Patent Description:
Spinal pathologies and disorders such as kyphosis, scoliosis and other curvature abnormalities, 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. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. The rods may be attached via the fasteners to the exterior of two or more vertebral members. This disclosure describes an improvement over these prior technologies.

From <CIT> a spinal construct is known, comprising: a body defining a first groove, a first band disposable in the first groove, a base connectable with the body and engageable with the first band, the base defining a second groove and a slot, a second band disposable in the second groove and defining an opening aligned with the slot, and a shaft connectable with the base and engageable with the second band, the shaft being configured to penetrate tissue, and the opening being aligned with the slot to facilitate an angular range of movement of the shaft relative to the body.

Further spinal constructs are known from e.g. <CIT> and <CIT>.

The present invention provides a spinal construct with the features according to claim <NUM>. Further preferred embodiments of the spinal construct are described in the dependent claims.

The exemplary embodiments of a surgical system disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a spinal construct. In some embodiments, a spinal implant system includes a spinal construct having a spinal rod having a body connectable with a screw shaft. In some embodiments, the spinal implant system includes a selectively coupled spinal construct system that allows for assembly during surgery and/or with operating room back-table assembly without use of instrumentation. In some embodiments, the systems of the present disclosure are employed with a spinal joint fusion or fixation procedure, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine. The surgical methods and treatments described herein do not form part of the invention but are helpful in understanding the invention.

In some embodiments, the present spinal implant system comprises a spinal implant, such as, for example, a spinal construct having a screw shaft that is engageable with tissue surfaces of one or more vertebral levels. In some embodiments, the spinal implant system includes a selectively coupled spinal construct system that allows for a biased angle configuration. In some embodiments, the spinal construct includes a body with a spinal rod extending therefrom and being connectable with a screw shaft. In some embodiments, the connection of the body and the screw shaft provide a range of angulation to allow the body and/or spinal rod to be positioned in a relaxed or non-stressed orientation relative to the screw shaft. In some embodiments, this configuration allows the components of adjacent spinal constructs, which may include bone screws and/or spinal rods, to be disposed in a relatively parallel orientation. In some embodiments, the spinal implant system comprises a spinal construct including one or more components configured for angulation in a cephalad-caudal direction of a patient body. In some embodiments, the spinal construct includes a body with a spinal rod extending therefrom and being connectable with a screw shaft in a non-instrumented assembly. In some embodiments, this configuration avoids a surgical step of seating a separate spinal rod with an implant receiver.

In some embodiments, the spinal construct body is connectable with a screw shaft configured for angulation in a range of approximately <NUM> through approximately <NUM> degrees relative to a patient body. In some embodiments, the spinal construct comprises a body with a spinal rod extending therefrom, a crown, a base, a head-base ring, a crown ring, and bone screw shaft ring and a bone screw shaft. In some embodiments, the crown includes a temporary retention slot and/or ramp. In some embodiments, a head of the bone screw shaft includes a base retention slot. In some embodiments, the spinal rod extends from the body at an angle in a range of approximately <NUM> through approximately <NUM> degrees relative to the body. In some embodiments, the spinal rod extends at an angle of <NUM> degrees relative to a transverse axis of the body.

In some embodiments, the spinal construct body includes ring slots to facilitate a manual engagement of the body and the screw shaft. In some embodiments, the base includes a biased angle slot. In some embodiments, the base includes a screw shaft ring slot configured to resist and/or prevent the screw ring from rotation.

In some embodiments, the spinal construct comprises a crown having a flat top, knurled features and mating features to facilitate positioning with the screw head. In some embodiments, the crown includes a cavity configured for disposal of the screw shaft. In some embodiments, the crown includes planar surfaces configured for a keyed connection with the screw head. In some embodiments, the planar surfaces are utilized to position the biased angle feature on the base.

