Patent Description:
Most solutions for fractures in the proximal fifth metatarsal, such as, Jones fractures, involve the placement of a lateral plate or a central fixation screw. Generally, plates are used because of the ease of surgical access. In addition, plates are generally easier to use for avulsion fractures of the fifth metatarsal tuberosity. However, using a plate may result in an uncomfortable prominence for the patient. In addition, in some circumstances plating techniques do not provide optimal stability which may be found with central fixation of an intramedullary screw. An intramedullary screw may be placed through the central axis and in the intramedullary canal of the fifth metatarsal. The currently used intramedullary screw approach, however, may be hampered or rendered impossible by difficulty in accessing the central axis and/or by approach conflicts with the lateral malleolus, i.e. ankle, as well as soft tissue irritation. Thus, new and improved bone fixation systems, assemblies, insertion guides, and methods for inserting an intramedullary screw are needed which improve the stability of the patient's foot during healing and after fusion. Relevant technology can be found in, for example, <CIT>, <CIT>, <CIT>, and <CIT>.

The present invention is directed toward devices for use in fixation of a fracture. The insertion guides provide an orientation for insertion of a fixation screw into the central axis of a bone, such as, the fifth metatarsal, and across a patient's fracture.

In one aspect of the present invention provided herein, is an insertion guide. The insertion guide including a handle member and a guide member coupled to a second end of the handle member. The guide member being curved relative to the longitudinal axis of the handle member.

In another aspect of the present invention provided herein, is a bone fixation system. The bone fixation system including an insertion guide, a guide wire, and a fastener. The insertion guide has a handle member and a guide member coupled to an end of the handle member. The guide member is curved and has a through hole for receiving the guide wire. The fastener has a cannulation for receiving the guide wire.

These and other objects, features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings.

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate in <FIG> embodiments of the invention and in <FIG> examples not falling within the scope of the invention as claimed and together with the detailed description herein, serve to explain the principles of the invention. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the invention.

<FIG> do not fall within the scope of the claims of this application, however, they may be useful in understanding the implementation, usefulness, and advantages of the presently claimed invention.

Generally stated, disclosed herein are guides, devices, instruments, and systems for fracture fixation. Further, methods for using the guides, devices, instruments, systems to fix a fractured bone are discussed.

In this detailed description and the following claims, the words proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part or portion of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, "proximal" means the portion of a device or implant nearest the torso, while "distal" indicates the portion of the device or implant farthest from the torso. As for directional terms, "anterior" is a direction towards the front side of the body, "posterior" means a direction towards the back side of the body, "medial" means towards the midline of the body, "lateral" is a direction towards the sides or away from the midline of the body, "superior" means a direction above and "inferior" means a direction below another object or structure. Further, specifically in regards to the foot, the term "dorsal" refers to the top of the foot and the term "plantar" refers the bottom of the foot.

Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current implants, devices, instrumentation and methods are described herein with reference to use with the bones of the foot, the bones of the foot, ankle and lower leg may be used to describe the surfaces, positions, directions or orientations of the implants, devices, instrumentation and methods. Further, the implants, devices, instrumentation and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the implants, devices, instrumentation and methods, and the aspects, components, features and the like thereof, described and/or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the scope of the invention. For example, the implants, devices, instrumentation and methods, and the aspects, components, features and the like thereof, described herein with respect to the right foot may be mirrored so that they likewise function with the left foot. Further, the implants, devices, instrumentation and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the foot for brevity purposes, but it should be understood that the implants, devices, instrumentation and methods may be used with other bones of the body having similar structures.

Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to <FIG>, there is illustrated an exemplary embodiment of a bone fixation system <NUM>. The bone fixation system <NUM> includes an insertion guide <NUM>, a k-wire <NUM> and a fastener <NUM>. The insertion guide <NUM> may include a handle member or handle portion <NUM> coupled to a guide member <NUM>, as shown in <FIG>. The handle member <NUM> of the insertion guide <NUM> may include a first end <NUM> opposite a second end <NUM> and a first surface <NUM> opposite the second surface <NUM>. The guide member <NUM> may couple to the handle member <NUM> at the second end <NUM> and extend away from a second surface <NUM> of the handle member <NUM>.

