Spinal correction system and method

A spinal correction system comprises a first member configured for attachment to a first portion of vertebral tissue and a second member is configured for attachment to a second portion of the vertebral tissue spaced from the first portion. A third member has a non-flexible configuration relative to the first and second members and is configured for attachment to an apical portion of the vertebral tissue and along at least a portion of at least two vertebrae. The third member extends between a first end connected to the first member at a first transition configured for attachment to the first vertebral tissue and a second end connected to the second member at a second transition configured for attachment to the vertebral tissue. Methods of use are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for correction of a spine disorder.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumor, 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 correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. Correction treatments used for positioning and alignment may employ implants, such as vertebral rods, for stabilization of a treated section of a spine. This disclosure describes an improvement over these prior art technologies.

SUMMARY

Accordingly, a spinal correction construct is provided. The spinal correction construct comprises a first member configured for attachment to a first portion of vertebral tissue. A second member is configured for attachment to a second portion of the vertebral tissue spaced from the first portion. A third member includes a non-flexible configuration relative to the first and second members. The third member is configured for attachment to an apical portion of the vertebral tissue and along at least a portion of at least two vertebrae. The third member extends between a first end and a second end. The first end is connected to the first member at a first transition and is configured for attachment to the first vertebral tissue. The second is end connected to the second member at a second transition and is configured for attachment to the second vertebral tissue.

DETAILED DESCRIPTION

The exemplary embodiments of the spinal correction system and related methods of use are discussed in terms of medical devices for the treatment of musculoskeletal disorders. In some embodiments, the spinal correction system may be employed in applications for correction of deformities, such as scoliosis, with a device for applying a constant load to a flexible longitudinal element.

In one embodiment, an apical fusion system is provided with adjacent level tethering. In one embodiment, the system includes a less-fusion device employed with a method for scoliosis correction utilizing the growth of a child for continuous correction. In one embodiment, an apex of a curve, for example, including three vertebral levels and/or intervertebral disc space is fused with a spinal rod. In some embodiments, the system tethers adjacent vertebral levels. In one embodiment, the system includes a transition from a non-deformable longitudinal member, for example, a metal spinal rod or a PEEK spinal rod for fusion, to a deformable member, for example, a polymer member, an autograft member, an allograft member, and/or a flexible metal member. The transition is disposed at one vertebral body, on opposite sides, for example, anterior and posterior. In some embodiments, the system includes a device employed with a method for scoliosis correction utilizing part fusion/part fusionless for pediatric patients, and can be used for more aggressive curves.

In one embodiment, an apical fusion system is provided that includes a non-deformable member, a first deformable member, a second deformable member, a first transition and a second transition. In some embodiments, the non-deformable member provides rigid fixation to vertebrae. In one embodiment, an apical fusion system provides adjacent level tethering. In one embodiment, the system includes a rod attached to a tether. In one embodiment, the system includes a rigid rod fixed to a fusion section of vertebrae and a deformable tether. In one embodiment, the rod is fixed to vertebrae via a bone fastener. In one embodiment, the system provides apical fusion at two or more vertebral bodies. In one embodiment, tethering occurs at two or more vertebral levels.

In one embodiment, the system includes at least two rods connected to at least one tether. In some embodiments, the rods and tether can be separately attached, integrally connected or formed as a single piece. In one embodiment, the tether can be contained within at least one plate and/or within at least one rod for permanent fixation of the system with vertebrae. In one embodiment, the at least one tether can be contained within at least one rod. In one embodiment, two tethers can be inserted into two hollow rods. In one embodiment, at least one tether can be attached to a rod. In one embodiment, the rod comprises internal threading at an end that matingly engages with a tether. In some embodiments, the mating ends of the rod and tether comprise a metal. In one embodiment, at least one tether is non-permanently fixed to a plate via a set screw.

In one embodiment, the system includes a single rod attached to at least one tether. In one embodiment, the system includes a double plate and bone fasteners. In some embodiments, the bone fasteners are inserted into openings in the plate and the rod is set within the head of one of the bone fasteners. In some embodiments, a set screw fixes the rod with the bone fastener. In some embodiments, the tether is set within the head of one of the bone fasteners and a set screw fixes the tether with the bone fastener. In one embodiment, the system includes a single plate and a bone fastener.

In one embodiment, an apical fusion system is provided that is positioned on the lumbar region of the spine. In one embodiment, the system is configured to be positioned either anteriorly or posteriorly. In one embodiment, the system is configured for bilateral fusion.

In one embodiment, the system includes a posterior dual rod fusion portion and a posterior tether. In one embodiment, the tether is fixed to a convex side of a vertebral curve. In one embodiment, the system includes a posterior dual rod fusion portion and a posterior tether disposed along a costo-vertebral space, a transverse process/rib junction adjacent a costo-vertebral space and/or a costo-transverse ligament.

In some embodiments, one or all of the components of the spinal correction system may be disposable, peel-pack, pre-packed sterile devices. One or all of the components of the system may be reusable. The system may be configured as a kit with multiple sized and configured components.