In some embodiments, the screw shaft ring includes a thickness. In some embodiments, the screw shaft ring includes two chamfers. In some embodiments, the screw shaft ring includes a cavity. In some embodiments, the cavity is configured to facilitate axial translation of the screw shaft ring relative to the base. In some embodiments, the cavity is engageable with the base to resist and/or prevent rotation of the screw shaft ring such that the screw shaft ring slot is positioned in alignment with the biased angle slot of the base. In some embodiments, the screw shaft ring slot is configured to allow angulation of the screw shaft at approximately <NUM> degrees. In some embodiments, the screw shaft ring slot and the biased angle slot can be rotated <NUM> degrees about the screw shaft.

In some embodiments, the screw shaft includes a base having notches configured for engagement with ends of the screw shaft ring to resist and/or prevent disengagement of the screw shaft ring from the base. In some embodiments, engagement of the screw shaft ring with surfaces of the notches allows for axial translation of the screw shaft ring relative to the base while resisting and/or preventing rotation of the screw shaft ring relative to the base to maintain alignment of an opening of the bone screw shaft ring with the biased angle slot.

In some embodiments, the spinal implant system comprises a modular spinal construct. In some embodiments, the spinal implant system comprises a modular spinal construct including screw shaft assemblies and body/spinal rod assemblies that may be joined together during manufacturing or intra-operatively, such as, for example, during a surgical procedure in an operating room.

In some embodiments, the spinal construct is configured for assembly without the use of an instrument, such as, for example, a practitioner, surgeon and/or medical staff utilizes their hands for assembly. In some embodiments, the system requires minimal force to attach a body and a screw shaft assembly in-situ thereby reducing a pre-load on the vertebrae, such as, for, example, the pedicle.

In some examples, the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis, kyphosis and other curvature abnormalities, tumor and fractures. In some embodiments, the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed spinal implant system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The spinal implant system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.

The following discussion includes a description of a surgical system including a spinal construct, related components and methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to <FIG>, there are illustrated components of a spinal implant system <NUM>.

For example, the components of spinal implant system <NUM>, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade <NUM> titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELlTE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO<NUM> polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations.

Spinal implant system <NUM> includes a spinal implant, such as, for example, a spinal construct <NUM>. Spinal construct <NUM> comprises a body <NUM> connectable with a bone screw <NUM>, as described herein. Body <NUM> includes a wall <NUM>, as shown in <FIG>. Wall <NUM> in various embodiments has a substantially circular profile or cross section, and extends along an axis X1, as shown in <FIG>. In some embodiments, wall <NUM> extends in alternative configurations relative to axis X1, such as, arcuate, offset, staggered and/or angled portions. Wall <NUM> includes an outer surface <NUM> and an inner surface <NUM>.

A spinal rod <NUM> is formed with body <NUM>. Rod <NUM> extends from surface <NUM> along an axis L1. Rod <NUM> extends transverse to axis X1. In some embodiments, rod <NUM> may extend in alternate orientations relative to axis X1, such as, for example, arcuate, tapered, perpendicular, and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. Rod <NUM> extends between a first end <NUM> and a second end <NUM>. In some embodiments, rod <NUM> may have various cross-section configurations, such as, for example, circular, oval, oblong, polygonal, irregular, uniform, non-uniform, variable, offset and/or tapered. Rod <NUM> includes a surface <NUM> configured for connection with a receiver of one or a plurality of bone fasteners <NUM> (<FIG>), as described herein.

Rod <NUM> extends such that axis L1 is disposed at an angle α1 relative to axis X1. In some embodiments, angle α1 is in a range of about <NUM> degrees to about <NUM> degrees. In some embodiments, angle α1 is about <NUM> degrees. In some embodiments, rod <NUM> can be offset in various axial, planar and/or other orientations, such as, for example, a transverse plane, a coronal plane, or a sagittal plane, or perpendicular or parallel to axis X1.

In some embodiments, rod <NUM> is monolithically formed with body <NUM>. In some embodiments, rod <NUM> is integrally connected with body <NUM> by welding or other connection technique. In some embodiments, rod <NUM> is integrally connected with body <NUM> by fastening elements and/or instruments to facilitate connection.

