Patent Description:
Spinal pathologies and disorders such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumor and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. The rods may be attached via the fasteners to the exterior of two or more vertebral members. Surgical treatment may employ surgical instruments and implants that are manipulated for engagement with vertebrae to position and align one or more vertebrae. This disclosure describes an improvement over these prior technologies.

<CIT> discloses a surgical instrument and a method.

The invention provides a surgical instrument according to claim <NUM> and a surgical system according to claim <NUM>.

The exemplary embodiments of the surgical system and not claimed related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a spinal implant system and a not claimed method for treating a spine. In some embodiments, the systems of the present disclosure comprise medical devices including surgical instruments and implants that are employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system includes a surgical instrument that comprises a screw driver configured for use with robotic guidance. In some embodiments, the screw driver is configured for use with a spinal implant, for example, a bone fastener. In some embodiments, the screw driver includes an outer diameter of about <NUM>. In some embodiments, the screw driver is configured for insertion through an end effector having an inner diameter of about <NUM>. The configuration of the screw driver avoids using an instrument with an incorrectly sized arm guide that may affect accuracy.

In some embodiments, the present surgical system includes a surgical instrument that comprises a screw driver having an inner shaft, an inner sleeve and an outer sleeve. In some embodiments, the screw driver has an inner sleeve with a flexible collet. In some embodiments, the flexible collet is configured to snap around a spherical head of a bone fastener. In some embodiments, the inner sleeve includes an engagement surface, for example, a tapered surface, configured for slidable engagement with the outer sleeve to lock the collet around a head of a bone screw. In some embodiments, the outer sleeve compresses the engagement surface and the collet to reduce an outer diameter of the collet. In some embodiments, this configuration allows the screw driver to maintain an outer diameter of about <NUM>.

In some embodiments, the present surgical system includes a surgical instrument that comprises a screw driver having an actuator. In some embodiments, the actuator includes a knob and a coupling member. In some embodiments, the coupling member includes external threads configured to engage internal threads on the knob. In some embodiments, the coupling member is configured to engage the inner sleeve with pins. In some embodiments, the coupling member is threaded forward to retract the outer sleeve from the taper of the inner sleeve, which allows the collet to open. In some embodiments, the actuator is configured to slide and translate back and forth freely. In some embodiments, the inner shaft is keyed with the inner sleeve to resist and/or prevent relative rotation. In some embodiments, the present surgical system includes a surgical instrument that comprises a screw driver having a collet that expands and snaps over a bone screw head. In some embodiments, the actuator causes the outer sleeve to translate along the engagement surface to snap the collet onto the head of the bone screw.

In some embodiments, the present surgical system includes a surgical instrument that comprises a screw driver having an actuator with a knob and a coupling member such that rotating the knob draws the inner sleeve back axially to clamp on the bottom of the bone screw. As such, the outer sleeve clamps on a taper of the collet to fix the collet with the head of the bone fastener. In some embodiments, the outer sleeve is keyed to the inner sleeve. In some embodiments, the inner sleeve is configured to draw the bone fastener into engagement with the driver. In some embodiments, the head is drawn tight against a shoulder of a hexalobular drive on the inner shaft.

In some embodiments, the present surgical system includes a surgical instrument that comprises a screw driver having an inner shaft with datum surfaces configured to mate with a navigation component and are detectable by image guidance to calculate a position of the navigation component. In some embodiments, the screw driver is configured to connect the navigation component with the screw driver. In some embodiments, the present surgical system includes a bushing that connects the navigation component with the screw driver. In some embodiments, the bushing is assembled from the distal end of the inner shaft to prevent damaging the datum surfaces.

