Cross Reference to Related Applications

[ΌΘ0 ] This application claims the priority benefit under 35 U.S.C. § 1 19(e) of U.S. Provisional Patent Application No. 61 /940,802, filed February 17, 2014, the entirety of which s hereby incorporated by reference herein.

BACKGROUND

Field

[0002] This application generally relates to spinal fusion, and more specifically, to spinal implants and related systems, tools and methods.

Description of the Related Art

[0003] Intervertebral discs can degenerate or otherwise become damaged over time. n some instances, an intervertebral implant can be positioned within a space previously occupied by a disc. Such implants can help maintain a desired spacing between adjacent vertebrae and/or promote fusion between adjacent vertebrae. The use of bone graft and/or other materials within spinal implants can facilitate the fusion of adjacent vertebral bodies. Accordingly, a need exists for an improved intervertebral impiant, as well as related instrumentation, tools, systems and methods.

SUMMARY

[0004] According to some embodiments, an expandable spinal implant comprises an implant comprising a first end and a second end, and an upper portion and a lower portion, the impiant further comprising a cavity within an interior portion of the impiant; wherein the first end of the implant is configured to recei ve an insert, the insert being configured to be advanced at least partially within the cavity of the implant to vertically expand at least one portion of the implant, wherein during a vertical expansion of the implant, the upper portion is moved relative to the lower portion of the implant; and an insert configured to be selectively advanced at least partially into the cavit of the impiant through the first end of the implant; wherein the implant is configured to receive a volume of graft material into the ca vity through the first end of the impiant after the insert has been secured at least partially within the cavity of the implant. OOOS] According to some embodiments, the insert is initially at least partially positioned within an interior portion of the implant, the insert being configured to be advanced into the cavity of the implant. In one embodiment, the insert is advanced relative to the cavity of the implant via a threaded connection between the insert and the implant. In some embodiments, the insert is advanced relative to the cavity of the implant by imparting a force on the insert. In some embodiments, the implant further comprise a graft material positioned at least partially within the cavity of the implant after the insert has been at least partially positioned within the cavity of the implant. In some embodiments, the graft material is delivered into the cavity via a graft delivery system. In one embodiment, the graft delivery system comprises a conduit and a pusher member configured to push graft material through the conduit.

[0006] According to some embodiments, the insert is at least partially advanced into the cavity of the implant via a threaded connection. In one embodiment, the insert comprises a proximal end, wherein the proximal end comprises an opening for receiving graft material, the opening being in fluid communication with the cavity of the implant such that graft material delivered through the opening along the proximal end of the insert is configured to be delivered into the cavity of the implant. In some embodiments, the insert is initially positioned within the implant and delivered to a user with the insert at least partially within the implant. In some embodiments, the insert comprises a proximal end comprising at least one engagement feature, said engagement feature being configured to engage a tool to selectively advance the insert at least partially within the cavity of the implant.

[0007] According to some embodiments, the insert comprises at least one positive engagement feature, the at least one positive engagement feature being configured to contact and engage at least one portion of the implant when the insert is advanced relative to the implant, wherein the at least one positive engagement feature is configured to ensure that the insert remains irremovably secured or engaged to the implant once advanced sufficiently deep relative to the implant. In one embodiment, the positive engagement feature comprises at least one protmsion that engages at least one recess or other portion of the implant.

[00081 According to some embodiments, the insert of the implant is configured to raise only one end of the implant in an effort to treat lordosis of the subject. In some embodiments, the insert is configured to raise both ends of the implant. In some embodiments, the insert comprises a space, the space being configured to be at least partially filled by graft material delivered through the first end of the implant. In some embodiments, graft material delivered into the cavity of the implant is configured to extend from each of the adjacent eiidplates of the vertebrae of the subject across which the implant extends.

According to some embodiments, the implant comprises at least one opening along a first side and/or a second side of the implant, wherein graft material delivered into the cavity of the implant is configured to at least partially exit the first and/or the second side of the implant. In some embodiments, the insert comprises a main insert body and wings along each side of the main insert body, wherein the wings of the insert are configured to engage corresponding features along at least a portion of the implant. In some embodiments, the main insert body comprises a generally circular, oval or elliptical cross-sectional shape. In other embodiments, the main insert body comprises a rectangular (e.g., square), other polygonal and/or other shape (e.g., irregular).

[0010J According to some embodiments, the wings of the insert extend to a lateral periphery of the implant once properly inserted within the implant. In some embodiments, the wings of the insert do not extend to a lateral peripher of the implant once properly inserted within the implant.

