Bone fixation implant and means of fixation

An implant for osteosynthesis which can be used to repair fractures and or fuse joints. The implant comprises one or more through holes for the passage of one or more sutures therethrough and or one or more sutures may be an integral part of the implant. The one or more sutures may be used to pull bone segments together and create compression therebetween and or to affix soft tissue to a bone segment.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention is in the technical field of bone fixation or arthrodesis or deformity correction. The invention relates to a fixation system for bones of all types utilizing an implant that is placed within all or part of a bony structure. Such systems are used in osteosynthesis, wherein the implant bridges a fracture or joint to provide rigidity and aid in healing of the fracture or fusion site. The implant devices of the present invention may be placed in an intramedullary canal or within a bone either completely or partially. The implant may primarily be used for fixation or for aiding in creating a fusion across more than one bone or within a single bone or bone segment. The implant may be constructed of a biologic material, a synthetic material, and or a resorbable material which may be biologic or synthetic. The implant may have material properties or other means for promoting bone growth (osteoinductive) and or for providing a structure for promoting bone growth (osteoconductive). The implant may be provided in a sterile kit and may be preassembled to an instrument for means of insertion. In addition, the present invention provides resistance to pull-out and or rotation and/or pistoning once implanted. Furthermore, the implant includes a means for attaching a suture for additional tissue fixation. The implant may be indicated for the various bones of the entire skeleton. A “fixation device” or the implant may include any of a variety of devices that secure an object to a bone, including but not limited to staples, bone plates, modular staples, bone screws, pins, blades, suture anchors, and the like.

SUMMARY OF THE INVENTION

The present invention includes an implant or other bone fastening device. The implant may be placed fully or partially within a bone's intramedullary canal or within the bone itself. The implant is used for fixation or for aiding in the creating a fusion across more than one bone or within a single bone or bone segment. The implant may be constructed from a number of biocompatible materials including but not limited to a biologic material, a synthetic material, and or a resorbable material which may be biologic or synthetic. The implant may have material properties or other means for promoting bone growth (osteoinductive) and or for providing a structure for bone growth (osteoconductive). The implant may be provided in a sterile kit and may be preassembled to an instrument for means of insertion. The implant of the present invention can be inserted in an axial direction by simply pushing it into the bone. It does not have to be screwed in. It may optionally be rotated when it is pushed in, but rotation usually is not necessary. In addition, the implant devices of the present invention provide resistance to pull-out and or rotation and or pistoning once implanted. Furthermore, the implant includes a means for attaching a suture for additional tissue fixation.

The devices of the present invention may be of one piece construction or of more than one piece. The embodiments described herein are of one piece construction but it will be apparent to those skilled in the art how to make them from more than one piece based upon the disclosures herein. The preferred embodiment may have a tapered geometry for better purchase in the bone in order to resist pull-out and may provide tissue fixation. The implant also has features for engaging bone in a manner to resist pull-out and or rotation and or pistoning. The present invention has a means for attaching a suture that may be utilized for soft or hard tissue attachment.

The terms “implant”, “implant device”, “fixation device” and “device” are used interchangeably herein to refer to the devices of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention includes an implant for spanning and or fixating at least two bone segments of different bones or the same bone. Exemplary embodiments of the current invention are discussed in the figures below. The implant may have bone engaging features and fixation features which are used for tissue attachment. The fixation features provide a means for generating compression across the bone segments to further aid in the healing of the bone. The present invention may have an apparatus or instrument for inserting the implant that is pre-assembled or affixed to the implant. The embodiments described herein may be constructed of any suitable biocompatible material which may be biologic or synthetic. The implant of the current invention may be packaged as an implant kit with the associated instruments needed to complete the implantation.

