Patent Description:
The sacro-iliac joint is a diarthrodial joint that joins the sacrum to the ilium bones of the pelvis. In the sacro-iliac joint, the sacral surface has hyaline cartilage that moves against fibrocartilage of the iliac surface. The spinal column is configured so that the weight of an upper body rests on the sacro-iliac joints at the juncture of the sacrum and ilia. Stress placed on the sacro-iliac joints in an upright position of the body makes the lower back susceptible to injury.

Disorders of the sacro-iliac joint can cause low back and radiating buttock and leg pain in patients suffering from degeneration and laxity of the sacro-iliac joint. In some cases, the sacro-iliac joint can undergo dehydration and destabilization, similar to other cartilaginous joints, which causes significant pain. The sacro-iliac joint is also susceptible to trauma and degeneration, from fracture and instability. It is estimated that disorders of the sacro-iliac joint are a source of pain for millions of people suffering from back and radicular symptoms.

Non-surgical treatments, such as medication, injection, mobilization, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these disorders can include the use of implants for fusion and/or fixation to provide stability to a treated region. During surgical treatment, surgical instruments can be used to deliver the implants to a surgical site for fixation with bone to immobilize a joint. This disclosure describes an improvement over these prior technologies.

A surgical instrument is known from the <CIT>, from which the preamble of claim <NUM> derives.

According to the present invention, a surgical instrument comprises an outer sleeve including an inner surface that defines a cavity; an inner shaft fixed with the outer sleeve and extending within the cavity, the inner shaft including a drive engageable in a torque interface with a first mating surface of a bone fastener; and an inner sleeve disposed between the inner shaft and the outer sleeve, the inner sleeve being axially fixed and rotatable relative to the outer sleeve, the inner sleeve including an element connectable in a connection interface with a second mating surface of the bone fastener, wherein the inner sleeve includes a tip that extends to the element, the tip including a tapered portion having a decreasing diameter and an axial portion having a uniform diameter, and the axial portion has a diameter substantially equal to a minor diameter of the bone fastener.

In one embodiment, the surgical instrument includes an outer sleeve including an inner surface that defines an axial cavity. An inner shaft is fixed with the outer sleeve and extends within the cavity. The inner shaft includes a hexalobular drive tip engageable in a torque interface with a hexalobular socket of a bone fastener. An inner sleeve is disposed between the inner shaft and the outer sleeve in a relative coaxial orientation. The inner sleeve is axially fixed and rotatable relative to the outer sleeve. The inner sleeve includes a proximal end having a rotatable actuator and a threaded tip connectable in a connection interface with an inner threaded surface of the bone fastener.

In one example, a spinal implant system is provided. The spinal implant system comprises a surgical instrument including an outer sleeve, an inner shaft fixed with the outer sleeve, and an inner sleeve. The inner shaft includes a drive and the inner sleeve is rotatable relative to the outer sleeve and includes an element. A sacro-iliac bone screw has an inner surface and an outer threaded surface. The inner surface includes a socket engageable with the drive in a torque interface and an inner threaded surface connectable with the element in a connection interface. A guide member includes an inner surface that defines a cavity configured for disposal of the outer sleeve and an image guide is oriented relative to a sensor to communicate a signal representative of a position of the guide member.

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 the surgical system (not claimed), the embodiments of the surgical instrument, and related methods of use (not claimed) 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 method for treating a spine. In some examples, the systems and methods 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 examples, the surgical system and methods disclosed provide stability and maintain structural integrity while reducing stress on a sacro-iliac (SI) joint. In some examples, the present disclosure may be employed to treat musculoskeletal disorders including SI dysfunction or syndrome, dehydration, destabilization and/or laxity.

In some embodiments, the present surgical system comprises a surgical instrument that includes a screw driver engageable with a SI implant having a fully threaded and cannulated body. In some embodiments, the SI implant includes a body that is fenestrated to enhance SI joint fusion. In some embodiments, the driver includes an outer sleeve and inner shaft that are configured as drive and guidance components. In some embodiments, the driver includes an inner sleeve configured with a screw to retain the bone fastener with the driver. In some embodiments, the inner shaft, inner sleeve and outer sleeve are co-axial to facilitate axial translation of the inner sleeve. In some embodiments, the driver includes an inner sleeve and a knob that do not translate axially. In some embodiments, the driver includes a tip that is tapered to allow the SI implant to be sunk deeper into bone.