[0011] According to some embodiments, the insert comprises at least one positive engagement feature configured to engage a corresponding portion or feature of the implant, said at least one positive engagement feature being configured to help ensure that the insert remains property secured to the implant following insertion of the insert within the implant. In one embodiment, the positive engagement feature comprises at least one tooth or other interdigitating member or feature. In some embodiments, the insert is advanced at least partially into the cavity of the implant using a threaded connection, a proximal end of the insert comprising an engagement feature for securing an advancement tool thereto. In some embodiments, the engagement feature comprises a feature configured to be engaged by a screwdriver.

[0012] According to some embodiments, the implant is configured to treat lordosis of a subject. In some embodiments, the implant is configured to treat another spinal ailment (e.g., scoliosis, etc.). In some embodiments, the expandable implant is configured to be delivered into a target intervertebral space laterally, translaterally, posteriorly, anteriorly and/or by any other approach, as desired or required. According to some embodiments, the implant comprises at least one of the following: a lateral implant, a posterior implant, an anterior implant and a TLIF implant,

[0013] According to some embodiments, the implant is configured to receive a volume of graft material that exceeds the internal capacity of the cavity such that excess graft material is selectively delivered out of at least one of the side walls of the implant to an area immediately adjacent the implant. In some embodiments, the insert of the implant is cannulated or otherwise comprises at least one internal passage through which graft material can be delivered into the cavity of the implant.

[0014] According to some embodiments, a method of delivering graft material into an expandable implant, the method comprising inserting an implant according to any one of implant embodiments disclosed herein, at least partially expanding at least one portion of the implant, and directing a volume of graft material into the cavity of the implant to promote fusion of adjacent vertebrae.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] These and other features, aspects and advantages of the present application are described with reference to drawings of certain embodiments, which are intended to illustrate, but not to limit, the concepts disclosed herein. The attached drawings are provided for the purpose of illustrating concepts of at least some of the embodiments disclosed herein and may not be to scale.

[0016] FIG. 1 illustrates a side view of one embodiment of an expandable implant;

[0017] FIGS. 2 and 3 illustrate side views of embodiments of wedges or other inserts configured to be placed at least partially within an interior of an expandable insert;

[0018] FIGS. 4 and 5 illustrate cross-sectional views of embodiments of wedges or other inserts configured to be placed at least partially within an interior of an expandable insert;

[0019] FIGS. 6A-6D illustrate various views of one embodiment of an insert having wings and configured to be placed within an interior portion of an implant to selectively expand at lea st one portion of the implant;

[0020] FIG. 7 illustrates a cross-sectional view of one embodiment of an expandable implant; 0021J FIG. 8 illustrates one embodiment of an insert having a screw or other fastener configured for insertion within an interior portion of an expandable insert;

[0022] FIG. 9 illustrates another embodiment of an insert having a screw or other fastener configured for insertion within an interior portion of an expandable insert;

[0023] FIG. 10 illustrates various views of another embodiment of an insert configured for placement within an interior of an expandable insert:

[0024] FIG. 1 1 illustrates one embodiment of an expandable implant comprising an insert configured to be selectively positioned therethrough to selectively expand said implant;

[0025] FIG. 12 illustrates another embodiment of an expandable implant comprising an insert configured to be selectively positioned therethrough to selectively expand said implant;

[0026] FIG. 13 illustrates cross-sectional views of another embodiment of an expandable implant configured to receive an insert;

[0027] FIG. 14 illustrates cross-sectional views of another embodiment of an expandable implant configured to receive an insert; and

[0028] FIGS. 15A-17 illustrate various views of another embodiment of an expandable implant configured to receive an insert.

DETAILED DESCRIPTION

[0029] A variety of embodiments and examples described herein illustrate various configurations that may be employed to achieve desired improvements. The particular embodiments and examples are only illustrative and not intended in any way to restrict the general nature of the inventions presented and the various aspects and features of and relating to these inventions. In any of the embodiments disclosed herein, the expandable implants can be filled, at least partially, with graft materials, as described in U.S. Patent No. 8,308,805, issued on November 13, 2012, the entirety of which is incorporated by reference herein and made a part of the present application.

