Spinal implant system and method

Abstract

A spinal implant includes a body having an inner surface and a connecting wall. The inner surface defines at least one cavity and the connecting wall is disposed about the at least one cavity. The connecting wall defines at least one opening. An agent can be disposed with the at least one cavity. Spinal constructs, surgical instruments, systems, and methods are disclosed.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to medical devices for treating musculoskeletal conditions, and more specifically to surgical systems and methods for treating the spine. BACKGROUND

[0002] Spinal conditions, such as degenerative disc disease, herniated discs, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures, can be caused by factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal conditions often result in symptoms including pain, nerve damage, and partial or complete loss of mobility.

[0003] Non-surgical treatments, such as medication, physical therapy, and exercise, can be effective, however, can fail to alleviate symptoms associated with these conditions. Surgical treatments for these spinal conditions include fusion, fixation, correction, discectomy, microdiscectomy, corpectomy, decompression, laminectomy, laminotomy, foraminotomy, facetectomy, and implantable prosthetics. As part of these surgical treatments, spinal constructs, including implants, such as bone grafts, 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 a spinal construct to a surgical site for fixation with bone to immobilize a joint. The present disclosure describes improvements over these techniques. SUMMARY

[0004] In one embodiment, a spinal implant is provided. The spinal implant includes a body having an inner surface and a connecting wall. The inner surface defines at least one cavity and the connecting wall is disposed about the at least one cavity. The connecting wall defines at least one opening. An agent can be disposed with the at least one cavity. In some embodiments, spinal constructs, surgical instruments, systems, and methods are disclosed.

[0005] In one embodiment, a spinal implant system is provided. The spinal implant system includes a polymeric mesh body having an inner surface defining a plurality of cavities. The body additionally includes a plurality of borders disposed about the cavities. The borders include at least one opening. At least one bone fastener can be disposed with the at least one opening. An agent can be disposed with the cavities.

[0006] In one embodiment, a method for treating a spine is provided. The method includes the steps of selecting an implant body for disposition with a spinal tissue, the implant body including a first layer and a second layer connectable to define at least one cavity of the implant body; disposing an agent with the implant body; connecting the layers in surgery to form a border of the implant body and define the at least one cavity for disposition of the agent; and connecting the implant body with the tissue. BRIEF DESCRIPTION OF DRAWINGS

[0007] The present disclosure will become more readily apparent from the specific description accompanying the following drawings, in which:

[0008] Figure 1 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure;

[0009] Figure 2 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure; Figure 1 Cross-sectional view of components of the system shown;

[0010] Figure 3 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure with a vertebra disposed therein;

[0011] Figure 4 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure with a vertebra disposed therein;

[0012] Figure 5 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure with a vertebra disposed therein;

[0013] Figure 6 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure with a vertebra disposed therein;

[0014] Figure 7 Perspective view of components of one embodiment of a surgical system according to the principles of the present disclosure;

[0015] Figure 8 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure; Figure 7 Cross-sectional view of components of the system shown;

[0016] Figure 9 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure with a vertebra disposed therein;

[0017] Figure 10 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure with a vertebra disposed therein;

[0018] Figure 11 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure;

[0019] Figure 12 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure with a vertebra disposed therein;

[0020] Figure 13 Plan view of components of one embodiment of a surgical system according to the principles of the present disclosure;

[0021] Figure 14 Plan view of components for one embodiment of a surgical system according to the principles of the present disclosure; and

[0022] Figure 15 Plan view of components for one embodiment of a surgical system according to the principles of the present disclosure. DETAILED DESCRIPTION

[0023] Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed in terms of medical devices for treating musculoskeletal conditions, and more specifically, in terms of surgical systems and methods for treating the spine. In some embodiments, the present surgical systems include one or more spinal implants that are employed with spinal joints and, for example, are fused with the cervical, thoracic, lumbar, and / or sacral regions of the spine. In some embodiments, the present surgical systems and methods are employed with decompression, discectomy, laminectomy, laminoplasty, fusion, fixation, and implantable prosthetic procedures. In some embodiments, the present surgical systems and methods can be used for posterolateral fusion using minimally invasive and percutaneous techniques.

