Patent Publication Number: US-2020289286-A1

Title: Sacro-iliac joint 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 surgical system and a method for treating a sacro-iliac joint. 
     BACKGROUND 
     The sacro-iliac joint is a diarthrodial joint that joins the sacrum to the ilium bones of the pelvis. In the sacro-iliac joint, the sacral surface has hyaline cartilage that moves against fibrocartilage of the iliac surface. The spinal column is configured so that the weight of an upper body rests on the sacro-iliac joints at the juncture of the sacrum and ilia. Stress placed on the sacro-iliac joints in an upright position of the body makes the lower back susceptible to injury. 
     Disorders of the sacro-iliac joint can cause low back and radiating buttock and leg pain in patients suffering from degeneration and laxity of the sacro-iliac joint. In some cases, the sacro-iliac joint can undergo dehydration and destabilization, similar to other cartilaginous joints, which causes significant pain. The sacro-iliac joint is also susceptible to trauma and degeneration, from fracture and instability. It is estimated that disorders of the sacro-iliac joint are a source of pain for millions of people suffering from back and radicular symptoms. 
     Non-surgical treatments, such as medication, injection, mobilization, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these disorders can include the use of implants for fusion and/or fixation to provide stability to a treated region. During surgical treatment, surgical instruments can be used to deliver the implants to a surgical site for fixation with bone to immobilize a joint. The present disclosure describes an improvement over these prior technologies. 
     SUMMARY 
     In one embodiment, a sacro-iliac implant is provided. The sacro-iliac implant includes a body having a proximal portion and a distal tip. The proximal portion includes an inner surface and a uniform diameter. The inner surface includes a first mating surface engageable with a first instrument surface and a second mating surface engageable with a second instrument surface. Systems, constructs, instruments and methods are disclosed. 
     In one embodiment, a sacro-iliac implant system is provided. The sacro-iliac implant system comprises a sacro-iliac implant including a proximal portion and a distal tip. The proximal portion includes an inner surface and a uniform diameter. The inner surface includes a connection interface surface and a torque interface surface. A surgical instrument includes a first surface engageable with the connection interface surface and a second surface engageable with the torque interface surface. 
    
    
     
       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 system in accordance with the principles of the present disclosure; 
         FIG. 2  is a side view of the components shown in  FIG. 1 ; 
         FIG. 3  is a cross section view of the components shown in  FIG. 1 ; 
         FIG. 4  is an end view of the components shown in  FIG. 1 ; 
         FIG. 5  is an enlarged break away view of the components shown in 
         FIG. 3 ; 
         FIG. 6  is an enlarged view of the components shown in  FIG. 2 ; 
         FIG. 7  is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure; 
         FIG. 8  is a side view of components of one embodiment of a system in accordance with the principles of the present disclosure; 
         FIG. 9  is a side view of components of one embodiment of a system in accordance with the principles of the present disclosure; 
         FIG. 10  is a side view of components of one embodiment of a system in accordance with the principles of the present disclosure; 
         FIG. 11  is a side view of components of one embodiment of a system in accordance with the principles of the present disclosure; 
         FIG. 12  is a cross section view of the components shown in  FIG. 11 ; 
         FIG. 13  is a perspective view of the components shown in  FIG. 11 ; 
         FIG. 14  is an enlarged break away view of the components shown in  FIG. 11 ; and 
         FIG. 15  is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure disposed with vertebrae. 
     
    
    
     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 surgical system and method for treating a sacro-iliac (SI) joint. In some embodiments, the surgical system and methods of use disclosed provide stability and maintain structural integrity while reducing stress on the SI joint. In some embodiments, the present disclosure may be employed to treat musculoskeletal disorders including SI dysfunction or syndrome, dehydration, destabilization and/or laxity. 
     In some embodiments, the surgical system of the present disclosure comprises an SI implant. In some embodiments, the SI implant includes a threaded body. In some embodiments, the SI implant is cannulated. In some embodiments, the SI implant includes a body that is fenestrated to enhance SI joint fusion and to provide fixation of large bones and large bone fragments of the pelvis. In some embodiments, the present system includes one or more spinal constructs having one or more SI implants that are provided having various lengths to accommodate patient anatomy. In some embodiments, the SI implant is utilized with an SI joint fusion procedure for conditions including SI joint disruptions and degenerative sacroiliitis. 
     In some embodiments, the SI implant includes a fully threaded body having a thread form that extends an entire length of the body from a proximal end to a tip of a distal end. In some embodiments, the SI implant is cannulated and fenestrated to allow for bony ingrowth and for bone graft material to be packed inside the SI implant and on or about one or more components of the spinal construct to promote fusion across the SI joint. In some embodiments, the SI implant includes a recess on a proximal end to facilitate a threaded engagement with a surgical instrument, such as, for example, an inserter. In some embodiments, the inserter is configured for manual insertion, assisted with navigation and/or with a powered driver. 
