Patent Description:
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. As part of these surgical treatments, spinal constructs including 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 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.

Further, <CIT> discloses an apparatus for connecting an implant with an elongated support comprises a body, a collet, an annular ring member, a washer, and a nut in one embodiment. The body defines a first channel configured for receipt of the rod and defines a second channel extending through the body. The collet is positionable in the second channel and defines an aperture configured for receipt of at least a portion of the implant. The ring member is annular in shape with a gap and defines an aperture sized to allow insertion of at least a portion of the collet therethrough. The washer is positionable adjacent the second channel and has a concave surface configured to contact the body to allow pivoting of the collet relative to the body. The nut is positionable adjacent the washer and operable to connect with the collet to move the collet within the second channel. Movement of the collet is operable to expand the ring member and contract the collet around at least a portion of the implant to secure the implant at a desired position.

In addition, further spinal constructs and spinal implant systems are known from <CIT>, <CIT> and <CIT>.

The claimed invention provides a spinal construct as set out in independent claim <NUM>. Further advantages embodiments are disclosed in the dependent claims.

According to the invention, a spinal construct is provided. The spinal construct includes a bone fastener including a post and a shaft portion engageable with vertebral tissue. The post being movable in one or more axes relative to the shaft portion. A receiver defines a first cavity configured for disposal of the bone fastener and a second open cavity configured for disposal of a spinal rod. A band is disposable in the first cavity. The band being contractible and defining an inner surface that is directly engageable with the post. A nut includes an inner surface being slidably engageable over the post and an end surface engageable with the band such that the band contracts to engage the post.

The present disclosure will become more readily apparent from the specific description accompanied by the following drawings. The systems shown in <FIG> do not form part of the claimed invention as such, but are useful in understanding the principles of the present disclosure.

The term "embodiment" used in the present specification does not necessarily indicate ways of carrying out the invention claimed but also examples which aid understanding the invention.

The exemplary embodiments of the surgical system and related methods of use (the methods not claimed) disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system and method for treatment of a spine disorder. In some embodiments, the present surgical system includes a spinal construct having one or more components that facilitate spatial adjustment of the spinal construct relative to vertebral tissue and/or components of the spinal construct implanted with vertebral tissue. In some embodiments, the spinal construct includes one or more components configured for height adjustment in a dorsal orientation relative to a bone screw fixed with vertebral tissue. In some embodiments, the spinal construct is adjusted without fully reducing a spinal rod with one or more receivers of the spinal construct. In some embodiments, the spinal construct includes one or more components that can be adjusted in orientations, for example, medial, lateral, sagittal, coronal, transverse, relative to vertebral tissue and/or components of the spinal construct implanted with vertebral tissue. In some embodiments, the systems and methods of the present disclosure are employed with a spinal joint fusion, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system includes a spinal construct comprising a connector. In some embodiments, the connector is configured for engagement with a spinal implant, for example, a top loading bone screw and a spinal implant, for example, a spinal rod. In some embodiments, a height of the connector is configured for adjustment in an orientation, for example, a dorsal orientation relative to the screw. In some embodiments, the connector is adjusted without fully reducing the spinal rod to a preset position to lock the spinal construct. In some embodiments, the connector is configured to accommodate procedures performed on a plane of a body and/or vertebrae, for example, a sagittal plane. In some embodiments, the connector is configured for use in deformity correction procedures including spondylolisthesis, kyphosis and scoliosis correction procedures.

In some embodiments, the present surgical system includes a connector configured to facilitate top loading of a screw with the connector and dorsal height forgiveness of the connector relative to the screw. In some embodiments, the screw includes a multi-axial screw, a multi-planar adjusting screw, and/or a uni-axial screw. In some embodiments, the connector is configured to clamp or lock onto a post of the screw. In some embodiments, the connector is configured to facilitate reduction of a spinal rod relative to a vertebral surface of a patient, for example vertebrae. In some embodiments, the connector is configured to suspend reduction of the spinal rod at any time during a procedure. In some embodiments, nerve monitoring and/or tactile feedback can be implemented during the procedure to determine whether to discontinue the application of a reduction force to the spinal rod.

In some embodiments, the present surgical system includes a connector, including a receiver. In some embodiments, the surgical system includes a band, for example, a collet. In some embodiments, the collet includes a split ring collet. In some embodiments, the collet is configured for disposal in a first cavity of the receiver and is configured for engagement with a post of a spinal implant, for example, a bone screw. In some embodiments, the surgical system includes a nut. In some embodiments the nut is configured for disposal in the first cavity and is configured for engagement with the collet. In some embodiments, the nut includes concave ends. In some embodiments, the receiver includes a second cavity. In some embodiments, the second cavity is transverse relative to the first cavity. In some embodiments, the second cavity is configured for engagement with a spinal implant, for example, a spinal rod. In some embodiments, the surgical system includes a saddle and a threaded pin. In some embodiments, the threaded pin is configured to retain the saddle within the second cavity. In some embodiments, the threaded pin includes a press fit pin or a laser welded pin. In some embodiments, the connector is configured for disposal about a multi-planar adjusting screw joint.

