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 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 fasteners for attachment to the exterior of two or more vertebral members. This disclosure describes an improvement over these prior art technologies.

<CIT> discloses a surgical instrument having a first member engageable with a first end of a fastener having a second end configured to penetrate tissue. A second member includes an expandable member configured for engaging the first end.

<CIT> discloses a rod persuader, a system and a method.

<CIT> discloses a surgical instrument which includes a first member including an inner surface defining a passageway. The first member extends between a first end that defines a first opening and a second end that defines a second opening. A second member extends between a first end and a second end. A third member extends between a first end and a second end. The second end of the third member is releasably engageable with the first end of the second member within the passageway such that the first end of the first member prevents passage of the first end of the third member through the first opening and the second end of the first member prevents passage of the second end of the second member through the second opening.

<CIT> discloses an instrument for holding and inserting a bone anchor.

The invention provides a surgical instrument according to claim <NUM> and a surgical system according to claim <NUM>. The methods disclosed herein do not form part of the invention as such, but are helpful for explaining and understanding the claimed invention.

<FIG> disclose components of a surgical system without all the feature of the independent claims. Nevertheless, <FIG> are useful for the understanding of the invention.

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

The exemplary embodiments of 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 and a method for treating a spine. In some embodiments, the system comprises a surgical instrument and related methods of use, which can be employed with spinal constructs including bone fasteners and connectors having a pop on, snap on, click on and/or slide on member that provides a universal connection system to spine surgeons. In some embodiments, the spinal construct allows the use of a singular bone screw component with multiple types of receivers thereby minimizing inventory while creating assemblies customized for a specific patient.

In some embodiments, the system comprises a surgical instrument and related methods of use, which can be employed with bone screw shanks that are not pre-coupled to a tulip head. In some embodiments, such bone screws without pre-coupled tulip heads allow for modular implant selection with minimal inventory in an operating room and an ability to provide a spinal rod receiver attachment in-situ.

In one embodiment, the system includes a surgical instrument, such as, for example, a bone screw driver configured to drive a bone screw shank without a tulip head. In one embodiment, the system includes a driver configured to provide a secure engagement to a bone screw that does not have a traditional tulip head or other type of spinal rod receiver member. In one embodiment, the system includes a driver having an inner sleeve with a flexible collet. In one embodiment, the system includes a driver having a flexible collet configured to snap around a spherical head of the bone screw by pushing an outer sleeve down that is configured to force the inner sleeve down. In one embodiment, the system includes a driver having inner and outer sleeves coupled together with a threaded interface and are configured for relative translation from a first open position to a second closed position.

In one embodiment, the system includes a driver having an outer sleeve configured to prevent a flexible collet from expanding in a closed position and allows disengagement from the bone screw in an open position. In one embodiment, the system includes a driver having an outer sleeve that is configured to apply a force to a retaining cap.

Of a driver shaft as the outer sleeve is translated. In one embodiment, the system includes a driver having an outer sleeve configured for translation to apply a compression force between a bone screw and a collet to secure the screw to the driver thereby reducing toggle between the bone screw and the driver shaft.

In one embodiment, the system includes a driver having a tip that simulates a shape of a tulip head and provides a hard stop preventing the bone screw from threading too far. In one embodiment, the system includes a driver having a tip that is a reamer configured to bore a path to allow a tulip head to be engaged without interference from a patient anatomy.

In one embodiment, the system includes a surgical instrument, such as, for example, a driver. In some embodiments, the driver has an outer sleeve having an outer sleeve tube. In some embodiments, the outer sleeve has a handle configured to rotate relative to the outer sleeve tube. In some embodiments, the driver has an inner sleeve and a driver shaft with an orientation pin. In some embodiments, the driver has a retainer cap. In one embodiment, the system includes a driver having a threaded handle configured to translate an outer sleeve and apply a compression force between a bone screw and an inner sleeve. In one embodiment, the system includes a driver having a reamer tip. In one embodiment, the system includes a driver having a collet on an inner sleeve configured to snap onto a sphere of a bone screw.

In one embodiment, the system includes a driver having a tip configured to simulate a tulip head and prevent a bone screw from being driven too deep into a patient anatomy to allow a tulip head attachment. In one embodiment, the driver has a collet on the inner sleeve.

In one embodiment, the system includes a driver that provides a secure and rigid connection between a bone screw without a tulip head or receiver component. In one embodiment, the system includes a driver that facilitates the use of implant systems in which a tulip head can be attached to the bone screw.

In one embodiment, the system includes an instrument having a collar that slides over a spherical head of a fastener. In one embodiment, the system includes an instrument having three sleeves. In one embodiment, the system includes an instrument having an internal shaft configured as a driver. In one embodiment, the system includes an instrument having a combination of two sleeves disposed around an outside of a driver. In one embodiment, the instrument includes a driver configured to extend beyond a sleeve such that an end of the driver extends past an end of the sleeve to the fastener. In one embodiment, the system includes an instrument having a sleeve configured to translate over a top of the fastener and rotated along a threaded engagement with a second sleeve for locking the instrument. In one embodiment, the system includes an instrument configured to prevent the fastener from penetrating too deep into tissue to allow an implant to be connected with the head of the fastener. In one embodiment, the system includes an instrument having an end tip of a sleeve configured to replicate a geometry of a fastener receiver to facilitate connection of the fastener receiver with the head of the fastener. In one embodiment, the system includes an instrument having a diameter at an end of an outer sleeve similar to a diameter of a tulip receiver for a fastener.

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

Further, as used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions 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. Also, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

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

The components of 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 system <NUM>, individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade <NUM> titanium, super- elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITETM manufactured by Biologic Inc. ), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 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, tricalcium phosphate (TCP), hydroxyapatite (HA)- TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. Various components of system <NUM> may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical perfonnance, durability and radiolucency or imaging preference. The components of 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 system <NUM> may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

System <NUM>, which includes surgical instrument <NUM>, is employed, for example, with an open or mini-open, minimal access and/or minimally invasive including percutaneous surgical technique to deliver and fasten an implant at a surgical site within a body of a patient, for example, a section of a spine. In one embodiment, the components of system <NUM> are configured to fix a bone fastener with tissue for a surgical treatment to treat various spine pathologies, such as those described herein.