     In some embodiments, the present surgical system includes a tapered, fully threaded, cannulated, fenestrated SI implant for stabilization and fusion of the SI joint. In some embodiments, the present surgical system is employed with a method for treating low back pain attributed to the SI joint. In some embodiments, the present surgical system includes a threaded SI implant that is cannulated, fenestrated, and designed to enhance SI joint fusion and provide fixation of large bones and large bone fragments of the pelvis. In some embodiments, the SI implant includes a distal tip having a blunt configuration. In some embodiments, the SI implant includes a bore having a threaded portion. In some embodiments, the threaded portion is configured to facilitate a revision procedure. In some embodiments, the bore includes a connection portion and/or a torque portion. 
     In some embodiments, the present system is employed with a method used with surgical navigation, such as, for example, fluoroscope or image guidance. In some embodiments, the presently disclosed system and/or method reduce operating time for a surgical procedure and reduce radiation exposure due to fluoroscope or image guidance, for example, by eliminating procedural steps and patient repositioning by implanting system components in one body position. 
     In some embodiments, the present system is employed with a method for treating an SI joint, which includes the step of identifying a posterior superior iliac spine on a patient that is positioned in a prone position on an operating table. In some embodiments, the step of identifying includes using the posterior superior iliac spine as a landmark for making an incision. In some embodiments, identification of the posterior superior iliac spine limits vascular and muscular disruption from a surgical approach. In some embodiments, the method includes the step of establishing a trajectory path using fluoroscopy and a guide wire inserted into the posterior superior iliac spine, for example, on an iliac side of an SI joint. In some embodiments, bone graft material, such as, for example, autograft and/or allograft is inserted into the SI joint space to create a bony contact between the iliac and sacrum sides. In some embodiments, the bone graft material is inserted into a cannula of a screw. 
     In some embodiments, the present system includes an SI fixation screw attached to a surgical driver. In some embodiments, the SI fixation screw is employed with a method for treating an SI joint, which includes the step of applying a downward force and driving the screw through the ilium, through the graft material and into the sacrum following a path created by a reamer until the screw is flush with the ilium and docked into the sacrum. In some embodiments, screw placement is confirmed with fluoroscopy and/or image guidance and the incision is closed. 
     In some embodiments, the present system is employed with a method for screw removal from the SI joint fusion. In some embodiments, the method includes the step of providing an implant inserter configured to attach to the screw. In some embodiments, the method includes the step of exposing an iliac side of the SI joint of a patient who underwent a SI fusion procedure. In some embodiments, a tube can be placed over the incision site. In some embodiments the dorsal aspect of the screw is positively identified. In some embodiments, the dorsal aspect of the screw is identified by fluoroscopy and/or image guidance. In some embodiments, the implant inserter is re-attached to the dorsal end of the screw and the screw is removed. 
     In some embodiments, the present system includes an SI implant and a surgical inserter that employs image guidance, for example, surgical navigation. In some embodiments, the present system includes an SI implant and a surgical inserter that selectively, precisely and/or accurately connects the SI implant with the surgical inserter such that the SI implant extends a selected distance from the surgical inserter in connection with surgical navigation. In some embodiments, the SI implant extends a selected distance from the surgical inserter within an accuracy and/or tolerance of ±1.0 millimeter (mm). In some embodiments, the SI implant extends a selected distance from the surgical inserter, and is connected at a first component interface having a selected distance within an accuracy and/or tolerance of ±0.5 mm. In some embodiments, the component interface has a selected distance within an accuracy and/or tolerance of ±0.2 mm. In some embodiments, the component interface includes a threaded pocket of the SI implant. In some embodiments, the surgical inserter includes a floating, relative rotating sleeve disposed along a shaft of a driver. In some embodiments, the sleeve comprises a portion of the component interface to selectively locate the SI implant at the end of the driver while allowing the driver to pass through the sleeve and engage a second component interface of the SI implant. In some embodiments, the SI implant extends a selected distance from and is fixed with the surgical inserter in connection with image guidance to provide position of the SI implant with tissue for a reliable explant strategy, which may include locating the SI implant with tissue and explant of the SI implant. 
     In some embodiments, one or all of the components of the system are disposable, peel-pack or pre-packed sterile devices. One or all of the components of the system may be reusable. The system may be configured as a kit with multiple sized and configured components. 
     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, micro discectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. As used in the specification and including the appended claims, the term “tissue” includes soft tissue, muscle, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise. 
     The following discussion includes a description of a surgical system including an SI implant, 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. 1-6 , there are illustrated components of an SI implant system  10 . 
     The components of SI 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 SI 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 SI 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 SI 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 SI implant system  10  may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. 