In some embodiments, the present connector includes a medial-lateral profile. In some embodiments, the multi-planar adjusting screw joint is positioned in a medial/lateral orientation. In some embodiments, the connector includes a low profile height. In some embodiments, the connector is configured to accommodate procedures performed on the sagittal plane of a body and/or vertebrae. In some embodiments, the saddle is configured for +/- <NUM> degrees of translation to accommodate the sagittal plane during rod reduction to selectively align the rod.

In some embodiments, the present surgical system includes a connector having a locking mechanism including a band, for example, a collet and a nut. In some embodiments, the collet includes an exterior surface that defines one or more flats that are configured to mate with one or more flats defined from an interior surface of a cavity of the receiver. In some embodiments, the exterior surface defines one or more threads and the nut includes an interior surface that defines one or more threads. In some embodiments, the collet and the nut are configured for threaded engagement. In some embodiments, the one or more flats are configured to prevent rotation of the collet as the nut threadingly engages with the collet. In some embodiments, the nut includes one or more chamfers configured for mating engagement with one or more chamfers on the post.

In some embodiments, the present surgical system includes a connector having a receiver configured for engagement with a bone screw and a spinal rod. In some embodiments, the bone screw includes a multi-axial screw. In some embodiments, the bone screw includes a shank and a head. In some embodiments, the head is configured for engagement with a post and a base. In some embodiments, the post is configured for modular connection with the bone screw. In some embodiments, modular connection includes a pop-on connection. In some embodiments, an end of the post is welded onto an inner surface of the base superior to a resilient member, for example, an upper ring. In some embodiments, the end of the post is spot welded onto the inner surface of the base. In some embodiments, a <NUM>-<NUM> Newton-Meter (Nm) breaking torque is applied to the post to break the weld such that the post can translate within the base to engage the head of the bone screw. In some embodiments, the post is configured for locked engagement with the bone screw. In some embodiments, the post includes a threaded end that translates within the base.

In some embodiments, the post of the present surgical system is translated within the body and the threads are fully threaded with an inner threaded surface of the base. In some embodiments, multi-axial rotation occurs when the threads are fully threaded within the base. In some embodiments, a portion of the thread is not disposed within the base to display that the post is in a non-locked orientation. In some embodiments, a surgical instrument, for example, a counter torque driver is employed to prevent the base from rotating on the shank. In some embodiments, the post is configured for disposal with a first cavity of the connector and is moved in a downward direction toward the base and the bone screw. In some embodiments, the spinal rod is configured for disposal with a second cavity of the receiver to secure the spinal rod with the connector. In some embodiments, the spinal rod is provisionally secured with a set screw. In some embodiments, the spinal rod is provisionally secured with the setscrew and can slide through a spinal implant. In some embodiments, the spinal rod is reduced along the post. In some embodiments, spinal rod reduction can be stopped at any location. In some embodiments, the base includes a multi-axial joint. In some embodiments, the multi-axial joint is locked relative to the bone screw. In some embodiments, the multi-axial joint is locked via a torque limit handle. In some embodiments, a surgical instrument, for example, a counter torque driver and/or a crow-foot device is implemented to prevent the base from rotating during locking. In some embodiments, a nut disposed with the first cavity of the receiver and the setscrew are tightened to fix the rod with the first cavity. In some embodiments, a user breaks off the post from the base and the head.

In some embodiments, one or all of the components of the surgical 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.

In some embodiments, the surgical system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the surgical system of 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 surgical 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, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The surgical system of 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 surgical 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 surgical system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references "upper" and "lower" are relative and used only in the context to the other, and are not necessarily "superior" and "inferior".

As used in the specification, "treating" or "treatment" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing regrowth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. In some embodiments, as used in the specification, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of a surgical system 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 disclosed. Reference is made to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to <FIG>, there are illustrated components of a surgical system, such as, for example, a spinal implant system <NUM>.

Spinal implant system <NUM> is employed, for example, with a minimally invasive procedure, including percutaneous techniques, mini-open and open surgical techniques to deliver and introduce instrumentation and/or components of spinal constructs at a surgical site within a body of a patient, for example, a section of a spine. In some embodiments, spinal implant system <NUM> is configured for use in deformity correction procedures including spondylolisthesis, kyphosis and scoliosis correction procedures. In some embodiments, one or more of the components of spinal implant system <NUM> are configured for engagement with existing spinal constructs, which may include fastener implants and/or spinal rod implants attached with vertebrae, in a revision surgery to manipulate tissue and/or correct a spinal disorder, as described herein.