[0030] The various embodiments of expandable implants disclosed herein are configured for placement between adjacent vertebrae of a patient. According to certain arrangements, the implant can be sized, shaped and otherwise adapted for placement with an intervertebral space along the lumbar, thoracic and/or cervical region of spine. In any of the embodiments disclosed herein, the implant can be inserted into a target intervertebral space using a lateral delivery approach (e.g., XLIF or TLIF), an anterior approach (e.g., ALIF), a posterior approach (e.g., PLIF) and/or any other approach or technique.

0Θ31] One embodiment of an expandable spinal implant 100 is illustrated schematically in FIG. 1. As shown, the implant can include a slot, cavity and/ or other opening 1 10 that extends along one or both ends of the implant 100. Such a slot or opening 1 10 can be configured to receive a wedge or other insert 150 that at least partially fills the slot, cavity or other opening 1 10, and advantageously causes the implant 100 to expand or otherwise become larger along one or more portions (e.g., vertically, laterally, diagonally, etc.).

0Θ32] Various embodiments of inserts 150 that can be configured to be positioned within the slot or other opening of an expandable implant (e.g., such as the one of FIG. 1) 100 are depicted in FIGS. 2, 3, 4 and 5 herein.

0Θ33] In some embodiments, as illustrated in FIGS. 2 and 3, the insert 150A, 150B can include a taper or slope at least partially along its lengih. The particular shape of the insert or wedge 150 can be selected based on the amount of distraction or expansion that is desired by the expandable implant. Thus, in some embodiments, an implant 100 can be provided with 2 or more different inserts 150 that can be placed therein. In such configurations, the user can select the insert or wedge 150 that corresponds with the desired amount of distraction for the specific treatment (e.g. lordosis correction procedure).

0Θ34] In some embodiments, the wedge or other insert is configured to fill-in or otherwise occupy, once properly inserted within a corresponding slot or opening of an expandable implant, appropriately 50- 100% of the cavity or space defined by the slot or opening (e.g., 50-55, 55-60, 60-65, 65-70, 70-75, 75-80, 80-85, 85-90, 90-95, 95-100%, percentages between the foregoing ranges, etc.). Accordingly, in some embodiments, the inserts or wedges are configured to securely occupy a majority of the corresponding cavity or space of the expandable insert. In some embodiments, the insert or wedge extends across all or most of the width or cross-sectional dimension of the slot or opening (and or the width or cross-sectional dimension of the implant), as desired or required. Such features can help create a more stable and secured expanded expandable implant (e.g., one that is less likely to inadvertently collapse or otherwise change shape after expansion). 003S] As illustrated in the cross-sectional views of FIGS, 4 and 5, the insert or wedge 150C, 150D can comprise one or more wings, protruding members and/or other engagements members 154C, 154D that are configured to engage corresponding recesses or features of the implant 100. Accordingly, the insert or wedge 150 can be securely, safely and predictably advanced within an interior portion of the implant. Also, in some embodiments, such features 154C, 154C can help prevent or reduce the likelihood of undesired or unintended separation (e.g., vertically) of the insert from the implant. Such features can be incorporated into any of the expandable implant embodiments disclosed herein.

[0036] FIGS. 6A-6C illustrate various views of insert embodiments 2.50 that comprise a main body portion 252 and adjacent wings 254 that extend (e.g. symmetrically or non- symmetrically) laterally from the main body portion. As shown, the insert 250 can include a main body portion 252 that includes a generally circular or oval cross section. However, in other embodiments, the main body portion 252 can include any- other cross sectional shape (e.g., square, rectangular, triangular, other polygonal, irregular, etc.), as desired or required. Further, in some embodiments, the main body- portion 252 or other portion forming the distal end of the insert 250 can include a tapered shape (e.g., to facilitate insertion within an interior of the implant).

[0037] With continued reference to the insert 250 illustrated in FIGS. 6A-6D, the wings 254 of the insert can be shaped, sized and/or otheiwise configured to extend the entire or substantially entire width of the implant into which they are inserted. However, in other embodiments, the wings 254 can terminate within an interior portion (e.g., with respect to width) of the implant.