As shown in <FIG>, the handle member <NUM> may include a body <NUM> and an alignment member <NUM>. The body <NUM> may be coupled to the alignment member <NUM> by a neck or tapered region <NUM>. The sides of the neck region <NUM> may be, for example, tapered or curved between the wider body portion <NUM> and the narrower ali gnment member <NUM>. The handle member <NUM> may also include an angle or curve p positioned at the neck region <NUM> to angle the alignment member <NUM> relative to the body <NUM>, as shown in <FIG>. The alignment member <NUM> may be angled relative to the body <NUM> by angle p. The angle p may be, for example, approximately <NUM>-<NUM> degrees, more specifically, approximately <NUM> degrees. It is also contemplated that the handle member <NUM> may not have an angle p and may be, for example, flat along the length of the handle member <NUM>.

The alignment member <NUM> may have an attachment portion <NUM> positioned at the second end <NUM>. The attachment portion <NUM> may include an opening <NUM> sized and shaped or configured to receive an end of the guide member <NUM>. The opening <NUM> may extend through the attachment portion <NUM> of the alignment member <NUM> from the first surface <NUM> through the second surface <NUM>. The attachment portion <NUM> may also include a fastener hole <NUM>, as shown in <FIG> and <FIG>. The fastener hole <NUM> may extend from an exterior surface through the attachment portion <NUM> and into the opening <NUM>. The fastener hole <NUM> may receive a fastener (not shown) to secure the guide member <NUM> to the handle member <NUM>, as shown in <FIG> and <FIG>.

As shown in <FIG>, the guide member <NUM> includes a guide body <NUM> with an engagement portion or coupling member <NUM> at a first end and a bone contacting member or portion <NUM> at a second end. The guide member <NUM> may have an angle or curve p. As noted above, the angle p may be, for example, approximately <NUM>-<NUM> degrees, more specifically, approximately <NUM> degrees. The guide member <NUM> may also have a radius of curvature R. The radius of curvature R of the guide member <NUM> may, for example, correspond to the length of the alignment member <NUM> from the angle to a center of the opening <NUM>. Alternatively, the radius of curvature R of the guide member <NUM> may be, for example, larger or small er than the length of the alignment member <NUM> from the angle to a center of the opening <NUM>. The guide body <NUM> may have a first diameter and the engagement portion <NUM> may have a second diameter. The second diameter may be, for example, smaller than the first diameter. The second diameter may also be sized to correspond with the size of the opening <NUM> in the handle member <NUM>. The guide member <NUM> may also include a through hole or cannulation <NUM> extending through the entire length of the guide member <NUM>. As shown in <FIG>, the cannulation <NUM> may be curved from the opening in the engagement portion <NUM> to the bone contacting member <NUM> and may have a straight portion <NUM> extending through the bone contacting member <NUM>. The portion <NUM> may extend, for example, generally perpendicular to the body portion <NUM> of the handle member <NUM>. The guide member <NUM> may also include a fastener hole <NUM>, as shown in <FIG>. The fastener hole <NUM> may extend from an exterior surface through the engagement portion <NUM> and into the through hole <NUM>. The fastener hole <NUM> may be aligned with the fastener hole <NUM> to receive the fastener (not shown). The fastener (not shown) may extend through the fastener hole <NUM> of the handle member <NUM> and the fastener hole <NUM> of the guide member <NUM> to secure the guide member <NUM> to the handle member <NUM>.

The bone contacting member <NUM> of the guide member <NUM> may include a tip <NUM> and a bone contacting surface <NUM>, as shown in <FIG> and <FIG>. The bone contacting surface <NUM> may be, for example, curved to match a portion of the exterior surface of a bone. For example, the bone contacting surface <NUM> may be shaped to match a portion of the exterior surface of the fifth metatarsal <NUM> to align the through hole <NUM> with the central axis of the shaft <NUM> of the fifth metatarsal <NUM>, as shown in <FIG>. In one embodiment, the curvature of the bone contacting surface <NUM> may be, for example, approximately <NUM> to <NUM>, more specifically, approximately <NUM>. As shown in <FIG> and <FIG>, the guide member <NUM> may also be sized and shaped or configured to receive a curved k-wire or guide wire <NUM>.