FIG. 1is a perspective view of an implant100having a first end110and a second end120. First end110may be placed into a first bone segment and second end120may be placed into a second bone segment or second end120may be placed into a first bone segment and first end110may be placed into a second bone segment. The bone segments may be adjacent, opposing bones or the same bone across a fracture or osteotomy site. First end110has features140that may be rings or barbs for engaging bone. The number of bone engaging features may vary by implant size and geometry. The style of the bone engaging features140may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features140may or may not be circular in cross-section. First end110also includes a through hole150that may be used with a suture or the like for tissue fixation. The suture and through hole150may be used to generate compression between the bone segments that are engaged with implant ends110and120. The compression may be generated by having the second end120engaged in bone, while the bone in which first end110may be engaged is pulled towards the second end120by passing the suture through the hole150then through the bone attached to the first end110and tightening the suture such that the bones segments are brought together. In this figure, the implant100may also act as a tissue anchor and as an aid in fusing or compressing the two bone segments. The use of the suture with through hole150also provides a means for resisting rotation and or pistoning of the implant relative to the bone. An alternate embodiment may have the suture pre-assembled to the implant either temporarily or permanently. The suture may or may not be packaged with the implant, pre-threaded through the suture hole, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant which may eliminate the through hole150, but still provide a means for anchoring, generating compression or controlling orientation as described herein. End110may also have a surface155that may be relatively flat for resisting rotation of the implant100in the bone. Hole150may have a feature152at the transition of the hole150to the surface155that may prevent tearing or breaking of the suture. End110may have a surface151that may be tapered for facilitating insertion into the bone. Surface151may also be of geometry to prevent stress risers in the bone at the end of the implant. The implant100has an end120for engaging a bone or segment of bone. As illustrated, end120has bone engaging features160that may be rings or barbs for engaging bone. The number of bone engaging features160may vary by implant size and geometry. The style of the bone engaging features160may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features160may or may not be circular in cross-section. The bone engaging features160may or may not be similar to the bone engaging features140. The type of bone engaging feature may also vary within the same implant. For example bone engaging features160may alternate between circular barbs and non-circular rings. End120may have surface125that may be tapered for facilitating insertion into the bone. Surface125may also be of geometry to prevent stress risers in the bone at the end120. Implant100has a cannulation105that may extend through the entire length of the implant100. First end110and second end120may have feature130interposed between them. Feature130may serve as a stop to prevent first end110or second end120from extending too far into a bone segment. Feature130may have faces135that create a non-circular cross-section and minimize the amount of implant material that may be between two opposing bone segments.

FIG. 2is a side view of the embodiment ofFIG. 1. The first end110of the implant100has bone engaging features with a major diameter of195and a minor diameter of196. In this figure, the bone engaging features140are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The first end110may be further defined as having a length102. Through hole150may pass through surface155and may extend through certain bone engaging features140. Through hole150may be configured at any location or angle to the long axis of the implant100. Furthermore, through hole150is intended to allow passage of a secondary element (i.e., a suture or insertion instrument) both into and out of the implant100. Through hole150is shown passing from one side of the implant100and out of the opposite side, an alternate embodiment may have a passage hole that enters and exits on the same side of the implant100. Still another embodiment may have a passage hole or suture that enters and exists from the top to bottom of the implant100. Second end120of the implant100has bone engaging features with a major diameter of190and a minor diameter of191. In this figure, the bone engaging features160are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The second end120may be further defined as having a length101. In this figure, second end120is shown not having a through hole150. (See alsoFIG. 21which has through holes403and404.) In an alternate embodiment, second end120may have a through hole150that may be used with the suture or the like for tissue fixation. The suture and through hole150may be used to generate compression between the bone segments that are engaged with the implant ends110and120. The compression may be generated by having the first end110engaged in bone, while the bone in which second end120may be engaged is pulled towards the first end110by passing the suture through the hole150then through the bone attached to the second end120and tightening the suture such that the bone segments are brought together. In this figure, the implant100may also act as a tissue anchor and as an aid in fusing or compressing the two bone segments. In yet other embodiments, both ends110and120may have through holes150. Yet further, alternate embodiments may have the suture pre-assembled to the both ends of the implant either temporarily or permanently. The suture may be simply packaged with or without the implant, pre-threaded through the suture holes, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant in multiple locations or positions which may eliminate the through holes150, but still provide multiple means for anchoring, generating compression or controlling orientation as described herein.FIG. 2shows feature130having an effective diameter136and a length103. Some embodiments may require feature130to be as small as possible so as not to reduce the bone to bone apposition between the two bone segments.

FIG. 3is a top view of the embodiment described inFIGS. 1 and 2. This figure shows first end110having two flats155and156that may be present. These flats155and156are used to resist rotation of the implant100relative to bone.FIG. 3shows first end110and second end120both having a circular cross-section. Alternate embodiments may have a combination of a circular and non-circular ends where first end110may be non-circular and second end120may be circular or visa versa. The implant is depicted has having a first end110and a second end120with different lengths101and102. Alternate embodiments may have length101and102that may or may not be of equal length. The implant is depicted as having a first end110and a second end120with similar effective outer diameters190and195. Alternate embodiments may have effective outer diameters or dimensions190and195that may or may not be of equal value. The implant is depicted as having a first end110with a centerline111and a second end120with a collinear centerline121. Alternate embodiments may have first end110with a centerline111and second end120with a centerline121that may or may not be collinear and or parallel.