Spinal implant system <NUM> comprises a spinal construct <NUM> including a connector <NUM> and a bone fastener, for example, a multi-planar adjusting screw <NUM>, as shown in <FIG>. Connector <NUM> is configured for dorsal height adjustment relative to a post <NUM> of screw <NUM>, as shown in <FIG> and described herein. Screw <NUM> extends along a longitudinal axis AA, as shown in <FIG>. Screw <NUM> includes post <NUM> connected to a threaded shaft <NUM>, as shown in <FIG> and <FIG>. Post <NUM> is movable to one or a plurality of axes relative to shaft <NUM> and longitudinal axis AA. Post <NUM> includes an end <NUM> and an end <NUM>, as shown in <FIG>. End <NUM> engages with one or more instruments, for example, a driver (not shown) to rotate screw <NUM>. End <NUM> includes threads <NUM>. In some embodiments, all or one or more portions of end <NUM> is smooth, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, all or one or more portions of end <NUM> can fracture and separate at a predetermined force or torque limit from end <NUM>. In some embodiments, all or one or more portions of end <NUM> includes one or more deformable elements, for example, a tab, wire, projection, tang, rim, and/or bar to facilitate fracture and separation. In some embodiments, end <NUM> may be fabricated from a homogenous material or heterogeneously fabricated from different materials, and/or alternately formed of a material having a greater degree, characteristic or attribute of plastic deformability, frangible property and/or break away quality to facilitate fracture and separation from end <NUM>. In some embodiments, end <NUM> is fabricated from a frangible material, including a rubber, adhesive, metal and/or a plastic. In some embodiments, end <NUM> disengages from end <NUM> via a surgical instrument, for example, a cutting device (not shown).

End <NUM> includes a joint <NUM> connected to a head <NUM> of shaft <NUM>, as shown in <FIG>. Joint <NUM> is configured to enable post <NUM> to move and/or rotate through one plane relative to shaft <NUM> and/or longitudinal axis AA. In some embodiments, joint <NUM> is configured as a mono-axial, bi-axial, multi-axial, fixed, spheroidal or cylindrical joint to facilitate movement and/or rotation of post <NUM> as described herein. In some embodiments, joint <NUM> is oriented in a medial lateral direction relative to screw <NUM>. In some embodiments, joint <NUM> is oriented in a selected direction, including sagittal, coronal, transverse, dorsal, medial, and/or lateral relative to screw <NUM>. Joint <NUM> is formed from a portion of head <NUM> and a portion of end <NUM>, as shown in <FIG>. End <NUM> includes openings <NUM>, <NUM> and head <NUM> includes openings <NUM>, <NUM>. A pin <NUM> is disposed with openings <NUM>, <NUM> and <NUM>, <NUM>. In some embodiments, joint <NUM> is a single monolithic piece formed from end <NUM> and engages a surface of head <NUM> in a modular and/or pop-on engagement. In some embodiments, post <NUM> disengages with shaft <NUM> at joint <NUM>. In some embodiments, post <NUM> disengages from shaft <NUM> when a torque limit is applied to post <NUM>.

Shaft <NUM> engages with vertebral tissue. Shaft <NUM> extends from an end <NUM> to an end <NUM>, as show in <FIG>. End <NUM> includes head <NUM> and end <NUM> includes a threaded portion <NUM>. In some embodiments, threaded portion <NUM> may include a single thread turn or a plurality of discrete threads. In some embodiments, all or portions of end <NUM> is smooth, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, the bone fastener may include sagittal angulation screws, pedicle screws, multi-axial screws, mono-axial screws, uni-planar screws, fixed screws, anchors, hooks, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, connectors, fixation plates and/or posts.