In some embodiments, the present surgical system includes a method of assembling components of a screw driver including the step of attaching the bushing with an inner shaft. In some embodiments, the method includes the step of inserting a distal end of the inner shaft into an opening of the bushing and the bushing is translated and selectively disposed adjacent at least one datum surface. In some embodiments, the present surgical system includes a method of assembling components of a screw driver including the step of attaching a key into a slot of the inner shaft; attaching the knob to the inner shaft by translating the knob from the distal end of the inner shaft; and inserting a retaining ring to connect the knob with the inner shaft. In some embodiments, the method includes the steps of inserting the distal end of the inner shaft into the outer sleeve and translating the outer sleeve along the inner shaft into engagement with the knob; attaching the inner sleeve by inserting the inner sleeve into a channel of the outer sleeve and translating the inner sleeve into alignment with the key; attaching the coupling member by translating the coupling member along the outer sleeve into a threaded engagement with the knob; and inserting pins to connect the coupling member with the inner and outer sleeves and welding the pins. See, for example, the embodiments and disclosure of systems and methods of assembling components of a screw driver, shown and described in commonly owned and assigned U. Patent Application Publication No. <CIT>.

In some embodiments, the present surgical system comprises a surgical instrument that comprises a screw driver that can be employed with bone fasteners and one or more implant supports for treating a spine. In some embodiments, the present surgical system includes a surgical instrument that can easily connect and disconnect from a bone fastener. In some embodiments, the present surgical system includes a surgical instrument that can be employed with an end effector of a robotic arm to facilitate implantation with the robotic arm. In some embodiments, the surgical instrument is guided through the end effector for a guide-wireless screw insertion. In some embodiments, the surgical instrument comprises a robot screw driver employed with robotic and/or navigation guidance, which may include an image guide.

In some examples, the surgical system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the surgical system of the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some examples, the disclosed surgical system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The surgical system of the present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The surgical system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.

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

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

The following discussion includes a description of a surgical system including a surgical instrument, related components and methods (not claimed) 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 spinal implant system <NUM>, in accordance with the principles of the present disclosure.

For example, the components of spinal implant 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, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), 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.

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

Spinal implant system <NUM> includes a surgical instrument, such as, for example, a surgical driver <NUM>. Surgical driver <NUM> can be employed with an end effector <NUM>, as shown in <FIG>, to facilitate implantation with a robotic arm R (<FIG>). Surgical driver <NUM> is guided through end effector <NUM> for guide-wireless insertion of a spinal implant, for example, a bone fastener <NUM>, as described herein.

Surgical driver <NUM> includes a member, for example, a driver shaft <NUM> extending along an axis L between a proximal end <NUM> and a distal end <NUM>, as shown <FIG>. End <NUM> is configured for engagement with an implant, 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, for example, smooth, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured. Shaft <NUM> includes a slot <NUM> configured for disposal of a part, for example, a key <NUM>. Key <NUM> is configured to connect shaft <NUM> with a member, as described herein, to resist and/or prevent relative rotation.

Shaft <NUM> includes an outer surface <NUM>. Surface <NUM> includes one or more datum surfaces <NUM>, 24a. Surface <NUM> is disposed on shaft <NUM> a selected distance from distal end <NUM>. Surface <NUM> is detectable by image guidance and utilized to calculate a position of a navigation component <NUM>, as described herein, surgical driver <NUM> and/or bone fastener <NUM> during a surgical procedure. Surface <NUM> is configured for connection with a portion of navigation component <NUM> to facilitate positioning and/or tracking of navigation component <NUM>, surgical driver <NUM> and/or bone fastener <NUM> during a surgical procedure. Shaft <NUM> includes a diameter A1 and surface <NUM> include a diameter A2. In some embodiments, diameter A2 is greater than diameter A1 such that surface <NUM> forms an edge <NUM>, as shown in <FIG>. Edge <NUM> is configured to provide a stop for a part, for example, a bushing <NUM> during assembly, as described herein. Bushing <NUM> is configured to connect navigation component <NUM> with surgical driver <NUM>. Bushing <NUM> includes a flange <NUM> and a flange <NUM> that is spaced apart from flange <NUM>. Bushing <NUM> includes a recess <NUM> between flanges <NUM>, <NUM>. Bushing <NUM> includes an inner surface <NUM> that defines an opening <NUM>.