     SI implant system  10  includes an implant, such as, for example, an SI implant  12 . SI implant  12  is configured for use with treatment of SI joint disorders, as described herein, and including those caused by degeneration or trauma. SI implant  12  includes a body  14 . Body  14  defines an axis X 1 . In some embodiments, body  14  can be variously configured, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, variable, hollow and/or tapered. Body  14  includes a proximal portion, such as, for example, a shaft  16  and a distal tip  18 . 
     Shaft  16  includes a cylindrical cross-section and extends between an end  52  and an end  54 . Shaft  16  includes an inner surface  20  that defines a longitudinal cavity  22 . In some embodiments, cavity  22  extends along axis X 1 . In some embodiments, cavity  22  may be disposed in various orientations, such as, for example, perpendicular, transverse and/or at angular orientations, such as acute or obtuse relative to axis X 1 . Cavity  22  extends through body  14  such that SI implant  12  includes a cannulated configuration. In some embodiments, cavity  22  extends through all or only a portion of shaft  16 . In some embodiments, cavity  22  extends through all or only a portion of tip  18 . 
     End  52  includes a proximal most end surface of shaft  16 . The proximal most end surface includes a substantially flat profile and is disposed in a plane substantially perpendicular to axis X 1 . In some embodiments, the proximal most end surface may be disposed in various orientations, such as, for example, perpendicular, transverse and/or at angular orientations, such as acute or obtuse relative to axis X 1 . End  52  and surface  20  include a mating surface  32 , which is threaded and disposed adjacent the proximal most end surface. In some embodiments, all or a portion of surface  32  is threaded. In some embodiments, end  52  defines a recess or pocket including surface  32 . 
     Surface  32  comprises a portion of a connection interface with a surgical instrument, as described herein, to releasably fix SI implant  12  with the surgical instrument at a selected position to facilitate guidance, insertion and manipulation of SI implant  12  to a surgical site, as described herein. In some embodiments, surface  32  provides a threaded connection with a surgical instrument, as described herein, to fix SI implant  12  with the surgical instrument. In some embodiments, SI implant  12  is connected with a surgical instrument such that SI implant  12  extends a selected distance from the surgical instrument in connection with treatment using surgical navigation, as described herein. 
     Surface  32  extends a distance A measured from the proximal most end surface of shaft  16  into cavity  22 , as shown in  FIG. 3 . In some embodiments, distance A is selected to connect SI implant  12  with a surgical instrument in connection with image guidance, as described herein, to dispose SI implant  12  relative to and/or extending from a surgical instrument, as described herein, and provide indicia of the position of SI implant  12  relative to the surgical instrument and/or tissue. In some embodiments, selected distance A effectively fixes SI implant  12  with a surgical instrument in connection with image guidance to provide position of SI implant  12  with tissue for a reliable explant strategy, which may include locating SI implant  12  with tissue and explant of SI implant  12 . In some embodiments, distance A can be selected in a range of 2 through 8 mm. In some embodiments, selected distance A is 4 mm. In some embodiments, surface  32  extends a selected distance A within an accuracy and/or tolerance of ±0.5 mm. In some embodiments, surface  32  extends a selected distance A within an accuracy and/or tolerance of ±0.2 mm. 
     End  52  and surface  20  include a mating surface that defines a socket  42 . Socket  42  is connected and/or directly adjacent with surface  32 . In some embodiments, socket  42  may be spaced apart and disposed adjacent to surface  32 . Socket  42  is disposed directly adjacent and distal to surface  32  such that socket  42  and surface  32  are co-axially disposed in a serial orientation along axis K 1 . In some embodiments, socket  42  and surface  32  may be disposed at alternate orientations relative to each other, such as, for example, proximal-distal, transverse, perpendicular, offset, non-concentric or staggered. In some embodiments, end  52  defines a recess or pocket including surface  32  and socket  42 . 
     The surface of shaft  16  defining socket  42  is configured for engagement with a drive surface of a surgical instrument, as described herein. Socket  42  defines a hexalobular cross section for disposal and engagement of a correspondingly shaped portion of the drive surface. In some embodiments, socket  42  defines a cruciform, phillips, square, polygonal or star cross sectional configuration for disposal and engagement of a correspondingly shaped portion of the drive surface. In some embodiments, a close fitting engagement and/or interference fit is created between the surface of shaft  16  defining socket  42  and the drive surface of the surgical instrument. The surface of shaft  16  defining socket  42  comprises a portion of a torque interface with the drive surface, as described herein, to drive, rotate, torque, insert, implant or otherwise connect SI implant  12  with tissue, for example, the articular surfaces of an SI joint, sacrum and ilium, as described herein. 