A portion of inner surface <NUM> includes a thread form <NUM> configured for engagement with a coupling member, such as, for example, a setscrew <NUM>, to fix body <NUM> with bone screw <NUM>. In some embodiments, surface <NUM> may be disposed with the coupling member in alternate fixation configurations, such as, for example, friction fit, pressure fit, locking protrusion/recess, locking keyway and/or adhesive.

A portion of inner surface <NUM> defines a cavity <NUM>, called out in <FIG>. Cavity <NUM> is configured for disposal of a head <NUM> of bone screw <NUM>, as shown in <FIG> and <FIG>. Cavity <NUM> has a substantially circular profile or cross section in various embodiments. In some embodiments, all or only a portion of cavity <NUM> has alternative cross-sectional configurations, such as closed, V-shaped, W-shaped, oval, U-shaped, oblong, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered.

Surface <NUM> defines a cavity, such as, for example, a groove <NUM>. Groove <NUM> is configured for disposal of a band, such as, for example, a circumferential ring <NUM>, as shown in <FIG>. Groove <NUM> includes a circumferential channel <NUM> that accommodates expansion of ring <NUM>. In various embodiments, ring <NUM> includes a circumference that extends between ends of ring <NUM>. In some embodiments, the ends do not meet, defining a gap therebetween. In some embodiments, the gap is sized such that the gap has a thickness that is less than the height and/or the width of the thickness. In some embodiments, upon disposal of ring <NUM> within groove <NUM>, upper and lower surfaces of groove <NUM> resists and/or prevents axial translation, proximally and distally, of ring <NUM> relative to axis X1.

Ring <NUM> is in various embodiments expandable and resilient between (i) a contracted and/or capture orientation, and (ii) an expanded orientation, as described herein. Ring <NUM> facilitates manual assembly of body <NUM> with a base <NUM> in a non-instrumented assembly, as described herein. In some embodiments, ring <NUM> is expandable and resilient between a contracted and/or capture orientation and an expanded orientation for assembly of body <NUM> with base <NUM>.

Body <NUM> is configured for disposal of a part, such as, for example, a crown <NUM>, as described herein. In some embodiments, all or only a portion of surface <NUM> has alternate surface configurations, such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. Crown <NUM> is configured for disposal within cavity <NUM> and engagement with surface <NUM>.

Crown <NUM> includes a wall <NUM> having an end surface <NUM> and an end surface <NUM>, as shown in <FIG>. The crown includes a surface <NUM> is configured to define at least a portion of cavity <NUM>. Surface <NUM> defines a curved portion of crown <NUM> configured for disposal of head <NUM>. In some embodiments, all or only a portion of surface <NUM> has alternate cross-sectional configurations, such as, for example, oval, oblong triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. Wall <NUM> defines a body engagement portion, such as, for example, a flange <NUM> configured for a provisional mating engagement with a portion of surface <NUM>.

In some embodiments, crown <NUM> includes planar surfaces, such as, for example, flats <NUM>, as shown in <FIG>. Flats <NUM> engage surface <NUM> in a keyed connection to resist and/or prevent rotation of crown <NUM> relative to body <NUM>. In some embodiments, engagement of flats <NUM> and surface <NUM> prevents rotation of crown <NUM> relative to body <NUM> and allows axial translation of crown <NUM> relative to body <NUM>.

Crown <NUM> is configured for translation within body <NUM> along surface <NUM>. Translation of crown <NUM> causes surface <NUM> to engage a ring <NUM>, as described herein. Surface <NUM> is disposed adjacent ring <NUM> such that axial translation of crown <NUM> causes crown <NUM> to displace ring <NUM> from a groove <NUM>, as described herein. Ring <NUM> is disengageable from groove <NUM> and surface <NUM> drives ring <NUM> from groove <NUM>. As such, ring <NUM> is movable between the contracted orientation and the expanded interference orientation in groove <NUM>, as described herein, to prevent migration of a ring <NUM> from a groove <NUM> into a groove <NUM> for fixed connection of the components of spinal construct <NUM>. Surface <NUM> is positioned with ring <NUM> to resist and/or prevent displacement of ring <NUM> from groove <NUM>.

