Patent Description:
Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis, kyphosis, and other curvature abnormalities, 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, ligamentotaxy, corpectomy, discectomy, laminectomy, fusion, fixation and implantable prosthetics. Correction treatments used for positioning and alignment of vertebrae may employ spinal implants including spinal constructs and interbody devices for stabilization of a treated section of a spine. In some cases, the spinal implants may be manipulated with surgical instruments for compression and distraction of vertebrae. From <CIT> a surgical system comprising a first member, a second member, a height controller and blades is known. Further surgical systems are known from <CIT>, <CIT> and <CIT>. The object of this disclosure is to describe and provide an improvement over these prior technologies.

This object is solved by a surgical system according to claim <NUM>. Further embodiments are subject of the dependent claims.

The exemplary embodiments of the system disclosed 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. Furthermore, in the following discussion of exemplary embodiments of the system, methods, techniques and medical devices are discussed to allow understanding of the practical use of the exemplary embodiments according to the invention, wherein the invention is defined by the attached claims. In some embodiments, the present surgical system includes surgical instruments that allow vertebral manipulation to treat spinal disorders, as described herein, for managing lordosis and/or kyphosis restoration. In some embodiments, the surgical instruments allow for parallel distraction and/or compression of vertebral tissue.

In some embodiments, the present surgical system includes a surgical trauma instrument. The present surgical system can be utilized with a method to correct complex spinal deformities. The present surgical system can be utilized with a method to treat degenerative spinal disorders and/or employed with transforaminal lumbar interbody fusion procedures. In some embodiments, the present surgical system is configured for utilization with a sagittal adjusting screw (SAS), a fixed axis screw (FAS) and/or a multi-axial screw (MAS). The present surgical system comprises a distractor, for example to treat degenerative spinal disorders, or for example for disposal along a side of vertebrae oriented for decompression and/or interbody cage insertion.

In some embodiments, the present surgical system includes a surgical instrument connected with an adaptor, which is utilized with a bone screw having extender tabs attached thereto. The present surgical system includes an implant support which can include a connector and an adaptor. In some embodiments, the connector includes an outer sleeve configured for connection with extenders. In some embodiments, the connector is connected with extenders for insertion of an implant, such as for example, a spinal rod. In some embodiments, the adaptor includes an arm having a pivot hinge that connects the connector with a compressor/retractor. In some embodiments, the pivot hinge allows movement of the components to provide surgical-site visibility for inter-operative imaging. In some embodiments, a compressor/distractor is utilized for generally parallel distraction. In some embodiments, a compressor/distractor is utilized for generally parallel compression. In some embodiments, the surgical instrument includes a compressor/distractor having a reversible ratchet with a neutral, freely moveable position. The present surgical system can be employed with a procedure for implantation of a bone fastener percutaneously.

The present surgical system can include a surgical instrument and can be employed with a surgical method including the step of: pre-assembly of the distractor; pre-loading of the alignment guides; preparing for implantation of screws; connecting screw tabs; removal of the alignment guides; attaching a compressor/retractor having an articulating rack for segmental distraction; implanting an interbody and decompressing tissue, inserting a rod length caliper; inserting the rod and setscrews; performing segmental compression; breaking of setscrew tabs; and removing the compressor/distractor.

The present surgical system can include an adaptor and can be employed with a surgical method including the step of inserting the implant support with a surgical site and the step of sliding a sleeve along the extender. The method can include the step of securing the connector to the extenders. The method can include the step of connecting a compressor/distractor with the implant support. The method can include the step of actuating a rack and pinion mechanism disposed with the compressor/distractor to facilitate distraction or compression.

The present surgical system includes a retractor, for example provided to maintain the tissue in a medial-lateral orientation creating a channel for accessing the spine anatomy. The retractor includes a first member including a mating surface being alternately connectable with a first blade and a part. The part is connectable with the compressor/distractor and configured to translate the first member relative to the compressor/distractor. The part is configured to translate the first member a height relative to the compressor/distractor. In some embodiments, the height is adjustable in a range between about <NUM> to about <NUM>. In some embodiments, the part is connected with the compressor/distractor by a dove tail projection disposed with the compressor/distractor. The dove tail projection facilitates a friction fit between the part and the compressor/distractor to fix the position of the part and/or the first member relative to the compressor/distractor. The retractor includes a second member connectable with a second blade. The second member is movable relative to the first member such that the blades are movable to space tissue adjacent a spine.

