Patent Publication Number: US-2021186532-A1

Title: Surgical implant system and methods of use

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for treating a spine. 
     BACKGROUND 
     Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor, and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including pain, nerve damage, and partial or complete loss of mobility. 
     Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, interbody devices can be employed with spinal constructs, which include implants such as bone fasteners and vertebral rods to provide stability to a treated region. These implants can redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. Surgical instruments are employed, for example, to engage the fasteners for attachment to the exterior of two or more vertebral members. This disclosure describes an improvement over these prior technologies. 
     SUMMARY 
     In one embodiment, a surgical device for treating a spine is provided. The surgical device has a shaft including a proximal portion and a distal portion being disposable with a surgical robot guide to engage vertebral tissue. The proximal portion defines a detectable marker and is connectable with at least one surgical instrument for manipulating the vertebral tissue. Systems, surgical instruments, spinal implants, constructs and methods are disclosed. 
     In one embodiment, a method for treating a spine is provided. The method comprises the steps of: engaging a distal portion of a surgical device with vertebral tissue via robotic guidance, the distal portion including a tap and a proximal portion including a detectable marker; connecting a surgical instrument with the proximal portion; and manipulating the surgical instrument to rotate a first vertebra of the vertebral tissue relative to a second vertebra. 
     In one embodiment, a surgical instrument is provided. The surgical instrument includes a shaft including a distal portion having a threaded tap and a proximal portion having a radiographically detectable marker. The distal portion is disposable with a surgical robot guide to engage vertebral tissue. The proximal portion is connectable with a distractor. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
         FIG. 1  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 2  is a plan view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 3  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 4  is a plan view of one embodiment of an implant strategy in accordance with the principles of the present disclosure; 
         FIG. 5  is an axial view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae; 
         FIG. 6  is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure disposed with vertebrae; 
         FIG. 7  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 8  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; and 
         FIG. 9  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The exemplary embodiments of a surgical system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system and a method for treating a spine. In some embodiments, the present surgical system includes a surgical device comprising one or more surgical instruments and/or spinal implants that provide marking and guidance for disposal of components of the present surgical system with vertebral tissue. In some embodiments, the surgical device provides marking and guidance for a selected position of vertebrae for implant of a pedicle screw. In some embodiments, the surgical device provides vertebral manipulation to treat spinal disorders, for example, to manage lordosis and/or kyphosis restoration. In some embodiments, the surgical device provides distraction and/or compression of vertebral tissue. In one embodiment, the systems and methods of the present disclosure are employed with a spinal joint fusion, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine. 
     In some embodiments, the present surgical system includes a surgical device comprising one or more surgical instruments and/or spinal implants that include a pedicle marker and a tap. In some embodiments, the pedicle marker includes a cannulated tap used to mark a location and a trajectory of a pedicle screw placement. In some embodiments, the pedicle marker is employed with surgical navigation. In some embodiments, the pedicle marker is employed to distract vertebrae. In some embodiments, the pedicle marker comprises a provisional instrument. 
     In some embodiments, the present surgical system includes a surgical device comprising one or more surgical instruments that include a pedicle screw marker utilized to mark a location and trajectory of a pedicle screw placement via surgical navigation or surgical guidance. In some embodiments, the pedicle screw marker is configured for connection with a surgical tool to facilitate manipulation of vertebrae. In some embodiments, the pedicle screw marker is configured for connection with a surgical tool, such as, for example, a distractor to distract vertebrae. 
     In some embodiments, the present surgical system includes a surgical device comprising one or more surgical instruments and/or spinal implants that include a pedicle marker. In some embodiments, the shaft is configured as a tap. In some embodiments, the pedicle marker is configured to distract tissue during a transforaminal lumbar interbody fusion (TLIF) procedure. In some embodiments, the present surgical system includes a surgical device that is employed with a method of treating a spine including the step of placing the surgical device under robotic guidance. In some embodiments, the pedicle marker has a solid shaft. In some embodiments, the pedicle marker has a cannulated shaft. 