Bone screw <NUM> includes a base <NUM>. Base <NUM> includes a wall <NUM>, which has a surface <NUM> that defines a cavity <NUM>. Cavity <NUM> is configured for disposal of head <NUM>. Surface <NUM> facilitates engagement of head <NUM> with base <NUM> via a pressure and/or force fit connection. In some embodiments, surface <NUM>, referenced in <FIG>, facilitates a non-instrumented assembly with base <NUM> and head <NUM> via an expandable ring <NUM>, as described herein. In some embodiments, base <NUM> may be disposed with head <NUM> in alternate fixation configurations, such as, for example, friction fit, pressure fit, locking protrusion/recess, locking keyway and/or adhesive. In some embodiments, base <NUM> is configured for rotation relative to head <NUM>. In some embodiments, base <NUM> is configured for rotation in a range of <NUM> degrees relative to head <NUM> to facilitate positioning of a shaft <NUM> of the bone screw <NUM> with tissue. In some embodiments, base <NUM> is configured for selective rotation in range of <NUM> degrees relative to and about head <NUM> such that shaft <NUM> is selectively aligned for rotation in a plane relative to body <NUM>.

Wall <NUM> includes a surface <NUM> that defines a cavity, such as, for example, a groove <NUM>, as shown in <FIG>. Groove <NUM> is configured for disposal of ring <NUM> to prevent displacement of ring <NUM> from channel <NUM> and to permanently fix base <NUM> with body <NUM>, as shown in <FIG>, forming a base/body assembly <NUM>/<NUM>. For example, alignment of groove <NUM> with channel <NUM> allows ring <NUM> to resiliently contract to the capture orientation, for disposal of ring <NUM> within groove <NUM> and channel <NUM>. Ring <NUM> is fixed within channel <NUM> and groove <NUM>. The surfaces of groove <NUM> resist and/or prevent disengagement of ring <NUM> from channel <NUM> and groove <NUM> to permanently assemble base <NUM> with body <NUM>.

Base <NUM> includes a surface <NUM>, as shown in <FIG>. Surface <NUM> defines a cavity, such as, for example, a groove <NUM>. Groove <NUM> is configured for disposal of a band, such as, for example, a circumferential screw shaft ring <NUM>, as described herein. In some embodiments, groove <NUM> extends about all or a portion of surface <NUM>.

An inner surface of wall <NUM> defines a slot, such as, for example a recess <NUM>, as shown in <FIG>. Recess <NUM> is configured for disposal of screw shaft <NUM>. In some embodiments, recess <NUM> is arcuate and/or concavely curved such that screw shaft <NUM> is disposable therein for movement of screw shaft <NUM> at an angle α2 as shown in <FIG>, to facilitate a biased angle configuration at a selected angle. In some embodiments, angle α2 includes a selected angle in an angular range of about <NUM> through about <NUM> degrees. In some embodiments, angle α2 is about <NUM> degrees relative to axis X1. In some embodiments, angulation of screw shaft <NUM> includes disposing body <NUM> at a sharp and/or acute angle α2 relative to screw shaft <NUM>, as shown in <FIG>, as described herein. For example, head <NUM> is positionable with recess <NUM> such that upon engagement with tissue, body <NUM> can be disposed in a non-stressed and/or relaxed configuration to facilitate engaging rod <NUM> with bone fastener <NUM>, as described herein.

Ring <NUM> is configured to fix screw shaft <NUM> with base <NUM>. Ring <NUM> includes a circumference that defines an opening <NUM>, as shown in <FIG>. Opening <NUM> is disposed between mating surfaces, such as, for example, ends <NUM>, 91a of ring <NUM>. Opening <NUM> is configured for alignment with recess <NUM>, as shown in <FIG>. Alignment of opening <NUM> and recess <NUM> facilitates movement of screw shaft <NUM> relative to body <NUM> in the angular range of motion, as described herein.

