Abstract:
Methods and devices for deploying biological implants are disclosed. The biological implants can include orthopedic, multi-component ankle implants. The target site can be prepared by fixing a rigid, alignable guide or jig with saw holes to the bone(s). Saws configured to fit through the saw holes can then be inserted through the saw holes to cut the bone(s). The jig can then be removed. Slidable implants can be positioned. Implants needing to be forced into place can be attached to elongated members to gently hold the implant and to provide a non-implant surface on which to apply the force.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of PCT Application No. PCT/US2008/070441, filed 18 Jul. 2008, which claims the benefit of U.S. Provisional Application No. 60/951,120, filed 20 Jul. 2007, both of which are incorporated by reference herein in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to methods and devices for deploying biological implants, more specifically for methods and devices for deploying bone implants. 
       BACKGROUND OF THE INVENTION 
       [0003]      FIGS. 1 and 2  illustrate anterior and lateral views of the tibia  6 , talus  12  and fibula  2  (not shown in  FIG. 2 ). A vertical axis  8  and an original talus thickness  10  are shown. The original talus thickness  10  is dependent on individual anatomical factors and the amount of pathological bone degradation. The talus has a talus head (caput tali) and talus neck (collum tali). The talus head has a rounded talus head crown. 
         [0004]    Osteoarthritis or trauma can result in ankle pathology of uneven wear on, and/or direct trauma to, the surface of the talus. This commonly leads to cartilage erosion and subsequent break down of subchondral bone. Osteoarthritis and certain trauma on the talus are often treated by fusing the talus to the tibia. This fusion procedure results in loss of mobility of the ankle, and the expected complications resulting from a loss of mobility including gait changes, further stress-related injuries, and a reduction of the patient&#39;s overall mobility. 
         [0005]    A secondary treatment for osteoarthritis in the talus—and in other bones—is to replace part of the damaged bone with a partial bone prosthesis. The partial bone prostheses, such as those for the talus or the long bones (e.g., femur, tibia, humerus, ulna), typically anchor into the remainder of the bone. 
         [0006]    Implantation of prosthetic orthopedic implants is often accomplished by removing bone surrounding the implant site in order to provide the proper geometry to seat the implant. The implant is then positioned into place. A surgeon may have to make multiple passes with a straight saw or osteotome to remove the proper portion of bone. The osteotome position may also need to be altered between the cuts. Multiple cuts with no guide or limited guides can result in variable results from procedure to procedure. 
         [0007]    Osteotome guides are known in the art, but are typically moved to accommodate various passes of a straight osteotome to accomplish anything other than a single straight removal of bone. 
         [0008]    An osteotome is desired that can perform a single cut with multiple angles is desired. Furthermore, a guide for such an osteotome and methods of using both are desired. 
       SUMMARY OF THE INVENTION 
       [0009]    Methods and devices for deploying biological implants are disclosed. The biological implants can include two-piece or three-piece ankle implants. For example, the implants can have a prosthesis talus component and/or a prosthesis tibia component and/or a prosthesis floating component configured to be placed between the prosthesis talus component and the prosthesis tibia component. A guide can be used to prepare the target implantation site before the prosthesis components are implanted. One or more osteotomes can be used, for example directed by the guide, to cut target bone in preparation for implantation of the prosthesis components. An atraumatic holder or setting tool can be used to releasably hold, guide and move the prosthesis components during implantation. 
         [0010]    The guide can be aligned at the target site. For example, a laser alignment line, or gravitation plumb bob, or anchored rod, or other alignment device can be secured to the lower leg (e.g., the tibia or patella) to provide a constant and reliable alignment line. The guide can have two or more holes for alignment pins. The guide can be aligned to the alignment line and fixed to the tibia or other bone, for example by inserting pins through the holes for the alignment pins, and fixing the pins into the bone. The alignment pins can be inserted through holes in a single plane (as shown in  FIGS. 11   a  and  11   b ) or multiple planes. 
         [0011]    The guide, also called a jig or frame, can be alignable with respect to the knee (e.g., patella) or tibia. The guide can have a rigid and fixed body. The guide body can be sufficiently thick, for example 19 mm (0.75 in.), for the material of the guide body, for example stainless steel, to prevent yaw, twist, or rotation of the guide during use (e.g., during cutting, for example to minimize cutting errors and tolerances). The guide body can have two or more slots passing therethrough to guide osteotomes. The slots can be at fixed positions with respect to each other in the guide. The guide can have a tongue or guide handle extending from the guide body at a talar declination angle, for example, to provide a field of view of the operating site for the surgeon during use. 
         [0012]    A prosthesis holder or setting tool can be used to atraumatically and releasably hold the prosthesis talus component and/or the prosthesis tibia component and/or the prosthesis floating component. The prosthesis holder can be made in whole or part of soft material, such as polycarbonate, plastic, a soft rubberized material, or combinations thereof. The prosthesis holder can have an abutment away from the prosthesis to receive an impact force from a mallet or hammer. The prosthesis holder can then atraumatically deliver the impact force to the prosthesis component being held. The prosthesis holder can be long enough to extend out of the surgical field to allow a hammer or mallet to impact the abutment and to control work spaces far enough away from surgical field so the patient will not obstruct manipulation and use of the prosthesis holder. 
         [0013]    The talus, tibia or floating components can also be positioned without use of the prosthesis holder, for example by positioning and inserting directly by hand. 
         [0014]    One or more osteotomes (or saws or cutting tools) can be used to prepare the bones (e.g., tibia and talus) to receive the prosthesis components. The osteotomes can be configured to fit the slots in the guide. The osteotomes can have straight and/or rounded transverse cross-sections. 
