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. Surgical instruments for treating the spine are known from <CIT>, <CIT>, <CIT> and <CIT>.

According to the present invention, a surgical instrument defined in claim <NUM> is provided.

The exemplary embodiments of the surgical system disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a spinal implant system. Furthermore, illustrative methods for treating a spine, which use the inventive surgical instrument, are discussed to further the understanding of the inventive surgical instrument. In some embodiments, the systems of the present disclosure comprise medical devices including surgical instruments and implants that can be 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 comprises a surgical instrument including an anchor and a dilator configured for engagement with bone utilizing navigation. In some embodiments, the surgical instrument is configured to guide a drill guide along the anchor to facilitate engagement of the drill guide with bone. In some embodiments, the surgical system includes a navigated cannulated dilator, an anchor and an anchor tool. In some embodiments, the anchor is disposed with the dilator and engaged with bone. In some embodiments, the anchor is tamped into bone and the dilator is removed. In some embodiments, the anchor is engaged with bone utilizing navigation. In some embodiments, a drill guide is guided over the anchor and tamped into bone. In some embodiments, the anchor is removable.

In some embodiments, the present surgical system comprises a surgical instrument including the anchor and the dilator being configured to confirm a trajectory when tamping the drill guide. In some embodiments, the drill guide is engaged with bone utilizing navigation. In some embodiments, the anchor is disposed with the dilator and the dilator is connected with a navigation component.

In some embodiments, the present surgical system comprises a surgical instrument including a disposable anchor. In some embodiments, the anchor includes a groove disposed at a proximal end. In some embodiments, the present surgical system comprises an anchor tool having a depressible button to connect and lock the anchor with the anchor tool. In some embodiments, the anchor tool includes a depth setting device.

In some embodiments, the present surgical system comprises a surgical instrument including a navigation component that is connected with the dilator and the anchor is inserted through the dilator. In some embodiments, a distal tip of the anchor extends beyond a distal end of the dilator. In some embodiments, the distal tip extends a distance from the dilator. In some embodiments, the distance the distal tip extends is equal to a length programmed into the navigation system and is utilized to calculate depth navigation. In some embodiments, the depth setting device maintains extension of the distal tip from the dilator.

The present surgical system can be used in an illustrative method (not claimed) of treating a spine including the step of inserting the surgical instrument through a cannula to a surgical site. The illustrative method can include the step of driving or malleting the anchor tool to provisionally engage the distal tip of the anchor into bone. The illustrative method can include the step of translating the depth setting device to a retracted position to allow for driving the anchor deeper once the trajectory has been set and then malleting the anchor to a selected depth. The illustrative method can include the step of actuating the button to disengage the anchor tool from the anchor and removing the dilator. The illustrative method can include the steps of mounting a drill guide over the anchor and malleting the drill guide into bone. The illustrative method can include the step of reconnecting the anchor tool with the anchor and using a slap hammer to remove the anchor from bone. A drill can be disposed with the drill guide and utilized to implant spinal implants. See, for example, the disclosure of systems and methods of engaging one or more surgical instruments with bone utilizing surgical navigation, shown and described in commonly owned and assigned <CIT> (docket no. A0002407US02).

In some embodiments, the present surgical system comprises a surgical instrument including a straight anchor having a pointed distal tip. In some embodiments, the anchor includes a groove at the proximal end to facilitate connection with the anchor tool. In some embodiments, the surgical instrument includes a cannulated dilator. In some embodiments, the dilator includes a tapered distal tip. In some embodiments, the dilator includes a passageway formed by slots milled from each side along the dilator.

In some embodiments, the present surgical system comprises a surgical instrument including an anchor tool having a depth setting device, an anchor retention button and a slap hammer. In some embodiments, the depth setting device is disposable in a fully extended position to set the depth of the anchor for navigation. In some embodiments, pins connect the depth setting device with the anchor tool in a keyed configuration. In some embodiments, the button is biased outwards by a spring. In some embodiments, the button is engageable with the groove on the anchor to fix the anchor tool with the anchor. In some embodiments, the slap hammer is moveable to facilitate removing the anchor from bone.

