US20220000636A1 - Spinal implant system and method - Google Patents

Abstract

A spinal implant comprises an implant body extending between an anterior surface and a posterior surface, and including a first vertebral engaging surface and a second vertebral engaging surface. The implant body includes an inner surface that defines at least one opening oriented to implant a fastener oblique relative to a lateral axis of a subject body and adjacent an intervertebral space of the subject body. The implant body defining a cavity such that a surgical instrument is connectable with the implant body adjacent the cavity and movable relative to the implant body. Systems, surgical instruments and methods are disclosed.

Description

TECHNICAL FIELD
• The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a spinal implant system and a method for treating a spine.
BACKGROUND
• Spinal pathologies and disorders such as degenerative disc disease, disc herniation, spondylolisthesis, stenosis, osteoporosis, tumor, scoliosis and other curvature abnormalities, kyphosis and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.
• Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes fusion, fixation, correction, discectomy, microdiscectomy, corpectomy, decompression, laminectomy, laminotomy, foraminotomy, facetectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs, such as, for example, bone fasteners, spinal rods and interbody devices can be used to provide stability to a treated region. For example, during surgical treatment, surgical instruments can be used to deliver components of the spinal constructs to the surgical site for fixation with bone to immobilize a joint. Certain spinal surgery approaches utilize a direct lateral approach to access intervertebral spaces, however, these techniques present certain challenges due to the location of musculature and neural structures embedded therein. This disclosure describes an improvement over these prior technologies.
SUMMARY
• In one embodiment, a spinal implant comprises an implant body extending between an anterior surface and a posterior surface, and including a first vertebral engaging surface and a second vertebral engaging surface. The implant body includes an inner surface that defines at least one opening oriented to implant a fastener oblique relative to a lateral axis of a subject body and adjacent an intervertebral space of the subject body. The implant body defining a cavity such that a surgical instrument is connectable with the implant body adjacent the cavity and movable relative to the implant body. In some embodiments, systems, surgical instruments and methods are provided.
BRIEF DESCRIPTION OF THE DRAWINGS
• The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
• FIG. 1 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;
• FIG. 2 is a perspective view of the components shown inFIG. 1;
• FIG. 3 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;
• FIG. 4 is a perspective view of the components shown inFIG. 3;
• FIG. 5 is a side view of vertebrae;
• FIG. 6 is a side view of vertebrae;
• FIG. 7 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 8 is an axial view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 9 is an axial view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 10 is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 11 is a side view, in part phantom, of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 12 is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 13 is a plan view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 14 is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae;
• FIG. 15 is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae; and
• FIG. 16 is a side view, in part phantom, of components of one embodiment of a system in accordance with the principles of the present disclosure disposed with vertebrae.
DETAILED DESCRIPTION
• The exemplary embodiments of the surgical system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system for implant delivery to a surgical site and a method for treating a spine. In some embodiments, the systems and methods of the present disclosure employ an oblique surgical pathway, which may include an oblique-lateral surgical pathway. In some embodiments, the systems and methods of the present disclosure are employed with a spinal joint and fusion, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine.
• In some embodiments, the surgical system includes an interbody implant configured as a stand-alone device. In some embodiments, the interbody implant can be employed with a method for lordotic correction. In some embodiments, the interbody implant is configured for insertion along an oblique pathway. In some embodiments, the interbody implant includes an oblique opening, such as, for example, a screw hole configured for disposal of a bone screw. In some embodiments, the oblique opening is configured to facilitate fixation of a bone fastener obliquely into and through the interbody implant and into an adjacent vertebral body endplate.
