Tool for bone fixation device

A tool for inserting a bone fixation device is provided. The tool generally includes an elongate outer body and an elongate inner body, each having a proximal end, a distal end, and a longitudinal axis. The tool typically includes a pin-receiving portion at the distal end of the outer body for receiving a proximal pin of a bone fixation device. The tool may further include first and second levers pivotally mounted to the inner member at respective pivot axes, and each of the levers having a gripping portion. The levers preferably include finger engagement portions, wire-gripping portions, and are preferably configured to be axially movable relative to the outer body. The levers are generally configured such that a proximal force on the finger engagement portions relative to the outer body will cause the pin engagement portions to close and to move proximally such that a guidewire of a bone fixation device placed between the wire-gripping portions may be gripped and pulled proximally.

BACKGROUND

1. Field of the Invention

The invention relates in general to the field of bone fixation devices, and more specifically to an insertion tool for a bone fixation device.

2. Description of the Related Art

Bones which have been fractured, either by accident or severed by surgical procedure, must be kept together for lengthy periods of time in order to permit the rectification and bonding of the severed parts. Accordingly, adjoining parts of a severed or fractured bone are typically clamped together or attached to one another by means of a pin or a screw driven through the rejoined parts. Movement of the pertinent part of the body may then be kept at a minimum, such as by application of a cast, brace, splint, or other conventional technique, in order to promote healing and avoid mechanical stresses that may cause the bone parts to separate during bodily activity.

The surgical procedure of attaching two or more parts of a bone with a pin-like device requires an incision into the tissue surrounding the bone and the drilling of a hole through the bone parts to be joined. Due to the significant variation in bone size, configuration, and load requirements, a wide variety of bone fixation devices have been developed in the prior art. In general, the current standard of care relies upon a variety of metal wires, screws, and clamps to stabilize the bone fragments during the healing process. Following a sufficient bone healing period of time, the percutaneous access site or other site may require re-opening to permit removal of the bone fixation device.

Long bone fractures are among the most common encountered in the human skeleton. Many of these fractures and those of small bones and small bone fragments must be treated by internal and external fixation methods in order to achieve good anatomical position, early mobilization, and early and complete rehabilitation of the injured patient.

The internal fixation techniques commonly followed today frequently rely upon the use of Kirschner wires (K-wires), intramedullary pins, wiring, plates, screws, and combinations of the foregoing. The particular device or combination of devices is selected to achieve the best anatomic and functional condition of the traumatized bone with the simplest operative procedure and with a minimal use of foreign-implanted stabilizing material. A variety of alternate bone fixation devices are also known in the art, such as, for example, those disclosed in U.S. Pat. No. 4,688,561 to Reese, U.S. Pat. No. 4,790,304 to Rosenberg, and U.S. Pat. No. 5,370,646 to Reese, et al.

Notwithstanding the common use of the K-wire to achieve shear-force stabilization of bone fractures, K-wire fixation is attended by certain known risks. For example, a second surgical procedure is required to remove the device after healing is complete. Removal is recommended, because otherwise the bone adjacent to an implant becomes vulnerable to stress shielding as a result of the differences in the modulus of elasticity and density between metal and the bone.

In addition, an implanted K-wire may provide a site for a variety of complications ranging from pin-tract infections to abscesses, resistant osteomyelitis, septic arthritis, and infected nonunion.

Another potential complication involving the use of K-wires is in vivo migration. Axial migration of K-wires has been reported to range from 0 mm to 20 mm, which can both increase the difficulty of pin removal as well as inflict trauma to adjacent tissue.

As conventionally utilized for bone injuries of the hand and foot, K-wires project through the skin. In addition to the undesirable appearance, percutaneously extending K-wires can be disrupted or cause damage to adjacent structures such as tendons if the K-wire comes into contact with external objects.

Notwithstanding the variety of bone fasteners that have been developed in the prior art, there remains a need for a bone fastener of the type that can accomplish shear-force stabilization with minimal trauma to the surrounding tissue both during installation and following bone healing.

In addition, there remains a need for a simple, easy to use tool for inserting and anchoring a bone fixation device while causing minimal trauma to the surrounding tissue during installation.

SUMMARY

Thus, in one embodiment, a method of fixing a first piece of bone to a second piece of bone comprises providing a pin having at least one laterally moveable distal anchor and a lumen extending therethrough. The distal anchor is inserted through the first piece of bone and into the second piece of bone while the distal anchor is permitted to move laterally inwardly as needed. A deployment tool grips a proximal portion of a wire that extends axially through the lumen. The deployment tool moves the wire axially through the lumen such that a distal portion of the wire resists radial inward deflection of the distal anchor, thereby locking the distal anchor with respect to lateral inward movement.

In another embodiment, a tool for inserting a bone fixation device is provided. The tool includes an outer body and an inner body, each having a proximal end, a distal end, and a longitudinal axis. The tool also includes a pin-receiving portion at the distal end of the outer body for receiving a proximal pin of a bone fixation device. The tool further includes first and second levers pivotally mounted to the inner member at respective pivot axes, and each of the levers having a gripping portion.

In another embodiment, a tool is provided which comprises body having a proximal end and a distal end. The tool further includes at least one finger grip portion, a pin-gripping portion at the distal end of the body. The tool is configured such that proximal movement of the at least one finger grip portion causes a guidewire of a bone fixation device to be gripped and moved proximally with respect to a pin of the bone fixation device.

In another embodiment of a tool for deploying a bone fixation device, the tool comprises a longitudinal tubular outer body having a proximal end, a distal end, and at least one longitudinal slot in the outer body. The tool also includes a longitudinal inner body slidably and concentrically disposed within the outer body, and at least one lever pivotally mounted to a distal portion of the inner body. The lever preferably includes a finger engagement portion, a wire-gripping portion, and is preferably configured to be axially movable within the slot. The lever is preferably configured such that a proximal force on the finger engagement portion relative to the outer body will cause the pin engagement portion to close and to move proximally.

