Patent Publication Number: US-2021161602-A1

Title: Surgical implant system and method

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a spinal implant system and a method for treating a spine. 
     BACKGROUND 
     Spinal pathologies and disorders such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, disc hemiation, 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. 
     SUMMARY 
     In one embodiment, a surgical instrument is provided. The surgical instrument comprises a first member including a drive engageable with a first mating surface of a bone fastener. A second member is rotatable relative to the first member and includes an engagement element connectable with a second mating surface of the bone fastener. A part is disposed with the first member and is alternately connectable with an actuator and an adaptor attachable with an image guide. In some embodiments, systems, surgical adaptors, spinal implants and methods are disclosed. 
     In one embodiment, a spinal implant system is provided. The spinal implant system comprises a surgical instrument including an outer sleeve having a drive engageable with a bone fastener shaft, and an inner sleeve being rotatable relative to the outer sleeve and including an element connectable with a threaded surface of a bone fastener receiver. A part is disposed with the outer sleeve. A removable handle is connectable with the part and engageable with the inner sleeve for rotation therewith. An adaptor is connectable with the part. An image guide is attachable with the adaptor and oriented relative to a sensor to communicate a signal representative of a position of the surgical instrument. 
     In one embodiment, the surgical system comprises a surgical instrument including an outer sleeve having a drive engageable with a bone fastener shaft, and an inner sleeve being rotatable relative to the outer sleeve and including an element connectable with a threaded surface of a bone fastener receiver. A part is disposed with the first member and alternately connectable with an actuator and an adaptor. A guide member includes an inner surface that defines a cavity configured for disposal of the outer sleeve. An image guide is attachable with the adaptor and being oriented relative to a sensor to communicate a signal representative of a position of the guide member. 
    
    
     
       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 perspective view of components of the surgical system shown in  FIG. 1 ; 
         FIG. 3  is a perspective view of the components shown in  FIG. 2  with parts separated; 
         FIG. 4  is a side, cross section view of the components shown in  FIG. 1 ; 
         FIG. 5  is a perspective view of components of the surgical system shown in  FIG. 1 ; 
         FIG. 6  is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 7  is a side, cross section view of the components shown in  FIG. 6 ; 
         FIG. 8  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 9  is a perspective view of the components shown in  FIG. 8 ; 
         FIG. 10  is a perspective view of one embodiment of components of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 11  is a perspective view of one embodiment of components of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 12  is a perspective view of one embodiment of components of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 13  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 14  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 15  is a perspective view of one embodiment of components of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 16  is a perspective view of one embodiment of components of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 17  is a side cross section view of one embodiment of components of a surgical system in accordance with the principles of the present disclosure; and 
         FIG. 18  is a side 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 the surgical system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a spinal implant system and a method for treating a spine. In some embodiments, the systems and methods of the present disclosure comprise medical devices including surgical instruments and implants that are employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine. 
     In some embodiments, the present surgical system comprises a surgical instrument that comprises a sleeveless surgically navigated driver. In some embodiments, the present surgical system comprises a surgical instrument that comprises a sleeveless surgically navigated driver employed with a surgical robotic guidance system. In some embodiments, the driver can be connected with extended tabs of a bone screw. In some embodiments, the driver can be connected with a break-away adapter. In some embodiments, the driver can be connected with fenestrated screws connectable with bone filler device (BFD) attachments. In some embodiments, the driver can be employed with a bone screw that provides bi-cortical fixation to enhance fixation with vertebrae and reduce the risk of screw loosening when used with a biologic or agent, for example, bone cement (PMMA), and/or reduce the risk of biologic or agent leakage outside of a vertebral body. 
     In some embodiments, the present surgical system comprises a surgical instrument that comprises a screw driver. In some embodiments, the driver is configured for use with a spinal implant, such as, for example, a bone fastener or screw. The bone fastener may include open tulip head receivers and/or closed tulip head receivers. In some embodiments, the driver can be employed with a posted screw, a pedicle screw, a bolt, a bone screw for a lateral plate, a uni-axial screw (UAS), a fixed angle screw (FAS), a multi-axial screw (MAS), a side loading screw, a sagittal adjusting screw (SAS), a transverse sagittal adjusting screw (TSAS), an awl tip (ATS) or a sacral bone screw. 
     In some embodiments, the present surgical system comprises a surgical driver instrument that comprises an internal thread to align/tighten a bone screw to the driver. In some embodiments, the driver employs a navigated break away adapter that provides a shortened over-all length of the driver and streamlines multiple-screw placement. In some embodiments, the driver includes a tip configured to mate with ATS, MAS, and SAS fenestrated screws. In some embodiments, the present surgical system comprises a surgical driver instrument employed with a handle. In some embodiments, the handle can be employed to tighten/align bone screws with the driver. In some embodiments, the handle can be used as a punch configured to displace material, for example, cement, which may become trapped in the driver tip. 