         [0015]    The osteotomes can have a cross-member. A leg can extend at an angle from either or both ends of the cross-member. The legs and cross-member can have a contiguous cutting edge. The osteotome can have a cutting edge with two, three or more contiguous elongated edge lengths (e.g., at the leading edge of the cross-member and legs). Each edge length can extend at an angle from the adjacent edge lengths. For example, a first cutting edge length along the cross-member can join at an angle with the second cutting edge length along a leg extending from the cross-member. 
         [0016]    The osteotomes and guides can provide repeatable cuts with low tolerances. The cuts can match the fit needed for the prosthesis components. 
         [0017]    Once the guide is fixed to the tibia and talus, the osteotomes can be inserted through the slots in the guide and cut the tibia and talus. The osteotomes and guides can be configured to preserve as much talus bone as possible, for example through the center of the talus head, while still sufficiently preparing the talus to receive the prosthesis. For example, the osteotomes can remove from about 3.18 mm (0.125 in.) or less to about 13 mm (0.5 in.) or less, for example about 6.4 mm (0.25 in.) or less of height of bone from the crown of the talus head. This height of removed bone can be substantially equivalent to the height of the shoulders of the prosthesis talus component. 
         [0018]    The prosthesis components can then be positioned and fixed on the tibia and talus, for example with the prosthesis holder. 
         [0019]    Once the prosthesis talus component and prosthesis tibia component have been fixed, the prosthesis floating component can be inserted between the prosthesis talus component and prosthesis tibia component, for example when surgically open joint is distended. 
         [0020]    During the procedure, halo stabilizers can be fixed to (e.g., fixation screws can be drilled into) the bones. The halo stabilizers can be used to fix the talar angle with respect to the tibia, for example, to minimize error of placement of the prosthesis components. 
     
    
     
       SUMMARY OF THE FIGURES 
         [0021]      FIG. 1  is not the invention and illustrates an anterior view of the bones of the upper ankle. 
           [0022]      FIG. 2  is not the invention and illustrates a lateral view of  FIG. 1  sans fibula. 
           [0023]      FIGS. 3   a ,  3   b  and  3   d  are front perspective, top perspective and side views, respectively, of a variation of the osteotomy guide. 
           [0024]      FIGS. 3   c ′ and  3   c ″ are front views of variations of the osteotomy guide. 
           [0025]      FIGS. 4   a ,  4   b  and  4   c  are front perspective, top, front and side views, respectively, of a variation of the osteotome. 
           [0026]      FIG. 4   d  illustrates a variation of cross-section A-A of  FIGS. 4   a  and  4   c.    
           [0027]    FIGS.  5  through  7 ″ are perspective views of variations of the prosthesis talus component. 
           [0028]      FIGS. 8   a ′,  8   b ′, and  8   c ′ are front, bottom and side views, respectively, of the prosthesis talus component of FIG.  7 ′. 
           [0029]      FIGS. 8   a ″ and  8   b ″ are front and bottom views, respectively, of the prosthesis talus component of FIG.  7 ″. 
           [0030]      FIGS. 9   a ,  9   b , and  9   c  are perspective, top, and side views of a variation of the prosthesis floating component. 
           [0031]      FIG. 9   d  is a variation of section C-C of  FIG. 9   c.    
           [0032]      FIGS. 10   a ,  10   b  and  10   c  are perspective, front and side views, respectively, of a variation of the prosthesis tibia component. 
           [0033]      FIGS. 11   a  and  11   b  are anterior and lateral views, respectively, of a variation of a method for aligning and attaching the osteotomy guide to the tibia and talus. 
           [0034]      FIGS. 12   a  and  12   b  are anterior and lateral views, respectively, of a variation of the osteotomy guide aligned and attached to the tibia and talus. 
           [0035]      FIGS. 13   a  and  13   b  are anterior and lateral views, respectively, of the osteotomes aligned with and inserted into the osteotomy guide before beginning the osteotomy. 
           [0036]      FIGS. 14   a  and  14   b  are anterior and lateral views, respectively, of the osteotomes concluding the cut of the osteotomy of the tibia and the talus. 
           [0037]      FIGS. 15   a  and  15   b  are anterior and lateral views, respectively, of a variation of the ankle after the cut of the osteotomes and removal of the loose bone. 
           [0038]      FIGS. 16   a  and  16   b  are anterior and lateral views, respectively, of a variation of the ankle after the cut of the osteotomes and removal of the loose bone. 
           [0039]      FIGS. 17   a  and  17   b  are anterior and lateral views, respectively, of a method for implanting the prosthesis talus component with a removable prosthesis handle (not shown in  FIG. 17   a  for illustrative purposes). 
           [0040]      FIGS. 18   a  through  18   c  illustrate variations of prosthesis handles attached to a variation of the prosthesis talus component. 
           [0041]      FIGS. 19   a  and  19   b  are anterior and lateral views, respectively, of the ankle with the prosthesis talus component in an implanted configuration. 
           [0042]      FIGS. 20   a  and  20   b  are anterior and lateral views, respectively, of the ankle of  FIGS. 19   a  and  19   b  with a variation of the tibia bone prosthesis attached. 
           [0043]      FIGS. 21   a  and  21   b  are anterior and lateral views, respectively, of the ankle of  FIGS. 19   a  and  19   b  with a variation of the tibia bone prosthesis attached. 
           [0044]      FIGS. 22   a  and  22   b  are anterior and lateral views, respectively, of the ankle of  FIGS. 19   a  and  19   b  with a variation of the tibia bone prosthesis attached. 
           [0045]      FIGS. 23   a  and  23   b  are anterior and lateral views, respectively, of the ankle of  FIGS. 19   a  and  19   h  with a variation of the tibia bone prosthesis attached. 
           [0046]      FIGS. 24   a  and  24   b  are anterior and lateral views, respectively, of the ankle of  FIGS. 20   a  and  20   b  with a variation of a prosthesis floating component. 