• In some embodiments, the surgical system is employed with a method for treating a spine that includes the step of creating additional lordosis using the interbody implant. In some embodiments, the interbody implant includes an oblique lateral shape. In some embodiments, the interbody implant includes a slidable inserter aperture.
• In some embodiments, the surgical system includes an interbody implant employed with a method of anterior posterior lordotic correction of vertebrae. In some embodiments, the method includes the step of treating vertebrae including a first vertebral surface and a second vertebral surface, the vertebral surfaces being disposed at a relative lordotic angle of approximately 5 angular degrees. In some embodiments, the method includes the step of removing vertebral tissue from between and/or including the vertebral surfaces. In some embodiments, the vertebrae defines a disc space between the vertebral surfaces and the method includes the step of inserting an interbody implant into the disc space. In some embodiments, the method includes the step of aligning an upper surface of the interbody implant into a flush orientation with a first vertebral surface. In some embodiments, the method includes the step of inserting a bone fastener through the interbody implant and into the first vertebral surface to lock the interbody implant into position with the vertebrae such that an angular gap is defined between the interbody implant and a second vertebral surface. In some embodiments, the method includes the step of removing posterior bone to facilitate angular correction. In some embodiments, the method includes the step of removing facet joints. In some embodiments, the method includes the step of removing a portion of a lamina. In some embodiments, the method includes the step of removing a portion of a spinous process.
• In some embodiments, the method includes the step of manipulating the vertebral surfaces to reduce and/or rotate the vertebral surfaces such that a lower surface of the interbody implant is flush with the second vertebral surface. In some embodiments, the method includes the step of manipulating the vertebral surfaces to a relative lordotic angle of approximately 20 angular degrees. In some embodiments, the step of manipulating includes utilizing instruments, external manipulation or posterior fixation devices, such as, for example, pedicle screws, to reduce and/or rotate the vertebral surfaces. In some embodiments, the method includes the step of locking the vertebral surfaces at a relative lordotic angle orientation with posterior implants, such as, for example, bi-lateral pedicle screws and spinal rods.
• In some embodiments, the surgical system includes an interbody implant employed with a method that includes an oblique lateral interbody fusion (OLIF) procedure. In some embodiments, the surgical system includes a surgical instrument, such as, for example, an inserter configured for connection with an interbody implant. In some embodiments, the inserter can be attached with the interbody implant in-line, at various oblique angles and/or modified inter-operatively.
• In some embodiments, the interbody implant is configured for connection with a single bone fastener. In some embodiments, the interbody implant is configured for connection with multiple bone fasteners. In some embodiments, the multiple bone fasteners are configured for fixation with only one vertebral endplate.
• In some embodiments, the surgical system includes an interbody implant employed with a method of treating a spine, which includes the step of inserting the interbody implant into a patient when a patient is disposed in a lateral position with the left side up and the bone fastener is connected with a superior vertebral endplate. In some embodiments, the surgical system includes an interbody implant employed with a method of treating a spine, which includes the step of inserting the interbody implant into a patient when a patient is disposed in a lateral position with the right side up and the bone fastener is connected with an inferior vertebral endplate. In some embodiments, the surgical system includes an interbody implant employed with a method of treating a spine, which includes the step of inserting the interbody implant into a patient when a patient is disposed in a lateral position with the left side up and the bone fastener is connected with an inferior vertebral endplate. In some embodiments, the surgical system includes an interbody implant employed with a method of treating a spine, which includes the step of inserting the interbody implant into a patient when a patient is disposed in a lateral position with the right side up and the bone fastener is connected with a superior vertebral endplate.
• In some embodiments, the surgical system includes an interbody implant employed with a method of treating a spine, which includes the step of providing posterior fixation with pedicle screws and spinal rods. In some embodiments, posterior fixation can include other implants, such as, for example, facet screws and/or spinous process plates.
