Patent Description:
Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, 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 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, which include implants such as tethers, bone fasteners, connectors, plates and vertebral rods are often used to provide stability to a treated region. These implants can redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members. Surgical instruments are employed, for example, to engage the implants for attachment to the exterior of one or more vertebral members. This disclosure describes an improvement over these prior technologies.

<CIT> relates to a tether clamp installation system according to the preamble part of claim <NUM> including a clamp housing a locking element, a band and a tensioning instrument. The tensioning instrument defines at least one slot which allows movement of a carriage between a non-tightened position and a tightened position, permitting a surgeon to tighten the band. A longitudinal cylinder of the tightening instrument permits the insertion of various tools.

<CIT> relates to systems including clamps and tensioner instrument with ta tensioner driver for tensioning an elastic member.

The present invention relates to a surgical system as claimed hereafter. Preferred embodiments of the invention are set forth in the dependent claims. Associated methods are also described herein to aid understanding of the invention, but these do not form part of the claimed invention. In one embodiment, a surgical system is provided. The surgical system comprises a tether. A connector is configured for disposal of the tether. A spinal rod is configured for disposal with the connector. A coupling member is engageable with the spinal rod and the connector. A surgical instrument includes a first member defining a cavity and includes a locking surface disposed with the cavity. The locking surface is engageable with the tether to fix the tether with the first member. The surgical instrument further includes a second member including an inner surface that defines a longitudinal passageway. At least one mating element is engageable with the connector and an actuator is connected with the first and second members to incrementally tension the tether. The first member includes a circumferential flange that movably supports the actuator, and the second member includes an outer surface that includes a threaded surface configured for engagement with a threaded inner surface of the actuator such that the actuator is rotatable relative to flange to axially translate the first member relative to the second member. A surgical driver is disposable with the longitudinal passageway and engageable with the coupling member.

A not claimed method for treating a spine is disclosed herein. The method comprises the steps of: delivering a spinal construct to a surgical site including vertebrae, the spinal construct including a connector configured for disposal of a tether and a spinal rod, the spinal construct further including a coupling member engageable with the spinal rod and the connector; connecting the tether with the vertebrae; mating a surgical instrument with the connector, the surgical instrument including a first member having a locking surface being engageable with the tether and a second member that defines a longitudinal passageway; tensioning the tether with the surgical instrument; and guiding a surgical driver through the longitudinal passageway for connection with the coupling member.

The exemplary embodiments of a surgical system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system for correction of a spine disorder. In some examples, the surgical system may be employed in applications for correction of deformities, such as scoliosis and kyphosis.

In some embodiments, the surgical system includes a surgical instrument that comprises a tether tensioner. In some embodiments, the surgical system includes a surgical instrument that comprises a sub-laminar tether tensioner. In some embodiments, the tether tensioner includes a counter-torque, which can be employed for final tightening of one or more components of a spinal construct connected with vertebrae. In some The surgical system provides a tensioner for providing tension to a tether portion of a connector. In some embodiments, the surgical system includes a surgical instrument that provides, for example, loading one or more implants of a spinal construct, for example, a connector to a spinal rod and into a body. As disclosed herein, the surgical system may be employed for use in a method that includes the step of affixing a connector to a spinal rod and providing counter-torque to tighten a set screw, and tensioning a tether. In some embodiments, the surgical instrument includes a threaded mechanism to tension a tether.

As disclosed herein, the surgical system may be employed for use in a method that includes the step of reducing a spinal rod to a spine and applying tension to a sub-laminar tether. As disclosed herein, the method may include the step employing a surgical tensioner instrument to reduce the spinal rod and apply tension to the sub-laminar tether. In some embodiments, the surgical instrument includes a threaded tensioner. In some embodiments, the surgical instrument includes a threaded tensioner that moves a threaded carriage away from a spinal construct while drawing a tether.

In some examples not claimed, the surgical instrument includes a ratcheting tensioner that includes a ratcheting mechanism. The ratcheting tensioner includes a catch that resists and/or prevents a carriage from translating downward while a pawl resets. In some embodiments, the catch cannot be released while a cam lever arm of the ratcheting mechanism is engaged, which resists and/or prevents accidental release of the carriage while a tether is under tension.

