamp slot 107, while the inward-facing surface 130 includes a recess 117a adjacent to the slot 109. The protrusions 115a and recesses 117a have complementary shapes, allowing one protrusion 115a to overlap the other recess 117a when the two end plates are rotated appropriately, allowing the opposing upper and lower surfaces of the two top end plates to contact. The protrusions 115a are configured to mate with the lamps 300a as an extension of the lamp surface of the lamp slot 107. The purpose of the protrusions 115a is to increase device stability at the upper limit of the allowable height expansion by maintaining a large contact area between the lamp and the end plate. The end plate 100a also includes an opening 119a extending from the inner surface to the outer surface.This feature is optional and is intended to allow graft material to exit the interior of the device and fill the space surrounding it. Endplate 100a further includes a relief 149a, the axis of which is substantially parallel to the longitudinal axis. Relief 149a is configured to mate with actuator 500a and to allow the endplates to be brought closer together than would otherwise be possible without relief 149a.
[0309] Second deployable fusion device 1000a further includes embodiment 500a of actuator 500. Actuator 500a includes proximal end 504a, distal end 502a, and cylindrical surface 506a connecting proximal end 504a and distal end 502a. Optionally, in any embodiment, actuator 500a further includes drive mechanism 512a on proximal end 504a, threads 517a proximal to proximal end 504a, and threads 508a proximal to distal end 502a. Threads 508a comprise helical grooves of an opposite direction to that of threads 508a (e.g., if threads 508a are right-handed, threads 517a are left-handed, and vice versa). This embodiment further includes a second drive mechanism on the distal end (not shown). This second drive mechanism is considered useful during revision surgery, where the revision approach is not the same as the approach used during the original surgery.
[0310] The second deployable fusion device 1000a further includes an embodiment 550a of a proximal wedge 550. The proximal wedge 550a is shown in anterior and posterior perspective views in FIGS. 55A and 55B, respectively. The proximal wedge 550a includes a first end 562a, a second end 560a, an upper surface 590a connecting the first end 562a and the second end 560a, and a lower surface 552 connecting the first end 562a and the second end 560a. The proximal wedge further includes a first ramp surface 580a and a second ramp surface 582a located proximate the second end 560a. The first ramp surface 580a includes a first ramp recess track 591a proximate the upper surface and a second ramp recess track 592a proximate the lower surface. First ramp surface 580a further includes a protrusion 564a having a generally T-shaped cross-section, extending from first ramp surface 580a toward surface 565a. Protrusion 564a divides ramp surface 580a into an upper portion and a lower portion. Second ramp surface 582a includes a first ramp recess track 593a proximate the upper surface and a second ramp recess track 594a proximate the lower surface. Second ramp surface 582a includes a protrusion 566 having a generally T-shaped cross-section, extending from second ramp surface 582a toward surface 567. Protrusion 566a divides ramp surface 582a into an upper portion and a lower portion. Ramp recess tracks 591a, 592a, 593a, and 594a do not break through the side surfaces of wedge 550a and function to limit travel of the ramp relative to the proximal wedge by acting as a depth stop for bottoming out of protrusions 337a and 338a of ramp 300a. Top surface 590a further includes protrusion 554a extending therefrom. Bottom surface 552a further includes protrusion 555 extending therefrom. Protrusions 554a and 555a include channels 599a and 598a extending through first end 562a and second end 560a.It should be understood that channels 599a and 598a are intended as mating mechanisms for auxiliary instruments used in the introduction, deployment, and / or graft delivery of second deployable fusion device 1000a, and may be configured, formed, and positioned in other manners so long as they are accessible from first end 562a. Proximal wedge 550a further includes a threaded central opening 568a and generally rectangular openings 570a and 572a that extend through respective sides of proximal wedge 550a. Proximal wedge 550a further includes a partial bore 597a that extends some depth from first end 562a toward second end 560a, but not all the way, and is centered on the outer diameter of threaded central opening 568a, interrupting its threads. The partial bore 597a allows access to the proximal end of the threaded actuator after the device is deployed and to deform the first thread thereon with a punch, awl, or automated punch tool. This is done to prevent or reduce the chance of unthreading the actuator, which would result in the device losing height post-operatively.
[0311] The second deployable fusion device 1000a further includes an embodiment 650a of a distal wedge 650 (best seen in the exploded view in FIG. 54C ). In this embodiment, the proximal wedge 650a is identical to the proximal wedge 550a, with the exception that the distal wedge 650a includes a central opening that threads in the opposite direction to that of the proximal wedge. For example, if the central opening of the proximal wedge 550a has left-handed threads, the central opening of the distal wedge 650a has right-handed threads. Optionally, in any embodiment, having all of the insertion mechanisms present on the proximal wedge and also on the distal wedge along with an actuator with a second drive mechanism on the distal end (as discussed above) is useful during revision surgery, where the revision approach is not the same as the approach used during the original surgery. Optionally, in any embodiment, the distal wedge may have a more rounded distal end to facilitate initial implantation.
[0312] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment in the specification. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, a second deployable fusion device may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0313] Third deployable fusion device Turning now to Figures 56A-56C, which illustrate an exemplary third deployable fusion device 1000b. Figure 56A illustrates the exemplary third deployable fusion device 1000b in a fully collapsed state, Figure 56B illustrates the exemplary third deployable fusion device 1000b in a fully deployed state, and Figure 56C illustrates an exploded view of the exemplary third deployable fusion device 1000b. The third deployable fusion device 1000b has similar functionality to the previously discussed embodiment in that it is configured to transition from an initial collapsed state (shown in Figure 56A) to a final deployed state (shown in Figure 56B), but deployment is achieved using an improved mechanism in which a ramp slot in the ramp 300b is configured to receive a pin 600 inserted through a mating opening in the end plate 100b. Because end plate 100b does not contain a ramp surface, height deployment is achieved by pin 600 moving along the ramp slot and by various curved surfaces of the end plate, making tangential contact with the ramp surface of the ramp. Disintegration due to over-deployment is prevented by having pin 600 bottom out at the limit of travel allowed in ramp slot 300b. Third deployable fusion device 1000b includes embodiment 300b of first ramp 300 (as well as ramps 350, 400, and 450, all of which are identical in this embodiment) shown in complementary views in FIGS. 57A and 57B and has first end 301b and second end 303b. First ramp 300b further includes inner surface 305b connecting first end 301b and second end 303b, and outer surface 307b (best seen in FIG. 57B) connecting first end 301b and second end 303b. The first ramp 300b further includes an upper surface 309b connecting the first end 301b and the second end 303b, and a lower surface 311b connecting the first end 301b and the second end 303b, the two surfaces 309b and 311b preferably being parallel to one another. The first ramp 300b further includes a protuberance 315b further including an upper branch 321b extending beyond the outer surface 307b and the upper surface 309b, and a lower branch 323b extending beyond the outer surface 307b and the lower surface 311b.Upper branch 321b includes upper end surface 341b, first lamp surface 302b, and preferably second lamp surface 310b. Lower branch 323b includes lower end surface 343b, first lamp surface 304b, and preferably second lamp surface 312b. Inner surface 305b includes protrusion 319b, which forms lamp surface 320b. Protrusion 319b includes first branch 314b and second branch 316b. First branch 314b extends from lamp surface 320b to surface 329b, and second branch 316b extends from lamp surface 320b to surface 330b. Ramp surface 320b and branches 314b and 316b form channel 328b with a generally T-shaped cross-section, which is formed due to branches 314b and 316b including respective protrusions that extend along and parallel to ramp surfaces 329b and 330b, respectively, and toward each other. First branch 314b further includes protrusion 348b, and second branch 316b further includes protrusion 349b. Protrusion 319b further includes relief 306b, the axis of which is substantially parallel to the longitudinal axis. Relief 306b is configured to mate with actuator 500a and to allow the ramps to be closer to each other than would otherwise be possible without relief 306b. Relief 306b may have any cross-section suitable for achieving the above functions, for example, a generally rectilinear cross-section. Lamp 300b further includes a first lamp slot 337b recessed into inner surface 305b and extending from the midplane of lamp 300b toward upper branch 321b but not breaking through upper end surface 341b, and a second lamp slot 338b recessed into outer surface 327b and extending from the midplane of lamp 300b toward branch 323b but not breaking through lower end surface 343b. Lamp 300b further includes a first lamp relief 341b extending from the midplane of lamp 300b toward branch 321b and positioned between inner surface 305b and an inner margin of protrusion 319b, and a second lamp relief 342b extending from the midplane of lamp 300b toward branch 323b and positioned between inner surface 305b and an inner margin of protrusion 319b.The slope of the ramp relief may or may not be parallel to the respective ramp slot, and the purpose of the ramp relief is to remove parts of the end plate during height development.
[0314] Third deployable fusion device 1000b further includes embodiment 100b of first endplate 100 (best seen in FIG. 58) (as well as endplates 150, 200, and 250, all of which are identical in this embodiment), which includes first end 102b and second end 104b. First endplate 100b further includes upper surface 134b connecting first end 102b and second end 104b, and lower surface 132b connecting first end 102b and second end 104b. First endplate 100b further includes first elongated opening 107b adjacent first end 102b and second elongated opening 109b adjacent second end 104b. Elongated openings 107b and 109b extend from lower surface 132b through upper surface 140b in a direction perpendicular to the longitudinal axis. First end plate 100b further includes a first elongated recess 110b extending from first end 102b past first elongated opening 107b and a second elongated recess 112b extending from second end 104b past second elongated opening 109b. Elongated recesses 110b and 112b extend perpendicular to the longitudinal axis from lower surface 132b toward but not through upper surface 140b, forming first inward facing 114b and second inward facing 116b, respectively.
[0315] Lower surface 132b includes a first protrusion 145b adjacent to opening 107b, a second protrusion 145b1 adjacent to opening 109b, a first recess 146b adjacent to first opening 107b, and a second recess 146b1 adjacent to second opening 109b. Because protrusions 145b and 145b1 and recesses 146b and 146b1 have complementary shapes, when the two end plates are folded toward each other, one protrusion 145b overlaps the other recess 146b1, and one protrusion 145b1 overlaps the other recess 146b, allowing the upper and lower surfaces of the two end plates to contact and the inner surfaces 130b of the two end plates to align. The centers of the protrusions are configured to generally align with the lamp slots of lamps 300b when assembled. Protrusions 145b and 145b1 further include through openings 147b and 147b1, respectively, configured to receive pins that would engage lamp slots in lamp 300b. Inner surface 130b further includes relief 149b, the axis of which is substantially parallel to the longitudinal axis. Relief 149b is configured to mate with actuator 500b and to allow the end plates to be closer to one another than would otherwise be possible without relief 149b. Inner surface 130b further includes opening 119b extending from the inward-facing surface to the outward-facing surface. This feature is optional and is intended to allow graft material to exit the interior of the device and fill the space surrounding it. First inward protrusion 114b and second inward protrusion 116b further include first protrusion 118b and second protrusion 120b, respectively. The protrusions are rounded on the surfaces facing each other. The rounded cross-sections of protrusions 114b and 116b are configured for tangential contact with lamp surfaces 310b and 312b of lamp 300b, increasing the contact area between the end plate and the lamp. At least the corners formed by first end 102b and inner surface 130b, and by second end 104b and inner surface 130b, include rounded surfaces 121b and 123b, respectively. The purpose of these rounded surfaces is to help prevent height deployment until the device is fully deployed in width.This is accomplished through rounded surfaces 121b and 123b, which are in tangential contact with the mating ramp surfaces of the wedges during most of the width deployment process. While they are in tangential contact with the wedges, the ramps 300b on the opposing sides of each endplate 100b can only move along the direction of the ramp surfaces of wedges 550b and 650b because their ramp surfaces are in tangential contact with rounded surfaces 121a and 123a. During this time, the ramps 300b remain stationary relative to each other. To achieve height deployment, however, the opposing ramps must be able to move toward each other along the longitudinal axis of the device. Once width deployment is substantially complete and once rounded surfaces 121a and 123a are no longer in tangential contact with the wedges, the ramps are allowed to move toward each other, resulting in height deployment. Top surface 134b includes texturing 140b to aid in gripping adjacent vertebrae. In the illustrated embodiment, the texturing 140b comprises a series of parallel grooves running transverse to the long axis of the end plate 100b, which may include, but are not limited to, teeth, ridges, areas of high surface roughness, metallic or ceramic coatings with relatively high surface roughness, friction-increasing elements, keels, spikes, or gripping or leveraging protrusions. Optionally, in any embodiment, one or more end plates may be shorter, longer, thinner, or wider than the others.