• In some embodiments, the surgical system includes an interbody implant employed with a method of treating a spine, which includes the step of providing an interbody implant having one or more openings configured for disposal of bone fasteners for connection with vertebrae having a first vertebral surface, such as, for example, a first vertebral endplate and a second vertebral surface, such as, for example, a second vertebral endplate. In some embodiments, the method includes the step of fixing the interbody implant with the first vertebral endplate from a lateral approach or an anterior approach. In some embodiments, the method includes the step of manipulating the vertebrae for posterior correction via a posterior approach with or without permanent posterior fixation attached. In some embodiments, the method includes the step of fixing the interbody implant with the second vertebral endplate from a lateral or anterior approach.
• In some embodiments, the surgical system is used with surgical navigation, such as, for example, fluoroscope or image guidance. In some embodiments, one or all of the components of the surgical system are disposable, peel-pack, pre-packed sterile devices. One or all of the components of the surgical system may be reusable. The surgical system may be configured as a kit with multiple sized and configured components.
• In some embodiments, the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The system and methods of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.
• The present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior”.
• As used in the specification and including the appended claims, “treating” or “treatment” of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. As used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.
• The following discussion includes a description of a surgical system and related methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning toFIGS. 1 and 2, there are illustrated components of a surgical system, such as, for example, aspinal implant system10.
• The components ofspinal implant system10 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate such as hydroxyapatite (HA), corraline HA, biphasic calcium phosphate, tricalcium phosphate, or fluorapatite, tri-calcium phosphate (TCP), HA-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations, biocompatible ceramics, mineralized collagen, bioactive glasses, porous metals, bone particles, bone fibers, morselized bone chips, bone morphogenetic proteins (BMP), such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized bone matrix (DBM), transforming growth factors (TGF, e.g., TGF-β), osteoblast cells, growth and differentiation factor (GDF), insulin-like growth factor 1, platelet-derived growth factor, fibroblast growth factor, or any combination thereof.
• Various components ofspinal implant system10 may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components ofspinal implant system10, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components ofspinal implant system10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.
• Spinal implant system10 is employed, for example, with a fully open surgical procedure, a minimally invasive procedure, including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrumentation and/or an implant, such as, for example, an interbody implant, at a surgical site of a patient, which includes, for example, a spine having vertebrae V, as shown inFIGS. 5-16. In some embodiments, a surgical pathway P to a surgical site is formed via an OLIF or DLIF procedure. In some embodiments, the implant can include spinal constructs, such as, for example, bone fasteners, spinal rods, connectors and/or plates.
• Spinal implant system10 includes an implant body, such as, for example, aninterbody cage12, as shown inFIGS. 1 and 2.Cage12 extends between aposterior surface14 and ananterior surface16 and defines an axis L1.Posterior surface14 is configured to face a posterior side of a subject body B (FIG. 8) and be disposed adjacent an posterior portion of vertebrae, such as, for example a posterior portion P1 of one or more intervertebral spaces of vertebrae V (FIG. 8).Anterior surface16 is configured to face an anterior side of subject body B and be disposed adjacent an anterior portion of vertebrae, such as, for example an anterior portion μl of one or more intervertebral spaces of vertebrae V (FIG. 8).
• In some embodiments,cage12 includes a convex distal end, such as, for example, abullet nose18 to facilitate insertion by a surgeon. In some embodiments,cage12 may include chamfers, such as, for example, cutouts20a,20bdisposed onbullet nose18 such thatcage12 may be placed in an intervertebral space to avoid impinging on various structures in or near vertebral tissue, such as, for example, a spinal foramina.
