Patent Publication Number: US-11642177-B2

Title: Spinal implant system and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/163,688, filed Oct. 18, 2018, which is incorporated herein by reference, in its entirety. 
    
    
     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 herniation, osteoporosis, spondylolisthesis, stenosis, tumor and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility. 
     Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. The rods may be attached via the fasteners to the exterior of two or more vertebral members. Surgical treatment may employ surgical instruments and implants that are manipulated for engagement with vertebrae to position and align one or more vertebrae. This disclosure describes an improvement over these prior technologies. 
     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 element engageable with a second mating surface of the bone fastener. The members are engageable with the bone fastener in a release configuration, an intermediate configuration and a locked configuration. In some embodiments, systems, surgical adaptors, spinal implants and methods are disclosed. 
     In one embodiment, the surgical instrument comprises an outer tubular sleeve including a drive engageable with a socket of a bone fastener shaft. An inner shaft is rotatable relative to the sleeve and includes a screw connectable with an inner threaded surface of a bone fastener receiver. Indicia of an orientation of the members with the bone fastener includes an eject position, a partially threaded position and a fully threaded position. The indicia includes a window of the first member and a marker of the second member. 
     In one embodiment, the surgical instrument comprises a first member including a window and 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 element engageable with a second mating surface of the bone fastener. The second member further includes a marker. The marker is movable relative to the window to display an indicia of a release configuration, an intermediate configuration and a locked configuration of the members with the bone fastener. 
    
    
     
       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 one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG.  3    is a side break away view of the components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG.  4    is a side break away view of the components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG.  5    is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG.  6    is a side break away view of the components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG.  7    is a side 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 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 present surgical system comprises a surgical driver instrument that includes indicia, for example, a window and/or visual indicia configured to display translation of an inner shaft relative to an outer sleeve and the bone screw. In some embodiments, the indicia includes one or markers that can be aligned with one or more markers to indicate positioning of the inner shaft relative to the bone screw between a release configuration and a locked configuration of the surgical driver with the bone screw. In some embodiments, the driver includes visual confirmation of an intermediate configuration, for example, a flexible or loosened state of the driver with the bone screw. For example, during lumbar surgeries, a vertebral curve can cause engagement and/or interference between adjacent drivers due to driver rigidity between the driver and the bone screw. 
     In some embodiments, the surgical driver instrument includes indicia configured to display an intermediate configuration comprising the inner shaft being partially threaded with the bone fastener. In some embodiments, the indicia is configured to display the surgical driver being fully engaged in the locked configuration such that the inner shaft is fully engaged with the bone screw to form a rigid connection between the driver and the bone screw. In some embodiments, the indicia is configured to display a non-locking configuration such that the inner shaft is fully disengaged from the bone screw. In some embodiments, between a locking configuration and a non-locking configuration there is an area of partially engaged or a flexible or loosened state of the driver with the bone screw in which the driver is attached to the screw head threads, but not in a rigid state, for example, the bone fastener receiver is movable relative to the bone fastener screw shaft. In some embodiments, this configuration allows the driver to use the multi-axial range of motion of the bone screw to allow the driver to counter the engagement and/or interference between adjacent drivers. In some embodiments, the indicia displays the partially engaged and/or intermediate configuration such that the driver can be tightened to the locking configuration, or loosened to the non-locking configuration, for ejecting the driver from the bone screw. 
     In some embodiments, the outer sleeve includes indicia, such as, for example, a marking or scoring. In some embodiments, a marking or scoring of the outer sleeve is configured for alignment with a marking or scoring of an extender tab of a bone screw assembly. In some embodiments, alignment of the marking or scoring displays and/or indicates a selected alignment and connection of the surgical driver instrument with the bone screw assembly. 
     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 - 9   , 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, for example, a driver  12 . Driver  12  includes a member, such as, for example, a tubular outer sleeve  14  and a member, such as, for example, an inner shaft  56  configured for translation and/or rotation relative to outer sleeve  14 . The components of driver  12  are configured for engagement and/or orientation with a bone fastener  200  for capture and release during a surgical procedure, which may include a release configuration, an intermediate configuration and a locked configuration, as described herein. Driver  12  includes indicia configured for displaying and/or indicating engagement and/or orientation of the components of driver  12 , for example, inner shaft  56  and outer sleeve  14 , with bone fastener  200 . In some embodiments, driver  12  can be employed with an end effector of a robotic arm R ( FIG.  9   ) to facilitate implant with robotic arm R. Driver  12  is guided through the end effector for guide-wireless insertion of a spinal implant, such as, for example, bone fastener  200 , 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. 16/163,666 filed Oct. 18, 2018, and published as U.S. Patent Application Publication 20200121397, on Apr. 23, 2020, the entire contents of which being incorporated herein by reference. 