[0038] In some embodiments, an insert or wedge, such the one illustrated in FIGS. 6A-6D, can be inserted in an opening, cavity or slot 210 of an expandable implant 200 such as the one depicted in FIG. 7. However, the size, shape and or other configuration of the slot or opening of the implant can vary, as desired or required,

[0039] In some embodiments, the main body portion 252 of the insert 250 is configured to be positioned within a corresponding central opening 212 of the implant (as illustrated in FIG. 7); whereas the wings or side extension members 254 of the insert 250 can be sized, shaped and/or otherwise configured to go between corresponding side slots 214 (e.g., positioned on either side of a central opening) of the implant, As the insert is advanced deeper into the corresponding slots or other opening of the implant, the implant can begin to expand (e.g., vertically), thereby advantageously producing a desired distraction or separation of the adjacent vertebrae between which the implant is positioned. In some embodiments, the insert is securely maintained within the interior of the implant by friction. For example, the wings of the insert illustrated in FIGS. 6A-6D can include a roughened or textured design to increase the factional resistance between it and the adjacent surfaces of the implant. In other embodiments, the insert can be maintained securely within the implant using one or more securement or attachments methods or devices (e.g., teeth, other positive engagement features, screws, pins, tabs, welds, rivets, other fasteners, adhesives, etc.).

0040J In some embodiments, any of the insert embodiments disclosed herein, or variations thereof, can be advanced into an interior of an implant using a threaded connection. For instance, in some arrangements, a screw 358 is used to advance the insert 350 into the cavity or space formed by the slot or opening of an implant. In other embodiments, the insert itself is a screw (e.g., such that one or more of its portions comprise a threaded exterior that is configured to engage a corresponding portion of the implant). One embodiment of an insert 350 that is configured to be advanced into (or retracted from) an expandable implant is illustrated in FIG. 8. As shown, the depicted embodiment comprises a recess 356 that is adapted to receive a screw or other fastener 358 for moving the insert into and/or out of an opening, cavity or slot of an im lant.

[0041] In other embodiments, the wedge or insert is configured to be positioned within the corresponding opening or slot of the implant by other methods, such as hammering or otherwise forcing the insert within the desired insert space.

[0042] Another embodiment of an expandable implant 400 is illustrated in FIG. 9. As shown, an insert 450 can be configured to be inserted or otherwise advanced deep enough into the interior of the insert slot or opening (e.g., from right to left in the depicted drawing) 410 so that the insert 450 becomes securely positioned within a corresponding portion (e.g., along the left side of the implan t in the depicted drawing).

[00431 As discussed above with reference to FIG, 8, in any of the embodiments disclosed herein, the insert 450 can be advanced into the corresponding space or cavity 410 of the implant 400 using any one of a variety of advancement methods or devices, such as, for example, a screw or other treaded mechanism. Different views of one embodiment of a screw system that can be used to advance an insert into the implant of FIG, 9 are shown in FIG. 10. 0Θ44] According to some embodiments, the expandable implant comprises a collar or other feature to help ensure that the insert is properly and securely maintained within the corresponding opening or slot of the implant after advancement therein. Examples of such features are illustrated in the embodiments depicted in FIGS. 1 1 and 12 herein. For instance, in FIG. 12, the insert 650 comprises one or more protruding portions 654, 655 that are sized, shape and otherwise configured to engage recesses or corresponding portions of the implant 600. In some embodiments, such protruding portions include upper and/or lower portions 654 and/or side portions 655, as desired or required.

0Θ45] In some embodiments, as illustrated in FIG. 13, one or more outer surfaces of the insert 750 and/or the implant 700 can include features or members that make it difficult or impossible to inadvertently retract or otherwise move (e.g., retract, otherwise pull-out, etc.) the insert 750 relative to the implant 700 in one or more directions. For example, in the depicted embodiment, the surfaces of the insert 750 can include ridges, teeth or other features that help prevent relative movement of the insert and the implant in one or more directions. Such features can be incorporated into any of the embodiments disclosed herein,

[0046] Other embodiments of an expandable implant 800 and a corresponding insert 850 configured to be inserted therein are illustrated in FIG. 14 herein. As shown, the implant 800 (e.g., the device located along the top in the illustrated drawing), includes a slot or other opening 810 that extends to the end of one side (e.g., the right side in the illustrated drawing) and a threaded portion 812 along the opposite end (e.g., the left side in the illustrated drawing). In some embodiments, the insert 850 (e.g., such as the device shown along the bottom in FIG. 14) can be inserted from the slot or opening side of the implant (e.g., from the right side in the illustrated drawing) and advanced toward the opposite side. Once the insert has been advanced far enough into the implant, a threaded portion of the insert can engage a corresponding threaded portion of the interior of the implant. As the insert is advanced further into the implant, the wedge or expanded portion of the insert (e.g., located along the trailing end or right side of the depicted insert) can move into the end of the implant, causing it to expand (e.g., vertically).

