ADJUSTABLE SPINAL IMPLANTS, ASSOCIATED INSTRUMENTS AND METHODS
20230013496 · 2023-01-19
Inventors
Cpc classification
A61F2002/30578
HUMAN NECESSITIES
A61F2002/4627
HUMAN NECESSITIES
A61F2002/30772
HUMAN NECESSITIES
A61F2/30749
HUMAN NECESSITIES
A61F2002/30518
HUMAN NECESSITIES
A61F2/447
HUMAN NECESSITIES
A61F2002/30579
HUMAN NECESSITIES
A61F2002/30405
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2002/3054
HUMAN NECESSITIES
A61F2002/4625
HUMAN NECESSITIES
A61F2002/30507
HUMAN NECESSITIES
A61F2002/30471
HUMAN NECESSITIES
A61F2002/3052
HUMAN NECESSITIES
International classification
Abstract
The present disclosure provides adjustable spinal devices, instruments for implanting the spinal devices, methods for adjusting the height and/or lordosis angles of the spinal devices and methods for implanting such devices. An adjustable spinal fusion device includes an upper plate having an outer surface for placement against a first vertebral body and a lower plate having an outer surface for placement against a second vertebral body. The device further includes a first translation member configured to move longitudinally relative to the upper and lower plates to adjust a distance between the upper and lower plates and a second translation member configured to move longitudinally relative to the upper and lower plates to adjust an angle between the upper and lower plates.
Claims
1. An adjustable spinal fusion device, comprising: an upper endplate having an outer surface for placement against a first vertebral body; a lower endplate having an outer surface for placement against a second vertebral body; a first translation member configured to move longitudinally relative to the upper and lower endplates to adjust a distance between the upper and lower endplates; and a second translation member configured to move longitudinally relative to the upper and lower plates to adjust an angle between the upper and lower endplates.
2. The adjustable spinal fusion device of claim 1, wherein longitudinal movement of the first translation member causes longitudinal movement of the second translation member to adjust the distance and angle between the upper and lower endplates.
3. The adjustable spinal fusion device of claim 1, wherein longitudinal movement of the second translation member relative to the first translation member adjusts the angle between the upper and lower endplates.
4. The adjustable spinal fusion device of claim 1, further comprising a first rotatable shaft coupled to the first translation member for moving the first translation member in the longitudinal direction and a second rotatable shaft coupled to the second translation member for moving the second translation member in the longitudinal direction.
5. The adjustable spinal fusion device of claim 4, wherein the first translation member includes a first movable wedge having at least one angled surface and wherein the upper and lower endplates each comprise a ramp for cooperating with the angled surface of the first movable wedge such that longitudinal movement of the first movable wedge adjusts a distance between at least a proximal portion of the upper and lower endplates.
6. The adjustable spinal fusion device of claim 5, wherein the upper and lower endplates each comprise first and second ramps extending towards each other in the proximal direction, wherein the first movable wedge comprises first and second upper angled surfaces for cooperating with the first and second ramps of the upper endplate and first and second upper angled surfaces for cooperating with the first and second ramps of the lower endplate.
7. The adjustable spinal fusion device of claim 1, wherein the first translation member comprises at least one projection extending laterally away from the first translation member and at least one of the upper and lower endplates comprises an angled slot for receiving the projection to stabilize the upper and lower endplates during longitudinal movement of the first translation member.
8. The adjustable spinal fusion device of claim 5, wherein the second translation member includes a second movable wedge with at least one angled surface and wherein the upper and lower endplates each comprise a ramp for cooperating with the angled surface of the second movable wedge of the second translation member such that longitudinal movement of the second movable wedge adjusts a distance between at least a distal portion of the upper and lower endplates.
9. The adjustable spinal fusion device of claim 8, wherein the upper and lower endplates each comprise first and second ramps extending towards each other in the proximal direction, wherein the second movable wedge comprises first and second upper angled surfaces for cooperating with the first and second ramps of the upper endplate and first and second upper angled surfaces for cooperating with the first and second ramps of the lower endplate.
10. The adjustable spinal fusion device of claim 1, wherein the second translation member comprises at least one guide arm that cooperates with at least one guide rail on the upper endplate to stabilize the upper and lower endplates during longitudinal movement of the second translation member.