In some embodiments, the present surgical system includes a stability element configured for disposal with the implant supports and alternately engageable with the first blade or the second blade. In some embodiments, the implant supports include rod slots configured for slidable translation of the stability element. In some embodiments, the stability element includes at least one mating pin being alternately engageable with the first blade or the second blade. In some embodiments, the retractor is provided to maintain the tissue in a medial-lateral orientation creating a channel for accessing the spine anatomy. In some embodiments, the stability element is utilized to widen the channel in a medial and/or lateral direction.

The present surgical system can be employed with a surgical technique for the implantation of spinal implants, such as, for example, spinal rods and setscrews. The spinal rods and setscrews can be implanted percutaneously. The spinal rods can be reduced relative to a screw head. The present surgical system can be employed with a surgical technique for release of pressure applied during spinal rod reduction.

In some embodiments, the present surgical system includes a surgical instrument configured to compress or distract and restore curvature of a spine. In some embodiments, the present surgical system includes instruments and tools for correcting a sagittal deformity and rebalancing a spine of a body. In some embodiments, the present surgical system is employed to treat degenerative deformities of a spine in a sagittal plane, for example, degenerative kyphosis. In some embodiments, the present surgical system is employed to treat hyper-kyphosis, flat lumbar back, including disorders that create an unbalance of a body and loss of alignment between body parts. In some embodiments, the present surgical system provides a selected amount of correction to apply a selected balance to a spine and provides control and adjustment to the amount of correction. In some embodiments, the present surgical system includes a series of tools and instruments that allow formulation of a type of correction applied and can control the correction stabilization using posterior instrumentation.

In some embodiments, one or all of the components of the surgical system are disposable, peel-pack, pre-packed sterile devices used with a spinal construct. 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.

The present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis, kyphosis and other curvature abnormalities, tumor and fractures. 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 posterior and/or posterior mid-line and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The 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.

The following discussion includes a description of a surgical system in accordance with the principles of the present disclosure and related methods of employing the surgical system. Alternative embodiments are disclosed. Reference is made to the embodiments of the present invention, which are illustrated in the accompanying <FIG>, wherein other accompanying figures are used for further explanations of the principles of the present disclosure and wherein elements shown in the other accompanying figures can be used in combination or as further elements of exemplary embodiments of the present disclosure. Turning to <FIG>, there are illustrated components of a surgical system <NUM>.

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

Surgical 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. One or more of the components of surgical system <NUM> can be configured for engagement with spinal constructs attached with vertebrae to manipulate tissue and/or correct a spinal disorder, such as, for example, a sagittal deformity, as described herein. Surgical system <NUM> may be employed with surgical procedures, such as, for example, corpectomy, discectomy and/or fracture/trauma treatment and may include fusion and/or fixation that employ implants to restore the mechanical support function of vertebrae.

Surgical system <NUM> includes a surgical instrument, such as, for example, an implant support <NUM> and an implant support 14a, similar to implant support <NUM>, as described herein. Implant supports <NUM>, 14a are connectable with a spinal implant, such as, for example, a bone fastener <NUM>. Bone fastener <NUM> includes a receiver <NUM> and a screw shaft <NUM>, as shown in <FIG>. Screw shaft <NUM> is fixed with patient tissue in use of fastener <NUM>. Each receiver <NUM> is connectable with one of implant supports <NUM>, 14a to releasably engage a surgical instrument, such as, for example, a compressor/distractor <NUM> to distract and/or compress tissue.

Each receiver <NUM> includes a pair of spaced-apart arms <NUM>, <NUM> (<FIG>) that define an implant cavity configured for disposal of a component of a spinal construct, such as, for example, a spinal rod <NUM> (e.g., <FIG>). Each receiver <NUM> includes an inner surface having a thread form, as shown in <FIG>. Bone fastener <NUM> includes screw shaft <NUM> configured to penetrate tissue, such as, for example, bone.

Arm <NUM> includes or is connected to a break-away tab <NUM> that is frangibly connected to arm <NUM>, as shown in <FIG>, 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. Arm <NUM> similarly includes or is connected to 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 force and/or torque is applied to tabs <NUM>, <NUM> and resistance increases, for example, the predetermined torque and force limit can be approached allowing tabs <NUM>, <NUM> to break off from arms <NUM>, <NUM>.

