Patent Publication Number: US-11660131-B2

Title: Bone fusion/fixation device and related systems and methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This application claims priority as a continuation to U.S. application Ser. No. 16/114,391, filed on Aug. 28, 2018 and entitled “Bone Fusion/Fixation Device and Related Systems and Methods,” which claims priority as a continuation to U.S. application Ser. No. 15/121,239, filed on Aug. 24, 2016 and entitled “Bone Fusion/Fixation Device and Related Systems and Methods,” now U.S. Pat. No. 10,080,599, which claims the benefit under 35 U.S.C. § 371 to International PCT Patent Application No. PCT/US15/18111, filed on Feb. 27, 2015, which claims priority to U.S. Provisional Application 61/945,511, filed Feb. 27, 2014 and entitled “Digital Deformity Fusion/Fixation Device and Related Methods,” all of which are hereby incorporated herein by reference in their entireties. 
    
    
     FIELD OF THE INVENTION 
     The various embodiments disclosed herein relate to bone fixation or fusion devices, including intramedullary fixation or fusion devices that are implanted around the target bone. In addition, other embodiments relate to implantation devices that can be used to implant or position the bone fixation or fusion devices. 
     BACKGROUND OF THE INVENTION 
     Digital arthrodesis of the foot is a common surgical procedure for correction of acquired or congenital digital deformities, including, for example, hammertoe, mallet toe deformities, and similarly encountered foot maladies affecting or involving the digits (toes). 
     Historically, the involved digit(s) and respective joints are corrected via a stepwise reduction using, for example, a specific joint resection arthoplasty, (cutting a small amount of articular cartilage and bone to straighten and maintain flexibility of the involved digit) or a specific joint arthrodesis (fusion or permanent stiffening of the joint in a corrected neutral position). Prior to the creation of the various embodiments disclosed herein, the “gold standard” of affixing and imparting mechanical stability to an intended digital arthrodesis has been the application of a single intramedullary positioned standard sized Kirschner wire (“K-wire”), which is routinely exposed externally to the distal tip of the involved digit. For example,  FIG.  1 A  depicts a K-wire positioned in an affected digit. Many surgeons have employed the K-wire for the express purpose of providing stability to the intended arthrodesis site and/or maintaining, stabilizing, and/or directly reducing concurrent metatarsophalngeal joint contracture associated with digital deformity. 
     Disadvantages of standard K-wire fixation include the defined requirement of removal, migration, bending, or breaking of the “K-wire,” loss of fixation and/or loss of stability at the intended arthrodesis site, pin tract site irritation, inflammation, pain, and/or development of infection, including deep infection, and the routine external exposure of the K-wire, which is recognized to leave patients and physicians dissatisfied. More specifically, K-wire fixation remains external to the distal aspect of the digit, resulting in a variety of potential problems, including wound complications, limitation of ambulation, and secondary events. Furthermore, following K-wire removal, the potential loss of stability at the intended arthrodesis site can be related to recurrence of deformity, fibrous union, non-union, and pain, as well as failure to gain lasting correction of the deformity. 
     Newer known intra-medullary devices—solid and cannnulated designs—are commercially available as an alternative fixation device to traditional K-wire fixation, offering completely internal placement.  FIG.  1 B  depicts one embodiment of solid intra-medullary devices. These newer devices are intended to afford a greater degree of intramedullary fixation and stability to the intended arthrodesis site and obviate the need for an exposed intra-medullary fixation device. (i.e. “K-wire” fixation.) 
     Complications of emerging solid and/or cannulated intramedullary devices are well established, including failure to impart stability, loss of stability, loss of fixation, breakage of device, fracture of adjacent cortical bone, device loosening, osteolysis, handling and storage constraints due to metallurgy properties, inventory control dissatifiers, cost, difficulty in removal, bone loss, secondary procedures, and complications salvaged via explanation, revisional arthrodesis, bone grafting considerations, adjacent digit syndactyly and/or digital amputation. Further, few of the newer intra-medullar technologies are compatible and approved (via 510K clearance) to be used concurrently with Kirschner wire fixation. 
     There is a need in the art for an improved extramedullary device designed specifically for the intended arthrodesis of a digital arthrodesis of the foot or hand. 
     BRIEF SUMMARY OF THE INVENTION 
     Discussed herein are various bone fixation or fusion devices and related systems and methods. 
     In Example 1, a bone fixation device comprises at least one spine, at least two distal arms extending from a distal end of the at least one spine, least two proximal arms extending from a proximal end of the at least one spine, and at least one opening defined in the bone fixation device, wherein the opening is sized and shaped to receive a portion of an implantation tool. Each of the at least two distal arms comprises at least one distal bone tine, and the at least two distal arms are configured to be positionable around a bone. Each of the at least two proximal arms comprises at least one proximal bone tine, and the at least two proximal arms are configured to be positionable around a bone. 
     Example 2 relates to the bone fixation device according to Example 1, wherein the at least one spine comprises a first spine and a second spine. 
     Example 3 relates to the bone fixation device according to Example 2, wherein the first and second spines comprise notches defined along a length of each of the first and second spines. 
     Example 4 relates to the bone fixation device according to Example 2, wherein the first and second spines are curvy spines. 
     Example 5 relates to the bone fixation device according to Example 1, wherein the opening comprises internal threads, wherein the internal threads are configured to receive external threads of the implantation tool. 
     Example 6 relates to the bone fixation device according to Example 1, wherein the at least one opening comprises at least four openings, wherein each of the at least two distal arms and the at least two proximal arms defines at least one of the at least four opening. 
     Example 7 relates to the bone fixation device according to Example 1, wherein the at least one opening comprises at least two openings, wherein the at least one spine defines the at least two openings. 
     Example 8 relates to the bone fixation device according to Example 1, further comprising at least one arm deformation opening defined in at least one of the at least two distal arms and the at least two proximal arms, wherein the at least one arm deformation opening is configured to facilitate deformation of the at least one of the at least two distal arms and the at least two proximal arms. 
     Example 9 relates to the bone fixation device according to Example 1, wherein the at least one spine comprises a joint or fracture site indicator line. 
     Example 10 relates to the bone fixation device according to Example 1, further comprising at least one arm deformation notch defined in at least one of the at least two distal arms and the at least two proximal arms, wherein the at least one arm deformation notch is configured to facilitate deformation of the at least one of the at least two distal arms and the at least two proximal arms. 
     In Example 11, a bone fixation device comprises a first spine comprising a first curved inner edge and a first outer edge comprising a plurality of notches, a second spine comprising a second curved inner edge and a second outer edge comprising a plurality of notches, at least two distal arms extending from a distal end of the first and second spines, at least two proximal arms extending from a proximal end of the first and second spines, at least one tool interface opening defined in the bone fixation device, and at least one arm deformation feature defined in the bone fixation device. Each of the at least two distal arms comprises at least one distal bone tine and the at least two distal arms are configured to be positionable around a bone. Each of the at least two proximal arms comprises at least one proximal bone tine and the at least two proximal arms are configured to be positionable around a bone. The at least one tool interface opening is sized and shaped to receive a portion of an implantation tool. The at least one arm deformation feature is configured to facilitate deformation of at least one of the at least two distal arms and the at least two proximal arms. 