In some examples, the ratcheting tensioner includes a lever that drives the pawl downward, forcing the carriage upward. In some embodiments, a single actuation or engagement, for example, squeezing of the lever produces translation of the carriage. In some embodiments, a single actuation of the lever produces <NUM> millimeters (mm) of translation of the carriage. The ratcheting tensioner can include a cam lock to attach the carriage with a tether. In some examples, the ratcheting tensioner includes a safety latch that resists and/or prevents disengagement of the tether from the carriage. The ratcheting tensioner includes a carriage that defines a tether path.

In some embodiments, the surgical instrument includes one or more locks to fix a spinal rod and/or a connector with the tensioner. In some embodiments, the surgical instrument includes one or more tabs to lock the surgical instrument to a connector. In some embodiments, the surgical instrument includes an outer sleeve that resists and/or prevents the tabs from releasing the connector. In some embodiments, the surgical instrument includes an outer sleeve that locks a spinal rod in position.

In some examples, the surgical system includes a surgical instrument configured to apply a tension to a sub-laminar tether. The surgical system includes a tensioner configured to apply a tension to a tether and/or a spinal construct. In some embodiments, the tensioner is configured for attachment with a spinal construct, such as, for example, a connector. The tensioner is configured for attachment with the connector via mating surfaces. In some embodiments, the mating surfaces include one or more slots. In some embodiments, the tensioner includes a mating element for engagement with slots disposed with the connector. In some embodiments, the tensioner comprises an implant holder.

The surgical system includes a tether configured for engagement with the connector. The surgical instrument includes a threaded shaft to facilitate translation of a carriage in a direction away from the connector by rotation along a threaded shaft. In some embodiments, the surgical instrument includes a knob to actuate translation and apply a tension to the tether.

In some embodiments, the surgical system includes one or more implants, such as, for example, a sub-laminar tether and a connector. In some embodiments, the surgical system includes one or more surgical instruments, such as, for example, a tensioner, a socket driver and a counter-torque handle. In some embodiments, the tether includes a tip having a <NUM> length to facilitate passage under a lamina. In some embodiments, the tether includes a <NUM> length to facilitate wrapping of the tether about the tensioner.

In some embodiments, the surgical system includes a connector having slots configured to facilitate connection of the connector with a surgical instrument. In some embodiments, the slots provide visual indicia of the connector for mating and/or docking with a surgical instrument. In some embodiments, the slots provide access to a top surface of the connector by a surgical instrument to control axial translation and facilitate engagement of the surgical instrument therewith. In some embodiments, the tether is connected with the connector by a screw similar to a screw utilized for connection of the connector with a spinal rod. In some embodiments, the surgical system includes a t25 torx screw for connection of the connector with a spinal rod and a t25 torx screw for connecting the tether with the connector.

In some embodiments, the surgical system includes a tensioner connected with a spinal rod such that the tensioner engages along a surface of the spinal rod and/or has a run on the spinal rod of <NUM>. In some embodiments, the surgical system includes a tensioner having a medial-lateral width of <NUM>. In some embodiments, the surgical system includes a tensioner having a member including a triple lead thread. In some embodiments, the triple lead thread is configured to provide for increase in advancement time of a carriage with a decrease in mechanical advantage. In some embodiments, the carriage is configured to translate <NUM> per rotation and includes <NUM> of thread length. In some embodiments, indicia, such as, for example, hash marks are provided on the member as a reference guide. In some embodiments, the carriage includes a cam lock having a decreased length and a larger actuation surface for manipulation.

In some embodiments, the surgical system includes a tensioner having a projection configured to straighten tension on the tether. In some embodiments, the projection is configured to resist and/or prevent the tether from contacting sharp surfaces. In some embodiments, the surgical system includes a socket driver. In some embodiments, the socket driver is configured to provide additional torque to facilitate tensioning. In some embodiments, the socket driver is configured to provide segmental tensioning if multiple tensioners are utilized. In some embodiments, the surgical system includes a counter-torque handle engageable with the tensioner. In some embodiments, the counter-torque handle is configured to facilitate fracturing break off portions of set screws.