• In some embodiments,cage12 includes any number and configuration of radiopaque markers (such as tantalum pins (not shown)) for visualizing a position ofcage12 using fluoroscopy during insertion, manipulation and implantation. In some embodiments, the markers may be placed obliquely onbullet nose18, in sidewalls ofcage12adjacent surfaces14,16 and/or in a proximal end ofcage12. In some embodiments, the markers may be placed parallel, oblique to and/or perpendicular tosurfaces14,16 as required to properly visualize the position ofcage12 relative to a surgical pathway P and/or relative to an oblique axis O (FIG. 8) to facilitate placement ofcage12, as described herein.
• Cage12 includes a vertebral engagingsurface22 and avertebral engaging surface24.Surface22 may be substantially planar and configured to engage endplate tissue of a vertebral body, such as, for example, an endplate E1 of a vertebral level V1 (FIG. 10).Surface24 may be substantially planar and configured to engage endplate tissue of a vertebral body, such as, for example, an endplate E2 of a vertebral level V2 (FIG. 14). In some embodiments,surface22 and/orsurface24 may be rough, textured, porous, semi-porous, dimpled, knurled, toothed, grooved and/or polished to facilitate engagement with tissue.
• In some embodiments,surface22 and/orsurface24 may be partially convex along axis L1 and/or at least partially convex in a direction substantially perpendicular to an axis L2 (i.e., fromsurface16 to surface14). In some embodiments,surface22 and/orsurface24 may be angled along axis L1 or angled perpendicular to axis L1 such thatanterior surface16 is taller thanposterior surface14 such thatcage12 may be capable of creating and/or augmenting lateral or lordotic curvature in a spine when implanted. In some embodiments, vertebral tissue includes intervertebral tissue, endplate surfaces and/or cortical bone. In some embodiments,surface22 and/orsurface24 may be coated with materials suitable for facilitating or encouraging bony ongrowth or fusion including but not limited to titanium and HA coatings. In some embodiments, a titanium coating is applied to surface22 and/orsurface24 in a porous layer using plasma spray technology.
• Cage12 has a substantially rectangular configuration and includes aninner surface26 and anouter surface28.Surface26 defines anopening30 configured to receive an agent, which may include bone graft (not shown) and/or other materials, as described herein, for employment in a fixation or fusion treatment. In some embodiments, a plan geometry ofcage12 may have various configurations, such as, for example, oval, round, cylindrical, oblong, triangular, rectangular, polygonal having planar or arcuate side portions, irregular, uniform, non-uniform, consistent, variable, horseshoe shape, U-shape or kidney bean shape.
• Cage12 includes asurface27 that defines an opening, such as, for example, ascrew hole42.Screw hole42 extends throughcage12 in a transverse configuration relative tosurfaces22,24, as described herein, for fixation with tissue. In some embodiments,surface27 defines a fastener opening that is substantially smooth. In some embodiments,surface27 defines one or a plurality of openings, each configured for disposal of a fastener.
• Screw hole42 defines an axis X1 oriented oblique relative to axis L1. Axis X1 is disposed at an oblique angle α1 relative to axis L1, as shown inFIG. 2. In some embodiments, angle α1 is in a range of approximately 0-60 degrees. In some embodiments,cage12 is selectively disposed with vertebral tissue, as described herein, such thatscrew hole42 is substantially aligned with an oblique surgical pathway P formed in subject body B, as shown inFIG. 8 and as described herein. For example, a surgical pathway P, as shown inFIG. 8, can be oriented oblique relative to a lateral axis XL of subject body B. In some embodiments, surgical pathway P is disposed at an oblique angle α relative to axis XL. In some embodiments, angle α is in a range of approximately 0-60 degrees. In some embodiments, substantial alignment of all or only a portion ofscrew hole42 with all or only a portion of surgical pathway P includes co-axial, spaced apart, offset, angularly offset and/or parallel alignment.
• In some embodiments, axis X1 is oriented oblique relative to axis XL such thatscrew hole42 implants a spinal implant, such as, for example, abone fastener90, as described herein, oblique relative to axis XL. In some embodiments, axis XL lies in a coronal plane CP defined by subject body B. In some embodiments,cage12 is selectively disposed with vertebral tissue, as described herein, such thatscrew hole42 is substantially aligned with an oblique surgical pathway P relative to axis XL at an oblique angle α, which is equivalent to angle α1. In some embodiments, angle α is oriented approximately 0-60 degrees relative to axis XL such thatbone fastener90 is delivered via surgical pathway P to screwhole42. In some embodiments,screw hole42 is disposed at an angular orientation relative to plane CP and/or axis XL such thatbone fastener90 is delivered to a surgical site including an intervertebral space of one or more of the L2-L5 vertebral levels via surgical pathway P and oriented to penetrate endplate tissue of a vertebral body, such as, for example, endplate E1. In some embodiments,screw hole42 and/orcage12 may be disposed at an angular orientation relative to plane CP and/or axis XL such thatbone fastener90 is oriented to penetrate endplate tissue of a vertebral body.