In yet another embodiment, a bone fixation system is disclosed which includes a bone fixation device and an insertion tool. The bone fixation device comprises: a first elongate tubular body, having a proximal end, a distal end and a longitudinal axis. A distal anchor is on the fixation device, movable from a low profile orientation for distal insertion through a bore in the bone to an inclined orientation to resist axial proximal movement through the bore. An elongate pin is axially movable within the tubular body and associated with the anchor, such that proximal retraction of the pin with respect to the tubular body advances the distal anchor from the axial orientation to the inclined orientation. The device also includes a second elongate tubular body, having a proximal end, a distal end, and a longitudinal axis. At least one retention structure lies in between the second elongate tubular body and the elongate pin. The retention structure permits proximal movement of the elongate pin with respect to the second elongate tubular body but resists distal movement of the pin with respect to the second elongate tubular body. The first tubular body may be used to deploy the distal anchor, and may then be removed and replaced by the second tubular body. The second tubular body cooperates with the pin to apply compression to the bone. The system also includes an insertion device comprising an elongate body having a proximal end, a distal end, and a central axis. The insertion device also includes a pair of levers configured to be pivotally and axially movable relative to the body. The levers preferably have finger engagement portions and pin engagement portions. The insertion device is preferably configured such that a force applied to the finger engagement portions causes the levers to be engaged on the pin of the fixation device, and causes the pin to be proximally retracted.

DETAILED DESCRIPTION

Although the application of the various embodiments will be disclosed in connection with the simplified bone fracture ofFIG. 1, the methods and structures disclosed herein are intended for application in any of a wide variety of bones and fractures, as will be apparent to those of skill in the art in view of the disclosure herein. For example, the bone fixation device can be applicable in a wide variety of fractures and osteotomies in the hand, such as interphalangeal and metacarpophalangeal arthrodesis, transverse phalangeal and metacarpal fracture fixation, spiral phalangeal and metacarpal fracture fixation, oblique phalangeal and metacarpal fracture fixation, intercondylar phalangeal and metacarpal fracture fixation, phalangeal and metacarpal osteotomy fixation as well as others known in the art. A wide variety of phalangeal and metatarsal osteotomies and fractures of the foot may also be stabilized using the bone fixation device of the present invention. These include, among others, distal metaphyseal osteotomies such as those described by Austin and Reverdin-Laird, base wedge osteotomies, oblique diaphyseal, digital arthrodesis as well as a wide variety of others that will be known to those of skill in the art. Fractures and osteotomies and arthrodesis of the tarsal bones such as the calcaneus and talus may also be treated. Spiked washers can be used, attached to the collar or freely movable beneath the collar. The bone fixation device may be used with or without plate(s) or washer(s), all of which can be either permanent, absorbable or comprising both.

Fractures of the fibular and tibial malleoli, pilon fractures and other fractures of the bones of the leg can be fixated and stabilized with or without the use of plates, both absorbable or non-absorbing types, and with alternate disclosed embodiments. One example is the fixation of the medial malleolar avulsion fragment fixation with the radially and axially expanding compression device. Each of the foregoing may be treated in accordance with the present invention, by advancing one of the fixation devices disclosed herein through a first bone component, across the fracture, and into the second bone component to fix the fracture.

To assist in the description of the disclosed embodiment, words such as upward, upper, downward, lower, vertical, horizontal, inward, outward, proximal, and distal are used to describe the accompanying figures. The term “axial” as used herein refers to the axis of a body or structure and therefore can be substantially synonymous with the term “longitudinal” as used herein. It will be appreciated, however, that the illustrated embodiments can be located or oriented in a variety of desired positions.

Referring toFIG. 1, there is illustrated generally a bone10, shown in cross-section to reveal an outer cortical bone component12and an inner cancellous bone component14. A fracture16is schematically illustrated as running through the bone to at least partially divide the bone10into what will for the present purposes be considered a proximal component19and a distal component21. The fracture is simplified for the purpose of illustrating the application of the disclosed embodiments. However, as will be understood by those skilled in the art, the fracture16may extend through the bone at any of a wide variety of angles, depths, and sizes.

Referring toFIGS. 2-9, there is illustrated an embodiment of a fixation device having presently desirable features and advantages. This embodiment is optimized for construction from a metal, such as titanium or titanium alloy, although other materials including those disclosed elsewhere herein may be utilized for the present embodiment. Referring toFIGS. 2 and 4, the fixation device includes a body32which is in the form of a pin26extending between a proximal end28and a distal end30. The distal end30includes a plurality of friction enhancing or interference fit structures such as ramped extensions or barbs50, for engaging the distal cortical bone or other surface or interior cancellous bone.

Although the illustrated embodiment includes four barbs50, oriented at 90° with respect to each other, anywhere from one to about twelve or more barbs50may be utilized as will be apparent to those of skill in the art in view of the disclosure herein. The barbs50may be radially symmetrically distributed about the longitudinal axis of the pin26. Each barb50is provided with a transverse engagement surface21, for contacting the distal surface of the cortical bone or other structure or surface against which the barb50is to anchor. Transverse engagement surfaces21may lie on a plane which is transverse to the longitudinal axis of the pin26, or may be inclined with respect to the longitudinal axis of the pin26.

Each of the transverse engagement surfaces21in the illustrated embodiment lies on a common plane which is transverse to the longitudinal axis of the pin26. Two or more planes containing engagement surfaces21may alternatively be provided. The transverse engagement surfaces21may also lie on one or more planes which are non-normal to the longitudinal axis of pin26. For example, the plane of a plurality of transverse engagement surfaces21may be inclined at an angle within the range of from about 35° or 45° to about 90° with respect to the longitudinal axis of the pin26. The plane of the transverse engagement surface may thus be selected to take into account the angle of the distal surface of the bone through which the pin may be positioned, as may be desired in certain clinical applications.

In order to facilitate the radially inward compression of the barbs50during the implantation process, followed by radially outward movement of the barbs50to engage the distal bone surface, each barb50in the illustrated embodiment is carried by a flexible or hinged lever arm23. Lever arms23may be formed by creating a plurality of axial slots15in the sidewall of the pin26. The axial slots15cooperate with a central lumen11to isolate each barb50on a corresponding lever arm23. The axial length of the axial slots15may be varied depending upon various desired physical characteristics, such as the desired length over which flexing is distributed, the range of lateral motion, and upon the desired construction material. For a relatively rigid material such as titanium, axial lengths of the axial slot15in excess of about 0.1 inches and preferably in excess of about 0.2 inches are utilized on a pin26having an outside diameter of about 0.1 inches and a length of about 1.25 inches. Axial slots15will generally extend within a range of from about 5% to about 90%, and often within about 10% to about 30% of the overall length of the pin26.