In some embodiments, the present surgical system comprises a surgical instrument including a depth setting device being moveable between a retracted position and an extended position. In some embodiments, in the retracted position, a spring tab locks the depth setting device. In some embodiments, the anchor tool includes pins to retain the button with a body of the anchor tool. In some embodiments, a flange is welded with the anchor tool after the slap hammer is assembled. In some embodiments, a proximal end of the anchor tool is hollow to reduce a weight of the anchor tool.

The present system can be employed with an illustrative method
(not claimed) used with surgical navigation, for example, fluoroscope or image guidance. The presently disclosed system can 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 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 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, 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 regrowth 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 an inventive surgical instrument, related components and illustrative 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 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, 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 <NUM>. Surgical instrument <NUM> can be employed with an end effector <NUM>, as shown in <FIG>, to facilitate implantation with a robotic arm R (<FIG>). Surgical instrument <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 instrument <NUM> includes a member, for example, an anchor <NUM>. Anchor <NUM> extends between a proximal end <NUM> and a distal end <NUM>, as shown in <FIG>. Proximal end <NUM> includes a surface <NUM> that defines a groove <NUM>. In some embodiments, groove <NUM> is disposed circumferentially about end <NUM>. Groove <NUM> is configured for disposal of a portion of a member, for example, an anchor tool <NUM> to releasably fix anchor tool <NUM> with anchor <NUM>, as described herein.

End <NUM> includes a tip <NUM>. In some embodiments, tip <NUM> is pointed or sharpened to facilitate penetration of tissue. In some embodiments, end <NUM> may have various surface configurations, for example, smooth, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured. Tip <NUM> is configured to fix anchor <NUM> with tissue to provide an orientation, for example, an axial trajectory for the components of surgical instrument <NUM>, as described herein.

Surgical instrument <NUM> includes a member, for example, a dilator <NUM>, as shown in <FIG>. Dilator <NUM> extends between a proximal end <NUM> and a distal end <NUM>. Dilator <NUM> defines a longitudinal axis X1. In some embodiments, dilator <NUM> may have various configurations including, for example, round, oval, polygonal, irregular, consistent, variable, uniform and non-uniform. Dilator <NUM> includes a surface <NUM> that defines a longitudinal passageway <NUM> extending between ends <NUM>, <NUM>. In some embodiments, passageway <NUM> is manufactured by milling overlapping slots <NUM> through surface <NUM> along dilator <NUM>, as shown in <FIG>.

End <NUM> includes a tapered configuration to facilitate spacing of tissue. In some embodiments, end <NUM> may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tubular.

Dilator <NUM> includes a mating element, for example, a bushing <NUM>. Bushing <NUM> is configured to connect a navigation component <NUM> with surgical instrument <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> is disposed with dilator <NUM>. Dilator <NUM> includes mating surfaces, for example, datum surfaces <NUM>. Surface <NUM> is disposed on shaft dilator <NUM> at a selected distance from distal end <NUM>. Surface <NUM> is detectable by image guidance and utilized to determine a position of navigation component <NUM>, as described herein, and/or surgical instrument <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> and/or surgical instrument <NUM> during a surgical procedure. In some embodiments, dilator <NUM> may include one or a plurality of mating surfaces, as described herein.

Navigation component <NUM>, as shown in <FIG>, 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 dilator <NUM> and a portion of bushing <NUM>. Collar <NUM> includes a lock, for example, a resilient prong or tab <NUM>. Navigation component <NUM> is connected with bushing <NUM> by tab <NUM>. In some embodiments, collar <NUM> may include one or a plurality of locks, as described herein.

Passageway <NUM> is configured for disposal of anchor <NUM>, as described herein. Dilator <NUM> is removably mounted with anchor <NUM> such that tip <NUM> is positioned at a selected distance from navigation component <NUM>. Navigation component <NUM> is positioned relative to a sensor to communicate a signal representative of the orientation of anchor <NUM> during engagement with tissue. Tip <NUM> is configured to fix anchor <NUM> with tissue to provide the axial trajectory for the components of surgical instrument <NUM>, as described herein.

