Abstract:
The present invention relates to a system, method, device and kit which utilize a modular pedicle screw implant that does not require the use of a guide wire for implantation and can be assembled in situ. The system, method, device, and kit include a surgical instrument for implanting a modular pedicle screw comprising a cannula coaxially aligned with a modified trocar style instrument or surgical shaft. The surgical shaft contains a first member of a surgical shaft-inner pedicle bone screw member joint, illustrated herein as a locking taper, for securing an inner member of a pedicle screw thereto. The inner member of a pedicle screw is further adapted to couple to an outer pedicle sheath. In combination, the inner member of a pedicle screw and the outer pedicle sheath form a solid modular pedicle screw.

Description:
PRIORITY CLAIM 
     In accordance with 37 C.F.R. 1.76, a claim of priority is included in an Application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority to U.S. Provisional Patent Application No. 61/781,860, entitled “SURGICAL SYSTEM, DEVICE, AND METHOD FOR IMPLANTING A SURGICAL DEVICE WITHOUT THE USE OF A GUIDE WIRE”, filed Mar. 14, 2013. The contents of which the above referenced application is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to surgical systems and methods which utilize implant devices; and more particularly to a system, method and device which utilizes a modular pedicle screw implant that does not require the use of a guide wire for implantation. 
     BACKGROUND OF THE INVENTION 
     The central nervous system, made primarily of the brain and the spine, is a vital part of the human physiology responsible for coordinating many aspects of human activity. The spinal cord is made up of a bundle of nerve tissue and acts as a conduit to communicate neuronal signals from the brain to the rest of the body. Protecting the spinal cord is the spinal, or vertebral, column. Anatomically, the spinal column is made up of several regions, including the cervical, thoracic, lumbar and sacral regions, each containing a plurality of vertebrae. 
     While most people have fully functional spinal cords, it is not uncommon for individuals to suffer some type of spinal ailment. For example, spinal fractures, or vertebra compression fractures, occur when one of the bones of the spinal column fractures. Such an event is often accompanied by sudden onset of pain in the back which intensifies when sitting or standing and decreases when lying down. The pain associated with vertebra compression fractures can be strong enough to limit the activities a person can undertake, thereby reducing the overall quality of life of the individual. 
     Spinal fusion is a surgical technique used to join two or more vertebrae. Such procedure is common for individuals suffering from a variety of spine related diseases, such as vertebral fracture. The fusion process typically involves stabilization of the vertebra using metallic screws, such as pedicle screws, rods, plates, or cages. Minimally invasive percutaneous techniques currently practiced utilize pedicle screw systems having a cannulated screw in order to use a guide wire for proper placement. U.S. Pat. No. 7,780,706 is an illustrative example of a pedicle screw assembly having a cannulated pedicle screw. In these procedures, the cannulated screw is passed over a guide wire which was positioned prior to the placement of the screw over the guide wire. While such technique is relatively safe and effective, several possible problems are known to exist. 
     Use of a guide wire in pedicle screw placement poses several possible risks to the patient. First, guide wires may advance through softer cancellous bone. If such event occurs, severe damage may result to the organs or vessels. Second, when placing guide wires in position, they need to travel a great distance. Such increased distance sometimes results in the guide wires forming kinks, becoming bound within the screw. Fixing the problem can be difficult for the surgeon, increasing the risk of the guide wire being advanced into a critical vessel. Use of guide wires cause increased length of surgical instruments. The increased length makes the instruments more cumbersome, particularly when moving around fluoroscopic imaging devices, such as C-arm, which are critical for percutaneous screw instrumentation. When using guide wires, cannulated screws are required. Since these screws have hollow sections therein, they are inherently less strong than solid screws. Finally, procedures which use guide wires require additional instrumentation, such as retraction devices. 
     Accordingly, what is needed in the art is a pedicle screw system, device, method, and kit that does not require the use of a guide wire for proper implantation. 
     SUMMARY OF THE INVENTION 
     The present invention relates to a system, method device, and kit which utilize a modular pedicle screw implant that does not require the use of a guide wire for implantation. As a result, the system, method, device, and kit eliminate the risk of puncture or damaging of organs and vessels and eliminates the risk of problems associated with guide wire kinking or breaking. Without the need for a guide wire, surgical procedures become less risky as there are less steps to undertake, and the instrumentation is smaller, thereby providing more room to accommodate imaging technology. The present invention also provides for more surgical options for a variety of indications, with the option of a unipolar or multi-polar screw head via one screw system. Finally, the present invention provides a low profile, one piece retractor which may attach to the screw and build off the system for visualization and surgical decompression. 
