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 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. Surgical treatment may employ surgical instruments and implants that are manipulated for engagement with vertebrae to position and align one or more vertebrae. From <CIT> an implant support cap according to the preamble of claim <NUM> is known. From <CIT> a further implant support cap is known. This disclosure describes an improvement over these prior technologies.

As an improvement over the prior technologies an implant support cap according to claim <NUM> and a spinal implant system according to claim <NUM> are provided.

Further embodiments are subject of the dependent claims.

The exemplary embodiments of the surgical system disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a spinal implant system. Associated methods are also described herein to aid understanding of the invention, but these do not form part of the claimed invention. Furthermore, illustrative methods of use and treatments are discussed to further the understanding of the inventive implant support cap and the inventive spinal implant system. In some embodiments, the systems of the present disclosure comprise medical devices including surgical instruments and implants that can be employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system comprises a surgical instrument, such as, for example, an extender cap configured to guide and/or align one or more components of an implant support, implant and/or spinal construct into engagement for connection and/or assembly of the components. In some embodiments, the surgical instrument includes a guide to align the implant support, for example, at least one extender tab with at least one longitudinal passageway for connection with the extender cap. In some embodiments, the guide includes at least one opening disposed in communication with the at least one passageway to facilitate connection with the implant support. The guide includes an angled surface configured to facilitate disposal of the extender tabs with the extender cap.

In some embodiments, the surgical instrument includes a guide engageable with at least one extender tab to guide and/or align the at least one extender tab into the at least one passageway, for example, axial slots. In some embodiments, the slots are configured to dispose the extender tabs with a cavity of the extender cap.

In some embodiments, the extender tabs are configured for aligning an implant, such as, for example, a bone fastener, with various instruments and providing an access path for set screws and rods. In some embodiments, the extender tabs are connectable with the bone fastener.

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 The surgical system of the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. 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. References to "embodiments" throughout the description which are not under the scope of the appended claims merely represent possible exemplary executions and are therefore not part of the present invention. In some embodiments, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references "upper" and "lower" are relative and used only in the context to the other, and are not necessarily "superior" and "inferior.

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

The following discussion includes a description of a surgical system including a surgical instrument, related components and illustrative methods of employing the surgical system. 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 surgical system, such as, for example, a spinal implant system <NUM>. An embodiment of system <NUM> is shown in <FIG>. <FIG> show a few components of the system.

Various components of spinal implant system <NUM> may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency for imaging preference.

Spinal implant system <NUM> is employed, for example, with a fully open surgical procedure, a minimally invasive procedure including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrumentation and/or a spinal implant, such as, for example, a bone fastener, at a surgical site of a patient, which includes, for example, a spine. In some embodiments, the spinal implant can include one or more components of one or more spinal constructs, such as, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft, and can be employed with various surgical procedures including surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine.

Spinal implant system <NUM> includes an implant support cap, for example, an extender cap <NUM>. Cap <NUM> is configured to guide and/or align an implant support member, such as, for example, extender tabs <NUM>, 152a into engagement with cap <NUM> for connection and/or assembly of the components of an extender connected to a bone fastener assembly <NUM>. Cap <NUM> comprises a guide <NUM> configured to facilitate connection of extender tabs <NUM>, 152a with cap <NUM>.

Cap <NUM> extends between an end <NUM> and an end <NUM> defining an axis X1. Cap <NUM> includes a wall <NUM>. Wall <NUM> includes portions 24a, 24b, 24c and 24d. Wall <NUM> includes an inner surface <NUM> extending along portions 24a, 24b, 24c and 24d. Surface <NUM> defines a cavity <NUM> configured for disposal of extender tabs <NUM>, 152a. Cavity <NUM> includes a substantially rectangular configuration. In some embodiments, cavity <NUM> has various configurations including, for example, round, oval, polygonal, irregular, consistent, variable, uniform and non-uniform.

Portions 24a, 24b, 24c and 24d meet respectively at corners <NUM> along the inner surface of wall <NUM>. In some embodiments, the inner surfaces of portions 24a, 24b, 24c and 24d include an arcuate, rounded, or partially rounded or arcuate, surface forming corners <NUM>, as shown by way of example in <FIG>. In some embodiments, corners <NUM> may have various configurations including, for example, irregular, consistent, variable, uniform and non-uniform. Corners <NUM> extend axially along wall <NUM>. In some embodiments, corners <NUM> extend at alternate orientations along wall <NUM>, such as, for example, at transverse, perpendicular and/or other angular orientations such as acute or obtuse, and/or may be offset or staggered, with respect to axis X1.