       
    
    
     DETAILED DESCRIPTION 
       [0047]      FIGS. 3   a ,  3   b  and  3   d  illustrate an osteotomy guide  20  that can have a guide body  22  having a guide body thickness  68 . A talus port or slot  26  and/or tibia port or slot  32  can pass through the entire guide body thickness  68 . The talus and tibia slots  26 ,  32  can be configured to receive and direct one or more osteotomes. The guide body  22  can have a narrowing guide neck  34  at the superior end of the guide body  22 . The guide body  22  can have one, two or more alignment holes  42  passing through the entire guide body thickness  68 . The alignment holes  42  can be configured in one or more lines, for example along a horizontally-centered, vertical axis  8 . A superior end of the guide body  22  can narrow along the vertical axis  8  into a guide neck  34 . The guide neck  34  can have additional alignment holes  42 . 
         [0048]    The guide body thickness  68  can be from about 6.4 mm (0.25 in.) to about 38 mm (1.5 in.), for example about 19 mm (0.75 in.). The guide body  22  can be sufficiently thick to prevent deformation of the guide body  22  during use, for example while fixed to adjacent, articulating bones. 
         [0049]    The guide handle  44  can extend in an anterior direction from the guide body  22 . The guide handle  44  can form a guide handle angle  46  with the plane of the guide body  22 . The guide handle angle  46  can be from about 60° to about 150°, for example about 105°. The guide handle  44  can be integral with, or removably or fixedly attached to, the guide body  22 . The guide handle  44  can have an elongated, substantially flat configuration. The guide handle  44  can be substantially rigid or flexible. 
         [0050]    The guide body  22  can have a talus notch  48 , for example, configured to avoid physical interference with the talus  12  during use. The talus notch  48  can have a talus notch height  50  and a talus notch depth  52 . The talus notch height  50  can be from about 0 mm (0 in.) to about 25 mm (1.0 in.), for example about 13 mm (0.50 in.). The talus notch depth  52  can be from about 0 mm (0 in.) to about 13 mm (0.50 in.), for example about 6.4 mm (0.25 in.). 
         [0051]    The guide body  22  can have a tibia slot and/or a talus slot  26 ,  32 . The tibia slot  32  and the talus slot  26  can extend through the entire guide body  22 . The tibia slot  32  can be a substantially straight or curved configuration. The talus slot  26  can have a talus slot body  56  having a substantially straight or curved configuration. The talus slot  26  can have a talus slot leg  58  extending contiguously (as shown) or separately from one or both ends of the talus slot body  56 . The talus slot legs  58  can have substantially straight or curved configurations. The talus slot leg  58  can extend from the talus slot body  56  at a talus slot angle  60  with respect to the vertical axis  8 . The talus slot angle  60  can be from about 0° to about 90°, more narrowly from about 20° to about 70°, for example about 40°. 
         [0052]      FIG. 3   c ′ illustrates that the talus slot  26  can have a talus slot width  62 . The tibia slot  32  can have a tibia slot width  64 . The talus slot width  62  can be substantially equal to the tibia slot width  64 .  FIG. 3   c ″ illustrates that tibia slot width  64  can be smaller than the talus slot width  62 . For example, the tibia slot width  64  can be about the width of the talus slot body  56 . 
         [0053]    The tibia slot width  64  can be from about 13 mm (0.5 in.) to about 64 mm (2.5 in.), for example about 36 mm (1.4 in.), or for example about 43 mm (1.7 in.). The talus slot width  62  can be from about 13 mm (0.5 in.) to about 76 mm (3.0 in.), for example about 43 mm (1.7 in.). 
         [0054]      FIGS. 4   a  through  4   d  illustrate that a bone chisel, bone saw, or osteotome  72  (referred to herein as any of the above, particularly an osteotome), can have an osteotome roof. The osteotome cross-member  74  can have a substantially straight or curved configuration. The osteotome cross-member  74  can have an osteotome leg  76  extending contiguously from one or both sides of the osteotome cross-member  74 . The osteotome legs  76  can have substantially straight or curved configurations. The osteotome leg  76  can extend from the osteotome cross-member  74  at an osteotome angle  78  with respect to the vertical axis  8 . The osteotome angle  78  can be from about 0° to about 90°, more narrowly from about 20° to about 70°, for example about 40°. The osteotome angle  78  can be substantially equivalent to the talus slot angle  60 . The osteotome  72  can be configured so part or all of the osteotome  72  can slidably fit through the talus and/or tibia slot  26 ,  32 . 
         [0055]    The proximal end of the osteotome  72  can have an osteotome body  82 . When viewed from a longitudinal end of the osteotome  72 , as shown in  FIG. 4   c , the osteotome body  82  can have the outer dimensions of the osteotome cross-member  74  and the osteotome legs  76 , and can also be solid in the area defined by the hollow between the osteotome legs  76 . 
         [0056]    The proximal end of the osteotome  72  can be an osteotome butt  84 , for example configured to receive a driving tool such as a hammer or mallet. The osteotome butt  84  can be configured to be a flat face. The osteotome butt  84  can be the proximal end of the osteotome body  82 . 
         [0057]    The distal end of the osteotome  72  can terminate in a cutting edge  88 . For example, the cutting edge  88  can extend along the distal terminal ends of the osteotome cross-member  74  and the osteotome legs  76 . 
         [0058]    The osteotome  72  can taper into the cutting edge  88  at a cutting slope  90 . The cutting slope  90  can extend along the distal ends of the osteotome cross-member  74  and the osteotome legs  76 . The body  82  can have a body cutting slope  92 . The legs  76  can each have a leg cutting slope  94 . 
         [0059]    The outside surface of the osteotome  72  can have one or more depth marks  96  indicating the depth along the osteotome  72 . The depth marks  96  can be referred to during use to determine how deep the osteotome  72  has been inserted into tissue. The depth marks  96  can each be a transverse mark that can optionally have a number, letter or symbol adjacent to marks, for example to indicate the depth of that depth mark  96 . The depth marks  96  can be spaced longitudinally along the osteotome  72 . Adjacent depth marks  96  can be separated by a depth mark spacing length  98 . The depth mark spacing length  98  can be from about 2.5 mm (0.10 in.) to about 20 mm (0.79 in.), for example about 5.0 mm (0.20 in.). 