[0316] The third deployable fusion device 1000b further includes a proximal wedge 550a, a distal wedge 650a, an actuator 500a, and a pin 600.
[0317] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, a third deployable fusion device 1000b may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0318] Fourth Deployable Fusion Device Turning now to Figures 59A-59C, which illustrate an exemplary fourth deployable fusion device 1000c. Figure 59A illustrates the exemplary fourth deployable fusion device 1000c in a fully collapsed state, Figure 59B illustrates the exemplary fourth deployable fusion device 1000c in a fully deployed state, and Figure 59C illustrates a top view of the exemplary fourth deployable fusion device 1000b. The fourth deployable fusion device 1000c is identical to the previously described third deployable fusion device 1000b, except that in the third deployable fusion device 1000c, the end plates include overlapping interlocking stabilization mechanisms (best seen in Figure 59D) to improve stability, ensure proper alignment, reduce "slop" between the top and bottom end plates on either side of the device, and allow for easier device deployment. Opposing endplates above and below fourth deployable fusion device 1000c (FIG. 59D, for example, shows opposing endplates 100c and 150c) include protrusions 111c1 and 111c2 that point toward each other and mating recesses 113c1 and 113c2 that extend the length of the protrusions and through the upper surfaces of the endplates. Because the recesses further contain dovetail track 103c2 on one endplate and dovetail protrusion 103c1 (best seen in FIG. 59C) on the opposing endplate, the mating endplates only move in one dimension relative to each other, toward or away from each other along the long axes of the dovetail tracks. Here, since the protrusions 111c1 and 111c2 and the recesses 113c1 and 113c2 have complementary shapes, when the two end plates are rotated appropriately, one protrusion 111c1 overlaps the other recess 113c2, and one recess 113c1 receives the other protrusion 111c2, allowing the lower surfaces of the two end plates to come into contact and the inner and outer surfaces of the two end plates to be aligned.Although the stabilization mechanism of this embodiment is shown slidably interconnecting upper and lower end plate portions, it should be understood that the same arrangement may also be used to slidably interconnect upper or lower pairs of end plate portions, or to slidably interconnect both upper and lower pairs with upper and lower end plate portions.
[0319] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, a fourth deployable fusion device 1000c may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0320] Fifth Deployable Fusion Device Turning now to Figures 60A-60C, which illustrate an exemplary fifth deployable fusion device 1000d, Figure 60A illustrates the exemplary fifth deployable fusion device 1000d in a fully deployed state, and Figure 60B illustrates a side view of the exemplary fifth deployable fusion device 1000d in a fully deployed state. The fifth deployable fusion device 1000d is identical to the previously described fourth deployable fusion device 1000c, except that in the fifth deployable fusion device 1000d, the endplates contain overlapping interlocking stabilization features, where protrusions 111c1 and 111c2 described above for device 1000c also include curved projections 111c3 and 111c4, respectively, and recesses 113c1 and 113c2 described above for device 1000c also include curved reliefs 113d3 and 113d4, respectively, configured to receive curved projections 111c3 and 111c4 in an overlapping manner. The curved projections are configured to tangentially contact the ramp surface of ramp 300b, thereby providing additional contact points between the ramp and the endplate, resulting in improved device stability at the upper limit of allowed height deployment. The endplate of the fifth deployable fusion device 1000d does not contain a ramp surface and relies on pin components to conduct deployment forces between the ramp and endplate, which can lead to unwanted movement (slop) between these components due to low contact area. Adding curved features (such as curved protrusions 1113 and 1114) to the endplate allows for closer continuous contact surfaces between the ramp and endplate, thereby improving stability as discussed above.
[0321] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, a fifth deployable fusion device 1000d may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0322] Sixth Deployable Fusion Device Turning now to Figures 61A-61B, which illustrate an exemplary sixth deployable fusion device 1000e. Figure 61A illustrates exemplary sixth deployable fusion device 1000e in a fully deployed state, and Figure 61B illustrates an exploded view of exemplary sixth deployable fusion device 1000e. Sixth deployable fusion device 1000e includes embodiment 100e of first endplate 100 (as well as endplates 150, 200, and 250, where endplates 100e and 150e are identical and endplates 250e and 200e are mirrors of endplates 100e and 150e), which is identical to endplate 100, with the following exceptions. In end plate 100e, slots 107 and 109 have a generally C-shaped cross-section with equal slopes inclined in the same direction, where both slots 107 and 109 begin at top surface 134 and slope toward second end 104, and bottom surface 132 includes protrusion 145e adjacent slot 109 and recess 146e adjacent slot 107, where protrusion 145e and recess 146e have complementary shapes such that when the top and bottom end plates are folded toward each other, one protrusion 145a overlaps the other recess 146e, allowing the respective upper and lower surfaces of the opposing end plates to contact. Protrusion 145e further includes opening 147e (shown on end plate 150a in FIG. 61B ), which, when assembled, generally aligns with lamp slot 335e of lamp 300e and is configured to receive pin 600, which then engages the lamp slot in lamp 300e.
[0323] End plate 100e does not include tapered grooves 122, 118, 124, and 120 present in previously discussed embodiments of end plate 100, but instead includes ramp surfaces 121e and 123e, which perform generally the same function as grooves 122, 118, 124, and 120, which is to prevent height deployment from occurring until the device is fully deployed in width. This is achieved through ramp surfaces 121e and 123e contacting the mating ramp surfaces of the wedges during most of the width deployment process; while they are in contact with the wedges, the ramps on opposite sides of each end plate can only move along the direction of the ramp surfaces of the wedges and ramp surfaces 121e and 123e, remaining static relative to one another; to achieve height deployment, the opposing ramps must be able to move toward one another along the long axis of the device. Once width expansion is substantially complete and once ramp surfaces 121e and 123e are no longer in contact with the wedges, the ramps are allowed to move toward each other, resulting in height expansion. End plate 100e further includes an opening 119e extending from the upper surface to the lower surface in a direction perpendicular to the longitudinal axis. The purpose of opening 119e is to be engaged by mating protuberance 315e of ramp 350e or 450e. End plate 100a further includes a linear relief 149e spanning the distance between slots 107 and 109. The purpose of relief 149e is to allow ramps 300e and 400e to properly mate with the end plate.
[0324] The sixth deployable fusion device 1000e further includes a distal ramp 350e and a distal ramp 450e, which are identical and will hereafter be referred to as distal ramp 350e. The sixth deployable fusion device 1000e further includes a proximal ramp 300e and a proximal ramp 400e, which are identical and will hereafter be referred to as proximal ramp 300e. Distal ramp 350e is the same as ramp 300b above, with the following exception: distal ramp 350e does not include protuberance 315b or the ramp slot present in ramp 300b, but instead includes protuberance 315e, which extends beyond upper surface 309b, beyond lower surface 311b, and beyond outer surface 307b, and has an elongated shape extending generally in a direction normal to the upper and lower surfaces. Proximal ramp 300e is the same as ramp 300b described above, with the following exceptions: in proximal ramp 300e, ramp slot 337b is recessed into outer surface 327b opposite inner surface 305b, as is done in previously described ramp 300b, resulting in both ramp slots 337b and 338b being on the same side of proximal ramp 300e and merging together at the midplane, proximal ramp 300e does not include ramp reliefs 341b and 342b, branches 323b and 321b of protrusion 315b have a generally C-shaped cross-section, and proximal ramp 300e further includes protrusion 315e1 connected to the tip of proximal ramp 300e by isthmus 315e2 and forming first end 301e of proximal ramp 300e. Protrusion 315e1 is identical to protrusion 315b, including having two lamp slots 338e and 337e recessed into outer surface 327e that are both coplanar with outer surface 327b. The tip of protrusion 315e1 that forms first end 301e is truncated so that it is shorter than that of protrusion 315b.
[0325] The sixth deployable fusion device 1000e further includes actuator 500a, proximal wedge 550a, distal wedge 650a, and pin 600 configured to press into mating openings in the endplates and engage ramp slots 338b, 337b, 338e, and 337e in the proximal ramps to provide stability and prevent device disassembly due to over-deployment by bottoming out in the ramp slots at the end of maximum allowable travel and height deployment. In other embodiments of the fusion device, after the sixth deployable fusion device 1000e has substantially reached maximum width deployment, further drawing of the wedges together causes the proximal and distal ramps to move toward each other. The proximal ramps are engaged with the ramp slots in the endplates and accomplish height deployment by moving relative to the endplates in both the direction of the device's long axis and the direction of height deployment, as well as along the angle between the mating ramp surfaces of the endplates and the proximal ramps, where the distal ramps only move in the direction of height deployment relative to the endplates. Optionally, in any embodiment, replacing lamps 350e and 450e with lamps 350a and 450a and adding mating lamp slots to the end plates to provide a mating geometry for lamps 350a and 450a would result in an embodiment with desirable features including improved end plate stability and easier, more uniform height deployment.
[0326] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, the sixth deployable fusion device 1000e may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0327] Seventh Deployable Fusion Device Turning now to Figures 62A-62B, which illustrate an exemplary seventh deployable fusion device 1000f. Figure 62A illustrates the exemplary seventh deployable fusion device 1000f in a fully deployed state, and Figure 62B illustrates an exploded view of the exemplary seventh deployable fusion device 1000f. In this embodiment, ramps on the anterior end of the seventh deployable fusion device 1000f engage posterior ramp surfaces on the endplates, and ramps on the posterior of the device engage an anterior ramp surface on the endplates, causing the device to deploy in height such that the anterior and posterior ramps are forced together when the actuator is actuated. The seventh deployable fusion device 1000f includes embodiment 100f of the first endplate 100 (as well as endplates 150, 200 and 250, where endplates 100f and 250f are identical and endplates 150f and 200f are mirrors of endplates 100f and 250f), where slots 107 and 109 have a "sideways T" shaped cross section, have equal slopes and are inclined in opposite directions, where slot 107f extends through inner surface 132f and slot 109f extends through outer surface 134f.
[0328] End plate 100f does not include the tapered grooves 122, 118, 124, and 120 present in the previously discussed embodiment of end plate 100, but instead includes rounded surfaces 121f proximate first end 102 and 123f proximate second end 104, which perform generally the same function as grooves 122, 118, 124, and 120, which is to prevent height deployment from occurring until the device is fully deployed in width. This is achieved through rounded surfaces 121f and 123f, which are in tangential contact with the mating ramp surfaces of the wedges during most of the width deployment process; while they are in contact with the wedges, the ramps on the opposing sides of each end plate are static relative to each other while only able to move along the direction of the ramp surfaces of the wedges because they maintain tangential contact with rounded surfaces 121f and 123f; where, to achieve height deployment, the opposing ramps must be able to move toward each other along the long axis of the device. Once width expansion is substantially complete and once rounded surfaces 121f and 123f lose their tangential contact with the wedges, the ramps are allowed to move toward each other, resulting in height expansion. Optionally, in any embodiment, rounded surfaces 121f and 123f are also ramp planar surfaces that are generally parallel to the ramp surfaces of the wedges to achieve the same height expansion limiting effect described above.
[0329] End plate 100f further includes a linear relief 149f spanning the distance between slot 107f and second end 104, as well as a corresponding relief on the other side that is the same and does not span the distance between slot 109 and first end 102. The purpose of the relief is to allow lamps 300f and 350f to properly mate with the end plate. End plate 100f further includes reliefs 149f3 on both inner surface 132f and outer surface 134f, the axes of which are substantially parallel to the longitudinal axis. Relief 149f3 is configured to mate with actuator 500a and to allow the end plates to be closer together than would otherwise be possible without relief 149f3. The reason for the presence of two reliefs 149f3 is that, as discussed above, endplate 100f is identical to endplate 250, endplate 150f is identical to endplate 200f, and depending on whether endplate 100f is assembled in a left or right configuration in seventh deployable fusion device 1000f, inner surface 132f of endplate 100f can form either the inner or outer margin of the assembled device. With this in mind, endplate 100f includes two reliefs 149f3 to keep the left and right endplate components identical in this embodiment, although only one of reliefs 149f3 actually contacts actuator 500a in any given endplate in any given assembly.
[0330] Seventh deployable fusion device 1000f further includes proximal outer ramp 300f and distal outer ramp 450f, which are identical and will hereafter be referred to as outer ramp 300f. Fusion device 1000e further includes proximal inner ramp 400f and distal inner ramp 350f, which are identical and will hereafter be referred to as inner ramp 350f. Here, the ramps are described as inner and outer based on whether their ramp surfaces contact inner or outer slots in the endplates. Inner ramp 350f is identical to ramp 300b above, with the following exceptions: inner ramp 350f does not include ramp slots 337b and 338b or ramp reliefs 341b and 342b present in ramp 300b, and branches 321f and 323f have a transverse T-shaped cross-section configured to mate with similarly shaped slots 107f and 109f in the endplates. Inner ramp 350f is longer than ramp 300b and has a truncated tip proximate first end 301b. Inner ramp 350f engages an inwardly facing slot in the end plate, while outer ramp 300f is configured to allow removal of the outer surface of outer ramp 350f, which itself engages an outwardly facing slot in the end plate.