With continued reference toFIGS. 2,4,5and9, the circumferential width of the slots15at the distal end30is selected to cooperate with the dimensions of the barbs50to permit radial inward deflection of each of the barbs50so that the pin26may be press fit through a predrilled hole having an inside diameter approximately equal to the outside diameter of the pin26just proximal to the transverse engagement surfaces21. For this purpose, at least a portion of each of the slots15tapers in circumferential direction width from a relatively larger dimension at the distal end30to a relatively smaller dimension at the proximal limit of the axial slot15, as shown inFIG. 2. In the illustrated embodiment, each slot15has a width of about 0.20 inches at the proximal end and a width of about 0.035 inches at the distal end in the unstressed orientation. The width of the slot15may taper continuously along its length, or, as in the illustrated embodiment, is substantially constant for a proximal section and tapered over a distal section of the slot15. The wall thickness of the lever arm23may also be tapered to increase the diameter of the central lumen11in the distal direction. This will allow a reduced compressed crossing profile before the inside surfaces of the lever arms bottom out against each other.

The pin26is additionally provided with a plurality of retention structures44for engaging with a proximal anchor36. Relative rotational movement between the pin26and the proximal anchor36can result in relative axial movement between the pin26and the proximal anchor36

The retention structures44are configured to engage with the proximal anchor36. In one embodiment, the retention structures44are spaced apart axially along the pin26between a proximal limit46and a distal limit48. The axial distance between proximal limit46and distal limit48is related to the desired axial travel of the proximal anchor36, and thus the range of functional sizes of the pin. In one embodiment of the pin26, the retention structures44comprise a plurality of threads, adapted to cooperate with the complimentary retention structures42on the proximal anchor36, which may be a complimentary plurality of threads. In this embodiment, the proximal anchor36may be distally advanced along the pin26by rotation of the proximal anchor36with respect to the pin26. Proximal anchor36may advantageously be removed from the pin26by reverse rotation to permit removal of the pin26from the patient. For this purpose, collar38is preferably provided with a gripping configuration or structure to permit a removal tool to rotate collar38with respect to the pin26. Any of a variety of gripping surfaces may be provided, such as one or more slots, flats, bores, or the like. In the illustrated embodiment, the collar38is provided with a polygonal, and in particular, a hexagonal circumference, as seen inFIG. 7.

The proximal end28of the pin26is similarly provided with a structure29for permitting rotational engagement with an installation or a removal tool. Rotational engagement may be accomplished using any of a variety of shapes or configurations, as will be apparent to those of skill in the art. One convenient structure is to provide the proximal end28with one or more flat side walls, for rotationally engaging a complimentary structure on the corresponding tool. As illustrated inFIG. 3, the proximal end28may be provided with the structure29having a square cross-section. Alternatively, the exterior cross-section through proximal end28may be any of a variety of configurations to permit rotational coupling, such as triangular, hexagonal, or other polygons, or one or more axially extending flat sides or channels on an otherwise round body.

The foregoing structures enable the use of an installation and/or deployment tool having a concentric core within a sleeve configuration in which a first component (e.g. a sleeve) engages the proximal anchor36(seeFIGS. 6 and 7) and a second component (e.g. a core) engages the proximal rotational engagement structure29of pin26. The first component may be rotated with respect to the second component, so that the proximal anchor36may be rotated onto or off of the retention structures44on pin26. In a modified arrangement, a first tool (e.g., a pair of pliers or a wrench) may be used to engage the proximal anchor36and a second tool (e.g., a pair of pliers or a wrench) may be used to engage the proximal rotational engagement structure29of pin26. In such an arrangement, the first tool may be rotated with respect to the second tool (or vice versa), so that the proximal anchor36may be rotated onto or off the retention structures44on the pin26.

Alternatively, the retention structures42on the proximal anchor36may be toleranced to permit distal axial advancement onto the pin26, such as by elastic deformation, but require rotation with respect to the pin26in order to remove the proximal anchor36from the pin26.

Any of a variety of alternative retention structures may be configured, to permit removal of the proximal anchor36preferably after implantation and a bone healing period of time. For example, the retention structures44can be threads with a plurality of axially extending flats or interruptions. These threads can correspond with a plurality of axial flats on the retention structures42of the proximal anchor36. This configuration enables a partial rotation (e.g., 90°) of the proximal anchor36with respect to the pin26to disengage the retention structures42,44and permit axial withdrawal of the proximal anchor36from the pin26. One or both of the retention structures42and44may comprise a helical thread or one or more circumferentially extending ridges or grooves. In one embodiment, the retention structures42,44can have a pitch to achieve the desired axial movement based on relative rotational movement between the pin26and the proximal anchor36. The threads of the retention structures42,44can have a fine pitch to a course pitch. For example, a fine pitch may be selected where a number of rotations of proximal anchor36is desired to produce a relatively small axial travel of the anchor36with respect to the pin26. In this configuration, relatively high compressive force can be achieved between the proximal anchor36and the distal anchor34. This configuration will also provide a relatively high resistance to inadvertent reverse rotation of the proximal anchor36. In another embodiment, the threads of the retention structures42,44have a relatively course pitch, such as might be found on a luer connector. These threads can provide quick twist connection for rapid relative axial movement of between the pin26and the proximal anchor36. A relatively low number of rotations or partial rotation of the proximal anchor36provides a significant axial travel with respect to the pin26. This configuration may enhance the tactile feedback with respect to the degree of compression placed upon the bone. The thread pitch or other characteristics of the corresponding retention structures can be optimized through routine experimentation by those of skill in art in view of the disclosure herein, taking into account the desired clinical performance.

With reference toFIG. 4, the pin26can have a break point to facilitate breaking and removal of a proximal portion of the pin26. The break point can be located proximal the proximal anchor36when the proximal anchor36is threadably coupled to the pin26.

In one embodiment, at least a first break point31can be a portion of the pin26with a reduced wall thickness. That is, the break point31of the pin26can have a cross-sectional area less than the cross-sectional area of other portions of the pin26. The proximal portion of the pin26which projects proximally of the collar38following tensioning of the fixation system. Break point31in the illustrated embodiment comprises an annular recess or groove, which provides a designed failure point if lateral force is applied to the proximal end28while the remainder of the attachment system is relatively securely fixed. At least a second break point33may also be provided, depending upon the axial range of travel of the proximal anchor36with respect to the pin26.

In one embodiment having two or more break points31,33, the distal break point31is provided with one or more perforations or a deeper recess than the proximal break point33. In this manner, the distal break point31will preferentially fail before the proximal break point33in response to lateral pressure on the proximal end28. This will ensure the minimum projection of the pin26beyond the collar38following deployment and severing of the proximal end28as will be appreciated in view of the disclosure herein.