System <NUM> includes surgical instrument <NUM>, which includes a member, such as, for example, a driver shaft <NUM> extending along an axis L between an end <NUM> and an opposite end <NUM>, as shown in <FIG>. End <NUM> includes a mating surface <NUM> configured to facilitate manipulation and/or maneuvering of surgical instrument <NUM>. Surface <NUM> is configured for engagement with a retaining cap <NUM>. In one embodiment, driver shaft <NUM> includes a surface <NUM> that defines a cavity <NUM> configured to receive an orientation pin <NUM>.

End <NUM> is configured for engagement with an implant, such as, for example, a bone fastener <NUM>, as shown in <FIG>. In some embodiments, end <NUM> may have different cross-sections such as square, hexagonal, polygonal, triangular, star or hexalobe. End <NUM> may have various surface configurations, such as, for example, smooth, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

A member, such as for example, a sleeve <NUM> is configured for disposal of driver shaft <NUM>. Sleeve <NUM> extends between an end <NUM> and an end <NUM> along axis L. Sleeve <NUM> includes an inner surface <NUM> and an outer surface <NUM>. Surface <NUM> defines a passageway <NUM> coaxial with axis L and configured for disposal of driver shaft <NUM>. Surface <NUM> includes a threaded portion <NUM> configured for engagement with a third member, as described herein. End <NUM> includes an expandable member, such as, for example, a collet <NUM>.

Collet <NUM> extends from end <NUM> and is configured for movement between a first configuration and a second configuration, as described herein. Collet <NUM> comprises an inner surface <NUM> defining a passageway <NUM>, as shown in <FIG>. Passageway <NUM> is coaxial with passageway <NUM>. Passageway <NUM> has a cylindrical cross- section configuration. In some embodiments, passageway <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered.

Collet <NUM> includes a locking surface <NUM> defined by a plurality of cantilevered fingers <NUM> extending radially outward. Fingers <NUM> are circumferentially disposed and are equidistantly spaced apart. Fingers <NUM> are spaced apart by a gap <NUM> defined by opposite planar sidewalls <NUM>. In one embodiment, collet <NUM> is flexible such that collet <NUM> is biased in the first, closed position, as described herein. Collet <NUM> is configured to snap fit around a first end, such as, for example, a head <NUM> of fastener <NUM>. As collet <NUM> translates over head <NUM> of fastener <NUM>, collet <NUM> moves from a first closed position to a second open position and back to the first closed position to capture head <NUM>.

System <NUM> includes a third member, such as, for example, a sleeve <NUM>. Sleeve <NUM> extends between an end <NUM> and an end <NUM> along axis L. Sleeve <NUM> includes an inner surface <NUM> and an outer surface <NUM>. Surface <NUM> defines a passageway <NUM> coaxial with axis L and configured for moveable disposal of sleeve <NUM>. In one embodiment, inner surface <NUM> may have various surface configurations to enhance engagement of sleeve <NUM> and/or collet <NUM>, such as, for example, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

End <NUM> includes a handle <NUM> having a threaded inner surface <NUM> configured to rotatably engage threaded portion <NUM> for axial translation of sleeve <NUM> relative to sleeve <NUM>, which causes releasable locking of collet <NUM> with bone fastener <NUM>, as discussed herein. End <NUM> includes a tip <NUM> defining a reamer end surface <NUM>. Reamer end surface <NUM> includes a plurality of teeth <NUM> configured to bore a path around head <NUM>. In one or more cases, the teeth <NUM> are angled to cut in the direction of rotation of the reamer end surface <NUM>. In one or more other cases, the teeth <NUM> may be angled to be bi-directional such that the teeth <NUM> may bore into tissue disposed about head <NUM> in a clockwise direction and/or a counter clockwise direction. In one or more cases, the teeth <NUM> are configured to spin independent of sleeve <NUM> such that they rotate independent to elongated shaft <NUM>.

Sleeve <NUM> is configured to lock collet <NUM> with head <NUM>, as discussed herein, for releasable fixation with bone fastener <NUM>. Sleeve <NUM> extends along a portion of sleeve <NUM> and is configured for axial translation relative to sleeve <NUM>. As sleeve <NUM> axially translates, in the direction shown in by arrow E in <FIG>, fingers <NUM> are driven further inwardly by the force of sleeve <NUM> engaging collet <NUM> such that fingers <NUM> are moveable to the locked position around head <NUM> with locking surface <NUM>.

System <NUM> includes a fastener, such as, for example, a bone fastener <NUM>. Fastener <NUM> includes a head <NUM> configured for engagement with driver shaft <NUM> and an elongated shaft <NUM> configured for penetrating tissue. Head <NUM> comprises a spherical configuration. Head <NUM> includes an outer circumferential surface <NUM> having a substantially uniform diameter thereabout. In some embodiments, all or only a portion of surface <NUM> includes a spherical configuration. Head <NUM> includes an inner surface <NUM> that defines a cavity, such as, for example, a mating surface <NUM>. Mating surface <NUM> is configured for disposal of an instrument and/or tool extension, such as, for example, end <NUM> of driver shaft <NUM>, as discussed herein. Mating surface <NUM> is centrally positioned with respect to head <NUM>. Mating surface <NUM> is coaxial with axis L. In some embodiments, mating surface <NUM> may have various cross-section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. In some embodiments, inner surface <NUM> may have various surface configurations, such as, for example, smooth and/or surface configurations to enhance engagement with the mating surface of driver shaft <NUM>, such as, for example, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

Shaft <NUM> has a cylindrical cross section configuration and includes an outer surface having an external thread form. In some embodiments, the thread form may include a single thread turn or a plurality of discrete threads. In some embodiments, other engaging structures may be disposed on shaft <NUM>, such as, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement of shaft <NUM> with tissue, such as, for example, vertebrae.

In some embodiments, all or only a portion of shaft <NUM> may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. In some embodiments, the outer surface may include one or a plurality of openings. In some embodiments, all or only a portion of the outer surface may have alternate surface configurations to enhance fixation with tissue such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, all or only a portion of shaft <NUM> may be disposed at alternate orientations, relative to a longitudinal axis of bone fastener <NUM>, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, all or only a portion of shaft <NUM> may be cannulated.

In assembly, operation and use, a surgical implant system <NUM>, similar to the systems and methods described herein, is employed with a surgical procedure for treatment of a spinal disorder affecting a section of a spine of a patient, as discussed herein. For example, system <NUM> can be used with a surgical procedure for treatment of a condition or injury of an affected section of the spine including vertebrae. In some embodiments, one or all of the components of system <NUM> can be delivered as a preassembled device or can be assembled in situ. System <NUM> may be completely or partially revised, removed or replaced.