[0024] In some embodiments, the present surgical systems include spinal implants, for example, configured for placement of a container or bag that can include one or more agents of bone graft and biologies. In some embodiments, the surgical systems include one or more single-use fillable bags with different geometries, features, and porosities for more accurate and safe placement of bone graft and / or biologies in lateral grooves and / or around screw heads and laminar fusions during posterior fixation procedures. In some embodiments, the surgical systems include a range of bags with different geometries, features, and mesh types that can contain bone graft / biologies products for use in posterior fixation procedures. In some embodiments, the bags allow for more accurate and safe placement of graft in lateral grooves and around screw heads and laminar fusions. In some embodiments, the bags are placed using screw trajectories, and the screw heads clamp down on the graft when tightened and hold it in place for fusion. In some embodiments, the surgical systems include spinal implant bodies that allow for more accurate and safe placement of bone graft and / or biologies for posterior fixation procedures using existing navigation and fixation techniques.

[0025] In some embodiments, the surgical system of the present application includes a spinal implant body that provides for precise placement and fixation of bone graft in lateral grooves and / or around screw heads, for example, with laminar fusion in posterior fixation procedures. In some embodiments, the surgical system can be used with a variety of biologicals, including synthetic and allograft grafts, as well as open, mini-open, and percutaneous screw systems. In some embodiments, the surgical system includes a spinal implant with a pocket for filling with biologicals / bone graft, which can be provided in various configurations or sealed or closed intraoperatively. In some embodiments, the surgical system includes a spinal implant with a pocket with holes and slots having different locations and geometries.

[0026] In some embodiments, the surgical system of the present application is used with a method that includes the steps of using C-arm fluoroscopy and identifying screw trajectory, making an incision, and inserting a PAK needle. In some embodiments, the method includes the step of inserting a guide wire and removing the PAK needle. In some embodiments, the method includes the step of placing a guide wire. In some embodiments, the method includes the step of debriding a fusion bed. In some embodiments, the method includes the steps of selecting a bone graft pocket with a desired geometry and features, inserting a bone graft into the pocket, and sealing the pocket. In some embodiments, the method includes the step of inserting a bone graft pocket into tissue. In some embodiments, the method includes the steps of pulling the pocket through the tissue with an inserter and placing the pocket around the guide wire maintaining the geometry. In some embodiments, the method includes the steps of removing the inserter and placing a screw with the pocket and tissue.

[0027] In some embodiments, the surgical system of the present application is used with a method that includes the steps of using surgical navigation and making an incision. In some embodiments, the method includes the step of debriding a fusion bed. In some embodiments, the method includes the steps of selecting a bone graft pocket with a desired geometry and features, inserting a bone graft into the pocket, and sealing the pocket. In some embodiments, the method includes the step of using surgical navigation to position the pocket at a surgical site. In some embodiments, the method includes the step of using surgical navigation to deliver the pocket to a surgical site with an inserter. In some embodiments, the method includes the step of using surgical navigation to deliver a pedicle screw through the pocket at a surgical site with a driver.

[0028] In some embodiments, one or all of the components of the surgical system are disposable peel packs that can be used with the implant, pre-packaged sterile devices. One or all of the components of the surgical system can be reusable. The surgical system can be configured as a kit with multiple sized and configured components.

[0029] In some embodiments, this disclosure can be used to treat spinal conditions such as degenerative disc disease, herniated disc, osteoporosis, vertebral lordosis, spinal stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In some embodiments, this disclosure can be used in conjunction with other bone and skeletal applications, including those associated with diagnosis and therapy. In some embodiments, the disclosed surgical systems and methods can alternatively be used for surgical treatment of patients in a prone or supine position, and / or for various surgical approaches to the spine and other body regions, including anterior, posterior, posterior midline, lateral, posterolateral, and / or anterolateral approaches. This disclosure can also alternatively be used in conjunction with procedures for treating the lumbar, cervical, thoracic, and pelvic regions of the spine. The systems and methods of this disclosure can also be used in animals, bone models, and other non-living substrates, for example, for training, testing, and demonstration.

[0030] This disclosure will be more readily understood through the following detailed description, taken in conjunction with the accompanying drawings that form a part of this disclosure. It should be understood that this disclosure is not limited to the specific apparatus, 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 limit the scope of the claimed disclosure. In some embodiments, as used in and including the appended claims, the singular forms “a” and “the” include the plural, and reference to a particular numerical value includes at least the stated particular value, unless the context explicitly states otherwise. Scopes herein may be expressed as “about” or “approximately” one particular value and / or up to “about” or “approximately” another particular value. When such scopes are expressed, another embodiment includes one particular value and / or up to another particular value. Similarly, when a value is expressed as an approximation using the preposition “about,” it should be understood that the particular value forms another embodiment. It should also be understood that all spatial references, such as horizontal, vertical, top, upper, lower, bottom, left, and right, are for illustrative purposes only and may vary within the scope of this disclosure. For example, the terms “upper” and “lower” are relative and are only used relative to other contexts, and do not necessarily refer to “above” and “below”.