FIG. 4is an end view of implant100that has a cannulation105that may extend the entire length of the implant100.FIG. 4shows feature130having a non-circular cross-section. In an alternate embodiment, feature130may or may not have a circular cross-section. The cannulation may be used to facilitate implantation or may be used to accommodate another means of additional fixation.

FIG. 5is a side view of implant100andFIG. 5Ais a section view A-A of the implant100. The section view A-A shows the cannulation105extending through the length of the implant100. It further shows the through hole150intersecting the cannulation and in this embodiment the through hole150may extend through the entire width of the implant. Alternate embodiments may or may not include the cannulation105.

FIG. 6is a perspective view of implant300, a second embodiment of the invention. Implant300has a first end310and a second end320. First end310may be placed into a first bone segment and second end320may be placed into a second bone segment. The bone segments may be opposing bones or the same bone across a fracture or osteotomy site. First end310has features340that may be rings or barbs for engaging bone. The number of bone engaging features may vary by implant size and geometry. The style of the bone engaging features340may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features340may or may not be circular in cross-section. First end310may also include a through hole350that may be used with a suture or the like for tissue fixation or for insertion of the implant into a surgical site. The suture and through hole350may be used to generate compression between the bone segments that are engaged with implant ends310and320. The compression may be generated by having the second end320engaged in bone, while the bone in which first end310is engaged is pulled towards the second end320by passing the suture through the hole350then through the bone attached to the first end310and tightening the suture such that the bones segments are brought together. In this embodiment, the implant300may also act as a tissue anchor and as an aid in compressing or fusing the two bone segments. The use of the suture with through hole350may also provide a means for resisting rotation and or pistoning of the implant relative to the bone. An alternate embodiment may have the suture pre-assembled to the implant either temporarily or permanently. The suture may be simply packaged with or without the implant, pre-threaded through the suture hole, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant, as shown inFIGS. 17a, 17b, 18a, and 18b, which may eliminate the through hole350, but still provide a means for anchoring, generating compression or controlling orientation as described herein. End310may also have a surface355that may be relatively flat for resisting rotation of the implant300in the bone. Hole350may have a feature(s)352at the transition of the hole350to the surface355that may prevent tearing or breaking of the suture. End310may have a surface351that may be tapered for facilitating insertion into the bone. Surface351may also be of a geometry to prevent stress risers in the bone at the end of the implant. Implant300may have an end320for engaging a bone or segment of bone. End320may have bone engaging features360that may be rings or barbs for engaging bone. The number of bone engaging features360may vary by implant size and geometry. The style of the bone engaging features360may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features360may or may not be circular in cross-section. The bone engaging features360may or may not be similar to the bone engaging features340. The type of bone engaging feature may also vary within the same implant. For example bone engaging features360may alternate between circular barbs and non-circular rings. End320may have surface325that may be tapered for facilitating insertion into the bone. Surface325may also be of geometry to prevent stress risers in the bone at the end of the implant. Implant300may be solid without the previously described cannulation105. First end310and second end320may have feature330interposed between them. Feature330may serve as a stop to prevent first end310or second end320from extending too far into a bone segment. Feature330may have faces335that create a non-circular cross-section and minimize the amount of implant material that may be between two opposing bone segments.

FIG. 7is a side view of the embodiment ofFIG. 6. The first end310of implant300is shown to have an angle307relative to second end320. The angle307may be useful in facilitating deformity correction or may help better correct the normal anatomy. In this figure, angle307is shown in one plane. Other embodiments may have more complex or compound angles. The first end310of the implant300may have bone engaging features with a major diameter of395and a minor diameter of396. This figure further shows the bone engaging features340are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The first end310may be further defined as having a length302. Through hole350may pass through surface355and may extend through certain bone engaging features340. Second end320of the implant300may have bone engaging features with a major diameter of390and a minor diameter of391. In this figure, the bone engaging features360are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The second end320may be further defined as having a length301. In this figure, second end320is shown not having a through hole350. In an alternate embodiment, second end320may have a through hole350that may be used with the suture or the like for tissue fixation. The suture and through hole350may be used to generate compression between the bone segments that are engaged with the implant ends310and320. The compression may be generated by having the first end310engaged in bone, while the bone in which second end320may be engaged is pulled towards the first end310by passing the suture through the hole350then through the bone attached to the second end320and tightening the suture such that the bones segments are brought together. This figure further shows that the implant300may also act as a tissue anchor and as an aid in compressing or fusing the two bone segments. In yet other embodiments both ends310and320may have through holes350. Yet further, alternate embodiments may have the suture pre-assembled to both ends of the implant either temporarily or permanently. The suture may be simply packaged with the implant, pre-threaded through the suture holes, tied to the suture hole, and or injection molded into the implant. The suture may be integral with the implant in multiple locations or positions which may eliminate the through holes150, but still provide multiple means for anchoring, generating compression or controlling orientation as described herein.FIG. 7shows feature330having an effective diameter336and a length303. Some embodiments may require feature330to be as small as possible so as not to reduce the bone to bone apposition between the two bone segments.