Groove <NUM> includes a surface <NUM> that defines a mating surface, such as, for example, a notch <NUM>, as shown in <FIG>. Groove <NUM> includes a surface <NUM> that defines a mating surface, such as, for example, a notch <NUM>. Notches <NUM>, <NUM> are disposed on opposite sides of recess <NUM>. End <NUM> is configured for disposal with notch <NUM> and end 91a is configured for disposal with notch <NUM>, as shown in <FIG>. In the expanded orientation, ends <NUM>, 91a engage surfaces <NUM>, <NUM> to fix ring <NUM> with base <NUM> for assembly, as described herein. Surfaces <NUM>, <NUM> resist and/or prevent disengagement of ring <NUM> from base <NUM>. Engagement of ends <NUM>, 91a with surfaces <NUM>, <NUM> of notches <NUM>, <NUM> allows for axial translation of ring <NUM> relative to base <NUM> as screw shaft <NUM> is engaged with base <NUM>, as described herein. Ends <NUM>, 91a engage surfaces <NUM>, <NUM> to resist and/or prevent rotation of ring <NUM> relative to base <NUM> to maintain alignment of opening <NUM> and recess <NUM>.

Base <NUM> includes groove <NUM>, as described herein. Groove <NUM> is configured for disposal of a circumferential ring <NUM>. Ring <NUM> is engageable with ring <NUM> to facilitate fixation of base <NUM> with screw shaft <NUM>, as described herein. Ring <NUM> includes a circumference that extends between ends of ring <NUM>. In some embodiments, the ends define an opening, such as, for example, a gap. In some embodiments, the gap is sized such that the gap has a thickness that is less than the height and the width. In some embodiments, the gap is sized to allow ring <NUM> to engage a surface <NUM> of groove <NUM> by contracting circumferentially.

Base <NUM> includes groove <NUM> configured for disposal of ring <NUM> and/or ring <NUM> to facilitate assembly and/or fixation of base <NUM> with screw shaft <NUM>, as described herein. In some embodiments, groove <NUM> extends about all or a portion of surface <NUM>. Groove <NUM> includes a circumferential channel <NUM> that accommodates expansion of ring <NUM> and/or ring <NUM>, as described herein. Grooves <NUM>, <NUM>, <NUM> are disposed in a serial orientation along axis X1, as shown in <FIG>. In some embodiments, grooves <NUM>, <NUM>, <NUM> are disposed in spaced apart relation.

A surface <NUM> is disposed between groove <NUM> and groove <NUM>. Surface <NUM> is disposed at an angle relative to axis X1 to define a ramp <NUM>. Ramp <NUM> is selectively inclined to facilitate translation of ring <NUM> between groove <NUM> and groove <NUM>, as described herein. In one example, ring <NUM> is engaged with screw shaft <NUM> for translation such that ring <NUM> slides along ramp <NUM>, which directs and/or guides ring <NUM> from groove <NUM> into groove <NUM> and expands into a provisional capture orientation with screw shaft <NUM>. In another example, ring <NUM> is engaged with ring <NUM> for translation such that ring <NUM> slides along ramp <NUM>, which directs and/or guides ring <NUM> from groove <NUM> into groove <NUM>, and contracts for fixed connection of the components of spinal construct <NUM> including permanent capture of body <NUM> and screw shaft <NUM>. In some embodiments, surface <NUM> is oriented substantially perpendicular to axis X1.

Ring <NUM> is resiliently biased to a contracted and/or capture orientation within groove <NUM>, and expandable to an expanded orientation within groove <NUM>, for provisional capture of screw shaft <NUM> with body <NUM>, as described herein. Ring <NUM> is expandable from the contracted and/or capture orientation to the expanded orientation for assembly of screw shaft <NUM> with body <NUM>, as described herein.