• Surface28 includes anoblique surface44 that defines a cavity, such as, for example, a counter bore46 disposed in communication and alignment withscrew hole42.Oblique surface44 is oriented withcage12 and in substantial alignment with axis X1. In some embodiments, counter bore46 is configured to guidebone fastener90 intoscrew hole42 relative to axis XL and in substantial alignment with surgical pathway P. In some embodiments,surface44 and/or counter bore46 includes a countersunk for disposal of a head ofbone fastener90.
• Cage12 includes asurface49 that defines a cavity, such as, for example, anelongated opening50.Surface49 includes atrack52 that extends within opening50 and is configured for engagement with amember54. The portions ofsurface49 that define opening50 include walls configured to retainmember54 withcage12 for slidable movement ofmember54 relative tocage12.Track52 is disposed with opening50 to define atrack pathway56 that facilitates translation ofmember54 therein.Track pathway56 extends substantially along axis L2 and transverse to axis L1.Track pathway56 includes a limit, such as, for example, alateral limit58 and a limit, such as, for example, anoblique limit60.Limits58,60 provide a range of translation ofmember54 relative tocage12 alongtrack pathway56, as described herein.
• Member54 is slidably engageable withtrack52 for translation relative tocage12 alongtrack pathway56. In some embodiments,member54 is movable alongtrack pathway56 for translation substantially along axis L2 and/or transverse to axis L1. In some embodiments,member54 is movable alongtrack pathway56 for rotation about axis L2 and/or axis L1. In some embodiments,track pathway56 includes an arcuate configuration. In some embodiments,track pathway56 extends along an arcuate configuration that is substantially concentric withtrack52 and/or a lateral surface ofcage12. In some embodiments,track52,surface44 and/ortrack pathway56 may be arcuate with a single radius defining an arcuate configuration. In some embodiments,track52,surface44 and/ortrack pathway56 may be arcuate with multiple radii defining one or more portions of an arcuate configuration.
• In some embodiments,track52,surface44 and/ortrack pathway56 may extend along a pathway having various configurations corresponding to an overall shape ofcage12, such as, for example, round, cylindrical, oblong, triangular, rectangular, polygonal having planar or arcuate side portions, irregular, uniform, non-uniform, consistent, variable, horseshoe shape, U-shape or kidney bean shape. In some embodiments,surface49 may be rough, textured, porous, semi-porous, dimpled, knurled, toothed, grooved and/or polished for selective translation ofmember54.
• In some embodiments, as shown inFIGS. 3 and 4,member54 is retained withcage12, as described herein, and configured for mating engagement with a surgical instrument, such as, for example, aninserter70 described herein, to delivercage12 adjacent a surgical site via surgical pathway P, as described herein. For example,member54 is configured to connectinserter70 withcage12 via opening50 disposed with a lateral surface ofcage12.Member54 includes a connectingsurface76 that defines asocket78.Socket78 is configured for releasable engagement with a portion80 ofinserter70. In some embodiments,member54 is freely translatable in situ within subject body B. In some embodiments,member54 is positioned within subject body B and locked into a fixed position withinserter70. In some embodiments,socket78 and portion80 can be configured for threaded engagement.
• In some embodiments,inserter70 is connected withmember54 andmember54 is translatable alongtrack52 andtrack pathway56 relative to subject body B and/orcage12 to provide selective positioning ofcage12 with respect to a patient's body for adapting to the configuration of the tissue surfaces of vertebrae. In some embodiments, oblique axis O (FIG. 8) includes any axis extending outward from an oblique surface (for example,surface44 described herein) ofcage12 betweenlateral limit58 andoblique limit60, including but not limited to axes that are co-axial with axis L1 and/or an axis defined by surgical pathway P.
• Spinal implant system10 includes one ormore bone fasteners90 depending on the configuration ofcage12. In some embodiments, one or more ofbone fasteners90 may comprise multi-axial screws, sagittal angulation screws, pedicle screws, mono-axial screws, uni-planar screws, facet screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, dips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts.