Connector <NUM> is configured to facilitate procedures performed on a body and/or vertebrae of a patient in a selected plane for example, a sagittal plane. Connector <NUM> is engageable with screw <NUM> and a spinal rod <NUM>, as shown in <FIG>. In some embodiments, connector <NUM> is configured for adjustment in a selected plane, including sagittal, coronal, transverse, dorsal and/or medial/lateral. Connector <NUM> includes a receiver <NUM>, as shown in <FIG>. Receiver <NUM> is configured for dorsal height adjustment relative to post <NUM>. An inner surface <NUM> of receiver <NUM> defines a cavity <NUM> for disposal of screw <NUM> and an inner surface <NUM> of receiver <NUM> defines an open cavity <NUM> for disposal of rod <NUM>. Cavity <NUM> extends along a longitudinal axis BB and includes a longitudinal passageway <NUM>. Surface <NUM> defines one or more gaps <NUM>, as shown in <FIG>. A band, such as a collet <NUM>, for example, is disposed with cavity <NUM> and gaps <NUM> facilitate inward flex of collet <NUM> to contract collet <NUM> within cavity <NUM>, as described herein. Cavity <NUM> includes a substantially circular cross section. In some embodiments, cavity <NUM> may have various cross section configurations, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In some embodiments, all or a portion of surface <NUM> is smooth, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, receiver <NUM> is configured for sagittal, coronal, transverse, dorsal and/or medial/lateral height adjustment relative to post <NUM>.

Collet <NUM> is contractible and defines an inner surface <NUM> that is directly engageable with post <NUM>, as shown in <FIG> and <FIG>. In some embodiments, surface <NUM> is smooth, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. Collet <NUM> includes a gap <NUM> that is adjustable to fix post <NUM> with receiver <NUM>, as shown in <FIG>. In some embodiments, gap <NUM> enables expansion and/or contraction of collet <NUM>. Collet <NUM> extends between an end <NUM> and an end <NUM>, as shown in <FIG>. End <NUM> is configured for engagement with a nut <NUM>, as described herein. Ends <NUM>, <NUM> are angled. In some embodiments, all or a portion of ends <NUM>, <NUM> include straight edges, are beveled, flared, and/or convex.

Nut <NUM> is disposable in cavity <NUM>, as shown in <FIG>. Nut <NUM> includes an inner surface <NUM> slidable over post <NUM>. Nut <NUM> extends between an end surface <NUM> and an end surface <NUM>. End surface <NUM> engages with collet <NUM> such that collet <NUM> contracts to fix post <NUM> with receiver <NUM>, as shown in <FIG> and <FIG>. End surface <NUM> is engageable with collet <NUM> between an orientation such that surfaces <NUM>, <NUM> are substantially aligned, as shown in <FIG>, and an orientation such that collet <NUM> is contractible to fix post <NUM> with receiver <NUM>, as shown in <FIG>. End surface <NUM> includes a concave surface <NUM>, as shown in <FIG>, disposed to abut collet <NUM> to drive collet <NUM> inward to contract collet <NUM>. In the orientation where collet <NUM> is contractible to fix post <NUM> with receiver <NUM>, force is applied to nut <NUM> by a user and/or instrument, for example, a driver (not shown) to drive collet <NUM> inward into cavity <NUM>, for example, into one of gaps <NUM>, as shown in <FIG>. In some embodiments, a portion of end surface <NUM> is driven inward into surface <NUM>. In some embodiments, nut <NUM> is torqued in a range of <NUM>-<NUM> to fix post <NUM> with receiver <NUM>.

Cavity <NUM> of receiver <NUM> extends along a longitudinal axis CC and includes a transverse passageway <NUM> relative to longitudinal passageway <NUM>, as shown in <FIG>. Cavity <NUM> includes a top loading cavity configured for disposal of rod <NUM>. Surface <NUM> includes a threaded portion <NUM> configured for engagement with threads of a setscrew (not shown). Cavity <NUM> includes a substantially U-shaped cross section. In some embodiments, cavity <NUM> may have various cross section configurations, such as, for example, circular, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In some embodiments, all or portions of surface <NUM> is smooth, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured.

A saddle <NUM> is disposed with cavity <NUM>, as shown in <FIG> and <FIG>. Saddle <NUM> translates relative to receiver <NUM> to accommodate movement of rod <NUM> supported by saddle <NUM> in a plane, for example, a sagittal plane of a body and/or vertebrae. Saddle <NUM> receives and movably supports rod <NUM> such that rod <NUM> can translate axially, rotate and/or pivot relative to receiver <NUM> along and about axis CC prior to fixation with saddle <NUM>. In some embodiments, saddle <NUM> facilitates +/- <NUM> degrees of translation to accommodate movement of rod <NUM> supported by saddle <NUM> in the sagittal plane.

Saddle <NUM> extends between an end <NUM> and an end <NUM>, as shown in <FIG>. Saddle <NUM> includes an outer surface <NUM> that defines a wall <NUM>, as shown in <FIG>. Wall <NUM> is configured to engage surface <NUM>. Surface <NUM> defines a concave portion <NUM>, as shown in <FIG>, that engages at least a portion of rod <NUM>. Saddle <NUM> includes an opening <NUM> for disposal with a threaded pin <NUM> as shown in <FIG> and described herein. In some embodiments, rod <NUM> may be disposed within passageway <NUM> for relative movement in orientations relative to axis CC, 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, saddle <NUM> may be monolithically formed as a portion of receiver <NUM>.

