US20210137696A1

US20210137696A1 - Interbody fusion devices, systems and methods

Info

Publication number: US20210137696A1
Application number: US16/907,992
Authority: US
Inventors: Raed Ali
Original assignee: RAED M ALI M D Inc
Current assignee: RAED M ALI M D Inc
Priority date: 2013-03-14
Filing date: 2020-06-22
Publication date: 2021-05-13
Also published as: US10687962B2; US20160374822A1

Abstract

According to some embodiments, a method of inserting a lateral implant within an intervertebral space defined between an upper vertebral member and a lower vertebral member includes creating a lateral passage through a subject in order to provide minimally invasive access to the intervertebral space, at least partially clearing out native tissue of the subject within and/or near the intervertebral space, positioning a base plate within the intervertebral space, wherein the base plate comprise an upper base plate and a lower base plate and advancing an implant between the upper base plate and the lower base plate so that the implant is urged into the intervertebral space and the upper vertebral member is distracted relative to the lower vertebral member.

Description

PRIORITY AND CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 15/006,009 filed on Jan. 25, 2016, which is a continuation-in-part (CIP) of U.S. patent application Ser. No. 14/774,640 filed on Sep. 10, 2015 and issued on Jan. 9, 2018 as U.S. Pat. No. 9,861,495, which is a U.S. National Phase application of PCT Application No. PCT/US2014/025035 filed on Mar. 12, 2014 and published as PCT Publication No. WO 2014/159762 on Oct. 2, 2014, which claims the priority benefit of U.S. Provisional Patent Application No. 61/786,160, filed on Mar. 14, 2103. U.S. patent application Ser. No. 15/006,009 also claims the priority benefit of U.S. Provisional Patent Application No. 62/107,260, filed on Jan. 23, 2015. The entireties of all of the foregoing applications are incorporated herein and made part of the present application.

BACKGROUND

Field

This application relates generally to devices, systems and methods for the treatment of the spine, and more specifically, to spinal implants and related tools, systems and methods.

Description of the Related Art

Surgical approaches to the intervertebral space are utilized for a variety of indications and purposes, such as, for example, biopsy (e.g., for evaluation of possible infection, other pathology, etc.), discectomy (e.g., for decompression of nerve roots, to prepare for subsequent fusion procedures, etc.), disc height restoration or deformity correction, disc replacement or repair (e.g., annular repair), discogram, gene therapy and/or other procedures or treatments.
Various approaches are currently used to access the interbody or intervertebral space of a patient's thoracic, lumbar and sacral spine. These include anterior approaches (ALIF) (e.g., open, mini-open retroperitoneal, etc.), lateral approaches (e.g., costotranversectomy, extreme lateral, LLIF, etc.), posterolateral approaches (e.g., posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), etc.) and axial approaches (e.g., axial lumbar interbody fusion). Further, many minimally invasive and percutaneous approaches rely on radiographic landmarks with or without direct view to access a targeted interbody space. In addition, many, if not all, of these currently used approaches require violation of the disc annulus to access the disc space.
Fusion surgery of the thoracic, lumbar and sacral spine is often performed for a variety of indications, including degenerative joint disease, deformity, instability and/or the like. Typically, traditional fusion approaches involve relatively large, open incisions performed under direct vision. Minimally invasive surgical techniques and corresponding surgical implants have become more popular in an attempt to reduce morbidity and generally improve outcomes. Multiple variations of percutaneous systems (e.g., pedicle screw and rod systems, facet screw systems, etc.) have been developed. Such systems can allow for instrumentation placement with fluoroscopic guidance (e.g., using radiographically recognizable body landmarks) and/or other imaging technologies. Current fusion techniques, including those that utilize open and minimally invasive approaches, often require direct visualization. However, such techniques typically involve traversing spaces that are occupied by neural elements. Thus, these neural elements need to be retracted or otherwise moved during the execution of spinal procedures that precede implantation (e.g., annulotomy, discectomy, disc space and/or vertebral endplate preparation, etc.). Retraction of sensitive neural elements can also be required during the delivery of an implant to the spine.
These approaches typically require contact and retraction of nerve roots and/or sensitive visceral organs, blood vessels and/or other sensitive portions of the anatomy. Contact and retraction of these structures can place them at risk, thereby increasing the likelihood of complications and damage to a patient. Accordingly, a need exists for improved approaches for spinal fusion and/or access to intervertebral spaces.