     In some embodiments, the system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, kyphosis, scoliosis and other curvature abnormalities, tumor and fractures. In some embodiments, the 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 system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The system of the present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration, 
     The system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. 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. When such a range is expressed, another embodiment includes from the one particular value and/or to the other 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. Also, as used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise. 
     The following discussion includes a description of a surgical system including surgical instruments, spinal constructs, implants, 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. 1 , there is illustrated components of a surgical system, such as, for example, a spinal instrument system  10 . 
     The components of spinal instrument system  10  can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of spinal instrument system  10 , individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4  polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations, 
     The components of spinal instrument system  10 , individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of spinal instrument system  10  may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. 
     Spinal instrument system  10  can be employed, for example, with a minimally invasive procedure, including percutaneous techniques, mini-open and open surgical techniques to manipulate tissue, deliver and introduce instrumentation and/or components of spinal constructs at a surgical site within a body of a patient, for example, a section of a spine. In some embodiments, spinal instrument system  10  includes a surgical device, as described herein, which comprises one or more surgical instruments, which can be employed with surgical navigation and/or robotic guidance. In some embodiments, the surgical device provides marking and guidance with vertebral tissue, and vertebral manipulation to treat spinal disorders, for example, to manage lordosis and/or kyphosis restoration. In some embodiments, the surgical device provides a tissue tap for pilot holes, distraction and/or compression of vertebral tissue employed in connection with surgical treatment. In some embodiments, spinal instrument system  10  can include spinal constructs having, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft. The surgical procedure can include surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine. In some embodiments, spinal instrument system  10  is configured to distract tissue during a transforaminal lumbar interbody fusion (TLIF) procedure. 
     In some embodiments, spinal instrument system  10  includes a surgical device, as described herein, which comprises and/or is connectable with one or more surgical instruments, such as, for example, a driver, a cutter, a cannula, an osteotome, an inserter, a compressor and/or a distractor that can be employed with spinal implants. In some embodiments, the surgical device can be employed in connection with various access procedures to one or a plurality of surgical approaches for tissue tapping, marking guidance, compression/distraction maneuvers, leveraging vertebrae and/or, distributing loads across vertebrae. 
     Spinal instrument system  10  includes a surgical device that is configured as a surgical instrument  12 . Surgical instrument  12  is configured to engage tissue of, for example, a pilot hole to create threads in tissue. Surgical instrument  12  is configured to mark a location and/or a trajectory for other surgical instruments and/or devices and/or spinal implants. In some embodiments, surgical instrument  12  comprises a tissue marker, for example, a pedicle marker instrument that provides guidance with vertebral tissue, bone tapping and/or manipulation of adjacent vertebrae of a spine. In some embodiments, surgical instrument  12  is employed to relatively rotate vertebrae for distraction and/or compression. In some embodiments, surgical device  12  is configured as a spinal implant and is employed as a provisional instrument. 
     Surgical instrument  12  includes a shaft  14 . Shaft  14  extends between a proximal portion  16  and a distal portion  18 , Portion  16  includes a head  20 . Head  20  has a solid body and an end portion having a mating element, such as, for example, surfaces that define recesses  22  configured to facilitate engagement with a surgical instrument, as described herein. Portion  16  is configured for connection with one or a plurality of surgical instruments, as described herein, to facilitate manipulation of surgical instrument  12  and/or tissue. In some embodiments, head  20  can include a cylindrical or a spherical configuration. Head  20  or only a portion of head  20  may have cross section configurations, such as, for example, spherical, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. 