Each implant support <NUM>, 14a can include extender tabs <NUM>, <NUM> that are connectable with tabs <NUM>, <NUM> and/or bone fastener <NUM>. Each extender tab <NUM>, <NUM> extends between a proximal end <NUM> and a distal end <NUM>. Distal ends <NUM> are configured for slidable disposal of a portion of bone fastener <NUM>, such as, for example, tabs <NUM>, <NUM>. Tabs <NUM>, <NUM> can be configured to releasably fix extender tabs <NUM>, <NUM> to bone fastener <NUM> for connecting extender tabs <NUM>, <NUM> to implant support <NUM>, as described herein.

An extender cap <NUM> can be disposed with extender tabs <NUM>, <NUM>. Cap <NUM> is configured to align extenders tabs <NUM>, <NUM> to resist and/or prevent splaying of extender tabs <NUM>, <NUM>. Cap <NUM> is configured as a guide to facilitate positioning of surgical instruments.

Implant support <NUM> includes a connector <NUM> to facilitate engagement of implant support <NUM> with extender tabs <NUM>, <NUM>. Connector <NUM> includes elongate members, such as, for example, sleeves <NUM>, <NUM>, as shown in <FIG> and <FIG>. Sleeve <NUM> includes a surface <NUM> and sleeve <NUM> includes a surface <NUM>. Sleeves <NUM>, <NUM> are configured for translation over extender tabs <NUM>, <NUM>. Sleeves <NUM>, <NUM> are disposed in spaced apart relation and define a slot <NUM> configured for disposal of an implant, such as, for example, a spinal rod <NUM> (see e.g., <FIG>).

Connector <NUM> includes a wall <NUM>. As shown in <FIG>, wall <NUM> includes an inner surface <NUM> that defines a cavity, such as, for example, a pocket surface <NUM>. Pocket surface <NUM> is configured for disposal of proximal ends <NUM> of extender tabs <NUM>, <NUM>, as also shown in <FIG>. Pocket surface <NUM> is configured to resist and/or prevent disengagement of connector <NUM> from extender tabs <NUM>, <NUM>. Connector <NUM> can include a lock, such as, for example, a depressible button <NUM> configured for disposal between a lock, or locking, orientation and a non-locking orientation. In the lock orientation, button <NUM> releasably fixes implant support <NUM> with extender tabs <NUM>, <NUM>. In the non-locking orientation, implant support <NUM> is translatable relative to extender tabs <NUM>, <NUM> for engagement and disengagement with bone fastener <NUM>. Button <NUM> may be spring biased to a locked position, such as by a projection <NUM> defined by button <NUM> being biased in the lock orientation into engagement with a groove <NUM> to releasably fix implant support <NUM> with extender tabs <NUM>, <NUM>. Connector <NUM> can include one or a plurality of buttons <NUM>.

Implant support <NUM> includes an adaptor <NUM> extending from connector <NUM>, as shown in <FIG> and <FIG>. Adaptor <NUM> includes an extension <NUM> that extends along sleeve <NUM>. Extension <NUM> is pivotally connected to sleeve <NUM> such that extension <NUM> can be rotated and/or angled, as described herein. Sleeve <NUM> can include a stopping element, such as, for example, a reinforcement rib <NUM> configured to resist and/or prevent rotation of extension <NUM> relative to sleeve <NUM>. The reinforcement element can provide for an increased rigidity of implant support <NUM>. The reinforcement element can be configured to resist and/or prevent inward rotation of extension <NUM>. The reinforcement element can provide a reverse angle geometry to facilitate stability of extension <NUM>.

Adaptor <NUM> includes an extension <NUM> rotatably attached with extension <NUM> such that extension <NUM> is rotatable relative to connector <NUM>. Extension <NUM> extends transverse to extension <NUM>. Extension <NUM> may be variously oriented relative to extension <NUM>, such as, for example, perpendicular, angular and/or offset.

Extension <NUM> is connected with extension <NUM> by a pin hinge <NUM>. Pin hinge <NUM> facilitates rotation of extension <NUM> relative to extension <NUM> and/or bone fastener <NUM>. Extension <NUM> is rotatable through and angular range of about <NUM> degrees through about +/- <NUM> degrees. Extension <NUM> can include a lock <NUM> configured to fix extension <NUM> in a selected orientation relative to extension <NUM> and connector <NUM>. Lock <NUM> is disposable in a lock orientation and a non-locking orientation to facilitate selective orientation of extension <NUM>. Rotation of extension <NUM> facilitates connection of implant support <NUM> to compressor/distractor <NUM> by providing for manipulation of implant support <NUM> into alignment with compressor/distractor <NUM>, as described herein.