In some embodiments, the present surgical system comprises a surgical instrument that includes a SI implant driver guidable through an end effector of a robotic arm for guide-wireless screw insertion. In some embodiments, the present surgical system comprises a SI implant driver, a robot arm end effector and a SI cannulated bone screw having a fully threaded body that is fenestrated to enhance SI joint fusion. In some embodiments, the SI implant driver is configured to rotate within an inside diameter of a robotic arm guide without becoming disengaged therefrom. In some embodiments, the SI implant driver includes an inner sleeve and a knob that do not translate axially. In some embodiments, the SI implant driver includes a hex shaped drive that engages a hex shaped socket of a SI implant and is then threaded onto the driver. In some embodiments, the drive engages the socket prior to threading of the components. In some embodiments, the SI implant driver includes a tapered tip, which allows the SI implant to be sunk deeper into bone without bottoming out on the driver. In some embodiments, this configuration allows the SI implant driver to drive the SI implant at extreme angles to the bone surface and enables a sub-flush engagement of the surfaces.

In some embodiments, the present surgical system comprises a surgical instrument that includes a surgical SI bone tap guidable through an end effector of a robotic arm. In some embodiments, the present surgical system comprises a surgical instrument that includes a surgical SI cannula guidable through an end effector of a robotic arm. In some embodiments, the surgical SI bone tap has a larger outside diameter and a fully threaded outer body. In some embodiments, the surgical SI cannula has a larger inner diameter to accommodate the surgical SI bone tap. In some embodiments, the surgical SI cannula is configured as a tissue protector for the surgical SI bone tap.

In some embodiments, the driver includes a knob that serves as a visual indicator of whether or not the driver is fully disengaged from an implant. In some embodiments, the screw driver is employed with robotic guidance and provides indicia of the driver being fully unthreaded from an implant. In some embodiments, the screw driver provides visual indicia that the screw driver is unthreaded from the implant in a minimally invasive surgical procedure. For example, the screw driver provides visual indicia whether the screw driver is or is not engaged.

In some embodiments, the present surgical system includes a screw driver including an outer shaft or sleeve having an outside diameter that is slightly larger than a screw spin diameter of a bone screw. This configuration allows the bone screw and the screw driver to pass through the end effector. In some embodiments, the screw driver includes a thumb wheel that is connected to a retention screw that threads into the bone screw.

In some embodiments, the driver includes an inner shaft having a Torx tip configured for engagement with the bone fastener. In some embodiments, upon engagement of the Torx tip with the bone fastener, an actuator, for example, a thumb wheel is actuated to cause an inner sleeve and screw to tighten and pull the bone fastener into engagement with the driver. The outer sleeve is fixed to the inner shaft, for example, by welding.

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 embodiments, the surgical system of the present disclosure comprises a cannulated SI implant having a fully threaded body that is fenestrated to enhance SI joint fusion and to provide fixation of large bones and large bone fragments of the pelvis. In some embodiments, the present system includes one or more spinal constructs having one or more SI implants that are provided having various lengths to accommodate patient anatomy. In some embodiments, the SI implant is utilized with an SI joint fusion procedure for conditions including SI joint disruptions and degenerative sacroiliitis.

In some embodiments, the SI implant includes a fully threaded body having a thread form that extends an entire length of the body from a proximal end to a tip of a distal end. In some embodiments, the SI implant is cannulated and fenestrated to allow for bony ingrowth and for bone graft material to be packed inside the SI implant and on or about one or more components of the spinal construct to promote fusion across the SI joint. In some embodiments, the SI implant includes a recess on a proximal end to facilitate a threaded engagement with a surgical instrument, such as, for example, an inserter. In some embodiments, the inserter is configured for manual insertion, assisted with navigation and/or with a powered driver.