11. The adjustable spinal fusion device of claim 4, further comprising a stabilization plate coupled to the first rotatable shaft such that the stabilization plate remains fixed in place relative to the upper and lower endplates as the first and second translation members are moved in the longitudinal direction.
12. The adjustable spinal fusion device of claim 11, wherein the stabilization plate includes a projection defining a central channel and the first translation member comprises at least one vertical projection extending into the central channel, wherein the central channel stabilizes lateral movement of the first translation member.
13. The adjustable spinal fusion device of claim 11, wherein the stabilization plate includes one or more knobs extending laterally from the stabilization plate and at least one of the upper and lower endplates comprises an internal slot for receiving the at least one or more knobs to stabilize the upper and lower endplates as the first translation member is moved longitudinally.
14. A spinal fusion system, comprising: an adjustable spinal fusion device comprising: an upper plate component having an outer surface for placement against an endplate of a vertebral body; a lower plate component having an outer surface for placement against an endplate of a vertebral body; and a movable wedge configured to move longitudinally relative to the upper and lower plates to adjust a distance and an angle between the upper and lower plates; and an instrument having a proximal handle, an elongate shaft and an actuator within the elongate shaft coupled to the proximal handle and the movable wedge for translating the movable wedge longitudinally relative to the upper and lower endplates.
15. The system of claim 14, wherein the movable wedge comprises a first movable wedge, the system further comprising a second movable wedge, wherein the actuator comprises a first rotatable shaft coupled to the proximal handle the first movable wedge and a second rotatable shaft coupled to the proximal handle the second movable wedge.
16. The system of claim 14, further comprising a stabilization plate coupled to the first rotatable shaft such that the stabilization plate remains fixed in place relative to the upper and lower endplates as the first and second movable wedges are moved in the longitudinal direction, wherein the instrument further comprising first and second gripping arms configured for coupling to the stabilization plate.
17. An adjustable spinal fusion device, comprising: an upper endplate having an outer surface for placement against a first vertebral body; a lower endplate having an outer surface for placement against a second vertebral body, wherein the lower endplate is a separate component from the upper endplate; a translation member configured to move longitudinally relative to the upper and lower endplates to adjust a distance between at least a portion the upper and lower endplates; and wherein the translation member comprises one or more projections extending laterally from the translation member and wherein at least one of the endplates comprises one or more slots for receiving the projections to couple the upper endplate to the lower endplate.
18. The spinal fusion device of claim 17, wherein the translation member is a first translation member for adjusting the distance between the upper and lower endplates, the device further comprising a second translation member configured to move longitudinally relative to the upper and e lower plates to adjust an angle between the upper and lower endplates.
19. The spinal fusion device of claim 18, wherein the second translation member comprises one or more projections extending laterally from the second translation member and wherein at least one of the endplates comprises one or more slots for receiving the projections to couple the upper endplate to the lower endplate
20. The spinal fusion device of claim 17, further comprising a stabilization plate that is a separate component as the upper and lower endplates and the translation member, wherein the stabilization plate comprises one or more projections and at least one of the upper and lower endplates comprises one or more slots for receiving the one or more projections and coupling the stabilization member to the upper and lower endplates.
21. The spinal fusion device of claim 20, wherein the stabilization plate includes a projection defining a central channel and the first translation member comprises at least one vertical projection extending into the central channel to couple the first translation member to the stabilization plate.
22. The spinal fusion device of claim 17, wherein at least one of the upper and lower endplates comprises a surface with one or more exhaust openings for extracting metal powder from within the device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure.
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050]
[0051]
DESCRIPTION OF THE EMBODIMENTS
[0052] This description and the accompanying drawings illustrate exemplary embodiments and should not be taken as limiting, with the claims defining the scope of the present disclosure, including equivalents. Various mechanical, compositional, structural, and operational changes may be made without departing from the scope of this description and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.
[0053] It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.
[0054] Referring now to
[0055] Implant 10 includes upper and lower endplates 12, 14, a distal translation member 16, a proximal translation member 18, and a proximal stabilization plate 20. The implant 10 further includes distal and proximal shaft actuators 22, 24 for longitudinally translating the distal and proximal translation members 16, 18, respectively, relative to the endplates 12, 14. Movement of the translation members 16, 18 in substantially the longitudinal direction changes the height and angle of the endplates 12, 14, as discussed in more detail below.