Extension <NUM> can include a protrusion <NUM> engageable with compressor/distractor <NUM> to releasably fix implant support <NUM> with compressor/distractor <NUM>. Protrusion <NUM> includes a surface <NUM> that defines a transverse groove <NUM>, as shown in <FIG>. Protrusion <NUM> includes a lock, such as, for example, a spring-biased ball <NUM> that is configured for translation (and possibly also for some rotation) within groove <NUM> between a lock orientation and a non-locking orientation. A spring <NUM> disposed with groove <NUM> biases ball <NUM> toward the lock orientation.

Protrusion <NUM> is connectable with compressor/distractor <NUM>. Compressor/distractor <NUM> includes a portion, such as, for example, a depressible button <NUM> configured for engagement with protrusion <NUM>. Button <NUM> includes a wall <NUM> that extends circumferentially about protrusion <NUM> upon connection of compressor/distractor <NUM> to implant support <NUM>. Wall <NUM> includes an end surface <NUM> that is engageable to ball <NUM> to translate ball <NUM> between the lock orientation and the non-locking orientation.

Compressor/distractor <NUM> includes a longitudinal element, such as, for example, a rack <NUM>, as shown in <FIG>. Rack <NUM> extends between an end <NUM> and an end <NUM> defining a longitudinal axis A1. Rack <NUM> is configured to connect adjacent implant supports <NUM>, 14a to each other, as shown in <FIG>. Rack <NUM> includes an outer surface having a plurality of teeth, such as, for example, splines <NUM> engageable with an arm <NUM>, as described herein. Rack <NUM> includes an arm <NUM> extending from end <NUM>. Arm <NUM> can be attached with rack <NUM> with, for example, with clips, hooks, adhesives and/or flanges.

Arm <NUM> includes a surface that defines an opening <NUM> configured for disposal of protrusion <NUM> for connecting compressor/distractor <NUM> to implant support. Arm <NUM> is axially translatable along axis A1 relative to arm <NUM>. Arm <NUM> includes a surface that defines an opening <NUM> configured for disposal of protrusion <NUM> for connecting compressor/distractor <NUM> to implant support 14a.

Compressor/distractor <NUM> includes a ratchet, which includes splines <NUM> and arm <NUM> engageable in a bi-directional and/or two-way ratchet configuration. Arm <NUM> includes a latch <NUM>, which is engageable selectively with splines <NUM>. The latch <NUM> can include a pinion or pawl (not shown in detail) engageable with splines <NUM>.

Latch <NUM> is pivotable relative to arm <NUM> for disposal selectively in one or multiple positions. The positions can include a distraction position, a neutral position, and a compression position. In the distraction position, latch <NUM> engages rack <NUM> to allow axial and/or incremental translation of arm <NUM> relative to arm <NUM>/rack <NUM>, in the direction shown by arrows B in <FIG>. As such, distraction of vertebral tissue connected with implant supports <NUM>, 14a can be performed. Latch <NUM> is pivotable relative to arm <NUM> for disposal in a neutral position (not shown). In the neutral position, latch <NUM> disengages from rack <NUM> to allow free axial translation of arm <NUM> relative to arm <NUM>/rack <NUM>.

Surgical system <NUM> can include one or more alignment guides <NUM>, as shown in <FIG> and <FIG>. Each guide <NUM> is configured for disposal with receiver <NUM> of one or more bone fasteners <NUM> to orient implant supports <NUM>, 14a with respect to receiver <NUM> and to facilitate identifying, locating and/or engaging implant supports <NUM>, 14a with receiver <NUM>.

Latch <NUM> is pivotable relative to arm <NUM> for disposal in a compression position, as shown in <FIG>. In the compression position, latch <NUM> engages rack <NUM> to allow axial and/or incremental translation of arm <NUM> relative to arm <NUM>/rack <NUM>, in the direction shown by arrows C. As such, compression of vertebral tissue connected with implant supports <NUM>, 14a can be performed. A rotatable key <NUM> can include a gear surface engageable with splines <NUM> to axially and/or incrementally translate rack <NUM> to facilitate distraction and/or compression, as described herein.

Connection of implant supports <NUM>, 14a are possible to facilitate correction of a vertebral angle of vertebrae, for example, to achieve a selected lordosis and/or kyphosis, via manipulation of implant supports <NUM>, 14a, as described herein. Implant supports <NUM>, 14a can be connected with compressor/distractor <NUM> to maintain a corrected vertebral angle of vertebrae during distraction and/or compression, as described herein.