[0031] As used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a procedure that can include administering one or more drugs to a patient (human or other mammun) seeking to alleviate signs or symptoms of the disease or condition. Alleviation can occur by preventing the disease or condition from occurring in an asymptomatic patient or by improving signs or symptoms in a patient already diagnosed with the disease or condition. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing a disease from occurring in a patient, who can 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's condition. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the symptoms of 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 a supplement to surgery; and / or any repair procedure. Furthermore, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and / or bone, unless otherwise indicated.

[0032] The following discussion includes a description of a surgical system and related methods employing a surgical system in accordance with the principles of the present disclosure. Alternative embodiments are also disclosed. Referring in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying drawings, reference is first made to Figure 1 and 2 illustrating components of a surgical system 10 including a spinal implant 12.

[0033] The components of the surgical system 10 can be made of biologically acceptable materials suitable for medical applications, including synthetic polymers, ceramics, metals, and / or composites thereof. For example, the components of the surgical system 10, individually or collectively, can be fabricated from materials such as polymeric nets. In some embodiments, the spinal implant 12 includes a polymeric net covering. In some embodiments, the components of the surgical system 10 can be fabricated from materials such as thermoplastics, such as polyaryletherketone (PAEK) (including polyether ether ketone (PEEK), polyether ketone ketone (PEKK), and polyether ketone (PEK), carbon-PEEK composites, PEEK-BaS04polymeric 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, elastomer composites, rigid polymers (including polybenzene, polyamides, polyimides, polyetherimides, polyethylene), epoxy resins, partially resorbable materials (e.g., composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and resorbable polymers), fully resorbable materials (e.g., calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), calcium sulfate), or other resorbable polymers (such as polylactide, polyglycolide, polytyrosine carbonate, polycaprolactone, and combinations thereof), ceramics, and composites thereof (such as calcium phosphate (e.g., SKELITE®), stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloy (e.g., Nitinol), cobalt-chrome alloy, super-elastic metal alloy (e.g., GUM METAL®), and the like. TM )) and the like.

[0034] The various components of the surgical system 10 can have material composites including the above-described materials to achieve various desirable characteristics, such as strength, rigidity, elasticity, compliance, biomechanical performance, durability, and radiolucency or imaging preference. The components of the surgical system 10, individually or collectively, can also be fabricated from a heterogeneous material, such as a combination of two or more of the above-described materials. The components of the surgical system 10 can be unitarily formed, integrally connected, or include fastening elements and / or instruments, as described herein.

[0035] ​The components of the surgical system 10, including the spinal implant 12, can be employed with, for example, percutaneous surgical implantation, minimally invasive surgical procedures, mini-open and open surgical techniques to prepare a surgical site (including tissue) for connection with a surgical procedure, introduction of surgical instruments, and / or delivery and introduction of one or more biomaterials and / or spinal implants, such as a container, pouch, pocket, one or more agents, fastener, connector, plate, intervertebral implant, interbody device, and / or arthroplasty device at a surgical site (e.g., a segment of the spinal column) in a patient. In some embodiments, the surgical system 10 can be employed with surgical procedures, such as decompression, vertebral body resection, and discectomy, which can include fusion and / or fixation treatment employing the spinal implant.

[0036] In some embodiments, the spinal implant 12 is configured to facilitate accurate placement and fixation of an agent (e.g., bone graft) in the lateral grooves and around the screw head in a posterior fixation procedure. In some embodiments, the spinal implant system 10 includes a kit of one or more single-use fillable spinal implants 12 having various features (e.g., geometry, porosity, and / or size). The spinal implant 12 is selected for placement with a vertebra, as described herein. The selected spinal implant 12 can be placed with the vertebra, and features of the spinal implant 12 can be selected preoperatively and / or intraoperatively, such that one or more of the components of the spinal implant 12 can be connected and / or assembled preoperatively and / or intraoperatively.

[0037] The spinal implant 12 includes a container configured for placement of one or more agents, as described herein. The container includes a body 14 extending between an end 16 and an end 18. The body 14 comprises an overall rectangular configuration and a substantially rectangular cross-section having an arcuate edge connected to a connecting wall, as described herein. In some embodiments, the overall geometry and / or cross-section of the body 14 can have alternative configurations, for example, oval, cylindrical, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, variable, and / or tapered.

[0038] The body 14 is made of a flexible and / or elastic material. In some embodiments, the body 14 can have flexible and / or elastic properties, as corresponding to the flexible and / or elastic properties of the material examples described above, such that the body 14 provides a selective amount of pliability, deformability, ductility, and / or moldability with the structural anatomy of one or more components of the surgical system 10 and / or the tissue, as described herein. In some embodiments, the body 14 can be flexible, elastic, semi-rigid, or rigid. In some embodiments, the body 14 can be manipulated and / or contoured for placement with the structural anatomy of one or more components of the surgical system 10 and / or the vertebra preoperatively, in situ, and / or intraoperatively.