In some embodiments, the surgical system is used with surgical navigation, such as, for example, fluoroscope or image guidance. In some embodiments, one or all of the components of the surgical system are disposable, peel-pack, pre-packed sterile devices. One or all of the components of the surgical system may be reusable. The surgical system may be configured as a kit with multiple sized and configured components.

As disclosed herein, the present disclosure may be employed for use in the treatment of spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. For example, the present disclosure may be employed for use 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 for use in a surgical treatment with a patient in a prone, supine position, lateral and/or employ various surgical approaches to the spine, including anterior, posterior, posterior midline, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The present disclosure may also be alternatively employed for use with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The 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 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 and including the appended claims, 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. 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, micro discectomy 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 re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. 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 in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to 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 correction system <NUM>.

The components of spinal correction system <NUM> can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of spinal correction 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, cobaltchrome 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., SKELITEn. <NUM>), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaS04 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 such as hydroxyapatite (HA), corraline HA, biphasic calcium phosphate, tricalcium phosphate, or fluorapatite, tri-calcium phosphate (TCP), HA-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations, biocompatible ceramics, mineralized collagen, bioactive glasses, porous metals, bone particles, bone fibers, morselized bone chips, bone morphogenetic proteins (BMP), such as BMP-<NUM>, BMP-<NUM>, BMP-<NUM>, rhBMP-<NUM>, or rhBMP-<NUM>, demineralized bone matrix (DBM), transforming growth factors (TGF, e.g., TGF-p), osteoblast cells, growth and differentiation factor (GDF), insulin-like growth factor <NUM>, platelet-derived growth factor, fibroblast growth factor, or any combination thereof.

Various components of spinal correction 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 or imaging preference. The components of spinal correction system <NUM>, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of spinal correction system <NUM> may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

Spinal correction system <NUM> comprises a surgical instrument, such as, for example, a tensioner <NUM>. Tensioner <NUM> extends between an end <NUM> and an end <NUM>. Tensioner <NUM> defines a longitudinal axis X1. In some embodiments, tensioner <NUM> may comprise overall and/or cross-section configurations, such as, for example, cylindrical, round, oval, rectangular, polygonal, irregular, tapered, offset, staggered, uniform and non-uniform. In some embodiments, one or more of the surfaces of tensioner <NUM> may have alternate surface configurations, such as, for example, rough, threaded for connection with surgical instruments, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

Tensioner <NUM> includes a first member, such as, for example, a carriage <NUM>. Carriage <NUM> extends between an end <NUM> and an end <NUM>. In some embodiments, carriage <NUM> may have various configurations, for example, circular, cylindrical, square, oval, rectangular, polygonal, irregular, tapered, offset, staggered and uniform. Carriage <NUM> includes an outer surface <NUM>. In some embodiments, outer surface <NUM> may have alternate surface configurations, such as, for example, smooth, rough, threaded for connection with surgical instruments, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

Carriage <NUM> includes a surface <NUM> that defines an elongated cavity, such as, for example, a pathway <NUM>. Pathway <NUM> is configured for disposal of a longitudinal member, such as, for example, a tether <NUM>. In some embodiments, pathway <NUM> extends along an axis X2, as shown in <FIG>. In some embodiments, axis X2 is parallel to axis X <NUM>. In some embodiments, axis X2 extends transverse to axis X <NUM>. In some embodiments, pathway <NUM> may have various cross sectional and/or axial configurations, for example, square, oval, rectangular, polygonal, irregular, offset, staggered, uniform and non-uniform.

Carriage <NUM> includes an arm, such as, for example, a lever <NUM>. Lever <NUM> extends between an end <NUM> and an end <NUM>. End <NUM> includes a rotatable cam, such as, for example, a locking surface <NUM>. Lever <NUM> is configured to pivot relative to axis X2 about a pin <NUM> disposed with end <NUM>. Pin <NUM> is configured to facilitate engagement of locking surface <NUM> with tether <NUM>. Locking surface <NUM> is in communication with pathway <NUM> such that locking surface <NUM> engages tether <NUM> to resist and/or prevent disengagement of tether <NUM> from pathway <NUM>. In some embodiments, locking surface <NUM> is angled to facilitate engagement of tether <NUM> in a locked orientation, as described herein. In some embodiments, locking surface <NUM> may include penetrating members, such as, for example, a plurality of teeth <NUM>. In some embodiments, teeth <NUM> may have various configurations, for example, round, oval, rectangular, polygonal, irregular, tapered, offset, staggered, uniform and nonuniform.