In assembly, operation and use, surgical system <NUM>, similar to the systems and methods described herein, is employed with a surgical procedure, for treatment of a spine of a patient including vertebrae V, as shown in <FIG>. Surgical system <NUM> may also be employed with surgical procedures, such as, for example, discectomy, laminectomy, fusion, laminotomy, laminectomy, nerve root retraction, foramenotomy, facetectomy, decompression, spinal nucleus or disc replacement and bone graft and implantable prosthetics including plates, rods, and bone engaging fasteners.

Surgical system <NUM> is employed with a procedure for treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body. For example, vertebrae V includes a vertebral level V1, a vertebral level V2 and a vertebral level V3, as shown in <FIG>. Diseased and/or damaged vertebrae and intervertebral discs are disposed at vertebra V2 between vertebrae V1 and V3. Components of surgical system <NUM> can be configured for insertion with a vertebral space to space apart articular joint surfaces, provide support and maximize stabilization of vertebrae V.

In use, to treat the affected section of vertebrae V, a medical practitioner obtains access to a surgical site including vertebrae V in any appropriate manner, such as through incision and retraction of tissues, as shown in <FIG>. Surgical system <NUM> may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby vertebrae V is accessed through a mini-incision, or sleeve that provides a protected passageway to the area.

An incision I is made in the body of a patient P and a cutting instrument (not shown) creates a surgical pathway for implantation of components of surgical system <NUM>, as shown in <FIG>. 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.

Pilot holes or the like are made in selected vertebrae V1 and V3 for receiving bone fasteners <NUM>. A driver (not shown) is disposed adjacent vertebrae V at a surgical site and is manipulated to drive, torque, insert or otherwise connect bone fasteners <NUM> with vertebrae V1 and V3. Bone fasteners <NUM> are engaged with vertebrae V along a lateral side L of vertebrae V, as shown in <FIG>. Extenders <NUM>, <NUM> are engaged with bone fasteners <NUM>.

Implant supports <NUM>, 14a are connected with extenders <NUM>, <NUM>, as described herein. Compressor/distractor <NUM> is mounted with adaptors <NUM> via protrusion <NUM> for fixation therewith, as described herein. Connectors <NUM> capture extenders <NUM>, <NUM>, as shown in <FIG> and described herein. Compressor/distractor <NUM> is connected with implant supports <NUM>, 14a to allow for distraction and/or compression of vertebrae V connected with extenders <NUM>, <NUM>.

Guide <NUM> is disposed with (e.g., within) connector <NUM>. Guide <NUM> is translated into engagement with bone fastener <NUM> until fully seated with receiver <NUM>. Guide <NUM> is configured to orient implant supports <NUM>, 14a and facilitate identifying, locating and/or engaging implant supports <NUM>, 14a with receiver <NUM>, as shown in <FIG>.

Latch <NUM> is pivotable relative to arm <NUM> for disposal in a distraction position, as shown in <FIG>. In the distraction position, latch <NUM> engages rack <NUM> to allow axial and/or incremental translation of arm <NUM> relative to arm <NUM>/rack <NUM>, in the direction shown by arrows B in <FIG>, to distract vertebral tissue connected with implant supports <NUM>, 14a. The applied distraction forces on bone fasteners <NUM> will allow for opening of the foramen and the posterior wall of the spinal disc. Latch <NUM> can be released or re-adjusted at any time during the procedure. Latch <NUM> is pivotable relative to arm <NUM> for disposal in a neutral position (not shown). In the neutral position, latch <NUM> allows free axial translation of arm <NUM> relative to arm <NUM>/rack <NUM>.

A measuring device, such as, for example, a caliper <NUM> can be utilized to determine a length of spinal rod <NUM>, as shown in <FIG>. Caliper <NUM> is engaged with implant supports <NUM>, 14a such that a distance between bone fasteners <NUM> can be determined. Determining the distance provides a length of rod <NUM> for connection with bone fasteners <NUM>. A retractor <NUM>, as shown in <FIG>, can be disposed with tissue to form a surgical passageway to facilitate insertion of a spinal implant, such as, for example, an interbody spinal implant.

A rod inserter <NUM> can be engaged with spinal rod <NUM>, as shown in <FIG>. Rod inserter <NUM> directs and/or guides spinal rod <NUM> through slots <NUM> and into receiver <NUM>. A percutaneous endoscopic lumbar discectomy can be utilized.