[0039] In some embodiments, the body 14 is made of a polymer mesh. In some embodiments, the body 14 includes an agent, such as allograft bone within a polymer mesh bag, covering, and / or pouch, to provide targeted and controlled delivery of allograft bone to a selected tissue, as described herein. In some embodiments, the polymer mesh is configured to allow cellular ingrowth while also retaining bone graft within one or more cavities of the body 14. In some embodiments, the polymer mesh allows the body's natural cellular healing and remodeling mechanisms to coordinate remodeling bone by osteoclasts and formation of new bone by osteoblasts. In some embodiments, the polymer mesh is made of biodegradable suture material and provides efficient cellular ingrowth and complete absorption. In some embodiments, the polymer mesh is made of natural materials, synthetic polymeric resorbable materials, synthetic polymeric non-resorbable materials, and other materials. In some embodiments, the natural mesh materials include silk, extracellular matrix (such as DBM, collagen, ligament, tendon tissue, etc.), silk-elastin, elastin, collagen, and cellulose. In some embodiments, the synthetic polymeric resorbable materials include poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), polydioxanone, PVA, polyurethane, polycarbonate, and the like.

[0040] The body 14 includes an inner surface 20 that defines a cavity, such as a chamber 22 disposed between the ends 16, 18. The chamber 22 is configured for disposal of an agent, as described herein. In some embodiments, the surface 20 can have various surface configurations, such as rough, arcuate, wavy, porous, semi-porous, concave, polished, and / or textured. In some embodiments, the surface 20 defines one or more cavities that can be distinct and separate, or in communication, for example, via a connecting opening that facilitates the flow of gas or fluid between the cavities.

[0041] The body 14 includes a layer 32 and a layer 34. The layers 32, 34 extend between the ends 16, 18. The layers 32, 34 can be connected to form the container body 14. The layers 32, 34 can be connected to form a perimeter P of the body 14, as shown. In some embodiments, the layers 32, 34 are connected preoperatively, intraoperatively, and / or intraoperatively to dispose the body 14 into a selected implant configuration. In some embodiments, one or more portions of the layer 32 can be connected with one or more portions of the layer 34, such as by heat sealing, adhesion, pressure fitting, loop of wire, pull wire, suture, suture line, tie, or combinations thereof, to form the body 14 and / or one or more chambers 22, as described herein. Figure 1

[0042] ​Layer 32 is joined with layer 34 to form a connecting wall, such as a border 36 disposed about chamber 22. Layers 32, 34 are joined to form one or more chambers 22 of the container and / or body 14 of the spinal implant 12 of a selected configuration. Layer 32 includes a surface 40 and layer 34 includes a surface 42. Surfaces 40, 42 are disposed for joining to form a seam 44. In some embodiments, seam 44 is formed, such as by heat sealing, adhesion, pressure fitting, loop of wire, pull wire, suture, stitching, tie, or combinations thereof.

[0043] In some embodiments, seam 44 forms a seal about chamber 22 to block and / or prevent passage and / or egress of an agent from chamber 22 as described herein. In some embodiments, seam 44 forms an air and / or liquid tight seal about chamber 22 to prevent passage and / or egress of an agent from chamber 22. In some embodiments, seam 44 forms a seal about chamber 22 to selectively allow passage and / or egress of an agent from chamber 22, such as via one or more selectively positioned and / or spaced apart openings disposed along seam 44. In some embodiments, body 14 can include one or more borders to form one or more chambers of a spinal implant container. In some embodiments, body 14 can include one or more chambers of equal size, as described herein. In some embodiments, body 14 can include one or more chambers of alternative size, as described herein.

[0044] Layers 32, 34 can be joined to form seam 44 and a chamber 22 of a selected configuration. Chamber 22 includes a generally rectangular cross-section with an arcuate edge connected to seam 44 and a bulk rectangular configuration. In some embodiments, chamber 22 can have an alternative configuration, such as an oval, cylindrical, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, variable, and / or tapered shape.

[0045] Wall 30 includes a surface 50 defining an opening 52. Opening 52 extends through layers 32, 34 and provides an aperture for disposing a surgical instrument and / or bone fastener to facilitate positioning of spinal implant 12 with tissue. Opening 52 is configured for disposing a surgical instrument and / or bone fastener to align and / or guide spinal implant 12 in engagement with tissue, such as a vertebra.