Rotation of lever <NUM> causes locking surface <NUM> to pivot between a non-locked orientation and a locked orientation with tether <NUM>. In the non-locked orientation, tether <NUM> is movable relative to locking surface <NUM> such that tether <NUM> can translate along pathway <NUM> relative to one or more components of tensioner <NUM>. In the locked orientation, teeth <NUM> engage tether <NUM> to fix tether <NUM> with carriage <NUM>. Locking surface <NUM> applies a compressive force and/or a friction force, as described herein, to fix tether <NUM> in the locked orientation. Locking surface <NUM> is configured for engagement with tether <NUM> to resist and/or prevent disengagement of tether <NUM> from pathway <NUM>. In some embodiments, lever <NUM> includes an enlarged engagement surface <NUM> configured to facilitate pivoting of lever <NUM>. In some embodiments, lever <NUM> includes a shorter length to adjust a mechanical advantage of lever <NUM>.

Tensioner <NUM> includes a second member, such as, for example, a surgical instrument guide <NUM> that extends between an end <NUM> and an end <NUM>. Guide <NUM> includes a surface <NUM> that defines a cavity, such as, for example, a channel <NUM>. Channel <NUM> is configured for disposal of a surgical instrument, such as, for example a surgical driver, as described herein, to facilitate engagement of a coupling member <NUM> with a spinal implant, such as, for example, a connector <NUM>. Guide <NUM> includes channel <NUM>, which comprises an axially-aligned passageway along the length of guide <NUM> such that the surgical driver can be inserted therethrough for engaging and tightening a coupling member, as described herein. In some embodiments, guide <NUM> includes channel <NUM> for disposal of a surgical driver to directly engage an implant, for example, a bone fastener, fixation element, plate or connector. In some embodiments, channel <NUM> may have various cross section and/or axial configurations, for example, round, oval, rectangular, polygonal, irregular, tapered, offset, staggered, arcuate, uniform and non-uniform.

Coupling member <NUM> includes a break off head (not shown). In some embodiments, the break off head includes a tool engaging portion configured to engage a surgical tool or instrument such as, for example, a surgical driver. In some embodiments, the break off head is frangibly connected with a body of coupling member <NUM>. In some embodiments, the break off head is fabricated from a fracturing and/or frangible material such that manipulation of the head can fracture and separate the head at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to the break off head and resistance increases, for example, due to fixation of threads coupling member <NUM> with connector <NUM>, as described herein, the predetermined torque and force limit is approached.

The break off head can fracture and separate at a predetermined force or torque limit, which may be in a range of approximately <NUM> Newton meters (Nm) to <NUM>. In some embodiments, the break off head 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 the head. In some embodiments, the break off head includes an inner diameter that facilitates a desired breakoff torque.

Guide <NUM> includes an outer surface <NUM> that includes a threaded surface <NUM>. Threaded surface <NUM> extends between an end <NUM> and an end <NUM>. In some embodiments, threaded surface <NUM> is continuous along surface <NUM>. In some embodiments, threaded surface <NUM> includes a triple thread turn, spaced apart threads or a plurality of discrete threads. In some embodiments, threaded surface <NUM> includes one or more racks, as described herein. In some embodiments, indicia, such as, for example, hash marks are disposed on surface <NUM> to provide reference of dimension, such as, for example, length, depth and/or height.

Threaded surface <NUM> is configured for engagement with an actuator, such as, for example, a knob <NUM>, as described herein. Carriage <NUM> includes a circumferential flange <NUM> that movably supports knob <NUM>. Guide <NUM> includes a sleeve <NUM> having one or more capture elements, such as, for example, a capture element <NUM> and a capture element <NUM> disposed at an end <NUM>. Elements <NUM>, <NUM> are configured for releasable engagement with connector <NUM>. Elements <NUM>, <NUM> each include an inner surface that define an implant cavity configured for disposal of at least a portion of connector <NUM>, as described herein. The inner surfaces of elements <NUM>, <NUM> include at least one fixation surface, such as, for example, inward tab projections (not shown) respectively, configured to releasably capture connector <NUM>. The projections extend axially along sleeve <NUM>.