Anchor tool <NUM> includes a body <NUM>. Body <NUM> extends between an end <NUM> and an end <NUM>. End <NUM> includes slots <NUM> and spring tabs <NUM>, as shown in <FIG>. Anchor tool <NUM> includes a part, for example, a depth setter <NUM> and a button <NUM>, as shown in <FIG>.

Depth setter <NUM> includes a slider <NUM> and a sleeve <NUM>. Sleeve <NUM> includes a surface <NUM> configured for engagement with spring tabs <NUM> in a friction fit configuration to fix sleeve <NUM> in the extended position, as shown in <FIG> and/or the retracted position, as shown in <FIG>. In some embodiments, sleeve <NUM> and body <NUM> may be disposed with an integral connection, friction fit, pressure fit, interlocking engagement, mating engagement, dovetail connection, clips, barbs, tongue in groove, threaded, magnetic and/or key/keyslot. Sleeve <NUM> includes a surface that defines a channel <NUM>. Channel <NUM> is disposed in communication with a channel <NUM> of body <NUM>, as shown in <FIG>. Channels <NUM>, <NUM> are configured for disposal of anchor <NUM>, as described herein.

Pins <NUM> extend through slots <NUM> to connect slider <NUM> and sleeve <NUM> with body <NUM>, as shown in <FIG>, such that translation of slider <NUM> causes translation of sleeve <NUM> between an extended position and a retracted position relative to body <NUM>.

For example, translation of slider <NUM>, in a direction shown by arrow A1 in <FIG>, causes sleeve <NUM> to simultaneously translate via connection of pins <NUM>, in a direction shown by arrow A1 in <FIG>, to the extended position. In the extended position, sleeve <NUM> is disposed in an abutting engagement with collar <NUM> of navigation component <NUM>, as shown in <FIG>. In the extended position, sleeve <NUM> positions the extension and/or depth of tip <NUM> beyond end <NUM> a selected distance from navigation component <NUM>. Sleeve <NUM> resists and/or prevents extension of tip <NUM> further than the selected distance. Tip <NUM> is provisionally fixed with tissue under navigation by communication of navigation component <NUM> with a surgical navigation system <NUM>, as described herein.

Translation of slider <NUM> in the opposite direction, in a direction shown by arrow A2 in <FIG>, causes sleeve <NUM> to simultaneously translate, in the direction shown by arrow A2 in <FIG>, to the retracted position. In the retracted position, sleeve <NUM> is spaced a distance from collar <NUM>, as shown in <FIG>, to allow anchor <NUM> to translate through dilator <NUM> to extend further from end <NUM> of dilator <NUM> to facilitate driving anchor <NUM> a further depth into tissue for docking.

Button <NUM> is connected with body <NUM> by pins <NUM>. Button <NUM> includes a protrusion <NUM> having a surface <NUM> that defines an opening <NUM>. Opening <NUM> is configured for disposal of anchor <NUM> and surface <NUM> is configured to engage groove <NUM> to fix anchor <NUM> with anchor tool <NUM>. Button <NUM> is biased to a closed position by springs <NUM> such that protrusion <NUM> blocks channel <NUM>. To capture anchor <NUM>, a force is applied to button <NUM>, in a direction shown by arrow C in <FIG>, causing opening <NUM> to align with channel <NUM> to allow anchor <NUM> to translate therethrough. Button <NUM> is released and the bias of springs <NUM> pushes button <NUM>, in a direction shown by arrow D in <FIG>, causing surface <NUM> to engage surface <NUM> of groove <NUM> to capture anchor <NUM>. To release anchor <NUM>, a force is applied to button <NUM>, in the direction shown by arrow C in <FIG>, causing surface <NUM> to disengage surface <NUM> of groove <NUM> to release anchor <NUM>. Opening <NUM> aligns with channel <NUM> to allow anchor <NUM> to translate therethrough for disengagement from anchor tool <NUM>.

In some embodiments, anchor tool <NUM> includes a handle portion <NUM> that includes a flange <NUM>, a slap hammer <NUM> and an end flange <NUM>. Slap hammer <NUM> translates between flange <NUM> and end flange <NUM> to facilitate removing anchor <NUM> from the surgical site. In some embodiments, handle portion <NUM> is hollow to reduce the weight of anchor tool <NUM>.