• Bone fastener90 includes a portion, such as, for example, ahead92 and a portion, such as, for example, anelongated shaft94 configured for penetrating tissue.Head92 includes an engagement portion configured for engagement with a surgical instrument.Shaft94 has a cylindrical cross section configuration and includes an outer surface having an external thread form. In some embodiments, the external thread form may include a single thread turn or a plurality of discrete threads. In some embodiments, other engaging structures may be located onshaft94, such as, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement ofshaft94 with tissue, such as, for example, vertebrae.
• In some embodiments, all or only a portion ofshaft94 may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. In some embodiments, the outer surface ofshaft94 may include one or a plurality of openings. In some embodiments, all or only a portion of the outer surface ofshaft94 may have alternate surface configurations, such as, for example, smooth and/or surface configurations to enhance fixation with tissue, such as, for example, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured. In some embodiments, all or only a portion ofshaft94 may be cannulated.
• In some embodiments,spinal implant system10 may comprise various surgical instruments, such as, for example, drivers, extenders, reducers, spreaders, distractors, blades, damps, forceps, elevators and drills, which may be alternately sized and dimensioned, and arranged as a kit. In some embodiments,spinal implant system10 may comprise the use of microsurgical and image guided technologies, such as, for example, surgical navigation components employing emitters and sensors, which may be employed to track introduction and/or delivery of the components ofspinal implant system10 including the surgical instruments to a surgical site. See, for example, the surgical navigation components and their use as described in U.S. Pat. Nos. 6,021,343, 6,725,080, 6,796,988, the entire contents of each of these references being incorporated by reference herein.
• In assembly, operation and use, as shown inFIGS. 5-16,spinal implant system10, similar to the systems and methods described herein, is employed with a surgical procedure for treatment of a spinal disorder, such as those described herein, affecting a section of a spine of a patient.Spinal implant system10 may also be employed with other surgical procedures to treat the affected section of vertebrae V of a patient utilizing a surgical procedure, such as, for example, an OLIF and DLIF procedure. In some embodiments,spinal implant system10 may include retractors constrained via frame or semi-constrained using elastic or partial frame. In some embodiments, a surgical instrument, such as, for example, a retractor T2 is disposed in communication with surgical pathway P, disposed relative to axis XL at an oblique angle α, as described herein, for spacing tissue, as shown inFIG. 7. Retractor blades b1, b2 are inserted simultaneously as part of a unitary retractor instrument around one or more intervertebral spaces to protect vessels.
• In some embodiments, as shown inFIGS. 5 and 6, an annulotomy and/or discectomy is performed with a surgical instrument (not shown) with x-ray confirmation of the starting point that is central on one or more intervertebral spaces. In some embodiments,spinal implant system10 includes a semi-constrained retractor that facilitates minimal tissue pressures on surrounding abdominal structures and provides flexibility such that its blades rotate on a fixed pin allowing greater degrees of freedom of movement and working angles for a practitioner.
• In some embodiments, a probe is passed into a disc space to secure its location. In some embodiments, the oblique angle and lordotic angle of the probe as it enters the disc space is assessed preoperatively and measured intraoperative using image guidance or using a mechanical or digital protractor. Fluoroscopy, image guidance and/or surgical navigation, as described herein, are used to confirm proper probe alignment into the disc space. In some embodiments, a guide wire is placed through a cannula into the disc space and positioning is confirmed with fluoroscopy. Instruments, such as, for example, a Cobb, mallet, shaver, serrated curettes, rasp, a ring curette, a uterine curette and/or combo tools are utilized to perform a discectomy of a disc space. The instruments enter subject body B obliquely through retractor T2 and can be turned orthogonally to allow the surgeon to work orthogonally across the disc space. The disc space is distracted until adequate disc space height is obtained, as shown inFIG. 6.