SUMMARY

According to some embodiments, a method of inserting an implant within an intervertebral space defined between an upper vertebral member and a lower vertebral member comprises positioning an upper endplate and a lower endplate within the intervertebral space, securing an alignment member of a guiding assembly to each of the upper endplate and the lower endplate, wherein the alignment member is configured to extend from the endplates to an anatomical location away from the endplates, and advancing an implant between the alignment members and between the upper and lower endplates so that the implant is urged into the intervertebral space.
According to some embodiments, wherein advancing an implant between the upper and lower endplates comprises using a device (e.g., a mechanical device or a pneumatic device that helps to move the implant between the alignment members and the endplates). In some embodiments, the alignment members are configured to removably engage corresponding portions of the upper and lower endplates while the implant is advanced into the intervertebral space. In one embodiment, the alignment members are configured to release from the endplates when the implant has been properly secured between the endplates.
According to some embodiments, advancing the implant between the upper and lower endplates deploys at least one engagement member or feature of at least one of the upper endplate or the lower endplate, wherein the at least one engagement member or feature is configured to engage at least a portion of the an adjacent vertebral member. In some embodiments, the at least one engagement member or feature comprises a tooth, spike or similar member (e.g., bendable metallic member or other rigid, semi-rigid and/or flexible member).
According to some embodiments, the implant is configured to be advanced between the alignment members and the upper and lower endplates using a rail system. In some embodiments, the rail system comprises grooves or recesses within the alignment members and the endplates, wherein the rail system comprises protruding members or features along upper and/or lower surfaces of the implant, wherein the protruding members or features are sized, shaped and configured to engage the grooves or recesses of the alignment members and the endplates. In one embodiment, the grooves or recesses of the alignment members are generally aligned with the grooves or recesses of the endplates to permit the protruding members or features of the implant to be continuously engaged with the grooves and recesses during delivery between the upper and lower endplates.
According to some embodiments, the implant comprises a generally smooth outer surface. In other embodiments, the implant does not comprise any teeth or other engagement features. In some embodiments, the implant comprises PEEK, titanium, other thermoplastic, other metal or alloy and/or the like. In some arrangements, the upper and lower plates comprise at least one metal or alloy (e.g., titanium, stainless steel, etc.).
According to some embodiments, the method further includes securing at least one screw through an opening of the implant after the implant has been properly secured within the intervertebral space. In some embodiments, the at least one screw passes through at least a portion (e.g., openings) of the upper or lower plate. In some embodiments, the at least one screw passes through at least a portion of the upper or lower vertebral member.
According to some embodiments, the method further comprises creating a lateral passage through a subject in order to provide minimally invasive access to the intervertebral space. In some embodiments, the method additionally includes clearing out native tissue of the subject within and/or near the intervertebral space.
According to some arrangements, the at least one engagement member or feature of the endplates is configured to extend through at least one opening along an upper surface of the upper endplate and/or at least one opening along a lower surface of the lower endplate. According to some embodiments, the upper and/or lower endplate comprises a textured or porous surface adjacent the native anatomical tissue of a subject after implantation.
According to some embodiments, the implant is configured to lockingly engage the upper and lower endplates when the implant has been properly advanced relative to the endplates. In some embodiments, the locking engagement between the implant the endplates is configured to be selectively released if the implant needs to be removed or repositioned.
According to some embodiments, securing the alignment member to each of an upper or lower endplate comprises moving a distal portion of the alignment member within a central portion of the upper or lower endplate. In one embodiment, the alignment member comprises at least one flange or other protruding portion that is configured to engage and slide relative to at least one recess or groove of the upper or lower endplate. In some embodiments, the method further includes securing an engagement member or feature of the alignment member to a corresponding receiving member or feature of the upper or lower endplate. In some embodiments, the engagement member or features comprises a resilient tab. In one embodiment, the resilient tab comprises a sloped surface that is configured to be contacted and moved inwardly.
According to some embodiments, a spinal fusion system comprises an endplate system configured for placement within an intervertebral space of a subject, wherein the endplate system comprises an upper endplate and a lower endplate, and an implant configured to be advanced and positioned between the upper endplate and the lower endplate to secure the implant within the intervertebral space, wherein, when the implant is advanced between the upper endplate and the lower endplate, the upper endplates engage the upper vertebral member, and the lower endplate engages the lower vertebral member, and wherein, upon advancement of the implant between the upper and lower endplates, the upper vertebral member is distracted relative to the lower vertebral member.
According to some embodiments, the system further comprises a guiding assembly comprising upper and lower alignment members, wherein the upper alignment member is configured to removably couple to the upper endplate, and wherein the lower alignment member is configured to removably couple to the lower endplate. In some embodiments, at least one of the upper endplate and the lower endplate comprises at least one engagement member configured to engage a portion of the adjacent vertebral member when the implant has been advanced between the upper and lower endplates. In one embodiment, the at least one engagement member comprises a tooth, spike or barb.
According to some embodiments, the implant is configured to be advanced between the upper and lower endplates using a rail system. In one embodiment, the rail system comprises at least one protruding member or feature on the implant and at least one corresponding groove or recess on the upper endplate or lower endplate, wherein the at least one protruding member or feature is configured to slidably move within the at least one corresponding groove or recess on the upper endplate or lower endplate. In some embodiments, the rail system comprises at least one groove or recess on the implant and at least one corresponding protruding member or feature on the upper endplate or lower endplate, wherein the at least one protruding member or feature is configured to slidably move within the at least one corresponding groove or recess.
According to some embodiments, the implant comprises a generally smooth outer surface. In other embodiments, the implant does not comprise any teeth or other engagement features. In some embodiments, the implant comprises PEEK, titanium, other thermoplastic, other metal or alloy and/or the like. In some arrangements, the upper and lower plates comprise at least one metal or alloy (e.g., titanium, stainless steel, etc.).
According to some embodiments, the system further comprises at least one screw through an opening of the implant after the implant has been properly secured within the intervertebral space. In some embodiments, the at least one screw passes through at least a portion (e.g., one or more openings) of the upper or lower endplate. In some embodiments, the system further comprises a plate positioned adjacent the implant and the endplates, wherein the screw is configured to pass through an opening of the plate. In some embodiments, the at least one screw passes through at least a portion of the upper or lower vertebral member.
According to some embodiments, a method of inserting an implant within an intervertebral space defined between an upper vertebral member and a lower vertebral member comprises positioning a plate system within the intervertebral space, wherein the plate system comprises an upper plate and a lower plate, and advancing an implant between the upper plate and the lower plate so that the implant is urged into the intervertebral space, the upper plate engages the upper vertebral member, and the lower plate engages the lower vertebral member, wherein upon advancement of the implant between the upper and lower plates, the upper vertebral member is distracted relative to the lower vertebral member.
According to some embodiments, advancing an implant between the upper and lower base plates comprises using a device or tool (e.g., mechanical tool, pneumatic tool, etc.). In one embodiment, advancing the implant between the upper plate and the lower plate comprises advancing the implant at least partially through a guiding assembly (e.g., between upper and lower members of the assembly). In one embodiment, the guiding assembly is removably secured and/or aligned with the upper and lower plates.
According to some embodiments, the guiding assembly comprises upper and lower guiding members or plates, wherein the upper and lower guiding members or plates are configured to removably engage corresponding portions of the upper and lower plates when the implant is advanced into the intervertebral space. In some embodiments, advancing the implant between the upper and lower plates deploys at least one engagement member or feature of at least one of the upper plate or the lower plate, wherein the at least one engagement member or feature is configured to engage at least a portion of the an adjacent vertebral member. In some embodiments, the at least one engagement member or feature comprises a tooth, spike, barb and/or the like.
According to some embodiments, the implant is configured to be advanced between the upper and lower plates using a rail system. In one embodiment, the rail system comprises at least one protruding member or feature on the implant and at least one corresponding groove or recess on the upper plate or lower plate, wherein the at least one protruding member or feature is configured to (e.g., slidably or otherwise) move within the at least one corresponding groove or recess on the upper plate or lower plate. In some embodiments, the rail system comprises at least one groove or recess on the implant and at least one corresponding protruding member or feature on the upper plate or lower plate, wherein the at least one protruding member or feature is configured to (e.g., slidably or otherwise) move within the at least one corresponding groove or recess.
According to some embodiments, the implant comprises a generally smooth outer surface. In some embodiments, the implant does not comprise any teeth or other engagement features. In some embodiments, the implant comprises PEEK, stainless steel, titanium, other metals or alloys, other polymeric materials and/or the like.
According to some embodiments, the upper and lower plates comprise at least one metal or alloy and/or a polymeric material (e.g., PEEK). In some embodiments, the at least one metal or alloy comprises titanium, stainless steel and/or any other medical grade metal or alloy. In some embodiments, the lower plate and/or the upper plate is bead-blasted or is otherwise at least partially roughened (e.g., along one or more surfaces that are configured to contact and engage native vertebral tissue of the subject). In some embodiments, the lower plate and/or the upper plate comprises an ingrowth surface (e.g., along one or more surfaces that are configured to contact and engage native vertebral tissue of the subject).
According to some embodiments, the method further comprises securing at least one screw or other fastener through an opening of the implant (and/or an adjacent plate, washer or other member) after the implant has been properly secured within the intervertebral space. In some embodiments, the at least one screw passes through at least a portion of the upper or lower plate. In some embodiments, the at least one screw passes through at least a portion of the upper or lower vertebral member (and/or an adjacent plate, washer or other member).
According to some embodiments, the method further comprises creating a passage (e.g., lateral passage) through a subject in order to provide minimally invasive access to the intervertebral space. In one embodiment, the method further comprises clearing out native tissue of the subject within and/or near the intervertebral space (e.g., using one or more rasps and/or other native tissue removal tools or methods).
According to some embodiments, a spinal fusion system comprises a plate system configured for placement within an intervertebral space of a subject, wherein the plate system comprises an upper plate and a lower plate, an implant configured to be advanced and positioned between the upper plate and the lower plate to secure the implant within the intervertebral space, wherein, when the implant is advanced between the upper plate and the lower plate, the upper plates engages the upper vertebral member, and the lower plate engages the lower vertebral member, and wherein, upon advancement of the implant between the upper and lower plates, the upper vertebral member is distracted relative to the lower vertebral member.
According to some embodiments, the system additionally comprises a guiding assembly having upper and lower slides, wherein the upper slide is configured to removably couple to the upper plate, and wherein the lower slide is configured to removably couple to the lower plate. In one embodiment, the upper plate and/or the lower plate comprises at least one engagement member (e.g., tooth, spike, barb, etc.) configured to engage a portion of the adjacent vertebral member when the implant has been advanced between the upper and lower plates.
According to some embodiments, the implant is configured to be advanced between the upper and lower plates using a rail system. In one embodiment, the rail system comprises at least one protruding member or feature on the implant and at least one corresponding groove or recess on the upper plate or lower plate, wherein the at least one protruding member or feature is configured to slidably move within the at least one corresponding groove or recess on the upper plate or lower plate. In some embodiments, the rail system comprises at least one groove or recess on the implant and at least one corresponding protruding member or feature on the upper plate or lower plate, wherein the at least one protruding member or feature is configured to slidably move within the at least one corresponding groove or recess.
According to some embodiments, the implant comprises a generally smooth outer surface. In one embodiment, the implant does not comprise any teeth or other engagement features. In some embodiments, the implant comprises PEEK, titanium and/or any other metal, alloy and/or polymeric material. In one embodiment, the upper and lower plates comprise at least one metal (e.g., titanium, stainless steel, etc.), alloy and or polymeric material (e.g., PEEK).
According to some embodiments, the system further comprises at least one screw or other fastener, the screw or fastener being configured to be secured through an opening of the implant after the implant has been properly secured within the intervertebral space. In one embodiment, the at least one screw passes through at least a portion of the upper or lower plate. In some embodiments, the screw passes through at least a portion of the upper or lower vertebral member.
According to some embodiments, a method of inserting a lateral implant within an intervertebral space defined between an upper vertebral member and a lower vertebral member includes creating a lateral passage through a subject in order to provide minimally invasive access to the intervertebral space, at least partially clearing out native tissue of the subject within and/or near the intervertebral space, positioning a base plate within the intervertebral space, wherein the base plate comprise an upper base plate and a lower base plate and advancing an implant between the upper base plate and the lower base plate so that the implant is urged into the intervertebral space and the upper vertebral member is distracted relative to the lower vertebral member.
According to some embodiments, advancing an implant between the upper and lower base plates comprises using a mechanical device (e.g., a threaded-system using a rotatable handle to advance a rod or other actuator, manual or mechanically-assisted device, etc.). In some embodiments, the implant comprises at least one groove and at least one of the upper base plate member and the lower base plate member comprises at least one protruding feature, the at least one groove being configured to align and move relative to the at least one protruding feature. In some embodiments, the implant is delivered through the base plate using a rail or other alignment system. In some embodiments, the implant comprises at least one of PEEK, titanium and/or the like. In some embodiments, the base plate comprises titanium, stainless steel or another medically-acceptable metal or alloy.
According to some embodiments, the method further includes securing at least one screw (e.g., 1, 2, 3, 4, more than 4, etc.) through an opening of the implant after the implant has been properly secured within the intervertebral space. In one embodiment, the screw also passes through at least a portion of the upper or lower base plate member and/or the upper or lower vertebra.
The methods summarized above and set forth in further detail below describe certain actions taken by a practitioner; however, it should be understood that they can also include the instruction of those actions by another party. Thus, actions such as “advancing an implant” include “instructing advancing an implant.”

BRIEF DESCRIPTION OF THE DRAWINGS

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 present inventions. It is to be understood that these drawings are for the purpose of illustrating the various concepts disclosed herein and may not be to scale.

FIG. 1 schematically illustrates one embodiment of a spinal implant system with the implant not positioned within the target intervertebral space;

FIG. 2 illustrates the system of FIG. 1 with the implant positioned between the base plate members and implanted within the intervertebral space;

FIGS. 3A and 3B illustrate various views of a base plate of an implant system according to one embodiment;

FIG. 4 illustrates a side view of a spinal implant system according to one embodiment;

FIGS. 5A-5C illustrate various views of one embodiment of a base plate for use in a spinal implant system;

FIGS. 6A and 6B illustrate various views of one embodiment of an implant configured for use in a spinal implant system;

FIG. 7A illustrates one embodiment of a base plate configured for use in a spinal implant system;

FIG. 7B illustrates one embodiment of an implant configured to be used together with the base plate of FIG. 7A;

FIGS. 8A-8C illustrate various time-sequential side views during a spinal implant procedure according to one embodiment;

FIGS. 9A-9D illustrate different views of a fusion system according to one embodiment;

FIGS. 10A and 10B illustrate different views of one embodiment of an implant configured for use with a spinal fusion system;

FIG. 11 illustrates a partial cross-sectional view of an implant positioned within a guiding assembly and upper and lower plates, according to one embodiment;

FIG. 12 illustrates a perspective view of one embodiment of an implant secured between upper and lower plates of a fusion system;

FIG. 13 illustrates a perspective view of one embodiment of an implant secured between upper and lower plates of a fusion system reinforced by two screws;

FIG. 14 illustrates a schematic top view of a portion of a guiding assembly and a corresponding plate configured for use with a spinal fusion system according to one embodiment;

FIG. 15 schematically illustrates top views of different types of implants that can be used with the fusion system embodiments disclosed herein;

FIG. 16 illustrates a perspective view of one embodiment of a spinal fusion system comprising an implant positioned between adjacent plates;

FIG. 17 illustrates the spinal fusion system of FIG. 16 with a guiding assembly used to position the system within a targeted intervertebral space being withdrawn from the system, according to one embodiment;

FIG. 18 illustrates a cross-sectional view of the spinal fusion system of FIGS. 16 and 17 after positioning and deployment within a subject's intervertebral space;

FIG. 19 illustrates a top view of the system of FIGS. 16 and 17;

FIG. 20 illustrates a side view of the system of FIGS. 16 and 17 with the spinal implant being advanced between the adjacent plates to deploy the teeth or other engagement members, according to one embodiment;

FIG. 21 illustrates a side view of the system of FIG. 20, wherein the implant has been fully advanced between the adjacent plates, according to one embodiment;

FIG. 22 schematically illustrates a side view of an implant system comprising one or more keels or other extension members, according to one embodiment;

FIG. 23 schematically illustrates an orthopedic rod having a plurality of deployable members according to one embodiment;

FIG. 24A illustrates a top perspective view of an implant and adjacent plates according to one embodiment;

FIG. 24B illustrates a bottom perspective view of the implant and plates of FIG. 24A;

FIGS. 25A-25F illustrate different views of the implant and plates of FIGS. 24A and 24B;

FIG. 26 illustrates an exploded perspective view of the implant and plates of FIGS. 24A and 24B;

FIGS. 27A and 27B illustrates different perspective views of another embodiment of an implant and adjacent plates;

FIG. 28 illustrates a perspective view of an implant and adjacent endplates secured to a guiding assembly according to one embodiment;

FIG. 29 illustrates a perspective view of an alignment component of a guiding assembly according to one embodiment;

FIG. 30 illustrates a perspective view of a bottom plate (e.g., a bottom endplate) according to one embodiment;

FIG. 31A illustrates a top view of the alignment component of FIG. 29;

FIG. 31B illustrates a side view of the alignment component of FIG. 29; and

FIG. 32 illustrates a perspective view of one embodiment of an implant secured between upper and lower plates of a fusion system and comprising a plate and screws.