FIG. 8is a top view of the embodiment described inFIGS. 6 & 7. This figure shows first end310having two flats355and356that may be present. These flats355and356may be used to resist rotation of the implant300relative to bone.FIG. 8shows first end310and second end320both having a circular cross-section. Alternate embodiments may have a combination of a circular and non-circular ends where first end310may be non-circular and second end320may be circular or visa versa. The implant is depicted as having a first end310and a second end320with different lengths301and302. Alternate embodiments may have length301and302that may or may not be of equal length. The implant is depicted has having a first end310and a second end320with different effective outer diameters390and395. In this figure, first end310has a larger effective diameter395than the effective diameter390of second end320. An alternate embodiment may have first end310with a smaller effective diameter395than the effective diameter390of second end320. Alternate embodiments may have effective outer diameters or dimensions390and395that may or may not be of equal value. The implant is depicted has having a first end310with a centerline311and a second end320with a non collinear centerline321. In this embodiment centerline311may have angle307relative to centerline321. Alternate embodiments may have first end310with a centerline311and second end320with a centerline321that may or may not be collinear and or parallel in multiple planes.FIG. 8is a side view of the implant300andFIG. 8Ais a section view A-A of the implant300. The section view B-B shows the solid cross-section of the implant300.

FIG. 9is s a perspective view of implant500, a third embodiment of the invention. Implant500has a first end510and a second end520. First end510may be placed into a first bone segment and second end520may be placed into a second bone segment. The bone segments may be opposing bones or the same bone across a fracture or osteotomy site. First end510has features540that may be rings or barbs for engaging bone. The number of bone engaging features may vary by implant size and geometry. The style of the bone engaging features540may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features540may or may not be circular in cross-section. First end510may also include a through hole550that may be used with a suture or the like for tissue fixation. The suture and through hole550may be used to generate compression between the bone segments that are engaged with the implant ends510and520. The compression may be generated by having the second end520engaged in bone, while the bone in which first end510may be engaged is pulled towards the second end520by passing the suture through the hole550and then through the bone attached to the first end510and then tightening the suture such that the bones segments are brought together. The order/steps of passing the suture through the hole can vary. It can be placed through the implant first then the bone. Or it can be placed through the bone first then the implant. The order of steps isn't critical, as long as the suture passes through the implant. In this figure, the implant500may also act as a tissue anchor and as an aid in compressing or fusing the two bone segments. The use of the suture with through hole550may also provide a means for resisting rotation and or pistoning of the implant relative to the bone. End510may also have a surface555that may be relatively flat for resisting rotation of the implant500in the bone. Hole550may have a feature552at the transition of the hole550to the surface555that may prevent tearing or breaking of the suture. End510may have a surface551that may be tapered for facilitating insertion into the bone. Surface551may also be of a geometry to prevent stress risers in the bone at the end of the implant. Implant500may have an end520for engaging a bone or segment of bone. End520may have bone engaging features560that may be rings or barbs for engaging bone. The number of bone engaging features560may vary by implant size and geometry. The style of the bone engaging features560may also vary to include barbs of various styles, threads, rings, bumps, teeth or the like. The bone engaging features560may or may not be circular in cross-section. The bone engaging features560may or may not be similar to the bone engaging features540. The type of bone engaging feature may also vary within the same implant. For example bone engaging features560may alternate between circular barbs and non-circular rings. End520may have surface525that may be tapered. This tapered region525may facilitate insertion into the bone and may optimize the engagement with the bone segment. Surface525may also be of a geometry to prevent stress risers in the bone at the end of the implant. First end510and second end520may have feature530interposed between them. Feature530may serve as a stop to prevent first end510or second end520from extending too far into a bone segment. Feature530may have faces means535that create a non-circular cross-section and minimize the amount of implant material that may be between two opposing bone segments. Means535may also act as features that key into one or more bone segments. Means535may resist rotation of the implant500relative to the bone segment(s). Means535may also serve to maintain a relative orientation between the implant and bone segments.