In some embodiments, the present surgical system includes a tapered, fully threaded, cannulated, fenestrated SI implant for stabilization and fusion of the SI joint. In some examples, the present surgical system is employed with a method for treating low back pain attributed to the SI joint. In some embodiments, the present surgical system includes a threaded SI implant that is cannulated, fenestrated, and designed to enhance SI joint fusion and provide fixation of large bones and large bone fragments of the pelvis. In some embodiments, the SI implant includes a distal tip having a blunt configuration. In some embodiments, the SI implant includes a bore having a threaded portion. In some embodiments, the threaded portion is configured to facilitate a revision procedure. In some embodiments, the bore includes a connection portion and/or a torque portion.

In some examples, the present system is employed with a method used with surgical navigation, for example, fluoroscope or image guidance. In some examples, the presently disclosed system and/or method reduce operating time for a surgical procedure and reduce radiation exposure due to fluoroscope or image guidance, for example, by eliminating procedural steps and patient repositioning by implanting system components in one body position.

In some examples, the present system is employed with a method for treating an SI joint, which includes the step of identifying a posterior superior iliac spine on a patient that is positioned in a prone position on an operating table. In some examples, the step of identifying includes using the posterior superior iliac spine as a landmark for making an incision. In some examples, identification of the posterior superior iliac spine limits vascular and muscular disruption from a surgical approach. In some examples, the method includes the step of establishing a trajectory path using fluoroscopy and a guide wire inserted into the posterior superior iliac spine, for example, on an iliac side of an SI joint. In some examples, bone graft material, for example, autograft and/or allograft is inserted into the SI joint space to create a bony contact between the iliac and sacrum sides. In some examples, the bone graft material is inserted into a cannula of a screw.

In some embodiments, the present system includes an SI fixation screw attached to a surgical driver. In some examples, the SI fixation screw is employed with a method for treating an SI joint, which includes the step of applying a downward force and driving the screw through the ilium, through the graft material and into the sacrum following a path created by a reamer until the screw is flush with the ilium and docked into the sacrum. In some examples, screw placement is confirmed with fluoroscopy and/or image guidance and the incision is closed. In some examples, the present system is employed with a method for screw removal from the SI joint fusion. In some examples, the method includes the step of providing an implant inserter configured to attach to the screw. In some examples, the method includes the step of exposing an iliac side of the SI joint of a patient who underwent a SI fusion procedure. In some examples, a tube can be placed over the incision site. In some examples, the dorsal aspect of the screw is positively identified. In some examples, the dorsal aspect of the screw is identified by fluoroscopy and/or image guidance. In some examples, the implant inserter is re-attached to the dorsal end of the screw and the screw is removed.

In some embodiments, the present system includes an SI implant and a surgical inserter that employs image guidance, for example, surgical navigation. In some embodiments, the present system includes an SI implant and a surgical inserter that selectively, precisely and/or accurately connects the SI implant with the surgical inserter such that the SI implant extends a selected distance from the surgical inserter in connection with surgical navigation. In some embodiments, the SI implant extends a selected distance from the surgical inserter within an accuracy and/or tolerance of ±<NUM> millimeter (mm). In some embodiments, the SI implant extends a selected distance from the surgical inserter, and is connected at a first component interface having a selected distance within an accuracy and/or tolerance of ±<NUM>. In some embodiments, the component interface has a selected distance within an accuracy and/or tolerance of ±<NUM>. In some embodiments, the component interface includes a threaded pocket of the SI implant. In some embodiments, the surgical inserter includes a floating, relative rotating sleeve disposed along a shaft of a driver. In some embodiments, the sleeve comprises a portion of the component interface to selectively locate the SI implant at the end of the driver while allowing the driver to pass through the sleeve and engage a second component interface of the SI implant. In some embodiments, the SI implant extends a selected distance from and is fixed with the surgical inserter in connection with image guidance to provide position of the SI implant with tissue for a reliable explant strategy, which may include locating the SI implant with tissue and explant of the SI implant.

In some embodiments, 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 embodiments, 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 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 system, such as, for example, a spinal implant system <NUM>.