[0331] Outer ramp 300f is identical to ramp 300b described above with the following exceptions: inner ramp 300f does not include the ramp slots present in ramp 300b, and branches 321f and 323f have a transverse T-shaped cross-section configured to mate with similarly shaped slots 107f and 109f in the end plate. Inner ramp 350f is longer than ramp 300b and has a truncated tip proximate its first end. Furthermore, protuberance 315f of outer ramp 300f protrudes beyond both outer surface 307f and inner surface 305f, in contrast to protuberance 315b of ramp 300b, which only protrudes beyond outer surface 307b. Outer ramp 300f itself engages an inward-facing slot in the end plate, while inner ramp 350f is configured to engage an outward-facing slot in the end plate and to allow removal of the inner surface of outer ramp 300f.
[0332] The seventh deployable fusion device 1000f further includes an actuator 500a, a proximal wedge 550a, and a distal wedge 650a. In other embodiments of fusion devices, after the device 1000e has substantially reached its maximum width deployment, further pulling of the wedges together causes the proximal and distal ramps to move toward each other. The proximal ramps engage with ramp slots in the endplates and achieve height deployment by moving relative to the endplates in both the direction of the device's long axis and the direction of height deployment, as well as along the angle between the proximal ramps and the mating ramp surfaces of the endplates. Disassembly through over-deployment of the seventh deployable fusion device 1000f is prevented using various methods described in other embodiments above, as well as those that would be apparent to one skilled in the art. One additional contemplated method for achieving this is to assemble the device in a state of height deployment greater than the desired maximum allowed height, then slightly reduce the height once the device is fully assembled, and then deform the threads of actuator 500a in a manner that no longer allows the seventh deployable fusion device 1000f to return to its initial super-deployed state required for assembly or disassembly of the components.
[0333] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, the seventh deployable fusion device 1000f may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0334] Eighth Deployable Fusion Device Turning now to FIGS. 63A-63D, which illustrate an exemplary eighth deployable fusion device 1000g, each of the endplates includes an anterior portion and a posterior portion, which further include mating cut-outs and circular openings that allow the portions to be pivotally connected with pins (with an integral cylindrical protrusion on one of the portions that engages a mating recess in the other portion). The pin may be pressed, welded, or machined as a protrusion into one portion and inserted into the other portion, with its free end swaged to prevent disassembly. The ramp includes a cylindrical protrusion that engages a ramp slot in the wedge, allowing the ramp to both translate and rotate relative to the wedge. The slot also limits how far the ramp can translate relative to the wedge, including contemplated configurations in which translation is not possible and the ramp can only rotate relative to the wedge. Such configuration is achieved by adjusting the length of the slots, so that in the initial, collapsed state, the ramps simply pivot or rotate relative to their respective wedges as width deployment occurs. Eighth deployable fusion device 1000g functions in an identical manner to fusion device 1000a, with the following exception: The ramps of eighth deployable fusion device 1000g can both translate and rotate relative to the wedges, which, combined with the fact that each of the endplates consists of two pivotally connected sections, results in eighth deployable fusion device 1000g being able to deploy in width both by translating the opposing endplates away from each other and by allowing the endplates to articulate into a generally diamond-shaped or square configuration in the width-deployed state.
[0335] An eighth deployable fusion device 1000g includes embodiment 100g of first endplate 100 (as well as endplates 150, 200, and 250, where dual endplates 100g, 250g, 150g, and 200g are all identical but rotated relative to one another for proper assembly). Dual endplate 100g is identical to endplate 100a described above, with the following exceptions: Dual endplate 100g includes two portions 100g1 and 100g2 pivotally connected with pin 600 through the center of dual endplate 100g. Each of portions 100g1 and 100g2 contains complementary reliefs 149g1 and 149g2 and circular openings 119g1 and 119g2 which, when concentrically aligned, allow the upper and lower surfaces of portions 100g1 and 100g2 to be aligned in a generally coplanar manner and to be permitted to pivot about the axis of openings 119g1 and 119g2.
[0336] An eighth deployable fusion device 1000g further includes embodiment 300g of ramp 300 (as well as ramps 350, 400, and 450, where ramps 300g, 350g, 400g, and 450g are all identical in this embodiment but rotated relative to one another for proper assembly). Ramp 300g is identical to ramp 300a described above, with the following exceptions: Branches 316g and 314g form channel 328g having a generally rectangular cross-section, as opposed to channel 328a of ramp 300a, which has a T-shaped cross-section. Surfaces 330a and 329a do not include protrusions 349a and 348a, as they do in ramp 300a. Branches 316g and 314g, in addition to lamp surfaces 330a and 329a of lamp 300a, further include lamp surfaces 330g1 and 329g1, where surfaces 330g1 and 329g1 are at angles to surfaces 330a and 329a. Branches 316g and 314g further include cylindrical protrusions 349g and 348g, respectively, where the cylindrical protrusions share the same central axis and are tangent to surfaces 330a, 329a, 316g, and 314g. The purpose of protrusions 349g and 348g is to translationally and pivotally engage mating slots in the wedges.
[0337] Eighth deployable fusion device 1000g further includes embodiment 550g of distal wedge 550. Distal wedge 550g (shown in detail in FIG. 64) is identical to distal wedge 550a, with the following exceptions: Distal wedge 550g does not include ramp indentation tracks 591a, 592a, 593a, and 594a, but does include protrusions 564g and 566g, which include ramp indentation tracks 591g and 593g formed in the upper surfaces of protrusions 564g and 566g, respectively, and further include ramp indentation tracks 592g and 594g formed in the lower surfaces of protrusions 564g and 566g, respectively. Protrusions 555g and 554g include ramp surfaces 596g, 597g, which are configured to allow the endplates to move relative to the wedge once eighth deployable fusion device 1000g is fully deployed in width. The channel 598g in the proximal wedge does not break through the protrusion 555g.
[0338] The eighth deployable fusion device 1000g further includes embodiment 650g of distal wedge 650. In this embodiment, proximal wedge 650g is identical to proximal wedge 550g, with the exception that distal wedge 650a includes a central opening that threads in the opposite direction to that of the proximal wedge. For example, if the central opening of proximal wedge 550g has left-handed threads, the central opening of distal wedge 650g has right-handed threads. Optionally, in any embodiment, having all of the insertion mechanisms present on the proximal wedge and present on the distal wedge along with an actuator having a second drive mechanism on the distal end (as discussed above) is useful during revision surgery, where the revision approach is not the same as the approach used during the original surgery. Optionally, in any embodiment, the distal wedge may have a more rounded distal end to facilitate initial implantation.
[0339] Eighth deployable fusion device 1000 g further includes actuator 500 a and pin 600 .
[0340] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, an eighth deployable fusion device 1000g may utilize some or any of the actuator embodiments, height and width deployment mechanisms, configurations and embodiments, and endplate stabilization mechanisms and embodiments described herein.
[0341] 9. Deployable Fusion Device Turning now to Figures 65A-65E, which illustrate an exemplary ninth deployable fusion device 1000h, Figure 65A shows the exemplary ninth deployable fusion device 1000h in an initial folded state, Figure 65B shows the exemplary ninth deployable fusion device 1000h in a fully deployed state, Figure 65C shows a partially assembled view of the exemplary ninth deployable fusion device 1000h in a folded state, Figure 65D shows a partially assembled view of the exemplary ninth deployable fusion device 1000h in a full linear width deployed state, and Figure 65E shows a partially assembled view of the exemplary ninth deployable fusion device 1000h in a full linear and angular deployed state. In the ninth deployable fusion device 1000h, each of the end plates includes a front portion and a rear portion, which further include mating cutouts and circular openings (with an integral cylindrical protrusion on one of the portions that engages a mating recess in the other portion) that allow the portions to be pivotally connected with a pin. The pin can be pressed, welded, or machined as a protrusion into one portion and inserted into the other portion, with its free end swaged to prevent disassembly. The ramp includes a cylindrical protrusion that engages a ramp slot in the wedge, allowing the ramp to both translate and rotate relative to the wedge. The slot also limits how far the ramp can translate relative to the wedge. The ninth deployable fusion device 1000h functions in the same manner as the third deployable fusion device 1000b, with the following exceptions. The ramps of the ninth deployable fusion device 1000h can both translate and rotate relative to the wedge, which, combined with the fact that each of the endplates consists of two pivotally connected portions, results in the ninth deployable fusion device 1000h being able to deploy in width both by translating the opposing endplates away from each other and by allowing the endplates to merge into a roughly diamond-shaped or square configuration in the width-deployed state.
[0342] A ninth deployable fusion device 1000h includes embodiment 100h of first endplate 100 (as well as endplates 150, 200, and 250, where dual endplates 100h, 250h, 150h, and 200h are all identical but rotated relative to one another for proper assembly). Dual endplate 100h is identical to endplate 100b described above, including having rounded surfaces 121b and 123b, with the exception that dual endplate 100h includes two pivotally connected portions as described above for endplate 100g.
[0343] Ninth deployable fusion device 1000h further includes embodiment 300h of ramp 300 (as well as ramps 350, 400, and 450, where ramps 300h, 350h, 400h, and 450h are all identical in this embodiment but rotated relative to one another for proper assembly). Ramp 300h is identical to ramp 300b above, with a few exceptions. Ramp 300h differs from ramp 300b above just as ramp 300g above differs from ramp 300a above, including by having cylindrical protrusions 349g (best seen in FIG. 65C) and 348g (shown in figures related to the discussion of device 1000g). It should be understood that in the initial folded state of the ninth deployable fusion device 1000h, if the rounded surfaces 121b and 123b of the endplate 100h are concentric or nearly concentric with the cylindrical protrusions 349g and 348g of the ramp 300h (this articulation is best seen in Figures 65C, 65D and 65E), the ninth deployable fusion device 1000h will be able to expand in width both linearly and angularly and will begin immediately in the initial folded state due to the fact that in this scenario, both the ramp and endplate portions will be able to rotate relative to the wedge about a common axis. Here, if rounded surfaces 121b and 123b of endplate 100h were not concentric or with cylindrical protrusions 349g and 348g of ramp 300h, ninth deployable fusion device 1000h would begin width deployment in a linear manner and would only be able to deploy angularly after contact was lost between the rounded surface of the endplate and the wedge. This is because the rounded surface of the endplate and the cylindrical protrusion of the ramp are not coaxial but still maintain simultaneous tangential contact with the ramp surface of the wedge and therefore cannot rotate relative to the wedge until ninth deployable fusion device 1000h is fully deployed in width, where the rounded surface loses contact with the ramp surface of the wedge.
[0344] The ninth deployable fusion device 1000h further includes a proximal wedge 550g, a distal wedge 650g, an actuator 500a, and a pin 600.
[0345] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, the ninth deployable fusion device 1000h may utilize some or any of the actuator embodiments, height and width deployment mechanisms, configurations and embodiments, and endplate stabilization mechanisms and embodiments described herein.
[0346] 10. Deployable Fusion Device 66A , which illustrates an exemplary tenth deployable fusion device 1000k in a fully deployed state, wherein tenth deployable fusion device 1000k includes an upper endplate 100k including two portions 100k1 and 100k2 connected together into a single component by a series of diagonal deformable struts 100k3, and further includes a lower endplate 200k including two portions 200k1 and 200k2 connected together into a single component by a series of diagonal deformable struts 200k3. Portions 100k1, 100k2, and 200k1 and 200k2 may be identical to any of the embodiments of endplates 100, 150, 200, and 250 described above. Diagonal deformable struts 100k3 and 200k3 are chevron- or V-shaped in this embodiment, but may be of any other suitable shape, including U-, W-, Z-, etc. The struts are configured to deform during width deployment of the device, with the angle between the strut surfaces increasing throughout the width deployment process, from some initial angle in the initial collapsed state (shown in FIG. 66B) to a larger angle in the fully width-deployed state (shown in FIG. 66C). The components comprising tenth deployable fusion device 1000k are identical to any of the above embodiments, with the exception that the two portions, the upper and lower endplates, are integrally connected by diagonal deformable struts. During the width deployment process, the series of diagonal deformable struts connecting the portions comprising the upper and lower endplates are plastically deformed by the action of actuators and wedges, permanently forcing the upper and lower endplates from the initial collapsed state (shown in FIG. 66D) to the width-deployed state.