DETAILED DESCRIPTION

A variety of examples described below 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 concepts presented herein and the various aspects and features of such concepts.
According to some embodiments, the present application discloses various devices, systems and methods for accessing the intervertebral or interbody space of a patient's spine and/or performing certain procedures related to spinal fusion using minimally invasive surgery (MIS) techniques. As discussed in greater detail herein, the intervertebral or interbody space of the targeted portion of the patient's spine is accessed and/or treated minimally invasively using, at least in some embodiments, a lateral approach. The terms “intervertebral space” and “interbody space” are used interchangeably herein, and generally refer to the space, gap or region between adjacent vertebral members. By way of example, as illustrated in FIG. 1, the intervertebral space 14 between adjacent vertebrae 10, 12 can be accessed using one or more lateral openings or passages created laterally through the subject's anatomy (e.g., using one or more access device, such as, retractors, dilators, etc.). In some embodiments, such openings or passages are created, accessed and/or otherwise use using MIS techniques or procedures. The various devices, systems and methods disclosed herein, and variations thereof can be applied to any type of spinal implant, including, but not limited to, a lateral interbody fusion implant, a transforaminal lumbar interbody fusion (TLIF) implant, an oblique TLIF implant, a posterior lumbar interbody fusion (PLIF) implant, an anterior lumbar interbody fusion (ALIF) implant and/or the like. Accordingly, the various embodiments disclosed herein can be in a variety of MIS or non-MIS approaches, including, without limitation, lateral, TLIF, posterior, ALIF and/or the like.
Further, any of the embodiments disclosed herein can be modified or otherwise designed to be used along any portion of the spine. For example, the implants, plates (e.g., endplates), guiding assembly and/or any other component or feature can be adapted for use for a thoracic, cervical, lumbar or sacral implant, approach or treatment, as desired or required. Further, any of the embodiments disclosed herein can be modified for use as vertebral body replacement (corpectomy or other procedure involving the removing of all or a part of a vertebral body) and/or any similar or related spinal fusion technique, procedure or technology. Further, although the various devices, systems and/or methods described herein have specific applicability to the spine and spinal fusion procedures, such embodiments can be used (e.g., in the disclosed form or a modified form) for the delivery of any other member between adjacent plates, either within a subject or in another context, as desired or required.
FIG. 1 schematically illustrates one embodiment of a spinal fusion or stabilization system 50. As shown, the system 50 can include upper and lower plates (e.g., endplate members) 300 or other members that are positioned along the endplates of the upper and lower vertebral members 10, 12. In some embodiments, the plates 300 generally extend across the entire or substantially the entire width of the vertebrae 10, 12. In some embodiments, the plates 300 are the same length or substantially the same length as the spinal implant 200 that will be delivered between the plates 300 and into the intervertebral space 14. For example, the plates 300 and/or the implant 200 can be approximately 40 to 60 mm long (e.g., 40, 45, 50, 55, 60 mm, lengths between the foregoing ranges, etc.). In other embodiments, however, the length of the implant is greater than 60 mm or less than 40 mm, as desired or required.
According to some embodiments, the upper and lower plates comprise at least one metal or alloy and/or a polymeric material (e.g., PEEK). In some embodiments, the at least one metal or alloy comprises titanium, stainless steel and/or any other medical grade metal or alloy. In some embodiments, the lower plate and/or the upper plate is bead-blasted or is otherwise at least partially roughened (e.g., along one or more surfaces that are configured to contact and engage native vertebral tissue of the subject). In some embodiments, the lower plate and/or the upper plate comprises an ingrowth surface (e.g., along one or more surfaces that are configured to contact and engage native vertebral tissue of the subject). In some arrangements, such a configuration can assist to prevent movement between the plate and the vertebral body.
In some embodiments, as illustrated in FIG. 9A, each of the upper and lower plates 300 comprises at least one central opening O that can at least partially align with and provide access to (e.g., from a space generally between the upper and lower plates) to native tissue of the adjacent vertebral members V1, V2 of the subject.
In some embodiments, once the plates (e.g., endplate members) 300 have been properly positioned within the target intervertebral space 14, the implant 200 can be delivered (e.g., laterally) between the upper and lower plates or other members 300. The delivery of the implant 200 between the plates 300 can be performed with or without the use of a mechanical delivery tool (e.g., by using a threaded delivery device or other device providing for mechanical advantage, etc.). Regardless of the exact manner in which the implant 200 is advanced into the intervertebral space 14 between the upper and lower plates 300, the upper and lower plates 300 can provide one or more advantages or benefits. For example, the use of the plates 300 can help distribute forces and moments along a larger surface area. This is generally illustrated by the schematic force distribution diagram F in FIG. 2. Accordingly, the likelihood of potentially damaging localized forces, moments and/or other stresses on a particular portion or area of the adjacent vertebrae 10, 12 can be reduced or eliminated. The risk of damage to bone and/or other native tissues to the subject during a fusion procedure can be further reduced by advancing the implant 200, and thus separating the upper and lower plates 300 in a more predictable, gentler manner (e.g., as opposed to traditional methods of using great force to position an implant within a target intervertebral space).
Further, in some embodiments, the use of the upper and lower plates 300 can facilitate the delivery of the implant 200 within the target interbody space with greater ease and less resistance. As a result, the endplates and other portions of the adjacent vertebrae 10, 12 can be protected against shearing, fractures and/or other damage. This can be especially important when the implant 100 causes distraction (e.g., separation or opening) of a collapsed or partially collapsed interbody space 14, as represented by the arrows 16 in FIG. 2.
As discussed herein, one or both sides of the upper and/or lower plates can include spikes, teeth, other protruding members and/or other engagement features. For example, if such engagement features are positioned along the top of the upper plate or the bottom of the lower plate, the engagement features can be advanced into the adjacent endplate(s) as the implant 200 is moved between the plates 300. This can help secure the plates to the adjacent vertebrae 10, 12. In some embodiments, engagement features can be positioned along the opposite surfaces of the plates (e.g., along the bottom of the upper plate and/or along the top of the lower plate). Such engagement features can help prevent or reduce the likelihood of relative movement between the implant 200 and the plates 300 following implantation. In other embodiments, as discussed in greater detail herein with reference to, e.g., FIGS. 9A to 12, the implant 200 and the adjacent surfaces of the upper and lower plates 300 can include recesses, protrusions, other components of a “rail” system and/or any other feature to help maintain a particular orientation between the plates and the implant during use and/or after implantation, to help prevent or reduce the likelihood of any undesirable relative movement between the plates and the implant during use and/or after implantation and/or the like. Thus, the plates and/or the implant can include one or more other features, such as, for example, rails or guiding members (e.g., to assist in moving the implant more easily and more predictably between the plates), tabs or other portions configured to receive one or more screws or other fasteners (e.g., to further secure the system 100 to the spine after delivery into the intervertebral space) and/or the like.
FIGS. 3A and 3B illustrate different views of one embodiment of upper and lower plates (e.g., base plates or endplate members) 300 configured for use in a spinal fusion system. As shown, the base plates 300 can include upper and lower plates 310, 314. The base plates 300 can be shaped, sized and configured to span across an entire width of the subject's vertebrae 10, 12. As discussed herein, the upper and/or lower plates can include one or more openings to provide access to the adjacent native vertebral surfaces of the subject after implantation. In some embodiments, the base plates 300 extend beyond one or more side of the vertebral periphery or do not extend to the lateral edge of the vertebrae (e.g., are short by a certain clearance distance from one or more lateral edges of the vertebrae). In some embodiments, where the plates 300 extend beyond a perimeter of the upper and/or lower vertebrae, a portion of the plate 300 can be configured to be removed or manipulated after implantation. For example, in some embodiments, in such a configuration, a protruding portion of the plate can be folded or bent (e.g., either upwardly or downwardly) to move the folded or bent portion either toward or away from the intervertebral space. In some embodiments, such a bent or folded portion can include one or more openings or other holes that can be used to place a bone screw of other fastener therethrough (e.g., to secure that portion of the plate to an adjacent vertebral member, to another bent or folded plate used in a fusion system, to a separate washer or other plate member and/or the like.
As shown in FIG. 3A, the plate members 310, 314 can include one or more protruding members (e.g., teeth, rails, other engagement members or features, etc.) 320 that extend toward each other (e.g., toward the intervertebral space). Such protruding members can be fixed or movable. For example, in some embodiments, the protruding members 320 are deployable (e.g., before, during or after advancement of an implant between the base plates 300). In other embodiments, plate members 300 can include teeth, protruding members or other engagement features or devices along their opposite surfaces (e.g., along the top of the upper plate, along the bottom of the lower plate, etc.), either in lieu of or in addition to having inwardly-directed protruding members. As discussed in greater detail herein, outwardly-projecting protruding members 320 on the plates (e.g., FIG. 9A) can help secure the plates to the adjacent surfaces of the upper and lower vertebral members of the subject being treated. This can advantageously provide one or more clinical benefits, such as, for example, the preservation of long-term implantation (e.g., reducing the likelihood of dislodgement or movements of the implant system within the target intervertebral space following implantation).
With continued reference to FIG. 3A, a system can include a guiding assembly 500 that can be strategically positioned along one of the lateral ends of the targeted intervertebral space. The guiding assembly 500 can include an alignment device 510 that may comprise one or more alignment components 514, 516. Regardless of its exact configuration and design, the alignment device 510 can advantageously permit a surgeon or other practitioner to accurately position the guiding assembly 500 for the subsequent delivery of an implant therethrough and between the base plates 300. As discussed in greater detail herein, the guiding assembly 500 can include upper and lower alignment members or slide members 514, 516, which are generally aligned with the upper and lower plates 300. In some embodiments, each alignment member 514, 516 can be configured to removably attach to the corresponding plate 300 to help advance and position the plates 300 within the targeted intervertebral space (e.g., minimally invasively). In some embodiments, the distal ends of the alignment members or slides 514, 516 can be configured to be slidably received within slots, recesses or other portions of the plates 300. Thus, the guiding assembly 500 can be temporarily coupled to the plates when the plates are being advanced into the intervertebral space and when the implant is subsequently delivered between the plates (e.g., as discussed in greater detail below). However, in some embodiments, once the implant 200 has been properly advanced between the plates and the implant system has been adequately secured between the adjacent vertebrae, the alignment members or slides 514, 516 can be easily retracted (e.g., rearwardly or proximally) relative to the plates and implant for removal from the subject's anatomy and completion of the fusion procedure.