[0046] In some embodiments, the surgical instrument and / or bone fastener can be disposed with one or more openings 52 to allow for accurate and safe placement of the spinal implant container in the lateral groove of the lamina. In some embodiments, the surface 50 can be disposed about the head of the bone fastener and / or the laminectomy. In this way, the spinal implant 12 can be placed using the bone fastener trajectory and the bone fastener head. For example, when the bone fastener is tightened through the one or more openings 52, the bone fastener tightening or clamping body 14 is used to attach with the tissue and maintain the spinal implant 12 in position for fusion. In some embodiments, the surface 50 can be disposed about one or more guide wires such that the spinal implant 12 can be pulled through the tissue with an inserter and the retaining geometry of the body 14 is disposed about the guide wire.

[0047] In some embodiments, the agents as described herein can be disposed, packaged, coated, or layered within, on, near, or about the components and / or surfaces of the surgical system 10, and / or with the tissue. In some embodiments, the agents can include bone growth promoting materials, such as bone grafts, to enhance fixation of the components and / or surfaces of the surgical system 10 with the vertebrae. In some embodiments, the agents can include one or more therapeutic and / or pharmaceutical agents for release, including sustained release, to treat, for example, pain, inflammation, and degeneration. In some embodiments, the bone grafts can include bone materials including autografts, allografts, xenografts, collagen or transgenic cortical and / or corticocancellous bone and tissue growth or differentiation factors, partially resorbable materials (e.g., composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and resorbable polymers), fully resorbable materials (e.g., calcium-based ceramics such as calcium phosphate, TCP, HA-TCP, calcium sulfate), or other resorbable polymers (such as polylactide, polyglycolide, polycarboxylic acid, polycaprolactone, and combinations thereof). In some embodiments, the bone grafts comprise demineralized bone material, which can include demineralized bone, powder, chips, tri-prisms, spheres, cubes, cylinders, shreds, fibers, or other shapes having irregular or random geometry. In some embodiments, the bone grafts comprise at least one growth factor. These growth factors include bone inductors, e.g., agents that induce new bone growth in areas where bone growth is absent, and / or bone conductors, e.g., agents that induce cell ingrowth and / or growth through allografts. The bone inductors can be polypeptide or polynucleotide compositions.

[0048] In assembly, operation, and use, similar to the systems and methods described herein, the surgical system 10 is used to treat a selected segment of the vertebra V, as Figures 3-6The medical practitioner gains access to the surgical site including vertebra V in any appropriate manner, such as through an incision and retraction of tissue. In some embodiments, surgical system 10 can be used in any of the existing surgical methods or techniques including open surgery, mini-open surgery, minimally invasive surgical procedures, and percutaneous surgical implantation, whereby the vertebra V is accessed through a small incision or sleeve that provides a protected access to the area. Once access to the surgical site is gained, a particular surgical procedure can be performed to treat the spinal condition. In some embodiments, one or all of the components of surgical system 10 can be delivered or implanted in the surgical site as a pre-assembled device or can be assembled in situ. The components of surgical system 10 can be modified, removed, or replaced in whole or in part.

[0049] In some embodiments, the surgical procedure includes a posterolateral gutter fusion procedure, such that an incision is made in the patient and one or more screw trajectories T are identified via medical imaging (e.g., C-arm). A pedicle access kit (PAK) needle (not shown) is used to provide access to the vertebral tissue, including lamina, transverse process, pedicle, and / or adjacent tissue. In one example, the PAK needle is placed at the intersection of the facet and transverse process. The PAK needle is advanced across the junction of the pedicle and the selected vertebral body. The inner probe of the PAK needle is removed to allow insertion of a guide wire 202. The PAK needle is removed. The fusion bed of the tissue, for example, adjacent lumbar vertebral levels L4, L5, is stripped along the lateral gutters of L4, L5.

[0050] The spinal implant 12 is selected for placement along the lateral grooves of L4, L5 and adjacent tissues, together with the structural anatomy of the tissue including the prepared fusion bed. Selected configurations and / or features of the spinal implant 12 may include the selection of one or more agents as described herein, and / or the selection of a configuration of the body 14 as described herein, for accurate and secure placement of components of the spinal implant 12 along the lateral grooves of L4, L5 and / or around the bone fastener 200 with the prepared fusion bed during surgical treatment. In some embodiments, selected configurations of the body 14 may include selected parameters such as geometry, porosity, material, mesh type, and / or chamber 22 configuration, as described herein. In some embodiments, the spinal implant 12 and / or one or more components of the spinal implant 12 may be connected and / or assembled preoperatively, in situ, and / or during surgery. In some embodiments, the spinal implant 12 and / or one or more components of the spinal implant 12 may be connected and / or assembled preoperatively or during surgery on a back table in the operating room. In some embodiments, the surgical system 10 includes a kit comprising one or more alternatively configured spinal implants 12 and / or one or more components of the spinal implants 12 for connection and / or assembly. In some embodiments, the surgical system 10 includes a kit comprising a series of spinal implants 12 containing bags with different geometries, features, and mesh types, the bags containing one or more reagents as described herein. In some embodiments, the kit includes one or more alternatively configured single-use reagent-fillable bags.