[0056] As shown in
[0057] The upper endplate 12 includes: (1) first and second distal sloped surfaces or ramps 40, 42 that are laterally spaced from each other near either side of the upper endplate and extend towards the lower plate 14 in the proximal direction; and (2) third and fourth proximal sloped surfaces or ramps 44, 46 that are laterally spaced from each other near either side of the endplate and also extend towards the lower endplate 14 in the proximal direction. The lower endplate 14 includes: (1) first and second distal sloped surfaces or ramps 50, 52 laterally spaced from each other extending upwards towards the upper endplate 12 in the proximal direction; and (2) third and fourth proximal sloped surfaces or ramps 54, 56 that are laterally spaced from each other near either side of the endplate and also extend upwards towards the upper endplate 12 in the proximal direction. These ramps interact with wedges on the translation members to provide height and angular adjustment of the implant.
[0058] In an alternative embodiment, upper endplate 12 may include a single distal ramp and/or a single proximal ramp that extends laterally across a central portion of the endplate 12. Alternatively, endplate 12 may include more than two distal or proximal ramps.
[0059] The upper and lower endplates 12, 14 each further include a proximal cut-out 60, 62 for receiving upper and lower portions of stabilization plate 20, and vertical knobs or projections 64, 66 extending from the proximal translation member 18 (see
[0060] As shown in
[0061] In an alternative embodiment, distal translation member 16 may include a single distal ramp and/or a single proximal ramp that extends laterally across a central portion of the translation member 16. Alternatively, translation member 16 may include more than two distal or proximal ramps.
[0062] Lateral portions 74, 76 of distal translation member 16 also include outer guide arms 90, 92 that engage with openings, slots or grooves 94, 96 on the outer surfaces of the distal ramps on upper endplate 12 (see
[0063] Referring now to
[0064] As shown in
[0065] As shown in
[0066] Proximal translation member 18 further includes one or more projections 142 extending laterally away from the translation member. Projections 142 may, for example, comprise pins having a tapered end extending away from member 18. These tapered or conical pins 142 extend through angled slots 144 (see
[0067] As shown in
[0068] Stabilization plate 20 is secured to proximal actuator shaft 24 such that it remains fixed in place relative to endplates 12, 14 as the translation members are moved in the longitudinal direction. Plate 20 includes two longitudinal projections 164, 166 on both of its upper and lower surfaces that extend towards the endplates to form a U-shaped projection with a central channel 168. Proximal translation member 18 includes upper and lower vertical projections 64, 66 configured to extend into these channels 168 and to move through the channels 168 as proximal translation member 18 moves in the longitudinal direction. The U-shaped projections 164, 166 and channels 168 serve to stabilize the endplates and prevent seesaw or lateral movement of proximal translation member 18. In addition, these U-shaped channels 164, 166 serve as a backstop to prevent excessive movement of the proximal translation member 18 in the proximal direction.
[0069] In addition, stabilization plate 20 may further include projections 170 extending laterally from the longitudinal projections. Projections 170 may, for example, include tapered or conical-shaped knobs. In an exemplary embodiment, plate 20 includes two such knobs on each side for a total of four conical knobs. These knobs are configured to slide within internal slots 172 on the upper and lower endplates to further stabilize the implant during height adjustment (see
[0070] Stabilization plate 20 may further include lateral projections 174 on either side of the plate that create two lateral grooves or channels 178, 180 for mating with a gripping arm of an insertion instrument (discussed below).
[0071] Referring now to
[0072] An inner rotatable shaft 220 extends from the handle 204 to the distal actuator 22 and an outer rotatable shaft 222 extends from the handle 204 to the proximal actuator 24. Inner and outer shafts 220, 222 are both attached to rotatable knobs 224, 226, respectively, on the proximal handle for rotating shafts 220, 222 and thereby rotating proximal and distal actuators 22, 24. Alternatively, shafts 220, 222 may be configured to move longitudinally (i.e., rather than rotate) to move the translation members.
[0073] Handle 204 includes markings or indicia 230, 232 to correlate rotation of the shafts with height and angle adjustment of the endplates. Inner shaft 220 has a female mating feature 234 that may be coupled to the male mating feature of the distal actuator (i.e., the hexalobe 114) and the outer shaft 222 has a female mating feature 236 that can be coupled to the bolt 152 on the proximal actuator 24.