FIG. 10is a side view of the embodiment ofFIG. 9. The first end510of the implant500may have bone engaging features with a major diameter of595and a minor diameter of596. In this figure, the bone engaging features540are of uniform size. Other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The first end510may be further defined as having a length502. Through hole550may pass through surface555and may extend through certain bone engaging features540. Second end520of the implant500may have bone engaging features with a major diameter of590and a minor diameter of591. In this figure, the bone engaging features560vary along the length501. The minor diameter591may be equivalent for bone engaging features560while the major or outer diameters590,592and593vary in size along the length501. The varying diameters590,592, and593may be a result of taper geometry525. Based on the description herein, those skilled in the art will understand that other embodiments are possible that may have bone engaging features that are of varying sizes and configurations. The second end520may be further defined as having a length501. In this figure, second end520is shown not having a through hole550. In an alternate embodiment, second end520may have a through hole550that may be used with the suture or the like for tissue fixation or for insertion of the implant into a surgical site. The suture and through hole550may be used to generate compression between the bone segments that are engaged with the implant ends510and520. The compression may be generated by having the first end510engaged in bone, while the bone in which second end520may be engaged is pulled towards the first end510by passing the suture through the hole550then through the bone attached to the second end520and tightening the suture such that the bones segments are brought together. In this figure, the implant500may also act as a tissue anchor and as an aid in compressing the two bone segments. In yet other embodiments both ends510and520may have through holes550.FIG. 10is a side view showing feature530having an effective diameter536, a length503and a feature535. Some embodiments may require feature530to be as small as possible so as not to reduce the bone to bone apposition between the two bone segments.

FIG. 11is an end view of the implant500. This view shows the feature530having a relatively circular cross-section with means535that may be equally positioned on opposite sides of the implant500. Alternate embodiments are possible that may have one or more means535that may or may not be equally spaced. In an alternate embodiment, feature530may or may not have a circular cross-section.

FIG. 12is a top view and a section view of the third embodiment. This figure shows first end510having two flats555and556that may be present. These flats555and556may be used to resist rotation of the implant500relative to bone.FIG. 12shows first end510and second end520both having substantially circular cross-sections. Alternate embodiments may have a combination of circular and non-circular ends where first end510may be non-circular and second end520may be circular or visa versa. The implant is depicted has having a first end510and a second end520with different lengths501and502. Alternate embodiments may have lengths501and502that may or may not be of equal length. The implant is depicted has having a first end510with a centerline511and a second end520with a collinear centerline521. Alternate embodiments may have first end510with a centerline511and second end520with a centerline521that may or may not be collinear and or parallel. The section view C-C ofFIG. 12shows the implant500with a solid cross-section. It further shows the through hole550intersecting the centerline511which may also be off centerline.

Based on the description herein, those skilled in the art will understand that multiple variations of implant geometries are possible that are within the scope of the current invention. The descriptions herein discuss embodiments that may or may not include a pre-assembled suture or the like. A pre-assembled suture may be attached to the implant either temporarily or permanently. The suture may or may not be packaged with the implant, pre-threaded through the suture hole, tied to the suture hole or injection molded into the implant. The inclusion or exclusion of the suture for the descriptions herein is not intended to be limiting in scope. The foregoing embodiments and the embodiments described below may be manufactured from a number of materials including titanium, nitinol, stainless steels, PEEK, polymers, biologics, grafts, and/or resorbable materials. The exemplary embodiments described herein are not intended to be limiting.

FIG. 13is one possible embodiment of an instrument for means of insertion of an implant of the invention into the surgical site. The instrument for means of insertion, e.g. the inserter700may or may not be preassembled to the implant750. Inserter700has a handle region720to facilitate insertion and manipulation of the implant during insertion. The inserter700may have a connecting end730that may be customized for a particular implant embodiment. In this figure, connecting end730has a connecting member710that engages the through hole760of an implant750. The implant may or may not be preassembled to the inserter.

