Patent Description:
A surgical system including a bone fastener and a surgical instrument with a member connectable with the head of the bone fastener, an image guide connected with the member and a surgical navigation system is known, e.g., from <CIT>. Further, <CIT> discloses systems for determining a desired trajectory and/or monitoring the trajectory of surgical instruments and/or implants in any number of surgical procedures, such as (but not limited to) spinal surgery, including (but not limited to) ensuring proper placement of pedicle screws during pedicle fixation procedures and ensuring proper trajectory during the establishment of an operative corridor to a spinal target site. Spinal pathologies and disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor, and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including 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 fusion, fixation, correction, corpectomy, discectomy, laminectomy and implantable prosthetics. For example, fusion and fixation treatments may be performed that employ implants to restore the mechanical support function of vertebrae. Surgical instruments are employed, for example, to prepare tissue surfaces for disposal of the implants. Surgical instruments are also employed to engage implants for disposal with the tissue surfaces at a surgical site. This disclosure describes an improvement over these prior technologies.

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

The exemplary embodiments of a surgical system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system for preparing a surgical site, and a method for treating a spine. The surgical treatments described in the following do not form part of the invention but are useful in understanding the invention. In some embodiments, the surgical system includes a surgical instrument having an image guide oriented relative to a sensor to communicate a signal representative of a range of movement of a receiver of a bone fastener. In some embodiments, the surgical system includes a surgical navigation system and/or an automated rod bending device.

In some embodiments, the present surgical system includes a surgical instrument that identifies screw head impingement recognition with surgical navigation, which can provide rod bending optimization. In some embodiments, the present surgical system is employed with a method for posterior fusion rod bending. In some embodiments, the present surgical system is employed with a method such that a navigation system identifies individual screw head data points located in three dimensional space and a processor interpolates and displays an image between these points to form a shape of a spinal rod. In some embodiments, the method includes identifying flexibility of one or more receivers or tulip heads of bone fasteners. In some embodiments, the implanted flexibility in the receivers is based on the design of the receiver and the proximity of an outer boundary of the receiver to a patient's bony anatomy. For example, when the receiver contacts the bony anatomy, the potential flexibility is reduced due to the impingement.

In some embodiments, the present surgical system includes a surgical instrument employed with a method of using a navigation system to measure the actual receiver angular displacement by allowing a surgeon to perform a circular sweeping motion of the navigated surgical instrument and recording the allowable displacement of the receiver per the bony impingement points. For example, the identified true angular allowance can be used to optimize a rod bending software model and eliminate unnecessary contouring and/or weakening of fixation rods.

In some embodiments, the present surgical system includes a surgical instrument employed with a method used to measure the actual flexibility of a screw head after insertion into a pedicle. In some embodiments, the present surgical system provides data signals that are then delivered to an automated rod bending device for optimized rod shaping. In some embodiments, the present surgical system provides actual flexibility of each screw head to optimize a fixation rod path between screws during automated rod bending. In some embodiments, the present surgical system identifies impingement of the screw on the bony anatomy to avoid restriction on receiver flexibility.

In some embodiments, the present surgical system includes a surgical instrument that has an instrument tracker and a distal/working end. In some embodiments, the surgical tracker provides indicia and/or display of a location and angulation of the surgical instrument and its distal/working end. In some embodiments, the surgical system includes a surgical instrument having one or more image guides, which include one or more fiducial markers. In some embodiments, the fiducial marker includes a single ball-shaped marker. In some embodiments, the image guide is disposed adjacent a proximal end of the surgical instrument. In some embodiments, the image guide provides indicia and/or display of a precise rotational and/or linear position of the image guide on the surgical instrument. In some embodiments, this configuration provides indicia and/or display of an amount of manipulation, movement, translation and/or rotation of the implant with tissue.