     Head  20  comprises a detectable marker, for example, a pedicle marker  24 , as shown in  FIG. 1 . Marker  24  is utilized to mark a location and/or a trajectory of a pedicle screw placement. In some embodiments, marker  24  includes an identifiable shape and/or configuration, for example, a cylindrical or spherical configuration, which is detectable visually and/or via imaging, as described herein. In some embodiments, head  20  comprises marker  24  having a radiopaque and/or radiographically detectable marker for visualizing a position and/or alignment of surgical instrument  12  using fluoroscopy during insertion, manipulation and implantation thereof. Marker  24  may be utilized for identification under x-ray, fluoroscopy, CT, MRI or other imaging techniques. In some embodiments, marker  24  can include indicia comprising identifying information relating to marker  24 , a patient being treated and/or a medical procedure. In some embodiments, the indicia includes a memory device or data carrier, such as, for example, a RFID tag used in conjunction with an RFID system. In some embodiments, the indicia includes visual indicia, such as, for example, a label, color coding, numbers or an icon. In some embodiments, the indicia includes tactile indicia, such as, for example, raised portions, dimples and/or texturing. 
     Distal portion  18  has a cylindrical cross-sectional configuration and includes an outer surface having an external thread form. Distal portion  18  includes a solid configuration such that shaft  14  is non-cannulated, and surgical instrument  12  is employable in surgical applications without a guide wire. In some embodiments, portion  18  is configured to form an internal or female thread in tissue such that a spinal implant, such as, for example, a pedicle screw can be threaded into the internal thread formed by surgical instrument  12 . 
     In some embodiments, the external thread form may include a single thread or a plurality of discrete threads. In some embodiments, other engaging structures may be located on portion  18 , such as, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement of portion  18  with tissue. In some embodiments, all or only a portion of portion  18  may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. In some embodiments, all or only a portion of the outer surface of portion  18  may have alternate surface configurations to enhance fixation with tissue, such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, all or only a portion of portion  18  may be disposed at alternate orientations, relative to its longitudinal axis, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. 
     In some embodiments, surgical instrument  12  is engageable with a surgical instrument, such as, for example a driver  200 , as shown in  FIG. 8 . Driver  200  is configured for connection with surgical instrument  12  to facilitate insertion and engagement with tissue. In some embodiments, driver  200  is configured for connection with an actuator, such as, for example, a motorized actuator, such as, for example, a powered drill (not shown). In some embodiments, driver  200  is actuated to cause surgical instrument  12  to create threads in vertebral tissue about a pilot hole, 
     In some embodiments, driver  200  includes a navigation component  58  configured to generate a signal representative of a position of surgical instrument  12  relative to tissue. Surgical instrument  12  is configured for disposal adjacent a surgical site such that navigation component  58  is oriented relative to a sensor array  60 , as shown in FIGS,  2  and  3 , to facilitate communication between navigation component  58  and sensor array  60  during a surgical procedure, as described herein. Navigation component  58  is configured to generate a signal representative of a position of surgical instrument  12  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, the navigation component is connected 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  58  includes an emitter array  62 . Emitter array  62  is configured for generating a signal to sensor array  60 . In some embodiments, the signal generated by emitter array  62  represents a position of surgical instrument  12  relative to tissue, such as, for example, bone. In some embodiments, the signal generated by emitter array  62  represents a three-dimensional position of surgical instrument  12  relative to tissue. In some embodiments, emitter array  62  may include a reflector array configured to reflect a signal from sensor array  60 . 
     In some embodiments, sensor array  60  receives signals from emitter array  62  to provide a three-dimensional spatial position and/or a trajectory of surgical instrument  12  relative to tissue. Emitter array  62  communicates with a processor of a computer  64  to generate data for display of an image on a monitor  66 , as described herein. In some embodiments, sensor array  60  receives signals from emitter array  62  to provide a visual representation of a position of surgical instrument  12  relative to tissue. See, for example, similar surgical navigation components and their use as described in U.S. Pat. Nos. 6,021,343, 6,725,080, 6,796,988, the entire contents of each of these references being incorporated by reference herein. 