     In some embodiments, the present surgical system comprises a surgical driver instrument that includes an internal thread capture of a receiver of a bone screw. In some embodiments, the present surgical system comprises a surgical driver instrument that is engageable with driver tips for ATS, MAS and SAS bone screws. In some embodiments, the surgical driver instrument comprises a removable handle configured to tighten/align a screw to the driver. In some embodiments, the handle includes a tip configured as a punch that avoids cement overflow for fenestrated screws. 
     In some embodiments, the present surgical system comprises a surgical instrument that comprises a screw driver with a disengagement feature. In some embodiments, the driver is configured for use with a spinal implant, such as, for example, a bone fastener. The bone fastener may include open tulip head receivers and/or closed tulip head receivers. In some embodiments, the driver includes an inner thread to retain the bone fastener with the driver. In some embodiments, the screw driver is employed with robotic guidance. In some embodiments, the driver includes an inner shaft having a Torx tip configured for engagement with the bone fastener. 
     In some embodiments, the present surgical system comprises a surgical instrument that comprises a screw driver that can be employed with bone fasteners and one or more implant supports for treating a spine. In some embodiments, the present surgical system includes a surgical instrument that can easily connect and disconnect from a bone fastener. In some embodiments, the present surgical system includes a surgical instrument that can be employed with an end effector of a robotic arm to facilitate implant with the robotic arm. In some embodiments, the surgical instrument is guided through the end effector for a guide-wireless screw insertion. In some embodiments, the surgical instrument comprises a robot screw driver employed with robotic and/or navigation guidance, which may include an image guide. 
     In some embodiments, the present surgical system includes a screw driver having an outer shaft and a drive tip that engages a bone fastener. In some embodiments, the outer shaft and the drive tip are of one piece construction. In some embodiments, the one piece construction allows tolerances to be controlled tightly for improved accuracy of trajectory during implant insertion. In some embodiments, the drive tip includes a Torx configuration. In some embodiments, the present surgical system includes a screw driver having an internal retention mechanism. In some embodiments, the retention mechanism is fixed with a receiver of a bone fastener to resist and/or prevent disengagement of the retention mechanism from the receiver, for example, due to connection or friction with the end effector or tissue. 
     In some embodiments, the present surgical system includes a screw driver for use with robotic surgery. In some embodiments, the screw driver can be employed with FAS, UAS, SAS, TSAS and MAS, and allows the screws to be driven through a robotic end effector. In some embodiments, the screw driver includes a one piece outer sleeve having a tip. In some embodiments, the screw driver includes an internal retaining device that prevents accidental disengagement and/or unthreading. 
     In some embodiments, the present surgical system includes a screw driver including an outer shaft or sleeve having an outside diameter that is slightly larger than a screw spin diameter of a bone screw. This configuration allows the bone screw and the screw driver to pass through the end effector. In some embodiments, the screw driver includes a handle that is connected to a retention screw that threads into the bone screw. In some embodiments, the present surgical system includes tab extenders connected to the screw driver and prevented from extending outside the outside diameter of the screw driver by engaging undercuts of the screw driver. This configuration prevents an interference or hang-up if the bone screw needs to be removed through the end effector. 
     In some embodiments, the screw driver is configured for connection with a bone filler device. In some embodiments, the screw driver is cannulated. In some embodiments, connection of the bone filler device allows for injection of bone cement without removal of the screw driver. In some embodiments, the navigation component of the driver can facilitate determination of screw placement for disposal of bone cement therewith. In some embodiments, the navigation component can provide a secondary confirmation to check screw placement, driver trajectory and/or assess if a three dimensional navigation component spin has been compromised. 
     In some embodiments, the screw driver is connected with the adaptor. In some embodiments, the screw driver is connected with the navigation component by a flange of the screw driver. In some embodiments, the adaptor and the navigation component provide for navigation and torque. In some embodiments, the adaptor and navigation component are removed from the driver after a bone fastener is engaged with tissue. In some embodiments, the bone filler device is engaged with the flange of the screw driver and a shaft of the bone filler device is disposed through the screw driver. In some embodiments, the bone filler device injects cement into the bone fastener through the screw driver. 