     Example 12 relates to the bone fixation device according to Example 11, wherein the at least one tool interface opening comprises internal threads, wherein the internal threads are configured to receive external threads of the implantation tool. 
     Example 13 relates to the bone fixation device according to Example 11, wherein the at least one tool interface opening comprises at least four openings, wherein each of the at least two distal arms and the at least two proximal arms defines at least one of the at least four tool interface openings. 
     Example 14 relates to the bone fixation device according to Example 11, wherein the at least one arm deformation feature comprises an opening or a notch. 
     Example 15 relates to the bone fixation device according to Example 11, wherein the first and second spines comprise a joint or fracture site indicator line. 
     In Example 16, a bone fixation device comprises at least one spine, at least two distal arms extending from a distal end of the at least one spine, and at least two proximal arms extending from a proximal end of the at least one spine. Each of the at least two distal arms comprises at least one distal deformation control opening and the at least two distal arms are configured to be positionable around a bone. Each of the at least two proximal arms comprises at least one proximal deformation control opening, and the at least two proximal arms are configured to be positionable around a bone. The distal and proximal deformation control openings are configured to facilitate deformation of the at least two distal arms and the at least two proximal arms. 
     Example 17 relates to the bone fixation device according to Example 16, wherein the distal and proximal deformation control openings are configured to provide for deformation of the at least two distal arms and the at least two proximal arms in a desired direction. 
     Example 18 relates to the bone fixation device according to Example 16, wherein the distal and proximal deformation control openings are configured to provide for local bend radii of the distal and proximal arms that differ from local bend radii of the distal and proximal arms in the absence of the deformation control openings. 
     Example 19 relates to the bone fixation device according to Example 16, wherein each of the at least two distal arms and the at least two proximal arms comprise at least one bone tine, wherein each at least one bone tines is positioned at a radius of curvature that is more acute than a radii of curvature within the at least two distal arms and the at least two proximal arms. 
     Example 20 relates to the bone fixation device according to Example 16, wherein each of the at least two distal arms and the at least two proximal arms comprises a first bend radius imparted around the distal and proximal deformation control openings, a second bend radius imparted on the arm between the deformation control opening and a bone tine, and a third bend radius imparted on the bone tine. 
     Example 21 relates to the bone fixation device according to Example 20, wherein the first, second, and third bend radii are non-circular in cross-section. 
     In Example 22, a bone fixation kit comprises a bone fixation device, a support block on which the bone fixation device can be disposed such that the at least one spine, the first and second distal arms, and the first and second proximal arms conform to a shape of the support block, and an implantation tool that is coupleable with the first and second distal arms and the first and second proximal arms to remove the bone fixation device from the support block. The bone fixation device comprises at least one spine, first and second distal arms extending from a distal end of the at least one spine, each of the first and second distal arms comprising at least one distal bone tine, and first and second proximal arms extending from a proximal end of the at least one spine, each of the first and second proximal arms comprising at least one proximal bone tine. 
     In Example 23, a bone fixation method comprises providing a bone fixation device, positioning the first and second distal arms around a first target bone site, crimping the first and second distal arms around the first target bone site with an implantation tool such that the at least one distal bone tine is embedded in the first target bone site, positioning the first and second proximal arms around a second target bone site, and crimping the first and second proximal arms around the second target bone site with the implantation tool such that the at least one proximal bone tine is embedded in the second target bone site. The bone fixation device comprises at least one spine, first and second distal arms extending from a distal end of the at least one spine, each of the first and second distal arms comprising at least one distal bone tine, and first and second proximal arms extending from a proximal end of the at least one spine, each of the first and second proximal arms comprising at least one proximal bone tine. 
     Example 24 relates to the bone fixation method according to Example 23, further comprising deforming the at least one spine to replicate a natural bend at the first and second target bone sites. 
     Example 25 relates to the bone fixation method according to Example 23, wherein first target bone site comprises a first bone and the second target bone site comprises a second bone, wherein the bone fixation device is positioned across a joint between the first and second bones. 
     Example 26 relates to the bone fixation method according to Example 23, wherein the bone fixation device further comprises at least first and second distal tool interface openings defined in the first and second distal arms and at least first and second proximal tool interface openings defined in the first and second proximal arms, wherein the crimping the first and second distal arms further comprises coupling the implantation tool to the first and second distal tool interface openings, and wherein the crimping the first and second proximal arms further comprises coupling the implantation tool to the first and second proximal tool interface openings. 
     Example 27 relates to the bone fixation method according to Example 23, further comprising coupling the implantation tool to at least first and second distal tool interface openings defined in the first and second distal arms prior to positioning the first and second distal arms around the first target bone site and coupling the implantation tool to at least first and second proximal tool interface openings defined in the first and second proximal arms prior to positioning the first and second proximal arms around the second target bone site. 
     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1 A  is a front view of an X-ray image of a known K-wire device positioned in an affected digit. 
         FIG.  1 B  is a front view of an X-ray image of known intra-medullary devices positioned in affected digits. 
         FIG.  2 A  is a top view of a fusion or fixation device affixed to a target site on a digit, according to one embodiment. 
         FIG.  2 B  is a perspective view of the fusion or fixation device of  FIG.  2 A . 
         FIG.  2 C  is an underside view of the fusion or fixation device of  FIG.  2 A . 
         FIG.  3 A  is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  3 B  is a side view of the fixation/fusion device of  FIG.  3 A . 
         FIG.  3 C  is an underside view of the fixation/fusion device of  FIG.  3 A . 
         FIG.  3 D  is an end view of the fixation/fusion device of  FIG.  3 A . 
         FIG.  3 E  is an perspective view of the fixation/fusion device of  FIG.  3 A  prior to being formed into the desired shape. 
         FIG.  3 F  is a perspective view of the fixation/fusion device of  FIG.  3 A  in which formation of the desired shape has begun. 
         FIG.  3 G  is an perspective view of the fixation/fusion device of  FIG.  3 A  in which formation of the desired shape is complete. 
         FIG.  4    is a perspective view of a fixation/fusion device implanted or fixed in place across a joint, according to one embodiment. 
         FIG.  5 A  is a perspective view of a fixation/fusion device coupled to an application tool for purposes of implantation, according to one embodiment. 
         FIG.  5 B  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which an advancement tool is being advanced toward the fixation/fusion device, according to one embodiment. 
         FIG.  5 C  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which an advancement tool is in contact with the fixation/fusion device, according to one embodiment. 
         FIG.  5 D  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which an advancement tool urges the tines of the fixation/fusion device into the bone, according to one embodiment. 