[0051] As described in this article, Figure 3 The configuration and / or features of the spinal implant 12 shown are selected for placement in conjunction with a posterolateral groove fusion surgery along the lateral grooves of L4, L5 and / or around the bone fastener 200, together with the prepared fusion bed. In some embodiments, one or more reagents are placed together with the surface 20, and layers 32, 34 are joined during surgery to form a seam 44 to define a chamber 22 for receiving one or more reagents.

[0052] The spinal implant 12 is introduced through the incision, such as Figure 4 As shown, it is used for delivery near the prepared fusion bed along the lateral grooves of L4 and L5. The spinal implant 12 is connected to the inserter I, as shown. Figure 5The inserter I is detached from the body 14. The extender 204 with the bone fastener 200 removably attached thereto is delivered along the guidewire 202 to the surgical site including the lateral groove. The bone fastener 200 is aligned with the opening 52 for seating therein. The bone fastener 200 engages with the tissue near the L4, L5 vertebrae and the guidewire 202 is removed from the tissue as shown. The bone fastener 200 is seated within the opening 52. As the bone fastener 200 is tightened with the tissue through the opening 52, the bone fastener 200 tightens or clamps the body 14 for attachment along the lateral groove of L4, L5 with the prepared fusion bed and maintains the spinal implant 12 in position for fusion. In some embodiments, a spinal rod (not shown) can be connected with the bone fastener 200. Figure 6 The bone fastener 200 is seated within the opening 52. As the bone fastener 200 is tightened with the tissue through the opening 52, the bone fastener 200 tightens or clamps the body 14 for attachment along the lateral groove of L4, L5 with the prepared fusion bed and maintains the spinal implant 12 in position for fusion. In some embodiments, a spinal rod (not shown) can be connected with the bone fastener 200.

[0053] In some embodiments, the surgical system 10 can be employed along a single vertebral level or multiple vertebral levels with spinal rods, connectors, plates, bone fasteners, and / or fixation elements. Upon completion of the procedure, the surgical instruments, components, and non-implanted parts of the surgical system 10 are removed and the incision is closed. The components of the surgical system 10 can be made of radiolucent materials, such as polymers. Radioactive markers can be included for identification under x-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, with the surgical system 10, the use of surgical navigation, microsurgery, and image-guided techniques can be employed to access, view, and repair spinal degeneration or injury.

[0054] In some embodiments, the components of the surgical system 10 contain radioactive markers and / or radiopacity enhancing agents. In some embodiments, the radioactive markers and / or radiopacity enhancing agents enable a surgeon to visualize the delivery of components of the spinal implant 12 to the site (e.g., via C-arm radiography) and assess the quality of the implant at the intended delivery site. In some embodiments, the radioactive markers include, but are not limited to, barium, calcium phosphate, bismuth, iodine, tantalum, tungsten, and / or metallic beads or particles.

[0055] In some embodiments, surgical system 10 can include various surgical instruments, such as drivers, inserters, extenders, repositioners, dilators, retractors, reamers, peelers, blades, forceps, elevators, and drills, which can alternatively be sized and dimensioned, and arranged as a kit. In some embodiments, surgical system 10 can include the use of microsurgical and image-guided techniques, such as surgical navigation components employing emitters and sensors, which can be used to track components of surgical system 10 and the described surgical instruments to surgical site introduction and / or delivery. See, e.g., surgical navigation components and uses thereof as described in U.S. Patent Nos. 6,021,343, 6,725,080, 6,796,988, the entire contents of each of which are incorporated herein by reference.

[0056] In one embodiment, as shown in Figures 7-10 surgical system 10 (similar to the systems and methods described above with respect to Figures 1-6 surgical system 10 (similar to the systems and methods described above with respect to

[0057] Body 314 includes an inner surface 320 that defines a plurality of cavities, such as chambers 322 (similar to chambers 22 described herein). Chambers 322 are configured for placement of an agent, as described herein. Body 314 includes a layer 332 and a layer 334 that are connectable to form container body 314. Layer 332 and layer 334 are connectable to form a perimeter PI of body 314. In some embodiments, layers 332, 334 are connected preoperatively, intraoperatively, and / or intraoperatively to place body 314 into a selected implant configuration, similar to described herein.