     Shaft  16  includes an outer surface  50  that includes a thread  56 . Thread  56  extends along a length L of shaft  16  between end  52  and end  54 , as shown in  FIG. 6 . Thread  56  is continuous along surface  50 . In some embodiments, thread  56  may be intermittent, staggered, discontinuous and/or may include a single thread turn or a plurality of discrete threads. In some embodiments, other penetrating elements may be located on shaft  16 , such as, for example, a nail configuration, barbs, expanding elements, raised elements, ribs, and/or spikes to facilitate engagement of shaft  16  with tissue. In some embodiments, thread  56  may be self-tapping or intermittent. In some embodiments, length L is a distance selected from a range including 25 mm through 75 mm. 
     Thread  56  includes a major diameter D 2  and a minor diameter D 3 , as shown in  FIGS. 3 and 4 . In some embodiments, diameter D 2  and/or diameter D 3  is uniform along length L. In some embodiments, a trailing edge  58  of thread form  56  is disposed perpendicular to surface  50  to resist and/or prevent back out of SI implant  12  from tissue. In some embodiments, a leading edge  60  of thread form  56  is disposed transverse to surface  50  to facilitate engagement of SI implant  12  with tissue. In some embodiments, thread  56  is trans-articular and penetrates tissue, including bone, of a sacrum to secure SI implant  12  with a sacro-iliac joint for stabilization and immobilization thereof. In some embodiments, all or only a portion of shaft  16  may have alternate surface configurations, for alternative fixation configurations with a body cavity, such as, for example, non-threaded, arcuate, undulating, substantially smooth, rough, spiked, semi-porous, dimpled and/or polished, textured for friction fit and/or oversized for pressure fit to facilitate fixation with tissue and/or include fastening elements such as anchors, barbs, spikes, detents and/or slots. 
     In some embodiments; shaft  16  includes a plurality of lateral openings, such as, for example, fenestrations  62 . Fenestrations  62  extend between surfaces  20 ,  50  and are in communication with cavity  22 . In some embodiments, fenestrations  62  allow the flow of an agent disposed within cavity  22  to promote bone growth adjacent a surgical site. 
     In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of SI implant  12  and/or other components of a spinal construct with tissue, as described herein. Osteogenic material may be included in the agent such as, for example, autologous bone harvested from the patient receiving the implant device, bone allograft, bone xenograft, any number of non-bone implants (for example ceramic, metallic, polymer), bone morphogenic protein, and/or bio-resorbable compositions. For example, the osteogenic material may comprise minerals such as calcium phosphate or calcium sulfate minerals, bone, including xenograft, allograft or autograft bone. The osteogenic material may also comprise demineralized bone matrix (DBM), osteoinductive factors such as bone morphogenetic proteins (for example human BMP-2 or human BMP-7 or heterodimers thereof) whether recombinantly produced or purified from tissues, LIM mineralization proteins (LMPs), or the like. The osteogenic material may also comprise a binder material such as blood, clottable blood fractions, platelet gel, collagen, gelatin, carboxymethyl cellulose, or other similar materials that will serve to bind together harder particles or materials such as mineral particles (for example bone or synthetic mineral particles) to create a three-dimensionally stable mass when compacted into the cavities of SI implant  12  and/or other components of a spinal construct. 
     In some embodiments, the agent can contain other bioactive agents or other active agents, which may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, into an SI joint to treat, for example, pain, inflammation and degeneration. The agents may include pharmacological agents, such as, for example, antibiotics, pain medications, analgesics, anesthetics, anti-inflammatory drugs including but not limited to steroids, anti-viral and anti-retroviral compounds, therapeutic proteins or peptides, therapeutic nucleic acids (as naked plasmid or a component of an integrating or non-integrating gene therapy vector system), and combinations thereof. 
     Tip  18  includes an outer surface  70  that extends between an end  72  and an end  74 , as shown in  FIG. 6 . Surface  70  defines a profile that is disposed transverse to axis X 1  forming a tapered configuration of tip  18 . In some embodiments, surface  70  is disposed at an angle α in a range of 10 to 15 degrees relative to axis X 1 . End  72  defines diameter D 4  and surface  70  tapers to a diameter D 5  at end  74  to define the tapered profile of tip  18 , which facilitates penetration of tissue. In some embodiments, tip  18  is tapered, for example, with a bevel for easier insertion and less tearing of the tissue, such as the cortical layers of the ilium and the sacrum. The distal most surface of tip  18  has a blunt configuration. In some embodiments, the distal most surface of tip  18  includes a sharpened point. 
     Surface  70  includes a thread  76  that extends along a length L 1  of tip  18 . Thread  76  is continuous along surface  70 . In some embodiments, thread  76  may be intermittent, staggered, discontinuous and/or may include a single thread turn or a plurality of discrete threads. In some embodiments, other penetrating elements may be located on tip  18 , such as, for example, a nail configuration, barbs, expanding elements, raised elements, ribs, and/or spikes to facilitate engagement of tip  18  with tissue. In some embodiments, thread  76  may be self-tapping or intermittent. In some embodiments, thread  56  includes a first thread form and thread  76  includes a second thread form, which may be the same or different than thread  56 . In some embodiments, thread  76  may include a different pitch, diameter and/or crest shape than thread  56 . In some embodiments, thread  76  is integral with thread  76 . 