• In some embodiments,cage12 is configured for insertion within an intervertebral space S. In some embodiments, trial implants are delivered along surgical pathway P and used to distract one or more intervertebral spaces and apply appropriate tension in the intervertebral space allowing for indirect decompression. In some embodiments, a direct decompression of the disc space is performed by removing a portion of a herniated disc. In some embodiments, the size ofcage12 is selected after trialing,cage12 is visualized by fluoroscopy and oriented before malleting into space S. Trialing is utilized to establish a starting point forcage12 insertion. In some embodiments, an anterior longitudinal ligament (ALL) release procedure can be performed using an OLIF or a DLIF approach post-discectomy. For example, loosening the ALL can be performed by placing holes or partial cuts in the ALL such that the OLIF surgical pathway is immediately closer to the ALL. A pilot hole or the like is made in vertebra V1 adjacent space S, via surgical pathway P, for receivingbone fastener90.
• Cage12 includingmember54, as described herein, allows a surgeon to manipulate thecage12 construct relative to retractor T2. For example, as shown inFIGS. 7-9,inserter70 is connected withmember54 such that portion80 engagessocket78.Inserter70 is translatable withmember54 betweenlimits58,60, as described herein, to facilitate insertion ofcage12 along surgical pathway P into position between vertebra V1 and vertebra V2 relative to subject body B and/orcage12 to provide selective positioning ofcage12 with respect to subject body B for adapting to the configuration of the tissue surfaces of vertebrae V.
• Inserter70 andcage12 are inserted along surgical pathway P substantially between blades b1, b2 of retractor T2, as shown inFIG. 7. The surgeon may freely rotateinserter70 andcage12 into position relative to vertebrae V1, V2. After positioningcage12, the surgeon may utilizeinserter70, connected withmember54, to rotatecage12 into position within space S to obtain a selected position ofcage12 relative to vertebrae V1, V2.
• Inserter70 orientscage12 such thatscrew hole42 is aligned oblique relative to axis XL. In some embodiments,cage12 is selectively disposed with vertebrae V1, V2 such thatscrew hole42 is substantially aligned with surgical pathway P relative to axis XL at angle α, which is equivalent to angle α1.Inserter70 orientscage12 such thatsurface22 contacts and is disposed in flush engagement with an endplate E1 of vertebra V1, as shown inFIG. 10.Surface22 engages endplate E1 such thatcage12 defines a gap G betweensurface24 and an endplate E2 of vertebra V2.Bone fastener90 is disposed withscrew hole42 and engaged in fixation with vertebra V1 such thatbone fastener90 is oriented oblique relative to lateral axis XL, as shown inFIG. 11. In some embodiments,cage12 includes an alternately configured screw hole and/or is oriented with vertebrae V1, V2 such thatbone fastener90 is engaged in fixation with vertebra V2 such thatbone fastener90 is oriented oblique relative to lateral axis XL. In some embodiments,cage12 includes a plurality of screw holes for disposal ofbone fasteners90 that are engaged in fixation with vertebra V1 and/or vertebra V2 in an oblique orientation relative to lateral axis XL.
• In some embodiments, after fixation ofcage12 with vertebra V1, portions of facet joints FJ, laminae L and/or spinous process SP are removed to facilitate selected angular correction of vertebrae V, as shown inFIGS. 12 and 13, with surgical instruments, external manipulation of subject body B and/or posterior fixation devices such as pedicle screws attached with vertebrae V1, V2. For example, implant supports, such as, for example, extenders can be attached to the pedicle screws attached with vertebrae V1, V2. The extenders/screws act as levers for reducing and/or rotating vertebrae V to reduce and/or eliminate gap G and/or until endplate E2 is disposed in flush engagement withsurface24 such that a selected angular correction of vertebrae V is achieved, as shown inFIG. 14. In some embodiments, the components ofspinal implant system10 provide axial compression or distraction to restore vertebral body height, achieve lordosis and/or restore curvature of the spine. In some embodiments, a spinal construct including pedicle screws100 and/orspinal rods102, as shown inFIGS. 15 and 16, are employed to provide posterior fixation of vertebrae V1, V2 in a selected orientation and/or angular correction.
• Upon completion of a procedure, as described herein, the surgical instruments, assemblies and non-implanted components ofspinal implant system10 are removed and the incision(s) are closed. One or more of the components ofspinal implant system10 can be made of radiolucent materials such as polymers. Radiopaque markers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid ofspinal implant system10. In some embodiments,spinal implant system10 may include one or a plurality of plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels.
• In some embodiments,spinal implant system10 includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces ofspinal implant system10. In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the components and/or surfaces ofspinal implant system10 with vertebrae. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.
• It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims (21)