Pin <NUM> retains saddle <NUM> within cavity <NUM>. Surface <NUM> defines an opening <NUM> for disposal of pin <NUM>, as shown in <FIG>. Pin <NUM> is fixed with saddle <NUM> and opening <NUM>. In some embodiments, all or a portion of pin <NUM> is threaded. In some embodiments, all or a portion of pin <NUM> is rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured to facilitate engagement or fixation with saddle <NUM> and opening <NUM>. In some embodiments, pin <NUM> includes a press fit pin, a laser welded pin, or other mechanical fixture.

In some embodiments, connector <NUM> includes a set screw (not shown). The set screw is disposed with cavity <NUM> and engages with thread portion <NUM> of surface <NUM> and rod <NUM> to fix rod <NUM> with cavity <NUM>. In some embodiments, surface <NUM> may be disposed with the set screw in alternate fixation configurations, such as, for example, friction fit, pressure fit, locking protrusion/recess, locking keyway and/or adhesive. In some embodiments, all or only a portion of surface <NUM> may have alternate surface configurations to enhance engagement with spinal rod <NUM> and/or the set screw such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. The set screw is configured for engagement with rod <NUM> to facilitate fixation and/or locking of rod <NUM> with passageway <NUM>. The set screw is disposable with cavity <NUM> between a non-locking orientation, such that rod <NUM> is translatable relative to connector <NUM> and a locked orientation, such that the set screw fixes rod <NUM> with connector <NUM>.

In some embodiments, spinal implant system <NUM> can include one or a plurality of connectors <NUM> such as those described herein, which may be employed with a single vertebral level or a plurality of vertebral levels. In some embodiments, one or more connectors <NUM> may be engaged with vertebrae in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, one or more connectors <NUM> may be employed with multi-axial screws, sagittal angulation screws, pedicle screws, mono-axial screws, uni-planar screws, fixed screws, anchors, hooks, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, connectors, fixation plates and/or posts.

In assembly, operation and use, spinal implant system <NUM>, similar to the systems and methods described herein, is employed with a surgical procedure, such as, for example, a surgical treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body. In some embodiments, spinal implant system <NUM> includes spinal construct <NUM> including connector <NUM> and screw <NUM>, as described herein. Connector <NUM> is configured for dorsal height adjustment relative to post <NUM> of screw <NUM>, as shown in <FIG>. In some embodiments, connector <NUM> is configured to facilitate procedures performed on a body and/or vertebrae of a patient on a selected plane for example, a sagittal plane. Connector <NUM> is configured for connection with screw <NUM> and spinal rod <NUM>, as shown in <FIG>.

In some embodiments, connector <NUM> can be employed for use in deformity correction procedures including spondylolisthesis, kyphosis and scoliosis correction procedures. In some embodiments, connector <NUM> can be employed in a surgical treatment such as a revision surgery to strengthen, revise, repair and/or extend an existing spinal construct. In some embodiments, spinal implant system <NUM>, including spinal construct <NUM>, is employed in a revision surgery to connect with an existing spinal construct and strengthen the existing spinal construct to span one or more spinal levels. In some embodiments, the existing spinal construct may include one or more implants connected or fixed with tissue in a prior or different surgical procedure, separate in time and/or over a duration of time in the same surgical procedure. In some embodiments, during a surgical treatment, spinal implant system <NUM> may be completely or partially revised, removed or replaced.

In connection with the surgical procedure, to treat a selected section of vertebrae V, as shown in <FIG>, 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 implant system <NUM> can be used in any 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 a 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 to access the surgical site. The surgical pathway is utilized for implantation of components of spinal implant system <NUM>. 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.

Screw <NUM> is fixed with vertebral tissue via shaft <NUM>. Collet <NUM> is disposed within cavity <NUM>, as shown in <FIG>. Connector <NUM> engages with screw <NUM> via disposal of post <NUM> with cavity <NUM>, as shown in <FIG>. Rod <NUM> is disposed with cavity <NUM>. Connector <NUM> is translated in a direction, as shown by arrow A in <FIG>, toward joint <NUM> to dorsally adjust connector <NUM>. Nut <NUM> engages with post <NUM> and is translated in the direction shown by arrow A. End surface <NUM> of nut <NUM> is disposed with cavity <NUM> and abuts with end <NUM> of collet <NUM> in an orientation to substantially align inner surface <NUM> of nut <NUM> with inner surface <NUM> of collet <NUM>, as shown in <FIG>. Torque is applied to nut <NUM> and end surface <NUM> abuts end <NUM> to drive collet <NUM> inward to contract collet <NUM> to fix post <NUM> with receiver <NUM> positioning nut <NUM> in an orientation, thereby locking post <NUM> with receiver <NUM>.