Surface 24a is disposed on shaft <NUM> a selected distance from distal end <NUM>. Surface 24a is detectable by image guidance and utilized to calculate a position of a navigation component <NUM>, as described herein, surgical driver <NUM> and/or bone fastener <NUM> during a surgical procedure. Surface 24a is configured for connection with a portion of navigation component <NUM> to facilitate positioning and/or tracking of navigation component <NUM>, surgical driver <NUM> and/or bone fastener <NUM> during a surgical procedure. Surface 24a includes a diameter A2a. In some embodiments, diameter A2a is greater than diameter A1 such that surface 24a forms an edge 28a, as shown in <FIG>.

A member, for example, a sleeve <NUM> is configured for disposal of 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 shaft <NUM>. Surface <NUM> includes an opening <NUM> configured for disposal of key <NUM> for a keyed connection between shaft <NUM> and sleeve <NUM>, as shown in <FIG>. Connection of shaft <NUM> with sleeve <NUM> allows for axial translation of shaft <NUM> and sleeve <NUM> thereby preventing and/or resisting relative rotation. Surface <NUM> includes an opening <NUM> configured for alignment with a member, for example, a sleeve <NUM> to facilitate relative axial translation, as described herein.

End <NUM> includes an expandable member, 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>. In one embodiment, collet <NUM> is flexible such that collet <NUM> is biased to the closed position, as described herein, for a provisional lock between collet <NUM> and bone fastener <NUM>. Collet <NUM> is configured to snap fit around an end, for example, a head <NUM> of bone fastener <NUM>. As collet <NUM> translates over head <NUM> of bone fastener <NUM>, collet <NUM> moves from a closed position to an open position and back to the closed position to provisionally capture head <NUM>.

End <NUM> of sleeve <NUM> includes an engagement surface <NUM> disposed proximal to collet <NUM>. Surface <NUM> is configured for translation of a member, for example, a sleeve <NUM>, as described herein. Surface <NUM> includes a tapered configuration that defines a ramp <NUM>. Ramp <NUM> includes an inclined configuration from end <NUM> to collet <NUM>. Sleeve <NUM> is configured to slidably engage surface <NUM> to lock collet <NUM>, as described herein.

Sleeve <NUM> extends between a proximal end <NUM> and a distal 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 with sleeve <NUM> and/or collet <NUM>, for example, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.

End <NUM> includes a surface <NUM> that defines an elongated slot <NUM> configured for disposal of a pin <NUM>, as shown in <FIG>. Pin <NUM> is disposed with opening <NUM> and slot <NUM> to facilitate relative axial translation. Slot <NUM> extends a distance x along a portion of sleeve <NUM> between an end 74a and an end 74b.

Sleeve <NUM> is configured to lock collet <NUM> with head <NUM>, as discussed herein, for releasable fixation with bone fastener <NUM>. End <NUM> is slidably engageable with surface <NUM>. Surface <NUM> is moveably positioned within passageway <NUM> to move between a configuration in which surface <NUM> is spaced apart from passageway <NUM> and a configuration in which surface <NUM> is positioned within passageway <NUM> for disposal adjacent collet <NUM> to lock collet <NUM>. As end <NUM> axially translates along surface <NUM>, fingers <NUM> are driven further inwardly by the force of sleeve <NUM> engaging surface <NUM> such that fingers <NUM> are moveable to the locked position around head <NUM>.

Sleeve <NUM> includes a diameter D1 and collet <NUM> includes a diameter D2. Diameter D1 is about <NUM> to about <NUM> to facilitate insertion through end effector <NUM> having an inner diameter D4 of about <NUM> to about <NUM>. Diameters D1, D2 are slightly larger than a proximal end diameter D3 of bone fastener <NUM>, as shown in <FIG>. As sleeve <NUM> translates over surface <NUM>, sleeve <NUM> compresses collet <NUM> to decrease diameter D2 to about diameter D1. This configuration allows bone fastener <NUM> and surgical driver <NUM> to pass through end effector <NUM>, as described herein.