     In assembly, operation and use, SI implant system  10 , similar to the systems and methods described herein, is employed with a surgical procedure for treatment of an SI joint of a patient. SI implant system  10  may also be employed with other surgical procedures. In some embodiments, SI implant system  10  comprises a kit including a plurality of SI implants  12  of varying configuration and/or dimension, as described herein. In some embodiments, SI implant  12  is selected from the kit for employing with a treatment at the surgical site. SI implant  12  is connected with a surgical instrument  120  to facilitate insertion and manipulation of SI implant  12  utilizing an image guide, such as, for example, a navigation component  200 , as shown in  FIG. 7 , of a medical imaging and navigation system (not shown), as described herein. 
     Surgical instrument  120  includes a driver  124 , as shown in  FIGS. 7-10 . Driver  124  includes a shaft  125  that extends between an end  126  and an end  128 . Driver  124  defines a longitudinal axis X 1 . In some embodiments, all or a portion of shaft  125  may have alternate cross section configurations, such as, for example, circular, oval, oblong, triangular, square, hexagonal, polygonal, irregular, uniform, non-uniform and/or tapered. In some embodiments, surgical instrument  120  may comprise and/or is connected with a tap, drill or a screwdriver. 
     End  126  includes a mating surface  130  having a hexalobular drive  132 . Drive  132  is engageable with the surface of shaft  16  defining socket  42 . Drive  132  includes a distal most surface of end  126 . In some embodiments, drive  132  contacts the surface of socket  42  in a close fitting engagement and/or interference fit. Drive  132  comprises a portion of a torque interface with the surface of socket  42  to drive, rotate, torque, insert, implant or otherwise connect SI implant  12  with the articular surfaces of an SI joint and adjacent bone of the ilium and sacrum. In some embodiments, drive  132  may include a square, triangular, polygonal, star or torx cross section configured to engage the surface of socket  42 . 
     End  128  includes a circumferential flange  136  disposed with shaft  125  at a position adjacent end  128  for connection with navigation component  200  at a selected position along shaft  125  to facilitate guidance, insertion and manipulation of SI implant  12  to a surgical site, as described herein. In some embodiments, flange  136  can be disposed at other various positions along driver  124 . Flange  136  includes a proximal most surface and is configured to facilitate assembly with navigation component  200 . Flange  136  is employed for a selected distance of components of SI implant system  10  from navigation component  200  in connection with a treatment using the surgical navigation system, as described herein. An adaptor  140  is engageable with shaft  125  to facilitate releasable engagement with an actuator  142 , such as, for example, a powered drill, hand drill or other tool. 
     Surgical instrument  120  includes an inserter  150 , as shown in  FIGS. 8-14 , to facilitate insertion and manipulation of SI implant  12  for delivery to a surgical site. Inserter  150  includes a sleeve  152 . Sleeve  152  extends between an end  154  and an end  156 . End  154  includes a shoulder  170  that defines a distal facing surface. 
     Sleeve  152  includes a housing  153  that is attached with a collar  180 . Collar  180  is fixed with shaft  125  via a pin  182  to connect sleeve  152  with driver  124 . Collar  180  is fixed along axis X 1  and extends into openings  183  of housing  153  to capture sleeve  152  with shaft  125  and fix axial position of sleeve  152  along axis X 1  to facilitate guidance, insertion and manipulation of SI implant  12  to a surgical site, as described herein. Sleeve  152  is rotatable about axis X 1  relative to driver  124 . For example, as shaft  125  is rotated to torque drive  132 , as described herein, sleeve  152  can be held manually to resist and/or prevent rotation of sleeve  152 . As such, sleeve  152  is fixed and shaft  125  is rotated such that collar  180  rotates through openings  183  and relative to housing  153 . In another example, shaft  125  can be fixed and sleeve  152  manually rotated relative to driver  124  such that openings  183  rotate about collar  180 , for example, to connect or release sleeve  152  from SI implant  12 , as described herein. Sleeve  152  includes a shaft  155  that includes a surface  158 . Surface  158  defines a passageway  160  configured for disposal and relative rotation of driver  124  therein. 