Rod <NUM> is reduced to a selected position. A setscrew (not shown) is disposed with cavity <NUM> and engages with threads <NUM>. A surgical instrument, for example, a driver (not shown) is employed to drive the setscrew into cavity <NUM> to lock rod <NUM> with passageway <NUM>. All or a portion of post <NUM> is removed via break away and/or a surgical instrument, for example, a cutting device (not shown) above nut <NUM>, as described herein.

Upon completion of the procedure, the surgical instruments, assemblies and non-implanted components of spinal implant system <NUM> are removed from the surgical site and the incision is closed. One or more of 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. In some embodiments, the use of surgical navigation, robotics, 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>.

In some embodiments, 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 embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the bone fasteners with vertebrae. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.

In one embodiment, as shown in <FIG> and <FIG>, spinal implant system <NUM>, similar to the systems and methods described herein, includes a spinal construct <NUM>, similar to spinal construct <NUM>. Spinal construct <NUM> includes a connector <NUM> and a bone fastener, for example, a multi-planar adjusting screw <NUM>, as shown in <FIG>, similar to screw <NUM> described herein. Connector <NUM> is configured for dorsal height adjustment relative to a post <NUM> of screw <NUM>, as shown in <FIG> and described herein. Screw <NUM> extends along a longitudinal axis DD, as shown in <FIG>. Screw <NUM> includes post <NUM>, similar to post <NUM>, connected to a threaded shaft <NUM>, similar to shaft <NUM>. Post <NUM> is movable in one or a plurality of axes relative to shaft <NUM> and longitudinal axis DD. Post <NUM> includes an end <NUM> and an end <NUM>, as shown in <FIG>. End <NUM> engages with one or more instruments, for example, a driver (not shown) to rotate screw <NUM>.

End <NUM> includes a joint <NUM>, similar to joint <NUM> described herein, as shown in <FIG>. Joint <NUM> is connected to a head <NUM>, similar to head <NUM> described herein, of shaft <NUM>. Joint <NUM> is configured to enable post <NUM> to move and/or rotate through one plane relative to shaft <NUM> and/or longitudinal axis DD. In some embodiments, joint <NUM> is positioned in a medial lateral direction relative to screw <NUM>. Joint <NUM> is formed from a portion of head <NUM> and a portion of end <NUM>, as shown in <FIG>. End <NUM> includes openings <NUM>, <NUM> and head <NUM> includes openings <NUM>, <NUM>. A pin <NUM> is disposed with openings <NUM>, <NUM> and <NUM>, <NUM>. In some embodiments, post <NUM> disengages from shaft <NUM> when a torque limit is applied to post <NUM>.

Shaft <NUM>, similar to shaft <NUM> described herein, engages with vertebral tissue. Shaft <NUM> extends from an end <NUM> to an end <NUM>, as show in <FIG>. End <NUM> includes head <NUM> and end <NUM> includes a threaded portion <NUM>.

Connector <NUM> is configured to facilitate procedures performed on a body and/or vertebrae of a patient on a selected plane for example, a sagittal plane. Connector <NUM> is engageable with screw <NUM> and a spinal rod <NUM>, as shown in <FIG>. Connector <NUM> includes a receiver <NUM>, similar to receiver <NUM> described herein, as shown in <FIG>. Receiver <NUM> is configured for dorsal height adjustment relative to post <NUM>. An inner surface <NUM> of receiver <NUM> defines a cavity <NUM>, similar to cavity <NUM> as described herein, for disposal of screw <NUM> and an inner surface <NUM> of receiver <NUM> defines an open cavity <NUM> for disposal of rod <NUM>. Cavity <NUM> extends along a longitudinal axis EE and includes a longitudinal passageway <NUM>. Surface <NUM> includes one or more flats <NUM>. In some embodiments, flats <NUM> may be discrete, planar portions. A band, such as a collet <NUM>, for example, includes an outer surface <NUM> that defines one or more flats <NUM>. Flats <NUM> are configured for disposal with cavity <NUM> and engagement with flats <NUM>, as shown in <FIG>. Engagement between flats <NUM>, <NUM> prevents rotation of collet <NUM> when a nut <NUM> is in a threaded engagement with collet <NUM>, described herein.

