WO2018035309A1

WO2018035309A1 - Corpectomy device and methods of use thereof

Info

Publication number: WO2018035309A1
Application number: PCT/US2017/047318
Authority: WO
Inventors: Daniel GELB; Michael Schular
Original assignee: University Of Maryland, Baltimore; K2M, Inc.
Priority date: 2016-08-17
Filing date: 2017-08-17
Publication date: 2018-02-22

Abstract

A coupler includes a first unit and a second unit. The first unit includes a first outer portion having a first projection and a first inner portion including a pair of wings extending therefrom in spaced relation relative to each other. The second unit includes a second outer portion having a second projection and a second inner portion including a pair of tabs extending therefrom in spaced relation relative to each other. The pair of wings of the first unit are coupled to the pair of tabs of the second unit such that the first and second units are pivotable with respect to one another about a pivot axis that is transverse to first and second longitudinal axes defined respectively through the first and second units.

Description

CORPECTOMY DEVICE AND METHODS OF USE THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application Serial No. 62/375,974, which was filed on August 17, 2016, the entire contents of which is hereby incorporated herein by reference.

TECHNICAL FIELD

[0002] The present disclosure relates generally to vertebral implants, and more particularly, to couplers which can pivot and be used in conjunction with other elements, such as mesh units, endplates, and spacing units, to form a corpectomy device, and methods of using the same.

BACKGROUND

[0003] The human spine includes thirty-three vertebrae. The vertebrae interlock with one another to form a spinal column. Each vertebra has a cylindrical bony body (vertebral body), two pedicles extending from the vertebral body, a lamina extending from the pedicles, two winglike projections extending from the pedicles, a spinous process extending from the lamina, a pars interarticularis, two superior facets extending from the pedicles, and two inferior facets extending from the lamina. The vertebrae are separated and cushioned by thin pads of tough, resilient fiber known as intervertebral discs. Intervertebral discs provide flexibility to the spine and act as shock absorbers during activity. A small opening (i.e., foramen) located in each vertebra allows passage of nerves. When the vertebrae are properly aligned, the nerves pass through without a problem. However, when the vertebrae are misaligned or a constriction is formed in the spinal canal, the nerves get compressed and may cause back pain, leg pain, or other neurological disorders.

[0004] Disorders of the spine that may cause misalignment of the vertebrae or constriction of the spinal canal include spinal injuries, infections, tumor formation, herniation of the

intervertebral discs (i.e., slippage or protrusion), arthritic disorders, and scoliosis. In these pathologic circumstances, surgery may be tried to either decompress the neural elements and/or fuse adjacent vertebral segments. Decompression may involve laminectomy, discectomy, or corpectomy. Corpectomy involves removal of the vertebral body as well as the adjacent intervertebral discs.

[0005] One of the challenges during spinal surgery is to build a prosthetic vertebral implant, in real time, that matches the curvature of the spine and the dimensions of the removed vertebral body.

[0006] Therefore, a need exists for devices usable in spinal surgery that provides a user, such as a surgeon, with the ability to quickly and accurately design a corpectomy device with a curvature and/or dimensions that are approximate to the discarded vertebral body.

SUMMARY

[0007] In accordance with an aspect of the present disclosure, a coupler includes a first unit including a first outer portion having a first projection and a first inner portion including a pair of wings extending therefrom in spaced relation relative to each other, and a second unit including a second outer portion having a second projection and a second inner portion including a pair of tabs extending therefrom in spaced relation relative to each other. The pair of wings of the first unit are coupled to the pair of tabs of the second unit such that the first and second units are pivotable with respect to one another about a pivot axis that is transverse to first and second longitudinal axes defined respectively through the first and second units.

[0008] The first unit may define a first cavity therethrough and the second unit may define a second cavity therethrough, the first and second cavities may be in communication with each other and the first and second longitudinal axes of the first and second units may be aligned with each other when the first and second units are in a first orientation. The first and second units may be pivotable between a first orientation in which first and second faces of the first and second units are spaced apart from each other and define a gap therebetween, and a second orientation in which the first and second faces abut each other. Each wing of the pair of wings of the first unit may be paired with a tab of the pair of tabs of the second unit, and each paired wing and tab may be configured to receive a dowel therethrough.

[0009] In embodiments, the first unit includes a protruding portion disposed above the pair of wings. The protruding portion includes a first aperture defined therethrough and extending along a lateral axis that is parallel to the pivot axis, and a hole defined therethrough and extending along a normal axis that is transverse to the lateral axis. In some embodiments, the second unit includes a second aperture defined therethrough and extending along an axis parallel to the lateral axis of the first unit. In certain embodiments, the coupler further includes a screw and nut assembly including a first nut, a screw, and a second nut. The first nut is positioned in the first aperture of the first unit, the second nut is positioned in the second aperture of the second unit, and the screw is positioned through the hole of the first unit and the first nut, and into the second nut. The second nut may include a threaded inner bore, and the screw may include a threaded portion threadingly engaged with the threaded inner bore of the second nut.

[0010] The first unit may include first connecting element openings and the second unit may include second connecting element openings, the first and second connecting element openings defined through at least the first and second projections, respectively, and extending along axes that are substantially parallel to the respective first and second longitudinal axes of the first and second units. The first unit may include first set screw orifices and the second unit may include second set screw orifices, the first and second set screw orifices extending along axes substantially perpendicular to the axes of the first and second connecting element openings.