With continued reference to FIG. 3A, the alignment members or components 514, 516 and/or one or more other portions or components of the assembly can include a flange or other abutment or securement portion 518. Such a flange 518 can be fixedly or movable positioned along the adjacent vertebrae 10, 12 of the subject to ensure proper alignment into the targeted intervertebral space. In other arrangements, as noted herein, the alignment members and other components of the guiding assembly are configured to completely decouple from the plates and the implant after implant has been properly delivered into the target intervertebral space.
As illustrated in FIG. 4, an implant 200 can be delivered between the plates 300 and into the intervertebral space using a mechanical advancement device. Therefore, in some embodiments, the guiding assembly 500 can advantageously comprise a mechanical advancement device or feature. For example, in FIG. 4, the guiding assembly comprises a threaded delivery portion that is configured to advance an implant 200 between the base plate members 310, 314 by turning a rotatable handle or other advancement tool. As a user rotates the handle 520, a rod 522 or other actuator is moved forwardly (e.g., distally) in the direction of the implant 200. The implant 200 can be directly or indirectly coupled to the actuator 522 via one or more coupling or other detachable connections 526, as desired or required. As the rod is advanced distally, the implant (e.g., lateral cage) can be guided between the base plate members 310, 314 and into the intervertebral space. Consequently, the base plate members 310, 314 separate and are urged toward the adjacent endplates of the vertebrae. In some embodiments, as illustrated schematically in FIG. 4, the implant can include a taper (e.g., bullet design) along its distal end to facilitate initial entry and subsequent distraction and separation of the base plate 300.
In other embodiments, one or more other devices can be used to help advance the implant between the plates. For example, a pneumatic tool (e.g., air or liquid driven tool) can be used to apply the required force on the implant to move it into position. Any other type of user-assisting device or system can be used to help advance the implant between the plates, such as, for example, other types of mechanical devices, electromechanical devices, motorized devices, pumps and/or the like.
With continued reference to FIG. 4, the guiding assembly 500 can include one or more structures 510 that help ensure that the implant stays within the guiding assembly 500 and maintains its alignment with the intervertebral space during advancement between the plates. Such structure 510 can, for example, help reduce any deflection or misdirection of the implant's leading end during distal delivery to the intervertebral space, especially when relatively high forces are being exerted on the implant (e.g., that may otherwise cause the implant to move out of alignment with the base plates). In some embodiments, the implant 200, the base plates 300 and/or any other portion of the system can include rails or other alignment features that further help maintain a proper alignment of the implant during advancement between a subject's vertebrae. As discussed in greater detail herein, the guiding assembly can include alignment members (e.g., slides) 514, 516 that removably secure to the plates 300 and provide a reliable and predictable path for advancement of the implant within the intervertebral space. In some embodiments, such slides 514, 516 can be subsequently removed and decoupled or separated (e.g., slidably, mechanically, etc.) from the plates 300.
FIGS. 5A-5C illustrate various views of a different embodiment of a system comprising base plates 300 for receiving a spinal implant. As shown, an alignment device 510′ can be positioned relative to one or more of the adjacent vertebrae 10, 12 and subsequently secured thereto using additional fasteners or other connection devices or methods. For example, one or more screws S or other fasteners can be used to secure one or more portions of the alignment device to the upper and/or lower vertebral members of the subject. In some embodiments, the alignment devices 510′ comprise one or more flanges or plates P through which the screws S or other fasteners can be placed. Once the alignment device 510′ has been secured to the subject, the implant can be delivered between the base plate members 310, 314. The alignment device 510′, base plate 300 and/or other portions of the system can be left in place after the implant has been secured between the subject's vertebrae. In other embodiments, however, one or more components of the system (e.g., base plate 300, screws, etc.) can be left in place after implantation, and in some instances, may help reinforce or otherwise benefit the treated area.
One embodiment of an implant 200 that can be used with the spinal fusion systems disclosed herein is illustrated in FIGS. 6A and 6B. As best shown in the top view of FIG. 6B, the implant 200 can include one or more open regions or chambers 210 for holding a grafting material. In addition, the implant can include one or more grooves 220 or other recesses along its anterior and/or posterior walls. In some embodiments, such grooves 220 or other features can align and mate with corresponding rails, protrusions or features of the base plate 300. Accordingly, the grooves, rails and/or other features can help safely, accurately and predictably move the implant 200 into the target intervertebral space (e.g., between adjacent base plate members). In other embodiments, however, the rail system between the implant 200 and the adjacent plates 300 can be reversed. For example, as illustrated in the embodiments of FIGS. 9A to 16, the implant can include one or more protruding or raised portions that generally align and correspond to grooves or recesses along the adjacent surfaces of the plates 300. Regardless of the exact orientation and design of the rail system, such a system can help ensure that an implant is accurately and safely delivered to a target intervertebral space.
In some embodiments, the implants disclosed herein comprise PEEK, titanium or other acceptable materials. For example, in some embodiments, the implant 200 comprises a metal edge plate or other surface or feature 226 through which one or more screws (not shown in FIGS. 6A and 6B) can be subsequently delivered to secure the implant 200 to one or more of the subject's vertebrae. In some arrangements, the plate 226, which can be positioned along the proximal end of the implant 200, comprises titanium or other acceptable metal or alloy and/or other rigid or semi-rigid material.
FIG. 7A illustrates a side view of one embodiment of a base plate 300 comprising upper and lower plate members 310, 314. As shown, the base plate members 310, 314 can include one or more protruding members 320. Such protruding members 320 can include tabs, bumps, spikes, teeth, grasping members, engagement members, other sharp, smooth and/or rounded features or members and/or the like. In some embodiments, the protruding members 310, 314 can be fixed (e.g., non-movable, non-deployable, etc.) and/or movable (e.g., selectively retractable, deployable, etc.). For example, in some embodiments, the protruding members 320 of the upper and/or lower plate members 310, 314 are deployable using a mechanical connection, a temperature change and/or using some other mechanism of action, device or method. In some embodiments, such protruding members 320 can help engage the plates 300 to the implant 200. In other embodiments, however, the protruding members 320 can be configured to reverse their orientation (e.g., in a direction away from the interior of the intervertebral space or toward the adjacent vertebral member) when the implant is advanced over the protruding members during implantation. Therefore, in some embodiments, as the implant is advanced between the plates 300, the protruding members 320 can deform or otherwise change orientation so as to engage the upper and lower vertebral members. This can provide positive engagement of the plates into the adjacent vertebrae, which may, in some circumstances, result in a more secure implantation of the system within the subject.
FIG. 7B illustrates a top view of one embodiment of an implant 200 that is configured to be used with the base plate 300 of FIG. 7A. Specifically, as shown, the implant 200 can include one or more grooves, holes, recesses or other openings 240 that are shaped, sized and otherwise configured to receive corresponding protruding members 320 of the base plate 300. As discussed in greater detail herein, in other arrangements (e.g., FIG. 9A), an implant 200 can include one or more protruding members or features that are sized, shaped and otherwise configured to engage and move within grooves or corresponding recesses of the adjacent plates 300.
With continued reference to FIG. 7B, the protruding members 320′ of the base plate 300 can include a curved leading edge to permit the groove 240 of the implant 200 to only temporarily engage the member 320′ as the implant is advanced into the target intervertebral space. Thus, the protruding members can sequentially engage and disengage a groove on the implant (e.g., in a ratcheting manner). In some embodiments, the implant can only be permitted to be advanced in one direction (e.g., distally). Such an embodiment can be helpful when using base plates 300 that have fixed protruding members 320. In embodiments comprising deployable protruding members, the need for such ratcheting system (e.g., that permits movement in at least one direction) may not be needed, as the protruding members 320 can be selectively deployed only when the implant is properly positioned between the base plate members.
In some embodiments, the use of protruding members and corresponding grooves or other recesses can help with guiding an implant 200 between adjacent base plate members (e.g. during delivery). Such embodiments can also assist in securely maintaining the implant in its implanted position following the delivery of the implant in the target intervertebral space.
As illustrated schematically in FIGS. 8A-8C, a lateral implant device in accordance with the various embodiments disclosed herein, can be delivered to the target intervertebral space minimally invasively (e.g., through one or more tissue dilators, cannulas or other openings). As discussed in greater detail herein, once the plates 300 have been properly positioned between the subject's vertebrae 10, 12, a guiding assembly 500 can be positioned through a dilator or other access device and in general alignment with the targeted intervertebral space. The implant can be advanced using a mechanical device (as illustrated in FIG. 8A), manually and/or using some other method or device. Further, the implant and base plate can include one or more features or members (e.g., rails, grooves, etc.) to assist in accurately moving the implant in the desired anatomical location of the subject's spine. Once the implant has been advanced between the base plate members 310, 314 and properly within the intervertebral space, the guiding assembly 500 can be removed.