A projection <NUM> is disposed with portions 24b, 24d, as shown in <FIG>. Projection <NUM> is configured to abut extender tabs <NUM>, 152a to retain extender tabs <NUM>, 152a within cavity <NUM>. For example, as extender tabs <NUM>, 152a translate into engagement with cap <NUM>, projection <NUM> resists and/or prevents extender tabs <NUM>, 152a from passing through cavity <NUM> during insertion.

Portion 24a includes a surface <NUM> connectable with a portion of extender tabs <NUM>, 152a, such as, for example, a spring tip <NUM> or a spring tip <NUM>, as described herein. Surface <NUM> defines at least one groove, such as, for example, a pocket <NUM>, as shown in <FIG>. Portion 24a includes a pair of pockets <NUM>. Pockets <NUM> are configured for a mating engagement with spring tips <NUM>, as described herein. Surface <NUM> is configured as a lock <NUM> to resist and/or prevent disengagement of spring tips <NUM> from pocket <NUM>, as described herein.

Portion 24c includes a surface <NUM>, similar to surface <NUM>, connectable with a portion of extender tabs <NUM>, 152a, such as, for example, spring tip <NUM> or spring tip <NUM>, as described herein. Surface <NUM> defines at least one groove, such as, for example, a pocket <NUM>, as shown in <FIG>. Portion 24c includes a pair of pockets <NUM>, as shown in <FIG>. Pockets <NUM> are configured for a mating engagement with spring tips <NUM>, as described herein. Pockets <NUM> are disposed in alignment with pockets <NUM>, as shown in <FIG>, to facilitate engagement of spring tips <NUM>. Surface <NUM> is configured as a lock <NUM> to resist and/or prevent disengagement of spring tips <NUM> from pocket <NUM>, as described herein.

Pockets <NUM>, <NUM> are configured for engagement with spring tips <NUM>, <NUM>, as shown in <FIG>. Disposal of spring tips <NUM>, <NUM> with pockets <NUM>, <NUM> is configured to resist and/or prevent extender tabs <NUM>, 152a from disengaging from cap <NUM>. In some embodiments, pockets <NUM>, <NUM> are disposed parallel to axis X1. In some embodiments, pockets <NUM>, <NUM> are disposed at alternate orientations relative to axis a, such as, for example, at transverse, perpendicular and/or other angular orientations such as acute or obtuse, and/or may be offset or staggered. In some embodiments, locks <NUM>, <NUM> are configured to provide audible and/or tactile indicia, such as, for example, an audible click indicating engagement of spring tips <NUM>, <NUM> with cap <NUM>.

Wall <NUM> includes longitudinal rails 60a, 60b, 60c and 60d extending along axis X1. Rail 60a includes surface <NUM>. Rail 60b includes a surface <NUM>. Surfaces <NUM>, <NUM> define a passageway, such as, for example, an axial slot <NUM>. Slot <NUM> extends along axis X1. Slot <NUM> is configured to facilitate engagement of extender tab <NUM> with cap <NUM>, as described herein. In some embodiments, all or only a portion of surfaces <NUM>, <NUM> may have alternate configurations, such as, for example, irregular, uniform, non-uniform, offset, staggered, tapered, arcuate or undulating. Surfaces <NUM>, <NUM> direct and/or guide insertion of extender tab <NUM> into cavity <NUM>.

Rail 60c includes surface <NUM>. Rail 60d includes a surface <NUM>. Surfaces <NUM>, <NUM> define a passageway, such as, for example, an axial slot <NUM>. Slot <NUM> extends along axis X1. Slot <NUM> is configured to facilitate engagement of extender tab 152a with cap <NUM>, as described herein. In some embodiments, all or only a portion of surfaces <NUM>, <NUM> may have alternate configurations, such as, for example, irregular, uniform, non-uniform, offset, staggered, tapered, arcuate or undulating. Surfaces <NUM>, <NUM> direct and/or guide insertion of extender tab 152a into cavity <NUM>.

Extender tabs <NUM>, 152a are configured to slide and/or translate along slots <NUM>, <NUM> to position extender tabs <NUM>, 152a within cavity <NUM> and into locking engagement with cap <NUM>, as described herein. Slots <NUM>, <NUM> are configured to splay extender tabs <NUM>, 152a to facilitate engagement of spring tips <NUM>, <NUM> with pockets <NUM>, <NUM>.

Guide <NUM> is configured to guide and/or direct extender tabs <NUM>, 152a into cavity <NUM>. Guide <NUM> includes a distal surface <NUM> of wall <NUM> and an extension <NUM> extending from portion 24c, as shown in <FIG>. Surface <NUM> includes an opening <NUM> disposed in communication with slot <NUM>. Surface <NUM> includes an opening <NUM> disposed in communication with slot <NUM>. Surface <NUM> is configured to guide and/or direct extender tabs <NUM>, 152a into slots <NUM>, <NUM>.