[0347] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, the tenth deployable fusion device 1000k may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0348] 11. Deployable Fusion Device Turning now to FIG. 67A, which illustrates an exemplary eleventh deployable fusion device 1000m in a fully deployed state, the eleventh deployable fusion device 1000m includes an endplate composite 100m (shown in FIG. 67B) including upper portions 100m1 and 100m2 and lower portions 200m1 and 200m2. Here, all four portions are integrally connected together by a series of diagonal (or, in other embodiments, curved) deformable struts, while the two upper portions are connected together by diagonal deformable struts 250m1 and the two lower portions are connected together by diagonal deformable struts 250m1, where the upper portions are connected to the lower portions by diagonal deformable struts 250m2. Portions 100m1, 100m2, and 200m1 and 200m2 may be identical to any of the embodiments of endplates 100, 150, 200, and 250 described above. Diagonal deformable struts 250m1 and 250m2 are chevron or V-shaped in this embodiment, but may be of any other suitable shape, including U-shaped, W-shaped, Z-shaped, etc. Strut 250m1 is configured to deform with width deployment, and strut 250m2 is configured to deform with height deployment of the device, with the angle between the strut surfaces increasing throughout the deployment process, from some initial angle in the initial collapsed state (shown in FIG. 67C) to a larger angle in the fully width-deployed state (shown in FIG. 67D) and the fully width- and height-deployed state. The components comprising eleventh deployable fusion device 1000m are identical to any of the above embodiments, with the exception that portions of the endplate are integrally connected to endplate composite 100m by diagonal deformable struts. During device deployment, a series of diagonal deformable struts connecting the sections comprising the endplate composite are plastically deformed by the action of the actuators, wedges and ramps, permanently causing the endplate composite 100m to move from an initial collapsed state to a width-deployed state and then to a width-and-height-deployed state.
[0349] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment in the specification. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, an eleventh deployable fusion device 1000m may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0350] 12. Deployable Fusion Device Turning now to Figures 68-72C, which illustrate an exemplary twelfth deployable fusion device 1000n and its components. Figure 68 illustrates exemplary twelfth deployable fusion device 1000n in an initial, folded state, which is identical to third deployable fusion device 1000b, described above, with the following exceptions. Twelfth deployable fusion device 1000n includes a proximal wedge 550n, which is identical to proximal wedge 550a, with the following exceptions: Proximal wedge 550n (shown in Figures 69A and 69B) includes side openings 570n and 572n that are generally circular in cross section and do not break through the side walls of the wedge (although they may in other embodiments), but rather angle toward the centerline of proximal wedge 550n. Proximal wedge 550n further includes a stepped central opening 568n, which further includes a through recess 568n1 proximate first end 562n and a blind bore 568n2, where blind bore 568n2 includes a threaded cross-section proximate first end 562. Proximal wedge 550n does not include channels 598a and 599a present in proximal wedge 550a.
[0351] The twelfth deployable fusion device 1000n further includes a distal wedge 650n (shown in FIGS. 70A and 70B), which is identical to the proximal wedge 550n, with the following exceptions: The distal wedge 650n does not include a central opening, but instead includes a threaded blind bore 668n through the second end 660n, which is generally aligned with the central opening 568n of the proximal wedge 550n. The distal wedge 650n further includes a relief groove 662n1 proximate the first end 662n, which is intended to compensate for the thickness of a tension member that loops around the wedge and engages the side opening.
[0352] The twelfth deployable fusion device 1000n further includes a flexible tensioning member 715n looped through side openings 670n and 672n of distal wedge 650, where free ends of tensioning member 715n extend further past side openings 570n and 572n and from first end 562n of proximal wedge 550n, where these free ends may then be tied, clamped, or otherwise restrained or coupled to an actuator (not shown) of the inserter / tensioner tool. The flexible tensioning member 715n may comprise a suture, tape, fiber rope, monofilament, or a bundle of any of the above, and may be made from one or more of the following: a polymer (e.g., UHMWPE, PET, nylon, PEEK, Kevlar, etc.), a metal (e.g., titanium, titanium alloy, stainless steel, CoCrMo, etc.), or other fibers such as, for example, silk, carbon fiber, etc.
[0353] Twelfth deployable fusion device 1000n further includes a setscrew 700n (best seen in FIG. 71), which is identical to setscrew 700 described above, with the following exceptions: drive mechanism 708n extends throughout the setscrew (which may be hexagonal, hexalobe, trilobe, square, double square, etc.), and setscrew 700n is relatively larger than setscrew 700 in order to function properly as described below. Setscrew 700n threads into a threaded portion of bore 568n2 of proximal wedge 550n and is configured to contact flexible tension member 715n (when actuated or tightened), while it passes through side openings 570n and 572n of proximal wedge 550n at the pinch point shown in FIG. 72C. The through drive mechanism of the set screw 700n is configured to pass through the threaded shaft 840n of the tensioning instrument (not shown in its entirety) (first seen in FIG. 71, which shows the twelfth deployable fusion device 1000n engaged with the threaded shaft 840n of the tensioning instrument in a fully collapsed state), allowing it to access the threaded recess 668n of the distal wedge (best seen in FIG. 72A, which shows a cross-sectional view of the twelfth deployable fusion device 1000n engaged with the threaded shaft 840n of the tensioning instrument in a fully collapsed state), through which graft material can be delivered to the interior of the device 1000n after the device is deployed. Further allowing delivery (seen in the cross-sectional view of the twelfth deployable fusion device 1000n in FIG. 72B), the threaded shaft 840n is withdrawn and the set screw 700n is actuated or tightened to lock the flexible tension member 715n by contacting it at the pinch point shown in the cross-sectional view of the twelfth deployable fusion device 1000n in FIG. 72C, thereby causing the flexible tension member 715n to maintain tension generated by the vertebral bodies applying a compressive force to the endplates, thereby allowing the twelfth deployable fusion device 1000n to remain in its deployed state.
[0354] Unlike the third deployable fusion device 1000b, the twelfth deployable fusion device 1000n does not include an actuator 500a; instead, the functionality of the threaded (or more generally, linear) actuator 500a that effects deployment of the fusion device 1000n and maintains the twelfth deployable fusion device 1000n in a desired state of deployment is divided between the threaded shaft 840n of the tensioning instrument (not shown in its entirety here), which threads into the distal wedge 650n and is applied thereto by the tensioning instrument. The tensioning instrument has a linear tension applied to it while the body of the tensioning instrument simultaneously withstands the proximal wedge 550n causing the proximal and distal wedges 550n and 650n to move toward each other, causing the twelfth deployable fusion device 1000n to deploy in the manner described above for other embodiments of the device, with a flexible tensioning member 715n attached to the tensioning instrument during device deployment allowing the twelfth deployable fusion device 1000n to be maintained in a desired state of deployment by means of tightening the set screw 700n. It should be understood that the tensioning member 715n can also be locked by other means besides the set screw 700n, including tying the end of the tensioning member or employing other means to prevent loss of tension or slippage of the tensioning member, such as those commonly understood, known, and utilized in the design of suture anchors and buttons used in orthopedic surgery. The end of the tensioning member 715n may need to be trimmed off after the deployment and locking process.
[0355] While various alternative forms of various components are shown herein as separate embodiments, it should also be understood that these alternative forms have optional features that can be substituted or mixed / combined with any other embodiment herein. It should also be understood that substitution of any of the above optional alternative features on any component may or will require that the mating component use the inverse or complementary form of those features for proper engagement, and that the shape of that inverse or complementary form will necessarily derive from the above optional alternative feature forms and from the detailed description of the embodiment described as utilizing those forms. By way of example, a twelfth deployable fusion device 1000n may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0356] 13. Deployable Fusion Device 73A-74B, Figures 73A, 73B, 73C, and 73D show an initial collapsed state, a fully width-deployed state, a fully height-deployed state, and an exploded view, respectively, of an exemplary thirteenth deployable fusion device 1000p, including endplates 100a, 150a, 200a, and 250a (all identical in this embodiment), ramps 300p, 350p, 400p, and 450p (all identical in this embodiment), proximal wedge 550p, distal wedge 650p (the distal and proximal wedges are identical in this embodiment), and actuator 500a. The thirteenth deployable fusion device 1000p is identical to the second deployable fusion device 1000a described above, with the following exceptions. Ramp 300p is identical to ramp 300a described above, with the exception that surfaces 320p, 329p, and 330p are not angled, but are generally transverse to the longitudinal axis of thirteenth deployable fusion device 1000p (they are either perpendicular as shown or at an angle to the longitudinal axis, depending on whether the mating surfaces of the detailed embodiment of the wedge are perpendicular or at an angle to the longitudinal axis of the device). Distal wedge 650p is identical to distal wedge 650a described above, with the following exceptions. Note that while distal wedge 650a was described above as simply being identical to proximal wedge 550a, proximal wedge 550a is described in the detailed description. Surfaces 680p and 682p are not angled relative to one another, as are the corresponding surfaces of wedge 650a, but instead are generally parallel and generally transverse to the longitudinal axis of thirteenth deployable fusion device 1000p (optionally, in any embodiment, they are perpendicular as shown or at an angle to the longitudinal axis of the device). Surfaces 680p and 682p further include slots 691p and 692p, respectively, which penetrate one side of the wedge but not the other side of the wedge and serve the purpose of limiting translation of the ramp relative to the wedge on the side where the slot does not penetrate the sidewall of wedge 650p. To limit translation of the ramp relative to the wedge on the other side of the wedge, the openings of the slots can be plastically deformed or "swaged" after the device is assembled to prevent disassembly.Additionally, the upper and lower surfaces 652p and 690p of distal wedge 650p do not include protrusions or channels as found in wedge 650a. Distal wedge 650p is identical to proximal wedge 550p.
[0357] Because the mating sliding surfaces of the ramps and their respective mating wedges are generally collectively parallel and transverse to the longitudinal axis of the thirteenth deployable fusion device 1000p (which can be perpendicular or at an angle, as shown), this arrangement prevents the thirteenth deployable fusion device 1000p from expanding in width when the actuator 500a is actuated. Instead, when the actuator 500a is actuated, the device 1000p only expands in height, which differs from the behavior of all of the previously described embodiments. Because the mating sliding surfaces of the ramps and wedges are collectively parallel and transverse to the longitudinal axis, the thirteenth deployable fusion device 1000p expands in width by application of an external force, for example, by an insertion / deployment instrument. Thus, the articulation between the ramps and wedges no longer acts as a deployment mechanism, but simply maintains the device components in proper alignment while preventing disassembly at the upper limit of instrument-influenced width expansion. Width expansion is now independent of height expansion, which can be beneficial in some applications. 74A and 74B show the thirteenth deployable fusion device 1000p assembled with an insertion-deployment instrument 840p in its initial folded state and its fully expanded width state, respectively. The insertion-deployment instrument 840p (not shown in its entirety) includes a pair of anterior wedges 840p1 and a pair of posterior wedges 840p2 that can be drawn together or forced apart using a screw, gripping, or any other mechanism (not shown). The insertion-deployment instrument engages the thirteenth deployable fusion device 1000p in the device's fully expanded width state, which is then folded to its initial state for insertion. Once inserted into the disc space, the anterior and posterior wedges of the instrument are drawn together, causing the thirteenth deployable fusion device 1000p to expand to its expanded width when the anterior wedges no longer contact the device 1000p (as best seen in FIG. 74B) and are withdrawn. As that occurs, the height of the device is expanded. This arrangement means that the device must be expanded wide enough to allow the anterior wedge to be withdrawn in order for the instrument 840p to disengage from the thirteenth fusion device 1000p.Optionally, in any embodiment, multiple different anterior wedge widths can be provided to the end user to allow them to determine the target deployed width that best suits their particular application. Manipulating the deployed width with two opposing wedges does not allow the width to be reduced from a wider to a narrower state without a dovetail, hook, L-shaped, or other articulation between the anterior and posterior wedges and the device, thereby allowing the instrument to exert both tension and compression on the device, thereby allowing the instrument to both deploy and collapse the width of the device as discussed above. This functionality is discussed in the following embodiment. It should also be mentioned at this point that all of the deployment mechanisms and configurations described above, with the exception of device 1000p, are configured to allow deployment of the device in both width and height by reversing the actuation direction; this is because all of the angled articulations described above, with the exception of thirteenth deployable fusion device 1000p, have forward-facing and rearward-facing angled contact surfaces that allow these articulations to take both tensile and compressive forces, and these devices can be deployed and collapsed by actuating the actuator in the "forward" and "reverse" directions, respectively.