[0011] In accordance with another aspect of the present disclosure, a corpectomy device includes a coupler, a first mesh unit, and a first endplate. The coupler includes a first unit and a second unit pivotable with respect to one another about a pivot axis that is transverse to first and second longitudinal axes defined respectively through the first and second units. The first mesh unit includes a body defining a central opening therethrough, and the first endplate includes an endplate projection on a first end thereof and a plurality of grooves on a second end thereof. First and second end portions of the first mesh unit are configured to connect with the first projection, the second projection, or the endplate projection.

[0012] In embodiments, the first and second units are pivotable between a first orientation in which the first and second longitudinal axes of the first and second units are substantially aligned with each other and a second orientation in which the first and second longitudinal axes of the first and second units are angled with respect to each other. In some embodiments, the corpectomy device further includes a second mesh unit and a second endplate. The endplate projection of the first endplate is coupled to a first end portion of the first mesh unit, a second end portion of the first mesh unit is coupled to the first projection of the coupler, the second projection of the coupler is coupled to a first end portion of the second mesh unit, and a second end portion of the second mesh unit is coupled to an endplate projection of the second endplate.

[0013] The corpectomy device may further include at least one spacing unit including first and second spacing unit projections on opposed ends thereof. The first and second end portions of the first mesh unit may be configured to connect with the first or second spacing unit projections.

[0014] In embodiments, the first unit includes first connecting element openings and the second unit include second connecting element openings. The first and second connecting element openings are defined through at least the first and second projections, respectively, and the first endplate includes endplate connecting element openings defined through at least the endplate projection. The corpectomy device may further include connecting elements that are configured to extend through the first or second connecting element openings of the first unit of the coupler, the central opening of the first mesh unit, and the endplate connecting element openings of the first endplate.

[0015] In some embodiments, the first unit includes first set screw orifices, the second unit includes second set screw orifices, and the first endplate includes endplate set screw orifices. The first, second, and endplate set screw orifices extend along axes substantially perpendicular to axes of the respective first, second, and endplate connecting element openings. The corpectomy device may further include set screws that are positionable within the first, second, and endplate set screw orifices to secure the connecting elements within the first, second, and endplate connecting element openings.

[0016] In accordance with yet another aspect of the present disclosure, a kit for spinal surgery includes at least one coupler, at least one mesh unit, at least one endplate, a plurality of connecting elements, and a plurality of set screws. The at least one coupler includes a first unit including a first outer portion having a first projection and a first inner portion including a pair of wings extending therefrom in spaced relation relative to each other, and a second unit including a second outer portion having a second projection and a second inner portion including a pair of tabs extending therefrom in spaced relation relative to each other. The pair of wings of the first unit are coupled to the pair of tabs of the second unit such that the first and second units are pivotable with respect to one another about a pivot axis that is transverse to first and second longitudinal axes defined respectively through the first and second units. The at least one mesh unit includes a body defining a central opening therethrough, and the at least one endplate includes an endplate projection on a first end thereof and a plurality of grooves on a second end thereof. The kit may further include at least one spacing unit including first and second spacing unit projections on opposed ends thereof.

[0017] In accordance with another aspect of the present disclosure, a method of customizing a corpectomy device includes: joining a first projection of a first unit of a coupler to a first end of a first mesh unit, the first mesh unit including a body defining a central opening therethrough; joining a second end of the first mesh unit with an endplate projection of a first endplate, the first endplate including the endplate projection on a first end thereof and a plurality of grooves on a second end thereof; and positioning a first set of connecting elements into first connecting element openings of the first unit, through the central opening of the first mesh unit, and into endplate connecting element openings of the first endplate.

[0018] The method may further include inserting a first set of set screws into first set screw orifices of the first unit and endplate set screw orifices of the first endplate to lock the first set of connecting elements in place.

[0019] In embodiments, the method further includes: joining a second projection of a second unit of the coupler to a first end of a second mesh unit, the second mesh unit including a body defining a central opening therethrough; joining a second end of the second mesh unit with an endplate projection of a second endplate, the second endplate including the endplate projection on a first end thereof and a plurality of grooves on a second end thereof; and positioning a second set of connecting elements into second connecting element openings of the second unit, through the central opening of the second mesh unit, and into endplate connecting element openings of the second endplate. In some embodiments, the method includes inserting a second set of set screws into second set screw orifices of the second unit and endplate set screw orifices of the second endplate to lock the second set of connecting elements in place.

[0020] The method may further include adjusting an angle between the first unit of the coupler and a second unit of the coupler, the first and second units pivotably coupled together about a pivot axis that is transverse to first and second longitudinal axes defined respectively through the first and second units of the coupler. Adjusting the angle may include rotating a screw extending into the first and second units of the coupler to pivot the first and second units relative to each other. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the disclosure, wherein:

[0022] FIG. 1 A is a perspective view of a coupler, in a first orientation, in accordance with an embodiment of the present disclosure;

[0023] FIG. IB is an exploded view of the coupler of FIG. 1A; [0024] FIG. 1C is a side view of the coupler of FIG. 1A; [0025] FIG. ID is an end view of the coupler of FIG. 1C;

[0026] FIG. IE is a cross-sectional view of the coupler of FIGS. 1C and ID, taken along line lE-lE of FIG. ID;

[0027] FIG. IF is a side view of the coupler of FIG. 1A, in a second orientation; [0028] FIG. 1G is an end view of the coupler of FIG. IF;