1-20. (canceled)

21. A spinal implant comprising:

an implant body comprising a wall, the wall defining a cavity and a track; and

a member having a first portion movably disposed in the cavity and a second portion movably disposed in the track.

22. The spinal implant recited inclaim 21, wherein the wall includes opposite first and second vertebral engaging surfaces, the first vertebral engaging surface defining the track.

23. The spinal implant recited inclaim 22, wherein the track is in communication with the cavity.

24. The spinal implant recited inclaim 23, wherein the track has an arcuate configuration.

25. The spinal implant recited inclaim 23, wherein the track is continuously curved from a first end of the track to an opposite second end of the track.

26. The spinal implant recited inclaim 22, wherein a portion of the wall between the first and second vertebral engaging surfaces defines the opening.

27. The spinal implant recited inclaim 26, wherein the track is in communication with the cavity.

28. The spinal implant recited inclaim 27, wherein the track has an arcuate configuration.

29. The spinal implant recited inclaim 27, wherein the track is continuously curved from a first end of the track to an opposite second end of the track.

30. The spinal implant recited inclaim 21, wherein the first portion includes a threaded inner surface defining a socket.

31. The spinal implant recited inclaim 21, wherein the body comprises an aperture extending through opposite top and bottom surfaces of the wall and a screw hole, the screw hole being spaced apart from the cavity and in communication with the aperture.

32. The spinal implant recited inclaim 31, wherein the aperture is spaced apart from the cavity.

33. The spinal implant recited inclaim 31, further comprising a screw comprising a head and a shank, the head being positioned in the screw hole, the shank extending through the aperture.

34. The spinal implant recited inclaim 33, wherein the aperture is spaced apart from the cavity.

35. The spinal implant recited inclaim 21, further comprising a screw comprising a head and a shank, the head being positioned in a screw hole of the body, the shank extending through an aperture of the body, the screw hole being spaced apart from the cavity and in communication with the aperture.

36. The spinal implant recited inclaim 35, wherein the aperture is spaced apart from the cavity.

37. The spinal implant recited inclaim 21, wherein the body includes a bullet nose opposite the cavity.

38. The spinal implant recited inclaim 21, wherein the wall includes opposite first and second vertebral engaging surfaces and a side surface extending from the first vertebral engaging surface to the second vertebral engaging surface, the first vertebral engaging surface defining the track, the cavity extending through the side wall, the body further including opposite first and second holes extending through the side wall, the first hole being coaxial with the second hole along a transverse axis of the body.

39. A spinal implant comprising:

an implant body comprising a wall, the wall including opposite first and second vertebral engaging surfaces, the wall defining an aperture, a screw hole, a cavity and a track, the screw hole being spaced apart from the cavity, the aperture extending through the first and second vertebral engaging surfaces;

a member having a first portion movably disposed in the cavity and a second portion movably disposed in the track; and

a screw comprising a head and a shank, the head being configured to be positioned in the screw hole, the shank extending through the aperture.

40. A spinal implant comprising:

an implant body comprising a wall, the wall including opposite first and second vertebral engaging surfaces, the wall defining an aperture, a screw hole, a cavity and a track, the screw hole being spaced apart from the cavity, the aperture extending through the first and second vertebral engaging surfaces;

a member having a first portion movably disposed in the cavity and a second portion movably disposed in the track, the first portion having a threaded inner surface; and

an instrument comprising a shaft, the shaft having a threaded outer surface configured to mate with the threaded inner surface to connect the instrument to the member.

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