         FIG.  5 E  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which the advancement tool is being removed, according to one embodiment. 
         FIG.  5 F  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which the tines of the fixation/fusion device are embedded into the bone, according to one embodiment. 
         FIG.  5 G  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which the two rods of the advancement tool are urged apart to bend the device, according to one embodiment. 
         FIG.  5 H  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which the advancement tool is being removed, according to one embodiment. 
         FIG.  5 I  is a perspective view of the fixation/fusion device of  FIG.  5 A  in which an advancement tool has been removed and the device is implanted, according to one embodiment. 
         FIG.  6 A  is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  6 B  is a side view of the fixation/fusion device of  FIG.  6 A . 
         FIG.  6 C  is an end view of the fixation/fusion device of  FIG.  6 A . 
         FIG.  6 D  is an perspective view of the fixation/fusion device of  FIG.  6 A  prior to being formed into the desired shape. 
         FIG.  7    is a perspective view of a fixation/fusion device implanted or fixed in place across a joint, according to one embodiment. 
         FIG.  8 A  is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  8 B  is a side view of the fixation/fusion device of  FIG.  8 A . 
         FIG.  8 C  is an end view of the fixation/fusion device of  FIG.  8 A . 
         FIG.  8 D  is a perspective view of the fixation/fusion device of  FIG.  8 A  prior to being formed into the desired shape. 
         FIG.  9    is a perspective view of a fixation/fusion device implanted or fixed in place across a joint, according to one embodiment. 
         FIG.  10 A  is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  10 B  is a perspective view of the fixation/fusion device of  FIG.  10 A  in which the arms have been deformed into a desired configuration. 
         FIG.  10 C  is an end view of the fixation/fusion device of  FIG.  10 A . 
         FIG.  11 A  is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  11 B  is a side view of the fixation/fusion device of  FIG.  11 A . 
         FIG.  11 C  is an end view of the fixation/fusion device of  FIG.  11 A . 
         FIG.  12 A  is a perspective view of a fixation/fusion device coupled to an application tool for purposes of implantation, according to one embodiment. 
         FIG.  12 B  is a perspective view of the fixation/fusion device of  FIG.  12 A  in which the application tool is urging the tines of the fixation/fusion device into the bone, according to one embodiment. 
         FIG.  13 A  is a perspective view of a fixation/fusion device coupled to an application tool for purposes of implantation, according to one embodiment. 
         FIG.  13 B  is a perspective view of the fixation/fusion device of  FIG.  13 A  in which the application tool is urging the tines of the fixation/fusion device into the bone, according to one embodiment. 
         FIG.  14 A  is a side view of a fixation/fusion device positioned adjacent to a target bone, according to another embodiment. 
         FIG.  14 B  is a side view of the fixation/fusion device of  FIG.  14 A  in which the device has been positioned around the target bone, according to one embodiment. 
         FIG.  14 C  is a side view of the fixation/fusion device of  FIG.  14 A  in which an application tool is urging the tines of the fixation/fusion device into the bone, according to one embodiment. 
         FIG.  15 A  is a side view of a fixation/fusion device, according to another embodiment. 
         FIG.  15 B  is a perspective view of the fixation/fusion device of  FIG.  15 A . 
         FIG.  15 C  is a side view of the fixation/fusion device of  FIG.  15 A  coupled to an application tool for purposes of implantation, according to one embodiment. 
         FIG.  16    is a side view of a fixation/fusion device coupled to an application tool for purposes of implantation, according to one embodiment. 
         FIG.  17 A  is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  17 B  is a top view of the fixation/fusion device of  FIG.  17 A . 
         FIG.  17 C  is a side view of the fixation/fusion device of  FIG.  17 A . 
         FIG.  17 D  is an end view of the fixation/fusion device of  FIG.  17 A . 
         FIG.  18    is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  19 A  is a perspective view of a fixation/fusion device with adjustable connection components, according to another embodiment. 
         FIG.  19 B  is a perspective view of the fixation/fusion device of  FIG.  19 A  in which the adjustable connection components have been shortened, according to one embodiment. 
         FIG.  20 A  is a perspective view of a fixation/fusion device with adjustable connection components, according to another embodiment. 
         FIG.  20 B  is a perspective view of the fixation/fusion device of  FIG.  20 A  in which the adjustable connection components have been shortened, according to one embodiment. 
         FIG.  21 A  is a perspective view of a fixation/fusion device, according to another embodiment. 
         FIG.  21 B  is a top view of the fixation/fusion device of  FIG.  21 A . 
         FIG.  21 C  is a perspective side view of the fixation/fusion device of  FIG.  21 A . 
         FIG.  21 D  is a side view of the fixation/fusion device of  FIG.  21 A . 
         FIG.  21 E  is a side view of the fixation/fusion device of  FIG.  21 A . 
         FIG.  22    is a top view of a fixation/fusion device, according to another embodiment. 
         FIG.  23    is a top view of a fixation/fusion device, according to another embodiment. 
         FIG.  24 A  is a top view of a fixation/fusion device, according to another embodiment. 
         FIG.  24 B  is a side view of the fixation/fusion device of  FIG.  24 A . 
         FIG.  24 C  is a side view of the fixation/fusion device of  FIG.  24 A . 
         FIG.  25    is a side view of a fixation/fusion device, according to another embodiment. 
         FIG.  26    is a side view of a fixation/fusion device, according to another embodiment. 
         FIG.  27    is a side view of a fixation/fusion device, according to another embodiment. 
         FIG.  28    is a side view of a fixation/fusion device, according to another embodiment. 
         FIG.  29 A  is a front view of a implantation device, according to one embodiment. 
         FIG.  29 B  is an expanded perspective view of the jaw of the implantation device of  FIG.  29 A . 
         FIG.  29 C  is an expanded front view of the ratchet mechanism of the implantation device of  FIG.  29 A . 
         FIG.  30 A  is an expanded perspective view of the locking mechanism of the implantation device of  FIG.  29 A . 
         FIG.  30 B  is an expanded perspective view of the locking mechanism of the implantation device of  FIG.  29 A . 
         FIG.  31 A  is a perspective view of a fixation/fusion device on a holder block and coupled to an application tool, according to one embodiment. 
         FIG.  31 B  is a perspective view of the application tool removing the fixation/fusion device of  FIG.  31 A  from the holder block, according to one embodiment. 
         FIG.  31 C  is a perspective view of the application tool positioning the fixation/fusion device of  FIG.  31 A  at a target bone site, according to one embodiment. 
         FIG.  31 D  is a perspective view of the application tool crimping the fixation/fusion device of  FIG.  31 A  in place at the target bone site, according to one embodiment. 
         FIG.  31 E  is a perspective view of the application tool crimping the opposite end of the fixation/fusion device of  FIG.  31 A  in place at the target bone site, according to one embodiment. 
         FIG.  31 F  is a perspective view of the fixation/fusion device of  FIG.  31 A  implanted at the target bone site, according to one embodiment. 