A driver <NUM> can be utilized to engage a set screw <NUM> with bone fasteners <NUM>, as shown in <FIG>. Driver <NUM> directs and/or guides set screw <NUM> through each of implant supports <NUM>, 14a into engagement with receivers <NUM>. Set screw <NUM> engages receivers <NUM> to fix spinal rod <NUM>. If segmental compression is required, set screws <NUM> can be loosened and latch <NUM> can be pivotable relative to arm <NUM> for disposal in a compression position, as shown in <FIG>. In the compression position, latch <NUM> engages rack <NUM> to allow axial and/or incremental translation of arm <NUM> relative to arm <NUM>/rack <NUM>, in the direction shown by arrows C, to compress vertebral tissue connected with implant supports <NUM>, 14a. A rotatable key <NUM> can include a gear surface engageable with splines <NUM> to axially and/or incrementally translate rack <NUM> to facilitate distraction and/or compression, as described herein. Adaptor <NUM> can be pivotally connected to connector <NUM> such that connectors <NUM> can be rotated and/or angled, as shown in <FIG>, to facilitate compression.

A tab hook counter torque handle <NUM> and a tab hook counter torque sleeve <NUM> can be engaged with implant supports <NUM>, 14a, as shown in <FIG>. Handle <NUM> and sleeve <NUM> are configured to provide additional leverage to facilitate removing and/or separating a frangible or break off portion of set screw <NUM> at a selected torque limit. Counter torque sleeve <NUM> can be configured to reinforce connection of connectors <NUM> and protect break-away tabs <NUM>, <NUM> during break off of set screw <NUM>. Connectors <NUM> can be disposed in contact at a center of a radius of a pre-bent rod. A break off handle <NUM> can be disposed with driver <NUM> and is manipulated to apply a force to set screw <NUM> for tightening and the torque limit for break off. Compressor/distractor <NUM> and implant supports <NUM>, 14a are removed, as shown in <FIG> and <FIG>. Vertebrae V is aligned to a selected orientation for sagittal, coronal and/or axial correction.

Upon completion of a procedure, as described herein, the surgical instruments, assemblies and non-implanted components of surgical system <NUM> are removed and the incision(s) are closed. One or more of the components of surgical 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. 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 surgical system <NUM>. Surgical system <NUM> may include one or a plurality of plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels.

In one embodiment, surgical system <NUM>, similar to the components described herein, includes a retractor <NUM>, as shown in <FIG>, compressor/distractor <NUM> and implant supports <NUM>, 14a. Retractor <NUM> can in any way to be like retractor <NUM> described herein. Retractor <NUM> includes a first member, such as, for example, a first arm <NUM> and a second member, such as, for example, a second arm <NUM>. Arms <NUM>, <NUM> are connected by a longitudinal element, such as, for example, a ratchet <NUM>, as shown in <FIG>.

Ratchet <NUM> extends between an end <NUM> and an end <NUM>, defining a longitudinal axis A5. Ratchet <NUM> is configured to connect arms <NUM>, <NUM> to each other and translate arm <NUM> relative to arm <NUM>. Ratchet <NUM> includes an outer surface having a plurality of teeth, such as, for example, splines <NUM>, engageable with a portion <NUM> of ratchet <NUM>, as described herein. Ratchet <NUM> includes a latch <NUM> that is movable, for example, pivotable, relative to portion <NUM> to dispose and/or fix arm <NUM> relative to arm <NUM> in one or multiple positions.

In various embodiments, one of arms <NUM>, <NUM> is fixedly connected to the ratchet <NUM>. In the embodiment of <FIG>, arm <NUM> is. The fixed arm can extend from anywhere at or between ends <NUM>, <NUM>. In <FIG>, the arm <NUM> extends from end <NUM> of ratchet <NUM>. Arm <NUM> defines an axis X3, as shown in <FIG>. Arm <NUM> includes a mating surface, such as, for example, an opening (not shown) configured for connection with a blade <NUM>, as described herein.

The opening or arm <NUM> to facilitate rotation of blade <NUM> about axis X3, as described herein. Blade <NUM> includes an inner surface and an outer surface configured for engagement with tissue. In some embodiments, all or only a portion of blade <NUM> may have various cross-section configurations, such as, for example, arcuate, cylindrical, oblong, rectangular, polygonal, undulating, irregular, uniform, non-uniform, consistent, variable, and/or U-shape. Blade <NUM> is moveable within multiple dimensions to space tissue selectively. Latch <NUM> is movable or otherwise pivotable, as mentioned, to dispose and/or fix arm <NUM> relative to arm <NUM> in one or multiple positions, causing blade <NUM> to be fixed in a selected orientation with respect to at least one degree of freedom.