Ring <NUM> is disposable in a contracted orientation within groove <NUM> and resiliently biased to an expanded interference orientation within groove <NUM>. In the interference orientation, ring <NUM> is disposed in groove <NUM> and adjacent to ring <NUM> for abutting and/or contacting engagement therewith to resist and/or prevent translation of ring <NUM> from groove <NUM> into groove <NUM>, and fixed connection of the components of spinal construct <NUM> including permanent capture of base <NUM> and screw shaft <NUM>, as described herein.

Bone screw <NUM> includes head <NUM> and screw shaft <NUM>, as described herein. Screw shaft <NUM> is configured to penetrate tissue, such as, for example, bone. In some embodiments, screw shaft <NUM> 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. Head <NUM> includes a tool engaging portion <NUM> configured to engage a surgical tool or instrument, as described herein. In some embodiments, portion <NUM> includes a hexagonal cross-section to facilitate engagement with a surgical tool or instrument, as described herein. In some embodiments, portion <NUM> may have alternative cross-sections, such as, for example, rectangular, polygonal, hexalobe, oval, or irregular. In some embodiments, head <NUM> includes a surface <NUM> that defines a plurality of ridges <NUM> to improve purchase of head <NUM> with crown <NUM>. Head <NUM> is configured for attachment with base <NUM> and/or body <NUM>, as described herein.

In some embodiments, base <NUM> and/or body <NUM> is manually engageable with bone screw <NUM> in a non-instrumented assembly, as described herein. In some embodiments, manual engagement and/or non-instrumented assembly of base <NUM> and/or body <NUM> and bone screw <NUM> includes coupling without use of separate and/or independent instrumentation engaged with bone screw <NUM> components to effect assembly. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping base <NUM> and/or body <NUM> and bone screw <NUM> and forcibly assembling the components. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping base <NUM> and/or body <NUM> and bone screw <NUM> and forcibly snap fitting the components together, as described herein. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping base <NUM> and/or body <NUM> and bone screw <NUM> and forcibly pop fitting the components together and/or pop fitting base <NUM> and/or body <NUM> onto bone screw <NUM>, as described herein. In some embodiments, a force in a range of <NUM>-<NUM> N is required to manually engage base <NUM> and/or body <NUM> and bone screw <NUM> and forcibly assemble the components. For example, a force in a range of <NUM>-<NUM> N is required to snap fit and/or pop fit assemble base <NUM> and/or body <NUM> and bone screw <NUM>. In some embodiments, a force in a range of <NUM>-<NUM> N is required to manually engage base <NUM> and/or body <NUM> and bone screw <NUM> and forcibly assemble the components. For example, a force in a range of about <NUM> to about <NUM> N is required to snap fit and/or pop fit assemble base <NUM> and/or body <NUM> and bone screw <NUM>. In some embodiments, bone screw <NUM> is manually engaged with base <NUM> and/or body <NUM> in a non-instrumented assembly, as described herein, such that removal of base <NUM> and/or body <NUM> and bone screw <NUM> requires a force and/or a pull-out strength of at least <NUM> N. In some embodiments, this configuration provides manually engageable components that are assembled without instrumentation, and subsequent to assembly, the assembled components have a selected pull-out strength and/or can be pulled apart, removed and/or separated with a minimum required force. In some embodiments, spinal implant system <NUM> comprises a spinal implant kit, as described herein, which includes a plurality of bone screws <NUM> and/or bodies <NUM> connectable with base <NUM>.

Base <NUM> is connected with body <NUM> in a non-instrumented assembly to form base/body assembly <NUM>/<NUM>. In some embodiments, base <NUM> is assembled with bone screw <NUM> prior to body <NUM> being assembled with base <NUM>. Ring <NUM> is disposed with base <NUM>. Ring <NUM> is disposed with base <NUM> and fixed with base <NUM> via engagement of ends <NUM>, 91a with notches <NUM>, <NUM>. Base <NUM> is engaged with body <NUM>. Ring <NUM> is expandable and resilient between a contracted and/or capture orientation, and an expanded orientation within groove <NUM> and channel <NUM> to permanently fix base <NUM> with body <NUM>. The surfaces of groove <NUM> resist and/or prevent disengagement of ring <NUM> from channel <NUM> and groove <NUM> to permanently assemble base <NUM> with body <NUM>.