Surgical driver <NUM> includes an actuator <NUM> connected with sleeve <NUM> and sleeve <NUM>. Actuator <NUM> includes a coupling member <NUM> and a knob <NUM>. Coupling member <NUM> includes an inner surface <NUM>. Surface <NUM> includes one or more pins <NUM> extending therefrom to connect actuator <NUM> with sleeves <NUM>, <NUM>, as described herein. Coupling member <NUM> includes a threaded portion <NUM>. Knob <NUM> includes 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.

Actuator <NUM> is engaged to cause relative translation of sleeves <NUM>, <NUM>. For example, to fix surgical driver <NUM> with bone fastener <NUM>, knob <NUM> is rotated in a clockwise direction, as shown by arrow B in <FIG>. Rotation of knob <NUM> in the clockwise direction causes translation of coupling member <NUM>, in a direction shown by arrow E in <FIG>. Connection of coupling member <NUM> and sleeve <NUM> by pins <NUM> causes sleeve <NUM> to simultaneously translate, in the direction shown by arrow E in <FIG>. As pins <NUM> approach ends 74b, pins <NUM> cause sleeve <NUM> to translate, in the direction shown by arrow E in <FIG>, such that distal end <NUM> slidably engages surface <NUM> and surface <NUM> is positioned within passageway <NUM> for disposal adjacent collet <NUM> to lock collet <NUM>, as described herein.

To disengage surgical driver <NUM> from bone fastener <NUM>, knob <NUM> is rotated in a counter-clockwise direction, as shown by arrow C in <FIG>, causing translation of coupling member <NUM>, in a direction shown by arrow D in <FIG>. Connection of coupling member <NUM> and sleeve <NUM> by pins <NUM> causes sleeve <NUM> to simultaneously translate, in the direction shown by arrow D in <FIG>. As pins <NUM> approach ends 74a, pins <NUM> cause sleeve <NUM> to translate, in the direction shown by arrow D in <FIG>, such that distal end <NUM> slidably disengages from surface <NUM> and surface <NUM> is spaced apart from passageway <NUM> to release collet <NUM>, as described herein.

Bone fastener <NUM> includes a head <NUM> configured for engagement with shaft <NUM> and an elongated shaft <NUM> configured for penetrating tissue. Head <NUM> comprises a spherical configuration. Head <NUM> includes an outer circumferential surface having a substantially spherical configuration. Head <NUM> includes an inner surface <NUM> that defines a cavity, for example, a mating surface <NUM>. Mating surface <NUM> is configured for disposal of an instrument and/or tool extension, for example, end <NUM> of 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, 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, for example, smooth and/or surface configurations to enhance engagement with the mating surface of shaft <NUM>, 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>, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement of shaft <NUM> with tissue, for example, vertebrae.

In some embodiments, all or only a portion of shaft <NUM> may have alternate cross section configurations, 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 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>, 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 some embodiments, spinal implant system <NUM> includes a method of assembling the components of surgical driver <NUM>, as shown in <FIG>, which includes the step of attaching bushing <NUM> with shaft <NUM>. Distal end <NUM> is inserted into opening <NUM> such that bushing <NUM> translates along shaft <NUM> from distal end <NUM>, in a direction shown by arrow G in <FIG>. The inner diameter of opening <NUM> allows relative translation of the portion of shaft <NUM> having diameter A1, as shown in <FIG> and <FIG>. Bushing <NUM> is translated into an abutting engagement with edge <NUM>, as shown in <FIG>. The inner diameter of bushing <NUM> is less than diameter A2 of surfaces <NUM> to resist and/or prevent translation of bushing <NUM> over edge <NUM> and along surfaces <NUM>. Edge <NUM> prevents further translation of bushing <NUM> such that inner surface <NUM> does not contact surfaces <NUM>, 24a to resist and/or prevent damaging surfaces <NUM>, 24a during assembly. Bushing <NUM> is selectively disposed adjacent along shaft <NUM> to facilitate positioning of a navigation component <NUM> relative to surfaces <NUM> for image guidance.