[0358] While various alternative forms of various components are presented herein as separate embodiments, it should be understood that these alternative forms have optional features that can be substituted or mixed / matched with any other embodiment herein. It should also be understood that substituting any of the previously described alternative features on any component may require the mating component to use the inverse or complementary form of those features for proper engagement, and that the configuration of that inverse or complementary form will necessarily follow from the detailed description of any of the alternative feature forms described above and the embodiment described as utilizing that form. As an example, a thirteenth deployable fusion device 1000p may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0359] 14. Deployable Fusion Device 75A-75E, which show an initial collapsed state, a fully deployed width state, a fully deployed height state, a fully deployed width and height state, and an exploded view, respectively, of an exemplary fourteenth deployable fusion device 1000r, including endplates 100r, 150r, 200r, and 250r (all identical in this embodiment), ramps 300r, 350r, 400r, and 450r (all identical in this embodiment), proximal wedge 550p, distal wedge 650p (the distal and proximal wedges are identical in this embodiment), and actuator 500a. The fourteenth deployable fusion device 1000r is identical to the thirteenth deployable fusion device 1000p described above, with the following exceptions. End plate 100r has a first end 102r and a second end 104r. First end plate 100r further includes an upper surface 134r, a lower surface 132r, and an inner surface 130r connecting the first and second ends. As with all other embodiments described herein, the upper surface includes surface features that increase the surface roughness. The inner surface includes a cylindrical relief 149r whose axis is parallel to the longitudinal axis. First end plate 100r further includes a first angled surface 110r adjacent the first end and a second angled surface 112r adjacent the second end. The angled surfaces 110r and 112r further include dovetailed angled slots 107r and 109r, respectively. As discussed above, in this embodiment, the slots are dovetailed and have a generally trapezoidal cross-section, although they may have a T-shape, a Y-shape, or any other suitable cross-section that allows the mating articulation to possess both leading and trailing contact surfaces. Endplate 100r further includes openings 119r extending through the side surfaces in a direction transverse to the longitudinal axis. Relief 149r. The edges formed by the intersection of angled surfaces 110r and 112r with interior surface 130r include chamfers 121r and 123r configured to mate with insertion-deployment instrument 840p described above.
[0360] Ramp 300r is identical to ramp 300p, described above, with the following exceptions: Branches 321r and 323r do not have a U-shaped cross-section like the corresponding features of ramp 300p; instead, branches 321r and 323r include sloped surfaces 302r and 304r, respectively; these sloped surfaces include dovetailed fins 302r1 and 304r1, respectively. The dovetailed fins are configured to mate with dovetailed sloped slots in the end plates. Ramp 300r does not include the recessed slots present in ramp 300p. Fourteenth deployable fusion device 1000r has similar functionality to thirteenth deployable fusion device 1000p, described above, including reliance on an external deployment instrument for width deployment.
[0361] While various alternative forms of various components are presented herein as separate embodiments, it should be understood that these alternative forms have optional features that can be substituted or mixed / matched with any other embodiment herein. It should also be understood that substituting any of the previously described alternative features on any component may require the mating component to use the inverse or complementary form of those features for proper engagement, and that the configuration of that inverse or complementary form will necessarily follow from the detailed description of any of the alternative feature forms described above and the embodiment described as utilizing that form. As an example, a fourteenth deployable fusion device 1000r may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein.
[0362] 15. Deployable Fusion Device 76A-76D, which show an initial collapsed state, a fully width-deployed state, a fully height-deployed state, and an exploded view, respectively, of an exemplary fifteenth deployable fusion device 1000s, including endplates 100r, 150r, 200r, and 250r (all identical in this embodiment), ramps 300s, 350s, 400s, and 450s (all identical in this embodiment), proximal wedges 550s, distal wedges 650s (the distal and proximal wedges are identical in this embodiment), and actuator 500a. The fifteenth deployable fusion device 1000s is identical to the fourteenth deployable fusion device 1000r described above, with the following exceptions. Proximal wedge 550s is identical to proximal wedge 550a described above, with the following exceptions: the upper and lower surfaces of wedge 550s do not include protrusions or channels, unlike wedge 550a, and the opposing angled surfaces of wedge 550s have a greater angle "A" between them than that of wedge 550. This angle is best seen in FIG. 76A and is contemplated to be greater than 100 degrees and less than 179 degrees, more preferably greater than 140 degrees, and most preferably greater than 160 degrees (a 150-degree angle is shown for illustrative purposes). Ramp 300s is identical to ramp 300r, with the following exceptions: surfaces 330s, 320s, and 329s, as they are within ramp 300r, are not perpendicular to the major axis, but are angled relative to the major axis at an angle equal to half of angle "A" discussed above, as best seen in FIG. 76A. Ramp 300s further includes angled undercuts 337s1 and 337s2, which are configured to mate with a deployment instrument and may have either rectangular sections or L-shaped, T-shaped, or dovetailed sections. End plate 100s is identical to end plate 100r described above, with the exception that it also includes angled undercuts 147s1 and 147s2, which are configured to mate with a deployment instrument and may have either rectangular sections or L-shaped, T-shaped, or dovetailed sections.When having rectangular sections, undercuts 337s1, 337s2, 147s1, and 147s2 serve the purpose of preventing expansion in height of the device while the expansion in width is under the influence of the deployment instrument. When these undercuts have L-shaped, dovetail, or similar sections, they serve the additional purpose of allowing the deployment instrument to both increase and decrease the width of the device by reversing the direction of actuation. As discussed above, this is because L-shaped, T-shaped, dovetail, etc. sections encompass both anterior and posterior contact surfaces, can capture mating components, and apply tension or compression to the interface.
[0363] The significance and usefulness of the large included angle "A" between the sloped surfaces of the wedges is not clear and requires further clarification. The functionality and clinical utility of many embodiments of the deployable fusion devices described herein (e.g., 1000a, 1000b, 1000c, 1000d, 1000e, etc.) depend on the fact that full or significant width deployment must occur before height deployment can begin. This is achieved by the endplates maintaining sliding contact with the mating surfaces of the wedges during the width deployment step; when configured in the manner described above, this contact continues while preventing the ramps from moving closer together (which is necessary to affect height deployment). During the course of width deployment, this contact between the endplates and wedges is eventually lost, allowing height deployment to begin. However, the fifteenth deployable fusion device 1000s does not include such a delay mechanism; it appears that both width and height deployment can occur simultaneously by turning the actuator. If we imagine an alternative fifteenth deployable fusion device 1000s1 (not shown), which is identical to the fifteenth deployable fusion device 1000s, except that angle "A" is relatively small (e.g., about 90 degrees), we imagine this alternative fifteenth deployable fusion device 1000s1 in a deployed state in which the width of the device is less than the fully deployed state and the height of the device is at least somewhat expanded. If the actuator is held stationary and typically maintained while not actuated (i.e., by thread friction) and compression is applied to the endplates of the device, such as adjacent vertebral endplates applied in clinical use, the alternative fifteenth deployable fusion device 1000s1 will tend to collapse in height and simultaneously expand in width until it reaches either the fully deployed width or the fully collapsed height (whichever occurs first based on the initial extent of the height and width expansion). This is because, in a device state that has not yet reached full width deployment, there is a range of achievable deployment states for each position of the actuator relative to the wedge, and consequently, each separation distance between the proximal and distal wedges.In other words, in this situation, the alternative fifteenth deployable fusion device 1000s1 is not in an equilibrium state, and its height expansion is "converted" into width expansion by the following mechanism of action: In such a state, when height compression is applied to the endplates, the actuators remain stationary, so the ramp components see the force separating them generated by the sloped surfaces involved in height expansion, and the ramps move only by sliding relative to the wedges, resulting in a larger width expansion state, increasing the distance between the ramps and decreasing the height of the device. In similar height-only or width-only deployment mechanisms, friction in the actuator threads, related to the "locking" characteristics of the threads used, prevents reversal of this expansion. Locking threads are characterized by a small "helical angle," for example, preventing a mean screw from being forced axially into a mating thread without the application of any torque (a purely axial force would prevent the locking thread from following a helical path into the mating thread). This contrasts with non-locking (or overhaul) threads, such as those used in cork screws, which are forced to screw into the workpiece by the application of a purely axial force. However, in this case, the actuator does not move, and the non-equilibrium condition is inherent in the mechanism, so the locking properties of the actuator threads cannot prevent height loss. Similar to threads with a mechanical effect controlled by the helix angle of the thread (with a small helical angle imparting the locking properties to the thread), ramps or "inclined planes" (applied by wedge mechanisms) are also known to possess a mechanical effect (or advantage), which is expressed as the length of the ramp, expressed by its rise, or more simply - the thread angle of the wedge. The greater the thread angle, the smaller the mechanical advantage of the wedge mechanism.Furthermore, for any wedge mechanism and material used (and friction generated), there will be a maximum thread angle at which, once the wedge ceases to act as a wedge, no attempt to force the wedge between two objects will force them apart, no matter how great the friction, load, and material strength stress.
[0364] Returning now to the fifteenth deployable fusion device 1000s, because the proximal and distal wedges 550s and 650s utilize a high angle "A," they do not function as a width deployment mechanism; instead, they function as a locking mechanism that prevents the fifteenth deployable fusion device 1000s from spontaneously losing height and gaining width. This means that when the actuator 500 is turned in an initial collapsed state, the fifteenth deployable fusion device 1000s will only deploy in height, not width; a reasonable compressive force acting in the height direction will cause the device to lose height and gain width, as discussed above. The fifteenth deployable fusion device 1000s relies on an outer insertion-deployment instrument 840s (seen in FIGS. 77A and 77B) to affect width deployment.
[0365] The insertion-deployment instrument 840s (not shown in its entirety) includes a pair of anterior wedges 840s1 and a pair of posterior wedges 840s2 that can be drawn together or forced apart using a screw operation, a gripping operation, or any other mechanism (not shown). The instrument 840s is configured to simultaneously actuate (here, turn) an actuator in a forward or reverse direction to translate the anterior and posterior wedges together or apart. Turning the actuator in the process of width deployment does not cause or substantially contribute to width deployment itself (due to the high angle "A" of the wedges and their resulting near-zero mechanical effect), but merely allows the proximal and distal wedges to move toward each other, providing room for width deployment to be influenced by the force supplied by the instrument 840s. The insertion-deployment instrument engages the fifteenth deployable fusion device 1000s in the device's fully deployed width, which then folds to its initial state for insertion into the disc space (best seen in FIG. 77A). Once inserted into the disc space, the anterior and posterior wedges of the instrument are drawn together, causing the fifteenth deployable fusion device 1000s to deploy in width to its deployed width, at which point the anterior wedge moves out of contact with the device 1000p (best seen in FIG. 77B) and is withdrawn. Once that occurs, the height of the device is expanded. This arrangement means that the device must be deployed in width enough to allow the anterior wedge to be withdrawn in order for the instrument 840s to be disengaged from the device 1000p. Optionally, in any embodiment, multiple different anterior wedge widths may be provided to the end user to allow them to determine the target deployed width that best suits their particular application. Optionally, in any embodiment, a number of different front wedge widths can be supplied to the end user to allow them to determine the optimum target deployment width for their particular application.Manipulating the width expansion with two opposing wedges does not allow the width to be reduced from a wider state to a narrower state without a dovetail, hook, L-shaped or other articulating joint between the anterior and posterior wedges and used in the device, which allows the instrument to exert both tension and compression on the device, thereby allowing the instrument to both expand and collapse the width of the device as discussed above.
[0366] While various alternative forms of various components are presented herein as separate embodiments, it should be understood that these alternative embodiments have any features that can be substituted or mixed / matched with any other embodiment herein. It should also be understood that substituting any of the previously described alternative features on any component may or may require a mating component to use the inverse or complementary form of those features for proper engagement, and that the configuration of that inverse or complementary form will necessarily follow from any of the alternative feature forms described above and the detailed description of the embodiment described as utilizing that form. As an example, the fifteenth deployable fusion device 1000s may utilize some or any of the actuator aspects, height and width deployment features, configurations and aspects, and endplate stabilization features and aspects described herein (e.g., as shown in embodiments 1000c and 1000d).