Surgical instrument <NUM> includes a member, for example, a drill guide <NUM>, as shown in <FIG>. Drill guide <NUM> extends between a proximal end <NUM> and a distal end <NUM>. Distal end <NUM> is configured to engage tissue. Drill guide <NUM> includes a surface <NUM> that defines a passageway <NUM> configured for disposal of a drill. Drill guide <NUM> is utilized to assist in control and guidance of a surgical drill. Drill guide <NUM> is securely docked by mounting drill guide <NUM> with anchor <NUM>. Anchor <NUM> guides drill guide <NUM> along the axial trajectory to engage distal end <NUM> of drill guide <NUM> with bone.

In assembly, operation and use, as shown in <FIG>, spinal implant system <NUM>, similar to the systems and illustrative methods (not claimed) described herein, can be 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, 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.

A scalpel (not shown) is oriented for disposal with end effector <NUM> of robotic arm R, as described herein. An incision is made in the skin S1 of a patient with the scalpel, 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. Surgical instrument <NUM> is assembled. Anchor <NUM> is disposed with passageway <NUM> of dilator <NUM>. Navigation component <NUM> is connected with dilator <NUM>. Navigation component <NUM> is translated along dilator <NUM> into a mating engagement with surface <NUM> and connected with bushing <NUM> by tab <NUM>.

Anchor tool <NUM> is connected with anchor <NUM>. Anchor <NUM> is translated into channel <NUM> and channel <NUM>. Button <NUM> is actuated causing opening <NUM> to align with channel <NUM> to allow anchor <NUM> to translate therethrough. Button <NUM> is released and the bias of springs <NUM> pushes button <NUM> causing surface <NUM> to engage surface <NUM> of groove <NUM> to capture anchor <NUM>.

Slider <NUM> is translated and causes sleeve <NUM> to simultaneously translate via connection of pins <NUM> into the extended position. In the extended position, sleeve <NUM> is disposed in an abutting engagement with collar <NUM> of navigation component <NUM>, as shown in <FIG>. In the extended position, sleeve <NUM> positions the extension and/or depth of tip <NUM> beyond end <NUM> a selected distance from navigation component <NUM> and surface <NUM>. Sleeve <NUM> resists and/or prevents extension of tip <NUM> further than the selected distance.

Surgical instrument <NUM> is inserted into cannula <NUM>. Dilator <NUM> expands skin S1 along the surgical pathway. 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 anchor <NUM> relative to 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 anchor <NUM> relative to tissue, for example, bone. In some embodiments, the signal generated by emitter array <NUM> represents a three-dimensional position of anchor <NUM> relative to tissue.

Sensor array <NUM> can receive signals from emitter array <NUM> to provide a three-dimensional spatial position and/or a trajectory of anchor <NUM> relative to 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. Sensor array <NUM> can receive signals from emitter array <NUM> to provide a visual representation of a position of anchor <NUM> relative to tissue. See, for example, similar surgical navigation components and their use as described in <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. Pre-acquired images of a patient can be collected. 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>.

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>.

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>. 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>. 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.

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>, 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. Images may also be displayed to the surgeon through a heads-up display.

Surgical navigation system <NUM> can provide for real-time tracking of the position of bone fastener <NUM> relative to surgical instrument <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. Fiducial markers <NUM> of emitter array <NUM> can 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 instrument <NUM> is configured for use with a guide member, for example, an end effector <NUM> of robotic arm R to determine axial trajectory of a surgical pathway and/or facilitate positioning of one or more surgical instruments, implants and/or components of spinal implant system <NUM> in alignment with the axial trajectory of a surgical pathway. End effector <NUM> includes an inner surface <NUM> that defines a cavity, for example, a channel <NUM>. Channel <NUM> is configured for disposal of one or more components of surgical instrument <NUM> and/or implants. 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 surgical instrument <NUM> with tissue. The position sensors of robotic arm R can be 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>.