     The system, method and device include a surgical instrument for implanting a modular pedicle screw comprising a cannula coaxially aligned with a surgical shaft. The surgical shaft contains a first member of a surgical shaft-inner pedicle bone screw member joint, illustrated herein as a locking taper, for securing an inner member of a pedicle screw thereto. The locking taper is designed to provide accurate alignment within and a firm seat into a corresponding second member of the surgical shaft-inner pedicle bone screw member joint. The inner member of a pedicle screw is further adapted to couple to an outer pedicle sheath. In combination, the inner member of a pedicle screw and the outer pedicle sheath form a solid modular pedicle screw that is assembled in situ. The present invention provides a device in which the trocar style or surgical shaft needle is the actual implant. The tip of the surgical shaft forms the center of the solid screw shank. The modular outer pedicle sheath is placed over the surgical shaft, assembling the solid, guide wireless screw in situ. Once assembly is completed, the surgical shaft is designed to be detachable from the implant. 
     In an illustrative embodiment, a surgical instrument for implanting a modular pedicle screw without the use of a guide wire is described. The surgical instrument comprises a first outer member having a first proximal end, a second opposing distal end, and an elongated first outer member main body there between; and a second inner member having a first end, a second end, and an elongated inner member body, said elongated inner member sized and shaped to rest within said first outer member, thereby forming a coaxial relationship, said first end having a first portion of a modular pedicle screw attached thereto. The second inner member and the first portion of a modular pedicle screw may be secured together via a joint. 
     In another illustrative embodiment, a surgical system for implanting a modular pedicle screw without the use of a guide wire is described. The surgical system comprises a surgical instrument comprising an outer cannula having a first proximal end, a second opposing distal end, and an outer cannula main body there between; and a surgical shaft having a first end, a second end, and a surgical shaft body, said surgical shaft sized and shaped to rest within said outer cannula thereby forming a coaxial relationship, said surgical shaft second end frangibly coupled to a modular bone screw implant; and a threaded modular bone screw implant outer sheath. 
     The modular bone screw implant includes a plurality of coupling members, such as but not limned to grooves, sized and shaped to interlock with the threaded modular bone screw implant outer sheath. The surgical system for implanting a modular pedicle screw without the use of a guide wire may include a modular bone screw implant outer sheath which comprise threading having the same thread pitch as the modular bone screw implant, whereby said modular bone screw implant outer sheath locks to said modular bone screw implant. The surgical shaft and the modular bone screw implant are secured tighter via a joint, which may include a locking taper and corresponding socket sized and shaped to receive and hold said locking taper. 
     In another embodiment, a method of performing a surgical procedure for implanting a modular pedicle screw without the use of a guide wire is described. The method compromises: forming an opening in the skin of a patient; inserting a surgical instrument for implanting a modular pedicle screw without the use of a guide wire through said opening; and delivering said surgical instrument to a target area, said surgical instrument having an outer cannula having a first proximal end, a second opposing distal end, and an outer cannula main body there between; and a surgical shaft having a first end, a second end, and a surgical shaft body, said surgical shaft sized and shaped to rest within said outer cannula thereby forming a coaxial relationship, said surgical shaft second end frangibly coupled to a modular bone screw implant; removing said outer cannula once said surgical instrument has reached said target area, whereby when said outer cannula has been removed, said surgical shaft remains in place at said target site; placing a modular bone screw implant outer sheath onto the surgical shaft; guiding said modular bone screw implant outer sheath to said target site by moving said modular bone screw implant outer sheath along said surgical shaft; securing said outer bone screw implant outer sheath to said modular bone screw implant, whereby when secured to each other, a solid pedicle screw is formed. One in place, the surgical shaft can be is removed by detaching the body from the formed solid pedicle screw 
     Finally, a kit for use in performing a surgical procedure for implanting a modular pedicle screw without the use of a guide wire is described. The kit comprising at least one outer cannula having a first proximal end, a second opposing distal end, and an outer cannula main body there between; at least one surgical shaft having a first end, a second end, and a surgical shaft body, said surgical shaft sized and shaped to rest within said at least one outer cannula thereby forming a coaxial relationship, said surgical shaft second end frangibly coupled to a modular bone screw implant; and at least one modular bone screw implant outer sheath configured to couple with said modular bone screw implant secured to said surgical shaft. The kit may include a plurality of outer cannula, said plurality of outer cannula being the same size, different sizes, or combinations thereof; a plurality of surgical shafts, said plurality of surgical shafts having modular bone screw implants coupled thereto of the same size, different sizes, or combinations thereof; and a plurality of modular bone screw implant outer sheaths, said plurality of modular bone screw implant outer sheaths being the same size, different sizes, or combinations thereof. 