Bone screw <NUM> is manually engageable, as described herein, with base/body assembly <NUM>/<NUM>, as shown in <FIG>. Base/body assembly <NUM>/<NUM> is assembled with bone screw <NUM> by translating base/body assembly <NUM>/<NUM>, in a direction shown by arrow A in <FIG>. Engagement of head <NUM> with base/body assembly <NUM>/<NUM> causes ring <NUM> to translate, in a direction shown by arrow B in <FIG>, such that ring <NUM> is positionable and allowed to expand into groove <NUM> to an expanded orientation, as described herein. Engagement of head <NUM> with an inner surface of ring <NUM> causes ring <NUM> to expand and slide along ramp <NUM> into channel <NUM>. As head <NUM> translates further into base/body assembly <NUM>/<NUM>, ring <NUM> passes over head <NUM> and resiliently contracts about head <NUM> within channel <NUM> to provisionally capture screw shaft <NUM>.

Crown <NUM> is manipulated, for example, via engagement of coupling member <NUM> with body <NUM> or by surgical instrument, to translate crown <NUM>, in a direction shown by arrow C in <FIG>. Surface <NUM> engages ring <NUM> such that ring <NUM> is displaced from groove <NUM>, as shown in <FIG>. Ring <NUM> translates and engages ring <NUM> driving ring <NUM> from groove <NUM> into groove <NUM>. Ring <NUM> axially translates along base <NUM> and/or slides along ramp <NUM> into groove <NUM>. Ring <NUM> translates into groove <NUM> and resiliently expands to an expanded, interference orientation, as described herein. Ring <NUM> is oriented for abutting and/or contacting engagement with ring <NUM> to resist and/or prevent translation of ring <NUM> from groove <NUM> into groove <NUM>, and fixed connection of the components of spinal construct <NUM> including permanent capture of base/body assembly <NUM>/<NUM> and bone screw <NUM>. Surface <NUM> is positioned with ring <NUM> to resist and/or prevent displacement of ring <NUM> from channel <NUM>.

In assembly, operation and use, spinal implant system <NUM>, similar to other systems described herein, is employed with a surgical procedure for treating disorders of the spine, such as those described herein. In some examples, one or all of the components of spinal implant system <NUM> can be delivered as a preassembled device or can be assembled in situ.

A surgical treatment including spinal implant system <NUM> can be used for correction and alignment in stabilization of a treated section of vertebrae V. In an exemplary use, a medical practitioner obtains access to a surgical site including vertebrae V via a posterior surgical approach. The surgical site may be accessed in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, spinal implant system <NUM> can 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.

An incision is made in the body of a patient and a cutting instrument (not shown) creates a surgical pathway for delivery and implantation of components of spinal implant system <NUM> with vertebrae V. 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.

Spinal implant system <NUM> includes spinal construct <NUM>, as described herein, and bone fasteners <NUM>, which are delivered to the surgical site for disposal with vertebrae V in connection with the surgical procedure. In some embodiments, one or more bone fasteners <NUM> are disposed in a serial and/or substantially linear orientation along vertebrae V, as shown in <FIG>. In some embodiments, one or more bone fasteners <NUM> are disposed with vertebrae V in alternate orientations relative to each other, such as, for example, parallel, perpendicular, adjacent, co-axial, co-planar, arcuate, offset, staggered, transverse, angular and/or relative posterior/anterior orientations and/or at alternate vertebral levels.

Pilot holes are made in vertebrae V. Spinal construct <NUM> is assembled in situ or prior to implant, as described herein. In some embodiments, spinal construct <NUM> components may be assembled in a non-instrumented assembly on a back table of an operating room during a surgical procedure, as described herein. In some embodiments, spinal construct <NUM> is assembled in an instrumented assembly.