     In some embodiments, the navigation system comprises image capturing portion  70  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  180  degrees from each other and mounted on a rotor (not shown) relative to a track of image capturing portion  70 . Image capturing portion  70  can be operable to rotate  360  degrees during image acquisition. Image capturing portion  70  may rotate around a central point or axis, allowing image data of the patient to be acquired from multiple directions or in multiple planes. The surgical navigation system can include those disclosed in U.S. Pat. Nos. 8,842,893, 7,188,998; 7,108,421; 7,106,825; 7,001,045; and 6,940,941; the entire contents of each of these references being incorporated by reference herein. 
     In some embodiments, the surgical navigation system can include C-arm fluoroscopic imaging systems, which can generate three-dimensional views of a patient. The position of image capturing portion  70  can be precisely known relative to any other portion of an imaging device of the navigation system. In some embodiments, a precise knowledge of the position of image capturing portion  70  can be used in conjunction with a tracking system  72  to determine the position of image capturing portion  70  and the image data relative to the patient. 
     Tracking system  72  can include various portions that are associated or included with the surgical navigation system. In some embodiments, tracking system  72  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  60  and/or an EM tracking system that can include an EM localizer. Various tracking devices can be tracked with tracking system  72  and the information can be used by the surgical navigation system to allow for a display of a position of an item, such as, for example, a patient tracking device, an imaging device tracking device  74 , and an instrument tracking device, such as, for example, emitter array  62 , to allow selected portions to be tracked relative to one another with the appropriate tracking system. 
     In some embodiments, the EM tracking system can include the STEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo. Exemplary tracking systems are also disclosed in U.S. Pat. Nos. 8,057,407, 5,913,820, 5,592,939, the entire contents of each of these references being incorporated by reference herein. 
     In some embodiments, the surgical navigation system provides for real-time tracking of the position of surgical instrument  12  relative to tissue. Sensor array  60  is located in such a manner to provide a clear line of sight with emitter array  62 , as described herein, In some embodiments, fiducial markers  80  of emitter array  62  communicate with sensor array  60  via infrared technology. Sensor array  60  is coupled to computer  64 , which may be programmed with software modules that analyze signals transmitted by sensor array  60  to determine the position of each object in a detector space. 
     Surgical instrument  12  is configured for use with an end effector  120  of a robotic arm  126 . End effector  120  includes a surface  122  that defines a channel  124 . Channel  124  is configured for passage and/or disposal of the components of surgical instrument  12  relative to tissue, as described herein. Robotic arm  126  includes position sensors (not shown), similar to those referenced herein, which measure, sample, capture and/or identify positional data points of end effector  120  in three dimensional space for a guide-wireless insertion of components of surgical instrument  12  relative to tissue, for example, with selected vertebral levels. In some embodiments, surface  122  comprises an axial trajectory guide configured for passage and/or disposal of the components of surgical instrument  12  relative to tissue, as described herein. In some embodiments, a sleeve, which comprises an axial trajectory guide, is connected with surface  122 . In some embodiments, the position sensors of robotic arm  126  are employed in connection with the surgical navigation system to measure, sample, capture and/or identify positional data points of end effector  120  in connection with surgical treatment, as described herein. The position sensors are mounted with robotic arm  126  and calibrated to measure positional data points of end effector  120  in three dimensional space, which are communicated to the components of a surgical robotic guidance system and/or computer  64 . See, for example, the surgical robotic guidance systems and methods described in U.S. Pat. No. 8,571,638, the contents of which being hereby incorporated by reference herein in its entirety. 
     The surgical robotic guidance system includes a surgical robot  130  including robotic arm  126 , which positions one or more surgical instruments, as described herein, with respect to a surgical site and is employed with a method for using robot  130  to assist in surgical procedures, as shown in  FIG. 2 . In some embodiments, robot  130  attaches to patient anatomy, for example, bone with a clamp (not shown) or K-wires of robot  130 . Robotic arm  126  extends and moves relative to a base of robot  130  to assist in surgical procedures. See, for example, the surgical robot configurations described in U.S. Pat. No. 8,571,638, the contents of which being hereby incorporated by reference herein in its entirety. In some embodiments, robot  130  is not physically connected with the patient anatomy, for example, a navigation system, as described herein, registers the patient anatomy with respect to the location of robot  130 , which includes the location of the robot&#39;s end effector  120 , such that robotic arm  126  extends and moves relative to the base of robot  130  to assist in surgical procedures. 