[0058] Layers 332 and 334 are joined to form a connecting wall, such as a border 336 disposed about chambers 322. Layers 332, 334 are connected to form chambers 322 of container and / or body 314 of selected configuration of spinal implant 312. Layers 332, 334 include surfaces disposed for joining to form a seam 344 similar to seam 44 described herein about chambers 322. Layers 332, 334 are joinable to form seam 344 and chambers 322 of selected configuration. Chambers 322 are separated and spaced apart in an orientation about a circumference of body 314. Each chamber 322 has a substantially circular cross-section with an edge connected to seam 344. In some embodiments, one or more of chambers 322 can include a spherical configuration.

[0059] Wall 330 includes a surface 350 that defines an opening 352 (similar to opening 52 described herein). Opening 352 extends through layers 332, 334 and provides an aperture for seating surgical instruments and / or bone fasteners to facilitate positioning of spinal implant 312 with tissue. Opening 352 is configured for seating surgical instruments and / or bone fasteners to align and / or guide spinal implant 312 into engagement with tissue (e.g., a vertebra).

[0060] In assembly, operation, and use, surgical system 10 is employed with spinal implant 312 to treat a selected segment of vertebrae V, as shown in Figures 1-6 and Figure 9 and 10 A medical practitioner gains access to a surgical site including vertebrae V in connection with a posterolateral gutter fusion procedure, similar to described herein. An incision is made in the patient to provide access to vertebral tissue including lamina, transverse processes, pedicles, and / or adjacent tissue. A surgical navigation-enabled drill (not shown) strips the fusion bed adjacent lumbar vertebrae levels L4, L5 along lateral gutters of L4, L5. The surgical navigation drill includes a navigation component coupled thereto to facilitate communication with one or more sensors of a surgical navigation system during the surgical procedure. See, e.g., surgical navigation components and uses thereof as described in U.S. Patent Nos. 6,021,343, 6,725,080, 6,796,988. The navigation assembly generates a signal indicative of the position of the surgical navigation drill relative to the tissue.

[0061] Spinal implant 312 is selected for seating along lateral gutters of L4, L5 and adjacent tissue and / or around bone fasteners 200 that can be seated with opening 352 in connection with a posterolateral gutter fusion procedure with the anatomical configuration of the tissue including the prepared fusion bed, similar to described herein. In some embodiments, one or more agents are seated with surface 320 and layers 332, 334 are joined in-situ to form seam 344 to define chamber 322 for containing one or more agents.

[0062] Spinal implant 312 is introduced through the incision, as shown in Figure 9The spinal implant 312 is connected with a surgical navigation-enabled inserter II (similar to the surgical navigation-enabled instruments described herein) and introduced through the incision to position the body 314 with the lateral grooves. The inserter II is detached from the body 314. Similar to the surgical navigation-enabled instruments described herein, a surgical navigation-enabled driver D is connected with the bone fastener 200 for delivery to the surgical site including the lateral grooves. The bone fastener 200 is aligned with the opening 352 for seating therein. The bone fastener 200 engages with tissue in the vicinity of the L4, L5 vertebrae as Figure 10 The bone fastener 200 is seated within the opening 352. As the bone fastener 200 is tightened with the tissue through the opening 352, the bone fastener 200 tightens or clamps the body 314 for attachment with the prepared fusion bed along the lateral grooves of the L4, L5 and maintains the spinal implant 312 in position for fusion. Upon completion of the procedure, the surgical instruments, components, and non-implanted parts of the surgical system 10 are removed and the incision is closed.

[0063] In one embodiment, as Figure 11 and 12 illustrated, the surgical system 10 (similar to the systems and methods described herein) includes a spinal implant 412 (similar to the spinal implant 12 described herein). The spinal implant 412 includes a container configured to seat one or more agents as described herein and a body 414 (similar to the body 14 described herein). The body 414 includes a generally rectangular configuration and a cross-section of separate cavities as described herein with edges extending to connecting walls similar to described herein.

[0064] The body 414 defines a plurality of chambers 422 (similar to the chambers 22 described herein). The chambers 422 are configured to seat agents as described herein. The body 414 includes layers similar to described herein that can be connected to form the container body 414 and a border 436 seated around the chambers 422. The layers of the body 414 are connected to form the container and chambers 422 of the selected configuration of the spinal implant 412. The layers of the body 414 include surfaces seated for engagement to form a seam 444 similar to the seam 44 described herein around the chambers 422. The chambers 422 are separated and spaced apart in a serial and / or linear orientation along the body 414.