     In some embodiments, the surgical system includes a handle configured as a hex key. In some embodiments, the hex key is configured to lock and/or unlock the driver. In some embodiments, the hex key includes an extension sized for disposal with a cannulated portion of the driver tip. In some embodiments, the extension is configured to punch and/or dislodge bone cement that may have leaked inside the cannulated portion of the driver tip. In some embodiments, the extension is configured to facilitate removal of bone cement from the cannulated portion. 
     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, 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. In some embodiments, as used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise. 
     The following discussion includes a description of a surgical system including a surgical instrument, related components and methods 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  FIGS. 1-13 , there are illustrated components of a surgical system, such as, for example, a spinal implant system  10 . 
     The components of spinal implant 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 implant 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. 
     Various components of spinal implant system  10  may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of spinal implant 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 implant system  10  may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. 
     Spinal implant system  10  is employed, for example, with a fully open surgical procedure, a minimally invasive procedure including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrumentation and/or a spinal implant, such as, for example, a bone fastener, at a surgical site of a patient, which includes, for example, a spine. In some embodiments, the spinal implant can include one or more components of one or more spinal constructs, such as, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft, and can be employed with various surgical procedures including surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine. 
     Spinal implant system  10  includes a surgical instrument, such as, for example, a driver  12 . Driver  12  can be employed with a guide member, such as, for example, an end effector  200  ( FIGS. 8, 9, 11 and 12 ) of a robotic arm R ( FIG. 13 ) to facilitate implant with robotic arm R. Driver  12  is guided through end effector  200  for guide-wireless insertion of a spinal implant, such as, for example, a bone fastener  100 , as described herein. See also, the examples and disclosure of surgical instruments, spinal implant systems and methods shown and described in commonly owned and assigned U.S. patent application Ser. No. ______(Attorney Docket No. A0000294US01) filed ______, 2018, and published as U.S. Patent Application Publication No. ______, on ______, ______, the entire contents of which being incorporated herein by reference. 
     Driver  12  includes a member, such as, for example, a tubular outer sleeve  14 . Outer sleeve  14  extends between a proximal end  18  and a distal end  20 . Outer sleeve  14  defines a longitudinal axis a. In some embodiments, outer sleeve  14  may have various configurations including, for example, round, oval, polygonal, irregular, consistent, variable, uniform and non-uniform. Outer sleeve  14  includes a diameter D 1 . In some embodiments, diameter D 1  is slightly larger than a screw spin diameter D 2  of bone fastener  100 . This configuration allows bone fastener  100  and driver  12  to pass through end effector  200  of robotic arm R, as described herein. 
     Outer sleeve  14  includes a surface  50  that defines a channel  52 . Channel  52  is configured for disposal of a member, such as, for example, an inner shaft  56  and an engagement element, such as, for example, a screw  64 , as described herein. Driver  12  includes a part  58  disposed with sleeve  14 . Part  58  is alternately connectable with an actuator and an adaptor attachable with an image guide, as described herein. Part  58  has a flange  80  and a flange  82  that is spaced apart from flange  80  by a recess  84 . Part  58  has a surface  86  that defines a cavity  88  alternately configured for disposal of an actuator, such as, for example, a removable handle  90  therein and an adaptor, such as, for example, an adaptor  250  therein. See also, the examples and disclosure of surgical instrument adaptors, spinal implant systems and methods shown and described in commonly owned and assigned U.S. patent application Ser. No. ______ (Attorney Docket No. C00017501.USU1) filed ______, 2018, and published as U.S. Patent Application Publication No. ______, on ______, ______, the entire contents of which being incorporated herein by reference. Cavity  88  is in alignment with channel  52  to facilitate insertion of inner shaft  56  into end  18 , through part  58  and into channel  52  for assembly, as described herein. Handle  90  is configured to actuate rotation of inner shaft  56  and screw  64 , as described herein. Handle  90  includes a shaft  92  and a gripping portion  94  that is connected with shaft  92 . Shaft  92  extends through part  58  such that shaft  92  is rotatable relative to part  58 . 
     Inner shaft  56  extends between an end  60  and an end  62 . End  60  is engageable with shaft  92  for rotation of inner shaft  56  and screw  64 , as described herein. Shaft  92  includes a surface  96  that engages a surface  66  of inner shaft  56  in an interference fit to facilitate simultaneous rotation of handle  90  and inner shaft  56 . In some embodiments, shaft  92  includes various configurations, such as, for example, hexalobe, cruciform, phillips, square, hexagonal, polygonal, star cross sectional configuration for a mating engagement with correspondingly shaped portion of surface  66 . In some embodiments, a distal end of handle  90  includes a punch  98  that is connected with shaft  92 . Punch  98  has a maximum diameter that is less than a maximum diameter of shaft  92 . Punch  98  is configured to dislodge material, such as, for example, cement that may trapped in a tip of driver  12 . 