[0367] 16. Deployable Fusion Device 78, 79A, and 79B, Fig. 78 illustrates an initial, folded state of a deployable device 1000t, Fig. 79A illustrates an exemplary sixteenth deployable fusion device 1000t with a deployment instrument attached in the initial folded state, and Fig. 79B illustrates an exemplary sixteenth deployable fusion device 1000t with a deployment instrument attached in a width-expanded state. The sixteenth deployable fusion device 1000t includes endplates 100t, 150t (best seen in Fig. 79B), 200t, and 250t (all of which are identical in this embodiment), ramps 300s, 350s, 400s, and 450s (all of which are identical in this embodiment), proximal wedges 550s, distal wedges 650s (the distal and proximal wedges are identical in this embodiment), and actuator 500a. The sixteenth deployable fusion device 1000t is identical to device 1000s described above with the following exceptions: Endplate 100t includes an angled slot 107t2 formed in upper surface 134t, which is configured to engage insertion-deployment instrument 840t (best seen in FIGS. 79A and 79B).
[0368] The insertion-deployment instrument 840t (not shown in its entirety) includes a set of forward branch ramps 840t1 that are pushed or pulled while the main body of the instrument (not shown) is attached to and bears on the proximal wedges. The instrument 840t is configured to simultaneously actuate (here, turn) actuators in a forward or reverse direction, causing the branch ramps to translate forward or backward depending on the direction of actuation. Turning the actuators in the process of width deployment does not cause or substantially contribute to width deployment itself (due to the high angle "A" of the wedges and the resulting near-zero mechanical effect of these wedges), but simply allows the proximal and distal wedges to move toward each other, providing room for width deployment to be influenced by the force supplied by the instrument 840t. The insertion-deployment instrument engages the sixteenth deployable fusion device 1000t in the device's fully expanded width state, and then the device is folded to its initial state for insertion into the disc space (best seen in FIG. 79A). Once inserted into the disc space, the instrument's proximal ramps are pulled toward the proximal end of the instrument, bearing the body of the instrument against the proximal wedge while simultaneously turning the actuator. This causes the sixteenth deployable fusion device 1000t to expand in width to its expanded width (best seen in FIG. 79B) where the proximal ramps no longer contact the sixteenth deployable fusion device 1000t, and then it is withdrawn. Once that occurs, the device's height is expanded. This arrangement means that in order for the instrument 840t to be disengaged from the sixteenth deployable fusion device 1000t, the device must be expanded in width enough to allow the anterior wedge to be withdrawn. Optionally, in any embodiment, multiple different front wedge widths may be supplied to the end user to allow them to determine the optimum target deployment width for their particular application. Because the bifurcated ramps of the instrument have both front and rear contact surfaces with the end plates, if actuating the instrument in one direction causes the device to deploy in width, the deployment process is reversible and reversing the actuation direction causes the device to collapse in width.
[0369] 17. Deployable Fusion Device 80, which shows a diagram of the general width deployment functionality of exemplary seventeenth deployable fusion device 1000u, which is identical to the thirteenth deployable fusion device 1000p described above with certain exceptions noted below. The seventeenth deployable fusion device 1000u is a variation of the thirteenth deployable fusion device 1000p in that the generally parallel articulating surfaces between the proximal wedge and its two mating ramps, and between the distal wedge and its two mating ramps, are angled relative to the longitudinal axis of the device, possessing the desirable property of allowing the device to deploy width nonlinearly, such that the width of the device in its deployed state has the general shape of a parallelogram instead of the rectangle produced by the thirteenth deployable fusion device 1000p. This is useful for some surgical approaches where the approach axis is angled relative to a standard anatomical plane, such as a transforaminal (or TLIF) approach.
[0370] 18th Deployable Fusion Device 81A-86 provided herein are an eighteenth deployable fusion device 1000v for implantation between two adjacent vertebrae. Optionally, in any embodiment, device 1000v of FIG. 81A includes: an actuator 500v including a drive mechanism 503v and a longitudinal shaft 504v; a wedge assembly 750v coupled to actuator 500v; a ramp assembly 800v slidably coupled to wedge assembly 750v; an upper endplate assembly 850v slidably coupled to ramp assembly 800v; and a lower endplate assembly 900v slidably coupled to ramp assembly 800v.
[0371] Optionally, in any embodiment, device 1000v of Figure 81B has a width 1100v that includes the external width of at least one of upper end plate assembly 850v and lower end plate assembly 900v. Optionally, in any embodiment, device has a height 1200v that includes the external distance between upper end plate assembly 800v and lower end plate assembly 900v.
[0372] Optionally, in any embodiment, actuation of drive mechanism 503v a first number of actuations in first actuation direction 1300v of FIG. 87C increases width 1100v without increasing height 1200v. Optionally, in any embodiment, actuation of drive mechanism 503v a second number of actuations greater than the first number of actuations in first actuation direction 1300v increases at least one of height 1200v and width 1100v. Optionally, in any embodiment, actuation of drive mechanism 503v a second number of actuations greater than the first number of actuations in first actuation direction 1300v increases both height 1200v and width 1100v, and actuation of drive mechanism 503v a third number of actuations greater than the second number of actuations in first actuation direction 1300v increases height 1200v without increasing width 1100v. Optionally, in any embodiment, actuation of drive mechanism 503v a second number of actuations greater than the first number of actuations in the first actuation direction 1300v increases neither height 1200v nor width 1100v, and actuation of a third drive mechanism 503v greater than the second number of actuations in the first actuation direction 1300v increases height 1200v without increasing width 1100v. Optionally, in any embodiment, width 1100v of device 1000v reaches a limit when drive mechanism 503v is actuated by at least the first number of actuations. Optionally, in any embodiment, height 1200v of device 1000v reaches a limit when drive mechanism 503v is actuated by at least the first and second numbers of actuations.
[0373] Optionally, in any embodiment, actuation of drive mechanism 503v a second number of actuations greater than the first number of actuations in first actuation direction 1300v increases both height 1200v and width 1100v. Optionally, in any embodiment, actuation of drive mechanism 503v a second number of actuations greater than the first number of actuations in first actuation direction increases height 1200v without increasing width 1100v.
[0374] Optionally, in any embodiment, actuation of drive mechanism 503v in first actuation direction 1300v by at least a first number of actuations increases height 1200v of device 1000v by about 30% to about 400%. Optionally, in any embodiment, actuation of drive mechanism 503v in first actuation direction 1300v by at least a first and second number of actuations increases width 1100v of device 1200v by about 14% to about 150%.
[0375] Optionally, in any embodiment, actuator 500v of FIG. 82 includes a cylindrically shaped elongated shaft with a distal end and a proximal end. Optionally, in any embodiment, at least a portion of the distal end includes first thread mechanism 501v. Optionally, in any embodiment, at least a portion of the proximal end includes second thread mechanism 502v, and the proximal end includes drive mechanism 503v. Optionally, in any embodiment, at least one of first thread mechanism 501v and second thread mechanism 502v includes threads disposed externally around actuator 500v. Optionally, in any embodiment, first thread mechanism 501v and second thread mechanism 502v have opposite thread directions. Optionally, in any embodiment, first thread mechanism 501v and second thread mechanism 502v have the same thread direction. Optionally, in any embodiment, at least one of first thread feature 501v and second thread feature 502v includes a right-hand thread. Optionally, in any embodiment, at least one of first thread feature 501v and second thread feature 502v includes a left-hand thread. Optionally, in any embodiment, drive feature 503v includes a recessed area configured to receive a drive instrument. Optionally, in any embodiment, the recessed area includes a slot, Phillips, Pozidriv, Frearson, Robertson, 12-point flange, hex socket, security hex socket, star drive, security Torx®, TA, three-point, three-wing, spanner head, clutch, one-way, double square, triple square, Polydrive, spline drive, double hex, bristles, or pentalobe recess, or any combination thereof. Optionally, in any embodiment, the drive feature includes a protuberance extending therefrom and configured to couple to a drive instrument. Optionally, in any embodiment, the protuberance comprises a hexagonal, hexalobular, or square protuberance, or a protuberance of any other shape. Optionally, in any embodiment, drive mechanism 503v is coincident with longitudinal axis 504v.
[0376] Optionally, in any embodiment, the wedge assembly of FIG. 81C includes a distal wedge 650v and a proximal wedge 550v. Optionally, in any embodiment, actuation of the drive mechanism in a first direction causes the distal wedge 650v and the proximal wedge 550v to move toward each other. Optionally, in any embodiment, the distal wedge 650v of FIGS. 89A-B is an isosceles trapezoidal prism including a distal face and a proximal end. Optionally, in any embodiment, the distal wedge 650v includes a third thread feature 654v. Optionally, in any embodiment, the third thread feature 654v extends from the distal face of the distal wedge 650v to the proximal face of the distal wedge 650v. Optionally, in any embodiment, the distal wedge 650v further includes one or more features configured for temporary attachment to an inserter tool. Optionally, in any embodiment, third thread feature 654v is threadedly coupled to second thread feature 502v of actuator 500v. Optionally, in any embodiment, distal wedge 650v further includes first slot 651v and second slot 652v. Optionally, in any embodiment, first slot 651v includes an upper left first slot 651v, an upper right first slot 651v, a lower left first slot 651v, and a lower right first slot 651v. Optionally, in any embodiment, upper left first slot 651v and upper right first slot 651v, as well as lower left first slot 651v and lower right first slot 651v, have mirror symmetry about a sagittal plane of distal wedge 650v. Optionally, in any embodiment, the upper left first slot 651v and the lower left first slot 651v, and the upper right first slot 651v and the lower right first slot 651v have mirror symmetry with respect to the transverse plane of the distal wedge 650v. Optionally, in any embodiment, the medial plane of each of the upper left first slot 651v, the upper right first slot 651v, the lower left first slot 651v, and the lower right first slot 651v is oriented at an angular position that intersects the sagittal plane of the distal wedge 650v.Optionally, in any embodiment, at least one of the third thread feature 654v and the fourth thread feature 554v of the distal wedge 650v and the proximal wedge 550v, respectively, includes a thread-locking mechanism configured to prevent actuation of at least one of the third first feature 501v and the second thread feature 502v of the actuator 500v in a direction opposite the first actuation direction 1300v. Optionally, in any embodiment, the thread-locking mechanism includes a deformable insert, a deformable thread, a distorted thread, a flexible lip, or any combination thereof. Optionally, in any embodiment, the thread-locking mechanism includes a bore in at least one of the distal wedge 650v and the proximal wedge 550v configured to provide access to the third thread feature 654v or the fourth thread feature 554v and / or configured to receive an insert, such as a pin, a screw, a dowel, a nut, or any combination thereof, to prevent actuation of the actuator 500v.
[0377] Optionally, in any embodiment, the second slots 652v include an upper left second slot 652v, an upper right second slot 652v, a lower left second slot 652v, and a lower right second slot 652v. Optionally, in any embodiment, the upper left second slot 652v and the upper right second slot 652v, as well as the lower left second slot 652v and the lower right second slot 652v, have mirror symmetry with respect to a sagittal plane of the distal wedge 650v. Optionally, in any embodiment, the upper left second slot 652v and the lower left second slot 652v, as well as the upper right second slot 652v and the lower right second slot 652v, have mirror symmetry with respect to a transverse plane of the distal wedge 650v. Optionally, in any embodiment, the midplanes of the upper left second slot 652v, the upper right second slot 652v, the lower left second slot 652v, and the lower right second slot 652v are oriented at an angular position that intersects the sagittal plane of the distal wedge 650v.
[0378] Optionally, in any embodiment, the proximal wedge 550v of FIG. 83B has an isosceles trapezoidal prism shape including a distal surface and a proximal surface. Optionally, in any embodiment, the proximal wedge 550v includes a fourth thread feature 554v. Optionally, in any embodiment, the fourth thread feature 554v extends from the distal surface of the proximal wedge 550v to the proximal surface of the proximal wedge 550v. Optionally, in any embodiment, the proximal wedge 550v further includes one or more features configured for temporary attachment to an inserter tool. Optionally, in any embodiment, the fourth thread feature 554v is threadedly coupled to the first thread feature 501v of the actuator 500v. Optionally, in any embodiment, the third thread feature 654v includes a screw disposed internally within the distal wedge 650v. Optionally, in any embodiment, fourth thread feature 554v includes threads disposed internally within proximal wedge 650v. Optionally, in any embodiment, third thread feature 654v and fourth thread feature 554v have opposite thread directions. Optionally, in any embodiment, third thread feature 654v and fourth thread feature 554v have the same thread direction. Optionally, in any embodiment, at least one of third thread feature 654v and fourth thread feature 554v includes right-hand threads. Optionally, in any embodiment, at least one of third thread feature 654v and fourth thread feature 554v includes left-hand threads.
[0379] Optionally, in any embodiment, lamp assembly 800v of FIG. 81C includes a first proximal lamp 300v, a second proximal lamp 400v, a first distal lamp 350v, and a second distal lamp 450v.