With reference to FIG. 8B, in some embodiments, a screwdriver or other mechanical device 600 can be delivered through a dilator, cannula or other access device C to engage and advance one or more screws S or other fasteners through corresponding openings along the proximal end of the implant 200. In some embodiments, the use of such fasteners can assist with maintaining the position of the implant 200 relative to the subject's spine following implantation, as shown in FIG. 8C. The screws S can be routed through the implant, the base plate and/or the vertebra, as desired or required. However, in other embodiments, the use of screws S or other fasteners is not needed or required to maintain the implanted implant between the base plate members and the adjacent vertebrae. In some embodiments, a total of four fixation screws are positioned through the proximal end of the implanted implant (e.g., two above and two below). In some embodiments, the screws or other fasteners can be passed through openings of one or more plates or washers that at least partially cover or otherwise shield the intervertebral space, provide additional structural support and/or provide one or more other benefits or advantages. In other embodiments, more or fewer screws or other fasteners can be used, as desired or required.
In order to remove disk material, cartilage, endplate or other vertebral tissue and/or native tissue of a subject during an implantation procedure, a surgeon or other practitioner can use any of the rasping or other tissue cutting devices and methods disclosed in U.S. patent application Ser. No. 13/422,816, titled TRANSPEDICULAR ACCESS TO INTERVERTEBRAL SPACES AND RELATED SPINAL FUSION SYSTEMS AND METHODS, filed Mar. 16, 2012 and published as U.S. Publ. No. 2012/0265250 on Oct. 18, 2012, and U.S. Provisional Patent Application No. 61/783,839, titled DEVICES AND METHODS FOR TRANSPEDICULAR STABILIZATION OF THE SPINE and filed on Mar. 14, 2013, the entireties of both of which are hereby incorporated by reference herein and made a part of the present application.
FIGS. 9A-9D illustrate different views of another embodiment of a spinal fusion system 100. As discussed above with reference to other arrangements, the system 100 can include upper and lower plates 300 that are sized, shaped and otherwise configured to be positioned between the adjacent vertebral members V1, V2 where fusion is targeted. The system 100 further comprises a guiding assembly 500. In some embodiments, as discussed above, the alignment members (e.g., slides) 514, 516 of the guiding assembly 500 are configured to releasably secure or otherwise temporarily engage to or with the plates 300. Accordingly, the plate-slide assembly can be placed within the subject and advanced to the target intervertebral space. For example, in some embodiments, one or more distal portions of the alignment members or slides 514, 516 can releasably attach to and/or slide within adjacent portion(s) of the plates 300. In other embodiments, such as the system 100A illustrated in FIG. 14, one or both of the slides 514A, 516A comprise an extension portion 518A that extends into the targeted intervertebral space and provides a surface over which the implant can move when the implant is advanced in the vicinity of the vertebral members. The use of such extension portion 518A can help maintain the graft material within the interior chambers of the implant during advancement to the intervertebral space. Accordingly, the use of extension portions 518A or similar members or features can be advantageously incorporated into any implant system embodiments disclosed herein or equivalents thereof.
With continued reference to FIGS. 9A-9D, the system 100 can comprise a delivery device or feature 520 that can facilitate the surgeon or other practitioner with the advancement of the implant 200 through the guiding assembly and into the intervertebral space (e.g., between the plates 300). In some embodiments, the implant 200 is initially inserted at or near the proximal end of the guiding assembly 500, generally between the alignment members or slides 514, 516. Then, once the surgeon has advanced the guiding assembly 500, and in some configurations, the plates 300 and the implant 200 to which the assembly 500 is engaged, through the subject's anatomy (e.g., through an access device), the surgeon can begin to move the implant distally by manipulating the handle or other portion of the guiding assembly.
For example, with reference to the side view of FIG. 9B, by turning the handle 522 of the guiding assembly 500, the threaded rod 526 can move relative to a housing 528. Such manipulation of the handle 522 can result in moving the distal end 524 of the rod 526 forwardly (e.g., distally) so as to engage the implant 200 positioned between the slides 514, 516 and exert a force on the implant 200. In some embodiments, the distal end 524 of the rod comprises a coupling or other blunt member or feature that can help avoid damage to the adjacent portion of the implant 200 during the advancement process.
As illustrated in FIG. 9A, as the implant is advanced distally within the interior of the guiding assembly 500 (e.g., between the upper and lower slides or alignment members 514, 516), the distal end of the implant 200 will reach the proximal end of the plates 300 that have been positioned within the intervertebral space. With continued advancement of the implant 200 in the distal direction (e.g., as schematically represented by arrow 50 in FIG. 9C), the implant 200 will move between the upper and lower plates 300, causing the plates 300 to separate apart from each other, in certain arrangements. In some configurations, the implant 200 is moved far enough distally between plates 200 so that is spans across an entire length or substantially an entire length of the plates 300.
FIGS. 10A and 10B illustrate one embodiment of an implant 200 that is configured to be used with one or more of the fusion systems disclosed herein, including the system 100 of FIGS. 9A-9D. As shown, the implant 200 can include one or more internal chambers 210. Such chambers 210 can be sized, shaped and otherwise configured to be at least partially filled with graft material (not shown) before the implant 200 is advanced between the plates 300. As noted above, the implant 200 can comprise one or more materials, such as, for example, PEEK, titanium, other metals or alloys, other polymeric materials and/or the like.
With continued reference to FIGS. 10A and 10B, the implant 200 can include one or more protrusions, ridges or similar members or features 220 that extend at least partially along one or more surfaces of the implant 200. In some embodiments, such protrusions 220 can be sized, shaped and otherwise configured to be moved relative to corresponding grooves or recesses of the upper and lower plates 300 and/or the upper and lower slides or alignment members 514, 516 of the guiding assembly 500. For example, as shown in the embodiment of FIG. 11, the upper plate and/or the lower plate 300 can include one or more grooves or recesses 320 that are configured to receive the protrusions 220 of the implant 200 when the implant is properly positioned within the guiding assembly 500 and between the plates 300. Although not illustrated in the view of FIG. 11, the grooves or recesses 320 can extend proximal to the plates 300 and be present, either continuously or intermittently along at least a portion of the slides 514, 516 of the guiding assembly 500. Thus, the implant 200 can be predictably moved between the slides 514, 516 and the plates 300 to properly, safely and securely position the implant 200 within a targeted intervertebral space.
In the embodiments illustrated herein, the guiding assembly 500 and the plates 300 are generally straight, and the path that the implant follows through the guiding assembly 500 is generally linear. However, in other embodiments, the grooves or recesses of the guiding assembly and/or the plates (and thus, the corresponding protruding members or features of the implant 200), or vice versa, can be at least partially curved, so that the implant is moved along a non-linear pathway. In some embodiments, the non-linear pathway can comprise a continuous curve (e.g., with a constant or variable diameter along the length of the curve). However, in other arrangements, the curve or turn is more abrupt (e.g., piecemeal turn or short radius turn) so as to avoid a longer, sweeping turning radius. Such embodiments can be helpful with certain MIS approaches where an implant needs to be maneuvered more carefully and precisely around sensitive nerve structures, such as, for example, in a TLIF procedure.
In the embodiments of a “rail” system illustrated in FIGS. 10A, 10B and 11 herein, and discussed in greater detail above, the implant comprises generally smooth outer surfaces (e.g., does not comprises teeth or other engagement features). Since the implant will not directly contact or engage the adjacent surfaces of the vertebral members, the need for teeth, other protruding members and/or other roughened surface features may not be necessary. This can advantageously simplify the design, manufacturability, cost and other aspects of the implant.
In the illustrated embodiments, the implant includes generally rounded protruding members or features 220 along both of its lateral ends and along both its upper and lower surfaces. Further, the protruding features 220 are generally continuous along an entire length of the implant 200. However, in other embodiments, the implant 200 can include more or fewer protruding features 220. The protruding features 220 can include any desired cross-sectional shape or configuration (e.g., rounded, circular, oval, rectangular, triangular, other polygonal, irregular, etc.), as desired or required. Further, the protruding features 220 can extend only partially or intermittently along one or both surfaces of the implant 200. Thus, the total number of protruding members 220 (e.g., and thus, corresponding grooves or recesses in the plates 300 and guiding assembly 500) can be less or more than four (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, more than 10, etc.), as desired or required. For example, in some arrangements, the protruding members 220 are included only the top or the bottom of the implant 200.
According to some embodiments, as illustrated in FIG. 11, the grooves or recesses 320 of the plates 300 can include one or more deployable teeth, spikes or other engagement features 322. For example, in one embodiment, the teeth or other features 322 are configured to be pushed through the bottom of the corresponding groove or recess 320, at least partially, when the protruding member or feature 220 of the implant 200 is moved over such teeth or features 322. Thus, the teeth, spikes or other engagement features 322 can be sequentially deployed away from the implant and toward the adjacent vertebral member. In some embodiments, the teeth or other engagement features 322 are deployed within the native tissue of the vertebral member to help secure the plates within the target intervertebral space during and after implantation. One schematic embodiment of an implant 200 that has passed within upper and lower plates 300 and has caused a number of teeth, spikes or other engagement features 322 to deploy away from the implant 200 is illustrated in FIG. 12.
As discussed in greater detail herein, after the implant 200 has been properly positioned between the plates 300 of the system, one or more screws or other fasteners can be used to further strengthen and reinforce the system. For example, as illustrated in FIG. 13, upper and lower screws S can be positioned through one or both of the plates 300 and/or the implant 200. Such screws can be advanced through one or more cortical structures of the adjacent vertebral members of the subject to provide additional strength and support to the fusion system. In some embodiments, one or more washers, plates or other rigid or semi-rigid members P can also be used in conjunction with the screws or other fasteners S. For example, the plate or other member P can include one or more holes or other openings that are sized, shaped, oriented and/or otherwise configured to secure a screw or other fastener therethrough, as desired or required. In some embodiments, the plate P is sized, shaped and configured to be flush or substantially flush with adjacent surfaces of the upper and lower vertebrae.
As illustrated schematically in FIG. 15, for any of the embodiments disclosed herein, the spinal fusion system can include components that have a closed or open structure. For example, as depicted in FIG. 15, the implant 200 a can include a closed structure, such as, e.g., a closed circular, oval, rectangular and/or other shape. In alternative embodiments, however, the implant 200 b, can include at least a partially open structure (e.g., wherein one or more or ends or portions of the implant, plates and/or other components of the system) are open or otherwise do not form a closed loop or structure. Likewise, as noted above, the adjacent plates that are configured to be positioned on either side of the implant (e.g., top and bottom plates) can either include an open or closed structure, as desired or required. Thus, in some embodiments, a closed configuration can be used to help maintain graft material that is provided within an interior chamber or space of the implant. Such configurations can assist with fusion between adjacent endplates of vertebral members, as graft material is contained within an interior portion of the corresponding implant, irrespective of the type of implant that is used (e.g., LLIF or other lateral, TLIF, anterior, posterior, etc.).
