Tools and Systems for Solid Form and Graft Implantation

Abstract

This invention provides tools and kits for removal of a graft and/or for implantation of a solid or semi-solid form or graft within an appropriate desired tissue minimizing the potential for or actual breakage of the implant or graft during the stated process. Kits comprising such tools and methods making use of same are provided, as well.

1 . An implantation alignment tool comprising:
 an elongated body having a central hollow spanning the length of said body;   a stabilization structure terminally joined to said elongated body by a joint region having a central hollow and further comprising:
 a first region comprising a first diameter, which first diameter is smaller than a diameter of said elongated body; and 
 a second region having a second diameter, which second diameter is smaller than a diameter of said elongated body and larger than said first diameter, 
   wherein said second region is sized to be of a dimension to facilitate a snug fit within the borders of a site of implantation.   
     
     
         2 . The implantation alignment tool of  claim 1 , wherein said elongated body has a varying outer diameter, varying inner diameter or a combination thereof along the length of said elongated body. 
     
     
         3 . The implantation alignment tool of  claim 1 , wherein said elongated body has an outer diameter, inner diameter or a combination thereof that does not vary along the length of said elongated body. 
     
     
         4 . The implantation alignment tool of  claim 1 , wherein at least a portion of a first region, at least a portion of a second region or a combination thereof contact a boundary of an implantation site. 
     
     
         5 . The implantation alignment tool of  claim 1 , wherein said first region is proximal to said joint region and said second region is proximal to said first region and distal to said joint region. 
     
     
         6 . The implantation alignment tool of  claim 1 , wherein said stabilization structure comprises alternating first and second regions arranged in a desired pattern such that a second region is located at a distal terminus of said stabilization structure. 
     
     
         7 . The implantation alignment tool of  claim 6 , wherein said second region contains at least one terminally extending scoring protrusion. 
     
     
         8 . The implantation alignment tool of  claim 1 , wherein said stabilization structure comprises alternating first and second regions along a horizontal axis of said stabilization structure. 
     
     
         9 . The implantation alignment tool of  claim 1 , wherein said stabilization structure comprises alternating first and second regions along a vertical axis of said stabilization structure. 
     
     
         10 . The implantation alignment tool of  claim 1 , wherein said stabilization structure comprises alternating first and second regions resembling a screw structure. 
     
     
         11 . The implantation alignment tool of  claim 1 , wherein said stabilization structure comprises alternating first and second regions resembling a drill bit structure. 
     
     
         12 . The implantation alignment tool of  claim 1 , wherein said elongated body comprises a material that is a metal, metal alloy, ceramic, glass or plastic. 
     
     
         13 . The implantation alignment tool of  claim 1 , wherein said stabilization structure comprises an a metal, metal alloy, ceramic, glass or plastic and may optionally incorporate a flexible or shock-absorbing material. 
     
     
         14 . The implantation alignment tool of  claim 1 , wherein said stabilization structure and said elongated body are comprised of the same material. 
     
     
         15 . The implantation alignment tool of  claim 1 , wherein said alignment tool is adapted to fit over a rod-like structure. 
     
     
         16 . A kit comprising the implantation alignment tool of  claim 1 . 
     
     
         17 . The kit of  claim 16 , further comprising a surgical cutter adapted to fit over said implantation alignment tool in situ, wherein said alignment tool maintains a desired orientation of said surgical cutter during tissue harvest. 
     
     
         18 . The kit of  claim 17 , wherein said surgical cutter comprises laterally extending protrusions, which protrusions extend into the tissue walls proximally located to the defect site. 
     
     
         19 . The kit of any one of  claim 16  or  18 , further comprising one or more rod-like structures. 
     
     
         20 . The kit of  claim 19 , wherein said one or more rod-like structures may vary in terms of their composition, length, diameter or a combination thereof. 
     
     
         21 . The kit of any one of  claim 16  or  18  or  19 , further comprising a surgical reamer, adapted to fit over a rod-like structure. 
     