Proximal projection of the proximal end28from the proximal anchor36following implantation and breaking at a breakpoint31may additionally be minimized or eliminated by allowing the breakpoint31or33to break off within the proximal anchor36. Referring toFIG. 6, the retention structure42may terminate at a point61distal to a proximal surface63on the anchor36. An inclined or tapered annular surface65increases the inside diameter of the central aperture through proximal anchor36, in the proximal direction. After the proximal anchor36has been distally advanced over a pin26, such that a breakpoint31is positioned between the proximal limit61and the proximal surface63, lateral pressure on the proximal end28of pin26will allow the breakpoint31to break within the area of the inclined surface65. In this manner, the proximal end of the pin26following breaking resides at or distally of the proximal surface63, thus minimizing the profile of the device and potential tissue irritation.

For any of the axially deployable embodiments disclosed above, installation can be simplified through the use of an installation tool. The installation tool may comprise a pistol grip, a syringe-type grip, or plier-type grip so that the clinician can position the tool at the proximal extension of pin32and through one or more contractions with the hand, the proximal anchor36,52and distal anchor34can be drawn together to appropriately tension against the bone fragments. The use of a precalibrated tool can permit the application of a predetermined tension in a uniform manner from pin to pin.

Calibration of the installation device to set a predetermined load on the pin can be accomplished through any of a variety of means which will be understood to those of skill in the art. For example, the pin32may be provided with one or more score lines or transverse bores or other modifications which limit the tensile strength of the part at one or more predetermined locations. In this manner, axial tension applied to the proximal end28with respect to the collar54will apply a predetermined load to the bone before the pin32will separate at the score line. Alternatively, internal structures within the installation tool can be provided to apply tension up to a predetermined limit and then release tension from the distal end of the tool.

FIG. 8illustrates a locking guide wire150that may be used with the fixation device25described above. The guide wire has a distal end152and a proximal end154. The illustrated guide wire150comprises a locking portion156that is located at the distal end152of the guide wire150and an elongated portion158that preferably extends from the distal portion156to the proximal end154of the guide wire150. The diameter D1of the elongated portion158is generally smaller than the diameter D2of the distal portion154. The guide wire150can be made from stainless steel, titanium, or any other suitable material. Preferably, in all metal systems, the guide wire150and locking portion156are made from the same material as the remainder of the fixation device25to prevent cathodic reactions.

The locking portion156on guide wire150can take any of a variety of forms, and accomplish the intended function as will be apparent to those of skill in the art in view of the disclosure herein. For example, a generally cylindrical locking structure, as illustrated, may be used. Alternatively, any of a variety of other configurations in which the cross section is greater than the cross section of the proximal portion158may be used. Conical, spherical, or other shapes may be utilized, depending upon the degree of compression desired and the manner in which the locking portion156is designed to interfit with the distal end30of the pin.

The guide wire150is configured such that its proximal end can be inserted through the lumen11of the pin26. With reference toFIG. 4, the lumen11preferably comprises a first portion160and a second portion162. The first portion160is generally located at the distal end30within the region of the lever arms of the pin26. The second portion162preferably extends from the first portion160to the proximal end28of the pin26. The inside diameter of the first portion160is generally larger than the diameter of the second portion162. As such, the junction between the first portion160and the second portion162forms a transverse annular engagement surface164, which lies transverse to the longitudinal axis of the pin26.

As mentioned above, the guide wire150is configured such that its proximal end can be inserted through the lumen11of the pin26. As such, the diameter D1of the elongated portion158is less than the diameter of the second portion162of the lumen11. In contrast, the diameter D2of distal portion156is generally equal to or larger than the diameter of the first portion160and larger than the diameter of the second portion162. This arrangement allows the distal portion156to be retracted proximally into the first portion160but prevents the distal portion156from passing proximally through the pin26. In embodiments in which the distal portion156is larger than the diameter of the first portion160, the first portion may expand the distal anchor34beyond its relaxed diameter.

In addition, any of a variety of friction enhancing surfaces or surface structures may be provided, to resist distal migration of the locking guide wire150, post deployment. For example, any of a variety of radially inwardly or radially outwardly directed surface structures may be provided along the length of the locking guide wire150, to cooperate with a corresponding surface structure on the inside surface of the lumen11, to removal retain the locking guide wire150therein. In one embodiment, a cylindrical groove or ridge is provided on the inside surface of the lumen11to cooperate with a radially outwardly extending annular flange or groove on the outside diameter of the locking guide wire150. The complementary surface structures may be toleranced such that the locking guidewire or guide pin may be proximally retracted into the lumen11to engage the locking structure, but the locking structure provides a sufficient resistance to distal migration of the locking guide wire150such that it is unlikely or impossible to become disengaged under normal use.

Embodiments of an insertion tool200for inserting and deploying a bone fixation device are illustrated inFIGS. 10-20. As will be described below, the illustrated insertion tool200is particularly configured for deploying bone fixation devices that utilize a pin26and a locking guide wire150such as the bone fixation devices described above and those described in U.S. Pat. No. 6,632,224 filed Mar. 22, 2001, which is incorporated by reference herein in its entirety. Accordingly, the insertion tool will be described with reference to the locking device described above. However, it should be appreciated, certain features of the insertion tool200may also find utility in bone fixation devices that do not utilize a pin and/or a locking guide wire150.

With reference toFIG. 10, the insertion tool200of the illustrated embodiment generally comprises an elongate tubular outer body210, a pair of levers230, and central member250slidably positioned within the tubular outer body210and coupled to the levers230. As will be explained below, the levers230are configured to engage the locking guidewire150. The tool200also comprises a distal portion220that is coupled to the outer body210and is configured to engage the pin26of the bone fixation device. The insertion tool200is configured to grip and move the locking guidewire150in a proximal direction with respect to the pin26. In this manner, the distal portion156of the locking guidewire150may be retracted proximally into the first portion160(seeFIG. 9) of the lumen11to resist compression of the lever arms of the pin26.

With reference toFIGS. 10 and 11, the outer body210is a generally tubular body that has a proximal end212and a distal end214. In the illustrated embodiment, the outer body210has a pair of diametrically spaced elongated openings or slots216that are configured so that a portion of the levers230extend from the outer body210. The slots216may be generally parallel and extend from an opening or window218, which is between the distal end214and an upper body253of the outer body210. In the illustrated embodiment, the levers230may slide along the slots216in the axial direction and at least a portion of the levers230maybe moved away from and/or toward the longitudinal axis of the tool200. Although not illustrated, the slots216and the elongated body210may have various shapes and configurations depending on the desired application and deployment environment. In the illustrated embodiment, the outer body210is formed from a tubular body having portions removed to form the window218and the slots216. In other embodiments, the outer body210may have other cross-sectional shapes (e.g., rectangular, elliptical, etc.)