According to some embodiments, as illustrated, for example, in FIGS. 16 to 19, the deployable protruding members 1320 (e.g., spikes, teeth, nubs, anchors, etc.) positioned on the upper and lower plates 1300 can be placed in on two or more rows on either lateral end of the implant 1200 and/or are staggered (e.g., longitudinally and/or laterally), as desired or required. As shown, such deployable protruding members 1320 can be placed on the top and/or the bottom of the implant. For example, as depicted in the illustrated embodiments, each lateral end of the plate 1300 (e.g., along one or more both ends of the implant, i.e., the upper end and/or the lower end) can include two rows of protruding members 1320. Such protruding members 1320 in adjacent rows can be aligned or not aligned relative to each other. Although the depicted arrangements show a total of two rows of protruding members 1320 on each lateral end of the system, fewer rows (e.g., a single row) or additional rows (e.g., 3, 4, 5 rows, more than 5 rows, etc.) can be included on one or both sides of the plates 1300, as desired or required. Further, in some embodiments, the protruding members (e.g., spikes, teeth, nubs, anchors, etc.) 1320 are positioned in one or more additional or different rows than illustrated herein. For example, such protruding members along one or more rows or portions located or oriented along or near a longitudinal centerline of the plates 1320 and/or implant 1200.
As discussed with respect to several embodiments disclosed herein, and as illustrated in, e.g., FIG. 17, the system can be delivered to the desired intervertebral space (e.g., between two adjacent vertebrae of a subject) with the assistance of a guiding assembly 500. In some embodiments, the guiding assembly 500 comprises one or more alignment components 514, 516 (e.g. upper and lower alignment components or members). In some arrangements, as depicted in FIG. 17, the alignment members 514, 516 are configured to engage, at least partially, corresponding upper and/or lower plates or other members or components 1300 of the spinal fusion system. For example, the distal ends 515, 517 (e.g., insertion or guiding members) of the alignment members 514, 516 can be sized, shaped and/or otherwise designed and configured to slide or otherwise be positioned within corresponding features (e.g., openings, recesses, grooves, etc.) of the upper and/or lower plates 1300. After the implant 1200 has been properly positioned within (e.g., between) the adjacent plates or other members 1300, such alignment members 514, 516 can be retracted or otherwise removed relative to the alignment members to leave the spinal fusion system within the desired intervertebral space, as desired or required by a particular application or use. In some embodiments, the distal portions or ends 515, 517 of the alignment members 515, 517 are sized, shaped and/or otherwise configured to slide or otherwise be positioned within corresponding portions or features (e.g., grooves, slots, etc.) of the corresponding plate members 1300 of the system. Thus, in some embodiments, the guiding assembly and its components can be properly and predictably positioned relative to the plates and/or other components or portions of the spinal implant system.
With reference to FIG. 18, as discussed in greater detail with respect to several embodiments herein, the implant 1200 comprises features 1202 that are sized, shaped and otherwise configured to engage and mate with corresponding features (e.g., recesses) of the upper and lower plates 1300 of the fusion system. Thus, the implant 1200 can be advanced relative to the upper and lower plates 1300 to create the desired expansion or distraction between the subject's vertebral members located on either side of the plates 1300. In addition, in accordance with the various embodiments disclosed herein, the protruding features (e.g., prongs, teeth, anchors, etc.) 1322 a, 1322 b on the plates 1300 can be deployed to advantageously extend and engage at a portion of the adjacent vertebral tissue of the subject (e.g., endplate of the adjacent vertebral member). Although the protruding members 1322 in the illustrated embodiment are in two different planes on each side of the system, as discussed herein, each side of the system can include fewer rows (e.g., a single row) or more rows (e.g., 3, 4, 5 rows, more than 5 rows, etc.), as desired or required. As discussed herein, the use of the upper and lower plates 1300 and a central implant 1200 can help provide for a more predictable, safe and consistent delivery, and thus implantation of a system and distraction of adjacent vertebral members.
In some embodiments, as illustrated in FIG. 18, upper and/or lower portions of the implant 1202 can be shaped, sized and/or otherwise configured to slide within corresponding portions of the upper and/or lower plates 1300. In such arrangements, a locking mechanism or feature is created to prevent or reduce the likelihood of vertical movement between the implant 1200 and the adjacent plates 1300 once the implant has properly been positioned relative to the plate(s) 1300.
According to some embodiments, the distal end(s) or portion(s) of the implant 1200 is/are configured to positively engage corresponding features of the upper and/or lower plates 1300 of the implant system. For example, in some embodiments, the implant comprises a protruding and/or recessed portion that clicks or otherwise positively (e.g., lockingly) engages corresponding portions of the adjacent lower and/or upper plates 1300. Thus, a surgeon or other user of the system can know with the necessary or desired degree of certainty that the implant 1200 has been properly and adequately advanced relative to the plates. In some embodiments, the engagement between the implant 1200 and the adjacent plate(s) 1300 includes a tactical and/or audible confirmation (e.g., click or other confirmation of engagement and proper advancement of the implant). Thus, the surgeon or other use can know with a requisite degree of certainty when the implant has been properly moved relative to the plates and/or other members or components of the fusion system. As shown, as discussed with reference to other arrangements herein, the implant 1200 can urge one or more protruding member 1322 of the adjacent plates 1300 outwardly (e.g., upwardly or downwardly, toward and/or at least partially through the endplates of the adjacent vertebral members of the subject) to engage the protruding members (e.g., prongs, teeth, anchors, etc.) of the plates 1300 to the native tissue (e.g., endplate tissue) of the subject, thereby fixating the implant system to the subject and promoting fusion (e.g., over an extended time period by virtue of the bone graft material of the implant).
FIGS. 20 and 21 illustrate one embodiment of an implant being advanced between adjacent (e.g., upper and lower) plates 1300 of a spinal fusion system. As shown, as the implant 1200 is advanced further between the plates 1300, the protruding members 1322 of the plates 1300 are deployed and extended toward the adjacent endplates of the subject's vertebral members.
For any of the embodiments disclosed herein, the upper and/or lower surfaces of the plates 300, 1300 (e.g., the surfaces that are at least in partial contact with the vertebral endplate surfaces of the subject) can be textured to promote fusion. For example, such surfaces can include a porous, roughened, undulating and/or other features or texture, as desired or required. As a result, according to some arrangements, such plate surfaces can attract bone cells and/or tissue and help further secure and/or otherwise fuse the system to the adjacent native tissue (e.g., vertebral endplate tissue) of the subject. In some embodiments, such surfaces can be bead-blasted or otherwise textured after formation. In alternative embodiments, the surfaces can be initially formed with a desired texture or other pattern. For example, the surfaces of the plates 1300 can be formed using plasma pour (e.g., Titanium plasma pour) or other molding or forming technique and/or any other manufacturing method.
Further, in some embodiments, the system (e.g., the plates 1300, the implant 1200 and/or any other component) can include one or more keels and/or other positive engagement features that help secure the system to the anatomy of the subject, irrespective of any engagement features 1322 used on the upper and/or lower plates 1300). For example, as illustrated in FIG. 22, the upper and/or lower plates 1300 of the fusion system can include one or more keels or other extension members 1350 that are configured to at least partially cut into and/or otherwise extend into the adjacent vertebral members upon implantation. Such features can help (e.g., in addition to and/or in lieu of the protruding members of the plates 1300) to secure the fusion system within a subject, as desired or required. In some embodiments, the ends and/or other portions of the keels and/or other extension members 1350 can be at least partially sharp and/or otherwise configured for easier penetration and/or engagement with the subject's native tissue. Although the illustrated embodiment illustrated only a single such keel or other extension members 1350 per plate, additional members 1350 can be included on either or both of the plates of the system, as desired or required for a particular application or use.
According to some embodiments, the protruding members (e.g., teeth, prongs, anchors, etc.) and/or the keels or other extension members 1350 of the plates can include a fish-hook design so at to positively engage the endplates and/or other native tissue of the subject and to prevent or reduce the likelihood of pull-out, pull-through or release after tissue engagement. Thus, in some embodiments, the protruding members and/or other extension members of the plates 1300 comprise one or more barbed portions with an angled design. For example, in some arrangements, such engagement features or members comprise a fish-hook design, one or more reverse tapered or ratcheting surfaces and/or the like. In other embodiments, the protruding members, other extension members and/or other members/features of the system comprise anchors (e.g., Mitek-type anchors, other bone and/or tissue anchors, other tissue fixation members, suture-based systems, other locking members, etc.).
FIGS. 24A and 24B illustrate different perspective views of a spinal fusion system similar to other embodiments disclosed herein. As shown, the system can include an implant 2200 and adjacent upper and lower plates (e.g., endplates) 2300. As noted herein with respect to other arrangements, the upper and lower plates 2300 are configured to contact and securely engage upper and lower surfaces of the implant 2200 after implantation (e.g., within a targeted intervertebral space of a subject).
As with any other embodiments disclosed herein, the implant can comprise PEEK, any other thermoplastic, one or more metals or alloys (e.g., titanium, stainless steel, etc.) and/or any other material, as desired or required. Similarly, any of the plate (e.g., endplate) embodiments disclosed herein can comprise PEEK, any other thermoplastic, one or more metals or alloys (e.g., titanium, stainless steel, etc.) and/or any other material.
As with other embodiments disclosed herein, the implant 2200 can be shaped, sized and otherwise configured to be predictably, securely and/or non-intrusively moved relative to the adjacent plates (e.g., endplates) 2300. As discussed in greater detail herein, this can be accomplished with the assistance of a guiding assembly (see, e.g., FIGS. 28, 29 and 31A-31B). Such as guiding assembly 500 can provide a predictable pathway and guiding mechanism for moving the implant to the target intervertebral space and eventually between the adjacent plates 2300.