The k-wire, guide wire, or alignment wire <NUM>, as shown in <FIG> and <FIG>, may include a first end <NUM> and a second end <NUM>. The guide wire <NUM> may be a straight wire made of a flexible or deformable material, for example, nitinol, to allow the guide wire <NUM> to bend as the wire <NUM> follows the through hole <NUM> through the guide member <NUM>. Once inserted into the through hole <NUM>, the guide wire <NUM> may deform to the shape shown in <FIG> and <FIG> and include a first wire portion <NUM> extending from the first end <NUM> to a curved portion <NUM>. In addition, when inserted into the guide member <NUM>, the guide wire <NUM> may include a second wire portion <NUM> extending from the curved portion <NUM> to the second end <NUM>. The curved portion <NUM> may curve or angle the first wire portion <NUM> relative to the second wire portion <NUM> to correspond to the curvature of the through hole <NUM> of the guide member <NUM>.

As shown in <FIG> and <FIG>, the fastener, bone screw, or fixation member <NUM> of the bone fixation system <NUM> may include a head <NUM> at a first end and an insertion tip or end <NUM> at a second end. The fastener <NUM> may have a shank <NUM> extending between the head <NUM> and the insertion tip <NUM>. The shank <NUM> may include a threaded portion <NUM> for engaging the bone, for example, the shaft <NUM> of the fifth metatarsal <NUM>. The fastener <NUM> may also include a cannulation or through hole <NUM> extending through the fastener <NUM>. As shown in <FIG>, the cannulation <NUM> of the fastener <NUM> may engage the guide wire <NUM> for inserting the fastener <NUM> into a patient's bone, for example, the fifth metatarsal <NUM>. Further, the fastener <NUM> may also include a drive opening <NUM> in the head <NUM> for inserting or driving the fastener <NUM> into the patient's bone, for example, the fifth metatarsal <NUM> of the patient's foot <NUM>.

A method (not part of the present invention as claimed) of using the bone fixation system <NUM> is shown in <FIG>. As shown in <FIG>, the assembled insertion guide <NUM> may be positioned on the fifth metatarsal <NUM> of a patient's foot <NUM>. The bone contacting surface <NUM> of the guide member <NUM> may be positioned on the surface of the fifth metatarsal <NUM> to align the through hole <NUM> with the shaft or central axis <NUM> of the fifth metatarsal <NUM>. Next, as shown in <FIG> and <FIG>, the k-wire <NUM> is inserted into and through the through hole <NUM> in the guide member <NUM> and into the fifth metatarsal <NUM>. After the k-wire <NUM> is inserted into the fifth metatarsal <NUM> and placement or positioning is confirmed, the insertion guide <NUM> may be removed from the patient's foot <NUM>, as shown in <FIG>. Then, the fastener <NUM> may be inserted over the curved k-wire <NUM> and into the shaft <NUM> of the fifth metatarsal <NUM>, as also shown in <FIG>. Next, the k-wire <NUM> may be removed from the fastener <NUM> and the patient's foot <NUM> leaving the fastener <NUM> positioned in the fifth metatarsal <NUM>, as shown in <FIG>. The fastener <NUM> may be positioned to cross the fracture of the fifth metatarsal <NUM> to assist with fusion. Finally, the procedure may be completed and the patient's incision may be closed.

Referring now to <FIG>, another bone fixation system <NUM> (not part of the presently claimed invention) is shown. The bone fixation system <NUM> may include an alignment guide or polyaxial targeting guide <NUM>, a pivoting member <NUM>, a guide sleeve <NUM>, and a k-wire or guide wire <NUM>, as shown in <FIG>. The alignment guide <NUM> may include a body <NUM> and a pivoting assembly <NUM>. The body <NUM> may include a first end <NUM> and a second end <NUM>. The body <NUM> may also include a first opening <NUM> extending through the first end <NUM> of the body <NUM>. The first opening <NUM> may be sized and shaped or configured to receive the guide sleeve <NUM>, as shown in <FIG>. The guide sleeve <NUM> may be secured to the body <NUM>, once a desired position is achieved, with at least one set screw <NUM>, as shown in <FIG>, inserted into openings that extend from an exterior surface into the first opening <NUM>.