For example, system <NUM> can be employed with a surgical treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body, such as, for example, vertebrae (not shown). In some embodiments, system <NUM> may be employed with one or a plurality of vertebra. To treat a selected section of the vertebrae, a medical practitioner obtains access to a surgical site including the vertebrae in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, system <NUM> can be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery including percutaneous surgical implantation, whereby the vertebrae are accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure can be performed for treating the spine disorder.

An incision is made in the body of a patient and a cutting instrument (not shown) creates a surgical pathway for delivery of implantable components of system <NUM>. A preparation instrument (not shown) can be employed to prepare tissue surfaces of vertebrae, as well as for aspiration and irrigation of a surgical region.

Surgical instrument <NUM> is disposable in a first position such that collet <NUM> is in a biased closed position extending a distance from end <NUM> of sleeve <NUM>. End <NUM> of driver shaft <NUM> is engaged with mating surface <NUM>. Rotation of handle <NUM>, in the direction shown by arrow A in <FIG>, causes sleeve <NUM> to translate along axis L, in the direction shown by arrow B in <FIG>, to cause collet <NUM> to capture head <NUM>. Fingers <NUM> of collet <NUM> expand, in the direction shown by arrow C in <FIG>, into a second position as fingers <NUM> translate over surface <NUM>. As fingers <NUM> translate over surface <NUM>, fingers <NUM> are urged due to the resilient bias of fingers <NUM> into the first position, by moving in the direction shown by arrow D in <FIG>, to snap fit around head <NUM> to capture head <NUM> within fingers <NUM>. Locking surface <NUM> is in contact with surface <NUM>. Further rotation of handle <NUM> causes sleeve <NUM> to translate, in the direction shown by arrow E in <FIG>, such that end <NUM> of sleeve <NUM> translates over collet <NUM> and compresses fingers <NUM> of collet <NUM> and tighten fingers <NUM> about surface <NUM> of head <NUM> to releasably fix surgical instrument <NUM> with fastener <NUM>.

Translation of sleeve <NUM> causes' teeth <NUM> of reamer end surface <NUM> to bore into tissue disposed about head <NUM>. In some embodiments, reamer end surface <NUM> creates a circumferential pathway around head <NUM> providing space for an implant, such as, for example, a spinal rod receiver to be connected with head <NUM>.

Driver shaft <NUM> is rotated to apply a torsional force to bone screw <NUM> and increase the depth of the pilot hole and/or fasten bone screw <NUM> with tissue. As the depth of the pilot whole increases, shaft <NUM> engages the outer layer of cortical bone such that further rotation of bone screw <NUM> about axis L causes shaft <NUM> to move through the pilot hole and the outer layer of cortical bone and into a layer of cancellous bone. In some embodiments, bone screw <NUM> is rotated until the shaft of bone screw <NUM> penetrates the vertebra to fix bone screw <NUM> with the tissue.

The components of system <NUM>, including surgical instrument <NUM> and bone screw <NUM>, are employed to augment one or more surgical treatments. Surgical instrument <NUM> is disposable in the first, non-locking orientation, as described herein, to release bone screw <NUM> from collet <NUM>. To disengage instrument <NUM> from fastener <NUM>, handle <NUM> is rotated in the opposite direction, shown by arrow F in <FIG>, to translate sleeve <NUM>, in the direction shown by arrow G, to release the compression force about collet <NUM>. Rotation of handle <NUM> causes sleeve <NUM> to translate, in the direction shown by arrow H in <FIG>, to translate fingers <NUM> away from head <NUM> to disengage fingers <NUM> from head <NUM>. End <NUM> of driver shaft <NUM> is disengaged from mating surface <NUM>.

Surgical instrument <NUM> may be re-assembled for use in a surgical procedure. In some embodiments, system <NUM> may comprise various instruments including a lock and collet configuration of the present disclosure, with, for example, inserters, extenders, reducers, spreaders, distractors, blades, retractors, clamps, forceps, elevators and drills, which may be alternately sized and dimensioned, and arranged as a kit.

Upon completion of a procedure, surgical instrument <NUM>, surgical instruments and/or tools, assemblies and non-implanted components of system <NUM> are removed and the incision(s) are closed. One or more of the components of system <NUM> can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of system <NUM>. In some embodiments, 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, as shown in <FIG>, spinal implant system <NUM>, similar to the systems and methods described herein, comprises instrument <NUM> described herein, having driver shaft <NUM>, sleeve <NUM> and a sleeve <NUM>, similar to sleeve <NUM>, described herein. Driver shaft <NUM> extends along an axis L between an end <NUM> and an opposite end <NUM>.

End <NUM> is configured for engagement with bone fastener <NUM>, as shown in <FIG>. Sleeve <NUM> is configured for disposal of driver shaft <NUM>. Sleeve <NUM> extends along axis L. Sleeve <NUM> includes a passageway <NUM> coaxial with axis L and configured for disposal of driver shaft <NUM>. Sleeve <NUM> includes collet <NUM>, as described herein. Collet <NUM> is configured for movement between a first configuration and a second configuration, as described herein. Collet <NUM> comprises an inner surface <NUM> defining a passageway <NUM>, as shown in <FIG>. Passageway <NUM> is coaxial with passageway <NUM>.

Sleeve <NUM> extends between an end <NUM> and an end <NUM> along axis Sleeve <NUM> includes an inner surface <NUM> and an outer surface <NUM>. Surface <NUM> defines a passageway <NUM> coaxial with axis L and configured for moveable disposal of sleeve <NUM>.

End <NUM> includes a handle <NUM> having a threaded inner surface (not shown), similar to threaded surface <NUM>. The threaded surface is configured to rotatably engage threaded portion <NUM> for axial translation of sleeve <NUM> relative to sleeve <NUM>, which causes releasable locking of collet <NUM> with bone fastener <NUM>, as discussed herein. End <NUM> is dimensioned and/or configured similar to a tulip head receiver, as shown in <FIG>. End <NUM> includes a diameter similar to a diameter of a tulip head receiver. End <NUM> defines a cavity configured to receive collet <NUM> and head <NUM> such that end <NUM> is disposed about head <NUM> and collet <NUM> such that there is space disposed about head <NUM> for connection of a receiver.