     Sleeve  152  is connected with shaft  125  such that SI implant  12  extends a selected distance from surgical instrument  120  in connection with treatment using surgical navigation, as described herein. The distal facing surface of shoulder  170  extends a distance Y measured from the proximal most surface of flange  136 . In some embodiments, distance Y is selected to connect sleeve  152  with driver  124  in connection with navigation component  200  to dispose SI implant  12  relative to and/or extending from surgical instrument  120  and provide indicia of the position of SI implant  12  relative to the surgical instrument  120  and/or tissue. In some embodiments, distance Y can be selected in a range of 175 through 225 mm. In some embodiments, selected distance Y is 201 mm. In some embodiments, distance Y extends a selected distance within an accuracy and/or tolerance of ±0.25 mm. In some embodiments, distance Y extends a selected distance within an accuracy and/or tolerance of ±0.12 mm. 
     The distal facing surface of shoulder  170  includes a substantially flat profile and is disposed in a plane substantially perpendicular to axis X 1 . In some embodiments, the distal facing surface of shoulder  170  may be disposed in various orientations, such as, for example, perpendicular, transverse and/or at angular orientations, such as acute or obtuse relative to axis X 1 . End  152  includes a mating surface, such as, for example, a threaded surface  162 . In some embodiments, all or a portion of surface  162  is threaded. Surface  162  comprises a portion of a connection interface with surface  32  to releasably fix SI implant  12  with surgical instrument  120  at a selected position relative to navigation component  200  to facilitate guidance, insertion and manipulation of SI implant  12  to a surgical site, as described herein. 
     Surface  162  extends a distance A 1  from the distal facing surface of shoulder  170 . In some embodiments, distance A 1  is selected to connect SI implant  12  with surgical instrument  120  to dispose SI implant  12  relative to and/or extending from sleeve  152  and/or driver  124 , and provide indicia of the position of SI implant  12  relative to surgical instrument  120  and/or tissue. In some embodiments, distance A 1  can be selected in a range of 2 through 8 mm. In some embodiments, selected distance A 1  is 3.5 mm. In some embodiments, surface  162  extends a selected distance A 1  within an accuracy and/or tolerance of ±0.5 mm. In some embodiments, surface  162  extends a selected distance A 1  within an accuracy and/or tolerance of ±0.2 mm. In some embodiments, distance A 1  is equal to distance A. Surface  162  is connected with surface  32  such that SI implant  12  extends a selected distance from surgical instrument  120  and navigation component  200 , as described herein. 
     Surgical Instrument  120  includes an image guide, such as, for example, navigation component  200 , as described herein. Navigation component  200  is configured to generate a signal representative of a position of surgical instrument  120  and SI implant  12  to the navigation system. In some embodiments, the image guide may include one or more components having markers for identification under x-ray, fluoroscopy, CT or other imaging techniques, at least one light emitting diode, a wireless component, a wired component, a near field communication component and/or one or more components that generate acoustic signals, magnetic signals, electromagnetic signals and/or radiologic signals. 
     Navigation component  200  includes a housing  202  configured for disposal with shaft  125 . Housing  202  is rotatable relative to shaft  125  about axis A 1 . In some embodiments, housing  202  is axially fixed with shaft  125  such that housing  202  is connected with shaft  125  and axial translation of housing  202  relative to shaft  125  is resisted and/or prevented. 
     Navigation component  200  includes a tracking device having an emitter array  204  that extends from and is connected to housing  202  via a post  206 . Emitter array  204  is rotatable with housing  202  relative to shaft  125  about axis A 1  In some embodiments, emitter array  204  is axially fixed with shaft  125  such that axial translation of emitter array  204  relative to shaft  125  is resisted and/or prevented. In some embodiments, emitter array  204  may be adjusted in rotation and/or an axial direction. In some embodiments, emitter array  204  may be disposed at alternate orientations relative to axis A 1  such as, for example, parallel, perpendicular, transverse and/or other angular orientations, such as, acute or obtuse. 
     Emitter array  204  is configured for generating a signal representing a spatial position and/or a trajectory of surgical instrument  120  and SI implant  12  relative to a portion of a patient&#39;s anatomy and/or a depth of an SI implant within the patient&#39;s anatomy. Emitter array  204  includes four spaced apart arms having a substantially X-shape. Emitter array  204  includes markers, such as, for example fiducials  208 . Fiducials  208  appear in an image produced by a surgical navigation system (not shown) for use as a point of reference or a measure. Emitter array  204  generates signals representing the position of various body reference points of the patient&#39;s anatomy. 
     Surgical instrument  120  is configured for disposal adjacent a surgical site such that navigation component  200  is oriented relative to a sensor array of a surgical navigation system. Orientation of navigation component  200  relative to the sensor array facilitates communication between navigation component  200  and the sensor array during a surgical procedure, as described herein. The sensor array receives signals from emitter array  204  to provide information regarding the spatial position and/or trajectory of surgical instrument  120  and SI implant  12  relative to a portion of the patient&#39;s anatomy, as described herein. See, for example, similar surgical navigation components and their use as described in U.S. Pat. Nos. 6,021,343, 6,725,080, 6,796,988, the entire contents of each of these references being incorporated by reference herein. In some embodiments, navigation component  200  includes at least one light emitting diode. In some embodiments, navigation component  200  may include other tracking devices capable of being tracked by the sensor array, such as, for example, a tracking device that actively generates acoustic signals, magnetic signals, electromagnetic signals, radiologic signals. 