The following discussion includes a description of a spinal correction system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning toFIGS. 1-5, there are illustrated components of a system, such as, for example, a spinal correction system20, in accordance with the principles of the present disclosure.

System20is employed, for example, with an open, mini-open or minimally invasive surgical technique to attach one or a plurality of longitudinal elements to a first side, such as, for example, a convex side of a spine that has a spinal disorder. In one embodiment, the longitudinal element(s), such as, for example, a tether and/or a spinal rod, may be affixed to the convex side of each of a plurality of vertebrae such that system20prevents growth of vertebrae of a selected section of the spine while allowing for growth and adjustments to a second side, such as, for example, a concave side of the plurality of vertebrae for a correction treatment to treat various spine pathologies, such as, for example, adolescent idiopathic scoliosis and Scheuermann's kyphosis.

Spinal correction system20includes a member, such as, for example, a tether22configured for attachment to a first portion of vertebral tissue, such as, for example, a selected section of vertebrae, as discussed herein. Tether22comprises a flexible longitudinal element, as described herein, which extends between an end24and an end26. Tether22defines a longitudinal axis upon disposal in a linear orientation.

In some embodiments, all or only a portion of tether22may have flexible properties, such as the flexible properties corresponding to the material examples described above, such that tether22provides a selective amount of expansion and/or extension in an axial direction. In some embodiments, all or only a portion of tether22may have a semi-rigid, rigid or elastic configuration, and/or have elastic properties, such as the elastic properties corresponding to the material examples described above, such that tether22provides a selective amount of expansion and/or extension in an axial direction.

In some embodiments, tether22has a flexible configuration, which includes movement in a lateral or side to side direction and prevents expanding and/or extension in an axial direction upon fixation with vertebrae. In some embodiments, tether22may be compressible in an axial direction. Tether22can include a plurality of separately attachable or connectable portions or sections, such as bands or loops, or may be monolithically formed as a single continuous element.

Tether22can have a uniform thickness/diameter. In some embodiments, tether22may have various surface configurations, such as, for example, rough, threaded for connection with surgical instruments, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured according to the requirements of a particular application. In some embodiments, the thickness defined by tether22may be uniformly increasing or decreasing, or have alternate diameter dimensions along its length. In some embodiments, tether22may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered.

In some embodiments, tether22may have various lengths, according to the requirements of a particular application. In some embodiments, tether22may be braided, such as a rope, or include a plurality elongated elements to provide a predetermined force resistance. In some embodiments, tether22may be made from autograft and/or allograft, as described above, and be configured for resorbable or degradable applications. In one embodiment, tether22is a cadaver tendon. In one embodiment, tether22is a tendon that may be harvested, for example, from a patient or donor. In some embodiments, a tendon harvested from a patient may be affixed in remote locations with the patient's body.

A tether28, similar to tether22, extends between an ends30,32and is configured for attachment to a first portion of vertebral tissue, such as, for example, a selected section of vertebrae, as discussed herein. Tether28is configured for attachment to a selected section of vertebrae spaced from the selected section of vertebrae connected to tether22. Tether28defines a longitudinal axis upon disposal in a linear orientation. In some embodiments, the selected sections of vertebrae may be adjacent, staggered and/or offset. In some embodiments, tether28can have varying degrees of flexibility relative to tether22.

A member, such as, for example, a spinal rod34extends between ends36,38and has a non-flexible configuration relative to each of tethers22,28. Spinal rod34is configured for attachment to an apical portion of vertebral tissue and along at least a portion of a first vertebra and a second vertebra, as described herein. Spinal rod34is configured for disposal with vertebrae intermediate tethers22,28. In some embodiments, intermediate disposal of spinal rod34can include co-axial, offset, staggered, transverse, angular and/or relative posterior/anterior orientations with tethers22,28. Spinal rod34defines a longitudinal axis upon disposal in a linear orientation.

In some embodiments, spinal rod34has a rigid and/or non-flexible configuration relative to tether22and/or tether28such that all or only a portion of spinal rod34may have a semi-rigid, rigid or elastic configuration, and/or have elastic properties, such as the elastic properties corresponding to the material examples described above. In some embodiments, spinal rod34provides a selective amount of expansion and/or extension in an axial direction. In some embodiments, spinal rod34has a flexible configuration, which includes movement in a lateral or side to side direction and prevents expanding and/or extension in an axial direction upon fixation with vertebrae. In some embodiments, spinal rod34may be compressible in an axial direction. Spinal rod34can include a plurality of separately attachable or connectable portions or sections, or may be monolithically formed as a single continuous element. System20can include one or a plurality of spinal rods34. In some embodiments, spinal rod34is configured to extend over a plurality of vertebral levels.

Spinal rod34can have a uniform thickness/diameter. In some embodiments, spinal rod34may have various surface configurations, such as, for example, rough, threaded for connection with surgical instruments, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured according to the requirements of a particular application. In some embodiments, the thickness defined by spinal rod34may be uniformly increasing or decreasing, or have alternate diameter dimensions along its length. In some embodiments, spinal rod34may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered.