FIG. 14is one possible embodiment of a kit1000. Kit1000may be provided sterile or non-sterile and may include necessary instruments for completing a surgical procedure. This kit1000consists of a tray1100that may include an inserter/driver1150that may or may not be preassembled to the implant, a first drill/reamer1160, a second drill/reamer1170, and a k-wire or a suture passer1180. This embodiment includes implants1200and1300. The Implants1200and1300may be included in various sizes or may not be included in the kit. The implants1200and1300may be provided as individually packaged items or may be included as a component of kit1000. The drill/reamer1160and or1170may be included in a number of varying diameters. The reamers1160and1170may or may not be the same diameter. It may be advantageous for reamers1160and1170to be different diameters. The kit1000may include any number for reamers of the same diameter or different diameters. The size diameter used for drill/reamer1160and or1170may depend on the tightness of fit between the implant and bone as desired by the end user. The amount of pressfit or tightness of fit between the implant and bone may vary by user and may vary depending on surgeon preference, bone quality, bone geometry, etc. The drill/reamers1160and1170may include markings or indications1175that may be used to provide a reference for appropriate reaming or drilling depth. The reamers/drills1160and1170may have one or more markings1175. The markings1175may be in multiple locations or configurations. The indications or markings1175may provide a visual or physical calibration for indicating depth or some other predetermined measurement. The configuration of the implant kit1000is not intended to be limiting. Based on the description herein, those skilled in the art will agree multiple kit configurations may be possible.

The kit1000or a similar kit embodiment may be used to prepare a bone for implantation. For exemplary purposes, a possible hammertoe or PIP fusion technique is described. An implant template and the patient's radiographs may be used to approximate the appropriate sized implant to be used. The profile of the implant must fit within the internal boundary of the cortical shell of the phalanges under surgical consideration. The planned amount of bone resection should be taken into account when evaluating implant position and size. Correct implant sizing is critical. The final sizing and fit of the implant must be evaluated with the actual implant to ensure proper fit within the bone. The surgeon should create an appropriate incision over the dorsal aspect of the PIP joint. A transverse capsulotomy with release of the collateral ligaments off the head of the proximal phalanx should be performed. The joint dissection and access should provide complete visualization of the articular surfaces of the middle and proximal phalanges. The appropriate bone cuts should be made perpendicular to the long axis of the phalanges. The final toe orientation is achieved by the angle of the bone resection. If the implant is angled, the bone resection should approximate the angle of the implant. The distal head of the proximal phalanx just posterior to the head of the phalange may be resected. The appropriate sized implant is selected. The appropriately sized reamer may be used to verify implant sizing. The appropriate implant reamer may be sterile packaged with the implant kit. A smaller diameter drill or reamer may be used to create an initial pilot hole if desired. The tip of the reamer may be inserted into the proximal phalanx along its central axis while verifying the correct position of the reamer with dorsal-plantar and medial-lateral fluoroscopy views. After the reamer location has been verified, the reamer may be advanced to the minimum required depth as indicated on the reamer, ensuring no to pierce the proximal cortex of the proximal phalanx. Correct trajectory of the implant is critical. Implants that are misaligned may prevent proper bone apposition and subsequent healing of the fusion site. If the reamer is not fully seated to the indicated mark(s)1175, the hole may not be drilled to the correct depth. With insufficient reamer depth in the bone, final seating of the implant in the phalanx may be difficult or not possible. The tip of the implant reamer may be inserted into the middle phalanx along its central axis verifying the correct position of the reamer with dorsal-plantar and medial-lateral fluoroscopy views. The implant which may be preloaded onto the instrument for means of insertion, e.g. the inserter, is selected and driven into the proximal phalanx by pushing the implant into the proximal phalanx until the inserter bottoms out on the resected bone surface. Slight tapping may be needed to fully seat the implant in the proximal phalanx then the inserter is removed leaving the middle barbed portion exposed.

If the suture hole is to be used, prior to inserting the distal end of the implant into the middle phalanx, pass the desired suture though the hole in the implant. Prepare a small hole in the proximal dorsal aspect of the middle phalanx. The suture will be passed through this hole. The order/steps of passing the suture through the hole can vary. It can be placed through the implant first then the bone. Or it can be placed through the bone first then the implant. The order of steps isn't critical, as long as the suture passes through the implant. With the suture passed through the implant and the middle phalanx, insert the distal end of the implant into the middle phalanx by positioning inserting the end of the implant into the pre-drilled hole in the middle phalanx. Apply axial force by firmly compressing the joint until the implant is fully seated and the resected surfaces of the proximal and middle proximal phalanges come into contact. With the implant fully seated and the implant positioned and alignment verified, the surgeon may proceed with his preferred closure which may be used to provide additional compression or fixation by tightening the suture such that the bone segments are brought closer together. The final closure and ligament reattachment may be performed with the suture that has been passed through the implant suture hole.