         [0060]      FIG. 5  illustrates that the partial bone prosthesis can have a prosthesis body  24 . The contour line  242  shows curvature, such as an offset hemi-elliptical cam curvature, or hemi-oblong curvature, on the surface of the prosthesis body  24 . The prosthesis body  24  can have a central axis  104 . During use in a long bone, the central axis  104  can be substantially parallel and/or aligned with a longitudinal axis of the long bone. During use in the talus  12  or in a vertebra, the central axis  104  can be substantially parallel and/or aligned with a vertical axis  8 . 
         [0061]    The prosthesis body  24  can have a central portion  160 . The central axis  104  can pass through the central portion  160 . The prosthesis body  24  can have a perimeter anchor  30 . The perimeter anchor  30  can be radially distal to the central axis  104 . The perimeter anchor  30  can partially or completely surround the central portion  160 . 
         [0062]    The prosthesis can have a distal prosthesis surface  162 . The distal prosthesis surface  162  can be configured to substantially match the exterior of the portion of the bone being replaced by the prosthesis. The proximal and distal prosthesis surfaces are proximal and distal, respectively, to the remainder of the bone which is being partially replaced. 
         [0063]      FIG. 6  illustrates that the prosthesis body  24  can have one or more branches  166 . The branches  166  can extend radially from the central axis. The branches  166  can extend substantially parallel, or not substantially parallel, to the central axis  104  at a radius from the central axis  104 . 
         [0064]    The prosthesis can have a proximal prosthesis surface  164 . The proximal prosthesis surface  164  can be configured to attach to the bone. 
         [0065]    FIGS.  7 ′ and  7 ″ illustrate that the prosthesis body  24  can have one or more grooves  38  extending along a fore-aft (i.e., front-back or anterior-posterior) axis on the distal prosthesis surface  162 . The groove  38  can be laterally centered on the prosthesis body  24 . The groove  38  can be configured to align with a tongue in an adjacent implant or a protrusion in an adjacent bone to the groove  38 . The groove  38  can be configured to minimize or otherwise restrict lateral movement of the implant with respect to the adjacent implant or adjacent bone to the groove  38 . 
         [0066]    The distal prosthesis surface  162  can have one or more shoulders  40  on each side of the groove and between grooves  38 . The shoulders  40  can be flat and/or curved surfaces. The shoulders  40  and/or the grooves  38  can have low-friction coating, for example made from PTFE (e.g., Teflon® from E.I. du Pont de Nemours and Company of Wilmington, Del.). 
         [0067]    The prosthesis body  24  can have a prosthesis flat  168  and a prosthesis rise  170 . The prosthesis rise  170  can extend at an angle from the prosthesis flat  168  with measured parallel the up-down (i.e., dorsal-plantar or dorsal-palmar) axis. 
         [0068]    The prosthesis body  24  can have a sharp edge  172  at the front and/or back of the prosthesis body  24 . The prosthesis body  24  can have a flat, blunt face at the front and/or back of the prosthesis body  24 . 
         [0069]    The prosthesis body  24  can have a body channel. The bone channel  174  can pass through the prosthesis body  24  from the front to the back or from a first lateral side (i.e., left) to a second lateral side (i.e., right). The surface of the bone channel  174  can be formed by the proximal prosthesis surface  164 . The perimeter anchor  30  can extend along two opposite sides of the bone channel  174 . The perimeter anchor  30  can be vacant at the front port and/or back port of the bone channel  174 . 
         [0070]      FIGS. 8   a ′ and  8   a ″ illustrates that the shoulders  40  can have shoulder widths  176 . The shoulder width  176  can be from about 6.4 mm (0.25 in.) to about 19 mm (0.75 in.), for example about 12.7 mm (0.500 in.) or about 14.3 mm (0.563 in.). The shoulders  40  can have shoulder heights  178 . The shoulder height  178  can be from about 3.18 mm (0.125 in.) to about 13 mm (0.5 in.), for example about 6.4 mm (0.25 in.) or about 10 mm (0.4 in.) or about 3.8 mm (0.15 in.). 
         [0071]    The shoulders  40  can have a rounded transition to the sides of the prosthesis body having a distal chamfer radius  180 . The distal chamfer radius  180  can be from about 0.08 mm (0.03 in.) to about 3.0 mm (0.12 in.), for example about 2 mm (0.06 in.). 
         [0072]    The groove  38  can have a groove radius (of curvature)  70 . The groove radius  70  can be from about 10 mm (0.4 in.) to about 41 mm (1.6 in.), for example about 20.7 mm (0.813 in.). 
         [0073]    The ridge  182  can have a ridge height  184  and a ridge angle  186 . The ridge height  184  can be from about 1.3 mm (0.05 in.) to about 13 min (0.5 in.), for example about 2.54 min (0.100 in.) or about 6.99 mm (0.275 in). The ridge angle  186  can be from about 15° to about 70°, for example about 35° or about 25.66°. 
         [0074]    The bone channel  176  can have a bone channel width  190 . The bone channel width  190  can be from about 10 mm (0.4 in.) to about 41 mm (1.6 in.), for example about 20.7 mm (0.813 in.). 
         [0075]    As shown in  FIG. 8   a ″, the bone channel  176  can vary in width from front to back and/or from top to bottom (i.e., distal to proximal). The bone channel  176  can have a maximum bone channel width  192  and a minimum bone channel width  194 . The maximum bone channel width  192  can be from about 10 mm (0.4 in.) to about 41 mm (1.6 in.), for example about 32.61 mm (1.284 in.). The minimum bone channel width  194  can be from about 10 mm (0.4 in.) to about 41 mm (1.6 in.), for example about 29.36 mm 1.156 in.). A ridge width  244  can be the length from the ridge  182  to the radially inner surface of the remainder of the perimeter anchor  30  superior to the ridge  182 . 