     Screw  64  includes an inner surface  68  that defines a cavity  70  configured for disposal of a correspondingly shaped portion of end  62  of inner shaft  56 . Surface  68  engages inner shaft  56  in an interference fit to facilitate simultaneous rotation of inner shaft  56  and screw  64 , as described herein. In some embodiments, cavity  70  includes various configurations, such as, for example, hexalobe, cruciform, phillips, square, hexagonal, polygonal, star cross sectional configuration for a mating engagement with a correspondingly shaped end  62 . Screw  64  includes an outer surface having an engagement element, such as, for example, a thread form  72 . Thread form  72  is configured for engagement with a mating surface, such as, for example, thread forms of arms  104 ,  106  of bone fastener  100  to pull and or draw bone fastener  100  into engagement with driver  12 , as described herein. 
     Inner shaft  56  and screw  64  are configured for movement relative to outer sleeve  14 . Screw  64  is inserted laterally into channel  52 . Inner shaft  56  is inserted axially into channel  52  such that end  62  is positioned within cavity  70  and surface  68  engages inner shaft  56  in an interference fit. Part  58  is inserted axially into sleeve  14  to connect part  58  with sleeve  14  such that part  58  engages sleeve  14  in an interference fit. Shaft  92  is inserted axially through cavity  88  and into inner shaft  56  such that surface  96  engages surface  66  in an interference fit to facilitate simultaneous rotation of handle  90  and inner shaft  56 . Inner shaft  56  retains screw  64  with sleeve  14 . 
     End  20  of outer sleeve  14  includes a distal tip, such as, for example, drive  22 . In some embodiments, drive  22  is integrally connected or monolithically formed with outer sleeve  14 . This configuration facilitates control of tolerances to optimize accuracy of the connection of outer sleeve  14  with bone fastener  100 . In some embodiments, drive  22  is removably connected with outer sleeve  14 . Drive  22  is engageable with a spinal implant, such as, for example, bone fastener  100 . For example, drive  22  fits with and is engageable with a mating surface, such as, for example, a socket  110  of bone fastener  100 . Rotation of outer sleeve  14  simultaneously rotates drive  22  to drive, torque, insert or otherwise connect bone fastener  100  with tissue, as described herein. In some embodiments, drive  22  includes a hexalobe geometry for a mating engagement with a correspondingly shaped socket  110 . In some embodiments, drive  22  can alternatively include a cruciform, phillips, square, hexagonal, polygonal, star cross sectional configuration for disposal of a correspondingly shaped socket  110 . 
     Outer sleeve  14  includes an extension  30  and an extension  32 . Extensions  30 ,  32  include a wall  34  having a surface  36 . Surface  36  is connectable with an implant support, such as, for example, an extender tab  152 , as described herein. Surface  36  defines a mating groove, such as, for example, a pocket  38  configured for engagement with extender tab  152 , as described herein. Surface  36  is configured to resist and/or prevent disengagement of extender tab  152  from pocket  38 , as described herein. 
     Extensions  30 ,  32  include a wall  40  having a surface  42 . Surface  42  is connectable with an implant support, such as, for example, an extender tab  152   a , as described herein. Surface  42  defines a mating groove, such as, for example, a pocket  44  configured for engagement with extender tab  152   a , as described herein. Surface  42  is configured to resist and/or prevent disengagement of extender tab  152   a  from pocket  44 , as described herein. 
     Pockets  38 ,  44  are configured for engagement with extender tabs  152 ,  152   a . Disposal of extender tabs  152 ,  152   a  with pockets  38 ,  44  is configured to resist and/or prevent extender tabs  152 ,  152   a  from increasing diameter D 1  when engaged with driver  12 . In some embodiments, pockets  38 ,  44  are disposed parallel to axis a. In some embodiments, pockets  38 ,  44  are disposed at alternate orientations relative to axis a, such as, for example, at transverse, perpendicular and/or other angular orientations such as acute or obtuse, and/or may be offset or staggered. 
     Bone fastener  100  includes a receiver  102 . Receiver  102  extends along axis a when connected with outer sleeve  14 . Receiver  102  includes arms  104 ,  106 . Arms  104 ,  106  define an implant cavity configured for disposal of a component of a spinal construct, such as, for example, a spinal rod (not shown). Receiver  102  includes an inner surface having a thread form located adjacent arm  104  and a thread form located adjacent arm  106 . The thread forms of arms  104 ,  106  are configured for engagement with thread form  72  to retain bone fastener  100  with driver  12 , as described herein. Bone fastener  100  includes a threaded shaft  116 . Shaft  116  is configured to penetrate tissue, such as, for example, bone. 