     
         22 . The kit of any one of  claim 16  or  18  or  19  or  21 , further comprising a surgical smoother, optionally adapted to fit over said implantation alignment tool in situ, or over a rod-like structure. 
     
     
         23 . The kit of any one of  claim 16  or  18  or  19  or  21  or  22 , further comprising:
 a drill bit assembly unit suitable for drilling tissue comprising:
 a substantially hollow drill bit comprising a drilling region at a first terminus and a body region, wherein said body region comprises at least one lateral extension therefrom at a region distal to said first terminus; and 
 a substantially hollow drill bit protective sheath comprising a first region sized to accommodate insertion and permit free rotation of said drill bit around a longitudinal axis and a second region sized to prevent further advancement of said at least one lateral extension of said drill bit beyond a set point, 
 
 wherein when said second region engages said at least one lateral extension, advancement of said drill bit along a longitudinal axis is limited. 
 
     
     
         24 . The kit of any one of  claim 16  or  18  or  19  or  21  or  22  or  23 , further comprising an implantation tool stabilizing implement comprising:
 a hollow elongated body adapted for insertion of a rod-like structure therethrough; and 
 at least one stabilizing contact structure comprising an at least partially circular concave single piece structure having an inner tissue contact surface and an outer visualization surface, and an aperture adapted for insertion of said rod-like structure therethrough located centrally within said structure spanning said inner and outer surfaces. 
 
     
     
         25 . An implantation tool stabilizing implement comprising:
 a hollow elongated body adapted for insertion of a rod-like structure therethrough; and   at least one stabilizing contact structure comprising an at least partially circular concave structure having an inner tissue contact surface and an outer visualization surface, and an aperture adapted for insertion of said rod-like structure therethrough located centrally within said structure spanning said structure.   
     
     
         26 . The implantation tool stabilizing implement of  claim 25 , wherein said hollow cylindrical body is sized to accommodate insertion of a K-wire therethrough. 
     
     
         27 . The implantation tool stabilizing implement of  claim 25 , wherein a diameter of said hollow cylindrical body in comparison to a diameter of said rod-like structure is such that said rod-like structure insertion therethrough leaves a space between an outer surface of said rod-like structure and an internal surface of said hollow cylindrical body. 
     
     
         28 . The implantation tool stabilizing implement of  claim 25 , further comprising an adapter, which adapter possesses a diameter which is smaller than that of said hollow cylindrical body and which diameter is larger than a diameter of said rod-like structure and wherein said adapter is placed within said hollow cylindrical body and said rod-like structure may be inserted therethrough. 
     
     
         29 . The implantation tool stabilizing implement of  claim 25 , wherein said at least partially circular concave structure is comprised of a transparent or translucent material. 
     
     
         30 . The implantation tool stabilizing implement of  claim 29 , wherein said hollow elongated body and said at least one stabilizing contact region are comprised of a metal, metal alloy, glass or plastic. 
     
     
         31 . The implantation tool stabilizing implement of  claim 30 , wherein said hollow cylindrical body and said at least one stabilizing contact region are comprised of a different material. 
     
     
         32 . The implantation tool stabilizing implement of  claim 31 , wherein said hollow cylindrical body is comprised of a metal or metal alloy. 
     
     
         33 . The implantation tool stabilizing implement of  claim 32 , wherein said hollow cylindrical body is comprised of a plastic or glass. 
     
     
         34 . The implantation tool stabilizing implement of  claim 25 , wherein said hollow cylindrical body and said at least one stabilizing contact region are comprised of the same material. 
     
     
         35 . A kit comprising the implantation tool stabilizing implement of  claim 25 . 
     
     
         36 . The kit of  claim 35 , further comprising the implantation alignment tool of  claim 1 . 
     
     
         37 . An implantation scoring tool comprising:
 a longitudinal body which is optionally hollow and optionally adapted for insertion of a rod-like structure therethrough; and   at least one laterally extending protrusion, which protrusion is oriented substantially perpendicularly to a long-axis of said longitudinal body, optionally wherein said laterally extending protrusion possesses a deployed and a compact position;   wherein when said implantation scoring tool is placed within an implant site and said laterally extending protrusion is in a deployed position, said laterally extending protrusion inserts within a tissue wall bounding said implant site thereby scoring said tissue wall.   
     