Knob <NUM> includes a surface <NUM> configured to facilitate gripping and rotation of knob <NUM>. In some embodiments, surface <NUM> may have alternate surface configurations, such as, for example, grooved, rough, threaded for connection with surgical instruments, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured. In some embodiments, knob <NUM> includes a surface, such as, for example, a tool engaging surface <NUM>. Tool engaging surface <NUM> is configured for a mating engagement with a tool, such as, for example, a socket driver, as described herein. In some embodiments, tool engaging surface <NUM> includes configurations, such as, for example, triangular, square, polygonal, hexalobular, star or torx.

A threaded inner surface <NUM> of knob <NUM> engages threaded surface <NUM> such that knob <NUM> is rotatable relative to flange <NUM> to axially translate carriage <NUM> relative to the guide <NUM>, in a direction shown by arrow A and a direction shown by arrow B in <FIG>. Knob <NUM> is rotatable in a clockwise and a counter clockwise direction to facilitate axial translation of carriage <NUM> relative to guide <NUM>. Translation of carriage <NUM> relative to guide <NUM> causes an increase and/or a decrease in tension and/or tensile force in tether <NUM>, as described herein. In some embodiments, carriage <NUM> is translated relative to guide <NUM> to incrementally increase and/or decrease tension in tether <NUM>. In some embodiments, carriage <NUM> is translated relative to guide <NUM> to continuously increase and/or decrease tension in tether <NUM>.

Tether <NUM> is a flexible longitudinal element that extends between an end <NUM> and an end <NUM>. Tether <NUM> is configured for engagement with connector <NUM>, as described herein. In some embodiments, end <NUM> and end <NUM> form a loop configured to surround all or a portion of tissue, such as, for example, laminae and/or a spinal implant, such as, for example, a spinal rod <NUM>, as described herein. Tether <NUM> is configured for tensioning about a targeted portion of an anatomy of a body for attachment of tether <NUM> with the targeted portion of the anatomy, as described herein. In some embodiments, the targeted portion of the anatomy may include laminae, transverse process and/or pedicle regions of a vertebral level. In some embodiments, spinal correction system <NUM> may include one or a plurality of tethers <NUM>, each tether being configured for disposal about a single and separate vertebral level. In some embodiments, a single vertebral level may include one or a plurality of tethers <NUM>.

Tether <NUM> has a flexible configuration and may be fabricated from materials, such as, for example, fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers and elastomeric composites. In some embodiments, the flexibility of tether <NUM> includes movement in a lateral or side to side direction and prevents expanding and/or extension in an axial direction upon tensioning and attachment with a targeted portion of the anatomy. In some embodiments, all or only a portion of tether <NUM> may have a semi-rigid, rigid or elastic configuration, and/or have elastic properties, similar to the material examples described above, such that tether <NUM> provides a selective amount of expansion and/or extension in an axial direction. In some embodiments, tether <NUM> may be compressible in an axial direction. Tether <NUM> can include a plurality of separately attachable or connectable portions or sections, such as bands or loops, or may be monolithically formed as a single continuous element.

Tether <NUM> can have a uniform thickness/diameter. In some embodiments, tether <NUM> may have various surface configurations, such as, for example, smooth and/or surface configurations to enhance fixation, such as, for example, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured. In some embodiments, the thickness defined by tether <NUM> may be uniformly increasing or decreasing, or have alternate diameter dimensions along its length. In some embodiments, tether <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In some embodiments, the surface of tether <NUM> may include engaging structures, such as, for example, barbs, raised elements and/or spikes to facilitate engagement with tissue of the targeted anatomy.

In some embodiments, tether <NUM> may have various lengths. In some embodiments, tether <NUM> may be braided, such as a rope, or include a plurality elongated elements to provide a predetermined force resistance. In some embodiments, tether <NUM> may be made from autograft and/or allograft, and be configured for resorbable or degradable applications. In some embodiments, tether <NUM> is a cadaver tendon. In some embodiments, tether <NUM> is a tendon that may be harvested, for example, from a patient or donor. In some embodiments, a tendon harvested from a patient may be affixed in remote locations with the patient's body.