Plate40has a double plate configuration and includes an opening46configured for disposal of bone fastener42and an opening48configured for disposal of bone fastener44. Opening46is spaced from opening48along the surface of plate40for alignment with tether22, tether28and/or spinal rod34, according to the requirements of a particular application. Openings46,48are substantially circular and extend through the thickness of plate40. In some embodiments, opening46and/or opening48can be variously configured, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform and/or tapered.

Opening46is configured to receive bone fastener42that connects tether22to plate40and/or tissue, as will be described. Bone fastener42has a length that is extendable along a longitudinal axis. Bone fastener42comprises a head50and an elongated shaft52configured for penetrating tissue, as shown inFIG. 3.

Shaft52has 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 on shaft52, such as, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement of shaft52with tissue, such as, for example, vertebrae.

In some embodiments, all or only a portion of the shaft52may 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 of shaft52may include one or a plurality of openings. In some embodiments, all or only a portion of the outer surface of shaft52may have alternate surface configurations to enhance fixation with tissue such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured according to the requirements of a particular application. In some embodiments, all or only a portion of shaft52may be disposed at alternate orientations, relative to the longitudinal axis, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, that all or only a portion of shaft52may be cannulated.

Head50includes a pair of spaced apart arms having an inner surface that defines a U-shaped passageway54. Passageway54is configured for disposal of an implant, such as, for example, tether22. In some embodiments, all or only a portion of passageway54may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. In some embodiments, the arms of head50may be disposed at alternate orientations, relative to the longitudinal axis, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered.

The inner surface of head50includes a thread form configured for engagement with a coupling member, such as, for example, a set screw56. Screw56is threadably engageable with the inner surface of head50to connect, attach, fix and/or lock, provisionally, removably and/or permanently, tether22to plate40and/or tissue, as will be described. Screw56includes an element58that penetrates tether22to facilitate connection of the components of system20and tissue.

Opening48is configured to receive bone fastener44that connects spinal rod34to plate40and/or tissue, as will be described. Bone fastener44has a length that is extendable along a longitudinal axis. Bone fastener44, similar to bone fastener42, comprises a head60and an elongated shaft62configured for penetrating tissue, as shown inFIG. 3. The inner surface of head60includes a thread form configured for engagement with a coupling member, such as, for example, a set screw64. Set screw64is threaded with head60to connect, attach, fix and/or lock, provisionally, removably and/or permanently, spinal rod34to plate40and/or tissue, as will be described.

A transition, such as, for example, a plate66, similar to plate40, includes bone fasteners68,70configured for fixation with vertebrae. Plate66has a double plate configuration and includes an opening72configured for disposal of bone fastener68and an opening74configured for disposal of bone fastener70. Opening72is spaced from opening74along the surface of plate66for alignment with tether22, tether28and/or spinal rod34, according to the requirements of a particular application.

Opening72is configured to receive bone fastener68that connects tether28to plate66and/or tissue, as will be described. Bone fastener68has a length that is extendable along a longitudinal axis. Bone fastener68, similar to bone fastener42, comprises a head76and an elongated shaft (not shown) configured for penetrating tissue.

Head76includes a pair of spaced apart arms having an inner surface that defines a U-shaped passageway configured for disposal of an implant, such as, for example, tether28. The inner surface of head76includes a thread form configured for engagement with a coupling member, such as, for example, a set screw78, similar to screw56. Screw78is threadably engageable with the inner surface of head76to connect, attach, fix and/or lock, provisionally, removably and/or permanently, tether28to plate66and/or tissue, as will be described.

Opening74is configured to receive bone fastener70that connects spinal rod34to plate66and/or tissue, as will be described. Bone fastener70has a length that is extendable along a longitudinal axis. Bone fastener70, similar to bone fastener44, comprises a head80and an elongated shaft (not shown) configured for penetrating tissue. The inner surface of head80includes a thread form configured for engagement with a coupling member, such as, for example, a set screw82, similar to set screw64. Set screw82is threaded with head80to connect, attach, fix and/or lock, provisionally, removably and/or permanently, spinal rod34to plate66and/or tissue, as will be described.

A plate84, as shown inFIG. 4, has a single plate configuration and includes an opening86configured for disposal of bone fastener42, described herein, to connect, attach, fix and/or lock, provisionally, removably and/or permanently, tether22to tissue, as will be described. A plate88, as shown inFIG. 5, has a single plate configuration and includes an opening90configured for disposal of bone fastener44, described herein, to connect, attach, fix and/or lock, provisionally, removably and/or permanently, spinal rod34to tissue, as will be described. A plate92has a single plate configuration and includes an opening94configured for disposal of bone fastener68, described herein, to connect, attach, fix and/or lock, provisionally, removably and/or permanently, tether28to tissue, as will be described.