[0029] FIG. 1H is a cross-sectional view of the coupler of FIGS. IF and 1G, taken along line lH-lH of FIG. 1G;

[0030] FIG. 2A is a perspective view of a corpectomy device, in a first orientation, in accordance with an embodiment of the present disclosure;

[0031] FIG. 2B is an exploded view of the corpectomy device of FIG. 2A; [0032] FIG. 2C is a partial exploded view of the corpectomy device of FIG. 2A;

[0033] FIG. 2D is a perspective view of the corpectomy device of FIG. 2A, in a second orientation;

[0034] FIG. 3 A is a perspective view of a corpectomy device in accordance with another embodiment of the present disclosure;

[0035] FIG. 3B is an exploded view of the corpectomy device of FIG 3 A; and

[0036] FIG. 4 is a perspective view of a corpectomy device in accordance with yet another embodiment of the present disclosure.

DETAILED DESCRIPTION

[0037] Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. In the drawings and in the description that follows, terms such as "top", "bottom", "above", "below", "side", and similar directional terms are used simply for convenience of description and are not intended to limit the disclosure.

[0038] Referring now to the drawings, FIGS. 1 A and IB illustrate a coupler 100 in accordance with an embodiment of the present disclosure. The coupler 100 is configured and adapted for use with a corpectomy device (e.g., FIG. 2A) in a corpectomy procedure to replace a vertebral body. The coupler 100 includes a first unit 1 10 pivotably coupled with a second unit 120 about a center of the coupler 100 via a screw and nut assembly 130 and a plurality of dowels 140. The coupler 100 is transitionable between a first orientation (see e.g., FIG. 1C) and a second orientation (see e.g., FIG. IF), and may be used in the first orientation or the second orientation, as well as any orientation therebetween to provide a desired amount of curvature to the coupler 100, as described in further detail below.

[0039] The first unit 110 includes a first outer portion 110a and a first inner portion 110b. A first cavity 111 is defined through the first unit 110 and extends along a first longitudinal axis "XI" of the first unit 110 of the coupler 100. The first cavity 111 is configured and dimensioned to receive a bone graft material including, but not limited to, bone cement, bone chips, among other materials suitable for promoting bone growth, remodeling, and/or regeneration as is within the purview of those skilled in the art.

[0040] The first outer portion 110a of the first unit 110 includes a first projection 112 configured and dimensioned to be received within and connect with another component, such as a mesh unit, an endplate, and/or a spacing unit, as described in further detail below. It should be understood that the first outer portion 110a may have any configuration adapted to couple with a portion of another component (e.g., a mating connector or fastener) as is within the purview of those skilled in the art.

[0041] The first unit 110 includes one or more first connecting element openings 113 defined in at least the first projection 112 that extend along axes substantially parallel to the first longitudinal axis "XI" of the first unit 110 of the coupler 100. It should be understood that the first connecting element openings 113 are the same as the second connecting element openings 123 of the second unit 120 of the coupler 100. The first connecting element openings 113 are configured and dimensioned to receive connecting elements 150 (see e.g., FIG. 2B). The first unit 110 further includes one or more first set screw orifices 115 that are configured and dimensioned to receive set screws 160 (see e.g., FIG. 2B). The first set screw orifices 115 are located two to a side, on opposed sides of the first unit 110. The first set screw orifices 115 extend along axes that are substantially perpendicular to the axes of the first connecting element openings 113 and in communication therewith. When the set screws 160 are placed into the first set screw orifices 115, they engage the respective connecting elements 150 inserted into the first connecting element openings 113 and fix the respective connecting elements 150 in position.

[0042] The first inner portion 110b of the first unit 110 includes wings 114 extending therefrom in opposed parallel relation relative to each other and on opposed sides of the cavity 111. Each wing 114 includes a dowel opening 117 extending transversely therethrough along a first lateral axis or pivot axis "Yl" that is transverse to the first longitudinal axis "XI" of the first unit 110 of the coupler 100. Each dowel opening 117 is configured and dimensioned to receive a dowel 140 for connecting the first and second units 110, 120 of the coupler 100 together.

[0043] The first inner portion 110b includes a protruding portion 116 having a receiving section 118 extending laterally above the cavity 111 and the wings 114. The receiving section 118 includes a first aperture 119a extending therethrough along a second lateral axis "Y2" that is parallel to the first lateral axis "Yl ." The first aperture 119a is configured and dimensioned to receive a first nut 132 of the screw and nut assembly 130. The receiving section 118 includes a hole 119b extending therethrough along a normal axis "Z" that is transverse to both the first longitudinal and second lateral axes "XI," "Y2." The hole 119b is configured and dimensioned to receive a screw 134 of the screw and nut assembly 130. The screw 134 includes a head portion 134a, a body portion 134b, and a threaded portion 134c. [0044] The second unit 120 includes a second outer portion 120a and a second inner portion 120b. A second cavity 121 is defined through the second unit 110 and extends along a second longitudinal axis "X2" of the second unit 120 of the coupler 100. When the first and second units 110, 120 are assembled together and the coupler 100 is in the first orientation (see e.g., FIG. 1C), the first and second cavities 111, 121, and the first and second longitudinal axes "XI", "X2", are coincident and aligned with each other. The second cavity 121 is configured and dimensioned to receive a bone graft material, as described above with regard to the first cavity 111 of the first unit 110.