     The surgical navigation system 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, the surgical navigation system can include an O-Arm® imaging device sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo., USA. An imaging device may have a generally annular gantry housing that encloses an image capturing portion. 
     In some embodiments, the image capturing portion 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 relative to a track of the image capturing portion. The image capturing portion can be operable to rotate 360 degrees during image acquisition. The image capturing portion may rotate around a central point or axis, allowing image data of the patient to be acquired from multiple directions or in multiple planes. The surgical navigation system can include those disclosed in U.S. Pat. Nos. 8,842,893, 7,188,998; 7,108,421; 7,106,825; 7,001,045; and 6,940,941; the entire contents of each of these references being incorporated by reference herein. 
     In some embodiments, the surgical navigation system can include C-arm fluoroscopic imaging systems, which can generate three-dimensional views of a patient. The position of the image capturing portion can be precisely known relative to any other portion of the imaging device. In some embodiments, a precise knowledge of the position of the image capturing portion can be used in conjunction with a tracking system to determine the position of the image capturing portion and the image data relative to the patient. 
     The tracking system can include various portions that are associated or included with the surgical navigation system. In some embodiments, the tracking system 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, a sensor array and/or an EM tracking system that can include an EM localizer. Various tracking devices can be tracked with the tracking system and the information can be used by the surgical navigation system to allow for a display of a position of an item, such as, for example, a patient tracking device, an imaging device tracking device, and an instrument tracking device, such as, for example, navigation component  200 , 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 to a computer where they may be forwarded to a surgical navigation computer. Image transfer may be performed over a standard video connection or a digital link including wired and wireless. The computer provides the ability to display, via a monitor, 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, the surgical navigation system provides for real-time tracking of surgical instrument  120  and SI implant  12 . The sensor array is located in such a manner to provide a clear line of sight with emitter array  204 , as described herein. In some embodiments, emitter array  204  communicates with the sensor array via infrared technology. The sensor array is coupled to the computer, which may be programmed with software modules that analyze signals transmitted by the sensor array to determine the position of each object in a detector space, A processor sends the information to the monitor, which provides a visual representation of the position of surgical instrument  120  and SI implant  12  relative to the patient&#39;s anatomy to allow the medical practitioner to move surgical instrument  120  and SI implant  12  to a desired location within the patient&#39;s anatomy. 
     In some embodiments, the patient tracking device provides a reference frame. The reference frame may be securely attached to the anatomy in the region of the body which is to receive the implant. By sensing the patient tracking device, the computer can determine the position of the anatomy in the detector space. The sensor array receives and triangulates signals generated by emitter array  204  to identify the relative position of each of the reference points and surgical instrument  120  and SI implant  12 . The processor and the computer modify the image data set according to the identified relative position of each of the reference points during the procedure. The position and trajectory of surgical instrument  120  and SI implant  12  provided by emitter array  204  are processed by the processor and the computer, and are visually displayed against the preoperative image data set stored in the computer to provide the medical practitioner with a visual representation of the position, path and/or trajectory and depth of surgical instrument  120  and SI implant  12  relative to a portion of the patient&#39;s anatomy. 
     For example, SI implant system  10  is employed with a surgical arthrodesis procedure, such as, for example, fusion for treatment of an applicable condition or injury of an affected SI joint J, as shown in  FIG. 15 . SI implant  12  is connected with surgical instrument  120  to facilitate insertion and manipulation of SI implant  12  utilizing navigation component  200  and the navigation system, as described herein. In some embodiments, components of SI implant system  10  are inserted with SI joint J to space apart articular joint surfaces, establish joint tension, provide support and maximize stabilization of sacro-iliac joint J. In some embodiments, the components of SI implant system  10  are inserted with SI joint J as a SI joint spacer to restore ligamentous tension; eliminate painful micro-motion, and/or separate and cushion opposing articulating surfaces that cause pain. In some embodiments, SI implant system  10  may maintain joint tension without promoting bone growth. 
     In use, to treat a selected section of SI joint J, the body of a patient is disposed in a prone position on a surface, such as, for example, a surgical table (not shown). A surgical pathway of a posterior superior iliac spine (PSIS) of the body is identified. In some embodiments, the PSIS is identified through manipulation or tactile feedback by touching the skin of the patient. In some embodiments, the PSIS is identified through medical imaging, such as, for example, x-ray and/or fluoroscopy. 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 SI implant system  10 . A preparation instrument (not shown) can be employed to prepare tissue surfaces of SI joint J, as well as for aspiration and irrigation of a surgical region. 