Surface <NUM> is disposed at an angle relative to axis X1 such that surface <NUM> is disposed in a transverse orientation relative to slots <NUM>, <NUM> to define a ramp <NUM>, as shown in <FIG> and <FIG>. Ramp <NUM> is selectively inclined to facilitate translation and/or guiding of extender tabs <NUM>, 152a into slots <NUM>, <NUM> and/or slots <NUM>, <NUM>. In some embodiments, surface <NUM> is disposed at alternate orientations relative to axis X1, such as, for example, at transverse, perpendicular and/or other angular orientations such as acute or obtuse, and/or may be offset or staggered. In some embodiments, surface <NUM> is selectively inclined to facilitate translation and/or disengagement of extender tabs <NUM>, 152a from cap <NUM>.

Extension <NUM> includes a slot <NUM> and a slot <NUM>. Slot <NUM> is disposed coaxially with slot <NUM>, as shown in <FIG>. Slot <NUM> is disposed coaxially with slot <NUM>. Extender tabs <NUM>, 152a are guided, directed and/or aligned via slidable translation along slots <NUM>, <NUM> into slots <NUM>, <NUM>. This configuration facilitates alignment of extender tabs <NUM>, 152a for assembly with cap <NUM>.

Bone fastener assembly <NUM> includes a bone fastener <NUM>. Bone fastener <NUM> includes a receiver <NUM>. Receiver <NUM> is connected to extender tabs <NUM>, 152a that extend along axis X1. Receiver <NUM> includes a pair of spaced apart arms <NUM>, <NUM> that define an implant cavity configured for disposal of a component of a spinal construct, such as, for example, a spinal rod (not shown). Receiver <NUM> includes a socket configured for engagement with a surgical instrument. Receiver <NUM> includes an inner surface having a thread form located adjacent arm <NUM> and a thread form located adjacent arm <NUM>. The thread forms of arms <NUM>, <NUM> are configured for engagement with a coupling member. Bone fastener <NUM> includes a threaded shaft <NUM>. Shaft <NUM> is configured to penetrate tissue, such as, for example, bone.

Arm <NUM> includes a break away tab <NUM> that is frangibly connected to arm <NUM> such that manipulation of tab <NUM> relative to arm <NUM> can fracture and separate tab <NUM> from arm <NUM> at a predetermined force and/or torque limit, as described herein. Arm <NUM> includes a break away tab <NUM> that is frangibly connected to arm <NUM> such that manipulation of tab <NUM> relative to arm <NUM> can fracture and separate tab <NUM> from arm <NUM> at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to tabs <NUM>, <NUM> and resistance increases, for example, the predetermined torque and force limit is approached.

In some embodiments, tabs <NUM>, <NUM> can fracture and separate at a predetermined force or torque limit, which may be in a range of approximately <NUM> Newton meters (N-m) to approximately <NUM> N-m. In some embodiments, tabs <NUM>, <NUM> and arms <NUM>, <NUM> may have the same or alternate cross section configurations, 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 of tabs <NUM>, <NUM>.

Bone fastener assembly <NUM> includes extender tabs <NUM>, 152a connected to bone fastener <NUM>. Extender tabs <NUM>, 152a extend between a proximal end <NUM> and a distal end <NUM>. Proximal end <NUM> includes spring tips <NUM>, <NUM>, as shown in <FIG>. Spring tips <NUM>, <NUM> are interchangeably attachable with pockets <NUM>, <NUM> of cap <NUM> to resist and/or prevent disengagement of spring tips <NUM>, <NUM>, as described herein. Distal ends <NUM> are configured for slidable disposal of a portion of bone fastener <NUM>, such as, for example, tabs <NUM>, <NUM>. In some embodiments, tabs <NUM>, <NUM> are configured to releasably fix extender tabs <NUM>, 152a with bone fastener <NUM>.

In assembly, operation and use, spinal implant system <NUM>, similar to the systems described herein, is employed with a surgical procedure, such as, for example, a treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body. In such treatments, one or all of the components of spinal implant system <NUM> can be delivered or utilized as a pre-assembled device or can be assembled in situ. Spinal implant system <NUM> may be completely or partially revised, removed or replaced.

In use, to treat vertebrae (not shown), a medical practitioner obtains access to a surgical site in any appropriate manner, such as through incision and retraction of tissues. The inventive 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 the vertebrae 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 implant system <NUM>. A preparation instrument (not shown) can be employed to prepare tissue surfaces of the vertebrae as well as for aspiration and irrigation of a surgical region.