[0045] The second outer portion 120a includes a second projection 122 configured and dimensioned to be received within and connect with another component, such as a mesh unit, an endplate, and/or a spacing unit, as described above with regard to the first projection 112 of the first unit 110. The second unit 120 includes one or more second connecting element openings 123 defined in at least the second projection 122 that extend along axes substantially parallel to the second longitudinal axis "X2" of the second unit 120 of the coupler 100, and one or more second set screw orifices 125 extending along axes substantially perpendicular to the axes of the second connecting element openings 123 and in communication therewith, as described above with regard to the first connecting element openings 113 and the first set screw orifices 115 of the first unit 110. The second connecting element openings 123 are configured and dimensioned to receive connecting elements 150 (see e.g., FIG. 2B), and the second set screw orifices 125 are configured and dimensioned to receive set screws 160 (see e.g., FIG. 2B) that act to secure the connecting elements 160 with respect to the second unit 120. [0046] The second inner portion 120b includes tabs 124 extending therefrom in opposed parallel relation relative to each other and on opposed sides of the cavity 121. Each tab 124 includes a dowel opening 127 extending transversely therethrough that is configured and dimensioned to receive a dowel 140 for connecting the first and second units 110, 120 of the coupler 100 together, as described above with regard to the dowel openings 117 of the first unit 110.

[0047] Specifically, first and second units 110, 120 are aligned such that the wings 114 of the first unit 110 are positioned between and abut the tabs 124 of the second unit 120, with the respective dowel openings 117, 127 aligned. The dowels 140 are inserted through the dowel openings 117, 27 of each paired wing 114 and tab 124 located on each side of the coupler 100 thereby connecting the first and second units 110, 120 together. In this configuration, the first and second cavities 111, 121 of the first and second units 1 10, 120 are in fluid communication through the first projection 112, the wings 114, the tabs 124, and the second projection 122. As explained in detail below, the coupler 100 can pivot about the dowels 140 by manipulating the screw 134 of the screw and nut assembly 130 thereby allowing a discrete angular relationship to be established between the first and second units 110, 120 and permitting fine tuning of that relationship, as needed or desired.

[0048] The second inner portion 120b includes a second aperture 129 located laterally below the cavity 121 that is configured and dimensioned to receive a second nut 136 of the screw and nut assembly 130. The second aperture 129 extends along an axis that is parallel to the second lateral axis "Y2" of the first unit 110. [0049] The first and second units 110, 120 of the coupler 100 are also connected together by the screw and nut assembly 130. The first nut 132 is positioned within the first aperture 119a of the first unit 110 and the second nut 136 is positioned within the second aperture 129 of the second unit 120. The first and second nuts 132, 136 may be the same or different, and in embodiments, the first and second nuts 132, 136 are barrel nuts. As shown in FIGS. IB and IE, the screw 134 is inserted through the hole 119b, the first nut 132, a washer 137, a circlip or snap ring 138, the first and second cavities 111, 121, and into the second nut 136. The second nut 136 includes a threaded inner bore 136a configured to engage the threaded portion 134c of the screw 134. When a force (e.g., a rotational force) is applied to the screw 134, it manipulates the degree of insertion of the screw 134 into the first and second nuts 132, 136 which, in turn, manipulates the amount by which the first and second units 110, 120 pivot about the dowels 140.

[0050] As shown in FIG. 1 A, in conjunction with FIGS. 1C-1E, the coupler 100 is disposed in a first orientation. In the first orientation, the first and second longitudinal axes "XI", "X2" of the first and second units 110, 120 of the coupler 100 are substantially aligned (e.g., coaxial). The screw 134 is fully inserted into the first and second nuts 132, 136, with the head portion 134a of the screw 134 visible above the receiving section 118 of the protruding portion 116 of the coupler 100. The coupler 100 includes a gap "G" defined between first and second faces 110c, 120c of the first and second units 110, 120, on a side of the coupler 100 that is opposite the head 134a of the screw 134. In the first orientation, the first and second faces 110c, 120c of the first and second units 110, 120 may be disposed at an angle "a" relative to each other. In embodiments, the angle "a" is an acute angle and, in some embodiments, the angle "a" between the first and second faces 110c, 120c is up to about 30° relative to each other. [0051] As shown in FIGS. 1F-1H, the coupler 100 is disposed in a second orientation. In the second orientation, the first and second longitudinal axes "XI", "X2" of the first and second units 110, 120 of the coupler 100 are not aligned (see e.g., FIG. IF). The screw 134 is backed out of the coupler 100 such that the head 134a of the screw 134 is disposed above the receiving section 118 of the protruding portion 116 of the coupler 100, and the threaded portion 134c of the screw 134 is not fully threaded within the threaded inner bore 136a of the second nut 136. The gap "G" (FIG. 1C) defined between the first and second units 110, 120 of the coupler 100 when in the first orientation is now closed such that the first and second faces 110c, 120c of the first and second units 110, 120 abut each other and the angle "a" defined therebetween is at about 0°.