Collet <NUM> is contractible and defines an inner surface <NUM> that is directly engageable with post <NUM>. Collet <NUM> includes gaps <NUM> that are adjustable to fix post <NUM> with receiver <NUM>. In some embodiments, gaps <NUM> enable expansion and contraction of collet <NUM>. In some embodiments, gaps <NUM> can be variously configured including, but not limited to, axial and/or transverse gaps. Collet <NUM> extends between an end <NUM> and an end <NUM>. End <NUM> is configured for engagement with nut <NUM>, as described herein. End <NUM> is angled.

Nut <NUM>, similar to nut <NUM> as described herein, is adapted to engage collet <NUM>. Nut <NUM> includes an inner surface <NUM> slidable over post <NUM>. Nut <NUM> extends between an end surface <NUM> and an end surface <NUM>. End surface <NUM> is configured for engagement with receiver <NUM> such that collet <NUM> contracts to fix post <NUM> with receiver <NUM>. End surface <NUM> is engageable with collet <NUM> between an orientation such that surfaces <NUM>, <NUM> are substantially aligned, and an orientation such that collet <NUM> is contractible to fix post <NUM> with receiver <NUM>. End surface <NUM> includes a concave surface <NUM>, disposed to abut collet <NUM> to drive collet <NUM> inward to contract collet <NUM>.

Cavity <NUM>, similar to cavity <NUM> as described herein, extends along a longitudinal axis FF and includes a transverse passageway <NUM> relative to longitudinal passageway <NUM>, as shown in <FIG>. Cavity <NUM> includes a top loading cavity configured for disposal of rod <NUM>. In some embodiments, surface <NUM> includes a threaded portion configured for engagement with threads of a setscrew <NUM>, as shown in <FIG>. Cavity <NUM> includes a substantially U-shaped cross section. A saddle <NUM>, similar to saddle <NUM> as described herein, is disposed with cavity <NUM>, as shown in <FIG>. A pin <NUM>, similar to pin <NUM> as described herein, is configured for disposal with saddle <NUM>.

In one embodiment, as shown in <FIG>, spinal implant system <NUM>, similar to the systems and methods described herein, includes a spinal construct <NUM>, similar to spinal construct <NUM> described herein. Spinal construct <NUM> includes a connector <NUM>, similar to connector <NUM> described herein, and a bone fastener, for example, a multi-axial screw <NUM>, similar to screw <NUM> described herein. Connector <NUM> is configured for dorsal height adjustment relative to a post <NUM> of screw <NUM>, as shown in <FIG> and described herein. Screw <NUM> extends along a longitudinal axis GG, as shown in <FIG>. Screw <NUM> includes post <NUM>, similar to post <NUM>, connected to a threaded shaft <NUM>, similar to shaft <NUM>. Post <NUM> includes an end <NUM> and an end <NUM>, as shown in <FIG>. End <NUM> engages with one or more instruments, for example, a driver (not shown) to rotate screw <NUM>. End <NUM> includes threads.

End <NUM> includes a threaded portion <NUM> and a base <NUM>, as shown in <FIG>. Base <NUM> is configured for engagement with a head <NUM> of shaft <NUM>. Portion <NUM> and base <NUM> are configured for modular and/or pop-on connection with head <NUM>. In some embodiments, portion <NUM> and base <NUM> manually engage head <NUM> in a snap-fit and/or pop-fit engagement. An inner threaded surface <NUM> of base <NUM> is configured for threaded engagement with portion <NUM>. Portion <NUM> at an end <NUM> is welded onto an inner surface <NUM> of base <NUM> above a resilient member, for example, a ring <NUM>, as shown in <FIG>. In some embodiments, portion <NUM> is spot welded onto surface <NUM>. In some embodiments, a breaking torque of <NUM>-<NUM> is applied to post <NUM> via rotation and/or translation of post <NUM> such that portion <NUM> can rotationally translate within base <NUM>.

Ring <NUM> engages with head <NUM> and is configured for disposal with one or more grooves, for example, upper groove <NUM> and expansion groove <NUM> that are defined from surface <NUM> of base <NUM>, as show in <FIG> and <FIG>, as described herein. Ring <NUM> includes a circumference that defines an opening, for example, a gap. A resilient member, for example, a ring <NUM> engages with head <NUM> and is configured for engagement with a lower groove <NUM> defined from surface <NUM> and groove <NUM>, as described herein. Ring <NUM> includes a circumference that defines an opening, for example, a gap. Translation of head <NUM> within base <NUM> translates ring <NUM> from groove <NUM> into groove <NUM>. Rotation and disposal of portion <NUM> within base <NUM> translates ring <NUM> from groove <NUM> into groove <NUM>, and ring <NUM> is translated from groove <NUM> into groove <NUM> as portion <NUM> contacts head <NUM>, as shown in <FIG> and <FIG>. Ring <NUM> fixes portion <NUM> with head <NUM>, and ring <NUM> fixes head <NUM> with base <NUM>, as shown in <FIG>.