Key <NUM> is inserted into slot <NUM>. Knob <NUM> is attached by translating knob <NUM> from distal end <NUM> for positioning adjacent bushing <NUM>, as shown in <FIG>. A retaining ring <NUM> is inserted to connect knob <NUM> with shaft <NUM>, as shown in in <FIG>. Sleeve <NUM> is connected by inserting distal end <NUM> into passageway <NUM> and translating sleeve <NUM> along shaft <NUM> into engagement with knob <NUM>, as shown in <FIG>. Sleeve <NUM> is attached by inserting sleeve <NUM> into passageway <NUM> and translating sleeve <NUM> such that opening <NUM> is aligned with key <NUM>, as shown in <FIG>. Coupling member <NUM> is attached by translating coupling member <NUM> along sleeve <NUM> into a threaded engagement with knob <NUM>, as shown in <FIG>. Pins <NUM> are inserted into openings <NUM> and slot <NUM> to connect coupling member <NUM> with sleeves <NUM>, <NUM>, as shown in <FIG>.

Navigation component <NUM>, as shown in <FIG>, is assembled with surgical driver <NUM>. Navigation component <NUM> includes a collar <NUM> having an inner surface <NUM> and an outer surface <NUM>. Surface <NUM> defines a passageway <NUM>. Surface <NUM> is configured for releasable engagement with bushing <NUM>. Passageway <NUM> is configured to receive shaft <NUM> and a portion of bushing <NUM>. Collar <NUM> includes a lock, for example, at least one resilient prong or tab <NUM>. Navigation component <NUM> is translated from proximal end <NUM> into a mating engagement with surfaces <NUM>, 24a and connected with bushing <NUM> by tab <NUM>.

In assembly, operation and use, spinal implant system <NUM>, similar to the systems and methods described herein, is employed with a not claimed surgical procedure. for example, a treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body. In some embodiments, one or all of the components of spinal implant system <NUM> can be delivered or utilized as a preassembled device or can be assembled in situ. Spinal implant system <NUM> may be completely or partially revised, removed or replaced.

Navigation component <NUM> is oriented relative to a sensor array <NUM>, as shown in <FIG>, to facilitate communication between navigation component <NUM> and sensor array <NUM> during a surgical procedure, as described herein. Navigation component <NUM> is configured to generate a signal representative of a position of bone fastener <NUM> relative to surgical driver <NUM> and/or tissue. In some embodiments, the image guide may include human readable visual indicia, human readable tactile indicia, human readable audible indicia, one or more components having markers for identification under x-ray, fluoroscopy, CT or other imaging techniques, at least one light emitting diode, a wireless component, a wired component, a near field communication component and/or one or more components that generate acoustic signals, magnetic signals, electromagnetic signals and/or radiologic signals.

Navigation component <NUM> includes an emitter array <NUM>. Emitter array <NUM> is configured for generating a signal to sensor array <NUM> of a surgical navigation system <NUM>. In some embodiments, the signal generated by emitter array <NUM> represents a position of bone fastener <NUM> relative to surgical driver <NUM> and relative to tissue, for example, bone. In some embodiments, the signal generated by emitter array <NUM> represents a three-dimensional position of bone fastener <NUM> relative to tissue.

In some embodiments, sensor array <NUM> receives signals from emitter array <NUM> to provide a three-dimensional spatial position and/or a trajectory of bone fastener <NUM> relative to surgical driver <NUM> and/or tissue. Emitter array <NUM> communicates with a processor of a computer <NUM> of surgical navigation system <NUM> to generate data for display of an image on a monitor <NUM>, as described herein. In some embodiments, sensor array <NUM> receives signals from emitter array <NUM> to provide a visual representation of a position of bone fastener <NUM> relative to surgical driver <NUM> and/or tissue. See, for example, similar surgical navigation components and their use as described in US Patent Nos. <CIT>, <CIT>, and <CIT>.