Sleeve <NUM> is configured to lock collet <NUM> with head <NUM>, as discussed herein, for releasable fixation with bone fastener <NUM>. Sleeve <NUM> extends along a portion of sleeve <NUM> and is configured for axial translation relative to sleeve <NUM>. As sleeve <NUM> axially translates, in the direction shown by arrow I in <FIG>, fingers <NUM> are driven inwardly by the force of sleeve <NUM> engaging collet <NUM> such that fingers <NUM> are moveable to the locked position about head <NUM> with locking surface <NUM>.

End <NUM> includes a hard stop portion <NUM> configured to prevent fastener <NUM> from penetrating into tissue beyond a selected limit. Hard stop portion <NUM> allows for connection of a receiver with head <NUM>.

In one embodiment according to the present invention, as shown in <FIG>, surgical implant system <NUM> includes one or more of the same or similar features as described herein with respect to system <NUM>. The components of system <NUM> can be fabricated and/or formed using one or more of the materials described with respect to system <NUM>. Accordingly, a description of these materials is not repeated.

System <NUM>, which includes surgical instrument <NUM>, is employed, for example, with an open or mini-open, minimal access and/or minimally invasive including percutaneous surgical technique to deliver and fasten an implant at a surgical site within a body, for example, a section of a spine of a patient. In one embodiment, the components of system <NUM> are configured to fix a bone fastener, such as bone fastener <NUM>, for a surgical treatment to treat various spine pathologies, such as those described herein.

System <NUM> includes a fastener, such as, for example, a bone fastener <NUM>, as shown in <FIG>. Fastener <NUM> includes a head <NUM> configured for engagement with driver shaft <NUM> and an elongated shaft <NUM> configured for penetrating tissue. Head <NUM> comprises a spherical configuration. Head <NUM> includes an outer circumferential surface <NUM> having a substantially uniform diameter thereabout. In some embodiments, all or only a portion of surface <NUM> includes a spherical configuration. Head <NUM> includes an inner surface <NUM> that defines a cavity, such as, for example, a mating surface <NUM>. Mating surface <NUM> is configured for disposal of an instrument and/or tool extension, such as, for example, a mating surface 208a on an end <NUM> of driver shaft <NUM>, as discussed herein. Mating surface <NUM> is centrally positioned with respect to head <NUM>. Mating surface <NUM> is coaxial with axis L<NUM>. In some embodiments, mating surface <NUM> may have various cross-section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. In some embodiments, inner surface <NUM> may have various surface configurations, such as, for example, smooth and/or surface configurations to enhance engagement with the mating surface 208a of driver shaft <NUM>, such as, for example, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

Shaft <NUM> of the fastener <NUM> has a cylindrical cross section configuration and includes an outer surface having an external thread form. In some embodiments, the thread form may include a single thread turn or a plurality of discrete threads. In some embodiments, other engaging structures may be disposed on shaft <NUM>, such as, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement of shaft <NUM> with tissue, such as, for example, vertebrae.

In some embodiments, all or only a portion of shaft <NUM> may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. In some embodiments, the outer surface may include one or a plurality of openings. In some embodiments, all or only a portion of the outer surface may have alternate surface configurations to enhance fixation with tissue such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, all or only a portion of shaft <NUM> may be disposed at alternate orientations, relative to a longitudinal axis L<NUM> of bone fastener <NUM>, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, all or only a portion of shaft <NUM> may be cannulated.

In one or more embodiments, the outer circumferential surface <NUM> of the head <NUM> includes one or more screw flats, such as screw flat 240a and screw flat 240b. The screw flat 240a may be configured in a geometry that mates with a key portion, such as key portion 242a and 242b, of a collet <NUM>, as discussed herein. In one or more cases, the keyed surface <NUM> of the screw flat 240a may be notched into the outer circumferential surface <NUM> of the head <NUM>. In one or more other cases, the key surface <NUM> of the screw flat 240a may protrude from the outer circumferential surface <NUM> of the head <NUM>. The keyed surface <NUM> of the screw flat 240a may have a flat shape. The keyed surface <NUM> of the screw flat 240a may extend across the outer circumferential surface <NUM> of the head <NUM>. It is noted that the screw flat 240b includes one or more of the same or similar features as screw flat 240a. Accordingly, a description of such features for screw flat 240b is not repeated. It is also noted that two screw flats are described; however, embodiments are contemplated in which the head <NUM> includes one screw flat and in which the head <NUM> includes greater than two screw flats, for example, four screw flats, in which the collet <NUM> includes a corresponding number of key portions, such as, four key portions.

System <NUM> includes surgical instrument <NUM>, which includes a member, such as, for example, a driver shaft <NUM> extending along an axis L<NUM> between an end <NUM> and an opposite end <NUM>, as shown in <FIG>. The end <NUM> includes a mating surface <NUM> configured to facilitate manipulation and/or maneuvering of the surgical instrument <NUM>. The surface <NUM> is configured for engagement with a handle. The handle may have a receiving portion on an inner surface of the handle, in which the surfaces of the receiving portion are configured to receive the end <NUM> of the driver shaft <NUM>.

The driver shaft <NUM> may be an elongated rigid member having a solid center. The driver shaft <NUM> may include a stopper <NUM> disposed around the outer surface of the shaft <NUM>. The stopper <NUM> may be a rigid body having a bushing 296a positioned on one end of the stopper <NUM> and protrudes outwards from the shaft <NUM>. The stopper <NUM> may have a cylindrical disk 296b positioned on an end of the stopper <NUM> opposite the bushing 296a.

The bushing 296a and the cylindrical disk 296b may be positioned on the shaft <NUM> a set distance away from one another to prevent the shaft <NUM> from translating through sleeves <NUM> and <NUM> beyond the set distance. For example, the bushing 296a may contact an outer surface <NUM> of the knob <NUM> and may prevent the driver shaft <NUM> from moving a set distance towards the end <NUM>. In another example, the cylindrical disk 296b may contact an inner surface of the knob <NUM> and prevent the driver shaft <NUM> from moving a set distance away from the end <NUM>. In one or more cases, the knob <NUM> can rotate about the driver shaft <NUM> and can translate over the driver shaft <NUM> relative to the distance defined by the bushing 296a and the cylindrical disk 296b. In one or more cases, the bushing 296a may be used to facilitate connecting the surgical instrument <NUM> with a navigation tracking instrument, such as a NavLock™ Tracker available from Medtronic, Inc. The navigation tracking instrument may be coupled to the groove portion 296c of the bushing 296a, as shown in <FIG>.