         [0076]    The perimeter anchor  30  can have a perimeter anchor height  152  and a perimeter anchor width  196 . The perimeter anchor height  152  can be from about 3.3 mm (0.13 in.) to about 16 mm (0.63 in.), more narrowly about from 3.3 mm (0.13 in.) to about 14 mm (0.55 in.), for example about 6.99 mm (0.275 in.), also for example about 9 mm (0.35 in.). The perimeter anchor width  196  can be from about 3.6 mm (0.14 in.) to about 14 mm (0.56 in.), for example about 7.14 min (0.281 in.). 
         [0077]    The prosthesis body  24  can have a prosthesis body width  198  from about 17 mm (0.68 in.) to about 69.9 mm (2.75 in.), for example about 34.9 mm (1.375 in.), also for example about 38 mm (1.5 in.). 
         [0078]      FIG. 8   a ″ illustrates that the bone channel  176  side of the perimeters can extend from the shoulders  40  at a perimeter extension angle  154 . The perimeter extension angle  154  can be from about 0° to about 170′, more narrowly from about 15° to about 120°, for example about 40°. 
         [0079]      FIGS. 8   b ′ and  8   b ″ illustrate that the ridge  182  can have one, two, three, four or more teeth  200 . The teeth  200  can be sharpened. The teeth  200  can have a tooth angle  202  with respect to the face of closer end of the prosthesis body  24 . The tooth angle  202  can be from about 20° to about 80°, for example about 45°. The teeth  200  can be separated from each other by a tooth gap  204 . The tooth gap  204  can be from about 2 mm (0.08 in.) to about 12 mm (0.5 in.), for example about 3.96 mm (0.156 in.), also for example about 6.35 mm (0.250 in.). The teeth  200  can have a tooth slot  206  between the teeth. The tooth slot  206  can have a tooth slot diameter  208  from about 1 mm (0.05 in.) to about 5 mm (0.2 in.), for example about 2.4 mm (0.094 in.). 
         [0080]    The sides of the prosthesis rise  170  can taper at a rise taper angle inward as it approaches the end of the prosthesis body  24 . The rise taper angle  210  can be from about 0° to about 45°, more narrowly from about 4° to about 20°, for example about 9°. 
         [0081]    The bone channel can taper at a bone channel angle  212 . The bone channel angle  212  can be from about 0° to about 10°, for example about 2.4°. 
         [0082]      FIG. 8   c ′ illustrates that the distal surface  214  can have a distal surface radius (of curvature)  216 . The distal surface radius  216  can be from about 15 min (0.6 in.) to about 64 mm (2.5 in.), for example about 31.50 mm (1.240 in.). 
         [0083]    The prosthesis flat  168  can have a prosthesis flat length  102 . The prosthesis flat length  102  can be from about 8 mm (0.3 in.) to about 80 mm (3 in.), for example about 19.1 mm (0.750 in.). The prosthesis body  24  can have a prosthesis body length  218  from about 19 mm (0.75 in.) to about 80 mm (3 in.), for example about 38.10 mm (1.500 in.). The length of the prosthesis rise  170  can be the difference between the prosthesis flat length  102  and the prosthesis body length  218 : about 0 mm (0 in.) to about 69 mm (2.7 in.), for example about 38 mm (1.5 in.). 
         [0084]    The prosthesis rise  170  can have a rise lift angle  220  with respect to the bottom of the prosthesis flat  168 . The rise lift angle  220  can be from about 0° to about 45°, more narrowly from about 10° to about 40°, for example about 20.2°. 
         [0085]      FIG. 9   a  illustrates that the prosthesis floating component  108  can have a substantially square or rectangular transverse section. The prosthesis floating section  108  can have a tibia-side surface  110  opposite of a talus-side surface  112 . A tibia tongue  114  can extend from the tibia-side surface  110 . The tibia tongue  114  can be configured to act as a slidable guide within the groove on the tibia prosthesis. A talus tongue  116  can extend from the talus-side surface  112 . The talus tongue  116  can be configured to act as a slidable guide within the groove on the talus prosthesis. 
         [0086]      FIG. 9   b  illustrates that the prosthesis floating component  108  can have a floating component width  118  and a floating component length  120 . The floating component width  118  can be from about 18 mm (0.7 in.) to about 71 mm (2.8 in.), for example about 34.93 in. (1.375 in.). The floating component length  120  can be from about 18 mm (0.7 in.) to about 71 mm (2.8 in.), for example about 36 mm (1.4 in.). 
         [0087]    The one or more shoulders  40  on the prosthesis floating component  108  can each have a shoulder width  66  from about 6.4 mm (0.25 in.) to about 0.25 mm 1.0 in.). The tibia and talus tongues  114 ,  116  can have the about same widths as the corresponding grooves  38  in the respective prosthesis components. 
         [0088]      FIG. 9   c  illustrates that the shoulders  40  on the tibia-side surface  110  can be substantially flat. The talus tongue  116  and the shoulders  40  on the talus-side surface  112  can have a talus-side radius  122  (of curvature). The talus-side radius  122  can be from about 15 mm (0.6 in.) to about 64 mm (2.5 in.), for example about 32.13 mm (1.265 in.). 
         [0089]    The talus-side surface  112  can be flat. The tibia-side surface  110  can be rounded. 
         [0090]    The tongues  114 ,  116  can have a tongue height  124 . The tongue height  124  can be from about 0.3 mm (0.01 in.) to about 1.3 mm (0.05 in.), for example about 5.6 mm (0.022 in.). 