     Outer sleeve  14  extends between a proximal end  18  and a distal end  20 . Outer sleeve  14  defines a longitudinal axis a, as shown in  FIG.  3   . In some embodiments, outer sleeve  14  may have various configurations including, for example, round, oval, polygonal, irregular, consistent, variable, uniform and non-uniform. In some embodiments, outer sleeve  14  includes a diameter that is slightly larger than a screw spin diameter of bone fastener  200 . This configuration allows bone fastener  200  and driver  12  to pass through an end effector of a robotic arm R, as shown in  FIG.  9   . 
     Outer sleeve  14  includes a surface  50  that defines a channel  52 . Channel  52  is configured for disposal of 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 outer sleeve  14 , as shown in  FIG.  6   . Part  58  is alternately connectable with an actuator and/or 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  290  therein, as shown in  FIG.  8   . 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. 16/163,645, filed Oct. 18, 2018, and published as U.S. Patent Application Publication 20200121396, on Apr. 23, 2020, 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 . 
     The indicia of driver  12  includes a marker, for example, a window  102  disposed with outer sleeve  14 . Window  102  is configured for viewing a marker  110  disposed with inner shaft  56 , as described herein. In some embodiments, window  102  includes a lateral opening  104  and a lateral opening  106 . Openings  104 ,  106  are disposed axially along outer sleeve  14 . Translation of inner shaft  56  relative to outer sleeve  14  aligns marker  110  relative to openings  104 ,  106 , as described herein. Openings  104 ,  106  are separated by a flange  108 . Alignment of marker  110  with opening  104  displays and/or indicates that driver  12  is in a release configuration relative to bone fastener  200 , as described herein. Alignment of marker  110  with flange  108  displays and/or indicates driver  12  is in an intermediate configuration relative to bone fastener  200 , as described herein. Alignment of marker  110  with opening  106  displays and/or indicates driver  12  is in a locked configuration relative to bone fastener  200 , as described herein. 
     In some embodiments, outer sleeve  14  includes a marker  401 , as shown in  FIG.  7   . In some embodiments, marker  401  includes a scoring  402  that is configured for alignment with marker including a scoring  404  disposed with extender tab  252  of a bone fastener assembly  250 , as described herein. Alignment of scoring  402 ,  404  is configured to display and/or indicate proper alignment and connection of driver  12  with bone fastener assembly  250  such that screw  64  is selectively aligned with bone fastener  200 . 
     In some embodiments, openings  104 ,  106  may be disposed at alternate orientations relative to axis a, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, and/or may be offset or staggered. In some embodiments, openings  104 ,  106  include a square configuration. In some embodiments, the markers described herein may have various configurations including, for example, round, oval, polygonal, irregular, consistent, variable, uniform and non-uniform. In some embodiments, the markers described herein may be transparent or semi-transparent. In some embodiments, the markers described herein may include visual indicia, scoring, readable visual indicia, tactile indicia. 
     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  200 . 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  200 . For example, drive  22  fits with and is engageable with a mating surface, such as, for example, a socket  210  of bone fastener  200 . Rotation of outer sleeve  14  simultaneously rotates drive  22  to drive, torque, insert or otherwise connect bone fastener  200  with tissue, as described herein. In some embodiments, drive  22  includes a hexalobe geometry for a mating engagement with a correspondingly shaped socket  210 . 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  210 . 
     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  and an extender tab  152   a , as described herein. Surface  36  defines a mating groove, such as, for example, pockets  38  configured for engagement with extender tabs  152 ,  152   a , as described herein. Surface  36  is configured to resist and/or prevent disengagement of extender tabs  152 ,  152   a  from pocket  38 , as described herein. 
     Pockets  38  are configured for engagement with extender tabs  152 ,  152   a . Disposal of extender tabs  152 ,  152   a  with pockets  38  is configured to resist and/or prevent extender tabs  152 ,  152   a  from increasing the diameter of driver  12  when engaged with driver  12 . In some embodiments, pockets  38  are disposed parallel to axis a. In some embodiments, pockets  38  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. 
     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 . 