With reference toFIG. 11, which is a cross-sectional view of the device200, the outer body210has an inner surface211that defines a chamber in which the central body250, a biasing member260(e.g., a spring), a ratchet assembly243, and a portion of the levers230are positioned.

The levers230preferably comprise finger engagement portions232, elongated portions or arms233, and wire gripping portions234. The levers230are configured so that a person can comfortably grip and apply a force on the levers230. In the illustrated embodiment, the levers230of the have generally ‘L’ or ‘J’ shape. However, the levers230can have any shape or configuration so that a portion of the levers230can engage with the bone fixture device (e.g., the locking guidewire150) when the levers230are actuated.

The finger engagement portions232are at the proximal ends of the levers230and are generally curved, elongated members extending from the arms233and out of the outer body210(seeFIG. 10). The width of the finger engagement portions232can be reduced toward the ends235. The finger engagement portions232can be configured to be comfortably engaged by as many fingers of the user as desired. In one embodiment, for example, the finger engagement portions232are configured so that a person can use one finger to apply a force to the upper finger engagement portion232on one side of the tool200and another finger to apply a force to the lower finger engagement portion232on the other side of the tool200with the body210extending between the upper and lower fingers. It should be appreciated that the finger engagement portions232can be configured to engage more than one finger of the user.

A further advantage is provided where the ends235of the finger engagement portions232are curved in the distal direction to prevent a person's finger or fingers from sliding off of the levers230. Thus, when the person pulls on the levers230, the finger engagement portions232can inhibit outward movement (i.e., away from the longitudinal axis of the tool200) of the user's fingers. However, those skilled in the art recognize that the finger engagement portions232can have other shapes and sizes depending on, for example, the force applied to the levers230, the size of the user's fingers and hand, the application of the tool200, and the like.

With continued reference toFIG. 11, the arms233of the levers230extend from the finger engagement portions232to the wire gripping portion234near the distal end of the levers230. A substantial portion of the arms233may have a generally rectangular cross-sectional profile. The wire gripping portions234are pivotable with respect to the central body250. Accordingly, in the illustrated embodiment, the wire gripping portions234include holes237for receiving pivot pins236. The wire gripping portions234can be in the form of tangs or prongs. However, the wire gripping portions234can be any shape that can engage and hold a portion of the locking wire150when the levers230are moved to a certain position. As shown inFIG. 16, the wire gripping portions234are configured such that the distance between the proximal portions234aof the wire gripping portions234is less than the distance between distal portions234bof wire gripping portions234. Thus, a proximal force239(the arrow shown inFIG. 11) causes the proximal portions235ato pinch the guidewire to inhibit movement of the guidewire. In another embodiment, the distance between the proximal portions234aand distal portions234bare generally equal when then levers230grip the guidewire. The wire engagement portions234may also include features for enhancing the gripping force. For example, in one embodiment, the wire engagement portions234have grooves that engage the guidewire of the fixation device to ensure that the guidwire is securely held by the wire engagement portions234. However, the wire engagement portions234can have other surface treatments to achieve the desire interaction between the wire engagement portions234and portions of the fixation device. For example, the wire engagement portions234can have protuberances, spikes, or textured surface to provide adequate frictional forces between the wire engagement portions234and the bone fixture device.

With continued reference toFIG. 11, the holes237are located at the distal ends of the levers230. In one embodiment, the centers of the holes237are preferably located distally from at least a portion of the wire gripping portions234. This arrangement provides mechanical advantage so that the levers230securely grip the guide wire150when the user applies sufficient force. Thus, the location of the center of the holes237with respect to the finger grips235can be varied to achieve the desire leverage.

As mentioned above, the levers230are mounted to the central body250for rotating about the pivot axes defined by the pins236along the direction of arrow P to engage the locking wire150. In the illustrated embodiment, the outer body210can be held stationary by, for example, applying a distal force241to the outer body while the proximal force indicated by the arrows239can be applied to the lever230so that the lever pivots about the pivot pin236in the direction of the arrow P, thereby causing the proximal end of the lever230to move towards the central axis of the tool200. Thus, the upper lever230can be rotated clockwise about its respective pin236and the lower lever230can be rotated counter-clockwise about its respective pin236. The wire engagement portions234of the levers230are configured such that as the levers230pivot, the wire engagement portions234move towards one another, thus allowing a wire or pin positioned therebetween to be gripped.

A further advantage of the illustrated embodiment is that the effective length of the lever arms233of the levers230is chosen to provide a mechanical advantage, thereby allowing a relatively small generally proximal force on the finger engagement portions232to tightly grip the locking wire150(as shown inFIG. 14) placed between the wire gripping portions234. Those skilled in the art will understand how to optimize the various dimensions of the levers for the particular needs of a user. Alternatively, however, the tool may be configured to grip a bone fixation device guidewire in response to an axial, angled, rotational and/or otherwise-directed force. Such embodiments may incorporate additional levers, cables, pulleys, or other structures as will be clear to those skilled in the art in view of the present disclosure

To disengage the locking wire, the levers230may be moved in a distal direction (i.e., opposite the direction of the arrows239inFIG. 11) so that the wire-gripping portions234disengage the guidewire150. As shown inFIG. 11, in the illustrated embodiment, the levers230may be outwardly biased by a biasing member231(e.g., a helical spring) located towards their proximal ends. In this arrangement, the biasing member231may extend through an opening or hole277formed in the central body150.

While the preferred embodiment utilizes a pair of lever arms with wire-gripping portions234to grip the wire140, it should be appreciated that in other non-illustrated embodiments other arrangements and devices may be used to grip the wire.

With continued reference toFIG. 11, in the illustrated embodiment, the tool200comprises a stop258at its proximal end. The stop258is coupled to the proximal end212of the outer body210such that a distal portion of the stop258is disposed within the outer body210while a distal portion of the stop258extends from the outer body210. The distal portion of the stop258can engage the proximal biasing member260, which can be in the form of a helical spring.

The proximal biasing member260is preferably positioned between the stop258and a proximal end249of the central body250to bias the central body250in the distal direction. The proximal end249has a seat or engagement surface256and a cylindrical body263. In the illustrated embodiment, the proximal end of the proximal biasing member260engages the distal end of the stop258and the distal end of the proximal biasing member260engages the engagement surface256of the proximal end249. A distal portion of the spring260surrounds the cylindrical body263of the proximal end249. The cylindrical body263advantageously maintains the biasing member260in proper position during operation of the tool200. Preferably the distal portion of the biasing member260is between the inner surface211of the outer body210and the cylindrical body263.