Spinal correction system <NUM> includes connector <NUM>. Connector <NUM> includes a body <NUM> having a surface <NUM> that defines a cavity, such as, for example, a first passageway <NUM> configured for disposal of tether <NUM>. In some embodiments, first passageway <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In some embodiments, surface <NUM> may include gripping elements or surfaces, such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured to facilitate engagement with tether <NUM>. Body <NUM> includes a surface <NUM> that defines a cavity, such as, for example, an opening <NUM>. Opening <NUM> is configured for disposal of a coupling member, such as, for example, a set screw <NUM>.

Body <NUM> includes a surface <NUM> that defines a second passageway <NUM>. Second passageway <NUM> has an oblong configuration and extends transversely through body <NUM>. In some embodiments, second passageway <NUM> may have alternate cross section configurations, such as, for example, oval, cylindrical, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. Second passageway <NUM> is configured for disposal of spinal rod <NUM> such that connector <NUM> can be mounted with spinal rod <NUM>, as described herein. Body <NUM> includes an opening <NUM>. Opening <NUM> is configured for engagement with a coupling member, such as, for example, a set screw <NUM> to fix rod <NUM> with connector <NUM>, as described herein.

Body <NUM> includes a mating surface <NUM> that defines cavities, such as, for example, mating slots <NUM> configured to mate with the projections of sleeve <NUM> to facilitate connection of tensioner <NUM> with connector <NUM>. As such, guide <NUM> is connected with connector <NUM> and channel <NUM> is axially aligned with set screw <NUM>. This configuration facilitates disposal of a surgical driver with channel <NUM> such that the surgical driver is guided along channel <NUM> into an orientation for engagement with set screw <NUM> for tightening and fixation of spinal rod <NUM> with connector <NUM>, as described herein. In some embodiments, spinal correction system <NUM> may include one or a plurality of implant connectors spaced apart and disposed along a spinal implant, such as, for example, spinal rod <NUM>, which may be relatively disposed in a side by side, irregular, uniform, non-uniform, offset and/or staggered orientation or arrangement, along one or a plurality of spinal rods. In some embodiments, spinal rod <NUM> extends along one or a plurality of vertebra, as described herein. In some embodiments, spinal correction system <NUM> may include one or a plurality of spinal rods <NUM>, which may be relatively disposed in a side by side, irregular, uniform, nonuniform, offset and/or staggered orientation or arrangement.

In assembly, operation and use, spinal correction system <NUM>, similar to the systems described herein, is employed for use in a surgical procedure, such as, for example, a correction treatment of an affected portion of a spine, which may include a correction treatment to treat adolescent idiopathic scoliosis and/or Scheuermann's kyphosis of a spine. One or all of the components of spinal correction system <NUM> can be delivered or implanted as a pre-assembled device or can be assembled in situ. Spinal correction system <NUM> may be completely or partially revised, removed or replaced.

In use, 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. Spinal correction 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 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 for implantation of components of spinal correction 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.

A surgical instrument, such as, for example, an osteotome O is utilized to prepare tissue surfaces, such as, for example, laminae for disposal of tether <NUM> therewith, as shown in <FIG>. End <NUM> of tether <NUM> is threaded through passageway <NUM> of connector <NUM>, as shown in <FIG>. Screw <NUM> is disposed in a non-locked orientation such that tether <NUM> is movable within first passageway <NUM> and a cleat <NUM> is positioned therein.

Pilot holes are made in vertebrae V in a selected orientation. Bone fasteners <NUM> are aligned with the pilot holes and fastened with the tissue of vertebrae V, as shown in <FIG>. Tether <NUM> and connector <NUM> are delivered along the surgical pathway to a surgical site adjacent a lateral side of vertebrae V, and tether <NUM> is disposed with vertebrae V and/or spinal rod <NUM>, as shown in <FIG>. In one embodiment, a loop <NUM> of tether <NUM> is disposed about a transverse process of a vertebra. This configuration fixes and/or attaches tether <NUM> with the transverse process and/or lamina. In some embodiments, connector <NUM> is oriented medially and end <NUM> of tether <NUM> is threaded through first passageway <NUM> for connection with connector <NUM>, as shown in <FIG>. In some embodiments, additional tethers <NUM> and/or connectors <NUM> are engaged along multiple vertebral levels, as shown in <FIG>.