The mating surface 208a on the end <NUM>, as shown in <FIG>, is configured for engagement with an implant, such as, for example, a bone fastener <NUM>. In some embodiments, the end <NUM> may be formed with different cross-sectional shapes, such as, but not limited to, a square, hexagonal, polygonal, triangular, star, or, or preferably a hexalobe. The mating surface 208a may have various surface configurations, such as, for example, smooth, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured. The mating surface 208a may be formed in a shape capable of being inserted in a mating surface <NUM> of the fastener <NUM>.

The driver shaft <NUM> may be inserted through a passageway <NUM> of a member, such as for example, a sleeve <NUM>. The sleeve <NUM> may be configured for disposal of driver shaft <NUM>. The sleeve <NUM> may be an elongated tubular member having a cannulated center forming the passageway <NUM>. The sleeve <NUM> extends between an end <NUM> and an end <NUM> along axis L<NUM>. The sleeve <NUM> includes an inner surface <NUM> and an outer surface <NUM>. The surface <NUM> defines a passageway <NUM> coaxial with axis L<NUM> and configured for disposal of the driver shaft <NUM>. The surface <NUM> includes a threaded portion <NUM> configured for engagement with a third member, such as a sleeve <NUM> and preferably a knob <NUM> of the sleeve <NUM>. The end <NUM> includes an expandable member, such as, for example, a collet <NUM>.

The collet <NUM> extends from the end <NUM> and is configured for movement between an open position and a closed position, as described herein. The collet <NUM> comprises an inner surface <NUM> defining a passageway <NUM>, as shown in <FIG>. The passageway <NUM> is coaxial with the passageway <NUM>. The passageway <NUM> has a cylindrical cross-section configuration. In some embodiments, the passageway <NUM> may have various cross-section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered.

The collet <NUM> may be configured to snap fit around a head <NUM> of the fastener <NUM>. As the collet <NUM> translates over the head <NUM> of fastener <NUM>, the collet <NUM> moves from the closed position to the open position and back to the closed position to capture the head <NUM>. The collet <NUM> may snap fit around the head <NUM> of the fastener <NUM> via a plurality of cantilevered fingers 250a, 250b, 250c, and 250d. The plurality of cantilevered fingers 250a, 250b, 250c, and 250d may define the inner surface <NUM>, serving as a locking surface, of the collet <NUM>. The fingers 250a, 250b, 250c, and 250d may extend radially outward from the end <NUM> of the sleeve <NUM>. The fingers 250a, 250b, 250c, and 250d may be circumferentially disposed and are equidistantly spaced apart. The fingers 250a, 250b, 250c, and 250d are spaced apart by a gap <NUM> defined by opposite planar sidewalls <NUM>. The distal end of the fingers 250a, 250b, 250c, and 250d may include a first surface <NUM> configured to engage the outer circumferential surface <NUM> of the head <NUM>. The first surface <NUM> may taper towards the distal end of the fingers 250a, 250b, 250c, and 250d. The distal end of the fingers 250a, 250b, 250c, and 250d may include a second surface <NUM> integrally connected with the first surface <NUM>. The second surface may taper away from the distal end of the fingers 250a, 250b, 250c, and 250d. It is noted that the collet <NUM> is described as having four fingers; however, embodiments are contemplated in which the collet <NUM> includes fewer than four fingers and in which the collet <NUM> includes greater than four fingers.

In one embodiment, the collet <NUM> is flexible such that the fingers 250a, 250b, 250c, and 250d are configured to move from the closed position to the open position and from the open position to the closed position. <FIG> illustrates the collet <NUM> biased in the closed position. <FIG> illustrates the collet <NUM> fitted around the head <NUM> of the fastener <NUM> in the first closed position. In the closed position, the fingers 250a, 250b, 250c, and 250d may be cantilevered from the end <NUM> of the sleeve <NUM>, such that fingers 250a, 250b, 250c, and 250d extend parallel or substantially parallel with the inner surface <NUM> and/or outer surface <NUM> of the sleeve <NUM>. In the open position, the fingers 250a, 250b, 250c, and 250d may flex outwards away from the center of the passageway <NUM>.

In an example, the collet <NUM> may be biased in the closed position. In one or more cases, a user may insert the mating surface 208a of the driver shaft <NUM> into the mating surface <NUM> of the fastener <NUM>. Subsequently, the user may begin to position the head <NUM> of the fastener <NUM> within the collet <NUM> of sleeve <NUM>. As the collet <NUM> translates over the head <NUM> of the fastener <NUM>, the first surface <NUM> of one or more of the fingers 250a, 250b, 250c, and 250d contacts the outer circumferential surface <NUM> of the head <NUM> and flexes outwards, in the direction C as shown in <FIG>, away from the center of the passageway <NUM>, thereby moving the collet <NUM> into the open position. The tapered portion of the first surface <NUM> may facilitate translation of the fingers 250a, 250b, 250c, and 250d of the head <NUM>. Having passed the first surface <NUM>, the outer circumferential surface <NUM> of the head <NUM> contacts the second surface <NUM> of one or more of the fingers 250a, 250b, 250c, and 250d. As the second surface <NUM> translates over the head <NUM>, the fingers 250a, 250b, 250c, and 250d flex inwards, in the direction D as shown in <FIG>, towards the center of the passageway <NUM>, thereby returning the collet <NUM> to the closed position and coupling the fastener <NUM> to the instrument <NUM>.

In one or more embodiments, one or more of the fingers 250a, 250b, 250c, and 250d includes a key portion, such as key portion 242a and key portion 242b. The key portion 242a may be configured in a geometry that mates with a screw flat 240a of the fastener <NUM>. The collet <NUM> may include a number of key portions equal to the number of screw flats of the fastener <NUM>. The key portion 242a may include a surface extending across the inner surface <NUM> of the collet <NUM>. In one or more cases, the surface of the key portion 242a may be raised from the inner surface <NUM> of the collet <NUM> forming a notch. The raised surface of the key portion 242a may be configured to engage a keyed surface <NUM> of the screw flat 240a for the cases in which the keyed surface <NUM> of the screw flat 240a is notched. In one or more other cases, the surface of the key portion 242a may be a surface indented into the inner surface <NUM> of the collet <NUM> forming a cavity. The indented surface of the key portion 242a may be configured to engage the keyed surface <NUM> of the screw flat 240a for the cases in which the keyed surface <NUM> protrudes from the outer circumferential surface <NUM> of the head <NUM>. The surface of the key portion 242a may be of a different shape, such as, for example, a flat shape, than the inner surface <NUM> of the collet <NUM>. In one or more cases, the key portion 242a may be disposed entirely on one of the fingers 250a, 250b, 250c, and 250d. In one or more other cases, a portion of the key portion 242a may be disposed on a portion of one finger, such as finger 250b, and another portion of the key portion 242a may be disposed on a portion of an adjacent finger, such as 250c, as shown in <FIG>.