Pilot holes (not shown) are made in selected levels of vertebrae for receiving shafts <NUM> of bone fastener assemblies <NUM>. A surgical instrument, such as, for example, a driver is connected to bone fastener <NUM> and bone fasteners <NUM> are engaged with vertebrae. Extender tabs <NUM>, 152a are connected to bone fasteners <NUM>, as described herein.

Extender tabs <NUM>, 152a are positioned adjacent cap <NUM>, as shown in <FIG>. Extender tabs <NUM>, 152a are aligned with guide <NUM> such that ramp <NUM> directs extender tabs <NUM>, 152a into slots <NUM>, <NUM> of extension <NUM>. Extender tabs <NUM>, 152a slide and/or translate along slots <NUM>, <NUM>. Slots <NUM>, <NUM> direct and/or align extender tabs <NUM>, 152a through openings <NUM>, <NUM> into slots <NUM>, <NUM>.

Extender tabs <NUM>, 152a can be positioned with slots <NUM>, <NUM> of extension <NUM> such that extender tabs <NUM>, 152a slide and/or translate along slots <NUM>, <NUM>. Slots <NUM>, <NUM> direct and/or align extender tabs <NUM>, 152a through openings <NUM>, <NUM> for disposal into slots <NUM>, <NUM>. Ramp <NUM> facilitates directing and/or aligning extender tabs <NUM>, 152a into slots <NUM>, <NUM> of extension <NUM>.

Surfaces <NUM>, <NUM> of slot <NUM> and surfaces <NUM>, <NUM> of slot <NUM> are configured to cause extender tabs <NUM>, 152a to splay for disposal with pockets <NUM>, <NUM>, as shown in <FIG>. In some embodiments, spring tips <NUM>, <NUM> are configured to engage surfaces <NUM>, <NUM> and audible and/or tactile indicia, such as, for example, a click indicates engagement of spring tips <NUM>, <NUM> with cap <NUM>. Projection <NUM> resists and/or prevents disengagement of cap <NUM> from cavity <NUM> during insertion of extender tabs <NUM>, 152a.

A surgical procedure using an inventive spinal implant system can include delivering a spinal rod along the surgical pathway for connection with one or more bone fasteners <NUM>. A reduction instrument (not shown) engages the spinal rod for reduction with receivers <NUM> and fixed thereto. In some embodiments, a tab breaker is engaged with extender tabs <NUM>, 152a and is manipulated to apply a force to extender tabs <NUM>, 152a and/or tabs <NUM>, <NUM>. As the force applied reaches a selected torque limit, the tab breaker breaks off extender tabs <NUM>, 152a and/or tabs <NUM>, <NUM> from bone fasteners <NUM>.

Upon completion of a procedure the surgical instruments, assemblies and non-implanted components of spinal implant system <NUM> can be removed and the incision(s) can be 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, spinal implant system <NUM> may include one or a plurality of spinal rods, plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels.

One or more bone fasteners, as described herein, may be engaged with tissue in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, the bone fasteners may comprise multi-axial screws, sagittal adjusting screws, pedicle screws, mono-axial screws, uniplanar screws, facet 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.

Claim 1:
An implant support cap (<NUM>) extending along a longitudinal axis (X1) between ends (<NUM>, <NUM>) of the implant support cap (<NUM>), and comprising:
a wall (<NUM>) defining a cavity (<NUM>) and including mating grooves (<NUM>), the mating grooves (<NUM>) defining a first longitudinal passageway (<NUM>) and a second longitudinal passageway (<NUM>),
characterized in that the implant support cap (<NUM>) further comprises:
a guide (<NUM>) including an angled distal surface (<NUM>) of wall (<NUM>), engageable with an implant support member including spaced apart extender tabs (<NUM>, 152a), the guide (<NUM>) further including an extension (<NUM>) having a first slot (<NUM>) disposed coaxial with the first passageway (<NUM>) and a second slot (<NUM>) disposed coaxial with the second passageway (<NUM>), the angled distal surface (<NUM>) including a first opening (<NUM>) communicating with the first passageway (<NUM>) and a second opening (<NUM>) communicating with the second passageway (<NUM>) to orient the tabs (<NUM>, 152a) with the passageways (<NUM>, <NUM>) such that the implant support member is connectable with the wall (<NUM>),
wherein the angled distal surface (<NUM>) is disposed at an angle relative to the longitudinal axis (X1) such that surface (<NUM>) is disposed in a transverse orientation relative to the passageways (<NUM>, <NUM>) to define a ramp (<NUM>), wherein the guide (<NUM>), along the ramp (<NUM>), is open in a transverse direction to the longitudinal axis (X1), thereby exposing the first slot (<NUM>) and the second slot (<NUM>) in the transverse direction to the longitudinal axis (X1).