     
         38 . A kit of any one of  claim 16  or  18  or  19  or  21  or  22  or  23  or  25  or  37  further comprising an implantation scoring tool of  claim 34 . 
     
     
         39 . A graft or solid implant introducing tool suitable for the introduction of brittle grafts or solid implants, said graft or solid implant introducing tool comprising:
 a piston assembly containing a substantially elongated body and a first terminus comprised of a shock-absorbant material and an advancer structure located at a second terminus of said substantially elongated body; and   a sheath which sheath accommodates insertion of said piston assembly therewithin, which sheath comprises:   an insertion region for insertion of said piston assembly;   a substantially hollow substantially cylindrical body into which said piston assembly may insert;   a stopper region located proximally to said piston assembly when said piston assembly is inserted within said substantially hollow substantially cylindrical body, wherein said stopper region comprises a solid boundary containing an opening, which opening accommodates insertion of only a portion of said first terminus of said piston assembly; and   a graft or solid implant containment gripping part located proximally to said solid boundary of said stopper region, which gripping part is comprised of a flexible shock-absorbing material and which gripping part is sized to accommodate insertion of only a portion of a graft or solid implant therewithin.   
     
     
         40 . The graft or solid implant introducing tool of  claim 39 , wherein a most terminal part of said gripping part is inserted into a void into which said graft or solid implant is to be inserted, and wherein said most terminal part of said gripping part is substantially flat and smooth. 
     
     
         41 . The graft or solid implant introducing tool of  claim 39 , wherein said graft or solid implant introducing tool, including said elongated body of said piston assembly, said insertion region for insertion of said piston assembly, said substantially hollow substantially cylindrical body, said stopper region, graft or solid implant containment gripping part or a combination thereof comprise a void such that said rod-like structure may insert therethrough. 
     
     
         42 . The graft or solid implant introducing tool of  claim 39 , wherein said substantially elongated body of said piston assembly, said insertion region for insertion of said piston assembly, said substantially hollow substantially cylindrical body, said stopper region or a combination thereof are comprised of a glass or plastic. 
     
     
         43 . The graft or solid implant introducing tool of  claim 39 , wherein said first terminus of said piston assembly, said gripping part or a combination thereof is comprised of a silicon, rubber or latex material. 
     
     
         44 . A kit of any one of  claim 16  or  18  or  19  or  21  or  22  or  23  or  25  or  37  f further comprising a graft or solid implant introducing tool of  claim 39 . 
     
     
         45 . A method of tissue implantation in a subject, which method minimizes damage to an area of tissue implantation, said method comprising the steps of:
 inserting a rod-like structure within a target tissue implantation site in a subject, optionally with the aid of an implement orienting said rod-like structure to be in an orientation perpendicular to a plane of a surface of said target graft withdrawal or implantation site and in an orientation to be centralized within said implantation site;   drilling an area of tissue in said subject which is less than that of a desired tissue implantation site in an orientation perpendicular to a surface of said area of tissue, optionally with a drill bit adapted for application over said rod-like structure;   applying the implantation alignment tool of  claim 1  over said rod-like structure and positioning same within said area of tissue;   surgically excising tissue from an area of desired implantation, by optionally applying a surgical cutter over said implantation alignment tool of  claim 1 ; and   applying a tissue graft or solid implant within said area of tissue, optionally by inserting a cannulated implant within said sidte, over said rod-like structure   
       wherein drilling in an orientation perpendicular to a surface of the target tissue and subsequent application of said surgical cutter over said implantation alignment tool to surgically excise desired tissue from said area of tissue for implantation in said subject minimizes damage to an area of tissue implantation in said subject. 
     