It is noted that the key portion 242b includes one or more of the same or similar features as key portion 242a. Accordingly, a description of such features for key portion 242b is not repeated. It is also noted that two key portions are described; however, embodiments are contemplated in which the collet <NUM> includes one key portion and in which the collet <NUM> includes greater than two key portions.

System <NUM> includes a third member, such as, for example, a sleeve <NUM>, as shown in <FIG>. The sleeve <NUM> extends between an end <NUM> and an end <NUM> along axis L<NUM>. The sleeve <NUM> includes an inner surface <NUM> and an outer surface <NUM>. The inner surface <NUM> defines a passageway <NUM> coaxial with axis L<NUM> and is configured for moveable disposal of the sleeve <NUM>. In one embodiment, the inner surface <NUM> may have various surface configurations to enhance engagement of the sleeve <NUM> and/or the collet <NUM>, such as, for example, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

The surgical instrument <NUM> may include a translation stop <NUM>, as shown in <FIG>. The translation stop <NUM> may be configured to limit the distance, for example a distance D<NUM>, the sleeve <NUM> axially translates through the sleeve <NUM>. Moreover, the translation stop <NUM> may be configured to prevent the sleeve <NUM> from axially rotating within the sleeve <NUM>. The translation stop <NUM> may include one or more tracks, such as track 248a and track 248b, and one or more pins, such as pin 246a and 246b. In one or more cases, the track 248a and the track 248b may each be disposed on the sleeve <NUM> and the pin 246a and the pin 246b may each be disposed on the sleeve <NUM>, as shown in <FIG> and <FIG>. In one or more other cases, the track 248a and the track 248b may be disposed on the sleeve <NUM> and the pin 246a and the pin 246b may be disposed on the sleeve <NUM>.

For the cases in which tracks 248a and 248b are disposed on the sleeve <NUM>, the tracks 248a and 248b may be through-holes extending from the outer surface <NUM> of the sleeve <NUM> to the inner surface <NUM> of the sleeve <NUM>. The tracks 248a and 248b may be sized to receive the pins 246a and 246b, respectively. For the cases in which pins 246a and 246b are disposed on the sleeve <NUM>, the pins 246a and 246b may protrude into the passageway <NUM>. The pins 246a and 246b may be disposed on the sleeve <NUM> such that the pins 246a and 246b may be positioned within the tracks 248a and 248b, respectively. The pins 246a and 246b may protrude far enough into the passageway <NUM> to contact at least a portion of the stopping surface 292a of track 248a and the stopping surface 292b of the track 248b. The pins 246a and 246b may protrude far enough into the passageway <NUM> to contact at least a portion of the stopping surface 294a of track 248a and the stopping surface 294b of the track 248b. The pins 246a and 246b may protrude far enough into the passageway <NUM> to not interfere with the driver shaft <NUM> moving within the passageway <NUM>.

In one or more cases, the pins 246a and 246b and the stopping surfaces 292a and 292b are configured to prevent the sleeve <NUM> from moving beyond a set distance D<NUM>. For example, as the sleeve <NUM> translates through the sleeve <NUM>, the sleeve <NUM> may move the distance D<NUM> towards the distal end of the surgical instrument <NUM>. Having moved the distance D<NUM>, the stopping surfaces 292a and 292b contact the pins 246a and 246b, respectively, thereby limiting the distance the sleeve <NUM> axially translates through the sleeve <NUM>.

In one or more cases, the end <NUM> of the sleeve <NUM> may act as a depth stop to prevent the fastener <NUM> from penetrating into a body, for example, a vertebral body of a spine, beyond a distance D<NUM>. In one or more cases, the distance D<NUM> may range from at or about <NUM> millimeters (mm) to at or about <NUM>. More preferably, the distance D<NUM> may be at or about <NUM>. The end <NUM> of the sleeve <NUM> may be configured to surround a proximal thread 295f of the fastener <NUM>. In one or more cases, by surrounding a portion of the thread 295f, as the fastener <NUM> is being fastened into, for example, a vertebral body and the collet <NUM> is retracted within the end <NUM>, the outer surface 295d of the end <NUM> may contact an outer surface of the vertebral body, thereby preventing the fastener <NUM> from penetrating into the vertebral body any farther. That is, when the outer surface 295d of the end <NUM> of the sleeve <NUM> contacts the outer surface of the vertebral body, the surgical instrument <NUM> is prevented from inserting the full insertion depth 295e of the fastener <NUM> into the vertebral body. In one or more cases, the distance between the outer surface 295a of the collet <NUM> and the inner surface 295b of the end <NUM> of the sleeve <NUM> may define the length of the proximal thread 295f that can be surrounded by the end <NUM> of the sleeve <NUM>.

In one or more cases, the end <NUM> of the sleeve <NUM> includes the knob <NUM> attached therewith having a threaded inner surface <NUM>. The threaded inner surface <NUM> of the knob <NUM> may be configured to rotatably engage threaded portion <NUM> of sleeve <NUM>. By threading the threaded inner surface <NUM> with the threaded portion <NUM>, the knob <NUM> and sleeve <NUM> may be rotatably coupled with the sleeve <NUM>.

In one or more cases, the surgical instrument <NUM> may include a key <NUM> and cutout <NUM> to prevent the drive shaft <NUM> and the sleeve <NUM> from axially rotating about one another. In one or more cases, the sleeve <NUM> may include a cutout <NUM> that extends across a portion of the threaded portion <NUM>. In one or more other cases, the cutout <NUM> may extend across the threaded portion <NUM> and into an unthreaded portion 216a of the sleeve <NUM>. The cutout <NUM> may be a receptacle configured to receive the key <NUM> disposed on an outer surface of the driver shaft <NUM>. The key <NUM> may be an elongated protrusion that extends in the direction L<NUM> and protrudes from the outer surface of the driver shaft <NUM>. The key <NUM> may be configured to interlock with the cutout <NUM>. For the cases in which the key <NUM> and the cutout <NUM> are interlocked, the driver shaft <NUM> and the sleeve <NUM> may translate through the sleeve <NUM>, but are prevented from axially rotating about one another. That is, driver shaft <NUM> is prevented from axially rotating in a direction different than the axial rotation of the sleeve <NUM>, and vice versa. In one or more other cases, the driver shaft <NUM> may include the cutout <NUM>, and the sleeve <NUM> may include the key <NUM>. In one or more cases, the knob <NUM> may include a cavity <NUM> that houses a spring <NUM> therein. On the inner surface of the cavity <NUM>, one or more pins, such as pins 213a, 213b, and 213c may protrude from the inner surface of the cavity <NUM> towards the center of the cavity <NUM>.