Arm <NUM> extends from end <NUM>, or between end <NUM> and end <NUM>, of ratchet <NUM>. Arm <NUM> defines an axis X1, as shown in <FIG>. Arm <NUM> includes a mating surface, such as, for example, an opening <NUM>, as shown in <FIG>. Opening <NUM> is configured to be connectable with a part, such as a height controller <NUM>, and/or a blade <NUM>, as described herein. Height controller <NUM> is configured to adjust a height H of retractor <NUM> and/or blade <NUM> relative to compressor/distractor <NUM>, as shown in <FIG> and <FIG>.

As an aside, the manner by which dimensions or directions are indicated does not limit scope of the invention, such as limiting the orientation that any component may be disposed, connected, or moved. Here, for instance, reference to the height controller and height do not limit that component and dimension to a strictly vertical orientation in surgery.

Height controller <NUM> extends between a first end <NUM> and a second end <NUM> defining an axis X2, as shown in <FIG>. In various embodiments, height controller <NUM> includes longitudinal rails <NUM> that define a longitudinal groove <NUM>. Groove <NUM> extends along axis X2 between ends <NUM>, <NUM>. In some embodiments, groove <NUM> may be disposed at alternate orientations, relative to axis X2, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered. In some embodiments, height controller <NUM> includes one or a plurality of rails <NUM>.

Groove <NUM> is configured for disposal of an element, such as, for example, a projection <NUM> extending from compressor/distractor <NUM>, as shown in <FIG> and <FIG>. Projection <NUM> is slidably translatable within groove <NUM> to facilitate translation of height controller <NUM> along compressor/distractor <NUM>. Height controller <NUM> is selectively fixable in a position relative to compressor/distractor <NUM>. In some embodiments, height controller <NUM> is selectively fixable relative to compressor/distractor <NUM> via a friction fit engagement between a surface of groove <NUM> and a configuration, such as a tapered configuration, of projection <NUM>, such as, for example, a dove tail configuration. In a contemplated embodiment, the interface-i.e., the groove <NUM> and the projection <NUM>-is configured to provide haptic feedback, such as a clicking feeling, as the protrusion is translated within the groove.

As mentioned, translation of height controller <NUM> along compressor/distractor <NUM> facilitates adjustment of height H of retractor <NUM> and/or blade <NUM> relative to compressor/distractor <NUM>. In some embodiments, height H is adjustable in a range of about <NUM> to about <NUM> relative to compressor/distractor <NUM>.

In various embodiments, end <NUM> includes a protrusion <NUM> extending from a surface <NUM> of height controller <NUM>, as shown in <FIG>. Protrusion <NUM> extends perpendicular to axis X2. In some embodiments, protrusion <NUM> may extend at alternate orientations relative to axis X2, such as, for example, transverse and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered. Protrusion <NUM> matingly engages opening <NUM> of arm <NUM>. In various embodiments, protrusion <NUM> is releasably engageable with opening <NUM>. In some embodiments, protrusion <NUM> is engageable with opening <NUM> in a snap-fit connection. Engagement of protrusion <NUM> with opening <NUM> orients height controller <NUM> transverse to axis X1, as shown in <FIG>. In some embodiments, height controller <NUM> may extend at alternate orientations relative to axis X1, such as, for example, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered.

Blade <NUM> includes a pivot surface (not shown) engageable with opening <NUM> to facilitate rotation of blade <NUM> about axis X1, as described herein. Blade <NUM> and height controller <NUM> are interchangeable with arm <NUM>. Blade <NUM> includes an inner surface and an outer surface configured for engagement with tissue. In some embodiments, all or only a portion of blade <NUM> may have various cross-section configurations, such as, for example, arcuate, cylindrical, oblong, rectangular, polygonal, undulating, irregular, uniform, non-uniform, consistent, variable, and/or U-shape. In some embodiments, as shown in <FIG>, retractor <NUM> includes a handle <NUM> disposed with arm <NUM> to facilitate rotation of blade <NUM> about axis X1.

In one embodiment, surgical system <NUM> includes a stability element <NUM>, as shown in <FIG>. Stability element <NUM> is configured for disposal with slots <NUM> (<FIG> and <FIG>) of implant supports, <NUM>, 14a, as described herein. Stability element <NUM> is configured to stabilize lateral movement of one or more components of surgical system <NUM>, for example, implant supports <NUM>, 14a, blade <NUM> or blade1592, and/or components of retractor <NUM>, relative to a patient body.