In some embodiments, the surgical system includes a surgical instrument having one or more image guides, which include a tracker that provides location of a surgical instrument in three dimensions, and a tracker that provides location of the surgical instrument and/or a spinal implant in two dimensions, such as, for example, a selected plane. In some embodiments, this configuration provides indicia and/or display of implant position corresponding to an amount of manipulation, movement, translation and/or rotation of the implant with tissue.

In some embodiments, the surgical system comprises a navigation compatible, surgical instrument that detects and/or identifies range of movement of a spinal implant disposed with tissue. In some embodiments, the surgical instrument includes a tracking and/or mapping tool that identifies range of motion limits due to tissue impingement. In some embodiments, the surgical instrument has one or more image guides, which provide position and rotation indicia and/or display of a spinal implant via a camera sensor and a computer display screen. In some embodiments, the surgical system includes a surgical instrument that has two image guide arrays.

In some embodiments, the surgical instrument includes a navigation tracker that is optically tracked and requires a line-of-sight view to a sensor, such as, for example, a camera. In some embodiments, the surgical system includes a navigation tracker attached to a surgical instrument and is disposed in a direct line of sight of a sensor, which includes one or more cameras. In some embodiments, the surgical system includes an O-arm medical imaging device that digitally captures images of an anatomy. In some embodiments, the tracker communicates with a surgical navigation system to determine and/or display surgical instrument positioning relative to the anatomy.

In some embodiments, one or all of the components of the surgical system may be disposable, peel pack and/or pre packed sterile devices. One or all of the components of the surgical system may be reusable. The surgical system may be configured as a kit with multiple sized and configured components.

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 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, 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. As used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

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

The components of surgical system <NUM> can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers and/or ceramics. For example, the components of surgical system <NUM>, individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade <NUM> titanium, superelastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics, 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 and/or epoxy.

Surgical 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 customize and introduce instrumentation and/or a spinal implant, such as, for example, one or more bone fasteners at a surgical site of a patient, which includes, for example, a spine having vertebrae V, as shown in <FIG>.

Surgical system <NUM> includes a spinal implant, such as, for example, a bone fastener <NUM>. Bone fastener <NUM> comprises a screw shaft assembly <NUM> and a head assembly <NUM>. In some embodiments, screw shaft assembly <NUM> and head assembly <NUM> are assembled in situ or prior to implant to form bone fastener <NUM>, as described herein. Head assembly <NUM> includes a head, such as, for example, a receiver <NUM>. Receiver <NUM> extends along and defines an axis X1. Receiver <NUM> includes a pair of spaced apart arms <NUM>, <NUM> that define an implant cavity <NUM> therebetween configured for disposal of a component of a spinal construct, such as, for example, a spinal rod (not shown).

Arms <NUM>, <NUM> each extend parallel to axis X1. In some embodiments, arm <NUM> and/or arm <NUM> may be disposed at alternate orientations, relative to axis X1, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered. Arms <NUM>, <NUM> each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer surfaces and the side surfaces of arms <NUM>, <NUM> have at least one recess or cavity therein configured to receive an insertion tool, compression instrument and/or instruments for inserting and tensioning bone fastener <NUM>. In some embodiments, arms <NUM>, <NUM> are connected at proximal and distal ends thereof such that receiver <NUM> defines a closed spinal rod slot.

Cavity <NUM> is substantially U-shaped. In some embodiments, all or only a portion of cavity <NUM> may have alternate cross section configurations, such as, for example, closed, V-shaped, W-shaped, oval, oblong triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. In some embodiments, receiver <NUM> includes an inner surface having a thread form located adjacent arm <NUM> and a thread form located adjacent arm <NUM>. The thread forms are each configured for engagement with a coupling member, such as, for example, a setscrew (not shown), to retain the spinal rod within cavity <NUM>. In some embodiments, receiver <NUM> may include alternate configurations, such as, for example, closed, open and/or side access.