With reference toFIGS. 11,11A,14and15, the central body250preferably comprises the biasing end249(discussed above), a ratchet portion252, a wall251, a upper body253, and a lower body255. The biasing end249is at the proximal end of the central body250and the upper and lower bodies253,255are at the other end. The ratchet portion252is between the spring end249and the bodies253,255. The wall251is between portions of the upper and lower bodies253,255. The central body250is preferably slidably disposed within the outer body210and more preferably, the central body250is concentric with and axially movable within the outer body210.

As will be explained, the ratchet portion252may allow proximal movement of the central body250with respect to the outer body210while resisting distal movement of the central body with respect to the outer body210. In the illustrated embodiment, the ratchet portion252has a plurality of legs257(see e.g.,FIGS. 11 and 12) that are coupled to or integrally formed with the biasing end249and are configured to allow a portion of the central body250to move past a release button240. In one embodiment, one of the upper and lower legs257is on one side of the release button240and the other upper and lower legs257are on the other side of the release button240. The plurality of legs257form a pair of slots259. In the illustrated embodiment ofFIG. 11A, for example, the pair of upper legs257for form the upper slot259aand the pair of lower legs257form the lower slot259b.The slots259a,259bare sized so that the release button240is positioned within the slots259a,259bsuch that ratchet portion252can move relative to the release button240.

With reference toFIGS. 11 and 12, the ratchet portion252may comprise any of a variety or retention structures261to limit movement of the central body250relative the outer body210. In the illustrated embodiment, the ratchet portion252comprises structures261in the form of a plurality of ridges or teeth configured to engage a corresponding ratchet plate254, which is axially immobile relative to the outer body210. In one embodiment, the lower legs257of the ratchet portion252have an upper surface forming teeth261. Preferably, the ratchet plate254has corresponding structures, such as teeth, to engage with the teeth261of the lower legs257. However, the structures261can be grooves, threads or other suitable structures for cooperating with the ratchet plate254to control the movement of the central body250.

The ratchet plate254is configured such that it is biased towards the lower legs257of the ratchet portion252. In this manner, the ratchet plate254can be configured to allow unidirectional movement of the central body250. In the illustrated embodiment, allows the central body250to be axially movable in the proximal direction and restrained in a distal direction relative to the outer body210.

The ratchet plate254may be biased using a variety of devices and methods recognized by those skilled in the art. For example, in the illustrated embodiment, a biasing pin262(see e.g.,FIG. 12) biases the ratchet plate254towards the lower leg257and can be sized and disposed-such that it will engage opposite walls of the outer body210, and thus resist rotation about its transverse axis. The biasing pin262is disposed in a hole in the ratchet plate254(seeFIG. 11) such that the ratchet plate254will also resist rotation about the transverse axis of the biasing pin262. Thus, the biasing pin262can ensure that the lower surface of the ratchet plate254engages the upper surface of the lower legs257. In other embodiments, other suitable devices and structures that can be used to bias the ratchet plate254. For example, a spring can be used in combination with the biasing pin262to ensure that the ratchet plate254provides the desired travel of the central body250.

The release button240(seeFIGS. 11 and 12) is preferably provided to allow the ratchet plate254to release the central body250. After the central body250is released, the central body250may be returned to its original distal position by the bias of the biasing member260. In the illustrated embodiment, the release button240is a generally cylindrical member that extends from opposite walls of the outer body210and is coupled to the ratchet plate254. Preferably, the outer body210has a pair of diametrically spaced holes or openings for receiving the release button240. The release button240is therefore axially immobile relative the outer body210therefore resulting in the ratchet plate254also being axially immobile relative the outer body210.

In the illustrated embodiment ofFIG. 12, the release button240is in a first position so that the ratchet plate254engages with the legs257and inhibits movement of the central body250in the distal direction. When the release button240is in the first position, the lower portion of the release button240extends from the outer body210. The release button240can be moved vertically to a second position (not shown) so that the upper portion of the release button240extends from the outer body210. The user can move the release button240to the second position by applying a force in the vertical direction to the release button240. When the release button240is in the second position, the ratchet plate254, which is coupled to the release button240, is spaced from the lower legs257such that the teeth of the ratchet plate254disengages the teeth261of the lower legs257. The central body250can slide in either the distal or proximal direction when the release button240is in the second position. Although not illustrated, those of skill in the art will recognized other suitable arrangements and positions for the release button240.

The biasing pin262and release button240may be coupled to the ratchet plate254by a press fit, welds, adhesives, threads, or other mechanical fastener, or any other method recognized by those skilled in the art. In the illustrated arrangement, the release button240and biasing pin262are preferably sized to be press fitted tightly within the respective holes in the ratchet plate254. Alternatively, the release button240and/or biasing pin262may comprise annular ridges or grooves configured to interact with corresponding structures on the ratchet plate254such that the release button240and the biasing pin262are substantially fixed relative to the ratchet plate254.

As mentioned above, the ratchet portion252may allow proximal movement of the central body250with respect to the outer body210while resisting distal movement of the central body with respect to the outer body210. The release button240, in turn, disengages the ratchet portion252such that distal movement of the central body250is permitted. While the above described structure represents a preferred embodiment, it should be appreciated that other devices and structures may be provided for selectively allowing proximal movement of the central body250with respect to the outer body210while resisting distal movement of the central body with respect to the outer body210.

With reference now toFIG. 11A, the wall251, upper body253and lower body255of the central body250can be coupled or integrally formed with the distal end of the ratchet portion252. The wall251and bodies253,255cooperate to define a window275and slots or channels271that can receive at least a portion of the levers230.

In the illustrated embodiment, the wall251is connected the upper body253and the lower body255and defines the bottom of the channels271. The wall251extends from a location near the ratchet portion252to the proximal side of the window275. The proximal portion of the wall251has the opening or hole277for receiving at least a portion of the biasing member231as discussed above. In the illustrated embodiment, the opening277is generally circular and is sized to surround the central portion of the biasing member231, as shown inFIG. 11. Those skilled in the art recognize that opening277can be at various positions depending on the configuration of the levers230.

With reference toFIG. 11, in the illustrated embodiment, the wall251has a generally uniform width and is disposed between a portion of the pair of levers230. However, the wall251can have other suitable shapes depending on, for example, the size of the opening277and the desired movement of the levers230. As shown inFIG. 16, for example, the wall251can comprise at least a partial axial opening or hole281for receiving the guide wire150. The proximal end of the guide wire150can be inserted and advanced along the hole281.