     Sleeve  152  is attached with driver  124 , as described herein, such that drive  132  is disposed directly adjacent with surface  162 . As such, drive  132  is disposed directly adjacent and distal to surface  162  such that drive  132  and surface  162  are co-axially disposed in a serial orientation along axis X 1 . A distal facing surface of surface  162  extends a distance Y 2  measured from the proximal most surface of flange  136  and navigation component  200  to dispose SI implant  12  relative to and/or extending from surgical instrument  120  for display from the navigation system, as described herein. In some embodiments, distance Y 2  can be selected in a range of 175 through 225 mm. In some embodiments, selected distance Y 2  is 204.5 mm. In some embodiments, distance Y 2  extends a selected distance within an accuracy and/or tolerance of ±0.25 mm. In some embodiments, distance Y 2  extends a selected distance within an accuracy and/or tolerance of ±0.12 mm. 
     SI implant  12  is engaged with surgical instrument  120 . Sleeve  152  is manually rotated relative to shaft  125 , as described herein, in a clockwise direction to engage surface  162  with surface  32  in a threaded connection interface, as described herein. SI implant  12  is connected with surgical instrument  120  such that sleeve  152  captures end  52  and drive  132  is disposed with surface  42 . Surface  32  is threaded with surface  162  such that the distal facing surface of shoulder  170  abuts the proximal most surface of end  52  in a substantially flush engagement. As such, SI implant  12  extends a selected distance that can be reliably measured, as described herein, from the surgical instrument  120 . SI implant  12  and surgical instrument  120  are connected at the connection interface at a selected distance, which is measured from the proximal most surface of flange  136  and navigation component  200  within an accuracy and/or tolerance, as described herein, for display from the navigation system, as described herein. 
     SI implant  12  is delivered along the surgical pathway with surgical instrument  120  for implantation of components of SI implant system  10  including SI implant  12 . A distal most surface of distal tip  18  extends a distance Y 3  measured from the proximal most surface of flange  136  and navigation component  200  to dispose SI implant  12  relative to and/or extending from surgical instrument  120 . In some embodiments, distance Y 3  can be selected in a range of 200 through 275 mm. In some embodiments, selected distance Y 3  is 241 mm. In some embodiments, distance Y 3  extends a selected distance within an accuracy and/or tolerance of ±0.25 mm. In some embodiments, distance Y 3  extends a selected distance within an accuracy and/or tolerance of ±0.12 mm. This configuration provides indicia or display from the navigation system, as described herein, of components of SI implant system  10  including SI implant  12 , surgical instrument  120  and their relative positions with the tissue surfaces of SI joint J in connection with a surgical treatment, as described herein. 
     Driver  124  is engaged with SI implant  12  such that portion  132  is engaged with socket  42 , as described herein. SI implant  12  is manipulated to orient SI implant  12  with the tissue surfaces of SI joint J for implant therewith. Actuator  142  is actuated to transmit a torque from actuator  142  to driver  124  such that drive  132  comprises a portion of a torque interface with the surface of socket  42  to drive, rotate, torque, insert, implant or otherwise connect SI implant  12  with the articular surfaces of an SI joint and adjacent bone of the ilium and sacrum. In some embodiments, a range of torque generated by actuator  142  and transmitted to SI implant  12  is approximately in a range of 0 to 21 Newton-meters (Nm). 
     SI implant  12  is implanted at the surgical site and surgical instrument  120  is disengaged from SI implant  12 . Sleeve  152  is manually rotated relative to shaft  125 , as described herein, in a counter-clockwise direction to disengage the threaded connection interface of surfaces  32 ,  162 . SI implant  12  is fastened with the tissue surfaces of SI joint J, and released from sleeve  152  such that sleeve  152  and driver  124  disengage SI implant  12 . In some embodiments, the torque transmitted to disengage sleeve  152  from SI implant  12  is less than the torque transmitted to SI implant  12  to fasten SI implant  12  with the tissue surfaces of SI joint J. As such, sleeve  152  is rotatable, relative to shaft  125 , to release SI implant  12  therefrom and resists and/or prevents rotation of SI implant  12 , which avoids disturbance, tissue damage, loosening or interference of implant fixation. In some embodiments, the torque transmitted to engage and create the connection interface, as described herein, includes hand tightening, negligible torque more than zero and/or the torque transmitted to engage and create the torque interface, as described herein. In some embodiments, the torque transmitted to engage and create the connection interface is different, the same or less than the torque interface. 
     Upon completion of the procedure, the surgical instruments, assemblies and non-implanted components of SI implant system  10  are removed from the surgical site and the incision is closed. One or more of the components of SI 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, the use of surgical navigation, microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of SI implant system  10 . In some embodiments, SI implant  12  is guided to the surgical site via a guidewire, such as, for example, a K-wire (not shown) and/or without the use of an image guide, as described herein. 
     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.