     
         46 . A method of tissue graft extraction in a subject, which method minimizes damage to an area of tissue in said graft and tissue surrounding said graft extraction site, said method comprising the steps of:
 inserting a rod-like structure within a target graft withdrawal site in a subject, optionally with the aid of an implement orienting said rod-like structure to be in an orientation perpendicular to a plane of a surface of said target graft withdrawal and in an orientation to be centralized within said target graft withdrawal site;   drilling an area of tissue in said subject which is less than that of a desired graft extraction site in an orientation perpendicular to a surface of said area of tissue, optionally with a drill bit adapted for application over said rod-like structure;   applying the implantation alignment tool of  claim 1  over said rod-like structure and positioning same within said area of tissue; and   surgically excising tissue from an area of desired graft extraction, by optionally applying a surgical cutter over said implantation alignment tool of  claim 1 ;   wherein drilling in an orientation perpendicular to a surface of the target tissue and subsequent application of said surgical cutter over said implantation alignment tool to surgically excise desired tissue from said graft site in said subject minimizes damage to an area of tissue to an area of tissue in said graft and tissue surrounding said graft extraction site.   
     
     
         47 . A method for minimizing damage to an area of solid implant insertion in a tissue in a subject in need thereof, said method comprising the steps of:
 inserting a rod-like structure within an implantation site in a subject with the aid of an implement orienting said rod-like structure to be in an orientation perpendicular to a plane of a surface of said target implantation site;   applying an implement comprising a terminally located drill bit over said rod-like structure and drilling an area of tissue in said subject which is less than that of a desired implantation site, which implement is optionally said implantation alignment tool of any one of  claim 10  or  11 , and optionally wherein said implement is positioned within a drill bit protective sheath,   
       thereby minimizing damage to tissue located proximally to said area of tissue in said subject and optionally removing said implement;
 optionally applying the implantation alignment tool of  claim 1  over said rod-like structure; 
 applying a surgical cutter over said rod like structure or said implantation alignment tool of any one of  claim 1 ,  10  or  11  and surgically excising desired tissue from said area of implantation which is equal to or slightly smaller in size than that of a desired implantation site to ensure press-fit therewithin; 
 optionally applying a tissue reamer adapted to fit over a rod-like structure or said implantation alignment tool, to enlarge the implantation site, which reamer optionally contains markings indicating a depth of insertion; 
 optionally applying a smoothing tool over said rod-like structure or said implantation alignment tool and surgically smoothing said area of tissue in said implantation site; and 
 applying a tissue graft or solid implant within said area of tissue. 
 wherein insertion of said drill bit over said rod-like structure for minimal drilling in a tissue ensures optimized drilling in an orientation perpendicular to a surface of the target tissue and applying said surgical cutter over said stabilizing structure and surgically excising desired tissue from said area of desired solid implantation to an area of tissue in said subject ensures that minimal damage occurs to an area of solid implant insertion in said tissue and optimal orientation of solid implant insertion or a combination thereof is achieved. 
 
     
     
         48 . The method of  claim 47  further comprising the steps of:
 applying an implantation tool stabilizing implement to a surface of a target implantation site in a subject, wherein said implantation tool stabilizing implement comprises: 
 a hollow elongated body adapted for insertion of a rod-like structure therethrough; and 
 at least one stabilizing contact structure comprising an aperture adapted for insertion of said rod-like structure therethrough, and an at least partially circular concave single piece structure having an inner tissue contact surface and an outer visualization surface, 
 establishing a stabilized application of said implantation tool stabilizing implement such that insertion of said rod-like structure therewithin will be in an orientation perpendicular to a plane of said surface of a target implantation site and affixing said rod like structure within tissue of an area of desired solid implantation; 
 inserting said implement comprising a terminally located drill bit over said rod-like structure, drilling said area of tissue, optionally removing said drill bit, applying said implantation alignment tool and said surgical cutter and surgically excising said desired tissue; 
 removing said surgical cutter, said implantation tool alignment implement and said rod-like structure from said area of desired solid implantation; 
 optionally scoring lateral walls bounding said area of desired solid implantation; and 
 inserting a solid implant within said area of desired solid implantation by applying a graft or solid implant to form a tight fit within said area of desired solid implantation.