In some embodiments, spinal correction system20can include one or a plurality of fasteners, such as those described herein and/or fixation elements, which may be employed with a single vertebral level or a plurality of vertebral levels. In some embodiments, the fasteners may be engaged with vertebrae in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, the fasteners and/or fixation elements may include one or a plurality of multi-axial screws, sagittal angulation screws, pedicle screws, mono-axial screws, uni-planar screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts. These bone fasteners and/or fixation elements may be coated with an osteoinductive or osteoconductive material to enhance fixation, and/or include one or a plurality of therapeutic agents.

In assembly, operation and use, spinal correction system20, similar to the system described above, is employed with a surgical procedure, such as, for a correction treatment to treat adolescent idiopathic scoliosis and/or Scheuermann's kyphosis of a spine. In some embodiments, one or all of the components of spinal correction system20can be delivered or implanted as a pre-assembled device or can be assembled in situ. Spinal correction system20may be completely or partially revised, removed or replaced.

For example, as shown inFIGS. 1 and 2, spinal correction system20can be employed with a surgical correction treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body, such as, for example, vertebrae V1-V9of vertebrae V. In some embodiments, spinal correction system20may be employed with one or a plurality of vertebrae.

In use, to treat a selected section of vertebrae V, which includes an apical portion A of vertebrae V, a medical practitioner obtains access to a surgical site including vertebrae V in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, spinal correction system20can be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby vertebrae V is accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure can be performed for treating the spine disorder.

An incision is made in the body of a patient and a cutting instrument (not shown) creates a surgical pathway for implantation of components of spinal correction system20. A preparation instrument (not shown) can be employed to prepare tissue surfaces of vertebrae V, as well as for aspiration and irrigation of a surgical region according to the requirements of a particular surgical application.

Pilot holes are made in vertebrae V for receiving bone fasteners42,44,68,70that connect plates40,66,84,88,92, tethers22,28and spinal rod34with vertebrae V1-V9. In some embodiments, the sequence and/or order of connecting bone fasteners42,44,68,70, plates40,66,84,88,92, tethers22,28and spinal rod34with vertebrae V1-V9, may be variously arranged.

For example, a pilot hole is made in vertebra V3for receiving bone fastener42that connects tether22and plate84with vertebra V3. Plate84is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate84is delivered to a surgical site adjacent vertebra V3. Plate84is oriented for fixation with vertebra V3. Bone fastener42is inserted or otherwise engaged with vertebra V3to fix an intermediate portion of tether22with plate84and vertebra V3. Bone fasteners42are similarly inserted or otherwise engaged with vertebrae V1, V2to fix tether22with plates84and vertebrae V1, V2.

A pilot hole is made in vertebra V4for receiving bone fastener42. The pilot hole in vertebra V4is disposed to connect tether22in a selected alignment with bone fastener42attached to vertebra V3along vertebrae V. Bone fastener42connects end26of tether22and plate40with vertebra V4. A pilot hole is made in vertebra V4for receiving bone fastener44and is spaced laterally from the pilot hole for bone fastener42in vertebra V4. Bone fastener44connects end36of spinal rod34and plate40with vertebra V4. Plate40is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate40is delivered to a surgical site adjacent vertebra V4. Plate40is oriented for fixation with vertebra V4. Bone fastener42is inserted or otherwise engaged with vertebra V4to fix end26with plate40and vertebra V4. Bone fastener44is inserted or otherwise engaged with vertebra V4to fix end36with plate40and vertebra V4.

A pilot hole is made in vertebra V5for receiving bone fastener44. The pilot hole in vertebra V5is disposed to connect spinal rod34in a selected alignment with bone fastener44attached to vertebra V4and/or vertebra V6along vertebrae V. Bone fastener44connects an intermediate portion of spinal rod34and plate88with vertebra V5. Plate88is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate88is delivered to a surgical site adjacent vertebra V5. Plate88is oriented for fixation with vertebra V5. Bone fastener44is inserted or otherwise engaged with vertebra V5to fix an intermediate portion of spinal rod34with plate88and vertebra V5.

A pilot hole is made in vertebra V6for receiving bone fastener70. The pilot hole in vertebra V6is disposed to connect spinal rod34in a selected alignment with bone fastener44attached to vertebra V5along vertebrae V. Bone fastener70connects end38of spinal rod34and plate66with vertebra V6. A pilot hole is made in vertebra V6for receiving bone fastener68and is spaced laterally from the pilot hole for bone fastener70in vertebra V6. Bone fastener68connects end30of tether28and plate66with vertebra V6. Plate66is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate66is delivered to a surgical site adjacent vertebra V6. Plate66is oriented for fixation with vertebra V6. Bone fastener70is inserted or otherwise engaged with vertebra V6to fix end38with plate66and vertebra V6. Bone fastener68is inserted or otherwise engaged with vertebra V6to fix end30with plate66and vertebra V6.