Accordingly, the implant and adjacent plates for any of the spinal fusion systems disclosed herein, or equivalents thereof, can include certain features, components, design elements and/or the like to facilitate engagement of the various fusion system components to one another and/or the adjacent anatomy of the subject into which the system is being used. For example, the implant 2200 and/or the plates 2300 can be configured to lockingly (e.g., releasably or non-releasably) engage one another when the implant is positioned between the plates. Further, alignment components of a guiding assembly can be configured to secure to and/or release from a plate (e.g., an endplate) prior to and/or following delivery of the implant within the targeted anatomical space. In view of the foregoing, reference will be made to certain features illustrated in the embodiment of FIGS. 24A-24B and 25A-25F.
As discussed herein, the various spinal fusion systems and the various components and subcomponents thereof (e.g., spinal implant, adjacent endplates, guiding assemblies used to deliver various components within subjects, etc.) can be sized, shaped and/or otherwise configured for use with any approach or implant type, including, without limitation, anterior (ALIF) (e.g., open, mini-open retroperitoneal, etc.), lateral (e.g., costotranversectomy, extreme lateral, LLIF, etc.), posterolateral (e.g., posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), etc.), axial (e.g., axial lumbar interbody fusion), expandable and/or the like.
FIG. 28 illustrates one embodiment, in perspective view, of a fusion system that include an implant 2200, adjacent plates (e.g., endplates) 2300 and a guiding assembly 500. As shown in FIG. 28 and discussed in greater detail herein, the guiding assembly 500 can comprise upper and lower alignment members 514, 516. Each alignment member 514, 516 can include a distal end 515 that is sized, shaped and configured to slide within a corresponding portion of an adjacent plate (e.g., endplate) 2300. In some embodiments, at least a portion of one or more alignment members 514, 516 (e.g., the distal end 515 of the alignment member) is adapted to releasably secure to the plate 2300. Such a configuration can help ensure that the guiding assembly 500 remain properly aligned with the plates 2300 to reliably and securely deliver the implant 2200 between the plates 2300. Once the implant 2200 has been delivered between the adjacent plates (e.g., endplates) 2300, the alignment members 514, 516 can be configured to automatically release from the plates 2300 for removal from the subject's anatomy. Additional details regarding the manner in which the alignment members 514, 516 can secure to and/or release from the endplates 2300 is provided below.
FIGS. 29 and 30 illustrate an alignment member (e.g., lower alignment member) 516 and a plate (e.g., bottom endplate) 2300, respectively, that are designed to releasably secure to one another. The features included in the depicted embodiments can be incorporated into any of the guiding assemblies, endplates, implants and/or other components of a fusion system discussed herein. The guiding assembly 500 can comprise an alignment member 516 a proximal portion 519 and a distal portion 517 extending therefrom.
The distal portion 517 of the alignment member 516 can be tapered. In some arrangements, this can permit the distal portion 517 of the alignment member 516 to be positioned between a corresponding recess of the endplate 2300. Further, in some embodiments, the proximal portion 519 can be shaped, sized and configured to match and/or align with the adjacent endplate 2300 (e.g., with respect to cross-sectional shape) once the alignment member has been positioned relative to the endplate.
With continued reference to FIG. 29, the distal portion 517 of the alignment member 516 can include an engagement member or feature 530 that is configured to secure to a corresponding receiving member or feature 2350 of the endplate 2300 into which the alignment member 516 is advanced. One embodiment of an engagement member or feature 530 of the distal portion 517 of the alignment member 516 is shown in greater detail in FIG. 31A below. In some embodiments, the distal portion 517 of the alignment member 516 comprises one or more flanges or protrusions 520 (e.g., along one or both ends of the distal portion 517) that are sized, shaped and configured to slide into and be received within corresponding grooves or recesses 2340 of the plate 2300 (e.g., along one or more both interior surfaces of the plate). Thus, the use of such a sliding mechanism using protrusions 520 and corresponding recesses 2340 can help ensure that the distal portion 517 of the alignment member 516 is properly advanced within the central opening of the endplate 2300.
With reference to FIG. 31A, the engagement member 530 of the alignment member 516 can comprise a tab or finger 532 that is positioned along a proximal end of the distal member 517. In some embodiments, the engagement member 530 is resiliently biased such that it can flex inwardly (e.g., toward an interior space or cavity 531) when a force is directed to the outside of the tab 532. The tab 532 can include a sloped exterior surface 533 that is configured to be contacted by the endplate 2300 when the distal portion 517 of the alignment member 516 is advanced sufficiently far within the central opening of the endplate. Thus, an adjacent surface of the endplate 2300 (e.g., along an interior of the central opening) can contact the sloped surface 533 of the tab 532 and urge the tab 532 inwardly (e.g., toward the interior space 531 of the engagement member 530). In some embodiments, therefore, the exterior surface of the tab 532 can move from its normal location (e.g., along dashed line 536) to an interior location (e.g., along dashed line 534).
With continued reference to FIG. 30, once the distal end 517 of the alignment member 516 is moved within the central opening of the endplate 2300, the compressed tab 532 of the engagement member 530 is released outwardly within the receiving member or feature 2350 of the endplate 2300 and assumes its normal, extended orientation. As a result, the alignment member 516 engages the endplate 2300, thereby preventing the alignment member 516 to be separated from the adjacent endplate. As shown in FIG. 30, the receiving member 2350 includes a ridge 2351 that helps prevent retraction (e.g., in the lateral direction) of the alignment member 516 relative to the endplate 2300.
In some embodiments, an upper alignment member 514 is secured or coupled to an upper plate (e.g., endplate) 2300, and a lower alignment member 516 is secured or coupled to a lower plate (e.g., endplate) 2300. Once the alignment members 514, 516 are coupled to the endplates 2300, the two coupled assemblies can be placed adjacent to one another and advanced within the subject's anatomy so that the plates are positioned within the targeted intervertebral space. The implant can then be delivered between the alignment members 514, 516 of the guiding assembly 500 until it is finally moved between the endplates and implanted within the targeted intervertebral space to promote fusion. The size of the final assembly (e.g., an assembly that includes both the implant 2200 and the adjacent endplates 2300) can be selected based, at least in part, on the desired vertical spacing that is desired or required within a specific intervertebral space into which the assembly will be inserted. For example, as discussed in greater detail herein, the implant and endplates can be selected to create and/or maintain a certain distraction or clearance between the adjacent vertebrae. As noted herein, delivering the implant within an intervertebral space provides certain benefits and advantages over prior fusion systems and methods. For example, the need to forcibly advance into the subject is eliminated (e.g., thereby preventing or reducing the likelihood of damage to the subject's vertebral members and other native tissues). Further, the embodiments disclosed herein allow for the implant to be delivered into the targeted location in a more precise, accurate and predictable manner.
Relatedly, the predicable and non-abrupt manner in which the implant is delivered between adjacent plates (e.g., endplates) within the target intervertebral space can help ensure that any grafting material that is originally positioned within an interior portion (e.g., the central cavity) of the implant does not unintentionally escape before final implantation. For example, the structural configuration of the alignment members of the guiding assembly and the endplates helps ensure that the graft materials remains within the interior of the implant during and after delivery to the target portion of the subject's anatomy. Further, the non-abrupt manner (e.g., moving the implant along rails or recesses of the adjacent alignment members and/or the endplates) without the need to use an impacting force or jolt (e.g., as caused by a slap hammer) can further ensure that any grafting material placed within one or more interior cavities of the implant prior to implantation will essentially remain within such interior cavities after advancement of the implant to the desired intervertebral space or other anatomical location.
With continued reference to FIG. 29, and as discussed in greater detail in relation to other arrangements herein, the implant can be moved within the guiding assembly 500 (e.g., between upper and lower alignment members 514, 516) and the endplates 2300 for delivery and final implantation within a subject's intervertebral space. In some embodiments, the alignment members 514, 516 and the adjacent endplates 2300 (to which the alignment members can be releasably secured) comprises grooves, recesses, rails and/or other guiding members or features 540, 2310. In some configurations, such features 540, 2310 of the alignment members and the endplates are aligned to be continuous or generally continuous when the alignments members are coupled to the endplates.
As shown in FIGS. 24B and 26, the implant 2200 can include upper and lower protruding members or features 2202 that are shaped, sized and otherwise configured to fit within and move adjacent to the grooves, recesses, rails and/or other guiding members or features 540, 2310 of the alignment members 514, 516 and the endplates 2300. This can help ensure that the implant will maintain proper alignment with the guiding assembly 500 and the endplates, which have been positioned at the targeted intervertebral space, during delivery. As a result, undesirable or inadvertent lateral movement of the implant to a location within the subject's anatomy can be eliminated. In several illustrated embodiments, the implant includes two protruding members or features 2202 along both its top and bottom surfaces. However, in other configurations, any of the embodiments disclosed herein can be modified to include such members or features 2202 only along the top or bottom of the implant, as desired or required. Further, the number, shape, spacing, orientation and/or other properties or details of the protruding members or features 2202 can be different than disclosed herein. For example, in some embodiments, the members or features 2202 along the implant can be recessed relative to adjacent exterior surfaces of the implant. In such a configuration, the alignment members of the guiding assembly and the endplates can be differently designed so that they include protruding members or features that are shaped, sized and otherwise configured to engage the recessed members or features 2202 of the implant.
With continued reference to FIGS. 24A-24B, 25A-25F, 26 and 27A-27B, the implant 2200, 2200′ and the adjacent endplates 2300, 2300′ can comprise corresponding locking members or features that help ensure that the implant is lockingly (e.g., at least releasably lockingly) secured to the endplates when advanced sufficiently far between the endplates. For example, as shown in FIG. 30, the endplate 2300 can include a locking feature or member 2308 along one of its lateral sides. Complimentary, as best shown in FIG. 26, the implant 2200 can include a corresponding locking feature or member 2208 that is sized, shaped and otherwise configured to engage and at least temporarily or releasably lock or secure to the feature or member 2308 of the endplate 2300. In the illustrated arrangement, the implant 2200 comprises a cavity below or adjacent the locking feature or member 2208 to permit the locking feature or member 2208 to at least partially flex or otherwise move in order to engage with and secure to the corresponding feature or member 2308 of the adjacent endplate 2300. Such a configuration can help ensure that, once the implant 2200 has been advanced sufficiently far relative to the guiding assembly 500 and the endplates 2300, the position of the implant can be securely maintained relative to the endplates and the targeted intervertebral space. If needed, in some embodiments, a tool can be used to disengage the locking member or feature 2208 of the implant 2200 relative to the locking member or feature 2308 of corresponding endplates in order to remove and/or reposition the implant, as desired or required. For example, in some embodiments, a tool can be used to move the locking member or feature 2208 of the implant 2200 away (e.g., downwardly or upwardly) from the adjacent endplate 2300 to disengage the corresponding locking members or features, thereby permitted the implant to be retracted relative to the endplate.