Shaft assembly <NUM> extends along an axis X2 between a proximal portion <NUM> and a distal tip <NUM>. Shaft assembly <NUM> is configured for fixation with vertebrae, as described herein. Shaft assembly <NUM> includes a thread <NUM> configured for engagement with vertebrae V, as shown in <FIG>. Thread <NUM> is continuous along a length of shaft assembly <NUM>. In some embodiments, thread <NUM> may be intermittent, staggered, discontinuous and/or may include a single thread turn or a plurality of discrete threads. In some embodiments, other penetrating elements may be located on shaft assembly <NUM>, such as, for example, a nail configuration, barbs, expanding elements, raised elements, ribs, and/or spikes to facilitate engagement of shaft <NUM> with tissue. In some embodiments, thread <NUM> may be self-tapping or intermittent.

Receiver <NUM> includes a selected movement configuration with shaft assembly <NUM>. In some embodiments, receiver <NUM> is rotatable and/or pivotable relative to shaft assembly <NUM> in a selected range of movement configuration, as described herein. The selected range of movement can be limited due to engagement and/or impingement of receiver <NUM> with tissue. Such limitations of range of movement are identifiable and/or detectable with a surgical instrument <NUM>, as described herein. In some embodiments, bone fastener <NUM> is configured to selectively move between an orientation in which axis X1 extends parallel to axis X2 and is coaxial with axis X2, and an orientation in which axis X1 extends transverse to axis X2. In some embodiments, receiver <NUM> is connectable with shaft assembly <NUM> to include a selected range of movement configuration such that bone fastener <NUM> comprises, for example, a multi-axial screw (MAS), a uni-axial screw (UAS), a sagittal adjusting screw (SAS) or a transverse sagittal adjusting screw (TSAS). In some embodiments, surgical system <NUM> can include one or more multi-axial screws, sagittal angulation screws, pedicle screws, mono-axial screws, uni-planar screws, facet screws, tissue penetrating screws, conventional screws, expanding screws and/or posts. In some embodiments, surgical system <NUM> can include one or a plurality of bone fasteners, connectors, spinal rods and/or plates, which may be employed with a single vertebral level or a plurality of vertebral levels, and/or engaged with vertebrae in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, connection of receiver <NUM> with shaft assembly <NUM> can be actuated by a manual engagement and/or non-instrumented assembly, which may include a practitioner, surgeon and/or medical staff grasping receiver <NUM> and shaft assembly <NUM> and forcibly snap or pop fitting the components together.

Receiver <NUM> is connectable with surgical instrument <NUM>. Surgical instrument <NUM> includes a member <NUM> and is configured to identify a range of movement of receiver <NUM> relative to shaft assembly <NUM> and/or a range of movement of receiver <NUM> relative to tissue, as described herein. Member <NUM> includes a handle <NUM> and a shaft <NUM>. Shaft <NUM> is configured to connect member <NUM> with bone fastener <NUM>, as described herein. Handle <NUM> is configured to facilitate manipulating, moving, translating and/or rotating receiver <NUM> relative to shaft assembly <NUM> to identify and/or detect range of movement data points, as described herein. Handle <NUM> extends between an end <NUM> and an end <NUM> that extends from shaft <NUM>, as shown in <FIG>. In some embodiments, handle <NUM> may include alternate surface configurations to enhance gripping of handle <NUM>, such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, handle <NUM> may include alternate cross section configurations, such as, for example, oval, oblong, triangular, square, hexagonal, polygonal, irregular, uniform, non-uniform and/or tapered. In some embodiments, handle <NUM> may be assembled with shaft <NUM>, as described herein. In some embodiments, handle <NUM> may be monolithically formed with shaft <NUM>. In some embodiments, handle <NUM> may be disposed at alternate orientations relative to shaft <NUM>, such as, for example, transverse, parallel, perpendicular and/or other angular orientations such as acute or obtuse, co-axial, offset, and/or staggered.