Surgical navigation system <NUM> is configured for acquiring and displaying medical imaging, for example, x-ray images appropriate for a given surgical procedure. In some embodiments, pre-acquired images of a patient are collected. In some embodiments, surgical navigation system <NUM> can include an O-arm® imaging device <NUM> sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo. Imaging device <NUM> may have a generally annular gantry housing that encloses an image capturing portion <NUM>.

In some embodiments, image capturing portion <NUM> may include an x-ray source or emission portion and an x-ray receiving or image receiving portion located generally or as practically possible <NUM> degrees from each other and mounted on a rotor (not shown) relative to a track of image capturing portion <NUM>. Image capturing portion <NUM> can be operable to rotate <NUM> degrees during image acquisition. Image capturing portion <NUM> may rotate around a central point or axis, allowing image data of the patient to be acquired from multiple directions or in multiple planes. Surgical navigation system <NUM> can include those disclosed in U. <CIT>, <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

In some embodiments, surgical navigation system <NUM> can include C-arm fluoroscopic imaging systems, which can generate three-dimensional views of a patient. The position of image capturing portion <NUM> can be precisely known relative to any other portion of an imaging device of surgical navigation system <NUM>. In some embodiments, a precise knowledge of the position of image capturing portion <NUM> can be used in conjunction with a tracking system <NUM> to determine the position of image capturing portion <NUM> and the image data relative to the patient.

Tracking system <NUM> can include various portions that are associated or included with surgical navigation system <NUM>. In some embodiments, tracking system <NUM> can also include a plurality of types of tracking systems, such as, for example, an optical tracking system that includes an optical localizer, such as, for example, sensor array <NUM> and/or an EM tracking system that can include an EM localizer. Various tracking devices can be tracked with tracking system <NUM> and the information can be used by surgical navigation system <NUM> to allow for a display of a position of an item, such as, for example, a patient tracking device, an imaging device tracking device <NUM>, and an instrument tracking device, such as, for example, emitter array <NUM>, to allow selected portions to be tracked relative to one another with the appropriate tracking system.

In some embodiments, the EM tracking system can include the STEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo. Exemplary tracking systems are also disclosed in U. Patent Nos. <CIT>, <CIT>, and <CIT>.

Fluoroscopic images taken are transmitted to a computer <NUM> where they may be forwarded to computer <NUM>. Image transfer may be performed over a standard video connection or a digital link including wired and wireless. Computer <NUM> provides the ability to display, via monitor <NUM>, as well as save, digitally manipulate, or print a hard copy of the received images. In some embodiments, images may also be displayed to the surgeon through a heads-up display.

In some embodiments, surgical navigation system <NUM> provides for real-time tracking of the position of bone fastener <NUM> relative to surgical driver <NUM> and/or tissue can be tracked. Sensor array <NUM> is located in such a manner to provide a clear line of sight with emitter array <NUM>, as described herein. In some embodiments, fiducial markers <NUM> of emitter array <NUM> communicate with sensor array <NUM> via infrared technology. Sensor array <NUM> is coupled to computer <NUM>, which may be programmed with software modules that analyze signals transmitted by sensor array <NUM> to determine the position of each object in a detector space.

Surgical driver <NUM> is configured for use with a guide member, for example, an end effector <NUM> of robotic arm R. End effector <NUM> includes an inner surface <NUM> that defines a cavity, for example, a channel <NUM>. Channel <NUM> is configured for passage of bone fastener <NUM> and disposal of surgical driver <NUM>. Robotic arm R includes position sensors (not shown), similar to those referenced herein, which measure, sample, capture and/or identify positional data points of end effector <NUM> in three-dimensional space for a guide-wireless insertion of bone fasteners <NUM> with tissue. In some embodiments, the position sensors of robotic arm R are employed in connection with surgical navigation system <NUM> to measure, sample, capture and/or identify positional data points of end effector <NUM> in connection with surgical treatment, as described herein. The position sensors are mounted with robotic arm R and calibrated to measure positional data points of end effector <NUM> in three-dimensional space, which are communicated to computer <NUM>.