         FIG.  32    is a perspective view of the fixation/fusion device of  FIG.  31 A  being removed with a removal tool, according to one embodiment. 
         FIG.  33 A  is a perspective view of a fixation/fusion device on another holder block, according to another embodiment. 
         FIG.  33 B  is a perspective view of the fixation/fusion device of  FIG.  33 A  being removed from the holder block using an implantation tool, according to one embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     The various embodiments disclosed and contemplated herein relate to anatomic, site-specific extra-medullary fixation and/or fusion devices (and related systems and methods) designed to achieve satisfactory mechanical and clinical benefit over traditional K-wire fixation and emerging new solid and/or cannulated intramedullary fixation technologies. Certain implementations are designed specifically for digital arthrodesis of the foot (or hand). More specifically, the various embodiments relate to a system comprising an anatomically specific extramedullary digital fixation device and a related application tool. 
       FIGS.  2 A- 2 C  depict one specific exemplary embodiment of a fusion or fixation device  10  affixed to a target site on a digit  12 . Each of the various embodiments disclosed herein can be affixed to the target site as the sole fusion or fixation device. That is, any of these embodiments can be used on their own, without any other known devices. Alternatively, the various embodiments can also be used concurrently with “K-wire” fixation devices or other known devices per clinical need and/or surgeon preference. That is, the various embodiments are configured to be capable of and compatible with the concurrent use of a K-Wire. Surgeons may elect to adjunctively apply such “K-wire” adjunct to stabilize and control the position of the digit at the metatarsal philangeal joint level following a step-wise surgical release and correction to the proximal phalangeal joint contracture and deformity. The various implementations disclosed herein allow such adjunctive use. In contrast, other known technologies as described herein cannot be used in combination with or concurrently with a K-wire. 
     The various embodiments disclosed herein relate to a device of enhanced stability positioned over/against the intended arthrodesis site over time. In  FIGS.  2 A- 2 C , the device  10  is positioned across the joint  14  on digit  12 , thereby causing fusion of the two bones at the joint  14 . The embodiments disclosed herein, including the exemplary device  10 , relate to anatomically specific extra-medullary fixation and/or fusion devices that are affixed to the desired small joint arthrodesis and positioned over portions of each of the related phalanx segments and “crimped” or otherwise affixed thereto, thereby providing an entirely externally-based fixation method construct which provides satisfactory mechanical support to the intended arthrodesis site. In addition, the extra-medullar device embodiments disclosed herein allow for easier removal of such devices in comparison to the known intra-medullar designs. 
       FIGS.  3 A- 3 G and  4    depict one embodiment of an extramedullary fixation/fusion device  10 . The device  10  has a spine  20  coupled to a pair of distal arms  22 A,  22 B at the distal end and a pair of proximal arms  24 A,  24 B at the proximal end. In this implementation, the spine  20  also has a distal tine  26  and a proximal tine  28 . Similarly, the distal arms  22 A,  22 B each have a tine  30 A,  30 B, and the proximal arms  24 A,  24 B also each have a tine  32 A,  32 B. 
     In one embodiment, the device  10  is made of an appropriate semi-rigid, deformable material. In certain examples, the device  10  is made from any of a variety of metal alloys, including, for example, medical grade stainless steel, titanium, or other similar materials. 
     In the various embodiments disclosed and contemplated herein, including any embodiments described throughout this application, the device can have a thickness ranging from at least about 0.1 mm to about 2 mm. The length of the device (distance between the arm tines as best shown in  FIGS.  3 B and  3 C  as the distance between tine  32 A and tine  30 A) ranges from about 5 mm to about 10 cm. The width of the device between the arms (as best shown in  FIG.  3 D  as the distance between the distal ends of arms  22 A and  22 B) ranges from about 1 mm to about 20 mm. The width of the spine (best shown in  FIG.  3 C ) ranges from about 1 mm to about 10 mm, and the width of an arm (as shown for example in  FIG.  3 B ) ranges from about 1 mm to about 10 mm. 
     In this implementation, the spine  20  also has two mounting features  34 ,  36 . More specifically, the mounting features in this embodiment are two threaded openings  34 ,  36  configured to receive an application tool, as discussed in further detail below. 
     As best shown in  FIGS.  3 E,  3 F, and  3 G , in accordance with one embodiment, the device  10  can be cut from a sheet of metal (or other material) into a flat piece as shown in  FIG.  3 E  that is subsequently formed into the desired shape for the device  10 . In one embodiment, the specific configuration and footprint of the device  10 , including the length, width, geometry and thickness, is based upon the intended arthrodesis site morphology and anatomic restraints. That is, the specific size and dimensions of the device  10  can be determined by the size and dimensions of the target site. 
     In one specific embodiment, the device  10  can be formed from sheet metal. More specifically, it can be cut or stamped into the configuration of  FIG.  3 E  using any one of a variety of methods, including, for example, laser cutting, edm, die cutting, or any other known method. 
     Alternatively, it is understood that the flat piece could also be formed in any known way. 
     Any bends or desired deformations associated with the tines, arms, and/or spine can be introduced during the stamping process or post cutting using a variety of known forming methods such as, for example, stamping, fourslide bending, bending presses, etc. Alternatively, some or all of the bends or deformations can be introduced in the application process (during the fixation/implantation procedure) instead of in the manufacturing process. 
     In a further alternative, the arms and/or tine can be manufactured separately from the sheet metal or pins and attached by any known attachment method, such as welding. 
     Once the flat piece of  FIG.  3 E  is formed, the tines (such as tines  26 ,  30 A, and  30 B as shown in  FIG.  3 F ) are formed by bending the tines into their desired configuration as shown. According to one implementation, due to the amount of force required, the tines (such as tines  26 ,  30 A, and  30 B) are bent as desired during the manufacturing process (rather than being bent in the operating area immediately prior to or during a procedure). The arms (such as arms  22 A,  22 B as shown in  FIG.  3 G ) can then be bent into their desired configuration. This can be accomplished during the manufacturing process or anytime thereafter, including during the procedure as described in further detail below. Further, the spine  20  can also be bent into a curved configuration as best shown in  FIG.  3 B , and this can also occur at anytime (from the manufacturing process forward).  FIG.  4    depicts the device  10  implanted or fixed in place across a joint  14 . 
     In use in accordance with one embodiment, the device  10  (and any of the device embodiments disclosed or contemplated herein) can be placed onto, implanted, or fixed on the desired target site according to the following steps. As shown in  FIG.  5 A , the application tool  40  is coupled to the mounting features  34 ,  36  of the device  10 . More specifically, in this particular implementation, the tool  40  is made up of two application rods or bars  40 A,  40 B that are threadably coupled to the mounting features  34 ,  36  such that the rods  40 A,  40 B are coupled to the device  10 . Once the target site is surgically accessed and the digit(s) and respective joints have been prepared to facilitate joint fusion, the tool  40  can, in certain embodiments, be used to assist in positioning the device  10  as desired at the target site (such as a proximal phalangeal joint, for example). 