[0052] The coupler 100 is moved from the first orientation to a second orientation by applying a force (e.g., a rotational force) to the head portion 134a of the screw 134 and adjusting the insertion level of the threaded portion 134c of the screw 134 into the second nut 136. As the screw 134 is unscrewed, the first and/or second units 110, 120 of the coupler 100 can pivot about the dowels 140. It should be understood that the coupler 100 may also be moved from the second orientation to the first orientation by manipulating the screw 134 and fully inserting the screw 134 into the coupler 100. It should also be understood that the first and second units 1 10, 120 of the coupler 100 may be pivoted such that the first and second faces 110c, 120c are disposed at a desired angle "a" relative to each other (e.g., between about 0° to about 30°, or any angle in between). In embodiments, the angle "a" is 5°, 10°, 15°, 20°, or 25°. A user can adjust the angle "a" of the coupler 100 during a surgical procedure to more accurately match the curvature of the coupler 100 to adjacent vertebral bodies. [0053] While the screw 134 is shown inserted into a top side of the coupler 100, it should be understood that the screw 134 can be inserted into any side of the coupler 100, e.g., a side perpendicular to the first and second projections 112, 122. In such embodiments, the openings (e.g., the first aperture 119a and the hole 119b of the first unit 110, and the second aperture 129 of the second unit 120) and the first and second nuts 132, 136 of the screw and nut assembly 130 would be shifted internally to accommodate the side insertion of the screw 134. In some embodiments, the screw 134 is inserted through a rounded side, e.g., at an angle to the coupler 100. In such embodiments, it should be understood that the openings (e.g., the first aperture 119a and the hole 119b of the first unit 110, and the second aperture 129 of the second unit 120) and the first and second nuts 132, 136 of the screw and nut assembly 130 would be shifted internally to accommodate the angled insertion of the screw 134.

[0054] The coupler 100 is shown having a generally rectangular shape with rounded corners. It should be understood, however, that the coupler 100 may be any shape, such as square, square with rounded corners, round, oval, oblong, etc., so long as the coupler 100 is able to be placed between two vertebral bodies.

[0055] The coupler 100 and the components thereof are made from biocompatible materials. In embodiments, the coupler 100 is formed from biocompatible metals, such as titanium. In some embodiments, the coupler 100 is formed from biocompatible polymers, such as poly ether etherketone (PEEK). In certain embodiments, the coupler 100 and/or components thereof are formed from combinations of biocompatible materials, such as combinations of metals and polymers. The coupler and/or components thereof may be coated with a biocompatible material, for example, to reduce inflammation and/or promote osteogenesis. [0056] A coupler of the present disclosure may be utilized in a corpectomy device including at least one of said couplers, and optionally, at least one mesh unit, at least one endplate, and/or at least one spacing unit as will be discussed in more detail hereinafter.

[0057] As shown, for example, in FIG. 2A, a corpectomy device 10 includes a coupler 100, a plurality of mesh units 200 (designated as first and second mesh units 200a, 200b), and a plurality of endplates 300 (designated as first and second endplates 300a, 300b). Specifically, the corpectomy device 10 of the illustrated embodiment includes a first endplate 300a coupled to a first mesh unit 200a which, in turn, is coupled to the coupler 100 which, in turn, is coupled to a second mesh unit 200b which, in turn, is coupled to a second endplate 300b.

[0058] As shown in FIG. 2B, each of the first and second mesh unit 200a, 200b includes a body 202 having a central opening 202a defined therethrough and holes 203 defined in the body 202. The holes 203 of the body 202 of each of the first and second mesh units 200a, 200b may be disposed uniformly or randomly through the body 202 and have any diameter and/or shape including, but not limited to, round, oval, oblong, square, rectangular, triangular, and

combinations thereof. The holes 203 are configured to allow for ingrowth of tissue and/or bone. The first and second mesh units 200a, 220b may be the same or different. For example, the first and second mesh units 200a, 200b are shown substantially the same except that the first mesh unit 200a is shorter in length than the second mesh unit 200b.

[0059] The first and second mesh units 200a, 200b are shown having a generally rectangular shape with rounded corners. It should be understood, however, that the first and second mesh units 200a, 200b may be any shape, such as square, square with rounded corners, round, oval, oblong, etc., so long as the first and second mesh units 200a, 200b are dimensioned to flushly mount with the coupler 100, and/or another component of the corpectomy device 10 (e.g., an endplate 300). In embodiments, the outer dimension of the first and second mesh units 200a, 200b are coterminous with the outer dimension of the coupler 100.

[0060] First and second end portions 204, 206 of each of the first and second mesh units 200a, 200b are configured and dimensioned to receive and form a connection or joint with the respective first and second projections 112, 122 of the first and second units 110, 120 of the coupler 100, and to align the central openings 202a of the first and second mesh units 200a, 200b with the cavities 111, 121 (FIG. IE) of the coupler 100. The first and/or second end portions 204, 206 of the first and second mesh units 200a, 200b may define a recess or hole therein for receiving the first or second projection 112, 122 of the first or second unit 110, 120 therein such that the first and/or second unit 110, 120 may be coupled to the first and/or second mesh unit 200a, 200b by, for example, friction fitting, press fitting, interference fitting, among other mechanical connections within the purview of those skilled in the art. In embodiments, the connection may be a mortise and tenon type joint.