     In some embodiments, the surgical robotic guidance system includes a control unit  132  that matches data from CT scans and C-arm images to locate surgical robot  130  and allows a surgeon to control surgical robot  130 , through the use of a mouse, joystick, touch screen, or the like; and monitor  66 . In some embodiments, control unit  132  may include a central processing unit (CPU) and user interface communicating with monitor  66  and robot  130 . Robot  130  aligns end effector  120  and surgical instrument  12  with a surgical site requiring a surgical procedure percutaneously, mini-open or in open procedures. 
     In assembly, operation and use, spinal instrument system  10 , similar to the systems and methods described herein, is employed with a surgical procedure, such as, 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 instrument system  10  can be delivered or utilized as a pre-assembled device or can be assembled in situ. Spinal instrument system  10  may be completely or partially revised, removed or replaced. 
     In use, to treat vertebrae V, 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 instrument system  10  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 1 , V 2  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. 
     The surgical robotic guidance system includes intra-operative guidance such that a surgeon directs robot  130  to guide surgical instruments, as described herein, and implants at a trajectory and position. Robot  130  responds and moves end effector  120 , which includes an axial trajectory guide, for example, channel  124  and/or a sleeve disposed with surface  122 , into position, such that a surgical instrument disposed with end effector  120  can be aligned with a location. In some embodiments, the surgeon can insert a spinal construct component and/or surgical instrument with end effector  120  and visually verify positioning of the spinal construct component and/or surgical instrument from control unit  132  and/or monitor  66 . In some embodiments, a surgeon can manipulate robot  86  by use of a joystick, mouse and/or touch screen. 
     Channel  124  of end effector  120  provides an axial guide for surgical instruments according to an implant strategy and/or a surgical pathway for delivery of components of spinal instrument system  10 , which may include, such as, for example, drivers, extenders, reducers, spreaders, distractors, blades, clamps, forceps, elevators and drills, which may be alternately sized and dimensioned, and arranged as a kit. In some embodiments, the surgeon disposes a sleeve (not shown) with end effector  120 , which provides an axial guide. 
     For example, as shown in  FIGS. 4-6 , a surgical procedure includes selecting an implant trajectory T 1  of an insertion path and positioning of a surgical instrument  12   a,  similar to surgical instrument  12  described herein, with a lateral side of a vertebra V 1 . Implant trajectory T 1  includes an axial or linear pathway for delivering surgical instruments to a selected location of the lateral side of vertebra V 1 . In some embodiments, implant trajectory T 1  includes delivering spinal construct components to a selected location of the lateral side of vertebra V 1 , 
     A surgeon moves robot  130  such that channel  124  is aligned with screw trajectory T 1 . In some embodiments, surface  122  of end effector  120  may be connected, attached or monolithically formed with a sleeve, cannula and/or dilator to define the surgical pathway along screw trajectory T 1  to vertebra V 1 . A drill (not shown) is disposed within the surgical pathway. The drill is translated by the surgeon through channel  124  in alignment with screw trajectory T 1 . The drill is actuated to create a pilot hole in vertebra V 1  along implant trajectory T 1 . The drill is removed from the surgical pathway. 