     An advancement tool  50  is then advanced over one of the rods  40 A as shown in  FIG.  5 B . The advancement tool  50  has two protrusions  52 A,  52 B corresponding to the tines on the device (such as, for example, the distal tines  30 A,  30 B of device  10 ). Alternatively, the tool  50  can have any appropriate number of protrusions to match the number of tines. The tool  50  is then advanced distally along the rod  40 A until the protrusions  52 A,  52 B are in contact with the tines  30 A,  30 B, as best shown in  FIG.  5 C . 
     The tool  50  is then urged distally along the rod  40 A such that the protrusions  52 A,  52 B urge the tines  30 A,  30 B into the cortical bone as shown in  FIG.  5 D . In accordance with one embodiment, the tines  30 A,  30 B are advanced into the bone until the arms  22 A,  22 B rest flush with the bone surface. Once the tines  30 A,  30 B are placed as desired, the tool  50  can be removed by moving it proximally along the rod  40 A as shown in  FIG.  5 E . The tool  50  can then be advanced over the other rod  40 B and used to urge the proximal tines (such as tine  32 A) into the cortical bone to the desired position, as shown in  FIG.  5 F . Once the tines are positioned in the bone as desired, the two rods  40 A,  40 B can be urged in opposition directions to bend or otherwise form a curve in the spine  20  as best shown in  FIG.  5 G . Alternatively, the curve can be formed into the spine  20  before the tines are urged into the bone or after the distal set of tines  30 A,  30 B are urged into the bone (and before the proximal tines have been so positioned). Both rods  40 A,  40 B can then be removed as best shown in  FIG.  5 H  such that only the implanted or fixed device  10  remains, as shown in  FIG.  5 I . 
       FIGS.  6 A- 6 D and  7    depict another embodiment of a device  60 . In this embodiment, each of the arms  22 A,  22 B,  24 A,  24 B has two tines—an end tine, and a mid-arm tine that extends from central portion of the arm. Thus, the distal arm  22 A has an end tine  30 A and a mid-arm tine  62 A, while the distal arm  22 B has an end tine  30 B and a mid-arm tine  62 B. Similarly, the proximal arm  24 A has an end tine  32 A and a mid-arm tine  64 A, while the proximal arm  24 B has an end tine  32 B and a mid-arm tine  64 B.  FIG.  7    depicts the device  60  implanted at a target site. These additional tines, according to certain implementations, can provide additional rotational stability of the bone with respect to the plate. 
       FIGS.  8 A- 8 D and  9    depict another embodiment of a device  70 . In this embodiment, each of the arms  22 A,  22 B,  24 A,  24 B has three tines—an end tine, and two mid-arm tines that extend from the sides of the arm. Thus, the distal arm  22 A has an end tine  30 A and two mid-arm tines  72 A,  72 B, while the distal arm  22 B has an end tine  30 B and two mid-arm tines  72 C,  72 D. Similarly, the proximal arm  24 A has an end tine  32 A and two mid-arm tines  74 A,  74 B, while the proximal arm  24 B has an end tine  32 B and two mid-arm tines  74 C,  74 D.  FIG.  9    depicts the device  70  implanted at a target site. These additional tines can, in some embodiments, provide additional rotational and torsional stability of the bone with respect to the plate. 
       FIGS.  10 A- 10 C  depict another embodiment of a device  80 . In this embodiment, each of the arms  22 A,  22 B,  24 A,  24 B has a mounting features (in this case, threaded openings)  82 A,  82 B,  84 A,  84 B at a distal end of each arm (instead of along the spine), with each of the mounting features  82 A,  82 B,  84 A,  84 B having two tines. Thus, the distal arm  22 A has a threaded opening  82 A having two tines  86 A,  86 B and the distal arm  22 B has a threaded opening  82 B having two tines  86 C,  86 D. Similarly, the proximal arm  24 A has a threaded opening  84 A having two tines  88 A,  88 B and the proximal arm  24 B has a threaded opening  84 B having two tines  88 C,  88 D. These additional mounting points can provide the surgeon greater control and leverage when working to push the tines into the bone and wrap the arms around the bone. 
       FIGS.  11 A- 11 C  depict another embodiment of a device  100 . In this embodiment, the spine  20  has multiple mounting features (threaded openings). In fact, according to certain implementations, the entire spine  20  is made up solely of mounting features that are coupled together. Further, in this implementation, each of the arms  22 A,  22 B,  24 A,  24 B is made up of mounting features, with the distal mounting features of each arm having two tines. Thus, the distal arm  22 A has two tines  86 A,  86 B and the distal arm  22 B has two tines  86 C,  86 D. Similarly, the proximal arm  24 A has two tines  88 A,  88 B and the proximal arm  24 B has two tines  88 C,  88 D. in accordance with certain implementations, these mounting features can provide the surgeon flexibility to adjust the device to specific anatomical bends and incorporate additional fixation devices such as screws or locking screws. 
       FIGS.  12 A and  12 B  depict a cross-section cutaway view of a device  110  coupled to an application tool  40 , according to one embodiment. In this embodiment, a separate tine advancement tool  112  schematically represented by the small projections  112 A,  112 B is used to advance the tines into the bone. In this embodiment, the tool  112  applies force away from the rod  40  in a direction that is perpendicular to the longitudinal axis of the rod, thereby urging the tines into the bone as best shown in  FIG.  12 B . 
       FIGS.  13 A and  13 B  depict a cross-section cutaway view of a device  120  coupled to an application tool  40 , according to one embodiment. In this embodiment, a separate tine advancement tool  122  schematically represented by the small projections  122 A,  122 B is used to advance the tines into the bone. In this embodiment, the tool  122  applies force toward the bone in a direction that is parallel to the longitudinal axis of the rod  40 , thereby urging the tines into the bone as best shown in  FIG.  13 B . 
       FIGS.  14 A- 14 C  depict a cross-section cutaway view of a device  130  that is advanced over a target bone  132  and then fixed in place. It is understood that this device  130  can be any of the device embodiments disclosed herein, including, for example, the device  10  described in detail above. In this embodiment, the device  130  is semi-rigid, meaning that it has enough flexibility to allow the arms  22 A,  22 B to flex outwardly as shown by the arrows in  FIG.  14 A , thereby allowing the device  130  to be advanced to its desired positioned on the bone  132  as shown in  FIG.  14 B . A crimping or fixation tool  134  is then positioned such that the arms of the tool  134 A,  134 B are positioned against the arms  22 A,  22 B of the device  130 . The tool  134  is then actuated to urge the tines  30 A,  30 B into the bone as shown in  FIG.  14 C . 