With reference back toFIG. 11A, in the illustrated embodiment, the upper body253is connected to the upper portion of the wall251and defines the upper side of the channel271. The upper body253has a generally semi-circular cross-section along its length. The upper surface of the upper body253is curved to mate with the inner surface211of the outer body210(see e.g.,FIG. 12). The upper surface of the central body250can slidably engage the inner surface211of the outer body210so that the central body250can easily slide within the outer body210. The lower body255is connected to the lower portion of the wall251and defines the lower side of the channel271. The lower body255also has a generally semi-circular cross-section along its length. The lower surface of the upper body255is curved to mate with the inner surface211of the outer body210. The lower surface of the lower body255can slidably engage the inner surface211of the outer body210so that the central body250can easily slide within the outer body210. Although not illustrated, in other embodiments, the lower and upper bodies253,255can have other suitable shapes depending on the desired size and configuration of the channel271and/or the outer body210.

A distal wall273(seeFIG. 11A) extends from the upper body253to the lower body255. The distal wall273has a opening or hole279for receiving the locking wire150as shown inFIG. 16. The hole279can prevent substantial lateral movement of the guidewire and can ensure that the guidewire is located in the desired position. The hole279can position the guide wire150equidistant between the pivot pins236. Thus, when the user applies proximal forces to the levers230, the wire engagement portions234can contact the guide wire150at approximately the same time and maintain the desired position of the guide wire150. For example, the guide wire150can remain substantially straight during use of the tool200, thus preventing bending of the guide wire150.

With reference toFIGS. 11 and 11A, the channels271receive at least a portion of the levers230and the biasing member231. The channels271in this arrangement facilitate proper movement of the levers230about their respective pivot pins236. The walls or sides of the channels271also preferably limit the vertical movement of the levers230.

With reference toFIGS. 11,11A and12, a window275is formed between the wall251and the distal wall273. The window275is configured to receive at least a portion of the wire engagement portions234of the levers. As shown inFIG. 14, the guide wire150can pass through the window275.

As shown inFIGS. 11 and 12, the distal portion220of the tool200is preferably configured for receiving and at least temporarily retaining a proximal pin26of the bone fixation device. With particular reference to.FIGS. 16 and 17, the distal portion comprises a distal cap270that is attached to the distal end214of the outer body210. The distal cap270comprises a housing283, a washer272, a washer positioning screw274, and a pin-gripping lever arm280. The distal cap270also defines a wire receiving lumen278for receiving a portion of a bone fixation device. In the illustrated embodiment, for example, the wire receiving lumen278can receive the guide wire150.

The housing283comprises a tip302for receiving a portion of a bone fixation device (e.g., the pin26). The tip302comprises an opening304and a body306that defines at least a portion of a pin receiving lumen276. As shown inFIGS. 16 and 17, the opening304is sized so that the proximal end28of the pin26may be passed through the opening304and along the pin receiving lumen276. The proximal portion of the tip302is preferably adapted to receive the pin-gripping arm280. In the illustrated embodiment, the outer surface of the pin-gripping arm280is generally flush with the outer surface of the tip302.

The housing283can be coupled to the distal end214of the outer body210and can extend from the distal wall273of the central body250and past the pin-gripping arm280. In the illustrated embodiment, the proximal portion of the housing283is disposed within the distal opening of the outer body210. The housing283defines cylindrical chamber that surrounds the washer272, the washer positioning screw274, and a portion of the wire150.

With reference toFIG. 16, the washer272advantageously inhibits fluid from passing through the tool200. In the illustrated embodiment, the washer272forms a seal308with the guide wire150, which is inserted through the washer, so that fluid (e.g., blood) is prevented from migrating between the wire150and the washer272and into the gripping mechanism of the insertion tool200. The washer272may also provide a friction or elastic fit between the washer272and the guide wire150so as to hold the guide wire150in place. The washer272may also form a seal310between the washer272and the inner surface of the housing283. Preferably the seals308,310prevent fluid from passing proximal the washer272. The washer272is typically made of a flexible material such as rubber, latex, or other pliable material. The washer272can also be constructed from other types of materials with suitable sealing characteristics. One of ordinary skill in the art can determine the appropriate combination of material type, thickness, and shape to achieve the desired seals for preventing fluid flow into the mechanisms of the tool200.

In the illustrated embodiment, the washer positioning screw274holds and positions the washer272in the housing283. The washer positioning screw274of this arrangement has a generally cylindrical body having a proximal portion that engages the proximal portion of the inner surface of the housing283. The distal end of the washer positioning screw274has a circular recess for receiving the washer272. A portion of wire-receiving lumen278is defined by the by the washer positioning screw274so that the guide wire150can pass through the washer positioning screw274. In one embodiment, the washer positioning screw274has threads on a portion of its proximal end and the housing has corresponding threads, such the washer positioning screw274and the housing283can be thread ably coupled. The desired seal310between the washer272and the housing283can be achieved by rotating the screw274relative the housing283to cause relative axial movement between the screw274and the housing283. For example, if fluid migrates through the seal310, the screw274can be rotated relative the housing283so that the screw moves in the distal direction thereby pushing the washer272against the housing283. In this manner, the washer272can be compressed between the screw274and the housing283until the desired seal310is achieved. In another embodiment, the screw274is provided without threads and is sized to fit substantially tightly within the housing283. Although not illustrated, other types of members can be preferably tightly fit into the distal cap270to ensure that proper seals are formed by the washer272.

The screw274can be made of a material such as rubber, plastic, metal, and pliable materials. The screw274can also be constructed from other types of materials with suitable sealing characteristics. One of ordinary skill in the art can determine the appropriate combination of material type, thickness, and shape to achieve the desired seals for preventing fluid flow into the mechanisms of the tool200.

With continued reference toFIG. 16, the pin-gripping arm280may comprise a variety of structures configured to preferably removably hold a bone fixation device (e.g., the pin26) within the pin-receiving lumen276. In the illustrated embodiment, the pin-gripping arm280comprises a lever arm313with a pin-engaging ridge or tang314. The end of tang314can be configured and sized to hold the pin26. In the illustrated embodiment ofFIG. 17, the pin of the bone fixation device may be provided with an annular ridge or groove316sized and positioned to receive the end of the tang314of the pin-gripping arm280such that the bone fixation pin is preferably held substantially rigidly by the insertion tool200. Thus, the pin-gripping arm280inhibits substantial axial movement of the pin26relative to the tool200. The tang314can be outwardly moved to disengage the pin-gripping arm280so that the pin26can be removed from the tool200. The tang314of the pin-gripping arm280and the groove316of the pin26can have various suitable shapes and sizes to achieve the desired pin26attachment. For example, the groove316can have a generally U-shaped profile and the end of the tang314can have a similar shape. In some embodiments, the groove316has a generally V-shaped profile and the end of the tang314can have a similar shape.