FIG. 15is a side view of an implant200that may have been inserted into the proximal bone segment210with a technique similar to the one described here in. The implant200has a first end201that may be partially inserted into the bone210leaving a second end202of the implant200exposed. Suture230is shown passing through the implant suture hole205, but prior to full implantation.FIG. 16is a side view of the implant200fully implanted with the suture230passing through the suture hole205in the second end202of the implant200. The suture230may also pass through the second bone220for final closure and or tissue attachment. When the suture230is securely tightened to bone220it may provide additional compression between bones210and220.

FIG. 17is a top view of a fourth embodiment of the invention. Implant assembly800is illustrated with a section line A-A showing a double suture810integral to the implant820.FIG. 17Ais the section view showing the connection area830between the implant820and double suture810. The implant820may be of any configuration of the current invention described herein. The double suture810may be connected or attached to implant820at a connection area830. The double suture810may be non resorbable or resorbable. The suture810may be of any appropriate size. The attachment830may be temporary or the attachment830may be permanent. The double suture810may be integral to the implant820. The double suture810may be connected or attached to the implant820by means of permanently attaching the suture810to the implant820. The attachment830may be made by injection molding, insert molding, adhering, tying or other attachment means known to those skilled in the art.

FIG. 18is a top view of a fifth embodiment of the invention. Implant assembly850is illustrated with a section line A-A showing a single suture860integral to the implant870.FIG. 18Ais the section view showing the connection area880between the implant870and suture860. The implant870may be of any configuration of the invention described herein. The suture860may be connected or attached to implant870at a connection area880. The suture860may be non resorbable or resorbable. The suture860may be of any appropriate size. The attachment880may be temporary or the attachment880may be permanent. The suture860may be integral to the implant870. The suture860may be connected or attached to the implant870by means of permanently attaching the suture860to the implant870. The attachment880may be made by injection molding, insert molding, adhering, tying or other attachment means known to those skilled in the art.

FIG. 19is a side view showing the detail of one possible embodiment of the bone engaging features of the current invention. The implant900has bone engaging features901and902. Bone engaging features901and902may or may not be of the same geometry. In this embodiment bone engaging features901and902are mirror images and may allow improved purchase and prevent pullout of the implant900when the implant900is implanted into opposing bones. Bone engaging feature901has an angle910with a depth of920and a radius of930. Bone engaging feature901has a face935that is at an angle940. Bone engaging feature902has an angle950with a depth of960and a radius of970. Bone engaging feature902has a face975that is at an angle980. Angles910and950may or may not be of equal value or similar direction but the direction of the angle is critical to the implant locking into the canal of the bone. As shown inFIG. 19, angles910and950are angled toward the shoulder530. This orientation creates a sharp corner, angle940and980, that will tend to resistively engage the prepared bone canal when a force is applied in the reverse direction of insertion. This feature advantageously holds the middle and proximal phalanges in direct opposition. Depths960and920may or may not be of equal value, orientation or geometry. Radii930and970may or may not be of equal value or orientation. Faces935and975may or may not be of equal length or similar geometry. Faces935and975may or may not be collinear.

FIG. 20is a perspective view of multiple possible alternate embodiments of the bone engaging features of the current invention. Implant2100is shown with a first end2120. First end2120may have a plurality of bone engaging features2150that are barb like and may be spaced along the length of first end2120and around the perimeter of first end2120. First end2120may have areas2151that may be void of bone engaging features such as2150. Implant2200has a first end2220. First end2220may have bone engaging features2250that may be helical in nature. Implant2300has first end2320. First end2320may have bone engaging features2350. Bone engaging features2350may have features2352and a geometry that may be used to create features2351. Bone engaging features2351may vary in geometry and sharpness along the length of first end2320. Implant2400may have first end2420. First end2420may have bone engaging features2450and groove(s)2451. Bone engaging features2450may vary in size, sharpness and geometry along the length of first end2420. Implant2500may have a first end2520. First end2520may have bone engaging features2550. Bone engaging features2550may be interrupted by hole(s)2552. Bone engaging features may further be interrupted by slot2551that may cause the first end2520to expand or be expandable. As will be apparent to those skilled in the art based upon the disclosures herein, an implant of the invention may have one or multiple types of bone engaging features to optimize effectiveness of the implant for its intended purpose.