       FIGS.  15 A- 15 C  depict another embodiment of a device  140 . In this embodiment, the spine  20  has a mounting feature (in this case, threaded openings)  142 ,  144  at each end, with each of the mounting features  142 ,  144  having two tines. Thus, the distal end has a threaded opening  142  having two tines  146 A,  146 B and the proximal end has a threaded opening  144  having two tines  148 A,  148 B. Further, the two threaded openings  142 ,  144  are positioned at an angle in relation to the spine  20  as best shown in  FIGS.  15 A and  15 C . Thus, during fixation, the two application rods  40 A,  40 B can be coupled to the threaded openings  142 ,  144  and force applied as shown in  FIG.  15 C  to urge the tines into the bone. The resulting rotation of the threaded mounting features  144  and  142  can bring the proximal and distal bone portions towards one another as the tines are advanced. 
       FIG.  16    shows an application tool  40 , according to one embodiment. The tool  40  has a central rod  160  with two arms  162 A,  162 B at the distal end. The application tool  40  positions or implants the device  10  in two stages: first bending the arms to a certain point, and then applying a further bend that wraps the arms around the bone even further. This is accomplished using two different deployment components  164 ,  166 . The first deployment component  164  has a bar  168  coupled to two links  170 A,  170 B that are coupled at their distal ends to first pivotal paddles  172 A,  172 B. The first pivotal paddles  172 A,  172 B are pivotally coupled to the arms  162 A,  162 B of the application tool  40 , such that when the bar  168  of the first deployment component is urged downward, the distal ends of the first pivotal paddles  172 A,  172 B contact the arms of the device  10  and bend the arms (urge the arms toward the bone). 
     Once that is complete, the second deployment component  166  is deployed as follows. The second deployment component  166  has a bar  174  coupled to two links  176 A,  176 B that are coupled at their distal ends to second pivotal paddles  178 A,  178 B. The second pivotal paddles  178 A,  178 B are pivotally coupled to the first pivotal paddles  172 A,  172 B, such that when the bar  174  of the second deployment component  166  is urged downward, the distal ends of the second pivotal paddles  178 A,  178 B contact the arms of the device  10  and further bend the arms such that they are more fully wrapped around the bone. 
       FIGS.  17 A- 17 D  depict another embodiment of a device  190 . In this embodiment, the device  190  has two spines  20 A,  20 B with plates coupled to those spines  20 A,  20 B rather than arms. That is, the device  190  has a distal plate  192  and a proximal plate  194 . Each of the plates  192 ,  194  has multiple tines projecting from the plate as shown. Having a medial and lateral spine offset from the dorsal-most portion of the device lowers the profile of the implant, can provide more lateral support and can provide more clearance for the extensor tendon to sit. 
       FIG.  18    depicts another embodiment of a device  200 . In this embodiment, the device  200  has two split spines (spine  20 A,  20 B and spine  20 C,  20 D) with plates coupled to those spines rather than arms. That is, the device  200  has a distal plate  202  and a proximal plate  204 . Each of the plates  202 ,  204  has multiple tines projecting from the plate as shown. This is a depiction of how the surgeon may use an available tool to shorten the effective length of the device post placement by urging the split spines away from each other. Shortening the effective length of the spine brings the proximal and distal portions together, further engaging the tines and bringing the two fusion bones together. 
       FIGS.  19 A- 19 B  depict another embodiment of a device  210 . In this embodiment, the device  210 , instead of a spine or spines, has adjustable connection components  212 A,  212 B. In one implementation, the adjustable connection components  212 A,  212 B are zip-tie like components that have adjustable lengths. The components  212 A,  212 B couple together a distal plate  214  and a proximal plate  216 . Each of the plates  214 ,  216  has multiple tines projecting from the plate as shown. The components  212 A,  212 B can be shortened to apply force to the bones to which the device  210  is coupled, as shown in  FIG.  19 B . 
       FIGS.  20 A- 20 B  depict another embodiment of a device  220 . In this embodiment, the device  220 , instead of a spine or spines, has adjustable connection components  212 A,  212 B. In one implementation, the adjustable connection components  212 A,  212 B are adjustable screws. The components  212 A,  212 B couple together a distal plate  222  and a proximal plate  224 . Each of the plates  222 ,  224  has multiple tines projecting from the plate as shown. The components  212 A,  212 B can be shortened to apply force to the bones to which the device  220  is coupled, as shown in  FIG.  20 B . 
       FIGS.  21 A- 21 E  depict another embodiment of a device  250 . In this embodiment, the device  250  has two spines  252 A,  252 B with plates  254 ,  256  coupled to those spines  252 A,  252 B. That is, the device  250  has a distal plate  254  and a proximal plate  256 . Each of the plates  254 ,  256  has two arms extending from the plate as shown. More specifically, the distal plate  254  has arms  258 A,  258 B extending therefrom, while plate  256  has arms  260 A,  260 B. In this embodiment, each of the arms  258 A,  258 B,  260 A,  260 B has two tines—an end tine and a mid-arm tine that extends from the side of the arm. Thus, the distal arm  258 A has an end tine  262 A and a mid-arm tine  262 B, while the distal arm  258 B has an end tine  264 A and a mid-arm tine  264 B. Similarly, the proximal arm  260 A has an end tine  266 A (as best shown in  FIG.  21 A ) and a mid-arm tine  266 B (as best shown in  FIG.  21 B ), while the proximal arm  260 B has an end tine  268 A (as best shown in  FIG.  21 A ) and a mid-arm tine  268 B (as best shown in  FIG.  21 B ). 
     In this implementation, the device  250  also has four arm deformation features  280 A,  280 B,  280 C,  280 D. More specifically, the arm deformation features in this embodiment are four openings  280 A,  280 B,  280 C,  280 D configured to facilitate deformation of the arms  258 A,  258 B,  260 A,  260 B, as discussed in further detail below. That is, the presence of the openings  280 A,  280 B,  280 C,  280 D makes it easier to deform the arms  258 A,  258 B,  260 A,  260 B in comparison to an equivalent device without the openings. According to one embodiment, the openings  280 A,  280 B,  280 C,  280 D have cross-sectional areas designed to preferentially localize deformation within the device  250  in the area surrounding each opening  280 A,  280 B,  280 C,  280 D so that the device  250  more closely approximates the cross section of the target bone when the device  250  is crimped thereto. 
     According to one embodiment, the device  250  also has four tool interface features  282 A,  282 B,  282 C,  282 D. More specifically, the tool interface features in this implementation are four openings  282 A,  282 B,  282 C,  282 D configured to couple with a tool, such as a pair of pliers, for purposes of implanting or otherwise positioning the device  250 , as discussed in further detail below. 