Shaft <NUM> is configured for connection with receiver <NUM> such that member <NUM> can be fixed with receiver <NUM> to allow member <NUM> to move with receiver <NUM>. For example, as receiver <NUM> rotates or pivots relative to shaft assembly <NUM>, member <NUM> rotates or pivots relative to shaft assembly <NUM>. Receiver <NUM> and member <NUM> are configured to rotate about axis X2 relative to shaft assembly <NUM>, in the directions shown by arrows A and B in <FIG>, as provided by the selected movement configuration of a bone fastener <NUM>. In some embodiments, an outer surface of shaft <NUM> is threaded and configured to mate with the thread forms of arms <NUM>, <NUM> to facilitate engagement of member <NUM> with receiver <NUM>. A threaded engagement of member <NUM> with receiver <NUM>, for example a clockwise rotation of shaft <NUM> relative to receiver <NUM>, fixes receiver <NUM> with member <NUM> such that shaft <NUM> is oriented to apply a force to receiver <NUM>. This force fixes a position of shaft <NUM> relative to receiver <NUM> and/or forms a mating engagement between member <NUM> and bone fastener <NUM>. This configuration resists and/or prevents movement and/or rotation of member <NUM> relative to receiver <NUM>.

To release member <NUM> from receiver <NUM>, member <NUM> is disengaged from receiver <NUM>, for example a counter-clockwise rotation of shaft <NUM> relative to receiver <NUM>, to release member <NUM> from receiver <NUM>. In some embodiments, member <NUM> can be variously connected with receiver <NUM>, such as, for example, via an integral connection, friction fit, pressure fit, interlocking engagement, dovetail connection, clips, barbs, tongue in groove, threaded, magnetic, key/keyslot and/or drill chuck.

Bone fastener <NUM>, as described herein, includes receiver <NUM>, which is configured for rotation relative to shaft assembly <NUM> in a selected range of movement configuration ROM1. In some embodiments, a selected range of movement configuration ROM1 of receiver <NUM> relative to shaft assembly <NUM> includes a MAS configuration. The MAS configuration of receiver <NUM> relative to shaft assembly <NUM> includes a selected range of movement configuration ROM1 having movement of receiver <NUM> in one or a plurality of axial orientations relative to shaft assembly <NUM>. As such, receiver <NUM> is rotatable along a path x through an angle of <NUM> degrees about axis X2 to define a perimeter and/or circumference corresponding to ROM1, as shown in <FIG>, and includes relative rotation along the one or a plurality of axial orientations relative to shaft assembly <NUM>.

In some embodiments, upon disposal of bone fastener <NUM> with tissue, the ROM1 of receiver <NUM> relative to shaft assembly <NUM> can be limited and/or restricted due to engagement and/or impingement of receiver <NUM> by patient anatomy. For example, upon disposal of bone fastener <NUM> with tissue such that shaft assembly <NUM> penetrates tissue and an outer surface of receiver <NUM> is disposed adjacent the tissue, the actual flexibility and/or movement of receiver <NUM> relative to shaft assembly <NUM> can be limited and/or impinged. Such engagement and/or impingement of receiver <NUM> limits and/or restricts the MAS configuration of ROM1 and the actual movement of receiver <NUM> relative to shaft assembly <NUM> includes a limited and/or restricted range of movement ROM2. As such, receiver <NUM> is rotatable along a path xx through an angle of <NUM> degrees about axis X2 to define a limited and/or restricted perimeter and/or circumference corresponding to ROM2, as shown in <FIG>, and includes a limited and/or restricted rotation along the one or a plurality of axial orientations relative to shaft assembly <NUM>. ROM2 includes a limited and/or restricted range of movement of receiver <NUM> relative to shaft assembly <NUM> and/or tissue to which shaft assembly <NUM> is disposed that is limited due to impingement of receiver <NUM> by tissue. Path xx of receiver <NUM> is determined at least in part by the location of bone or other tissue relative to an outer surface of receiver <NUM>.