A pilot hole is made in vertebra V7for receiving bone fastener68. The pilot hole in vertebra V7is disposed to connect tether28in a selected alignment with bone fastener68attached to vertebra V6along vertebrae V. Bone fastener68connects an intermediate portion of tether28and plate92with vertebra V7. Plate92is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate92is delivered to a surgical site adjacent vertebra V7. Plate92is oriented for fixation with vertebra V7. Bone fastener68is inserted or otherwise engaged with vertebra V7to fix an intermediate portion of tether28with plate92and vertebra V7. Bone fasteners68are similarly inserted or otherwise engaged with vertebrae V8, V9to fix tether28with plates92and vertebrae V8, V9.

As shown inFIGS. 1 and 2, spinal rod34is attached with apical portion A, and tether22and tether28are axially spaced along vertebrae V. Tether22and tether28are disposed in a substantially co-axial arrangement along vertebrae V. Spinal rod34and tethers22,28are disposed in a substantially offset and/or staggered arrangement along vertebrae V. In this configuration, the components of spinal correction system20are attached with a first side, such as, for example, a convex side of vertebrae V to prevent growth of a selected section of vertebrae V, while allowing for growth and adjustments to a second side, such as, for example, a concave side of vertebrae V to provide treatment. Compression of vertebrae V occurs along the convex side. As forces and/or force changes are applied to spinal correction system20, such as, for example, patient growth, trauma and degeneration, and/or system20component creep, deformation, damage and degeneration, tether22and/or tether28adapts with a responsive force to maintain the applied force transmitted from the bone fasteners substantially constant.

In one embodiment, spinal correction system20includes an agent, which may be disposed, packed or layered within, on or about the components and/or surfaces of spinal correction system20. For example, the plates can comprise one or a plurality of surface treatments and/or coatings including the agent. In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the fixation elements with vertebrae V.

In some embodiments, the agent may include therapeutic polynucleotides or polypeptides. In some embodiments, the agent may include biocompatible materials, such as, for example, biocompatible metals and/or rigid polymers, such as, titanium elements, metal powders of titanium or titanium compositions, sterile bone materials, such as allograft or xenograft materials, synthetic bone materials such as coral and calcium compositions, such as HA, calcium phosphate and calcium sulfite, biologically active agents, for example, gradual release compositions such as by blending in a bioresorbable polymer that releases the biologically active agent or agents in an appropriate time dependent fashion as the polymer degrades within the patient. Suitable biologically active agents include, for example, BMP, Growth and Differentiation Factors proteins (GDF) and cytokines. The components of spinal correction system20can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. 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.

In some embodiments, the use of microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of spinal correction system20. Upon completion of the procedure, the surgical instruments, assemblies and non-implant components of spinal correction system20are removed from the surgical site and the incision is closed.

In some embodiments, the components of spinal correction system20may be employed to treat progressive idiopathic scoliosis with or without sagittal deformity in either infantile or juvenile patients, including but not limited to prepubescent children, adolescents from 10-12 years old with continued growth potential, and/or older children whose growth spurt is late or who otherwise retain growth potential. In some embodiments, the components of spinal correction system20and method of use may be used to prevent or minimize curve progression in individuals of various ages.

In one embodiment, as shown inFIGS. 6 and 7, spinal correction system20, similar to the systems and methods described herein, is employed with a surgical correction treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body, such as, for example, vertebrae V1-V9of vertebrae V.

Spinal correction system20comprises a spinal rod124, similar to spinal rod34described herein, extending between ends126,128and a plate102, similar to the plates40,66described above, having a double plate configuration and including an opening104configured for disposal of bone fastener44, described herein, and an opening106configured for disposal of bone fastener44. Opening106is spaced from opening104along the surface of plate102for alignment of spinal rods34,124described. Plate102includes a cavity108configured for disposal of tether22, described herein. The inner surface of cavity108includes a thread form configured for engagement with set screw56, described herein. Screw56is threadably engageable with the inner surface of cavity108to connect, attach, fix and/or lock, provisionally, removably and/or permanently, tether22with plate102to facilitate connection of the components of system20and tissue.

A plate110, similar to the plates40,66described above, has a double plate configuration and includes an opening112configured for disposal of bone fastener44and an opening114configured for disposal of bone fastener44. Opening114is spaced from opening112along the surface of plate110for alignment spinal rods34,124.

A plate116, similar to the plate102described above, has a double plate configuration and includes an opening118configured for disposal of bone fastener44and an opening120configured for disposal of bone fastener44. Opening120is spaced from opening118along the surface of plate116for alignment of spinal rods34,124. Plate116includes a cavity122configured for disposal of tether28. The inner surface of cavity122includes a thread form configured for engagement with set screw56to connect, attach, fix and/or lock, provisionally, removably and/or permanently, tether28with plate116to facilitate connection of the components of system20and tissue.

In use, similar to the methods described herein, pilot holes are made in vertebrae V for receiving bone fasteners42,44that connect plates84,102,110,116,92, tethers22,28and spinal rod34,124with vertebrae V1-V9. In some embodiments, the sequence and/or order of connecting bone fasteners42,44plates84,102,110,116,92, tethers22,28and spinal rod34,124with vertebrae V1-V9, may be variously arranged.