Shaft <NUM>, similar to shaft <NUM> described herein, engages with vertebral tissue. Shaft <NUM> extends from an end <NUM> to an end <NUM>, as show in <FIG>. End <NUM> includes head <NUM> and end <NUM> includes a threaded portion <NUM>. Head <NUM> includes a surface <NUM> that includes planar surfaces, for example, flats <NUM> and arcuate surfaces <NUM> for engagement with an arcuate surface <NUM> of end <NUM>, rings <NUM>, <NUM>, and/or base <NUM>, as shown in <FIG>.

Head <NUM> includes a tool engaging portion <NUM> to engage a surgical tool or instrument, as shown in <FIG>. 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, for example, rectangular, polygonal, hexalobe, oval, or irregular.

Connector <NUM> is configured to facilitate procedures performed on a body and/or vertebrae of a patient on a selected plane for example, a sagittal plane. Connector <NUM> is engageable with screw <NUM> and a spinal rod <NUM>, as shown in <FIG>. Connector <NUM> includes a receiver <NUM>, similar to receiver <NUM> described herein, as shown in <FIG>. Receiver <NUM> is configured for dorsal height adjustment relative to post <NUM>. An inner surface <NUM> of receiver <NUM> defines a cavity <NUM>, similar to cavity <NUM> as described herein, for disposal of screw <NUM> and an inner surface <NUM> of receiver <NUM> defines an open cavity <NUM> for disposal of rod <NUM>. Cavity <NUM> extends along a longitudinal axis HH and includes a longitudinal passageway <NUM>.

A collet (not shown), similar to collet <NUM> as described herein, and a nut <NUM> similar to nut <NUM> as described herein, are configured for disposal with cavity <NUM> and for engagement to fix post <NUM> with receiver <NUM>, as described herein. Alternatively, the collet may be similar to collet <NUM> and nut <NUM> may be similar to nut <NUM>.

Cavity <NUM>, similar to cavity <NUM> as described herein, extends along a longitudinal axis II and includes a transverse passageway <NUM> relative to longitudinal passageway <NUM>, as shown in <FIG>. Cavity <NUM> includes a top loading cavity configured for disposal of rod <NUM>. In some embodiments, surface <NUM> includes a threaded portion configured for engagement with threads of a setscrew <NUM>, as shown in <FIG>. Cavity <NUM> includes a substantially U-shaped cross section. In some embodiments, a saddle (not shown) is disposed with cavity <NUM> and engages with rod <NUM>.

To assemble screw <NUM> with connector <NUM>, head <NUM> of shaft <NUM> engages with base <NUM>, as shown in <FIG>. A breaking torque of <NUM>-<NUM> is applied to post <NUM> via rotation and translation of post <NUM> such that portion <NUM> can translate within base <NUM> to connect/fix portion <NUM> and base <NUM> with head <NUM>. Base <NUM> and portion <NUM> are connected/fixed to head <NUM> when threads of portion <NUM> are entirely disposed within base <NUM>. In some embodiments, multi-axial rotation of screw <NUM> can occur when threads of portion <NUM> are completely disposed within base <NUM>. In some embodiments, a portion of the threads of portion <NUM> are exposed to display that post <NUM> has not been connected/fixed with base <NUM>. In some embodiments, a surgical instrument, for example, a counter torque driver (not shown) is employed to prevent base <NUM> from rotating on shaft <NUM>.

Claim 1:
A spinal construct (<NUM>, <NUM>) comprising:
a bone fastener (<NUM>, <NUM>) including a post (<NUM>, <NUM>) and a shaft portion (<NUM>, <NUM>) engageable with vertebral tissue; the post (<NUM>, <NUM>) being movable in one or more axes relative to the shaft portion (<NUM>, <NUM>);
a receiver (<NUM>, <NUM>) defining a first cavity (<NUM>, <NUM>) configured for disposal of the bone fastener (<NUM>, <NUM>) and a second open cavity (<NUM>, <NUM>) configured for disposal of a spinal rod (<NUM>, <NUM>);
a band (<NUM>, <NUM>) disposable in the first cavity (<NUM>, <NUM>), the band (<NUM>, <NUM>) being contractible and defining an inner surface (<NUM>, <NUM>) that is directly engageable with the post (<NUM>, <NUM>); and
a nut (<NUM>, <NUM>) including an inner surface (<NUM>, <NUM>) being slidably engageable over the post and an end surface (<NUM>, <NUM>) engageable with the band (<NUM>, <NUM>) such that the band (<NUM>, <NUM>) contracts to engage the post (<NUM>, <NUM>).