     Arm  104  includes a break away tab  120  that is frangibly connected to arm  104  such that manipulation of tab  120  relative to arm  104  can fracture and separate tab  120  from arm  104  at a predetermined force and/or torque limit, as described herein. Arm  106  includes a break away tab  130  that is frangibly connected to arm  106  such that manipulation of tab  130  relative to arm  106  can fracture and separate tab  130  from arm  106  at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to tabs  120 ,  130  and resistance increases, for example, the predetermined torque and force limit is approached. 
     In some embodiments, tabs  120 ,  130  can fracture and separate at a predetermined force or torque limit, which may be in a range of approximately 2 Newton meters (N-m) to 8 N-m. In some embodiments, tabs  120 ,  130  and arms  104 ,  106  may have the same or alternate cross section configurations, may be fabricated from a homogenous material or heterogeneously fabricated from different materials, and/or alternately formed of a material having a greater degree, characteristic or attribute of plastic deformability, frangible property and/or break away quality to facilitate fracture and separation of tabs  120 ,  130 . 
     A bone fastener assembly  150  includes extender tabs  152 ,  152   a  connected with bone fastener  100 . Extender tabs  152 ,  152   a  extend between a proximal end  172  and a distal end  174 . Proximal end  172  includes spring tips  176 ,  178 , as shown in  FIG. 5 . Spring tips  176 ,  178  are aligned and disposable with pockets  38 ,  44 . Surfaces  36 ,  42  are configured to resist and/or prevent disengagement of spring tips  176 ,  178 , as described herein. Distal ends  174  are configured for slidable disposal of a portion of bone fastener  100 , such as, for example, tabs  120 ,  130 . In some embodiments, tabs  120 ,  130  are configured to releasably fix extender tabs  152 ,  152   a  with bone fastener  100  for connection with outer sleeve  14 . 
     In use, bone fastener assembly  150  is connected with driver  12 , as described herein, and drive  22  is oriented for engagement with socket  110 . Drive  22  is engaged with socket  110  and screw  64  is disposed with inner shaft  56  and assembled with outer sleeve  14  for axial translation relative to outer sleeve  14  and along inner shaft  56  between a non-locking configuration, as shown in  FIG. 2 , and a locking configuration, as shown in  FIG. 4 , with a spinal implant, such as, for example, bone fastener  100 . In the non-locking configuration, screw  64  is freely translatable relative to inner shaft  56  within channel  52 , in the direction shown by arrows A in  FIG. 2 , and rotatable relative to outer sleeve  14 . This configuration allows drive  22  to engage socket  110  prior to fixation of screw  64  with bone fastener  100 . 
     With bone fastener assembly  150  connected with outer sleeve  14 , thread form  72  is aligned with the thread forms of arms  104 ,  106  for engagement therebetween to retain bone fastener  100  with driver  12 . Screw  64  is keyed with end  62  for simultaneous rotation with inner shaft  56  and handle  90 . Handle  90  is manipulated for rotation such that inner shaft  56  rotates screw  64  relative to and independent of outer sleeve  14 . Thread form  72  engages the thread forms of arms  104 ,  106  and screw  64  axially translates into receiver  102  and relative to inner shaft  56 . The threaded engagement of screw  64  and receiver  102  pulls and/or draws bone fastener  100  into the locking configuration with driver  12  for releasable fixation therebetween. Drive  22  is connected with outer sleeve  14 , as described herein, and outer sleeve  14  is rotated to drive, torque, insert or otherwise connect bone fastener  100  with adjacent tissue. Screw  64  remains releasably fixed with receiver  102 , independent of outer sleeve  14  rotation and/or engagement or friction with components of spinal implant system  10  as described herein, to resist and/or prevent disengagement or unthreading of screw  64  from receiver  102 . 
     In some embodiments, as shown in  FIGS. 6 and 7 , handle  90  is removed from inner shaft  56 , sleeve  14  and part  58  after screw  64  is moved from the non-locking configuration to the locking configuration and an instrument, such as, for example, adaptor  250  is connected with driver  12  by inserting adaptor  250  through part  58  such that a tip  252  of adaptor  250  is positioned within shaft  56 . Adaptor  250  is configured to connect an image guide, such as, for example, a navigation component  300  to driver  12  and/or to connect an actuator, such as, for example, actuator  450  to driver  12 , as described herein. Adaptor  250  is fixed relative to shaft  56  and is rotatable relative to part  58 . In some embodiments, adaptor  250  is connected to shaft  56  such that adaptor  250  is fixed relative to shaft  56  such that rotation of adaptor  250  also rotates shaft  56 . For example, in some embodiments, tip  252  has a polygonal cross sectional configuration, such as, for example, a hexagonal cross sectional configuration and surface  66  of shaft  56  has a polygonal cross sectional configuration, such as, for example, a hexagonal cross sectional configuration that corresponds to the cross sectional configuration of tip  252  such that tip  252  directly engages surface  66  to prevent adaptor  250  from rotating relative to shaft  56 . 