     End  60  includes marker  110  configured for alignment with window  102  to indicate and/or display the orientation of inner shaft  56  relative to outer sleeve  14  and bone fastener  200 . In some embodiments, marker  110  includes visual indicia, such as, for example, a proximal end cap, a colored portion, scoring, readable visual indicia, tactile indicia or audible indicia. Marker  110  is aligned and viewable through openings  104 ,  106 . Inner shaft  56  and screw  64  are configured for movement relative to outer sleeve  14 . Inner shaft  56  translates screw  64  relative to outer sleeve  14  and bone fastener  200 . Marker  110  translates into alignment with openings  104 ,  106  and flange  108  to indicate an orientation of screw  64  relative to a receiver  202  of bone fastener  200 , as described herein. 
     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  204 ,  206  of bone fastener  200  to pull and or draw bone fastener  200  into engagement with driver  12 , as described herein. Thread form  72  includes a leading portion  74 . 
     Bone fastener  200  includes a receiver  202 . Receiver  202  extends along axis a when connected with outer sleeve  14 . Receiver  102  includes arms  204 ,  206 . Arms  204 ,  206  define an implant cavity configured for disposal of a component of a spinal construct, such as, for example, a spinal rod (not shown). Receiver  202  includes an inner surface having a thread form located adjacent arm  204  and a thread form located adjacent arm  206 . The thread forms of arms  204 ,  206  are configured for engagement with thread form  72  to retain bone fastener  200  with driver  12 , as described herein. Bone fastener  200  includes threaded shaft  216 . Shaft  216  is configured to penetrate tissue, such as, for example, bone. 
     In some embodiments, arms  204 ,  206  each include a break away tab (not shown) that is frangibly connected to arms  204 ,  206  such that manipulation of the break away tabs relative to arms  204 ,  206  can fracture and separate the break away tabs from arms  204 ,  206  at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to the break away tabs and resistance increases, for example, the predetermined torque and force limit is approached. 
     In some embodiments, the break away tabs 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, the break away tabs and arms  204 ,  206  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 the break away tabs. 
     A bone fastener assembly  250  includes extender tabs  252  connected with bone fastener  200 . Extender tabs  252  extend between a proximal end  272  and a distal end  274 . Proximal end  272  includes spring tips (not shown). The spring tips are aligned and disposable with pockets  38 . Surface  36  is configured to resist and/or prevent disengagement of the spring tips, as described herein. Distal ends  274  are configured for slidable disposal of a portion of bone fastener  200 , such as, for example, the break away tabs. In some embodiments, the break away tabs are configured to releasably fix extender tabs  252  with bone fastener  200  for connection with outer sleeve  14 . 
     For example, in use, bone fastener assembly  250  can be connected with driver  12 , as described herein, and drive  22  is oriented for engagement with socket  210 . Drive  22  is engaged with socket  210  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 release configuration, which can include an eject position, as shown in  FIG.  3   , and a locked configuration, which can include a fully threaded position, as shown in  FIG.  6   , with bone fastener  200 . Marker  110  is aligned with opening  102  in the release configuration displaying and/or indicating that screw  64  is translatable within channel  52  and relative to outer sleeve  14 . In some embodiments, this configuration allows drive  22  to engage socket  210  prior to fixation of screw  64  with bone fastener  200 . 
     With bone fastener assembly  250  connected with outer sleeve  14 , thread form  72  is aligned with the thread forms of arms  204 ,  206  for engagement therebetween to retain bone fastener  200  with driver  12 . Screw  64  is rotated simultaneously with inner shaft  56  by 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  204 ,  206  and screw  64  axially translates into receiver  202  and relative to inner shaft  56 . The threaded engagement of screw  64  and receiver  202  pulls and/or draws bone fastener  200  into the locked configuration with driver  12  for releasable fixation therebetween. Marker  110  is aligned with opening  104  in the locked configuration displaying and/or indicating that screw  64  is oriented in a fully threaded position with receiver  202 , which includes a rigid connection. 
     Drive  22  is rotated to drive, torque, insert or otherwise connect bone fastener  200  with adjacent vertebral tissue. Screw  64  remains releasably fixed with receiver  202 , 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  202 . 
     In some cases, a plurality of drivers  12  can be rigidly connected with bone fasteners  200  in the locked configuration, and attempted manipulation of the drivers  12  may be prevented due to the close proximity of the drivers  12  with vertebral tissue. For example, during a surgical procedure, manipulation of one or more drivers  12  may encounter resistance and/or be prevented, for example, due to a vertebral curve that causes engagement and/or interference between adjacent drivers  12  connected with a spine, as shown in  FIG.  5   . 