A pilot hole is made in vertebra V3for receiving bone fastener42that connects tether22and plate84with vertebra V3. Plate84is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate84is delivered to a surgical site adjacent vertebra V3. Plate84is oriented for fixation with vertebra V3. Bone fastener42is inserted or otherwise engaged with vertebra V3to fix an intermediate portion of tether22with plate84and vertebra V3. Bone fasteners42are similarly inserted or otherwise engaged with vertebrae V1, V2to fix tether22with plate84and vertebrae V1, V2.

Pilot holes are made in vertebra V4for receiving bone fasteners44. The pilot holes in vertebra V4are disposed to connect rods34,124in an offset alignment with bone fastener42attached to vertebra V3along vertebrae V. Pilot holes are made in vertebra V4for receiving bone fasteners44. Bone fasteners44connect end36of rod34and end126of rod124and plate102with vertebra V4. Plate102is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate102is delivered to a surgical site adjacent vertebra V4. Plate102is oriented for fixation with vertebra V4. Bone fasteners44are inserted or otherwise engaged with vertebra V4to fix end26and end126with plate102and vertebra V4. End26of tether22is fixed with plate102and connected to vertebra V4.

Pilot holes are made in vertebra V5for receiving bone fasteners44. The pilot holes in vertebra V5are disposed to connect spinal rods34,124in a selected alignment with bone fasteners44attached to vertebra V4and/or vertebra V6along vertebrae V. Bone fastener44connects an intermediate portion of spinal rods34,124and plate110with vertebra V5. Plate110is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate110is delivered to a surgical site adjacent vertebra V5. Plate110is oriented for fixation with vertebra V5. Bone fasteners44are inserted or otherwise engaged with vertebra V5to fix an intermediate portion of spinal rods34,124with plate110and vertebra V5.

Pilot holes are made in vertebra V6for receiving bone fasteners44being spaced laterally apart from each other along vertebrae V6. The pilot holes in vertebra V6are disposed to connect rods34,124in alignment with bone fasteners44attached to vertebra V5along vertebrae V. Bone fasteners44connect end38of spinal rod34, end128of spinal rod124and plate116with vertebra V6. Plate116is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate116is delivered to a surgical site adjacent vertebra V6. Plate116is oriented for fixation with vertebra V6. Bone fasteners44are inserted or otherwise engaged with vertebra V6to fix ends38,128with plate116and vertebra V6. End30of tether28is fixed with plate116and vertebra V6.

A pilot hole is made in vertebra V7for receiving bone fastener68. The pilot hole in vertebra V7is disposed to connect tether28in an offset alignment with bone fasteners44attached to vertebra V6along vertebrae V. Bone fastener68connects an intermediate portion of tether28and plate92with vertebra V7. Plate92is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate92is delivered to a surgical site adjacent vertebra V7. Plate92is oriented for fixation with vertebra V7. Bone fastener68is inserted or otherwise engaged with vertebra V7to fix an intermediate portion of tether28with plate92and vertebra V7. Bone fasteners68are similarly inserted or otherwise engaged with vertebrae V8, V9to fix tether28with plates92and vertebrae V8, V9.

As shown inFIG. 6, spinal rods34,124are attached with an apical portion of vertebrae V, and tether22and tether28are axially spaced along vertebrae V. Tether22and tether28are disposed in an offset arrangement with respect to rods34,124along vertebrae V. Spinal rods34,124are disposed in a substantially parallel arrangement along the apical portion of vertebrae V.

In one embodiment, as shown inFIGS. 8 and 9, spinal correction system20, similar to the systems and methods described herein, includes a spinal rod234, similar to the spinal rods described herein, and tethers222,228, similar to the tethers described herein.

Spinal rod234extends between ends236,238. End236includes a cavity240having an inner surface. The inner surface of cavity240includes a thread form configured for engagement and connection with an end of tether222. End238includes a cavity (not shown), similar to end236above, having an inner surface. The inner surface of the cavity at end238includes a thread form configured for engagement and connection with an end of tether228, discussed below.

Tether222includes a flange242extending from end226. Flange242is threadably engageable with cavity240such that rod234and tether222are in axial alignment. Tether228includes a flange (not shown), similar to flange242described above, extending from end230. The flange at end230is threadably engageable with the cavity of at end238of rod234such that rod234and tether222are in axial alignment. In some embodiments, the flange of tether222and/or tether228can be a rigid component, for example, those materials described herein, relative to the tether. System20includes plates244,246, similar to plate88discussed above. Tethers222,228and spinal rod234can be fixed and/or locked, provisionally, removably and/or permanently. In some embodiments, end236and/or end238can include a flange, as described above, and end226and/or end230can include a surface defining a cavity, as described above, for threaded engagement with the flange and connection of rod234and tethers222,228.