In one or more cases, the knob <NUM> may include an interlocking portion <NUM> that includes one or more tracks, such as tracks 209a, 209b, and 209c, and one or more interlocking notches, such as interlocking notches 211a, 211b, and 211c. The interlocking portion <NUM> may be a cylindrically rigid ring disposed on a proximal end of the knob <NUM>. In one or more cases, each track may be recessed within the interlocking portion <NUM> of the knob <NUM>. The tracks 209a, 209b, and 209c may be circumferentially disposed around the interlocking portion <NUM>. The tracks 209a, 209b, and 209c may each extend transversely across the width of the interlocking portion <NUM>. In one or more cases, the tracks 209a, 209b, and 209c may each be sized to accommodate a width of a pin, such as pins 213a, 213b, and 213c, therein. In one or more cases, the interlocking notches 211a, 211b, and 211c may be circumferentially disposed around the interlocking portion <NUM>. An interlocking notch, such as interlocking notch 211a, may be positioned between two tracks, such as tracks 209a and 209b, as shown in <FIG>. Each interlocking notch may be notched inwards from an inner surface 217a of the interlocking portion <NUM>. The interlocking notches 211a, 211b, and 211c may each be sized to accommodate at least a portion of a pin, such as pins 213a, 213b, and 213c, therein.

To assembly the sleeves <NUM> and/or <NUM> to the driver shaft <NUM>, the knob <NUM> is rotated such that a pin of the knob <NUM> aligns with a track of the interlocking portion <NUM>. For example, the knob <NUM> and/or the knob <NUM> may be rotated such that the pins 213a, 213b, and 213c align with the tracks 209a, 209b, and 209c and the key <NUM> is aligned with the cutout <NUM>. Having aligned the one or more pins to the one or more tracks and/or the key <NUM> to the cutout <NUM>, the knob <NUM> is moved in a direction K as shown in <FIG>, The one or more pins may move through their respective tracks and may be positioned over a rotation portion <NUM> of the knob <NUM>. The key <NUM> may be inserted into the cutout <NUM>.

By moving the knob <NUM> in the direction K, an outer surface 217b of the interlocking portion <NUM> contacts an outer surface of the spring <NUM> and compresses the spring <NUM> in a direction 297b, as shown in <FIG>. Having positioned the one or more pins over the rotation portion <NUM>, the knob <NUM> and/or the knob <NUM> are rotated in a direction L, as shown in <FIG>, to align the one or more pins with the one or more interlocking notches. For example, the pin 213a. may be aligned with the interlocking portion 211a, the pin 213b may be aligned with the interlocking portion 211b, and the pin 213c may be aligned with the interlocking portion 211c. Having aligned the one or more pins to the one or more interlocking notches, the knob <NUM> may move in a direction M, as shown in <FIG>. At least a portion of the one or more pins may enter into and interlock with the one or more interlocking portions, respectively. For example, at least a portion of the pin 213a may be positioned within the interlocking portion 211a.

In one or more cases, the spring <NUM> may decompress and apply a force in a direction 297a, as shown in <FIG>, thereby biasing the one or more pins into the respective one or more interlocking portions. In the interlocked positioned, a space <NUM> may be formed indicating the one or more pins are inserted into the respective one or more interlocking portions. In one or more cases, the knob <NUM> may include one or more ergonomic recesses, such as recess 220a, circumferentially disposed around the knob <NUM>. The one or more recesses 220a may be used to facilitate the rotation of the knob <NUM> about the driver shaft <NUM>. In one or more cases, the knob <NUM> may include one or more ergonomic recesses, such as recess 214a, circumferentially disposed around the knob <NUM>. The one or more recesses 214a may be used to facilitate the rotation of the knob <NUM>. In one or more cases, the one or more recesses 220a of the knob <NUM> and the one or more recesses 214a of the knob <NUM> may provide a visual feedback indicating that the one or more pins are aligned with the one or more interlocking notches. For example, when the one or more recesses 220a and the one or more recesses 214a are aligned with one another and form one or more continuous recesses extending from knob <NUM> to knob <NUM>, the one or more pins are aligned with the one or more interlocking notches.

The sleeve <NUM> is configured to lock the collet <NUM> with the head <NUM>, as discussed herein, for releasable fixation with the bone fastener <NUM>. The sleeve <NUM> extends along a portion of the sleeve <NUM> and is configured for axial translation relative to the sleeve <NUM>. As the knob <NUM> rotates in a direction I as shown in <FIG>, the sleeve <NUM> axially translates, in the direction B as shown in <FIG>. By axially translating the sleeve <NUM> in the direction B, the fingers 250a, 250b, 250c, and 250d move out of the sleeve <NUM>. The fingers 250a, 250b, 250c, and 250d may translate over the head <NUM> of the fastener <NUM>. In one or more cases, the key portions 242a and 242b of the collet <NUM> may be aligned with the one or more screw flats 240a of the fastener <NUM>. As the knob <NUM> rotates in a direction F as shown in <FIG>, the fingers 250a, 250b, 250c, and 250d move into the sleeve <NUM> and are driven further inwardly by the force of the sleeve <NUM> engaging the collet <NUM>. By engaging the sleeve <NUM> with the collet <NUM>, the fingers 250a, 250b, 250c, and 250d are moved from the open position to the closed position around head <NUM>. The knob <NUM> may be rotated in the direction F such that the surface 295a of the collet <NUM> and the surface 295b of the sleeve <NUM> press against one another and the sleeves <NUM> and/or <NUM> are axially rigid relative to the driver shaft <NUM>. The rotation force tensions the fastener <NUM> to the end <NUM> of the driver shaft <NUM>. Having engaged the fingers 250a, 250b, 250c, and 250d to the head <NUM> of the fastener <NUM>, the collet <NUM> may be locked with the head <NUM>.