     In some embodiments, to overcome such engagement and/or interference between adjacent drivers  12 , one or more drivers  12  can be disposed with bone fastener  200  in an intermediate configuration, which includes a partially threaded position, as shown in  FIG.  4   . Handle  90  is manipulated to partially disengage thread form  72  from receiver  202 . Leading portion  74  remains engaged with receiver  202 . Marker  110  is aligned with flange  108  in the intermediate configuration displaying and/or indicating that screw  64  is partially threaded with receiver  202 . Positioning of screw  64  in the intermediate configuration allows for movement of one or more drivers  12  and respective receivers  202  in a flexible or loosened state of driver  12  with bone fastener  200 . The intermediate configuration allows driver  12  to utilize a multi-axial range of motion of bone fastener  200  to counter the engagement and/or interference between adjacent drivers  12  such that one or more drivers  12  can be selectively manipulated. In some embodiments, from the intermediate configuration, driver  12  can be tightened with bone fastener  200  to the locking configuration, or loosened with bone fastener  200  to the non-locking configuration, for ejecting driver  12  from bone fastener  200 . 
     In some embodiments, as shown in  FIG.  8   , handle  90  is removed from inner shaft  56 , sleeve  14  and part  58  after screw  64  is moved from the release configuration to the locked configuration and an instrument, such as, for example, adaptor  290  is connected with driver  12  by inserting adaptor  290  through part  58 . Adaptor  290  is configured to connect an image guide, for example, a navigation component  300  to driver  12  and/or to connect an actuator to driver  12 . Adaptor  290  is fixed relative to shaft  56  and is rotatable relative to part  58 . In some embodiments, adaptor  290  is connected to shaft  56  such that adaptor  290  is fixed relative to shaft  56  such that rotation of adaptor  290  also rotates shaft  56 . 
     In some embodiments, driver  12  includes navigation component  300 , as shown in  FIGS.  8  and  9   . Navigation component  300  is configured to connect to adaptor  290  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  200  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  290  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.  9    and described herein. In some embodiments, the signal generated by emitter array  304  represents a position of bone fastener  200  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  200  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  200  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  200  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  200  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 (not shown). Navigation component  300  is connected with adaptor  290  and driver  12 , as discussed herein. 
     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  200 . One or more bone fastener assemblies  250  may connected with one or more respective drivers  12 , as described herein. Drive  22  is engaged with socket  210  and screw  64  is disposed in a non-locking configuration or release configuration, as described herein, such that screw  64  is translatable relative to inner shaft  56  within channel  52  and rotatable relative to outer sleeve  14 . Alignment of marker  110  with opening  104  provides visual confirmation of the release configuration. 
     With bone fastener assembly  250  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  202  pulls and/or draws bone fastener  200  into the locked configuration, as described herein, with driver  12  for releasable fixation therebetween. Alignment of marker  110  with opening  106  provides visual confirmation of the locked configuration. 
     During the surgical procedure, one or more drivers  12  may be manipulated in connection with a surgical treatment of vertebrae. Such manipulation of the drivers  12  may encounter resistance and/or be prevented due to a vertebral curve of the vertebrae that causes engagement and/or interference between adjacent drivers  12  connected with a spine, as shown in  FIG.  5   . To overcome such engagement and/or interference between adjacent drivers  12 , one or more drivers  12  can be disposed with bone fastener  200  in the intermediate configuration, as described herein. As such, handle  90  is manipulated to disengage thread form  72  from receiver  202 . Leading portion  74  remains engaged with receiver  202  in the partially engaged configuration. Alignment of marker  110  with collar  108  provides visual confirmation of the intermediate configuration. 
     Handle  90  is removed from driver  12  and adaptor  290  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  250 , is oriented for disposal with the end effector of robotic arm R, as described herein. The assembly of driver  12 /bone fastener assembly  250  are disposed with robotic arm R for implantation of bone fasteners  200  with vertebrae employing robotic arm R and/or surgical navigation system  306 , as described herein. An actuator is connected with shaft  292  of adaptor  290  and drive  22  engages bone fastener  200 , as described herein, and outer sleeve  14  is rotated to drive, torque, insert or otherwise connect bone fastener  200  with adjacent tissue. Screw  64  remains releasably fixed with receiver  202 , independent of outer sleeve  14  rotation and/or engagement or friction with the end effector to resist and/or prevent disengagement or unthreading of screw  64  from receiver  202 . 
     In some embodiments, driver  12  is manipulated to deliver one or more bone fasteners  200  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  250 , which may be disposed with the end effector, 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. 
     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.