Bone screw <NUM> is aligned with the pilot holes and fastened with the tissue of vertebrae V. In some embodiments, the bony structures of vertebrae V are disposed such that placement of spinal construct <NUM> includes an implant trajectory with bone screw <NUM> being angled in a cephalad-caudal orientation for engagement with tissue. Such an implant trajectory of bone screw <NUM> may include disposing body <NUM> at a sharp and/or acute angle α2 relative to bone screw <NUM> for connection of rod <NUM> with bone fasteners <NUM>, as described herein. As such, the assembled components of spinal construct <NUM>, as described herein, facilitate placement of bone screw <NUM> along a selected implant trajectory and orientation of body <NUM> in a non-stressed and/or relaxed configuration to facilitate disposal of spinal rod <NUM> with bone fasteners <NUM>. For example, with bone screw <NUM> engaged with vertebral tissue, body <NUM> is manipulated relative to bone screw <NUM> and/or to a selected angular orientation relative to bone screw <NUM>, for example, for disposal of bone screw <NUM> with recess <NUM>/opening <NUM>. In some embodiments, body <NUM> is manipulable relative to bone screw <NUM> to an angular limit that includes engagement of bone screw <NUM> with wall <NUM>. Opening <NUM> and recess <NUM> are aligned, as described herein, to allow bone screw <NUM> to be selectively angled within opening <NUM> and recess <NUM> to angle α2, as described herein. The selective angular positioning of bone screw <NUM> within opening <NUM> and recess <NUM> facilitates orienting body <NUM> for disposal of rod <NUM> with bone fasteners <NUM>. In some embodiments, the assembled components of spinal construct <NUM>, as described herein, facilitate parallel orientation of lateral and contra-lateral bodies <NUM> and/or bone fasteners <NUM> engaged with vertebral tissue for receiving rods <NUM>.

Rod <NUM> is shaped, contoured and/or bent to a selected configuration for a selected final lordosis of vertebrae V as attached with bone fasteners <NUM> in connection with the surgical procedure. Body <NUM> is delivered to the surgical site and oriented for alignment with the implant cavities of bone fasteners <NUM>. In some embodiments, this configuration avoids a surgical step of seating rod <NUM> with bone fasteners <NUM>. Coupling members <NUM> are engaged with bone fasteners <NUM> and coupling member <NUM> is engaged with body <NUM> to fix rod <NUM> with vertebrae V.

In some examples, spinal implant system <NUM> includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of spinal implant system <NUM>. In some examples, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the fixation elements with vertebrae. In some embodiments, the agent may be HA coating. 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.

Upon completion of the procedure, the non-implanted components, surgical instruments and assemblies of spinal implant system <NUM> are removed and the incision is closed. In some examples, 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 implant system <NUM>. The components of spinal implant system <NUM> can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques.

Claim 1:
A spinal construct (<NUM>) comprising:
a body (<NUM>) defining a first groove (<NUM>);
a transverse rod (<NUM>) formed with the body (<NUM>) and extending from the body (<NUM>);
a first band (<NUM>) disposable in the first groove (<NUM>);
a base (<NUM>) connectable with the body (<NUM>) and engageable with the first band (<NUM>), the base (<NUM>) defining a second groove (<NUM>) and a slot (<NUM>);
a second band (<NUM>) disposable in the second groove (<NUM>) and defining an opening (<NUM>) aligned with the slot (<NUM>); and
a shaft (<NUM>) connectable with the base (<NUM>) and engageable with the second band (<NUM>), the shaft (<NUM>) being configured to penetrate tissue, the opening being (<NUM>) aligned with the slot (<NUM>) to facilitate an angular range of movement of the shaft (<NUM>) relative to the body (<NUM>), wherein
the second band (<NUM>) includes a first mating surface engageable with a second mating surface (<NUM>) of the second groove (<NUM>), the mating surfaces being engageable to fix the second band (<NUM>) with the second groove (<NUM>), and
the mating surfaces are engageable to resist or prevent rotation of the second band (<NUM>) relative to the base (<NUM>).