         [0091]    The floating component  108  can have a floating component height  126 . The floating component height  126  without the tongues  114 ,  116  can be a tongueless height  128 . The floating component height  126  can be from about 1.5 mm (0.06 in.) to about 17 mm (0.68 in.), for example about 8.43 mm (0.332 in.). 
         [0092]      FIG. 9   d  illustrates that the prosthesis can have a minimum tongueless height  130 , and a maximum tongueless height  132 . The minimum tongueless height  130  can be about at the mid-point from front to back of the prosthesis floating component  108 . The minimum tongueless height  130  can be from about 1 mm (0.04 in.) to about 4.1 mm (0.16 in.), for example about 2.0 mm (0.079 in.). The maximum tongueless height  132  can be about at the front and/or back ends of the prosthesis floating component  108 . The maximum tongueless height  132  can be from about 3.6 mm (0.14 in.) to about 15 mm (0.58 in.), for example about 7.32 mm (0.288 in.). 
         [0093]    The tongues  114 ,  116  can have the same or different tongue radii  133 . The tongue radii  133  can be from about 10 mm (0.4 in.) to about 41 mm (1.6 in.), for example about 20.7 mm (0.813 in.). The tongue radii  133  can be about equal to the groove radii on the adjacent prosthesis component. For example, the groove radius  70  for the prosthesis tibia component  134  can be about the same as the tongue radius  133  for the tongue tibia-side surface  110  of the prosthesis floating component  108 . The groove radius  70  for the prosthesis talus component can be about the same as the tongue radius  133  for the tongue talus-side surface  110  of the prosthesis floating component  108 . 
         [0094]      FIG. 10   a  illustrates a prosthesis tibia component  134  that can have a perimeter anchor  30  that extends from a base  136  along a single side of the base  136 . The perimeter anchor  30  can extend at a right, obtuse, or acute angle from the base  136 . The perimeter anchor  30  can extend from one, two, three, four or more sides of the base  136 . The perimeter anchor  30  can have a first supplemental anchor port  138  and a second supplemental anchor port  140 . The anchor ports  138 ,  140  can be straight or tapered. The anchor ports  138 ,  140  can be threaded or unthreaded. The prosthesis tibia component  134  can have a groove  38  configured to slidably engage the tibia tongue  114  on the prosthesis floating component  108 . The prosthesis tibia component  134  can have a tongue  114 ,  116  configured to slidably engage the groove  38  on the prosthesis talus component  158 , for example when in use without the prosthesis floating component  108 . 
         [0095]    The tongues  114 ,  116  on the prosthesis floating component  108  can either or both be grooves  38 , and the grooves  38  on the prosthesis tibia component  134  and the prosthesis talus component  158  can either or both be tongues  114 ,  116  to engageably match the corresponding structure on the prosthesis floating component  108 . 
         [0096]      FIG. 10   b  illustrates that the prosthesis tibia component  134  can have a tibia component length  142  and a tibia component height  144 . The tibia component length  142  can be from about 17 mm (0.65 in.) to about 69 mm (2.7 in.), for example about 34.93 mm (1.375 in.). The tibia component height  144  can be from about 7.9 mm (0.31 in.) to about 31.8 mm (1.25 in.), for example about 15.9 mm (0.625 in.). 
         [0097]    The anchor ports  138 ,  140  can have an anchor port inner radius  146  and an anchor port outer radius  148 , for example if the anchor port is tapered or threaded. The anchor port inner radius  146  can be from about 1.5 mm (0.06 in.) to about 3.3 mm (0.13 in.), for example about 1.7 mm (0.065 in.). The anchor port outer radius  148  can be from about 1.5 mm (0.06 in.) to about 5.8 mm (0.23 in.), for example about 2.87 mm (0.113 in.). 
         [0098]    The groove radius  70  of the prosthesis tibia component  134  can be about equal to the groove radius  70  for the prosthesis talus component  158 . 
         [0099]      FIG. 10   c  illustrates that the perimeter anchor  30  can have a perimeter anchor width  196 . The perimeter anchor width  196  can be from about 2 mm (0.07 in.) to about 8 mm (0.3 in.), for example about 3.81 mm (0.150 in.). 
         [0100]    The base  136  can have a base height  150 . The base height  150  can be from about 2 mm (0.07 in.) to about 8 mm (0.3 in.), for example about 3.81 mm (0.150 in.). 
         [0101]    The prosthesis tibia component  134  can have a tibia component width  151 . The tibia component width  151  can be from about 17 mm (0.7 in.) to about 71 mm (2.8 in.), for example about 35.56 mm (1.400 in.). 
         [0102]    Any or all elements of the prosthesis and/or other devices or apparatuses described herein, including the prosthesis body  24  of the talus prosthesis, prosthesis floating component  108 , and/or tibial prosthesis, or any other prosthesis, can have a surface finish to about 1.6 □m (63 □in.) or less. 
         [0103]    Any or all elements of the prosthesis and/or other devices or apparatuses described herein, including the prosthesis body  24  of the talus prosthesis, prosthesis floating component  108 , and/or tibial prosthesis, or any other prosthesis, can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), other titanium alloys, cobalt-chrome alloys ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), aluminum and aluminum alloys (e.g., 6060-T6 aluminum, 6061-T6 aluminum), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphathalate (PET)/polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft, bone cement, morselized bone, bone morphogenic protein (BMP), osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold. 
         [0104]    Any or all elements of the prosthesis and/or other devices or apparatuses described herein can be or have a matrix for cell ingrowth (e.g., as described supra) or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be, for example, polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen, a cobalt-chrome alloy matrix, silicone or combinations thereof. 