[0380] Optionally, in any embodiment, second distal ramp 400v of Figures 84A and 84B includes a rectangular prism divided into two lobes. Optionally, in any embodiment, second distal ramp 400v includes first ridge 401v, first protrusion 402v, v-slot 403v, third protrusion 404v, third ridge 405v, and third slot 406v. Optionally, in any embodiment, first ridge 401v includes two first ridges 401v. Optionally, in any embodiment, first ridge 401v is located on the proximal end of second distal ramp 400v. Optionally, in any embodiment, the midplane of first ridge 401v is at a pivot angle from the midplane of second distal ramp 400v. Optionally, in any embodiment, first protrusion 402v includes two first protrusions 402v. Optionally, in any embodiment, first protrusion 402v is located on a mesio-proximal corner of second distal ramp 400v. Optionally, in any embodiment, v-slot 403v includes two v-slots 403v. Optionally, in any embodiment, v-slot 403v is located on a mesial plane of second distal ramp 400v. Optionally, in any embodiment, an extreme end of v-slot 403v is oriented toward the distal end of second distal ramp 400v. Optionally, in any embodiment, protrusion 404v includes two protrusions 404v. Optionally, in any embodiment, protrusion 404v is located on a lower surface of distal ramp 400v. Optionally, in any embodiment, third ridge 405v includes two third ridges 405v. Optionally, in any embodiment, the third ridge 405v is located on the top surface of the second distal ramp 400v. Optionally, in any embodiment, the midplane of the third ridge 405v is parallel to the mesial surface of the second distal ramp 400v. Optionally, in any embodiment, the third slot 406v includes two third slots 406v. Optionally, in any embodiment, the third slot 406v is located on the top surface of the second distal ramp 400v. Optionally, in any embodiment, the midplane of the third slot 406v is parallel to the mesial surface of the distal ramp 400v.Optionally, in any embodiment, first distal ramp 300v is mirror-equivalent to second distal ramp 400v. Optionally, in any embodiment, first distal ramp 350v includes second ridge 351v. Optionally, in any embodiment, second ridge 351v includes two second ridges 351v. Optionally, in any embodiment, second ridge 351v is located on a lateral side of first distal ramp 350v. Optionally, in any embodiment, first distal ramp 350v includes second protrusion 352v. Optionally, in any embodiment, second protrusion 352v includes two second protrusions 352v. Optionally, in any embodiment, second protrusion 352v is located on a lateral proximal end of first distal ramp 350v. Optionally, in any embodiment, the midplane of second protrusion 352v is perpendicular to the midplane of second ridge 351v. Optionally, in any embodiment, first distal ramp 350v includes tongue 353v. Optionally, in any embodiment, tongue 353v extends along a lateral proximal edge of distal ramp 350v from the bottom of distal ramp 350v to the top of distal ramp 350v. Optionally, in any embodiment, second distal ramp 450v is a mirror equivalent of first distal ramp 350v. Optionally, in any embodiment, upper end plate assembly includes first end plate 100v and second end plate 250v. Optionally, in any embodiment, lower end plate assembly includes third end plate 150v and fourth end plate 200v.
[0381] Optionally, in any embodiment, at least one of first endplate 100v, second endplate 250v, third endplate 150v, fourth endplate 200v, first proximal ramp 300v, second proximal ramp 400v, and first distal ramp 350v, second distal ramp 450v have mirror equivalents. Optionally, in any embodiment, at least one of second endplate 250v, fourth endplate 200v is larger than at least one of first endplate 100v, third endplate 150v, and fourth endplate 200v. Optionally, in any embodiment, at least one of the outer surfaces of first endplate 100v, second endplate 250v, third endplate 150v, and fourth endplate 200v includes a texture configured to grip a vertebra. Optionally, in any embodiment, the texturing comprises teeth, ridges, roughened areas, metal coatings, ceramic coatings, keels, spikes, protrusions, grooves, or any combination thereof.
[0382] Optionally, in any embodiment, the slidable connection between at least one of wedge assembly 750v and lamp assembly 800v, lamp assembly 800v and upper end plate assembly 850v, and lamp assembly 800v and lower end plate assembly 900v of Figures 81A and 81C is at an angle transverse to longitudinal axis 504v. Optionally, in any embodiment, the angle of transverse is between about 0° and about 90°.
[0383] Optionally, in any embodiment, the slidable connection between at least one of the wedge assembly 750v and the lamp assembly 800v, the lamp assembly 800v and the upper end plate assembly 850v, and the lamp assembly 800v and the lower end plate assembly 900v includes a protrusion and a slot. Optionally, in any embodiment, a protrusion extends from at least one of the wedge assembly 750v, the lamp assembly 800v, the upper end plate assembly 850v, and the lower end plate assembly 900v. Optionally, in any embodiment, a slot is disposed in at least one of the wedge assembly 750v, the lamp assembly 800v, the upper end plate assembly 850v, and the lower end plate assembly 900v. Optionally, in any embodiment, the protrusion includes a pin 600, a ridge, a dimple, a bolt, a screw, a bearing, or any combination thereof. Optionally, in any embodiment, the slot includes a through slot, a blind slot, a T-slot, a V-slot, a groove, or any combination thereof.
[0384] Optionally, in any embodiment, the slidable connection between the wedge assembly 750v and the ramp assembly 800v of Figures 81A-86B includes a first slot 651v and a second slot 652v in the distal wedge 650v, a third slot 551v and a fourth slot 552v in the proximal wedge 550v, a first protrusion 402v and a first ridge 401v in the first proximal ramp 300v and a second proximal ramp 400v, a second protrusion 352v, a second ridge 351v, and a tongue 353v in the first distal ramp 350v and a second distal ramp 450v. Optionally, in any embodiment, the number of at least one of the first slots 651v, second slots 652v, third slots 551v, fourth slots 552v, first protrusions 402v, first ridges 401v, second protrusions 352v, and second ridges 351v is about 1, 2, 3, 4 or more.
[0385] Optionally, in any embodiment, the slidable connection between the proximal wedge 550v and the first proximal ramp 300v or the second proximal ramp 400v includes a slidable connection between the third slot 551v and the first ridge 401v and a slidable connection between the fourth slot 552v and the first protrusion 402v.
[0386] Optionally, in any embodiment, the slidable connection between the distal wedge 650v and the first distal ramp 350v or the second distal ramp 450v includes a slidable connection between the first slot 651v and the second ridge 351v, a slidable connection between the second slot 652v and the second protrusion 352v, or any combination thereof.
[0387] Optionally, in any embodiment, the second slot 652v in the distal wedge 650v includes a first stop 653v to prevent the first protrusion 402v from exiting the second slot 652v in one direction. Optionally, in any embodiment, the fourth slot 552v in the proximal wedge 550v includes a second stop 553v to prevent the first protrusion 402v from exiting the second slot 652v in one direction.
[0388] Optionally, in any embodiment, the slidable connection between the ramp assembly 800v and the upper end plate assembly 850v or the lower end plate assembly 900v includes a tongue 353v in at least one of the first distal ramp 350 and the second distal ramp 450, as well as a v-slot 403v, a third protrusion 404v, a third ridge 405v, and a third slot 406v in at least one of the first proximal ramp 300 and the second proximal ramp 400, and a dovetail slot 101v, a fourth protrusion 102v, a fourth slot 104v, a fifth slot 103v, and a fourth ridge 105v in at least one of the first end plate 100v, the second end plate 250v, the third end plate 150v, and the fourth end plate 200v.
[0389] Optionally, in any embodiment, the slidable connection between the first distal ramp 350v or the second distal ramp 450v and the first end plate 100v, the second end plate 250v, the third end plate 150v, or the fourth end plate 200v includes a slidable connection between the dovetail slot 101v and the tongue 353v.
[0390] Optionally, in any embodiment, the slidable connection between the first proximal ramp 300v or the second proximal ramp 400v and the first endplate 100v, the second endplate 250v, the third endplate 150v, or the fourth endplate 200v includes a slidable connection between the v-slot 403v and the fourth protrusion 102v, a slidable connection between the third protrusion 404v and the fourth slot 104v, a slidable connection between the third ridge 405v and the fifth slot 103v, a slidable connection between the third slot 406v and the fourth ridge 105v, or any combination thereof.
[0391] Optionally, in any embodiment, fourth protrusion 102v includes a feature of first endplate 100v, second endplate 250v, third endplate 150v, or fourth endplate 200v. Optionally, in any embodiment, fourth protrusion 102v includes a separate component that is securely inserted into first endplate 100v, second endplate 250v, third endplate 150v, or fourth endplate 200v. Optionally, in any embodiment, fourth protrusion 102v includes pin 600v.
[0392] Optionally, in any embodiment, the slidable connection between the wedge assembly 750v and at least one of the upper endplate assembly 850v and the lower endplate assembly 900v includes a slidable connection between the distal chamfer 123v and the proximal chamfer 121v on at least one of the first endplate 100v, the second endplate 250v, the third endplate 150v, and the fourth endplate 200v and the guide surface 621v, 521v on at least one of the distal wedge 650v and the proximal wedge 550v. Optionally, in any embodiment, the slidable connection between the wedge assembly 750v and at least one of the upper endplate assembly 850v and the lower endplate assembly 900v prevents the height 1200v of the device from increasing until the width 1100v of the device 1000v reaches its limit.
[0393] Optionally, in any embodiment, at least one of actuator 500v, wedge assembly 750v, ramp assembly 8000v, upper end plate assembly 850v, and lower end plate assembly 900v comprises titanium, cobalt, stainless steel, tantalum, platinum, PEEK, PEKK, carbon fiber, barium sulfate, hydroxyapatite, ceramic, zirconium oxide, silicon nitride, carbon, bone graft, demineralized bone matrix product, synthetic bone substitute, bone forming agent, bone growth inducing material, or any combination thereof.
[0394] 81A provided herein is a deployable fusion system for implantation between two adjacent vertebrae, the system including a folding tool 5000v and an eighteenth deployable fusion device 1000v. Optionally, in any embodiment, when the actuator 500v is actuated in a first actuation direction 1300v by at least a first and second number of actuations such that the width 1100v and height 1200v of the device 1000v are at their extremes, actuation of the actuator 500v in a direction opposite the first actuation direction 1300v can reduce only the width 1100v without reducing the height 1200v of the device 1000v. Optionally, in any embodiment, a folding tool 5000v can be employed to allow reduction in the height 1200v without reducing the width 1100v. Optionally, in any embodiment, folding tool 5000v includes first branch 5001v and second branch 5001v, where first branch 5001v is configured to be inserted between proximal wedge 550v and / or distal wedge 650v and first proximal ramp 300v, and second branch 5002v is configured to be inserted between proximal wedge 550v and / or distal wedge 650v and second proximal ramp 400v. Optionally, in any embodiment, first branch 5001v and second branch 5001v have the same length. Optionally, in any embodiment, first branch 5001v and second branch 5001v have different lengths. Optionally, in any embodiment, first branch 5001v and second branch 5001v have the same thickness. Optionally, in any embodiment, first branch 5001v and second branch 5001v have different thicknesses.
[0395] Optionally, in any embodiment, eighteenth deployable fusion device 1000v may additionally or alternatively include any feature, component, or characteristic of any of the previously described deployable fusion devices.
[0396] The component metrics of an exemplary eighteenth deployable fusion device are summarized in Table 1 below. [Table 1-1] [Table 1-2]
[0397] 19. Deployable Fusion Device 87A-94D provided herein are a nineteenth deployable fusion device 1000w for implantation between two adjacent vertebrae. Optionally, in any embodiment, device 1000w of FIG. 81A includes: actuator 500w including drive mechanism 503w and longitudinal shaft 504w; wedge assembly 750w coupled to actuator 500w; ramp assembly 800w slidably coupled to wedge assembly 750w; upper endplate assembly 850w slidably coupled to ramp assembly 800v; and lower endplate assembly 900w slidably coupled to ramp assembly 800w. Optionally, in any embodiment, upper endplate assembly 850w is further slidably coupled to lower endplate assembly 900w.
[0398] Optionally, in any embodiment, device 1000w of Figure 87A has a width 1100w that includes the external width of at least one of upper end plate assembly 850w and lower end plate assembly 900w. Optionally, in any embodiment, device has a height 1200w that includes the external distance between upper end plate assembly 800w and lower end plate assembly 900w.