Tip <NUM> is provisionally fixed with bone B1 to define an axial trajectory AT, as shown in <FIG>. Axial trajectory AT of anchor <NUM> is confirmed by communication of navigation component <NUM> with surgical navigation system <NUM>, as described herein.

To dock anchor <NUM>, slider <NUM> is translated into the retracted position. Translation of slider <NUM> causes sleeve <NUM> to simultaneously translate into the retracted position. In the retracted position, sleeve <NUM> is spaced a distance from collar <NUM>, as shown in <FIG>, to allow anchor <NUM> to translate through dilator <NUM> to extend further from end <NUM> of dilator <NUM> to drive anchor <NUM> a greater depth into bone B1 for docking. Anchor <NUM> is docked with bone B1 along axial trajectory AT.

Anchor tool <NUM> is removed from anchor <NUM>, as shown in <FIG>. To release anchor <NUM>, button <NUM> is actuated to cause surface <NUM> to disengage surface <NUM> of groove <NUM> to release anchor <NUM>. Opening <NUM> aligns with channel <NUM> to allow anchor <NUM> to translate therethrough for disengagement from anchor tool <NUM>. Slap hammer <NUM> can be utilized to facilitate releasing anchor <NUM> from bone B1. Dilator <NUM> is removed from anchor <NUM>, as shown in <FIG>.

Drill guide <NUM> is mounted with anchor <NUM>, as shown in <FIG>, such that anchor <NUM> is disposed with passageway <NUM>. Anchor <NUM> directs and/or guides drill guide <NUM> along axial trajectory AT through cannula <NUM>. End <NUM> of drill guide <NUM> extends from a distal end of cannula <NUM>. Drill guide <NUM> is tamped along anchor <NUM> and axial trajectory AT causing end <NUM> to engage bone B1. As such, drill guide <NUM> is docked with bone B1 along navigated axial trajectory AT thereby maintaining the alignment and/or trajectory of drill guide <NUM> during docking.

Anchor <NUM> is removed from bone B1 by reattaching anchor tool <NUM>. Anchor <NUM> is translated into channel <NUM> and channel <NUM>. Button <NUM> is actuated causing opening <NUM> to align with channel <NUM> to allow anchor <NUM> to translate therethrough. Button <NUM> is released and the bias of springs <NUM> pushes button <NUM> causing surface <NUM> to engage surface <NUM> of groove <NUM> to capture anchor <NUM>. Slap hammer <NUM> can be utilized to facilitate releasing anchor <NUM> from bone B1. Anchor <NUM> is removed from bone B1 and the surgical site.

A drill (not shown) is paired with a selected drill bit and inserted into drill guide <NUM>. Drill guide <NUM> directs and/or guides the drill along the axial trajectory AT. In some embodiments, the drill includes a navigation component, similar to navigation component <NUM> as described herein. The navigation component is oriented relative to sensor array <NUM> to confirm trajectory by communication of the navigation component with surgical navigation system <NUM>, similar to that described herein. Pilot holes (not shown) are made with the selected areas of bone for receiving spinal implants such as bone fasteners for the surgical procedure.

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.

In one embodiment, 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.

Claim 1:
A surgical instrument (<NUM>):
a first member (<NUM>) extending between a proximal end (<NUM>) and a distal end (<NUM>) configured for fixation with tissue;
a second member (<NUM>) defining a longitudinal passageway (<NUM>) and being connected with a navigation component (<NUM>) such that the distal end (<NUM>) is disposable with the passageway (<NUM>) at a selected distance from the navigation component (<NUM>), the navigation component (<NUM>) being positioned relative to a sensor to communicate a signal representative of an axial orientation of the first member (<NUM>);
a third member (<NUM>) extending between a proximal end (<NUM>) and a distal end (<NUM>), the third member (<NUM>) being mountable with the first member (<NUM>) along the orientation such that the distal end (<NUM>) of the third member (<NUM>) is engageable with the tissue; and
a fourth member (<NUM>) connectable with the first member (<NUM>) and configured to adjust a depth of the first member (<NUM>), wherein the fourth member (<NUM>) includes a part (<NUM>) configured to adjust a depth of the first member (<NUM>) relative to tissue and the navigation component (<NUM>).