     In some embodiments, driver  12  includes navigation component  300 , as shown in  FIGS. 10-13 . Navigation component  300  is configured to connect to adaptor  250  and part  58  to couple navigation component  300  to driver  12 , as discussed herein. Driver  12  is configured for disposal adjacent a surgical site such that navigation component  300  is oriented relative to a sensor array  302  to facilitate communication between navigation component  300  and sensor array  302  during a surgical procedure, as described herein. Navigation component  300  is configured to generate a signal representative of a position of bone fastener  100  relative to driver  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, navigation component  300  is connected with adaptor  250  or part  58  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  300  includes an emitter array  304 . Emitter array  304  is configured for generating a signal to sensor array  302  of a surgical navigation system  306 , as shown in  FIG. 13  and described herein. In some embodiments, the signal generated by emitter array  304  represents a position of bone fastener  100  relative to driver  12  and relative to tissue, such as, for example, bone. In some embodiments, the signal generated by emitter array  304  represents a three dimensional position of bone fastener  100  relative to tissue. 
     In some embodiments, sensor array  302  receives signals from emitter array  304  to provide a three-dimensional spatial position and/or a trajectory of bone fastener  100  relative to driver  12  and/or tissue. Emitter array  304  communicates with a processor of computer  308  of navigation system  306  to generate data for display of an image on monitor  310 , as described herein. In some embodiments, sensor array  302  receives signals from emitter array  304  to provide a visual representation of a position of bone fastener  100  relative to driver  12  and/or 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. 
     Surgical navigation system  306  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  306  can include an O-ARM® imaging device  320  sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo., USA. Imaging device  320  may have a generally annular gantry housing that encloses an image capturing portion  312 . 
     In some embodiments, navigation system  306  comprises an image capturing portion  314  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  314 . Image capturing portion  314  can be operable to rotate 360 degrees during image acquisition. Image capturing portion  314  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  306  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, surgical navigation system  306  can include C-arm fluoroscopic imaging systems, which can generate three-dimensional views of a patient. The position of image capturing portion  314  can be precisely known relative to any other portion of an imaging device of navigation system  306 . In some embodiments, a precise knowledge of the position of image capturing portion  314  can be used in conjunction with a tracking system  316  to determine the position of image capturing portion  314  and the image data relative to the patient. 
     Tracking system  316  can include various portions that are associated or included with surgical navigation system  306 . In some embodiments, tracking system  316  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  302  and/or an EM tracking system that can include an EM localizer. Various tracking devices can be tracked with tracking system  316  and the information can be used by surgical navigation system  306  to allow for a display of a position of an item, such as, for example, a patient tracking device, an imaging device tracking device  318 , and an instrument tracking device, such as, for example, emitter array  304 , 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. 
     Fluoroscopic images taken are transmitted a computer  314  where they may be forwarded to computer  308 . Image transfer may be performed over a standard video connection or a digital link including wired and wireless. Computer  308  provides the ability to display, via monitor  310 , 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  306  provides for real-time tracking of the position of bone fastener  100  relative to driver  12  and/or tissue can be tracked. Sensor array  302  is located in such a manner to provide a clear line of sight with emitter array  304 , as described herein. In some embodiments, fiducial markers  330  of emitter array  304  communicate with sensor array  302  via infrared technology. Sensor array  302  is coupled to computer  308 , which may be programmed with software modules that analyze signals transmitted by sensor array  302  to determine the position of each object in a detector space. 
     Navigation component  300  includes a collar  406  having an inner surface  408  and an outer surface  410 . Surface  408  defines a passageway  412 . Surface  408  is configured for releasable engagement with part  58 , as discussed herein. Passageway  412  is configured to receive part  58 . Surface  408  defines a lock, such as, for example, at least one resilient prong or tab  414 . In one embodiment, collar  406  includes a plurality of tabs  414 , as shown in  FIG. 10 . Each tab  414  includes an inner surface  416  that defines a cutout  418  and an outer surface  420 . Each cutout  418  includes raised portions  422  that define edges of cutout  418 . Cutout  418  is configured to receive flange  80 . In its initial position, surface  420  is aligned with surface  410  of collar  406 . 