Spinal rod <NUM> is disposed with bone fasteners <NUM>. Spinal rod <NUM> is seated with connectors <NUM>, as shown in <FIG>. Tensioner <NUM> is disposed adjacent connector <NUM> and sleeve <NUM> is connected with connector <NUM> such that the projections engage mating slots <NUM>, as described herein. Guide <NUM> is connected with connector <NUM> and channel <NUM> is axially aligned with set screw <NUM> such that a surgical driver D is disposed with channel <NUM>. Driver D is guided along channel <NUM> into an orientation for engagement with set screw <NUM> for tightening and fixation of spinal rod <NUM> with connectors <NUM>, as described herein. Set screws <NUM> are individually engaged by driver D and rotated to provisionally fix connectors <NUM> with spinal rod <NUM>.

Tether <NUM> is threaded through pathway <NUM> of tensioner <NUM> and lever <NUM> is disposed in the non-locked orientation with tether <NUM>, as shown in <FIG>. Lever <NUM> is actuated to pivot, in a direction shown by arrow C in <FIG>, such that locking surface <NUM> engages tether <NUM>, as described herein, to dispose lever <NUM> in the locked orientation with tether <NUM>. Locking surface <NUM> applies a compression force to tether <NUM> to resist and/or prevent tether <NUM> from freely translating and/or disengaging from pathway <NUM>.

Knob <NUM> is rotated to axially translate guide <NUM>, as described herein. Knob <NUM> is rotatable in a counter clockwise direction to facilitate axial translation of carriage <NUM> relative to guide <NUM>, in a direction shown by arrow A in <FIG>, to cause an increase in tension and/or tensile force in tether <NUM>, as described herein. Knob <NUM> is rotatable in a clockwise direction to facilitate axial translation of carriage <NUM> relative to guide <NUM>, in a direction shown by arrow B in <FIG>, to cause a decrease in tension and/or tensile force in tether <NUM>, as described herein.

Translation of carriage <NUM>, in a direction shown by arrow A in <FIG>, draws tether <NUM> to apply a tensioning force to tether <NUM>. This configuration tensions tether <NUM> about the vertebra and tensions the spinal construct for attachment with vertebrae V and/or to apply corrective treatment to vertebrae V. In some embodiments, the tension and/or tensile force applied to tether <NUM> and/or corrective forces applied to vertebrae V can be increased by further actuation of knob <NUM> to incrementally and/or selectively tension tether <NUM>. In some embodiments, the tension and/or tensile force applied to tether <NUM> and/or corrective forces applied to vertebrae V can be increased and/or decreased by tensioner <NUM>. In some embodiments, a T-handle instrument <NUM> is engaged with tensioner <NUM> and/or knob <NUM> to facilitate tightening of tether <NUM>, as shown in <FIG>. In some embodiments, tensioner <NUM> is utilized at various vertebral levels and a sequential tensioning is applied to translate vertebrae V towards spinal rod <NUM>, as shown in <FIG>.

In some embodiments, a counter torque tool <NUM> is engaged with tensioner <NUM>, as shown in <FIG>. Driver D is translated along channel <NUM> of guide <NUM> into engagement with set screw <NUM>, as described herein. Driver D is rotated to finally tighten set screw <NUM> with connector <NUM> and spinal rod <NUM>. Tool <NUM> includes bifurcated extensions that are disposed about the outer surface of tensioner <NUM>. The extensions of tool <NUM> engage the outer surface of tensioner <NUM> to fix position and/or restrain tensioner <NUM> to resist and/or prevent rotation of tensioner <NUM> as driver D simultaneously tightens set screw <NUM> with connector <NUM> and spinal rod <NUM>. In some embodiments, tool <NUM> is configured to provide additional leverage to facilitate removing and/or separating a frangible or break off portion of set screw <NUM> engaged with connector <NUM> at a selected torque limit.