In some embodiments, system20can alternatively connect and/or join the relatively rigid and non-rigid components of system20, for example, to co-axially align spinal rod234and tethers222,228. For example, in one embodiment, as shown inFIG. 10, end236includes a cavity, such as, for example, a keyway436having an inner surface configured as a female mating part. The inner surface of keyway436is configured for engagement and connection with an end of tether222. Tether222includes a key424configured as a male mating part extending from end226. Key424is manipulated for lateral assembly with keyway436such that rod234and tether222are in co-axial alignment. The surface of key424and the surface that defines keyway436engage to prevent axial disengagement of tether222and rod234. In some embodiments, end236can include a key, as described above, and end226can include a surface defining a keyway, as described above, for engagement with the key and connection of rod234and tether222.

In one embodiment, as shown inFIG. 11, end236includes a hook536having an arcuate configuration and end226includes a suture loop524to connect and/or join the relatively rigid and non-rigid components of system20, for example, to co-axially align spinal rod234and tethers222,228. Loop524is configured to wrap around hook536such that loop524is removably connected with hook536. In one embodiment, as shown inFIG. 12, end236includes a plurality of spaced apart through openings636and end226includes a suture loop624to connect and/or join the relatively rigid and non-rigid components of system20, for example, to co-axially align spinal rod234and tethers222,228. Loop624is selectively disposed with one of openings636such that loop524is fixedly and/or permanently connected with end236. In some embodiments, openings636are spaced at increments along end236. In some embodiments, the incremental spacing allows for adjustment of the length of the tethers and/or rods. In some embodiments, end236can be cut to a desired length.

Pilot holes are made in vertebrae V for receiving bone fasteners42,44that connect plates84,88,244,246,92, tethers222,228and spinal rod234with vertebrae V1-V9. In some embodiments, the sequence and/or order of connecting bone fasteners42,44, plates84,88,244,246,92, tethers222,228and spinal rod234with vertebrae V1-V9, may be variously arranged.

A pilot hole is made in vertebra V3for receiving bone fastener42that connects tether222and plate84with vertebra V3. Plate84is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate84is delivered to a surgical site adjacent vertebra V3. Plate84is oriented for fixation with vertebra V3. Bone fastener42is inserted or otherwise engaged with vertebra V3to fix an intermediate portion of tether222with plate84and vertebra V3. Bone fasteners42are similarly inserted or otherwise engaged with vertebrae V1, V2to fix tether222with plate84and vertebrae V1, V2.

A pilot hole is made in vertebra V4for receiving bone fastener44. Tether224is fixed with spinal rod234. Bone fastener44connects end236of rod234and plate88with vertebra V4. A pilot hole is made in vertebra V4for receiving bone fastener44placed in axial alignment with bone fastener42of vertebrae V3. Bone fastener44connects end236of spinal rod234and plate88with vertebra V4. Plate88is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate88is delivered to a surgical site adjacent vertebra V4. Plate88is oriented for fixation with vertebra V4. Bone fastener44is inserted or otherwise engaged with vertebra V4to fix end236with plate88and vertebra V4.

A pilot hole is made in vertebra V5for receiving bone fastener44. The pilot hole in vertebra V5is disposed to connect spinal rod234in a selected alignment with bone fastener44attached to vertebra V4and/or vertebra V6along vertebrae V. Bone fastener44connects an intermediate portion of spinal rod234and plate244with vertebra V5. Plate244is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate244is delivered to a surgical site adjacent vertebra V5. Plate244is oriented for fixation with vertebra V5. Bone fastener44is inserted or otherwise engaged with vertebra V5to fix an intermediate portion of spinal rod234with plate244and vertebra V5.

A pilot hole is made in vertebra V6for receiving bone fastener44. The pilot hole in vertebra V6is disposed to connect spinal rod234in a selected alignment with bone fastener44attached to vertebra V5along vertebrae V. The flange disposed on end230of tether228is engaged with end238of spinal rod234. Bone fastener44connects end238of spinal rod234and plate246with vertebra V6. A pilot hole is made in vertebra V6for receiving bone fastener44and is spaced in axial alignment with fastener44in vertebrae V5. Plate246is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate246is delivered to a surgical site adjacent vertebra V6. Plate246is oriented for fixation with vertebra V6. Bone fastener44is inserted or otherwise engaged with vertebra V6to fix end238with plate246and vertebra V6.

A pilot hole is made in vertebra V7for receiving bone fastener42. The pilot hole in vertebra V7is disposed to connect tether228in a selected alignment with bone fastener44attached to vertebra V6along vertebrae V. Bone fastener42connects an intermediate portion of tether228and plate92with vertebra V7. Plate92is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate92is delivered to a surgical site adjacent vertebra V7. Plate92is oriented for fixation with vertebra V7. Bone fastener68is inserted or otherwise engaged with vertebra V7to fix an intermediate portion of tether28with plate92and vertebra V7. Bone fasteners42are similarly inserted or otherwise engaged with vertebrae V8, V9to fix tether28with plates92and vertebrae V8, V9.