     As best shown in  FIGS.  21 B and  21 C , both of the left  252 A and right  252 B spines have a curved inner edge  290 A,  290 B and a notched (or “serrated”) outer edge  292 A,  292 B. This specific configuration of the spines  252 A,  252 B is designed to facilitate deformation of the spines  252 A,  252 B, thereby facilitating the creation of an anatomical 3-D shape as the device  250  is implanted in the body of the patient. More specifically, the curved inner edge  290 A,  290 B and notched outer edge  292 A,  292 B allow for the spines  252 A,  252 B to be deformed or “bent” such that the plates  254 ,  256  are urged downward in relation to the middle of the spines  252 A,  252 B more easily than if the spines  252 A,  252 B did not have the curved inner edges  290 A,  290 B and the notched outer edges  292 A,  292 B. As one specific example,  FIGS.  21 D and  21 E  depict this feature of the device  250 . More specifically,  FIG.  21 D  depicts the device  250  in its un-deformed state, while  FIG.  21 E  depicts the device  250  in its deformed state as described above. 
     As best shown in  FIG.  21 B , each of the spines  252 A,  252 B also have spine corners  300 A,  300 B,  300 C,  300 D where each of the spines  252 A,  252 B are coupled to the plates  254 ,  256 . These spine corners  300 A,  300 B,  300 C,  300 D facilitate stability and are radiused to prevent fatigue fracture. 
     As also best depicted in  FIG.  21 B , each of the spines  252 A,  252 B also has a joint or fracture site indicator line  302 A,  302 B that can be used to align the device  250  with the target joint or fracture, as will be described in further detail below. 
       FIGS.  22  and  23    depict two alternative embodiments of devices  310 ,  320 . For example, the device  310  has arm deformation features  312 A,  312 B that are notches  312 A,  312 B defined in the arms  258 A,  258 B. Further, the device  320  has arm deformation features  322 A,  322 B,  322 C,  322 D that are notches  322 A,  322 B,  322 C,  322 D defined in the arms  258 A,  258 B. These arm deformation features as shown in these alternative embodiments can be similar in function to the arm deformation features  280 A,  280 B,  280 C,  280 D discussed above with respect to the device  250 . More specifically, these arm deformation features  312 A,  312 B and  322 A,  322 B,  322 C,  322 D reduce the cross-section of the arms, thereby facilitating deformation thereof. 
       FIGS.  24 A- 24 C  depict a further implementation of a device  340 . In this embodiment, the device  340  has two spines  342 A,  342 B, both of which are curvy (or “zig-zagged”) spines  342 A,  342 B that facilitate spine deformation. That is, much like the curved inner edges  290 A,  290 B and notched outer edges  292 A,  292 B described above, the curvy spines  342 A,  342 B allow for the spines  342 A,  342 B to be deformed or “bent” more easily than if the spines  342 A,  342 B did not have a curvy configuration. As one specific example,  FIGS.  24 B and  24 C  depict this feature of the device  340 . More specifically,  FIG.  24 B  depicts the device  340  in its un-deformed state, while  FIG.  24 C  depicts the device  340  in its deformed state as described above. 
       FIGS.  25  and  26    depict two additional alternative embodiments of devices  360 ,  380 . For example, the device  360  has four tool interface features  362 A,  362 B (other two features not visible as depicted) that are oval openings  362 A,  362 B configured to couple with a tool, such as a pair of pliers, for purposes of implanting or otherwise positioning the device  360 , as discussed in further detail below. Similarly, the device  380  has four tool interface features  382 A,  382 B (the other two features not visible as depicted) that are each made up of two openings  382 A,  382 B configured to couple with a tool, such as a pair of pliers. In both of these alternative embodiments, the features  362 A,  362 B,  382 A,  382 B are non-circular or multiple openings to prevent rotation when the tool is coupled thereto. 
       FIG.  27    depicts a further alternative embodiment of device  400 , which has eight arms  402 A,  402 B,  402 C,  402 D (with the other four arms not visible as depicted) instead of four. Such an implementation increases stability and robustness, which can be useful in applications that have higher loads (such as joint fixation of the big toe, for example) or for bone fracture fixation. 
       FIG.  28    depicts yet another alternative embodiment of a device  420  having two spine sections  422 ,  424 , with each of the sections having two spines  422 A,  422 B,  424 A,  424 B, along with six arms  426 A,  426 B,  426 C (with the other three arms not visible as depicted) instead of four. Such an implementation maintains stability over longer fixation distances, which can be useful in applications such as bone fracture fixation where more than two anchor points are desired. 
       FIGS.  29 A- 29 C  depict a placement or implantation tool  440 , which in this specific exemplary embodiment is a pair of pliers  440 . The pair of pliers  440  has a pair of jaws  442 A,  442 B, a jaw pivot  444 , and a pair of handles  446 A,  446 B. Further, as best shown in  FIG.  29 C , the pair  440  also has a ratchet mechanism  448  that includes a ratchet bar  450 , a ratchet spring  452 , a ratchet pivot  454 , a locking mechanism  456 , and a release mechanism  458 . The spring  452  is configured to be tensioned to urge the ratchet bar  450  toward the spring  452 , thereby urging the teeth  450 A on the bar toward the finger  459  (as best shown in  FIGS.  30 A and  30 B ) such that the finger  459  is positioned between two of the teeth  450 A and retained in that position such that the ratchet bar  450  is retained in that position. The release mechanism  458  in this specific embodiment is a release trigger  458  that can be depressed by a user to urge the bar  450  away from the finger  459  and thereby allow the bar  450  to be moveable in relation to the finger  459 , thereby allowing the handles  446 A,  446 B to move in relation to each other. 
     As best shown in  FIG.  29 B , each of the jaws  442 A,  442 B has a device coupling feature  460 A,  460 B on an interior surface at the distal end of the jaw  442 A,  442 B. Each of the features  460 A,  460 B is configured to interface with and couple with any of the device embodiments disclosed or contemplated here. More specifically, in certain implementations, the coupling features  460 A,  460 B are configured to couple with tool interface features on the device (such as, for example, the tool interface features  282 A,  282 B,  282 C,  282 D described above). In this specific exemplary implementation, the first coupling feature  460 A is a circular pin  460 A and the second coupling feature  460 B is a square peg  460 B. These features  460 A,  460 B and the corresponding tool interface features (such as features  282 A,  282 B,  282 C,  282 D described above) are configured to couple together to keep the device (such as device  250 , for example) locked in all degrees of freedom when it is coupled to the pair of pliers  440 . In an alternative embodiment, the two features  460 A,  460 B can be a single feature that is non-circular, a multiple pin feature, or any other known feature for achieving the same effect. 
       FIGS.  30 A and  30 B  depict one embodiment of the locking mechanism  456 . More specifically, in this embodiment, the locking mechanism  456  is a locking button  456  that can be depressed by a user to move the locking button  456  into and out of a locked position.  FIG.  30 A  depicts the locking button  456  in the unlocked position, while  FIG.  30 B  depicts the locking button  456  in the locked position in which the button  456  is positioned to urge the ratchet bar  450  toward the finger  459  such that the finger  459  is positioned between two teeth  450 A, thereby engaging the bar  450  such that the handles  446 A,  446 B are restrained from moving in relation to each other. The locking mechanism  456  can be depressed by the user to lock the handles  446 A,  446 B into a specific orientation. When the locking mechanism  456  is employed to urge the ratchet bar  450  toward the finger  459 , the entire device  440  is rigidly fixed and cannot be released by actuating the release mechanism  458 . If the lock  456  is unlocked (in the unlocked position) and the release mechanism  458  is engaged (not actuated to release the ratchet bar  450 ), then the handles  446 A,  446 B may be compressed (urged toward each other) but cannot be urged away from each other to cause the jaws  442 A,  442 B to separate from each other. If the lock  456  is unlocked and the release mechanism  458  is actuated, then the handles  446 A,  446 B may be compressed or released with respect to each other. 