[00471 Another embodiment of an expandable implant 900 is illustrated in FIGS. 15A and 15B. As shown, the implant 900, in accordance with other embodiments depicted and described herein, comprises an implant body with a cavity 910 or other opening, in some arrangements, such a cavity or other opening 910 is configured to receive an insert (e.g., a wedge) 950 to selectively expand at feast a portion of the implant (e.g., vertically). For example, according to some embodiments, the insert 950 expands a distal end of the implant 900 to help treat lordosis of a subject into which the implant is inserted. However, in other embodiments, the insert is configured to raise or vertically change a dimension or extent of two ends of the implants, as desired or required.

0Θ48] As shown in FIG. 15B, the implant 900 can be inserted between adjacent vertebrae or vertebral members VI, V2 of a subject being treated. The implant 900 can be inserted into a partially collapsed or otherwise diseased intervertebral space. In accordance with the various embodiments disclosed herein, in some arrangements, an insert or other movable member located between upper and lower portions of the expandable insert 900 can be advanced into such implant 900 to selectively expand (e.g., vertically raise) at least one end or portion of the implant 900. This is illustrated schematically in the lateral and anterior views of FIGS. 16 and 17, respectively.

[0049] Thus, according to some embodiments, an implant can comprise one or more inserts that are configured to be advanced through an interior of the implant to selectively expand one or more both ends of the implant, as desired or required. For example, in some embodiments, one end of the implant is configured to be vertically expanded more than an opposite end of the implant by using a wedge or otherwise sloped insert. In other embodiments, however, the implant comprises a. generally fiat or non- tapered designed to expand the entire implant, as desired or required.

[0050] Regardless of the exact shape, size and/or configuration of the insert configured to be moved within a cavity o other portion of the implant, the implant can be post filled with one or more grafting materials. For example, as discussed herein, the insert can include one or more passages through its structure that permits graft material to be injected or otherwise inserted thereihrough. In some embodiments, such graft material can be delivered into a cavity of the implant to help facilitate fusion of adjacent vertebral members. In some embodiments, the cavity is generally open between at least a portion of the bottom of the upper vertebral member and a top of the lower vertebral member to further promote fusion using the draft material delivered into the cavity of the implant.

[00511 With further attention to FIG. 16, the implant 900 can include a specific shape, size, design and/or configuration along its distal portion that is configured to receive a corresponding engagement feature of the insert 950, once the insert 950 is properly delivered into the implant interior. Thus, in some embodiments, the insert 950 lockingly or positively engages the implant 900 to ensure that the insert remains properly secured to the implant post-implantation.

0Θ52] In any of the embodiments disclosed herein, graft material can be delivered into the cavity of the implant once the insert has been adequately or properly advanced relative to the implant. For example, in some embodiments, graft material can be delivered postO-implantation using one or more graft delivery systems to at least partially fill the cavity of the implant and/or deliver excess graft material to areas immediately adjacent an exterior of the implant,

0Θ53] In some embodiments, for example, as illustrated in FIG. 16, graft material can be delivered through a posterior portion of the implant (e.g., a posterior portion of a cannulated insert 950) into the cavity. In some embodiments, such graft material can be maintained within the interior of the implant. However, in other embodiments, at least a portion of the graft material exits an interior of the implant to the area surrounding the implant (e.g., the area along either lateral end of implant, the space between the implant the endplaies of the adjacent vertebral members, etc.), as desired or required.

[0054] As noted above, in any of the illustrated embodiments, the expandable implants can be configured to be post-filled, at least partially, with one or more graft materials. Examples of instrumentation and tools that can be used to deliver grafting materials into an interior portion of an implant after implantation are provided in U.S. Patent No. 8,308,805, which is incorporated by reference herein in its entirety.

[0055] To assist in the description of the disclosed embodiments, words such as upward, upper, bottom, downward, lower, rear, front, vertical, horizontal, upstream, downstream have been used above to describe different embodiments and/or the accompanying figures. It will be appreciated, however, that the different embodiments, whether illustrated or not, can be located and oriented in a variety of desired positions.

[0056] Although the subject matter provided in this application has been disclosed in the context of certain specific embodiments and examples, it will be understood by those skilled in the art that the inventions disclosed in this application extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the subject matter disclosed herein and obvious modifications and equivalents thereof. In addition, while a number of variations of the inventions have been shown and described in detail, other modifications, which are within the scope of these inventions, will be readily apparent to those of skill in the art based upon this disclosure, it is afso contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the inventions disclosed herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combine with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the subject matter provided in the present application should not be limited by the particular disclosed embodiments described above.