     Navigation component  300  is connected with adaptor  250  and driver  12 , as discussed herein. To connect navigation component  300  with adaptor  250  and driver  12 , collar  406  is translated over a shaft  252  of adaptor  250 , in the direction shown by arrow B in  FIG. 6 , such that flange  80  engages portions  422  and applies a force to tabs  414  to move tabs  414  outwardly, in the direction shown by arrows C in  FIG. 10 , such that surface  420  is deflected from surface  410 . As flange  80  translates over portions  422 , flange  80  moves into cutouts  418  allowing tabs  414  to move back to their initial position. In some embodiments, navigation component  300  is configured for removable engagement with adaptor  250  and driver  12 . In some embodiments, navigation component  300  may be integrally formed with adaptor  250  and/or driver  12 . In one embodiment, flange  82  is configured to engage collar  406  to reduce vibrations resulting from the torque of an actuator, such as, for example, actuator  450 . 
     Driver  12  is configured for use with end effector  200  of robotic arm R. End effector  200  includes a surface  202  that defines a cavity, such as, for example, a channel  204 . Channel  204  is configured for passage of bone fastener assembly  150  and disposal of driver  12 . 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  200  in three dimensional space for a guide-wireless insertion of bone fasteners  100  with selected vertebral levels. In some embodiments, the position sensors of robotic arm R are employed in connection with surgical navigation system  306  to measure, sample, capture and/or identify positional data points of end effector  200  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  200  in three dimensional space, which are communicated to computer  308 . In some embodiments, effector  200  is connected with driver  12  after navigation component  300  is connected with adaptor  250  and driver  12 . In some embodiments, effector  200  is connected with driver  12  before navigation component  300  is connected with adaptor  250  and driver  12 . 
     In assembly, operation and use, spinal implant 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 implant system  10  can be delivered or utilized as a pre-assembled device or can be assembled in situ. Spinal implant system  10  may be completely or partially revised, removed or replaced. 
     In use, to treat vertebrae (not shown), a medical practitioner obtains access to a surgical site in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, spinal implant system  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 the vertebrae is 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 implantation of components of spinal implant system  10 . A preparation instrument (not shown) can be employed to prepare tissue surfaces of the vertebrae as well as for aspiration and irrigation of a surgical region. 
     Pilot holes (not shown) are made in selected levels of vertebrae for receiving bone fasteners  100 . Bone fastener assembly  150  is connected with driver  12 , as described herein. Drive  22  is engaged with socket  110  and screw  64  is disposed in a non-locking configuration, as described herein, such that screw  64  is freely translatable relative to inner shaft  56  within channel  52  and rotatable relative to outer sleeve  14 . With bone fastener assembly  150  connected with outer sleeve  14 , handle  90  is manipulated for rotation such that inner shaft  56  rotates screw  64  relative to and independent of outer sleeve  14 , as described herein. Threaded engagement of screw  64  and receiver  102  pulls and/or draws bone fastener  100  into the locking configuration with driver  12  for releasable fixation therebetween. 
     Handle  90  is removed from driver  12  and adaptor  250  is connected with driver  12 , as described herein. Navigation component  300  is connected with driver  12 , as described herein. Driver  12 , connected with bone fastener assembly  150 , is oriented for disposal with end effector  200  of robotic arm R, as described herein. The assembly of driver  12 /bone fastener assembly  150  are disposed with channel  204  for implantation of bone fasteners  100  with vertebrae employing robotic arm R and/or surgical navigation system  306 , as described herein. Actuator  450  is connected with shaft  252  and drive  22  engages bone fastener  100 , as described herein, and outer sleeve  14  is rotated to drive, torque, insert or otherwise connect bone fastener  100  with adjacent tissue. Screw  64  remains releasably fixed with receiver  102 , independent of outer sleeve  14  rotation and/or engagement or friction with end effector  200  to resist and/or prevent disengagement or unthreading of screw  64  from receiver  102 . In some embodiments, driver  12  is manipulated to deliver one or more bone fasteners  100  to a surgical site including vertebrae. Sensor array  302  receives signals from navigation component  300  to provide a three-dimensional spatial position and/or a trajectory of the assembly of driver  12 /bone fastener assembly  150 , which may be disposed with end effector  200 , relative to vertebrae and/or components of spinal implant system  10  for display on monitor  310 . 
     Upon completion of a procedure, as described herein, the surgical instruments, assemblies and non-implanted components of spinal implant system  10  are removed and the incision(s) are closed. One or more of the components of spinal implant 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, spinal implant system  10  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  10  includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of spinal implant system  10 . 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  10  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. 