[0399] Optionally, in any embodiment, actuation of drive mechanism 503w a first number of actuations in first actuation direction 1300w of FIG. 87C increases width 1100w without increasing height 1200w. Optionally, in any embodiment, actuation of drive mechanism 503w a second number of actuations greater than the first number of actuations in first actuation direction 1300w increases width 1100w without increasing height 1200w. Optionally, in any embodiment, actuation of drive mechanism 503w a second number of actuations greater than the first number of actuations in first actuation direction 1300w increases both height 1200w and width 1100w, and actuation of drive mechanism 503w a third number of actuations greater than the second number of actuations in first actuation direction 1300w increases height 1200w without increasing width 1100v. Optionally, in any embodiment, actuation of drive mechanism 503w a second number of actuations greater than the first number of actuations in first actuation direction 1300w increases neither height 1200w nor width 1100w, and actuation of a third drive mechanism 503w greater than the second number of actuations in first actuation direction 1300w increases height 1200w without increasing width 1100w. Optionally, in any embodiment, width 1100w of device 1000w reaches a limit when drive mechanism 503w is actuated by at least the first number of actuations. Optionally, in any embodiment, height 1200w of device 1000w reaches a limit when drive mechanism 503w is actuated by at least the first and second numbers of actuations.
[0400] Optionally, in any embodiment, actuation of drive mechanism 503w a second number of actuations in a first actuation direction 1300w that is greater than the first number of actuations increases both height 1200w and width 1100w. Optionally, in any embodiment, actuation of drive mechanism 503w a second number of actuations in a first actuation direction that is greater than the first number of actuations increases height 1200w without increasing width 1100w.
[0401] Optionally, in any embodiment, actuation of drive mechanism 503w in first actuation direction 1300w by at least a first number of actuations increases height 1200w of device 1000w by about 30% to about 400%. Optionally, in any embodiment, actuation of drive mechanism 503w in first actuation direction 1300w by at least a first and second number of actuations increases width 1100w of device 1200w by about 14% to about 150%.
[0402] Optionally, in any embodiment, actuator 500w of FIG. 88 includes a cylindrically shaped elongated shaft with a distal end and a proximal end. Optionally, in any embodiment, at least a portion of the distal end of actuator 500w includes first thread mechanism 501w. Optionally, in any embodiment, at least a portion of the proximal end of actuator 500w includes second thread mechanism 502w, and the proximal end includes drive mechanism 503w. Optionally, in any embodiment, at least one of first thread mechanism 501w and second thread mechanism 502w includes threads disposed externally around actuator 500w. Optionally, in any embodiment, first thread mechanism 501w and second thread mechanism 502w have opposite thread directions. Optionally, in any embodiment, first thread mechanism 501w and second thread mechanism 502w have the same thread direction. Optionally, in any embodiment, at least one of the first thread feature 501w and the second thread feature 502w includes a right-hand thread. Optionally, in any embodiment, at least one of the first thread feature 501w and the second thread feature 502w includes a left-hand thread. Optionally, in any embodiment, the drive feature 503w includes a recessed area configured to receive a drive instrument. Optionally, in any embodiment, the recessed area includes a slot, Phillips, Pozidriv, Frearson, Robertson, 12-point flange, hex socket, security hex socket, star drive, security Torx®, ta, three-point, three-wing, spanner head, clutch, one-way, double square, triple square, Polydrive, spline drive, double hex, bristles, or pentalobe recess. Optionally, in any embodiment, the drive feature includes a protuberance extending therefrom and configured to couple to a drive instrument. Optionally, in any embodiment, the protuberance comprises a hexagonal, hexalobular, or square protuberance. Optionally, in any embodiment, drive mechanism 503w is coincident with longitudinal axis 504w.
[0403] Optionally, in any embodiment, the wedge assembly of FIG. 87C includes a distal wedge 650w and a proximal wedge 550w. Optionally, in any embodiment, actuation of the drive mechanism in a first direction causes the distal wedge 650w and the proximal wedge 550w to move toward each other. Optionally, in any embodiment, the distal wedge 650w of FIGS. 89A-B is a crescent-shaped prism including a distal end, a proximal end, a top side, and a bottom side. Optionally, in any embodiment, the distal wedge 650w includes a third thread feature 654w. Optionally, in any embodiment, the third thread feature 654w extends from the distal end of the distal wedge 650w to the proximal end of the distal wedge 650w. Optionally, in any embodiment, the distal wedge 650w further includes one or more features configured for temporary attachment to an inserter tool. Optionally, in any embodiment, third thread feature 654w is threadedly engaged with second thread feature 502w of actuator 500w. Optionally, in any embodiment, distal wedge 650w further includes first slot 651w and second slot 652w. Optionally, in any embodiment, first slot 651w includes upper left first slot 651w, upper right first slot 651w, lower left first slot 651w, and lower right first slot 651w. Optionally, in any embodiment, upper left first slot 651w and lower left first slot 651w, as well as upper right first slot 651w and lower right first slot 651w, have mirror symmetry with respect to a transverse plane of distal wedge 650w. Optionally, in any embodiment, the midplanes of each of the upper left first slot 651w, the upper right first slot 651w, the lower left first slot 651w, and the lower right first slot 651w are oriented at an angular position that intersects the sagittal plane of the distal wedge 650w. Optionally, in any embodiment, the second slots 652w include an upper left second slot 652w, an upper right second slot 652w, a lower left second slot 652w, and a lower right second slot 652w.Optionally, in any embodiment, the upper left second slot 652w and the lower left second slot 652w, and the upper right second slot 652w and the lower right second slot 652w, have mirror symmetry with respect to the transverse plane of the distal wedge 650w. Optionally, in any embodiment, the central planes of the upper left second slot 652w, the upper right second slot 652w, the lower left second slot 652w, and the lower right second slot 652w are oriented at an angular position that intersects the sagittal plane of the distal wedge 650w. Optionally, in any embodiment, the proximal wedge 550w is equivalent to the distal wedge 650w. Optionally, in any embodiment, the sagittal plane of the distal wedge 650w in FIG. 87C is arranged to be coplanar with the sagittal plane of the proximal wedge 550w. Optionally, in any embodiment, the sagittal plane of distal wedge 650w in FIG. 87C is arranged such that it is arranged 180° from the sagittal plane of proximal wedge 550w.
[0404] Optionally, in any embodiment, at least one of the third thread feature 654w and the fourth thread feature 554w of the distal wedge 650w and the proximal wedge 550w, respectively, includes a thread-locking mechanism configured to prevent actuation of at least one of the third first feature 501w and the second thread feature 502w of the actuator 500w in a direction opposite the first actuation direction 1300w. Optionally, in any embodiment, the thread-locking mechanism includes a deformable insert, a deformable thread, a distorted thread, a flexible lip, or any combination thereof. Optionally, in any embodiment, the thread-locking mechanism includes a bore in at least one of the distal wedge 650w and the proximal wedge 550w configured to provide access to the third thread feature 654w or the fourth thread feature 554w and / or configured to receive an insert, such as a pin, a screw, a dowel, a nut, or any combination thereof, to prevent actuation of the actuator 500w. Optionally, in any embodiment, lamp assembly 800w of FIG. 87C includes a first proximal lamp 300w, a second proximal lamp 400w, a first distal lamp 350w, and a second distal lamp 450w.
[0405] Optionally, in any embodiment, second proximal ramp 400w of Figures 90A and 90B comprises a generally triangular prism. Optionally, in any embodiment, second proximal ramp 400w comprises first ridge 401w, first protrusion 402w, v-slot 403w, third protrusion 404w, third ridge 405w, and third slot 406w. Optionally, in any embodiment, first ridge 401w comprises two first ridges 401w. Optionally, in any embodiment, the midplane of first ridge 401w is at a pivot angle from the midplane of second proximal ramp 400w. Optionally, in any embodiment, first protrusion 402w comprises two first protrusions 402w. Optionally, in any embodiment, v-slot 403w is located on a transverse plane of second proximal ramp 400w. Optionally, in any embodiment, the extreme of v-slot 403w is oriented toward the mesial plane of device 1000w. Optionally, in any embodiment, protrusion 404w includes two protrusions 404w. Optionally, in any embodiment, protrusion 404w is located on the lower surface of distal ramp 400w. Optionally, in any embodiment, third ridge 405w includes two third ridges 405w. Optionally, in any embodiment, third ridge 405w is located on the lower surface of second proximal ramp 400w. Optionally, in any embodiment, the midplane of third ridge 405w is parallel to the mesial surface of second proximal ramp 400w. Optionally, in any embodiment, third slot 406w includes two third slots 406w. Optionally, in any embodiment, third slot 406w is located on the top surface of second proximal ramp 400w. Optionally, in any embodiment, the midplane of third slot 406w is parallel to the mesial surface of distal ramp 400w. Optionally, in any embodiment, second proximal ramp 300w is equivalent to first distal ramp 350w.
[0406] Optionally, in any embodiment, first proximal ramp 300w of Figures 91A and 91B comprises a generally triangular prism. Optionally, in any embodiment, second distal ramp 300w comprises first ridge 301w, first protrusion 302w, v-slot 303w, third protrusion 304w, third ridge 305w, and third slot 306w. Optionally, in any embodiment, first ridge 301w comprises two first ridges 301w. Optionally, in any embodiment, the midplane of first ridge 301w is at a pivot angle from the midplane of second distal ramp 300w. Optionally, in any embodiment, first protrusion 302w comprises two first protrusions 302w. Optionally, in any embodiment, v-slot 303w is located in a cross-section ...
Claims
1. 1. A deployable implant having a distal end and a proximal end, said implant comprising: a wedge assembly slidably coupled to the ramp assembly and configured to receive a single actuator, the wedge assembly having a proximal wedge and a distal wedge; an upper end plate assembly slidably coupled to the lamp assembly; and a lower end plate assembly slidably coupled to the lamp assembly; wherein a first movement of the wedge assembly by said single actuator increases the width of the fusion device; a second movement of the wedge assembly beyond the first movement increases the height of the implant; and The implant, wherein the first movement causes the proximal wedge to move toward the distal end of the implant and the distal wedge to move toward the proximal end.
2. 10. The implant of claim 1, wherein the implant deploys non-uniformly such that a distal end of the implant achieves a different height extension than a proximal end of the implant.
3. 10. The implant of claim 1, wherein the implant has a left side and a right side, and the fusion device deploys non-uniformly such that the left side of the fusion device achieves a different height extension than the right side of the fusion device.
4. the upper end plate assembly having a first end plate and a second end plate; the lower end plate assembly having a third end plate and a fourth end plate; and 10. The implant of claim 1, wherein the first endplate, the second endplate, the third endplate, and the fourth endplate are configured for lordotic engagement with the intervertebral endplate.
5. The implant of claim 4 , wherein the shape includes tapered end plates.
6. The implant of claim 4 , wherein the shape includes a pair of end plates having different heights.
7. The implant of claim 4 , wherein the shape includes a pair of end plates having different lengths.
8. The implant of claim 4 , wherein the shape includes a pair of end plates having different widths.
9. 1. A deployable fusion system comprising: Inserter; an actuator including a drive mechanism; and The system comprising the device of claim 1 .
10. 10. A method of using the apparatus of claim 1, comprising: Inserting a device into a subject; first expanding the width of the device with the single actuator; and increasing the height of the device.
11. 1. A deployable implant having a distal end and a proximal end, comprising: a wedge assembly having a distal wedge and a proximal wedge slidably coupled to the ramp assembly and configured to receive a single actuator; an upper end plate assembly slidably coupled to the lamp assembly; and a lower end plate assembly slidably connected to the lamp assembly; wherein a first movement of the wedge assembly by the single actuator increases the width of the implant; a second movement of the wedge assembly beyond the first movement increases the height of the implant; and The implant, wherein the first movement moves the proximal wedge toward the proximal end of the implant and the distal wedge toward the distal end.
12. 1. A deployable fusion system comprising: Inserter; an actuator including a drive; and The system comprises the device of claim 11.
13. A method of using the apparatus of claim 11, comprising the steps of: Inserting a device into a subject; Increasing the width of the device with the single actuator; and increasing the height of the device.
14. 12. The implant of claim 11, wherein the implant deploys non-uniformly such that a distal end of the implant achieves a different height extension than a proximal end of the implant.
15. 12. The implant of claim 11, having a left side and a right side, and wherein the implant deploys non-uniformly such that the left side of the implant achieves a different height extension than the right side of the implant.
16. an upper end plate assembly having a first end plate and a second end plate; the lower end plate assembly having a third end plate and a fourth end plate; and 12. The implant of claim 11, wherein the first endplate, the second endplate, the third endplate, and the fourth endplate are configured for lordotic engagement with the intervertebral endplate.
17. 17. The implant of claim 16, wherein the shape includes tapered end plates.
18. 17. The implant of claim 16, wherein the shape includes a pair of end plates having different heights.
19. The device of claim 16 , wherein the shape includes a pair of end plates having different lengths.
20. The device of claim 16 , wherein the shape includes a pair of end plates having different widths.