     It is understood that any of the device embodiments disclosed or contemplated herein can be bent or otherwise deformed along the spine (or spines) into a curved configuration. Such exemplary curved configurations are shown in  FIG.  3 B  and  FIG.  31 F  (discussed below). This spine deformation can occur at anytime (from the manufacturing process forward). 
     In use in accordance with one embodiment, the device  250  (and any of the other device embodiments disclosed or contemplated herein) can be placed onto, implanted, or fixed on the desired target site according to the following steps. As shown in  FIG.  31 A , the first step in certain implementations is to remove the device  250  positioned on the holder block  480  from the device packaging and couple the pliers  440  to it. To do that, the user can urge the locking button  456  on the pliers  440  into the unlocked position as shown in  FIG.  30 A , thereby making it possible to move the handles  446 A,  446 B in relation to each other, thereby allowing the jaws  442 A,  442 B to be moved into a desired configuration to position them around the device  250 . Then the pair of pliers  440  can be positioned such that the device coupling features  460 A,  460 B are coupled with the appropriate tool interface features as shown in  FIG.  31 A . At this point, the user can lock the pliers jaws  442 A,  442 B using the locking button  456  as described above, thereby locking the jaws  442 A,  442 B in position coupled to the device  250 . As shown in  FIG.  31 B , the user can then use the pliers  440  to urge the device  250  away from the holder block  480 . 
     Next, as depicted in  FIG.  31 C , the device  250  can then be positioned over the appropriate portion of the target site using the pliers  440  such that the tines are positioned against or adjacent to the correct portion of the bone. Further, as shown in  FIG.  31 D , the device  250  has a joint or fracture site indicator line  500  that the user can align with the target joint or fracture using the pliers  440 , thereby ensuring that the device  250  is positioned correctly. The user can then urge the locking button  456  into the unlocked position and then crimp the device  250  at the first end using the pliers  440  until the tines of the device  250  are fully advanced into the bone. In one embodiment, the pre-crimped shape of the device  250  and the placement of the tool interface features on the device  250  facilitate the deformation of the device  250  such that it closely conforms to the anatomical cross-section of the target bone, thereby minimizing the gap between the device  250  and the bone after crimping and thus limiting potential tissue irritation. 
     Once the arms at one end of the device  250  have been fully crimped onto the bone, the pliers  440  are removed from the device  250  by sufficiently spreading the jaws  442 A,  442 B such that the features  460 A,  460 B disengage from the device  250 . Then, as shown in  FIG.  31 E , the user then couples the jaws  442 A,  442 B to the other end of the device  250  by operating the pliers  440  as described previously above, positions the device  250  over the second section of the target bone, ensuring close approximation to the joint or fracture, and crimps the device  250  at that end until the tines of the device  250  are fully advanced into the bone. 
     The user can then release the pliers  440  and remove them from the device  250 , resulting in a fully implanted device as shown in  FIG.  31 F . According to one embodiment as shown in which the device  250  is being used to correct hammertoe, the desired result is a 10 to 20 degree bend across the bone joint to replicate the anatomic positioning of the toe. If necessary, this bend can be accomplished by the user manually manipulating the device  250  as described elsewhere herein. 
     It is also understood that the device  250  (or any device as disclosed or contemplated herein) can also be removed as shown in  FIG.  32   . More specifically, any known removal tool  520  (such as a mini-hohmann elevator or similar tool) can be used, with the end of the tool  520  being inserted into any one of the four deformation openings  280 A,  280 B,  280 C,  280 D and utilize leverage to pry the device  250  from the bone as shown until all the tines are extracted from the bone and provide sufficient clearance to remove the device  250 . 
     An alternative embodiment of a holding block  540  is depicted in  FIGS.  33 A and  33 B . This block  540  is a split holding block  540  comprised of a distal block  542  and a proximal block  544 . In this embodiment, the split between the two blocks  542 ,  544  can represent the joint or fracture of the target bone such that the device  250  is positioned with the indication line  546  aligned with the split. In accordance with one implementation, the block  540  is curved to mate with the device  250  geometry. 
     In use, as shown in  FIG.  33 B , a user can use a pliers  440  to couple to the device  250  as described above such that one end of the device  250  can be removed from the block  540 . According to one embodiment, the advantage of the split holding block  540  is that the device  250  can be coupled to the first bone portion without having to remove the second portion of the split holding block  540  (in this case, the second portion being the distal portion  542  as shown), thereby providing a stable base (in the form of the distal block  542 ) for attaching the pliers  440  to the second end of the device  250 . 
     Some of the advantages of certain embodiments disclosed herein include the following. The tine length can be short enough that when fully engaged into the bone there is sufficient room within the central portion of the bone to accommodate a “K-wire.” Further, certain embodiments provide the benefits of an extra-medullar placement without the drawbacks of using mounting hardware such as screws. Some devices disclosed herein can be positioned and affixed so that they are stable using one of the application tools disclosed or contemplated herein. In addition, certain implementations herein are configured to be utilized as the sole means of fusion/fixation and can be utilized in conjunction with an additional provisional or planned adjunctive intramedullary “K-wire” per the clinical need and/or surgeon preference. 
     In some implementations, the specific position, dimension and relationship of the tines provide anatomic specific mechanical stability to the intended digital arthrodesis. Furthermore, the anatomic position of the intended arthrodesis site can modulate to a patient specific position, ensuring a physiologic “slightly flexed” digital arthrodesis. This design feature is an improvement over many intra-medullary digital fixation devices as these devices do not readily allow a physiologic “slightly flexed” digital arthrodesis position when additional “k-wire” fixation of the anatomy is also required. 
     As discussed above, the various embodiments herein may be used in conjunction with a “K-Wire” or other intramedullar device. The intramedullar device may be placed prior to the application of the device embodiment to aide in the alignment and approximation of the metatarsophalangeal joint. After the device embodiment has been engaged into the metatarsophalangeal joint, the intramedullar device may be removed immediately, removed after a prescribed healing period or left in permanently depending on the type used. 
     The various embodiments may also be used in conjunction with known fasteners. In certain embodiments, the device can incorporate specialized holes for the use of fasteners when addition support or fixation is required in specific areas. Additionally the device embodiments can be used in conjunction with a screw placed in the central axis of the bone. 
     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
     Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.