Surgical instrument <NUM> is disposable in a first position, as shown in <FIG> such that the collet <NUM> is in a biased closed position extending a distance from the end <NUM> of the sleeve <NUM>. The mating surface 208a of the driver shaft <NUM> may be engaged with the mating surface <NUM> of the fastener <NUM>. Rotation of the knob <NUM>, in the direction I as shown in <FIG>, causes the sleeve <NUM> to translate along axis L<NUM> in the direction B, as shown in <FIG> and <FIG>. By translating the sleeve <NUM> in the direction B, the collet <NUM> may capture the head <NUM>.

When the sleeve <NUM> translates out of the sleeve <NUM>, the fingers 250a, 250b, 250c, and 250d of the collet <NUM> expand, in the direction C, as shown in <FIG>, into the biased closed position. As the fingers 250a, 250b, 250c, and 250d translate over the outer circumferential surface <NUM> of the fastener <NUM> into the open position, the fingers 250a, 250b, 250c, and 250d may expand farther in the direction C. As the fingers 250a, 250b, 250c, and 250d translate over the surface <NUM>, the fingers 250a, 250b, 250c, and 250d are urged, due to the resilient bias of the fingers 250a, 250b, 250c, and 250d, back into the closed position in the direction D, as shown in <FIG>. The fingers 250a, 250b, 250c, and 250d may snap fit around the head <NUM>, thereby capturing the head <NUM> within the fingers 250a, 250b, 250c, and 250d. Further rotation of the knob <NUM>, in the direction I as shown in <FIG>, causes the sleeve <NUM> to translate in the direction E as shown in <FIG>, such that the end <NUM> of the sleeve <NUM> translates over the collet <NUM> and compresses the fingers 250a, 250b, 250c, and 250d of the collet <NUM>. By compressing the fingers 250a, 250b, 250c, and 250d, the fingers 250a, 250b, 250c, and 250d may be tightened about the surface <NUM> of the head <NUM> to releasably fix the surgical instrument <NUM> with the fastener <NUM>, thereby engaging the driver shaft <NUM> to rotate with the rotation of the knob <NUM> and/or knob <NUM>.

In one or more cases, the driver shaft <NUM> may be rotated, via rotating the knob <NUM> and/or knob <NUM> in a direction A as shown in <FIG>. In one or more cases, the driver shaft <NUM> may be rotated, via rotating a handle attached to the end <NUM> of the driver shaft <NUM> or the driver shaft <NUM> itself in the direction A as shown in <FIG>. The handle, driver shaft <NUM>, knob <NUM>, and/or knob <NUM> may be rotated to apply a torsional force to the fastener <NUM> and increase the depth of the pilot hole and/or fasten the fastener <NUM> with tissue. As the depth of the pilot hole increases, the shaft <NUM> engages the outer layer of cortical bone such that further rotation of the fastener <NUM> about axis L<NUM> causes the shaft <NUM> to move through the pilot hole and the outer layer of cortical bone and into a layer of cancellous bone. In some embodiments, the fastener <NUM> is rotated until the shaft <NUM> of the fastener <NUM> penetrates the vertebra to fix the fastener <NUM> with the tissue. In one or more embodiments, the translation stop <NUM> and/or the depth stop of the surgical instrument <NUM> may prevent the fastener <NUM> from penetrating into the vertebra beyond a selected limit, as discussed herein. Rotation of the handle, driver shaft <NUM>, knob <NUM>, and/or knob <NUM> in the J direction causes the driver shaft <NUM> to unfasten the fastener <NUM> from the vertebral body.

The components of system <NUM>, including the surgical instrument <NUM> and the fastener <NUM>, are employed to augment one or more surgical treatments. The surgical instrument <NUM> may be disposable in the first, non-locking orientation, as described herein, to release the fastener <NUM> from the collet <NUM>. To disengage the surgical instrument <NUM> from the fastener <NUM>, the knob <NUM> is rotated in the opposite direction F, as shown in <FIG>, to translate sleeve <NUM> in the direction G as shown in <FIG>. Translating the sleeve <NUM> in the direction G may release the compression force about the collet <NUM>. Further rotation of the knob <NUM> in the direction F shown in <FIG> causes the sleeve <NUM> to translate in the direction H shown in <FIG> and <FIG>. As the sleeve <NUM> translates in the direction H, the fingers 250a, 250b, 250c, and 250d move away from the head <NUM> and disengage the fingers 250a, 250b, 250c, and 250d from the head <NUM>. The mating surface 208a of the driver shaft <NUM> may be disengaged from the mating surface <NUM> of the fastener <NUM>. It is noted that the rotation direction I and direction A causes one or more components to move in the directions B and/or E, and the rotation direction J and direction A causes one or more components to move in the directions G and/or H. However, it should be understood that in one or more other cases, the rotation direction I and direction A causes one or more components to move in the directions G and/or H, and the rotation direction J and direction A causes one or more components to move in the directions B and/or E.

Claim 1:
A surgical instrument (<NUM>) comprising:
an elongated first member (<NUM>) having a first end (<NUM>) and a second end (<NUM>);
a tubular second member (<NUM>) having a third end (<NUM>) and a fourth end (<NUM>), a portion of the elongated first member (<NUM>) being positioned within a first passageway (<NUM>) of the tubular second member (<NUM>); and
a tubular third member (<NUM>) having a fifth end (<NUM>) and a sixth end (<NUM>), the portion of the elongated first member (<NUM>) and a portion of the tubular second member (<NUM>) being positioned within a second passageway (<NUM>) of the tubular third member (<NUM>),
wherein the fifth end (<NUM>) of the tubular third member (<NUM>) comprises a first handle rotatably engaged to the third end (<NUM>) of the tubular second member (<NUM>) for axial translation of the tubular third member (<NUM>) relative to the tubular second member (<NUM>), and
wherein the fourth end (<NUM>) of the tubular second member (<NUM>) comprises an expandable member (<NUM>),
wherein the expandable member (<NUM>) is a flexible collet (<NUM>) configured to snap around the spherical head (<NUM>) of a fastener (<NUM>),
wherein the expandable member (<NUM>) comprises at least one key portion (242a) configured to interlock with at least one key portion (<NUM>) disposed on an end of a fastener (<NUM>),
characterised in that
the key portion (242a) of the expandable member (<NUM>) includes a surface extending across an inner surface (<NUM>) of the collet (<NUM>), and
wherein the surface of the key portion (242a) of the expandable member (<NUM>) is of a flat shape.