Stability element <NUM> includes a body <NUM> that extends between a first end <NUM> and a second end <NUM>. Body <NUM> includes a configuration for a mating engagement with the inner surface of blade <NUM> and/or blade <NUM>. In some embodiments, all or only a portion of body <NUM> may have various cross-section configurations, such as, for example, arcuate, cylindrical, oblong, rectangular, polygonal, undulating, irregular, uniform, non-uniform, consistent, variable, and/or U-shape.

In various embodiments, body <NUM> includes a surface <NUM>. Mating pins <NUM> extend from surface <NUM>. Pins <NUM> are configured for engagement with openings <NUM> (<FIG>) disposed with blade <NUM> and/or blade <NUM>. In some embodiments, body <NUM> includes at least one mating pin <NUM>.

End <NUM> is connected to a flange <NUM> extending therefrom. Flange <NUM> is configured for disposal with slot <NUM> of implant support <NUM> and/or implant support 14a. End <NUM> is connected to a flange <NUM> extending therefrom. Flange <NUM> is configured for disposal with slot <NUM> of implant support <NUM> and/or implant support 14a. Flanges <NUM>, <NUM> are configured for slidable translation within slots <NUM> to facilitate positioning of stability element <NUM>.

For example, in some embodiments, retractor <NUM> is provided to maintain tissue in a medial-lateral orientation creating a channel C (<FIG>) for accessing the spine anatomy. In some embodiments, retractor <NUM> is provided to maintain tissue in a plurality of blade angles on both a lateral and dorsal axis. Stability element <NUM> is utilized to space apart tissue and/or open channel C in a medial and/or lateral direction. For example, stability element <NUM> is positioned such that body <NUM> is disposed in a mating configuration with blade <NUM>, as described herein. Flange <NUM> is disposed with slot <NUM> of implant support <NUM>. Flange <NUM> is disposed with slot <NUM> of implant support 14a. In this orientation, stability element <NUM> moves blade <NUM> and implant supports <NUM>, 14a medially, such as for example, toward a midline of the patient's body, as shown by arrow M in <FIG>. Movement of blade <NUM> and implant supports <NUM>, 14a in the medial direction opens channel C toward the midline of the patient body.

In some embodiments, stability element <NUM> is utilized to space apart tissue and/or open channel C in the lateral direction. For example, stability element <NUM> is positioned such that body <NUM> is disposed in a mating configuration with blade <NUM>, as shown in <FIG>. Flange <NUM> is disposed with slot <NUM> of implant support <NUM>. Flange <NUM> is disposed with slot <NUM> of implant support 14a. In this orientation, stability element <NUM> moves blade <NUM> and implant supports <NUM>, 14a laterally, such as for example, away from the midline and toward a lateral side of the patient's body, as shown by arrow L in <FIG>. Movement of blade <NUM> and implant supports <NUM>, 14a in the lateral direction opens channel C toward the lateral side of the patient body.

In some embodiments, surgical system <NUM> includes one or a plurality of alternative surgical instruments, each configured for mating engagement in a quick release configuration with spinal constructs, as described herein. This configuration facilitates the interchangeability of the spinal constructs with the alternative surgical instruments. In some embodiments, surgical system <NUM> includes one or a plurality of alternative surgical instruments, such as, for example, inserters, extenders, reducers, spreaders, distractors, blades, retractors, clamps, forceps, elevators and drills, which may be alternatively sized and dimensioned, and arranged as a kit.

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

Claim 1:
A surgical system comprising:
a first implant support (<NUM>) and a second implant support (14a), the implant supports (<NUM>, 14a) being engageable with bone fasteners (<NUM>) fixable with vertebral tissue;
a surgical distractor (<NUM>) engageable with the implant supports (<NUM>, 14a); and
a surgical retractor (<NUM>) having a first member (<NUM>) including a first blade (<NUM>), and further including a mating surface connectable with the first blade (<NUM>) and a height controller (<NUM>), the height controller (<NUM>) being connectable with the surgical distractor (<NUM>) and configured to translate the first member (<NUM>) relative to the surgical distractor (<NUM>), the surgical retractor (<NUM>) further having a second member (<NUM>) including a second blade (<NUM>) and being movable relative to the first member (<NUM>) such that the blades (<NUM>, <NUM>) are movable to space tissue adjacent a spine.