With continued reference toFIG. 16, the pin-receiving lumen276typically includes a pin stop282to allow a sufficient length of the pin to be inserted into the lumen276. The distal end of the pin-receiving lumen276forms the opening304. The tang314is disposed midway between the proximal and distal end of the pin-receiving lumen276. In the illustrated embodiment, the diameter of the pin-receiving lumen276is reduced at its distal end. That is, the tip302can have an annular ridge318at its distal end where the inner surface of the ridge318defines the opening304.

The operation of a bone fixation device25and insertion tool200according to one embodiment of use will now be described with reference toFIGS. 18-20. After the clinician accesses the bone, a bone drill is selected and the clinician drills a hole290(or22inFIG. 1) through the two pieces of bone. A bone fixation device25may be inserted into the insertion tool200directly from a package, thereby preferably maintaining the sterility of the fixation device25. In the illustrated embodiment, with reference toFIGS. 16 and 17, the bone fixation device25is inserted into the insertion too by inserting the proximal end of the guide wire150into the opening304and advanced along the wire receiving lumen278until the desired portion of the guide wire150is between the wire gripping portions234of the levers230. The proximal end28of the pin26, in turn, is inserted into the opening304and advanced along the pin receiving lumen276until it contacts or is near the pin stop282. In a modified embodiment, the guidewire150and pin26may be pre-positioned in the insertion tool200and packaged together in a sterile package.

Using the insertion tool to hold the device25, the distal portion156of the guide wire150and the distal end30of the pin26are advanced into the passage290until the barbs50exit the passage290. In a non-through bore application (not illustrated), the pin26is advanced until the barbs are advanced a sufficient distance into the bone as determined by the clinician. In other embodiments, a different tool or the clinician's hand may be used to insert the fixation device25into the passage290.

With the guide wire150positioned within the insertion tool200, the clinician may apply a proximal force on the finger engagement portions232of the insertion tool while holding the outer body210relatively stationary. Preferably, the biasing member260provides a sufficient distal force on the biasing end249of the central body250so that the levers230rotate about the pivot pins236and can securely grip the guide wire150while the central body250is generally stationary relative the outer body210of the tool200. After the levers230grip the guidewire150, the user can provide sufficient proximal force to overcome the bias of the spring260and move the levers230, which are gripping the guide wire150, thereby moving the central body250in the proximal direction relative the outer body210of the tool200. In the illustrated embodiment, the levers230and the central body250can be moved in the proximal direction until the proximal end of the biasing end249of the central body250contacts the distal end of the biasing stop258. Alternatively, the proximal movement of the levers230and central body250relative the outer body210can be stopped when the bias of the spring260overcomes the proximal force applied by the clinician.

As the levers230and central body250slide within and along the outer body210, the levers230grip and pull the guidewire250while the tip302holds the pin26stationary relative the outer body210. Thus, the application of a proximal force on the finger engagement portions232will preferably result in retraction of the guide wire150relative to the pin26. The guide wire150is preferably retracted until the distal portion156enters, at least partially, the first portion160of the pin26(seeFIG. 9). As such, at least a part of the distal portion156of the guide wire150becomes locked within the first portion160of the pin26. This prevents the barbs50and lever arms24from being compressed radially inward and ensures that the barbs50remain seated snugly against the distal component21of the bone. Preferably, the outer surfaces of the barbs50contact inner surface of the passage290to provide frictional forces that inhibit movement of the pin26along the passage290. As mentioned above, in certain embodiments, the distal portion156may expand the lever arms24beyond their natural relaxed diameter.

The insertion tool200can be configured such that the maximum distance which the central body250is allowed to move (and thus the maximum distance a wire may be pulled) corresponds to a maximum distance necessary for properly deploying the distal portion156of the guide wire150within the first portion160of the pin26. Alternatively, additional structures may be provided in order to indicate a degree of retraction of the guide wire150. For example, a viewing window may be provided to allow a clinician to visually verify the grip and the distance of retraction of a guidewire.

Once the distal portion156of the guide wire150has been set within the first portion of the pin, the proximal anchor36may be rotated or otherwise distally advanced (e.g., by proximally retracting the pin) with respect to the pin body26so as to seat the proximal anchor36snugly against the proximal component19of the bone10. Proximal retraction or distal advancement of the fixation device may require additional tools. For example, the deployment device described in co-pending application entitled “DEPLOYMENT TOOL FOR DISTAL BONE ANCHORS WITH SECONDARY COMPRESSION”, Attorney Docket No. TRIAGE.019A, filed Mar. 1, 2004 and which is incorporated by reference as part of the specification of this application, or similar devices may be used to distally advance the proximal anchor36and/or proximally retract the pin body26with respect to the proximal anchor36. Alternatively, features of such tools may be combined with the insertion tool described herein to produce proximal retraction or distal advancement. It should be appreciated that the proximal anchor36may be positioned on the bone fixation device25prior to positioning of the pin body32in the hole or passage290or22, or following placement of the pin body32within the through passage290or22.

Following appropriate tensioning of the proximal anchor36, the proximal end28of the pin body32and the proximal end154of the guide wire150are preferably cut off or otherwise removed. These components may be cut using conventional bone forceps which are routinely available in the clinical setting, or snapped off using designed break points as has been discussed.

The tool200is preferably adapted to be removably coupled to the bone fixation devices so that the tool200can rapidly and conveniently deliver and deploy the fixation device. The tool200may also be reused in a similar manners to deliver a plurality of bone fixation devices. Thus, a single tool200can deliver a plurality of bone fixture devices during a surgical operation. In practice, various embodiments described above can be provided in a kit. The kit preferably comprises the tool200and at least one bone fixation device. In one embodiment, the kit comprises a plurality of bone fixation devices that be rapidly delivered by using the tool200. The plurality of bone fixation devices can comprise the pin26, the guidewire150, and other components described herein.

The method which is described and illustrated herein is not limited to the exact sequence of acts described, nor is it necessarily limited to the practice of all of the acts set forth. Other sequences of events or acts, or less than all of the events, or simultaneous occurrence of the events, may be utilized in practicing the embodiments of the invention.

Although certain preferred embodiments and examples have been described herein, it will be understood by those skilled in the art that the present inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present inventive subject matter herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.