     A driver  200   a,  similar to driver  200  described herein, is connected with surgical instrument  12   a,  as described herein. Alignment of channel  124  with screw trajectory T 1  is maintained and the surgeon positions surgical instrument  12   a  within the surgical pathway of channel  124 . Surgical instrument  12   a  is translated by the surgeon along the surgical pathway in alignment with implant trajectory T 1  and engaged with tissue of vertebra V 1 . With surgical instrument  12   a  engaged with the tissue of vertebra V 1 , for example, a pedicle, marker  24  is detected via imaging, as described herein, to confirm location and trajectory of surgical instrument  12   a,  for example, to confirm alignment with implant trajectory T 1 . Surgical instrument  12   a  is actuated for rotation to create threads in vertebra V 1  about the pilot hole. In some embodiments, surgical instrument  12   a  remains engaged with vertebra V 1  such that surgical instrument  12   a  provides guidance with vertebral tissue and/or manipulation of vertebrae V, as described herein. In some embodiments, surgical instrument  12   a  may be engaged with various portions of a vertebra, for example, anterior, posterior, interbody, intrabody, facet, laminae and/or one or more process. 
     In some embodiments, an implant trajectory T 2  is selected of an insertion path and positioning of a surgical instrument  12   b,  similar to surgical instrument  12  described herein, with a contra-lateral side of vertebra V 1 , similar to implant trajectory T 1  described herein, to create a pilot hole in vertebra V 1  along screw trajectory T 2 . The surgeon moves robot  130  such that channel  124  is aligned with screw trajectory T 2 . The drill is disposed within the surgical pathway. The drill is translated by the surgeon through channel  124  in alignment with screw trajectory T 2 . The drill is actuated to create a pilot hole in vertebra V 1  along implant trajectory T 2 . The drill is removed from the surgical pathway. 
     A driver  200   b,  similar to driver  200  described herein, is connected with surgical instrument  12   b.  Alignment of channel  124  with screw trajectory T 2  is maintained and the surgeon positions surgical instrument  12   b  within the surgical pathway of channel  124 . Surgical instrument  12   b  is translated by the surgeon along the surgical pathway in alignment with implant trajectory T 2  and engaged with tissue of vertebra V 1 . With surgical instrument  12   b  engaged with the pedicle of vertebra V 1 , marker  24  is detected via imaging, as described herein, to confirm location and alignment of surgical instrument  12   b  with implant trajectory T 2 . Surgical instrument  12   b  is actuated for rotation to create threads in vertebra V 1  about the pilot hole. 
     In some embodiments, an implant trajectory T 3  is selected of an insertion path and positioning of a surgical instrument  12   c,  similar to surgical instrument  12  described herein, with a lateral side of vertebra V 2 , similar to implant trajectory T 1  described herein, to provide guidance with vertebral tissue, tissue tapping and/or manipulation of vertebrae V, as described herein, In some embodiments, an implant trajectory T 4  is selected of an insertion path and positioning of a surgical instrument  12   d,  similar to surgical instrument  12  described herein, with a contra-lateral side of vertebra V 2 , similar to implant trajectory T 2  described herein, to provide guidance with vertebral tissue, tissue tapping and/or manipulation of vertebrae V, as described herein. 
     In some embodiments, spinal instrument system  10  is employed with a pedicle subtraction osteotomy (PSO) procedure for treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body. A preparation instrument (not shown) is employed to remove disc tissue, fluids, adjacent tissues and/or bone, and scrape and/or remove tissue from endplate surfaces of vertebra V 1  and/or endplate surface of vertebra V 2 . In some embodiments, vertebral facets are resected. A discectomy is performed to create vertebral space S between vertebral bodies V 1 , V 2 . 
     A compressor/distractor instrument, such as, for example, a distractor (not shown) is translated by the surgeon along the surgical pathway in alignment with screw trajectories T 1 , T 3  for engagement with surgical instrument  12   a / 200   a  and surgical instrument  12   c / 200   c,  and connection with the lateral side of vertebrae V. A second distractor (not shown) is translated by the surgeon along the surgical pathway in alignment with screw trajectories T 2 , T 4  for engagement with surgical instrument  12   b / 200   b  and surgical instrument  12   d / 200   d,  and connection with the contra-lateral side of vertebrae V The connection of the distractors with the surgical instruments described herein facilitates lateral distraction and/or parallel distraction. Surgical instruments  12   a - d  remain engaged with vertebrae V 1 , V 2  and connected to drivers  200  and the distractors to manipulate and/or relatively rotate selected vertebra of vertebrae V. 