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 at a surgical site of a patient, for example, regions of a spine including vertebrae, iliac bone and/or articular surfaces of the SI joint. In some embodiments, the components of spinal implant system <NUM> are employed to stabilize and maintain structural integrity while reducing stress on the SI joint and/or portions of the anatomy adjacent the SI joint. In some embodiments, spinal implant system <NUM> is configured to treat SI joint disorders including those caused by degeneration or trauma. In some embodiments, spinal implant system <NUM> is adapted to immobilize opposing naturally separated surfaces of a SI joint. 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, and/or iliac bone.

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

Driver <NUM> includes a member, for example, an outer tubular sleeve <NUM>. Outer sleeve <NUM> extends between a proximal end <NUM> and a distal end <NUM>. Outer sleeve <NUM> defines a longitudinal axis a. In some embodiments, outer sleeve <NUM> may have various configurations including, for example, round, oval, polygonal, irregular, consistent, variable, uniform and non-uniform. Outer sleeve <NUM> includes a diameter D1. In some embodiments, diameter D1 is slightly larger than a proximal end diameter D2 of bone fastener <NUM>. This configuration allows bone fastener <NUM> and driver <NUM> to pass through end effector <NUM> of robotic arm R, as described herein.

Outer sleeve <NUM> includes a surface <NUM> that defines an axial cavity <NUM>. Cavity <NUM> is configured for disposal of an inner sleeve <NUM> and an inner shaft <NUM>, as described herein. Outer sleeve <NUM> includes a collar body <NUM> having a surface <NUM>. Surface <NUM> defines a cavity <NUM>. Body <NUM> includes bifurcated arms <NUM> disposed about cavity <NUM> to facilitate disposal and access to an actuator, for example, a thumb wheel <NUM> therein. Body <NUM> includes opening <NUM> disposed at end <NUM>. Opening <NUM> is in communication with cavity <NUM> and in alignment with cavity <NUM> to facilitate insertion of inner shaft <NUM> into end <NUM>, through wheel <NUM> and into cavity <NUM> for assembly, as described herein. Wheel <NUM> is axially fixed and rotatable relative to outer sleeve <NUM> and is configured to be integrally connected with inner sleeve <NUM> such that wheel <NUM> and inner sleeve <NUM> do not translate axially. In some embodiments, wheel <NUM> can be monolithically formed with inner sleeve <NUM>. Wheel <NUM> includes a surface <NUM> that defines a cavity <NUM>. Cavity <NUM> is configured for disposal of a correspondingly shaped portion of inner sleeve <NUM>, as shown in <FIG>.

Wheel <NUM> includes a wall <NUM> having a surface <NUM>. Surface <NUM> defines a plurality of openings <NUM> and opposing holes <NUM>. Holes <NUM> are configured for engagement with pins <NUM> to integrally connect wheel <NUM> with inner sleeve <NUM>.

Inner sleeve <NUM> is configured for disposal between inner shaft <NUM> and outer sleeve <NUM> and is axially fixed and rotatable relative to outer sleeve <NUM>. Inner sleeve <NUM> extends between a proximal end <NUM> and a distal end <NUM>, as shown in <FIG>. End <NUM> is connected to wheel <NUM>. Wheel <NUM> is integrally connected with inner sleeve <NUM>. End <NUM> includes openings <NUM> that are each configured to engage with a pin <NUM> to connect wheel <NUM> to inner sleeve <NUM>. Wheel <NUM> actuates rotation of inner sleeve <NUM> relative to outer sleeve <NUM>. In some embodiments, surface <NUM> defines a circular cross section of cavity <NUM> for a mating engagement with correspondingly shaped end <NUM> of inner sleeve <NUM>. In some embodiments, cavity <NUM> includes various configurations, such as, for example, circular, hexalobe, cruciform, phillips, square, polygonal, star cross sectional configuration for a mating engagement with correspondingly shaped portion of inner sleeve <NUM>. In some embodiments, wheel <NUM> includes a surface <NUM> configured to facilitate gripping of wheel <NUM>, for example, an indented surface.