Member <NUM> tracks and/or maps the actual range of movement ROM2 when bone fastener <NUM> is implanted with tissue. In some embodiments, receiver <NUM> is manipulated by member <NUM> in a selected motion, such as, for example, a sweeping rotational motion to identify and/or detect tissue impingement of ROM1 to provide ROM2. In some embodiments, data points identified and/or detected by surgical instrument <NUM> include range of movement ROM2, which are transmitted to a computer <NUM>, which includes spinal rod bending software to determine a selected rod configuration and communicates commands to an automated rod bending device, as described herein. In some embodiments, surgical instrument <NUM> identifies and/or detects such data points to provide actual flexibility of each receiver <NUM> to optimize a fixation rod path between bone fasteners <NUM> during automated rod bending, as described herein.

In some embodiments, surgical instrument <NUM> includes an image guide, such as, for example, a navigation component <NUM> connected with member <NUM>. Navigation component <NUM> is configured to generate a signal representative of a position of receiver <NUM> and/or axis X1 relative to shaft assembly <NUM>, axis X2 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. In some embodiments, navigation component <NUM> is connected with member <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 a sensor array <NUM> of a surgical navigation system <NUM>, as shown in <FIG> and described herein, representing the range of movement of receiver <NUM> relative to shaft assembly <NUM>, for example ROM2, and/or a position or a trajectory of receiver <NUM> relative to shaft assembly <NUM> and/or tissue for display on a monitor <NUM>.

In some embodiments, the signal generated by emitter array <NUM> represents proximity of an outer surface of receiver <NUM> relative to tissue, such as, for example, bone. In some embodiments, the signal generated by emitter array <NUM> represents an actual range of movement of receiver <NUM> relative to shaft assembly <NUM> and/or tissue. 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, the signal generated by emitter array <NUM> represents tissue impingement on receiver <NUM> that limits the range of movement of receiver <NUM> relative to shaft assembly <NUM> and/or tissue. In some embodiments, the signal generated by emitter array <NUM> represents data points of bony impingement of receiver <NUM> with 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 receiver <NUM> and/or axis X1 relative to shaft assembly <NUM>, axis X2 and/or tissue. Emitter array <NUM> communicates with a processor of computer <NUM> of navigation system <NUM> to generate data for display of an image on monitor <NUM>, as described herein. In some embodiments, sensor array <NUM> receives signals from emitter array <NUM> to provide a visual representation of range of movement ROM2 and/or an angular position of receiver <NUM> and/or axis X1 relative to shaft assembly <NUM>, axis X2 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, such as, 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, navigation system <NUM> comprises an image capturing portion <NUM> that 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 <NUM> 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 bone fastener <NUM> such that ROM1, ROM2, the position of receiver <NUM> relative to shaft assembly <NUM> and/or tissue can be tracked. In some embodiments, real-time tracking of the position of receiver <NUM> relative to shaft assembly <NUM> and/or tissue can be limited due to impingement of receiver <NUM> with tissue, wherein such limitations of range of movement, for example ROM2 are identifiable and/or detectable with surgical instrument <NUM>, as described herein. 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.

In some embodiments, sensor array <NUM> communicates with computer <NUM> to transmit range of movement data of receiver <NUM> relative to shaft assembly <NUM>, as described herein. In some embodiments, the processor sends such information to monitor <NUM>, which provides a visual representation of the range of movement of receiver <NUM> relative to shaft assembly <NUM>. For example, range of movement ROM2 of receiver <NUM> relative to shaft assembly <NUM> may affect the contouring of a spinal rod that is configured to be positioned within implant cavities <NUM> of bone fasteners <NUM> to correct a spinal deformity. In some embodiments, the spinal correction and/or rod bending software can be employed to determine the shape of the spinal rod, based at least in part upon the range of movement of receiver <NUM> relative to shaft assembly <NUM>, as described herein, such that surgical instrument <NUM> identifies and/or detects ROM2 data points to provide actual flexibility of each receiver <NUM> to optimize a fixation rod path between bone fasteners <NUM> during automated rod bending, as described herein. In some embodiments, the software is utilized to determine a selected spinal correction and the corresponding shape and/or contour of the spinal rod to fit within implant cavities <NUM> of bone fasteners <NUM> by rotating receivers <NUM> relative to shaft assembly <NUM> within range of movement ROM2, as described herein.