     Accordingly, it is an objective of the present invention to provide an improved system, method and device used for inserting surgical implants. 
     It is a further objective of the present invention to provide an improved system, method and device which does not require the use of a guide wire for implantation. 
     It is yet another objective of the present invention to provide an improved system, method and device which reduces the risk associated with using a guide wire in surgical procedures. 
     It is a still further objective of the present invention to provide an improved system, method and device for percutaneous pedicle screw procedures which does not require the use of a guide wire for implantation and can be assembled in situ. 
     It is a further objective of the instant invention to provide a system, method and device for percutaneous pedicle screw procedures which does not require the use of a guide wire for implantation, can be assembled in situ, and forms a solid screw. 
     It is yet another objective of the instant invention system and method of assembling a modular pedicle screw in situ using a modified trocar type instrument for guiding and assembling the pedicle screw. 
     Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  is a perspective view of a surgical instrument for implanting a modular pedicle screw in accordance with the present invention illustrating a surgical shaft inserted within a cannula; 
         FIG. 2  is a perspective view of the surgical shaft in accordance with the present invention; 
         FIG. 3  is a partial view of the surgical shaft in accordance with the present invention; 
         FIG. 4  is a perspective view of the inner member of the modular pedicle bone screw; 
         FIG. 5A  is a perspective view of the outer sheath of the modular pedicle bone screw; 
         FIG. 5B  is a perspective view of the modular pedicle bone screw; 
         FIG. 6  is a cross sectional view of the main body of the outer sheath of the modular pedicle bone screw; 
         FIG. 7  illustrates the insertion of the surgical instrument for implanting a modular pedicle screw into the pedicle of the vertebra; 
         FIG. 8  illustrates the removal of the cannula, exposing the surgical shaft; 
         FIG. 9  illustrates the insertion of the bone screw shaft, using the surgical shaft as a guide; 
         FIG. 10  illustrates the formation of the modular pedicle screw and removal of the surgical shaft from the patient; 
         FIG. 11  is an illustrative embodiment of a kit in accordance with the present invention; 
         FIG. 12  is an alternative embodiment of a kit in accordance with the present invention; 
         FIG. 13  is an alternative embodiment of a kit in accordance with the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated. 
     Referring to  FIGS. 1-6 , a surgical instrument for implanting a modular pedicle screw, referred to generally as  10 , is illustrated. The surgical instrument for implanting a modular pedicle screw  10  is preferably modeled after a standard Jamshidi style needle. Accordingly, the surgical instrument for implanting a modular pedicle screw  10  contains a first outer member, illustrated herein as a cannula  12  and a second inner member, illustrated herein as a modified trocar style surgical instrument shaft, referred to generally as trocar or surgical shaft  14 . The cannula  12  contains a proximal end  16 , a distal end  18 , and an elongated main body  20 . The elongated main body  20  is preferably rod shaped, having a generally hollow interior sized and shaped to receive the trocar or surgical shaft  14 . In this orientation, the cannula  12  is co-axially aligned with the surgical shaft  14  to allow for the surgical shaft  14  to slide within the hollow interior. 
     A handle  24  attaches to the proximal end  16  via any means known to one of skill in the art, such as, but not limited to, threading or chemical fastening. The handle  24  may be ergonomically designed to provide a gripping means for the user. To allow for the surgical shaft  14  to be inserted into and removed or separated from the cannula  12 , the handle  24  contains an opening  26  and a corresponding lumen (not illustrated). A detachable cap  28  allows the surgical shaft  14  to be easy removed from the cannula  12 . The cannula  12  and the handle  24  may be made of any suitable materials for use in surgical procedures, including but not limited to stainless steel, platinum, or plastics such as thermoplastics such as polyether ether ketone (PEEK), or combinations thereof. 