[0061] Each of the first and second endplates 300a, 300b includes a first end 302 having an endplate projection 304 and a second end 306 having a plurality of grooves 305 defined thereon. The endplate projection 304 is configured and dimensioned to be joined with the first or second end portion 204, 206 of a respective first or second mesh unit 200a, 200b in a similar manner as described above with respect to the first and second projections 112, 122 of the first and second units 110, 120. The plurality of grooves 305 are configured and dimensioned to friction fit or grip a vertebral body and are disposed at a terminal end of the corpectomy device 10. [0062] The plurality of grooves 305 can be oriented in any direction, such as vertically, horizontally, and/or diagonally on the second end 304 of the first and second endplates 300a, 300b, and may be disposed in any form and/or pattern, such as continuous grooves, non- continuous grooves, an array of dots, etc. It should be understood that the second end 304 may have any textured pattern and/or shape so long as the first and second endplates 300a, 300b grip or friction fit with a vertebral body. In embodiments, a biocompatible material is disposed over the plurality of grooves 305. The biocompatible material may be coated, sprayed, dipped, etc. onto the second end 304 of the first and/or second endplates 300a, 300b. The biocompatible coating may, for example, reduce inflammation and/or promote osteogenesis.

[0063] Each of the first and second endplates 300a, 300b includes one or more endplate connecting element openings 307 aligned with the first and second connecting element openings 113, 123 of the coupler 100, and one or more endplate set screw orifices 309 extending along an axis substantially perpendicular to the endplate connecting element openings 307 and in communication thereof. The endplate connecting element openings 307 are configured and dimensioned to receive connecting elements 150, and the endplate set screw orifices 309 are configured and dimensioned to receive set screws 160.

[0064] The first and second endplates 300a, 300b are tapered so that its use in the corpectomy device 10 provides a desired degree of curvature to the corpectomy device 10. The endplates 300a, 300b taper from a top portion towards a bottom portion such that the first and second ends 302, 304 of the first and second endplates 300a, 300b are located in planes that intersect each other. The degree of taper can vary depending upon the degree of curvature (e.g., lordosis) of the corpectomy device 10 desired. One of ordinary skill in the art would readily select and use an endplate with the appropriate degree of taper. It should be understood that the first and/or second endplates 300a, 300b may be of uniform dimension (e.g., not tapered) such that the first and second ends 302, 304 of the first and second endplates 300a, 300b are located in planes that are substantially parallel to each other.

[0065] With continued reference to FIG. 2B, the corpectomy device 10 is assembled by placing the components (i.e., the coupler 100, the first and second mesh units 200a, 200b, and the first and second endplates 300a, 300b) in a desired order/configuration forming connections between adjacent components, as described above (e.g., mortise and tenon type joints). The first mesh unit 200a and the first endplate 300a are connected to the coupler 100 by positioning connecting elements 150 into the first connecting element openings 113 of the first unit 110 of the coupler 100, through the first mesh unit 200a, and into the endplate connecting element openings 307 of the first endplate 300a. The connecting elements 150 can be, for example, a wire of any gauge so long as it connects the components of the corpectomy device 10 together. Set screws 160 are inserted into the first set screw orifices 115 of the first unit 110 of the coupler 100 and the endplate set screw orifices 309 of the first endplate 300a to lock the connecting elements 150 in place. This assembly is shown in FIG. 2C.

[0066] Connecting elements 150 are also positioned in the second connecting element openings 123 of the second unit 120 of the coupler 100, through the second mesh unit 200b, and into the endplate connecting element openings 307 of the second endplate 300b. Set screws 160 are inserted into the second set screw orifices 125 of the second unit 120 of the coupler 100 and the endplate set screw orifices 309 of the second endplate 300b to lock the connecting elements 150 in place. The connecting elements 150 do not connect the first and second units 110, 120 of the coupler 100. Rather, the connecting elements 150 terminate in the respective first or second unit 110, 120 of the coupler 100 in which they are placed so that the coupler 100 may be adjusted to provide the corpectomy device 10 with a desired degree of curvature.

[0067] FIG. 2 A shows the corpectomy device 10 in a first orientation. In the first orientation, the gap "G" is at a maximum between the first and second faces 110c, 120c of the first and second units 110, 120 of the coupler 100. As shown in FIG. 2D, the corpectomy device 10 is in a second orientation. As described above, the coupler 100 and thus, the corpectomy device 10, may be moved to the second orientation by adjusting the screw 134 of the coupler 100. In the second orientation, the gap "G" (FIG. 2A) is closed (i.e., at a minimum), and the first and second faces 110c, 120c of the first and second units 110, 120 of the coupler 100 abut each other.

[0068] A corpectomy device 20 in accordance with another embodiment of the present disclosure is shown in FIG. 3 A. The corpectomy device 20 includes a plurality of mesh units 200 (designated as first, second, and third mesh units 200a, 200b, 200c), a plurality of endplates 300 (designated as first and second endplates 300a, 300b), and a plurality of spacing units 400 (designated as first and second spacing units 400a, 400b). Specifically, the corpectomy device 20 of the illustrated embodiment includes a first endplate 300a coupled to a first mesh unit 200a which, in turn, is coupled to a first spacer 400a which, in turn, is coupled to a second mesh unit 200b which, in turn, is coupled to a second spacer 400b which, in turn, is coupled to a third mesh unit 200c which, in turn, is coupled to a second endplate 300b.

[0069] As shown in FIG. 3B, each of the first and second spacing units 400a, 400b includes first and second spacing unit projections 402, 404 disposed on each end thereof that is used to form a connection or joint with the respective first, second, and/or third mesh units 200a-200c. Each of the first and second spacing units 400a, 400b includes a plurality of spacing unit connecting element openings 403 extending therethrough from the first spacing unit projection 402 to the second spacing unit projection 404. The first and second spacing units 400a, 400b are also shown having a tapered profile, as described above with regard to the first and second endplates 300a, 300b, however, it should be understood that spacing units 400a, 400b may not be tapered.