[0074] Handle 204 further includes a third rotatable knob 240 coupled to the shaft 202 for rotating the shaft 202 and the endplate 10 therewith relative to the handle. This allows for rotation of the endplate without rotating the handle to facilitate ease of use during implantation.
[0075] In use, implant 10 may be advanced into an intervertebral space in a collapsed configuration (see the resting state shown in
[0076] To adjust the angle of the endplates, rotatable knob 224 on handle 204 is rotated, causing inner shaft 234 to rotate. This rotation is translated to hexalobe 114 on distal actuator 22. As distal actuator 22 rotates, distal translation member 16 is translated in a proximal direction relative to both endplates 12, 14 and proximal translation member 18. Since proximal translation member 18 does not move, the proximal ends of the endplates remain fixed relative to each other. The upper and lower wedges of the distal translation member contact and engage the upper and lower distal ramps of the endplates, causing the distal ends of the endplates to move apart from each other, thereby adjusting the angle of the upper endplate relative to the lower endplate (the angularly adjusted state shown in
[0077] The process of height and angle adjustment may be reversible and may also be stepless, i.e., a continuous adjustment without discrete steps. Alternatively, the height and angle adjustment may be based on a series of discrete steps which correlate to discrete distances and angles of the endplates. The height and angle may be adjusted independently of each other. For example, the above process can be reversed such that the inner shaft is first rotated to adjust the angle, and then the outer shaft is rotated to adjust height.
[0078] In certain embodiments, the entire implant 10 is fabricated through additive manufacturing techniques, such as 3D printing or the like. The implant may be formed layer by layer in the longitudinal direction from the proximal end to the distal end. Upon completion of manufacturing, the upper and lower endplates are separated from each other. The endplates remain together during use by: (1) the knobs in the proximal translation member that slide through slots in the endplates; (2) the knobs in the stabilization plate that slide through slots in the endplates; (3) the side projections on the distal translation member that slide along the proximal ramps in the endplates; and (4) the upper and lower knobs in the proximal translation member that slide through the U-shaped channel in the stabilization plate.
[0079] In an exemplary embodiment, the implants are produced by Selective Laser Melting (SLM). For example, a substrate plate is fastened to an indexing table inside a chamber with a controlled atmosphere of inert gas (e.g., argon or nitrogen). Metal powder is applied flat to the substrate plate as a layer. The metal powder is preferably a titanium alloy, e.g., Ti-6Al-4V to enable biocompatibility. Each 2D slice of the cage is fused by selectively melting the metal powder via a laser. The laser has enough energy to fully melt or rather weld the metal particles to form solid metal. The substrate plate is lowered by the layer thickness (z-direction). New metal powder is applied and the process is repeated layer by layer until the part is complete. The completed part is removed from the substrate plate by cutting or breaking off.
[0080] Preferably, all components of the cage are printed nested within each other. Compared to separately 3D printing all components next to each other, a higher utilization rate can be achieved. This means that during 3D printing, a higher proportion which is melted and a lower proportion which stays as metal powder can be achieved. Thus, production time and costs can be reduced significantly.
[0081] After 3D printing, areas connecting single components of the cage are cut by electrical discharge machining (EDM) to enable their separate movement. Further, EDM can be used to realize smooth surfaces, e.g., to enable low-friction sliding of two components against each other. With EDM, the cage can also be removed from the substrate plate.
[0082] To lower production costs, several cages can be printed onto one substrate plate.
[0083] The implant may comprise one or more exhaust openings in the upper and lower endplates to allow for extraction of the metal powder remaining in the cage after 3D printing. Preferably, the exhaust opening is positioned on a lateral surface of the moving plate). It is also possible to position the exhaust opening on a horizontal surface of the cage, preferably on the base plate or on the moving plate. Preferably, the cage comprises multiple exhaust openings. Thus, more areas inside the cage are reachable and the metal powder can be extracted more efficiently. It is also possible to configure an external sliding mean, preferably a conical groove, in such a way that it can be additionally used as an exhaust opening. Therefore, the conical groove is deepened until a passage to the outside has been made.
[0084] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the embodiment disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the embodiment being indicated by the following claims.