[0065] The border 436 defines an opening 452 (similar to the opening 52 described herein). The opening 452 provides an aperture for seating a surgical instrument and / or a bone fastener to facilitate positioning of the spinal implant 412 with tissue. The opening 452 is configured to seat a surgical instrument and / or a bone fastener to align and / or guide the spinal implant 412 in engagement with tissue, such as a vertebra.

[0066] In assembly, operation, and use, similar to the systems and methods described herein, surgical system 10 is employed with spinal implant 412 to treat a selected segment of vertebrae V, as Figure 12 shown. A medical practitioner gains access to a surgical site including vertebrae V in conjunction with a posterolateral gutter fusion procedure to prepare a fusion bed along a lateral gutter of adjacent lumbar vertebrae levels.

[0067] Similar to described herein, spinal implant 412 is selected for placement with the structural anatomy of tissue including the prepared fusion bed. Spinal implant 412 is introduced through an incision and connected with an inserter, similar to described herein, for delivery adjacent the prepared fusion bed. Extender 204 with bone fastener 200 removably attached thereto is delivered to the surgical site including the lateral gutter. Bone fastener 200 is aligned with opening 452 for placement therein. Bone fastener 200 engages with tissue adjacent the vertebrae, as Figure 12 shown. Bone fastener 200 is placed within opening 452. As bone fastener 200 is tightened with tissue through opening 452, bone fastener 200 tightens or clamps body 414 for attachment with the prepared fusion bed and maintains spinal implant 412 in position for fusion. Upon completion of the procedure, surgical instruments, components, and non-implanted parts of surgical system 10 are removed and the incision is closed.

[0068] In some embodiments, surgical system 10 includes a kit including one or more alternative configurations of spinal implants and / or one or more components of spinal implants for connection and / or assembly. In some embodiments, the kit includes spinal implant 512 having a square configuration, as Figure 13 shown. In some embodiments, the kit includes spinal implant 612 having an oblong configuration (as Figure 14 shown) and a centrally disposed elongated slot (similar to openings described herein). In some embodiments, the kit includes spinal implant 712, as Figure 15 shown, having dual elongated chambers 722 spaced apart and disposed in a side-by-side and / or parallel orientation similar to chambers described herein.

[0069] It is to be understood that various modifications can be made to the embodiments disclosed herein. Accordingly, the description is not intended to be limiting, but merely illustrative. Other modifications will occur to those skilled in the art upon reading the specification. Therefore, it is intended that the scope of the application disclosed herein include all such modifications.

Claims

1. A spinal implant comprising: The body comprises a first layer and a second layer, the first layer being joined to form a connecting wall, the inner surfaces of the first and second layers defining a plurality of spaced-apart cavities, the connecting wall being disposed around the cavities, the body including an opening extending through the first and second layers, the opening being spaced apart from and not communicating with the cavities, and the cavities surrounding the opening, the first and second layers being connected during surgery, the connecting wall including a seam forming a seal disposed around the cavities; and A reagent that can be placed with at least one cavity, said reagent including autologous grafts or allogeneic grafts.

2. The spinal implant of claim 1, wherein the first layer and the second layer are connected during surgery to position the body as a selected implant configuration.

3. The spinal implant of claim 1, wherein the connecting wall comprises the periphery of the body disposed around the at least one cavity.

4. The spinal implant of claim 1, wherein at least one opening comprises an elongated groove centrally disposed with respect to the body.

5. The spinal implant of claim 1, wherein the cavity comprises a plurality of equal-sized chambers spaced apart by the connecting wall.

6. The spinal implant of claim 1, wherein the cavity comprises a plurality of chambers of alternative sizes spaced apart by the connecting wall.

7. The spinal implant of claim 1, wherein the body comprises a porous mesh.

8. A spinal implant system comprising: The body comprises a polymer mesh body including a first layer and a second layer, the inner surfaces of the first layer and the second layer defining a plurality of spaced cavities, the body further comprising a boundary disposed around the cavities, the body comprising an opening extending through the first layer and the second layer, the opening being spaced apart from the cavities so as not to communicate with the cavities, and the cavities surrounding the openings, the first layer and the second layer being connected during surgery, and a seal being disposed around the cavities; At least one bone fastener that can be placed together with the opening; and Reagents that can be placed together with the cavity; The opening is configured to allow the reagent from at least one of the chambers to pass through.

9. The spinal implant system of claim 8, wherein the reagent comprises a bone inducer or a bone conductant.

10. The spinal implant system of claim 8, wherein the polymer mesh body is configured to allow cells to grow inward while retaining the reagent within the cavity.

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