     Referring to  FIG. 2 , an illustrative example of the modified surgical shaft  14  is shown. The surgical shaft  14  contains a first proximal end  30 , an opposing second distal end  32 , and an elongated main body  34 . The elongated main body  34  is preferably rod shaped and solid, and sized to fit and slide within the hollow interior of the cannula  12 . The distal end  32  of the surgical shaft  14  secures to an inner member of a modular pedicle bone screw  36 A. The inner member of a modular pedicle bone screw  36 A is designed to secure to an outer bone screw sheath  36 B to form the modular pedicle bone screw, referred to in combination as  36 , see  FIG. 5B . As illustrated, the inner member of a modular pedicle bone screw  36 A is a solid elongated body, preferably cylindrical shape, with a sharp or pointed end. 
     As shown on  FIG. 3 , the distal end  32  of the surgical shaft  14  contains a first member of a surgical shaft-inner pedicle bone screw member joint, illustrated herein as a locking taper  38  having tapered surfaces  40 . Preferably, the first member of a surgical shaft-inner pedicle bone screw member joint is frangibly attached to the distal end  32  of the modified surgical shaft  14 . The locking taper is designed to provide accurate alignment with and mate to a corresponding surface so that when mated, frictional forces are sufficient to prevent rotation with respect to one another and require considerable force to separate. The locking taper  38  may include, but is not limited to a Morse locking taper or a Jarno locking taper, and may be designed to have a partial cone configuration or have a general cone shape having various angles of tapering. The locking taper  38  is inserted into a second member of a surgical shaft-inner pedicle bone screw member joint, illustrated herein as a matching tapered socket  42  positioned within the surface  44  at the proximal end  45  of the inner member of a pedicle bone screw  36 A, see  FIG. 4 . While the present invention describes the use of a locking taper and corresponding locking taper socket, other mechanisms to secure the surgical shaft to a portion of the screw may be used, including the threading and grooves or the use of male/female connectors. 
     The distal end  46  of the inner member of a modular pedicle bone screw  36 A preferably contains a pointed tip end  48 . As such, when the cannula  12  is placed over the surgical shaft  14 , the tip end  48  of the inner member of a modular pedicle bone screw  36 A forms the pointed end of the surgical instrument for implanting a modular pedicle screw  10 , thus providing for the pointed tip to be useful in targeting an implant site, thereby forming a part of the actual implant. The pointed tip end  48  forms the center of the pedicle bone screw  36 . The outer surface  50  of the inner member of a modular pedicle bone screw  36 A contains a plurality of finely machined grooves  52  sized and shaped to interlock with a bone screw shaft  36 B, see  FIG. 3 . 
     Referring to  FIG. 5A , an illustrative example of the bone screw shaft  36 B of the pedicle bone screw  36  is shown. The bone screw shaft  36 B comprises a proximal end  54 , a distal end  56 , and a bone screw shaft main body  58 . The bone screw shaft main body  58  is illustrated having a generally elongated, tubular shape sized to fit over the inner member of the modular pedicle bone screw  36 A. Accordingly, the bone screw shaft main body  58  has a hollow or partially hollow interior  59  to allow for the inner member of the modular pedicle bone screw  36 A to slidably engage therein. The distal end  56  has an opening  60  allowing the pointed end  48  of the inner member of the modular pedicle bone screw  36 A to extend upwardly. 
     The interior surface  62  contains threading  64  which engages with and secures to the grooves  52  of the inner member of the modular pedicle bone screw  36 A. Sliding the bone screw shaft  36 B over the inner member of the modular pedicle bone screw  36 A forms the solid bone screw  36 . At the proximal end  54  of the bone screw shaft  36 B is a connector member  66  which may be adapted to retain a screw set, locking cap, or spinal implant rod. The outer surface  68  contains a plurality of threading  70  to secure the modular pedicle bone screw  36  to the portion of the body inserted therein. 
     The present invention will further be defined by describing an illustrative example of method of use, see  FIGS. 7-10 . While the surgical instrument for implanting a modular pedicle screw is described for use in spinal implantation, such use is not intended to be limiting. As such, the surgical instrument for implanting a modular pedicle screw in accordance with the present invention can be adapted and used in any surgical procedure requiring screw implantation. 