FIG. 21is a side view of an implant400similar to the embodiment shown inFIGS. 9 and 10but in addition to a through hole404in the distal end402, the implant400also has a through hole403in the proximal end401. Implant400may also include bone engaging features406and or a means405for determining orientation and or position in a bone.

FIG. 22shows a seventh embodiment430of the current invention. Device430has an implant431that is attached to a driver end432. Implant431may be releaseably attached to driver432such that after implantation the driver end432may be snapped or broken off. The implant431has a proximal end433and a distal end434. The implant431may have bone engaging features435and or a through hole436as previously described herein. As depicted inFIG. 23, implant431is attached at one end to a driver432. As shown, the attachment437is at the distal end434of implant431but may also be at the proximal end433. The attachment437will be of a geometry that will allow transfer of sufficient force and manipulation for insertion while allowing the driver end432to be removed by either breaking, snapping or cutting the connection attachment means437. This may be advantageous to allow the implant and inserter to be manufactured from the same material by conventional manufacturing processes such as machining or injection molding. This may reduce the cost of the device and may provide for additional recycling of the driver material. This may be further advantageous in reducing surgical complexity and or surgical time.

FIG. 24is a top view and section view of an eighth embodiment450of an implant having a core member454. Implant450has other features and advantages of the current invention as described herein. The core member454is shown in the proximal end451of the implant but may also extend into or be partially or entirely within the proximal end452. The core member454may provide additional strength to implant450. For example if the implant450is comprised of PEEK or another plastic or biocompatible material or a resorbable material or bone, it may be advantageous to have a core member454comprised of a stronger material such as nitinol, stainless steel, titanium or other biocompatible material. The core454would be relatively stronger than the surrounding implant material. This may be particularly advantageous for enhancing the strength of smaller implants and may provide a means for creating bone engaging features on implants of small size with enhanced core strength. The core may also provide the benefit of being radio-opaque.

FIG. 25is a top view and section view of a ninth embodiment of the invention, implant470. Implant470has a core member474and may have other features and advantages of the current invention as described herein. The core member474is shown extending completely through the implant470and incorporates the through hole473. The core member474may provide additional strength to implant470. For example, if the implant470is comprised of PEEK or another plastic or biocompatible material or a resorbable material or bone, it may be advantageous to have a core member474comprised of a stronger material such as nitinol, stainless steel, titanium or other biocompatible material. The core474would be relatively stronger than the surrounding implant material. The core may also provide the benefit of being radio-opaque. Having a core extend completely through the implant470would provide a driver end476that is releaseably attached to the implant470. Implant470may be releaseably attached to driver end476such that after implantation the driver end476may be snapped or broken off. The implant470has a proximal end471and a distal end472. The implant470may have bone engaging features475and or a through hole473as previously described herein. As depicted inFIG. 25, implant470has a core member474that is attached at one end to a driver476. As shown, the attachment476is at the distal end472of implant470but may also be at the proximal end471depending on the intended use of the device. The attachment means477will be of a geometry that will allow transfer of sufficient force and manipulation for insertion while allowing the driver end476to be removed by either breaking, snapping or cutting the connection attachment means477. This may be advantageous to allow the implant and inserter to be manufactured by low cost processes such as injection molding or over molding. This may reduce the cost of the device and may provide for additional recycling of the driver material. This may be further advantageous in reducing surgical complexity and or surgical time.

FIG. 26is a side view of implant480. Implant480may have a proximal end481and a distal end482. Implant480may also have bone engaging means484and or a through hole483as well as other features and advantages of the current invention as described herein. Implant480may also have an extended proximal end485and or an extended distal end486. Extended ends485and486may be trimmed at the time of use to create a specific size. The extended ends485and486may be smooth or may have other features as described herein.

FIG. 27is an exploded view of an implant kit600that may have an implant of the current invention as described herein pre-assembled to an insertion or driver device602. The assembly of the inserter/driver and implant may be contained in a clamshell or other holding device601. The assembly of the inserter/driver and implant may be sterile packaged.

The descriptions of the implants, instruments, and surgical technique embodiment and configurations described herein are not limiting. Based on the description herein, those skilled in the art will understand that there are numerous configuration and or embodiments that will be within the scope of the current invention. The exemplary embodiments described herein are not intended to be limiting.