Set screw <NUM> is actuated by a driver <NUM> by rotating screw <NUM> in a clockwise direction to engage cleat <NUM>, as shown in <FIG>. Cleat <NUM> is translated within passageway <NUM> such that its teeth engage tether <NUM>. Translation of cleat <NUM> applies a compressive force and/or a friction force to fix tether <NUM> in a locked orientation with connector <NUM>. In some embodiments, a driver is rotatable to a predetermined force and/or torque limit to separate frangible portions of screw <NUM>. This configuration fixes tension of tether <NUM> about vertebrae V and tensions components of the spinal construct for attachment with vertebrae V and/or to apply corrective treatment to vertebrae V.

To disengage tensioner <NUM> from connector <NUM>, lever <NUM> is disposed in the non-locked orientation, as shown in <FIG>. Locking surface <NUM> disengages from tether <NUM> to allow tether <NUM> to disengage and/or translate through pathway <NUM>. The projections of sleeve <NUM> are released from connector <NUM>, as shown in <FIG>. Excess tether <NUM> is cut from connector <NUM>, as shown in <FIG>. In some embodiments, a tail of <NUM> of tether <NUM> remains and extends from connector <NUM>.

In some examples, spinal implant system <NUM> includes a second spinal rod <NUM>, as shown in <FIG>, delivered along the surgical pathway to the surgical site adjacent a contra-lateral side of vertebrae V. Second spinal rod <NUM> is connected with the contra-lateral side of vertebrae V via one or more tethers <NUM>, similar to spinal rod <NUM> described herein. In some examples, spinal rod <NUM> and second spinal rod <NUM> are fixed with vertebrae V in a side by side orientation and/or a bi-lateral arrangement to stabilize vertebrae V and affect growth for a correction treatment to treat spine pathologies, as described herein. In some examples, one or all of the components of spinal implant system <NUM> can be delivered or implanted as a pre-assembled device or can be assembled in situ, in a selected order of assembly or the order of assembly of the particular components of system <NUM> can be varied according to practitioner preference, patient anatomy or surgical procedure parameters. Spinal implant system <NUM> may be completely or partially revised, removed or replaced.

Upon completion of the procedure, the surgical instruments, assemblies and non-implanted components of spinal correction system <NUM> are removed from the surgical site and the incision is closed. One or more of the components of spinal correction 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 examples, the use of surgical navigation, microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of spinal correction system <NUM>.

In some examples, spinal correction system <NUM> includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of spinal correction system <NUM>. In some examples, 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 examples, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.

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

Claim 1:
A surgical system comprising:
a tether (<NUM>);
a connector (<NUM>) configured for disposal of the tether (<NUM>);
a spinal rod (<NUM>) configured for disposal with the connector (<NUM>);
a coupling member (<NUM>) engageable with the spinal rod (<NUM>) and the connector (<NUM>);
a surgical driver (D); and
a surgical instrument (<NUM>) comprising:
a first member (<NUM>) defining a cavity (<NUM>) and including a locking surface (<NUM>) disposed with the cavity (<NUM>), the locking surface (<NUM>) being engageable with the tether (<NUM>) to fix the tether (<NUM>) with the first member (<NUM>);
a second member (<NUM>) including an inner surface (<NUM>) that defines a longitudinal passageway (<NUM>) configured for disposal of the surgical driver (D) engageable with a spinal construct, the second member (<NUM>) further including at least one mating element being engageable with the spinal construct; and
an actuator (<NUM>) connected with the first and second members (<NUM>, <NUM>) and being configured to incrementally tension the tether (<NUM>),
wherein the first member (<NUM>) includes a circumferential flange (<NUM>) that movably supports the actuator (<NUM>), and the second member (<NUM>) includes an outer surface (<NUM>) that includes a threaded surface (<NUM>) configured for engagement with a threaded inner surface (<NUM>) of the actuator (<NUM>) such that the actuator (<NUM>) is rotatable relative to the flange (<NUM>) to axially translate the first member (<NUM>) relative to the second member (<NUM>),
wherein the surgical driver (D) is disposable with the longitudinal passageway (<NUM>) and engageable with the coupling member (<NUM>) having a break off head which includes a tool engaging portion configured to engage the surgical driver (D), wherein the break off head can fracture and separate at a predetermined toque limit in a range of <NUM> to <NUM>, and
wherein at least one mating element is engageable with the connector (<NUM>).