     In one embodiment, as shown in  FIGS. 14-18 , spinal implant system  10 , similar to the systems and methods described herein, includes a driver  612 , similar to driver  12  described herein. Driver  612  includes a tubular outer sleeve  614 , similar to sleeve  14  described herein. Outer sleeve  614  includes a surface  650  that defines a channel  652 . Channel  652  is configured for disposal of an inner shaft  656  and a screw  664  described herein. End  620  of outer sleeve  614  includes a drive  622 , similar to drive  22  described herein. Drive  622  includes a surface  624  that defines a channel  626  such that drive  622  is cannulated. 
     Driver  612  includes a part  658 , similar to part  58  described herein, disposed with sleeve  614 . Part  658  is connectable with a surgical instrument, such as, for example, a bone cement delivery device  700 . Part  658  has a flange  680  and a flange  682  that is spaced apart from flange  680  by a recess  684 . Part  658  has a surface  686  that defines a cavity  688  configured for attachment with bone cement delivery device  700 . 
     Inner shaft  656  includes a surface  666  that defines a passageway  670 . Passageway  670  extends along inner shaft  656  forming a cannulated inner shaft  656 . Passageway  670  is disposed in communication with channel  626  such that bone cement delivery device  700  extends through an entire length of driver  612 , as shown in  FIG. 17 . Inner shaft  656  is configured for disposal of bone cement delivery device  700 . Bone cement delivery device  700  is configured to deliver bone cement to a surgical site and/or bone fastener  100 , as described herein. 
     Bone cement delivery device  700  includes a handle  702  and a shaft  704 . Handle  702  is configured for connection with driver  612 . Handle  702  includes a pair of spring arms  706 . Arms  706  are configured for a snap fit connection with part  658 . Arms  706  each include a protrusion  710 . Protrusions  706  are configured to facilitate connection of bone cement delivery device  700  with driver  612 . For example, handle  702  is manipulated for disposal with driver  612 . Arms  706  are disposed adjacent part  658 . Protrusions  710  are disposed in an initial orientation. Handle  702  is translated, in a direction shown by arrow D in  FIG. 17 . As protrusions  710  translate over flange  680 , protrusions  710  are deflected outward, in a direction shown by arrows E in  FIG. 17 , into a second, expanded orientation. As protrusions  710  translate over flange  780  into recess  684 , protrusions  710  are resiliently biased, for example, snap back to the initial orientation for disposal with recess  684 . Flanges  680 ,  682  resist and/or prevent handle  702  from disengaging from part  658  by capturing protrusions  710  within recess  684 . Bone cement delivery device  700  is configured for removable engagement with driver  612 . 
     Handle  702  includes a mating surface  708  configured for connection with a bone cement source (not shown). Shaft  704  extends through handle  702  for communication with the bone cement source. In some embodiments, the bone cement source can include a syringe or a pump including a port for connection with a source of bone cement. In some embodiments, the bone cement may include a poly(methyl methacrylate) (PMMA); methyl methacrylate (MMA); calcium phosphate; a resorbable polymer, such as, for example, PLA, PGA or combinations thereof; a resorbable polymer with allograft, such as, for example, particles or fibers of mineralized bone and/or combinations thereof. 
     In some embodiments, driver  612  includes a handle  690 , similar to handle  90  described herein, as shown in  FIG. 18 . Handle  690  is configured to actuate rotation of inner shaft  656  and screw  664 , as described herein. Handle  690  includes a shaft  692  and a gripping portion  694  that is connected with shaft  692 . In some embodiments, gripping portion  694  includes curved portions for an ergonomic configuration. Shaft  692  extends through part  658  such that shaft  692  is rotatable relative to part  658 . In some embodiments, a distal end of handle  690  includes a punch  698 , similar to punch  98  described herein. Punch  698  has a maximum diameter that is less than a maximum diameter of shaft  692  and/or channel  626  of drive  622 . Punch  698  is inserted into channel  626  of drive  622  to dislodge material, such as, for example, cement that may trapped in channel  626  of drive  622 . 
     In use, bone fastener  100  is engaged with tissue, as described herein, utilizing adaptor  250  and navigation component  300 , as shown in  FIG. 15 . Adaptor  250  and navigation component  300  are disengaged from driver  612  and driver  612  remains engaged with bone fastener  100  and vertebrae, as shown in  FIG. 16 . Bone cement delivery device  700  is engaged with driver  612  such that shaft  704  is disposed with passageway  670  and channel  626 , as shown in  FIGS. 14 and 17 . Arms  706  are engaged with part  658 , as described herein. Cement is delivered through shaft  704  for disposal with bone fastener  100 . 
     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.