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

The components of surgical system <NUM> can be employed with a surgical treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body, such as, for example, vertebrae V. In some embodiments, the components of surgical system <NUM> may be employed with one or a plurality of vertebra. To treat a selected section of vertebrae V, a medical practitioner obtains access to a surgical site including vertebrae V in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, the components of surgical 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 vertebrae V are accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure can be performed for treating the spine disorder.

An incision is made in the body of a patient and a cutting instrument (not shown) creates a surgical pathway for delivery of components of surgical system <NUM> including bone fasteners <NUM>, as described herein, adjacent an area within the patient's body, such as, for example, vertebrae V. In some embodiments, a preparation instrument (not shown) can be employed to prepare tissue surfaces of vertebrae V, as well as for aspiration and irrigation of a surgical region.

Pilot holes are made in vertebrae V in a selected orientation. Bone fasteners <NUM> are each engaged with a driver. Each receiver <NUM> of the bone fasteners <NUM> to be attached with the tissue of vertebrae V includes a selected range of movement configuration ROM1. For example, an MAS bone fastener <NUM> includes a receiver <NUM> having a ROM1 relative to shaft assembly <NUM>, as shown in <FIG>, and is rotatable along path x through an angle of <NUM> degrees about axis X2 to define a perimeter and/or circumference corresponding to ROM1. Bone fasteners <NUM> are each aligned with one of the pilot holes and the drivers are rotated, torqued, inserted or otherwise connected with bone fasteners <NUM> such that bone fasteners <NUM> each translate axially within one of the pilot holes for engagement and fixation with the tissue of vertebrae V. In some embodiments, at least one of bone fasteners <NUM> includes a MAS or a SAS movement configuration.

Surgical instrument <NUM> is connected with each bone fastener <NUM> to identify a range of movement of receiver <NUM> relative to shaft assembly <NUM> and/or a range of movement of receiver <NUM> relative to tissue, as described herein. Shaft <NUM> is connected with each receiver <NUM> such that member <NUM> can be fixed with receiver <NUM> to allow member <NUM> to move with receiver <NUM>. As receiver <NUM> rotates or pivots relative to shaft assembly <NUM>, member <NUM> rotates or pivots relative to shaft assembly <NUM>.

Member <NUM> is engaged with the receiver <NUM> of each bone fastener <NUM> disposed with vertebrae V to track and/or map the actual range of movement ROM2 of each receiver <NUM> of the bone fasteners <NUM> implanted with vertebrae V. Bone fasteners <NUM> are disposed with vertebrae V such that an outer surface of receiver <NUM> is disposed adjacent bone and the actual flexibility and/or movement of receiver <NUM> relative to shaft assembly <NUM> can be limited and/or impinged. Such engagement and/or impingement of receiver <NUM> with tissue limits and/or restricts the ROM1 of bone fastener <NUM> and the actual movement of receiver <NUM> relative to shaft assembly <NUM> includes a limited and/or restricted range of movement ROM2. As such, receiver <NUM> is rotatable along a path xx through an angle of <NUM> degrees about axis X2 to define a limited and/or restricted perimeter and/or circumference corresponding to ROM2, as shown in <FIG>, and includes a limited and/or restricted rotation along the one or a plurality of axial orientations relative to shaft assembly <NUM>. Each receiver <NUM> is manipulated with member <NUM> in a sweeping rotational motion to identify and/or detect tissue impingement of ROM1 to provide ROM2 such that surgical instrument <NUM> identifies and/or detects ROM2 data points to provide actual flexibility of each receiver <NUM> to optimize a fixation rod path between bone fasteners <NUM> during automated rod bending, as described herein. Data points identified and/or detected by surgical instrument <NUM> include range of movement ROM2, which are transmitted to computer <NUM>, which includes spinal rod bending software to determine a selected rod configuration and communicates commands to an automated rod bending device, as described herein. In some embodiments, surgical instrument <NUM> is employed to identify and/or detect ROM2 data points of alternate movement configurations of a bone fastener, as described herein, for transmission to computer <NUM>.