[0070] The corpectomy device 20 is assembled by placing the components (i.e., the first, second, and third mesh units 200a-200c, the first and second endplates 300a, 300b, and the first and second spacing units 400a, 400b) in a desired order/configuration forming connections between adjacent components. The connecting elements 150 are inserted into the endplate connecting element openings 307 of the first endplate 300a, through the first mesh unit 200a, the spacing unit connecting element openings 403 of the first spacing unit 400a, the second mesh unit 200b, the spacing unit connecting element openings 403 of the second spacing unit 400b, the third mesh unit 200c, and into the endplate connecting element openings 307 of the second endplate 300b. Set screws 160 are inserted into the endplate set screw orifices 309 of the first and second endplates 300a, 300b to lock the connecting elements 150 in place.

[0071] A user of the corpectomy device 20 cannot adjust the curvature of the corpectomy device 20 once it has been formed, however, as can be seen, the first and second spacing units 400a, 400b and/or the first and second endplates 300a, 300b may be selected with desired tapered profiles so that the user can design a corpectomy device with a desired degree of curvature and/or a desired height. [0072] It should be understood that any combination of couplers, mesh units, endplates, and/or spacing units may be used in a corpectomy device of the present disclosure. The connections (e.g., projection and hole connections) between adjacent components provide strength, stability, and/or shear support to a corpectomy device, as well as a flush mount between adjoining components. A user can determine the appropriate combination of components, in real time, by connecting and/or disconnecting various components until the appropriate dimensions, such as height, width, length, curvature, etc. is achieved to tailor the corpectomy device to conform to the anatomy of an individual patient and to provide the best replacement for a vertebral body.

[0073] For example, as shown in FIG. 4, a corpectomy device 30 includes a coupler 100, a plurality of mesh units 200 (designated as first, second, and third mesh units 200a, 200b, 200c), a plurality of endplates 300 (designed as first and second endplates 300a, 300b), and a spacing unit 400. Specifically, the corpectomy device 30 includes a first endplate 300a coupled to a first mesh unit 200a which, in turn, is coupled to a spacing unit 400 which, in turn, is coupled to a second mesh unit 200b which, in turn, is coupled to a coupler 100 which, in turn, is coupled to a third mesh unit 200c which, in turn, is coupled to a second endplate 300b. The dimension of the mesh units are different, e.g., the third mesh unit 200c is longer in length than the first and second mesh units 200a, 200b, and the first and second endplates 300a, 300b, as well as the spacing unit 400, are tapered, which add to the degree of curvature of the corpectomy device 30.

[0074] The corpectomy device 30 is shown with the coupler 100 in a second orientation. As the corpectomy device 30 includes the coupler 100, the corpectomy device 30 is transitionable between the first orientation (see e.g., FIG. 1C) and the second orientation, as well as intermediate positions, as described above.

[0075] In embodiments, a corpectomy device may be provided in a kit. The kit is an assembled package including at least one coupler, at least one mesh unit, at least one endplate, at least one spacing unit, a plurality of connecting elements, and a plurality of set screws. In embodiments, the kit includes multiple compartments including, for example, one compartment having a plurality of endplates, another compartment having a plurality of mesh units, yet another compartment having a plurality of spacing units, and another compartment having a plurality of couplers. In some embodiments, each compartment may include sub-compartments for each component arranged by shape and/or size. For example, a compartment for the couplers may include a sub-compartment for couplers having a gap angle of 10°, another sub- compartment for couplers having a gap angle of 20°, and another sub-compartment for devices having a gap angle of 30°, etc. Additionally, the mesh unit, endplates, and/or spacing units may be provided in a variety of shapes, lengths, profiles, etc. such that a user may pick and choose the components necessary to assemble a corpectomy device and/or system for use in a desired surgical procedure.

[0076] In embodiments, a user may perform a corpectomy procedure, during which the user can select a coupler or assemble a corpectomy device which may be a combination of any of the components described above to form a construct that matches the removed vertebral body.

[0077] Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary

embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, the elements and features shown and described in connection with certain embodiments may be combined with the elements and features of certain other embodiments without departing from the scope of the present disclosure, and that such modifications and variation are also included within the scope of the present disclosure.

Accordingly, the subject matter of the present disclosure is not limited by what has been particularly shown and described.

Claims

WHAT IS CLAIMED IS:

1. A coupler comprising:

a first unit including a first outer portion having a first projection and a first inner portion including a pair of wings extending therefrom in spaced relation relative to each other, the first unit extending along a first longitudinal axis; and

a second unit including a second outer portion having a second projection and a second inner portion including a pair of tabs extending therefrom in spaced relation relative to each other, the second unit extending along a second longitudinal axis,

the pair of wings of the first unit coupled to the pair of tabs of the second unit such that the first and second units are pivotable with respect to one another about a pivot axis that is transverse to the first and second longitudinal axes defined through the first and second units.

2. The coupler according to claim 1, wherein the first unit defines a first cavity therethrough and the second unit defines a second cavity therethrough, the first and second cavities in communication with each other and the first and second longitudinal axes of the first and second units in alignment when the first and second units are in a first orientation.

3. The coupler according to claim 1, wherein the first and second units are pivotable between a first orientation in which first and second faces of the first and second units are spaced apart from each other and define a gap therebetween, and a second orientation in which the first and second faces abut each other.