As shown inFIG. 8, spinal rod234is attached with an apical portion of vertebrae V, and tether222and tether228are axially spaced along vertebrae V. Spinal rod234and tethers222,228are disposed in a substantially coaxial arrangement along vertebrae V.

In one embodiment, as shown inFIG. 13, spinal correction system20, similar to the systems and methods described herein, is employed with a lumbar section of vertebrae V. Spinal correction system20includes a plate302, similar to the plate66described above. Plate302has a double plate configuration and includes an opening304configured for disposal of bone fastener44and an opening306configured for disposal of bone fastener44. Opening306is spaced from opening304along the surface of plate302for alignment of spinal rods234,124, described above.

A plate308, similar to the plate302described above, has a double plate configuration and includes an opening310configured for disposal of bone fastener44and an opening312configured for disposal of bone fastener44. Opening312is spaced from opening310along the surface of plate308for alignment spinal rods234,124.

A plate314, similar to the plate302described above, has a double plate configuration and includes an opening316configured for disposal of bone fastener44and an opening318configured for disposal of bone fastener44. Opening318is spaced from opening316along the surface of plate314for alignment spinal rods234,124.

Pilot holes are made in vertebrae V for receiving bone fasteners42,44,68that connect plates84,302,308,314,92, tethers222,228and spinal rods234,124with vertebrae V1-V9. In some embodiments, the sequence and/or order of connecting bone fasteners42,44,68, plates84,302,308,314,92, tethers222,228and spinal rods234,124with vertebrae V1-V9, may be variously arranged.

A pilot hole is made in vertebra V3for receiving bone fastener42that connects tether222and plate84with vertebra V3. Plate84is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate84is delivered to a surgical site adjacent vertebra V3. Plate84is oriented for fixation with vertebra V3. Bone fastener42is inserted or otherwise engaged with vertebra V3to fix an intermediate portion of tether222with plate84and vertebra V3. Bone fasteners42are similarly inserted or otherwise engaged with vertebrae V1, V2to fix tether222with plate84and vertebrae V1, V2.

Pilot holes are made in vertebra V4for receiving bone fasteners44. Pilot holes in vertebra V4are disposed to connect rods234,124to vertebra V4along vertebrae V to plate302. Pilot holes are made in vertebra V4for receiving bone fasteners44being spaced laterally from each other in vertebra V4. End226of tether222is threadably engaged with end236of spinal rod234in axial alignment. Bone fasteners44connect end236of rod234and end126of rod124and plate302with vertebra V4. Rod124is positioned offset from rod234and tether222. Plate302is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate302is delivered to a surgical site adjacent vertebra V4. Plate302is oriented for fixation with vertebra V4. Bone fasteners44are inserted or otherwise engaged with vertebra V4to fix end236and end126with plate302and vertebra V4.

Pilot holes are made in vertebra V5for receiving bone fasteners44. The pilot holes in vertebra V5are disposed to connect spinal rods234,124in a selected alignment with bone fasteners44attached to vertebra V4and/or vertebra V6along vertebrae V. Bone fasteners44connect an intermediate portion of spinal rods234,124and plate308with vertebra V5. Plate308is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate308is delivered to a surgical site adjacent vertebra V5. Plate308is oriented for fixation with vertebra V5. Bone fasteners44are inserted or otherwise engaged with vertebra V5to fix an intermediate portion of spinal rods234,124with plate308and vertebra V5.

Pilot holes are made in vertebra V6for receiving bone fasteners44being spaced laterally apart from each other along vertebrae V6. The pilot holes in vertebra V6are disposed to connect spinal rods234,124in a selected alignment with bone fasteners44attached to vertebra V5along vertebrae V. Bone fasteners44connect end238of spinal rod234, end128of spinal rod124and plate314with vertebra V6. End230of tether228is threadably engaged with end238of rod234. Plate314is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate314is delivered to a surgical site adjacent vertebra V6. Plate314is oriented for fixation with vertebra V6. Bone fasteners44are inserted or otherwise engaged with vertebra V6to fix ends238,128with plate314and vertebra V6.

A pilot hole is made in vertebra V7for receiving bone fastener68. The pilot hole in vertebra V7is disposed to connect tether228in an axial alignment with rod234. Bone fastener68connects an intermediate portion of tether228and plate92with vertebra V7. Plate92is removably engaged with a delivery instrument (not shown) and delivered along the surgical pathway. Plate92is delivered to a surgical site adjacent vertebra V7. Plate92is oriented for fixation with vertebra V7. Bone fastener68is inserted or otherwise engaged with vertebra V7to fix an intermediate portion of tether228with plate92and vertebra V7. Bone fasteners68are similarly inserted or otherwise engaged with vertebrae V8, V9to fix tether228with plates92and vertebrae V8, V9.

As shown inFIG. 13, spinal rods234,124are attached in a side by side orientation with an apical portion of vertebrae V and disposed in a substantially parallel arrangement adjacent a lumbar region of vertebrae V, and tether222and tether228are disposed in a substantially co-axial arrangement with rod234along vertebrae V.