     Referring to  FIG. 7 , the surgical instrument for implanting a modular pedicle screw  10  is shown inserted through the skin  72  of patient  74 . To insert the surgical instrument for implanting a modular pedicle screw  10 , the patient  74  is placed in a prone position according to standard surgical procedures. To aid in insertion of the surgical instrument for implanting a modular pedicle screw  10 , imaging or guidance technology such as fluoroscopy, is utilized and positioned in according to standard surgical procedures. After the surgical site has undergone sterile preparation, the skin  72  is marked and an incision  76  is made. The surgical instrument for implanting a modular pedicle screw  10  is used under guidance to target and cannulate the target area, illustrated herein as the vertebral body  78 . The surgical instrument for implanting a modular pedicle screw  10  is tapped to the desired depth within the vertebral body  78 . Once securely in position to the desired depth, the cannula  12  of the surgical instrument for implanting a modular pedicle screw  10  is removed. To perform such procedure, the cap  28  is removed from the handle  24 . The surgeon lifts the cannula  12  in a direction away from the patient  74 , see arrows  80 ,  FIG. 8 . Once the cannula  12  is removed, the surgical shaft  14  with the inner member of the modular pedicle bone screw  36 A remains embedded in the pedicle. 
     With the surgical shaft  14  firmly in place, the main body  34  of the surgical shaft  14  is used as a guide for placing the bone screw shaft  36 B onto the inner member of the modular pedicle bone screw  36 A, thereby forming the modular pedicle bone screw  36 . The bone screw shaft  36 B is cannulated to fit over and coaxially align with the already implanted inner member of the modular pedicle bone screw  36 A. The inner threading  64  positioned within the interior surface  62  of the bone screw shaft  36 B secures to and locks onto the finely machined grooves  52  on the outer surface of the inner member of the modular pedicle bone screw  36 A. Preferably, all components with threading have the same thread pitch to allow for the inner and outer components to move as a single unit. Once secured to each other, a solid pedicle screw  36  is formed and is comparable in strength to single, non-cannulated screws. The threading  70  on the outer surface  68  of the bone screw shaft  36 B is screwed into place over the solid center thereby tapping the pedicle and allowing for removal as necessary as a standard screw. 
     The implanted main body  34  of the surgical shaft  14  may serve additional functions. The implanted main body  34  of the surgical shaft  14  may be utilized as a guide through which a cannulated screw head may be placed, either uni-planar or multi-planar. The implanted main body  34  of the surgical shaft  14  may also function as continued soft tissue retraction for visualization. Finally, the implanted main body  34  of the surgical shaft  14  may be used as a guide through which standard instruments are used to distract or compress the space according to surgical indications. Once the procedures are completed, the implanted main body  34  of the surgical shaft  14  is detached (such as through use of perforation within and around the surgical shaft perimeter, not shown or for example, constructing the detachable portion to have thinner diameter that breaks apart after a predetermined force, such as a predetermined bending force, is applied), leaving the pedicle screw implant  36  intact and in the proper, desired place. 
     The present invention further contemplates the use of a kit including one or more of the following: pre-assembled surgical instrument for implanting a modular pedicle screw and/or a plurality of individual components.  FIG. 11  illustrates a first example of a kit in accordance with the present invention. The kit  82  includes a sterilizable case having the contents of at least one cannula  12 , at least one surgical shaft with a locking member  38  unattached to an inner member of the pedicle screw  36 A, a plurality of different sized inner member of the pedicle screws  36 A, including 35 mm length  36 A 1 , 40 mm length  36 A 2 , 45 mm length  36 A 3 , and correspondingly sized bone screw shafts  36 B 1 ,  36 B 2 , and  36 B 3 . In this arrangement, the surgeon secures the inner member of the modular pedicle bone screws  36 A to the appropriately sized surgical shaft with a locking member  38  and cannula  12 .  FIG. 12  illustrates a kit  86  having a sterilizable case  84  having the contents of at least one cannula  12 , a plurality of surgical shaft  14   1 ,  14   2 ,  14   3  with differently sized inner members of the pedicle screw  36 , and a plurality of and correspondingly sized bone screw shafts  36 B 1    36 B 2 , and  36 B 3 .  FIG. 13  illustrates a kit  88  having a sterilizable case  84  having the contents of a plurality of surgical instrument for implanting a modular pedicle screw  10   1 ,  10   2 ,  10   3 , each pre-assembled and having differently sized inner members of the pedicle screw  36 A, and a plurality of and correspondingly sized bone screw shafts  36 B 1    36 B 2 , and  36 B 3 . 
     All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. 
     It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. 
     One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.