4. The coupler according to claim 1, wherein each wing of the pair of wings of the first unit is paired with a tab of the pair of tabs of the second unit, and each paired wing and tab is configured to receive a dowel therethrough.

5. The coupler according to claim 1, wherein the first unit includes a protruding portion disposed above the pair of wings, the protruding portion including a first aperture defined therethrough and extending along a lateral axis that is parallel to the pivot axis, and a hole defined therethrough and extending along a normal axis that is transverse to the lateral axis.

6. The coupler according to claim 5, wherein the second unit includes a second aperture defined therethrough and extending along an axis parallel to the lateral axis of the first unit.

7. The coupler according to claim 6, further including a screw and nut assembly including a first nut, a screw, and a second nut, the first nut positioned in the first aperture of the first unit, the second nut positioned in the second aperture of the second unit, and the screw positioned through the hole of the first unit and the first nut, and into the second nut.

8. The coupler according to claim 7, wherein the second nut includes a threaded inner bore, and the screw includes a threaded portion threadingly engaged with the threaded inner bore of the second nut.

9. The coupler according to claim 1, wherein the first unit includes first connecting element openings and the second unit includes second connecting element openings, the first and second connecting element openings defined through at least the first and second projections, respectively, and extending along axes that are substantially parallel to the respective first and second longitudinal axes of the first and second units.

10. The coupler according to claim 9, wherein the first unit includes first set screw orifices and the second unit includes second set screw orifices, the first and second set screw orifices extending along axes substantially perpendicular to the axes of the first and second connecting element openings.

11. A corpectomy device comprising:

a coupler including a first unit and a second unit pivotable with respect to one another about a pivot axis that is transverse to first and second longitudinal axes defined through the respective first and second units;

a first mesh unit including a body defining a central opening therethrough; and a first endplate including an endplate projection on a first end thereof and a plurality of grooves on a second end thereof,

wherein first and second end portions of the first mesh unit are configured to connect with the first projection, the second projection, or the endplate projection.

12. The corpectomy device according to claim 11, wherein the first and second units are pivotable between a first orientation in which the first and second longitudinal axes of the first and second units are substantially aligned with each other and a second orientation in which the first and second longitudinal axes of the first and second units are angled with respect to each other.

13. The corpectomy device according to claim 12, further comprising a second mesh unit and a second endplate, and wherein the endplate projection of the first endplate is coupled to a first end portion of the first mesh unit, a second end portion of the first mesh unit is coupled to the first projection of the coupler, the second projection of the coupler is coupled to a first end portion of the second mesh unit, and a second end portion of the second mesh unit is coupled to an endplate projection of the second endplate.

14. The coupler according to claim 11, further comprising at least one spacing unit including first and second spacing unit projections on opposed ends thereof, wherein the first and second end portions of the first mesh unit are configured to connect with the first or second spacing unit projections.

15. The corpectomy device according to claim 11, wherein the first unit includes first connecting element openings and the second unit include second connecting element openings, the first and second connecting element openings defined through at least the first and second projections, respectively, and the first endplate includes endplate connecting element openings defined through at least the endplate projection.

16. The corpectomy device according to claim 15, further including connecting elements, the connecting elements configured to extend through the first or second connecting element openings of the first unit of the coupler, the central opening of the first mesh unit, and the endplate connecting element openings of the first endplate.

17. The corpectomy device according to claim 16, wherein the first unit includes first set screw orifices, the second unit includes second set screw orifices, and the first endplate includes endplate set screw orifices, the first, second, and endplate set screw orifices extending along axes substantially perpendicular to axes of the respective first, second, and endplate connecting element openings.

18. The coupler according to claim 17, further comprising set screws, the set screws positionable within the first, second, and endplate set screw orifices to secure the connecting elements within the first, second, and endplate connecting element openings.

19. A method of customizing a corpectomy device comprising:

joining a first projection of a first unit of a coupler to a first end of a first mesh unit, the first mesh unit including a body defining a central opening therethrough;

joining a second end of the first mesh unit with an endplate projection of a first endplate, the first endplate including the endplate projection on a first end thereof and a plurality of grooves on a second end thereof; and

positioning a first set of connecting elements into first connecting element openings of the first unit, through the central opening of the first mesh unit, and into endplate connecting element openings of the first endplate.

20. The method according to claim 19, further comprising:

inserting a first set of set screws into first set screw orifices of the first unit and endplate set screw orifices of the first endplate to lock the first set of connecting elements in place.

21. The method according to claim 20, further comprising:

joining a second projection of a second unit of the coupler to a first end of a second mesh unit, the second mesh unit including a body defining a central opening therethrough;

joining a second end of the second mesh unit with an endplate projection of a second endplate, the second endplate including the endplate projection on a first end thereof and a plurality of grooves on a second end thereof; and

positioning a second set of connecting elements into second connecting element openings of the second unit, through the central opening of the second mesh unit, and into endplate connecting element openings of the second endplate.

22. The method according to claim 21, further comprising:

inserting a second set of set screws into second set screw orifices of the second unit and endplate set screw orifices of the second endplate to lock the second set of connecting elements in place.

23. The method according to claim 19, further comprising:

adjusting an angle between the first unit of the coupler and a second unit of the coupler, the first and second units pivotably coupled together about a pivot axis that is transverse to first and second longitudinal axes defined respectively through the first and second units of the coupler.

24. The method according to claim 23, wherein adjusting the angle includes rotating a screw extending into the first and second units of the coupler to pivot the first and second units relative to each other.