Shaft <NUM> is aligned with mating surface <NUM> of bone fastener <NUM>. Collet <NUM> snap fits around head <NUM> to provisionally capture head <NUM>. Actuator <NUM> is rotatable to cause relative translation of sleeves <NUM>, <NUM>. For example, knob <NUM> is rotated in the clockwise direction causing translation of coupling member <NUM> and sleeve <NUM>, as described herein. End <NUM> slidably engages surface <NUM> to drive fingers <NUM> inward to the locked position around head <NUM>, as described herein, to fix surgical driver <NUM> with bone fastener <NUM>. As sleeve <NUM> translates over surface <NUM>, sleeve <NUM> compresses collet <NUM> to decrease diameter D2 to about diameter D1. This configuration allows bone fastener <NUM> and surgical driver <NUM> to pass through end effector <NUM>.

Navigation component <NUM> is oriented relative to sensor array <NUM>, as shown in <FIG>, to facilitate communication between navigation component <NUM> and sensor array <NUM> during the surgical procedure. This configuration provides indicia or display from surgical navigation system <NUM>, as described herein, of components of spinal implant system <NUM>, including bone fastener <NUM> and surgical driver <NUM>, and their relative positions with tissue in connection with the surgical treatment. Surgical driver <NUM> is inserted through end effector <NUM> for insertion to the surgical site.

Bone fastener <NUM> is implanted at the surgical site and surgical driver <NUM> is disengaged from bone fastener <NUM>. To disengage surgical driver <NUM> from bone fastener <NUM>, actuator <NUM> is rotated in the opposite direction to cause relative translation of sleeves <NUM>, <NUM> in the opposite direction to disengage collet <NUM> from head <NUM>. Knob <NUM> is rotated in a counter-clockwise direction causing translation of coupling member <NUM>, as described herein. Distal end <NUM> slidably disengages from surface <NUM> and surface <NUM> is spaced apart from passageway <NUM> to release collet <NUM> from head <NUM>, as described herein. Surgical driver <NUM> is removed from the surgical site.

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

Upon completion of the procedure, the surgical instruments, assemblies and non-implanted components of spinal implant system <NUM> are removed from the surgical site and the incision is closed. One or more of the components of spinal implant system <NUM> can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, surgical driver <NUM> is guided to the surgical site via a guidewire, for example, a K-wire (not shown) and/or without the use of an image guide, as described herein.

Claim 1:
A surgical instrument (<NUM>) comprising:
a first member (<NUM>) being engageable with a fastener and including a slot (<NUM>) in which a key (<NUM>) is disposed;
a second member (<NUM>) including an expandable portion (<NUM>) configured for capturing the fastener;
a third member (<NUM>) being engageable with the expandable portion to releasably capture the fastener; and
an actuator (<NUM>) connected with the second member (<NUM>) and the third member (<NUM>), the actuator (<NUM>) including a threaded inner surface and a threaded coupling member engageable with the threaded inner surface to facilitate axial translation of the second member (<NUM>) relative to the third member (<NUM>),
wherein the second member (<NUM>) includes a sleeve (<NUM>) and an engagement surface (<NUM>) disposed between the sleeve (<NUM>) and the expandable portion,
wherein the sleeve (<NUM>) includes an inner surface (<NUM>) including an opening (<NUM>) in which the key (<NUM>) is disposed for a keyed connection between the first member (<NUM>) and the sleeve (<NUM>), and
wherein the first member (<NUM>) is keyed with the second member (<NUM>) to facilitate translation of the second member (<NUM>) relative to the first member (<NUM>).