     Each distractor is manipulated to axially translate an arm along a rack to facilitate compression and/or distraction of vertebrae V The distractors selectively rotate surgical instruments  12   a - d  / 200   a - d  to rotate vertebra V 1  relative to vertebra V 2  to decompress intervertebral space S between vertebrae V, relieve disc pressure, realign one or more vertebra and/or reduce compression on the spinal cord and adjacent nerves. In some embodiments, a spinal implant, such as, for example, an interbody implant (not shown) is disposed within intervertebral space S. 
     In some embodiments, one or more of surgical instruments  12   a - d  are configured as provisional instruments and are removed for engagement of permanent bone screws (not shown) with vertebrae V. In some embodiments, the permanent bone screws can be engaged with vertebrae V via the surgical robotic guidance system and similar to that described herein with regard to surgical instrument  12 . 
     In one embodiment, as shown in  FIG. 7 , spinal instrument system  10 , similar to the systems and methods described herein, includes a surgical instrument  312 , similar to surgical instrument  12  described herein. Surgical instrument  312  includes a shaft  314 . Shaft  314  extends between a proximal portion  316  and a distal portion  318 . Portion  316  includes a head  320 . Head  320  includes a surface  317  that defines an opening  319 . Opening  319  is disposed in communication with a passageway  330 . In some embodiments, head  320  can include a cylindrical or a spherical configuration. In some embodiments, head  320  includes a mating element, such as, for example, surfaces that define recesses  322  configured to facilitate engagement with a surgical instrument, as described herein. Portion  316  is configured for connection with one or a plurality of surgical instruments, as described herein, to facilitate manipulation of surgical instrument  312  and/or tissue. Head  320  comprises a detectable marker, for example, a pedicle marker  324 , similar to that described herein. Marker  324  is utilized to mark a location and/or a trajectory of a pedicle screw placement. 
     Distal portion  318  has a cylindrical cross-sectional configuration and includes an outer surface having an external thread form. In some embodiments, portion  318  is configured to form an internal or female thread in tissue such that a spinal implant, such as, for example, a pedicle screw can be threaded into the internal thread formed by surgical instrument  312 . 
     Portion  318  includes an inner surface  328  that defines a cavity, such as, for example, a passageway  330  forming a cannulated shaft  314 . In some embodiments, passageway  330  is configured for disposal of a surgical tool, such as, for example, a guide wire to facilitate minimally invasive procedures. In one embodiment, surgical instrument  312  is employed with driver  200 , as shown in  FIG. 8 , and similar to that described herein with regard to surgical instrument  12 . In some embodiments, surgical instrument  12 , and similarly surgical instrument  312 , is employed with a driver  220 , as shown in  FIG. 9 , which includes tabs  223  configured for engagement with recesses  22  of surgical instrument  12  in an external connection with surgical instrument  12 . 
     In some embodiments, spinal instrument system  10  may include one or a plurality of spinal constructs. In some embodiments, the spinal constructs may be disposed in various alternate orientations, such as, for example, side by side, parallel, transverse and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, the spinal constructs including spinal rods may provide a template configuration for permanently implantable spinal rods, such as, implantable, final, permanent, removable, non-removable, bio-absorbable, resorbable and/or bio-degradable, and/or comprise permanently implantable spinal rods. 
     Upon completion of a procedure, the surgical instruments and non-implanted components of spinal instrument system  10  are removed and the incision(s) are closed. One or more of the components of spinal instrument system  10  can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of spinal instrument system  10 . 
     In some embodiments, spinal instrument system  10  includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of spinal instrument system  10 . In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the fixation elements with vertebrae. In some embodiments, the agent may be HA coating, 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. 
     It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.