As shown in <FIG>, assembly of outer sleeve <NUM> with inner sleeve <NUM> and wheel <NUM> includes inserting wheel <NUM> through arms <NUM> and into cavity <NUM>. Inner sleeve <NUM> is then translated through cavity <NUM> of outer sleeve <NUM>. End <NUM> of inner sleeve <NUM> is translated into cavity <NUM> of wheel <NUM> and each pin <NUM> is inserted into each hole <NUM> and opening <NUM>. Pins <NUM> resist and/or prevent disengagement of inner sleeve <NUM> from wheel <NUM>.

Inner sleeve <NUM> includes an inner surface <NUM>. Surface <NUM> defines an axial channel <NUM> configured for moveable disposal of inner shaft <NUM>, as described herein. Channel <NUM> extends coaxial with cavity <NUM>. In some embodiments, channel <NUM> is disposed at alternate orientations relative to axis a, for example, at transverse, perpendicular and/or other angular orientations such as acute or obtuse, and/or may be offset or staggered. End <NUM> of inner sleeve <NUM> includes an element, for example, a screw <NUM>. Screw <NUM> includes a threaded outer surface <NUM>. Threaded outer surface <NUM> is disposed adjacent a distal most position of inner sleeve <NUM>. Threaded outer surface <NUM> is connectable or engageable in a connection interface with a mating surface, for example, an inner threaded surface <NUM> of bone fastener <NUM> to retain and/or draw bone fastener <NUM> into engagement with driver <NUM>, as described herein.

Distal end <NUM> of inner sleeve <NUM> includes a tapered tip or portion <NUM> that extends to screw <NUM>. Tapered portion <NUM> is configured such that bone fastener <NUM> can be implanted with tissue below an outer surface of bone, sunk into bone and/or disposed in a sub-flush orientation with and into bone, without bottoming out a distal end of driver <NUM> with adjacent bone surfaces. Tapered portion <NUM> includes a decreasing diameter D3 and an axial portion <NUM> has a uniform diameter D4, as shown in <FIG>. Diameter D4 has a diameter that is substantially equal to a minor diameter D5 of bone fastener <NUM>.

Inner shaft <NUM> extends between an end <NUM> and an end <NUM>. Inner shaft <NUM> extends within cavity <NUM> of outer sleeve <NUM> and is disposable with channel <NUM> of inner sleeve <NUM>, as described herein. Inner shaft <NUM> is fixed with outer sleeve <NUM> such that rotation of inner shaft <NUM> causes simultaneous rotation of outer sleeve <NUM>. In some embodiments, inner shaft <NUM> is welded with outer sleeve <NUM>. Inner shaft <NUM> rotates independently from inner sleeve <NUM>. In some embodiments, inner shaft <NUM> includes a portion <NUM> configured to facilitate connection of driver <NUM> with a surgical instrument, for example, an actuator/drill <NUM>, as shown in <FIG>. In some embodiments, inner shaft <NUM> includes quick connect surfaces or keyed geometry, such as, for example, triangle, hex, square or hexalobe to facilitate connection with actuator <NUM>.

End <NUM> of inner shaft <NUM> includes a distal tip, for example, drive <NUM>, as shown in <FIG>. Drive <NUM> is integrally connected or monolithically formed with inner shaft <NUM>. This configuration facilitates control of tolerances to optimize accuracy of the connection of inner shaft <NUM> with bone fastener <NUM>. Drive <NUM> and screw <NUM> of inner sleeve <NUM> are disposed in a serial orientation. Drive <NUM> is engageable in a torque interface with a spinal implant, for example, bone fastener <NUM>. For example, drive <NUM> fits with and is engageable with a mating surface, for example, a socket <NUM> of bone fastener <NUM>, as shown in <FIG>. Rotation of inner shaft <NUM> simultaneously rotates drive <NUM> to drive, torque, insert or otherwise connect bone fastener <NUM> with tissue, as described herein. Drive <NUM> includes a hexalobular geometry and includes a hexalobular cross section for a mating engagement with correspondingly shaped socket <NUM>. In some embodiments, drive <NUM> can alternatively include a cruciform, phillips, square, hexagonal, polygonal, star cross sectional configuration for disposal of socket <NUM>.