In some embodiments, the upper and lower endplates 2300 that are positioned adjacent the implant 2200 can include an identical design. Thus, each endplate 2300 can comprise both a locking member or feature 2208 (e.g., along one side, to engage a corresponding feature or member of the endplate, as discussed above) and a receiving member or feature 2350 (e.g., along the other side, to engage a corresponding feature or member of the implant 2200). As a result, in some configurations, if identical plate designs are used for both the upper and lower endplates 2300, the locking members or features 2208 and the receiving members or features 2350 can be on opposite lateral ends for the upper and lower endplates 2300. Alternatively, the endplates can be designed such that the upper and lower endplates 2300 are not identical, and instead, have a mirrored configuration. This can result in having the locking members or features 2208 of the endplates 2300 both along one lateral side of the implant 2200 and the receiving member or features 2350 both on the opposite side of the implant 2200, as desired or required.
As shown and described herein, any of the disclosed embodiments can include one or more deployable protruding members 2322 (e.g., spikes, teeth, nubs, anchors, etc.) positioned on the upper and lower plates (e.g., endplates) 2300 can be placed along one or more rows on either lateral end of the implant 2200. Such deployable protruding members 2322 can be configured to be deployed or expanded away from the adjacent exterior surface of the endplate 2300. Deployment of such members 2320 can help engage the endplate, and thus the entire implant-endplate assembly, to the adjacent native tissue (e.g., endplates or the portion of the vertebrae). As shown in FIGS. 24A-24B, 25A-25F, 26 and 27, the protruding members 2320 can be adapted to move through corresponding openings 2320 of the endplates 2320. The protruding members 2320 can comprise one or more rigid or semi-rigid materials, such as, for example, metal or alloy (e.g., nitinol or other shape memory material, titanium, stainless steel, etc.), thermoplastic (e.g., PEEK) and/or the like. As noted, any of the embodiments disclosed herein or equivalents thereof can include one or more (e.g., 2, 3, 4, more than 4, etc.) rows of openings 2320 (e.g., and protruding members 2320 configured to extend therethrough), as desired or required.
As shown in FIG. 31B, at least a portion of the tab 532 of the engagement member or feature 530 of the distal end 517 of the alignment member 516 can be raised relative to the adjacent surface of the alignment member (see, e.g., the difference in vertical prominence of the upper surface of the tab (e.g., generally aligned with dashed line 538) and the adjacent upper surface of the distal end 517 of the alignment member). Accordingly, the tab 532 can be configured to be downwardly and inwardly (e.g., toward the interior cavity 531) of the engagement member or feature 530 when the implant 2200 can be properly and securely positioned relative to the adjacent endplates 2300. In some embodiments, as a result, the implant 2200 can move the tab 532 into disengaging contact with the corresponding receiving member or feature 2350 of the endplate 2300. This can, in some arrangements, permit the alignment members 514, 516 to automatically (e.g., simultaneously) disengage from the adjacent endplates 2300, thereby allowing for the alignment members 514, 516, and thus the entire guiding assembly 500, to be separated from the endplates and removed from the subject's anatomy. As a result, the endplates 2300 and the implant 2200 can remain within the targeted intervertebral space to facilitate with the fusion of the adjacent vertebrae.
In addition, in accordance with the various embodiments disclosed herein, the protruding features (e.g., prongs, teeth, anchors, etc.) 2322 on the endplates 2300 can be deployed to advantageously extend and engage at a portion of the adjacent vertebral tissue of the subject (e.g., endplate of the adjacent vertebral member). Although the protruding members 2322 in the illustrated embodiment are in a single plane or axis on each side of the system, as discussed herein, each side of the system can include additional rows (e.g., 2, 3, 4, 5 rows, more than 5 rows, etc.), as desired or required. As discussed herein, the use of the upper and lower endplates 2300 and an implant 2200 can help provide for a more predictable, safe and consistent delivery, and thus implantation of a system and distraction of adjacent vertebral members.
As discussed in greater detail herein, after the implant 200, 1200, 2200 has been properly positioned between the plates 300, 1300, 2300 (e.g., endplates) of the system, one or more screws or other fasteners can be used to further strengthen and reinforce the system. For example, as illustrated in FIG. 32, upper and lower screws S can be positioned through openings O of one or both of the plates 300, 1300, 2300 and/or the implant 200, 1200, 2200. Such screws can be advanced through one or more cortical structures of the adjacent vertebral members of the subject to provide additional strength and support to the fusion system. In some embodiments, one or more washers, plates or other rigid or semi-rigid members P can also be used in conjunction with the screws or other fasteners S. For example, the plate or other member P can include one or more holes or other openings that are sized, shaped, oriented and/or otherwise configured to secure a screw or other fastener therethrough, as desired or required. In some embodiments, the plate P is sized, shaped and configured to be flush or substantially flush with adjacent surfaces of the upper and lower vertebrae.
As discussed in greater detail herein, any of the embodiments disclosed herein can be modified or otherwise designed to be used along any portion of the spine. For example, the implants, plates (e.g., endplates), guiding assembly and/or any other component or feature can be adapted for use for a thoracic, cervical, lumbar or sacral implant, approach or treatment, as desired or required. Further, any of the embodiments disclosed herein can be modified for use as vertebral body replacement (corpectomy or other procedure involving the removing of all or a part of a vertebral body) and/or any similar or related spinal fusion technique, procedure or technology. Further, although the various devices, systems and/or methods described herein have specific applicability to the spine and spinal fusion procedures, such embodiments can be used (e.g., in the disclosed form or a modified form) for the delivery of any other member between adjacent plates, either within a subject or in another context, as desired or required.
According to some embodiments, the height of the protruding members (e.g., barbs, anchors, tabs, etc.) 322, 1322, 2322 and/or other keels or extension members or features of the plates 300, 1300, 2300 can comprise a height of about 1 to 5 mm (e.g., 1-1.1, 1.1-1.2, 1.2-1.3, 1.3-1.4, 1.4-1.5, 1.5-1.6, 1.6-1.7, 1.7-.1.8, 1.8-1.9, 1.9-2, 2-2.5, 2.5-3, 3-4, 4-5 mm, heights between the foregoing, etc.). In other embodiments, the height of such members or features can be less than 1 mm (e.g., 0-0.1. 0.1-0.2, 0.2-0.3, 0.3-0.4, 0.4-0.5, 0.5-0.6, 0.6-0.7, 0.7-0.8, 0.8-0.9, 0.9-1 mm, values between the foregoing, etc.) or greater than 5 mm (e.g., 5-6, 6-7, 7-8. 8-9. 9-10 mm, values between the foregoing, greater than 10 mm, etc.), as desired or required. In any of the embodiments disclosed herein, the protruding members 322, 1322, 2322 can comprise Mitek-type anchors and/or similar members or features.
For any of the fusion system arrangements disclosed herein, the implant 200, 1200, 2200 can be rigid or movable. For example, in some embodiments, the implant portion 200, 1200, 2200 of the system can include a mechanical portion that is configured to articulate, bend and/or otherwise move, as desired or required.
In some embodiments, the deployment and/or engagement features described herein with respect to the plates and/or implants of spinal fusion systems can be adapted for use with other orthopedic systems and/or applications. For example, one or more protruding members (e.g., barbs, anchors, keels, etc.) can be included in non-spinal systems and applications, such as intramedullary rods (IM rods), intramedullary nails (IM nails), inter-locking nails, total hip arthroplasty (THA), total knee arthroplasty (TKA) and/or the like. In such embodiments, the portion of the system or device that is configured to engage and/or fuse with native bone or other tissue of a subject can include one or more protruding portions or features to help fixate the device to the subject. One embodiment of an IM rod 2000 having a plurality of such deployable members or features 2010 is schematically illustrated in FIG. 23. In some embodiments, the rod 2000 and/or other orthopedic implant can include an opening through which a member can be placed to selectively expand or otherwise deploy the protruding members 2010 (e.g., through corresponding openings or slots 2004).
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.
Although several embodiments and examples are disclosed herein, the present application extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the inventions and modifications and equivalents thereof. It is also 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. 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 present inventions herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.
While the inventions are susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the inventions are not to be limited to the particular forms or methods disclosed, but, to the contrary, the inventions are to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods summarized above and set forth in further detail below describe certain actions taken by a practitioner; however, it should be understood that they can also include the instruction of those actions by another party. Thus, actions such as “advancing an implant” include “instructing advancing an implant.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers. For example, “about 10 mm” includes “10 mm.” Terms or phrases preceded by a term such as “substantially” include the recited term or phrase. For example, “substantially parallel” includes “parallel.”

Claims

What is claimed is:

1. A method of inserting an implant within an intervertebral space defined between an upper vertebral member and a lower vertebral member, the method comprising:

positioning an upper endplate and a lower endplate within the intervertebral space;

securing an alignment member of a guiding assembly to each of the upper endplate and the lower endplate, wherein the alignment member is configured to extend from the endplates to an anatomical location away from the endplates; and

advancing an implant between the alignment members and between the upper and lower endplates so that the implant is urged into the intervertebral space.

2. A spinal fusion system comprising:

an endplate system configured for placement within an intervertebral space of a subject, wherein the endplate system comprises an upper endplate and a lower endplate; and

an implant configured to be advanced and positioned between the upper endplate and the lower endplate to secure the implant within the intervertebral space;

wherein, when the implant is advanced between the upper endplate and the lower endplate, the upper endplates engage the upper vertebral member, and the lower endplate engages the lower vertebral member; and

wherein, upon advancement of the implant between the upper and lower endplates, the upper vertebral member is distracted relative to the lower vertebral member.