         [0105]    The elements of the prosthesis and/or other devices or apparatuses described herein and/or the fabric can be filled and/or coated with an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. The agents within these matrices can include radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck &amp; Co., Inc., Whitehouse Station, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Any or all parts of the prosthesis or other elements, tools, bones or other parts of the implant site can be coated with hydroxyapetite. Examples of other agents are provided in Walton et al, Inhibition of Prostoglandin E 2  Synthesis in Abdominal Aortic Aneurysms,  Circulation, Jul.  6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae,  Brit. J. Surgery  88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic. Aneurysm Wall and Its Effect on Inflammation and Proteolysis,  Brit. J. Surgery  86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium,  J. Biological Chemistry  275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms,  J. Clinical Investigation  105 (11), 1641-1649 which are all incorporated by reference in their entireties. 
       Method of Use 
       [0106]    Any of the variations of the devices, methods and elements thereof described in PCT Application No. PCT/US2007/063233 filed 2 Mar. 2007, which is incorporated by reference herein in its entirety, can be used herein. 
         [0107]      FIGS. 11   a  and  11   b  illustrate that an alignment line  36  can be positioned in front of the tibia  6 . For example, the alignment line  36  can be a plumb bob lire attached to  11  and hanging from the patella or a laser line aligned with the patella. The guide can be positioned so the plane of the vertical axis of the guide aligns with the alignment line  36 . The guide can be positioned so the guide is substantially against the tibia  6  and the talus  12 . The guide can be positioned so the tibia slot  32  can align with the inferior end of the tibia  6  to match the size of the prosthesis tibia component (e.g., see  FIGS. 20   a - 23   b  and infra). The guide can be positioned so the talus slot  26  can align with the superior end of the talus  12  to match the size of the prosthesis talus component (e.g., see  FIGS. 17   a - b ,  19   a - b  and infra). The talus slot  26  and/or tibia slot  6  can be configured to overlap with some or all of the medial malleolus articular facet  240  during use. 
         [0108]    With the guide in a desired position, attachment pins  120  can be inserted through the alignment holes  42 . The attachment pins  120  can be inserted into the talus  12  and/or tibia  6 , as shown. The attachment pins  120  can detachably fixedly attach the guide to the tibia  6  and/or talus  12 . The attachment pins  120  can have heads with larger diameters than the alignment holes  42 , for example, to prevent the attachment pin  120  from being deployed too deep into the tibia  6  and/or talus  12 . 
         [0109]      FIGS. 12   a  and  12   b  illustrate that the alignment line  42  can be removed once the guide is secured to the tibia  6  and talus  12 , for example with the attachment pins  120 . 
         [0110]      FIGS. 13   a  and  13   b  illustrate that a tibia osteotome  222  can be aligned with the tibia slot  32 . A talus osteotome  224  can be aligned with the talus slot  26 . The tibia osteotome  222  and/or the talus osteotome  224  can have substantially straight or curved transverse cross-sections or be as shown and described in  FIGS. 4   a - 4   d . The osteotomes  72  can be aligned and used subsequent to each other or concurrently. The osteotomes  72  can be driven posteriorly subsequently or concurrently, for example by impacting the osteotome butt with a force, as shown by arrows. 
         [0111]      FIGS. 14   a  and  14   b  illustrate that the tibia osteotome  222  can be driven through the tibia  6 . The tibia osteotome  222  can severe the medial malleolus  128  from the remainder of the tibia  6  or leave the medial malleolus  128  integral with the remainder of the tibia. The terminal inferior end of the tibia can be severed from the remainder of the tibia. 
         [0112]    The talus osteotome  224  can be driven through part or all of the depth of the talus  12 . 
         [0113]      FIGS. 15   a  and  15   b  illustrate that the loose bone can be removed after the osteotomes  72  have cut the tibia  6  and/or the talus  12 . The inferior end of the tibia  6  can be planed by the tibia osteotome  222 . The inferior end of the tibia  6  can be configured to have a surface approximating an anatomical transverse plane.  FIGS. 16   a  and  16   b  illustrate that the medial malleolus can be left intact and that the plane can be cut starting medially (with respect to the tibia, not the body) of the medial malleolus  128 . 
         [0114]    The superior end of the talus  12  can be planed by the talus osteotome  224 . The talus osteotome  224  can also cut one or two side planes  156  part-way down the sides of the talus  12  starting from the superior end of the talus  12 . The side planes  156  can extend from the superior end of the talus  12  at the osteotome angle  78 . 
         [0115]    The depth of bone cut from the talus  12  can leave a substantially large percentage (e.g., greater than about 50% or greater than 75%, or greater than 90%) of the original talus thickness  10  as measured near the center of the talus  12 , for example at the sinus tarsi  226 , as shown in  FIGS. 15   b  and  16   b.    
         [0116]      FIGS. 17   a  and  17   b  illustrate that the prosthesis talus component  158  can be controllably releasably attached or otherwise removably attached to a prosthesis holder  228 . The prosthesis talus component  158  can be aligned with the planes  156  cut in the talus  12 . The prosthesis talus component  158  can be translated posteriorly, as shown by arrow. When the prosthesis talus component  158  initially contacts the talus  12 , the ridge  182  and teeth  200  can interference fit against bone. A force can then be applied (e.g., an impact force, for example by striking the proximal end of the prosthesis holder with a hammer or mallet) to force the teeth  200  and ridge  182  through the bone. 
         [0117]      FIG. 18   a  illustrates a prosthesis holder  228  than can have a rigid holder body  230  and holder arms  232 . A deformable or resilient holder pad  234  can be located between the holder arms  232  at the distal end of the prosthesis holder  228 . The holder pad  234  can atraumatically fit the proximal top surface  236  and proximal bottom surface  238  of the prosthesis talus component  158 . The holder pad  234  can be compressed by the prosthesis talus component  158  so that the holder pad  234  is between the prosthesis talus component  158  and the holder arms  232 . The prosthesis talus component  158  can adhere to the prosthesis holder  228  by friction fit against the holder pad  234  and/or adhesive. 