Wheel <NUM> is inserted laterally through arms <NUM> and into cavity <NUM>. Inner sleeve <NUM> is then translated through cavity <NUM> of outer sleeve <NUM>. End <NUM> of inner sleeve <NUM> is translated into cavity <NUM> of wheel <NUM> and each pin <NUM> is inserted into each hole <NUM> and opening <NUM>. Inner shaft <NUM> is inserted from end <NUM>, through opening <NUM>, through cavity <NUM> to provisionally connect wheel <NUM> with outer sleeve <NUM>. Inner shaft <NUM> is welded to outer sleeve <NUM>. Inner shaft <NUM> is disposed with channel <NUM> of inner sleeve <NUM>. Inner sleeve <NUM> is rotatable relative to outer sleeve <NUM> and inner shaft <NUM>. Inner shaft <NUM> and outer sleeve <NUM> simultaneously rotate relative to inner sleeve <NUM>.

Bone fastener <NUM> includes a body <NUM> that extends between a proximal end <NUM> and a distal end <NUM>. Body <NUM> is configured to penetrate tissue, for example, bone. An inner surface <NUM> disposed at end <NUM> includes socket <NUM> that is engageable with drive <NUM> in a torque interface, and inner threaded surface <NUM> that is connectable with screw <NUM> in a connection interface, as described herein. Bone fastener <NUM> includes an outer threaded surface <NUM> that is threaded an entire length of body <NUM>.

Bone fastener <NUM> includes a longitudinal cavity <NUM> and a plurality of lateral openings, such as fenestrations <NUM> that are in communication with cavity <NUM>. Bone fastener <NUM> is cannulated and fenestrated to allow for bony ingrowth and for bone graft material to be packed inside bone fastener <NUM> to promote fusion across the SI joint. See, for example, a similar bone fastener and its use, as described in <CIT>.

In use, drive <NUM> is aligned with end <NUM> of bone fastener <NUM> for disposal with socket <NUM> and screw <NUM> is aligned with inner threaded surface <NUM>, as shown in <FIG>. Driver <NUM> is axially translated to connect to bone fastener <NUM> in a non-locking configuration, as shown in <FIG>. Drive <NUM> is engaged with socket <NUM> and wheel <NUM> is manipulated for rotation such that inner sleeve <NUM> rotates screw <NUM> relative to and independent of outer sleeve <NUM>. Rotation of screw <NUM> creates a threaded engagement between outer threaded surface <NUM> of screw <NUM> and inner threaded surface <NUM> of bone fastener <NUM> to retain and/or draw bone fastener <NUM> into engagement with driver <NUM> in a locking configuration, as shown in <FIG>.

Inner shaft <NUM> with drive <NUM> is connected with outer sleeve <NUM>, as described herein, and inner shaft <NUM> and outer sleeve <NUM> are rotated to drive, torque, insert or otherwise connect bone fastener <NUM> with adjacent tissue. Screw <NUM> remains releasably fixed with inner threaded surface <NUM>, independent of inner shaft <NUM> and outer sleeve <NUM> rotation and/or engagement or friction with components of spinal implant system <NUM> as described herein, to resist and/or prevent disengagement or unthreading of screw <NUM> from inner threaded surface <NUM>. In some embodiments, wheel <NUM> is manipulated for rotation such that inner sleeve <NUM> and screw <NUM> rotate relative to outer sleeve <NUM>, and outer threaded surface <NUM> disengages with inner threaded surface <NUM>, to place driver <NUM> in the non-locking configuration, as shown in <FIG>.

In some embodiments, driver <NUM> includes a navigation component <NUM>, as shown in <FIG> and <FIG>. Driver <NUM> is configured for disposal adjacent a surgical site such that navigation component <NUM> is oriented relative to a sensor array <NUM> 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 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> is directly connected to actuator <NUM>, as shown in <FIG>. In some embodiments, navigation component <NUM> is connected with portion <NUM> of inner shaft <NUM> or outer sleeve <NUM> via an integral connection, friction fit, pressure fit, interlocking engagement, mating engagement, dovetail connection, clips, barbs, tongue in groove, threaded, magnetic, key/keyslot and/or drill chuck.