Sensor array <NUM> receives signals from emitter array <NUM> to provide a three-dimensional spatial position and/or a trajectory of receiver <NUM>, as described herein. Emitter array <NUM> communicates with the processor of computer <NUM> of navigation system <NUM> to generate ROM2 data points for display from monitor <NUM>. In some embodiments, this procedure is repeated for each of bone fasteners <NUM>.

The identified and/or mapped range of movement ROM2 includes data points that are employed with a selected rod contour, spinal rod template configuration and/or selected spinal correction treatment to calculate a selected spinal rod configuration for disposal with one or more of bone fasteners <NUM>. The data points are communicated to the software of computer <NUM>, as described herein, and based on such data points, computer <NUM> generates three dimensional coordinates of the shape of a spinal rod <NUM> to be implanted with vertebrae V. Computer <NUM> communicates a corresponding signal and/or commands to an automated implant bending device, which may be disposed within a sterile field, to contour spinal rod <NUM>. See, for example, the disclosure of automated implant bending devices, systems and methods shown and described in commonly owned and assigned <CIT>, the disclosure of automated implant bending devices, systems and methods shown and described in commonly owned and assigned <CIT>, the disclosure of automated implant bending devices, systems and methods shown and described in commonly owned and assigned Patent Application Ser. No. <CIT>, and the disclosure of automated implant bending devices, systems and methods shown and described in commonly owned and assigned <CIT>, the entire contents of each of these disclosures being incorporated herein by reference.

In some embodiments, computer <NUM> generates three dimensional coordinates of the shape of spinal rod <NUM>, which may be determined from intraoperative fluoroscopy with bone fasteners <NUM> installed. In some embodiments, fluoroscopic images taken are transmitted to computer <NUM>. Image transfer may be performed over a standard video connection or a digital link including wired and wireless. Computer <NUM> and/or the graphical interface, as described herein, 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, a graphical interface including monitor <NUM>, as described herein, provides three dimensional graphical representation of spinal rod <NUM> formation. In some embodiments, the implant bending device (not shown) communicates with computer <NUM> and/or the graphical interface to provide the curvature coordinates of spinal rod <NUM>, which may include a geometric angle between two consecutive points on spinal rod <NUM>. In some embodiments, the software of computer <NUM> determines how to manipulate each of receivers <NUM> relative to shaft assemblies <NUM> within selected range of movement configuration ROM2 such that spinal rod <NUM> can be positioned within implant cavities <NUM> to correct and/or treat a condition or injury of vertebrae V.

Claim 1:
A surgical system, comprising
a bone fastener (<NUM>) having a shaft attachable with tissue and a head,
a surgical instrument (<NUM>) comprising:
a member (<NUM>) connectable with the head of the bone fastener (<NUM>), the member (<NUM>) being movable with the head to identify a range of movement of the head relative to the shaft; and
an image guide (<NUM>) connected with the member (<NUM>), including an emitter array (<NUM>) and oriented relative to a sensor array (<NUM>) to communicate a signal representative of the range of movement, and
a surgical navigation system (<NUM>) including the sensor array (<NUM>) and a display,
wherein the signal generated by the emitter array (<NUM>) represents data points of bony impingement of the head with tissue that limits the range of movement of the head relative to the shaft and/or tissue, wherein the sensor array (<NUM>) of the navigation system (<NUM>) receives the signal and the navigation system (<NUM>) is configured to provide a visual representation of the range of movement in the form of range of movement data points and/or angular position of the head on the display.