         [0118]    The prosthesis holder  228  can have a hammer abutment  240  at the proximal end of the prosthesis holder  228 . The prosthesis holder  228  can be configured to receive an impact force from a hammer or mallet against the hammer abutment  240 . The prosthesis holder  228  can be configured to transmit an impact force atraumatically to the prosthesis talus component  158 . 
         [0119]      FIG. 18   b  illustrates that the prosthesis holder can have an atraumatic retractable pad  242  at the end of each holder arm  232 . The retractable pads  242  can be configured to friction fit against the proximal top surface  236  and proximal bottom surface  238  of the prosthesis talus component  158 . The retractable pads  242  can be deployed by one or more spring-loaded mechanisms internal to the prosthesis holder  228 . The prosthesis holder  228  can have one or more controls, such as buttons  246 , that can controllably retract or extend the retractable pads  242  into the holder arms  232 . Retracting the retractable pads  242  can detach the prosthesis talus component  158  from the prosthesis holder  228 . 
         [0120]      FIG. 18   c  illustrates that the holder arms  232  can be rotatably attached at a hinge  248 . Each holder arm  232  can be integral with or fixedly attached to a holder leg  250 . The proximal ends of the holder legs  250  can have hammer abutments  240 . The distal ends of the holder arms can have atraumatic holder pads  234 . The holder pad  234  on a first holder arm can be configured to atraumatically fit the proximal top surface  236  of the prosthesis talus component  158 . The holder pad  234  on a second holder arm can be configured to atraumatically lit the proximal bottom surface  238  of the prosthesis talus component  158 . 
         [0121]    The distance between the center of each hammer abutment  240  and the hinge  248  when measured along the lever arm axis  188  can be larger than the distance between the hinge  248  and the center of the contact patch of each holder pad  234  against the prosthesis talus component  158  when also measured along the lever arm axis  188 . For example, when an impact force is delivered to the hammer abutments  240 , the impact force can increase the squeeze force of the holder arms  250  against the prosthesis talus component  158  (i.e., tighten the grip of the holder arms). 
         [0122]    The holder pads  234  and retractable pads  242  can be coated, made entirely from, or made partially from a plastic, polycarbonate, plastic, rubber, a soft rubberized material, or other polymer, metal, ceramic, biomaterial such as bone (e.g., compressed morselized bone) or BMP, or combinations thereof. The holder pads  234  and retractable pads  242  can be soft enough to not scar the prosthesis talus component  158  while delivering impact force from a mallet or hammer impact on the hammer abutment  240 . 
         [0123]      FIGS. 19   a  and  19   b  illustrate that the prosthesis talus component  158  can be positioned on the talus  12 . The ridge  182  and/or teeth  200  can be substantially embedded in the talus  12 . The ridge  182  and/or teeth  200  can fix the prosthesis talus component  158  to the talus  12 . Measured with the talus  12  and the prosthesis talus component  158 , the original talus thickness  10  can be restored. 
         [0124]      FIGS. 20   a  and  20   b  illustrate that the prosthesis tibia component  134  can be attached to the tibia  6 , for example by inserting fixation pins  254  or screws through anchor ports  138 ,  140  and fixing the pins or screw into the tibia  6 . The grooves  38  on the prosthesis tibia component  134  and the prosthesis talus component can be aligned horizontally. The prosthesis tibia component  134  can be positioned sufficiently superior on the tibia to allow for the prosthesis floating component  108  to be positioned between the prosthesis tibia component  134  and the prosthesis talus component  158 . 
         [0125]      FIGS. 21   a  and  21   b  illustrate that the prosthesis tibia component  134  can be positioned to slidably contact the prosthesis talus component  158 . The prosthesis floating component  108  can be absent. The prosthesis tibia component  134  can have a talus tongue  116 . The talus tongue  116  can be configured to slidably fit in the groove  38  of the prosthesis talus component  158 . 
         [0126]    The distance between the tibia slot  32  and the talus slot on the guide can be configured based on whether a prosthesis floating component  108  is to be inserted between the prosthesis tibia component  134  and the prosthesis talus component. 
         [0127]    The prosthesis tibia component  134  can have an inferior surface radius of curvature  252 , for example that is substantially equivalent to the radius of curvature of the superior surface of the prosthesis talus component  158 . 
         [0128]      FIGS. 20   a  and  20   b  illustrate that the medial malleolus  128  can be removed.  FIGS. 22   a  and  22   b  illustrate a variation of the prosthesis and method of  FIGS. 20   a  and  20   b  where the medial malleolus  128  can be left attached to the tibia  6  or that the tibia prosthesis component  134  can have a configuration to approximate the medial malleolus  128 . Further, the perimeter anchor  30  can be configured to approximate the shape of the tibia  6 . 
         [0129]      FIGS. 21   a  and  21   b  illustrate that the medial malleolus  128  can be removed.  FIGS. 23   a  and  23   h  illustrate a variation of the prosthesis and method of  FIGS. 21   a  and  21   b  where the medial malleolus  128  can be left attached to the tibia  6  or that the tibia prosthesis component  134  can have a configuration to approximate the medial malleolus  128 . Further, the perimeter anchor  30  can be configured to approximate the shape of the tibia  6 . 
         [0130]      FIGS. 24   a  and  24   b  illustrate that the prosthesis floating component  108  can be inserted between the prosthesis tibia component  134  and the prosthesis talus component  158 . The prosthesis floating component  108  can be configured to slidably contact the prosthesis talus component and the prosthesis tibia component  134 . The tibia tongue  116  can slidably fit in the groove  38  in the prosthesis tibia component  134 . The talus tongue  116  can slidably fit in the groove  38  in the prosthesis talus component  158 . The prosthesis floating component  108 , the prosthesis tibia component  134 , and the prosthesis talus component  158  can be made from the same and/or different materials. 
         [0131]    It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention. Elements shown with any variation are exemplary for the specific variation and can be used in combination with, or otherwise on or in, other variations within this disclosure.