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>, as shown in <FIG> and described herein. In some embodiments, the signal generated by emitter <NUM> represents a position of bone fastener <NUM> relative to 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> receices signals from emitter array <NUM> to provide a three-dimensional spatial position and/or a trajectory of bone fastener <NUM> relative to 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 signal from emitter array <NUM> to provide a visual representation of a position of bone fastener <NUM> relative to driver <NUM> and/or tissue. See, for example, similar surgical navigation components and their use as described in <CIT>,<CIT>,<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 <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 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 <CIT>, <CIT>, <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 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.

Driver <NUM> is configured for use with a guide member, such as, 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 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>.

In assembly, operation and use, spinal implant system <NUM>, similar to the systems and methods described herein, is employed with a 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, spinal implant system <NUM> is employed with a surgical procedure for treatment of an SI joint of a patient. In some embodiments, one or all of the components of spinal implant system <NUM> can be delivered or utilized as a pre-assembled device or can be assembled in situ. Spinal implant system <NUM> may be completely or partially revised, removed or replaced.

In use, to treat an SI joint of a patient, a medical practitioner obtains access to a surgical site in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, spinal implant system <NUM> can be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby the SI joint is accessed through a mini-incision, or a sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure can be performed for treating the spine disorder.

In some embodiments, a scalpel <NUM> is oriented for disposal with end effector <NUM> of robotic arm R, as described herein. An incision is made in the body of a patient with scalpel <NUM>, as shown in <FIG> and <FIG>, which creates a surgical pathway for implantation of components of spinal implant system <NUM>. A speculum (not shown) can be employed to assist in creating the surgical pathway. A preparation instrument (not shown) can be employed to prepare tissue surfaces as well as for aspiration and irrigation of a surgical region. A cannula <NUM> is inserted into end effector <NUM> and is inserted into the surgical pathway. A dilator <NUM> is inserted into cannula <NUM> to expand the surgical pathway. In some embodiments, a drill guide <NUM> and a drill guide anchor <NUM> can be inserted into cannula <NUM> to assist in the control and guidance of a drill <NUM>, as shown in <FIG>. Drill guide <NUM> can be securely docked by employing a slap hammer (not shown) and tapping on drill guide <NUM>. Drill <NUM> is paired with a selected drill bit <NUM> and inserted into cannula <NUM>.

Pilot holes (not shown) are made with drill <NUM> in selected areas of bone, for example, in ilium (I), sacrum (S) and/or sacroiliac joint (J) for receiving bone fasteners <NUM>. Drill <NUM>, drill guide <NUM> and drill guide anchor <NUM> are removed from cannula <NUM> and a tap <NUM> is inserted into a cannula <NUM>. Cannula <NUM> is configured as a tissue protector for tap <NUM>. As shown in <FIG> and <FIG>, cannula <NUM> includes a proximal end <NUM> and a distal end <NUM>. An internal diameter D6 at end <NUM> is greater than an internal diameter D7 of cannula <NUM>. Internal diameter D6 is greater than internal diameter D7 to accommodate a tip <NUM> of tap <NUM>.

Tap <NUM> includes a proximal end <NUM> and a distal end <NUM>. End <NUM> includes a portion <NUM> configured to facilitate connection of tap <NUM> with actuator/drill <NUM>, as shown in <FIG>. In some embodiments, tap <NUM> includes quick connect surfaces or keyed geometry, such as, for example, triangle, hex, square or hexalobe to facilitate connection with actuator <NUM>. End <NUM> includes a threaded tip, such as an awl tip <NUM>. Tip <NUM> has an outer diameter D8. End <NUM> includes indicia <NUM> configured to visually indicate the depth of tap <NUM> when contacting bone. In some embodiments, the indicia can include a notch, slot, bead, detent, bump, print, label, score, color coding and/or increments of depth in millimeters, centimeters or inches disposed on tap <NUM>. Tap <NUM> is aligned with pilot holes and tapped to a selected depth to correlate with a length of bone fastener <NUM>. Tap <NUM> and cannula <NUM> are removed.

Drive <NUM> is aligned with end <NUM> of bone fastener <NUM> and screw <NUM> of inner sleeve <NUM> is aligned with inner threaded surface <NUM>, as shown in <FIG>. Driver <NUM> is axially translated to connect to bone fastener <NUM> in a non-locking configuration, as shown in <FIG>. Drive <NUM> is engaged with socket <NUM> and wheel <NUM> is manipulated for rotation such that inner sleeve <NUM> rotates screw <NUM> relative to and independent of outer sleeve <NUM>. Rotation of screw <NUM> creates a threaded engagement between outer threaded surface <NUM> of screw <NUM> and inner threaded surface <NUM> of bone fastener <NUM> to retain and/or draw bone fastener <NUM> into engagement with driver <NUM> in a locking configuration, as shown in <FIG>.

Driver <NUM> is oriented for disposal with end effector <NUM> of robotic arm R, as described herein. The assembly of driver <NUM>/bone fastener <NUM> is disposed with channel <NUM> for implantation of one or more bone fasteners <NUM> with sacroiliac joint J employing robotic arm R and/or surgical navigation system <NUM>, as described herein. Actuator <NUM> is connected with inner shaft <NUM> and drive <NUM> engages bone fastener <NUM>, as described herein, and inner shaft <NUM> and outer sleeve <NUM> are rotated to drive, torque, insert or otherwise connect bone fastener <NUM> with adjacent tissue. Screw <NUM> remains releasably fixed with inner threaded surface <NUM>, independent of inner shaft <NUM> and outer sleeve <NUM> rotation and/or engagement or friction with end effector <NUM> to resist and/or prevent disengagement or unthreading of screw <NUM> from inner threaded surface <NUM>. In some embodiments, driver <NUM> is manipulated to deliver one or more bone fasteners <NUM> to a surgical site including sacroiliac joint J.

Sensor array <NUM> receives signals from navigation component <NUM> to provide a three-dimensional spatial position and/or a trajectory of the assembly of driver <NUM>/bone fastener <NUM>, which may be disposed with end effector <NUM>, relative to sacroiliac joint J and/or components of spinal implant system <NUM> for display on monitor <NUM>. Wheel <NUM> is manipulated for rotation such that inner sleeve <NUM> and screw <NUM> rotate relative to outer sleeve <NUM>, and outer threaded surface <NUM> disengages with inner threaded surface <NUM>. Driver <NUM> is translated away from implant <NUM> to unthread driver <NUM> from inner threaded surface <NUM>, and driver <NUM> is considered in the non-locking configuration relative to bone fastener <NUM>, as shown in <FIG>.

Upon completion of a procedure, as described herein, the surgical instruments, assemblies and non-implanted components of spinal implant system <NUM> are removed and the incision(s) are closed. One or more of the components of spinal implant system <NUM> can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, spinal implant system <NUM> may include one or a plurality of spinal rods, plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels.

In some embodiments, one or more bone fasteners, as described herein, may be engaged with tissue in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, the bone fasteners may comprise multi-axial screws, sagittal adjusting screws, pedicle screws, mono-axial screws, uni-planar screws, facet screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts.

Claim 1:
A surgical instrument (<NUM>) comprising:
an outer sleeve (<NUM>) including an inner surface (<NUM>) that defines a cavity (<NUM>);
an inner shaft (<NUM>) fixed with the outer sleeve (<NUM>) and extending within the cavity (<NUM>), the inner shaft (<NUM>) including a drive (<NUM>) engageable in a torque interface with a first mating surface (<NUM>) of a bone fastener (<NUM>); and
an inner sleeve (<NUM>) disposed between the inner shaft (<NUM>) and the outer sleeve (<NUM>), the inner sleeve (<NUM>) being axially fixed and rotatable relative to the outer sleeve (<NUM>),
the inner sleeve (<NUM>) including an element (<NUM>) connectable in a connection interface with a second mating surface of the bone fastener (<NUM>)
characterized in that
the inner sleeve (<NUM>) includes a tip that extends to the element (<NUM>), the tip including a tapered portion (<NUM>) having a decreasing diameter and an axial portion (<NUM>) having a uniform diameter, and
the axial portion (<NUM>) has a diameter substantially equal to a minor diameter of the bone fastener (<NUM>).