The second end <NUM> of the body <NUM> may include a stepped portion <NUM>, as shown in <FIG> and <FIG>. The stepped portion <NUM> may include a second opening <NUM> and a third opening <NUM> extending into the body <NUM> in a direction along the length of the body <NUM>, as shown in <FIG>. The second opening <NUM> may extend into the first step of the stepped portion <NUM> and be sized and shaped or configured to receive a portion of a translating member <NUM>. The body <NUM> may also include a fifth opening <NUM> extending from a superior surface of the body <NUM> into the second opening <NUM>. The fifth opening <NUM> may receive a pin or fastener which may extend through the translating member <NUM>, as shown in <FIG> and <FIG>. The translating member <NUM> may include a slot <NUM> extending along the length of the translating member <NUM>. The pin extending through the fifth opening <NUM> may extend through the slot <NUM> allowing for the pivoting assembly <NUM> to translate in a proximal-distal direction with respect to the body <NUM>. In addition, the translating member <NUM> may include an opening for receiving a pin <NUM> to secure the translating member <NUM> to the pivoting assembly <NUM>.

The third opening <NUM> may extend into the second step of the stepped portion <NUM> and be sized and shaped or configured to receive a portion of a locking member <NUM>. The locking member <NUM> may include a coupling portion <NUM> at a first end and a groove portion <NUM> at a second end, as shown in <FIG> and <FIG>. The coupling portion <NUM> may also include an opening for receiving a pin <NUM> to secure the coupling portion <NUM> of the locking member <NUM> to the pivoting assembly <NUM>.

The stepped portion <NUM> may further include a fourth opening <NUM>, as shown in <FIG>. The fourth opening <NUM> may extend from a side of the body <NUM> through the second opening <NUM> and the third opening <NUM>. The fourth opening <NUM> may be sized and shaped or configured to receive an engagement button or locking button <NUM>, as shown in <FIG> and <FIG>. The engagement button <NUM> may include a head portion <NUM> coupled to a base member <NUM>, as shown in <FIG> and <FIG>. The base member <NUM> may also include an engagement or locking opening <NUM>. The locking member <NUM> may be positioned to extend through the locking opening <NUM>. The locking opening <NUM> may engage at least one of the grooves in the grooved portion <NUM> of the locking member <NUM> when in the secured position. In order to translate the pivoting assembly <NUM> relative to the body <NUM>, the engagement button <NUM> may be depressed and the pivoting assembly <NUM> may be moved relative to the body <NUM>. Once the desired position of the body <NUM> and pivoting assembly <NUM> is achieved, the engagement button <NUM> may be released and the opening <NUM> may engage the grooves of the groove portion <NUM>.

Referring now to <FIG> and <FIG>, the pivoting assembly <NUM> may include a first end <NUM> and a second end <NUM>. The pivoting assembly <NUM> may also include a stepped portion <NUM> corresponding to the stepped portion <NUM> of the body <NUM>. The first step of the stepped portion <NUM> may include a first opening <NUM> extending into the pivoting assembly <NUM>, as shown in <FIG>. The first opening <NUM> may be sized and shaped or configured to receiving a portion of the translating member <NUM>. In addition, the second stepped portion <NUM> of the pivoting assembly <NUM> includes a second opening <NUM> extending into the pivoting assembly <NUM>. The second opening <NUM> may be sized and shaped or configured to receive a portion of the translating member <NUM>. The pivoting assembly <NUM> may also include a third opening <NUM> extending from an exterior surface of the side into the opening <NUM>. The third opening <NUM> may receive a pin <NUM> to secure the translating member <NUM> to the pivoting assembly <NUM>. The pivoting assembly <NUM> may also include a fourth opening <NUM> extending from a superior surface into the second opening <NUM>. The fourth opening <NUM> may receive a pin <NUM> to secure the locking member <NUM> to the pivoting assembly <NUM>.

The second end <NUM> of the pivot assembly <NUM> may include a pivot slot <NUM> and a pivoting end <NUM> for receiving the pivoting member <NUM>. Although not shown, it is contemplated that the pivot slot <NUM> may be angled, for example, along the longitudinal axis of the alignment guide <NUM>. The pivoting end <NUM> may include, for example, a plurality of teeth, flanges, protrusions, or extension members <NUM> alternating with a plurality of grooves or reliefs <NUM> around the circumference of the pivoting end <NUM>. Each of the plurality of teeth <NUM> may be, for example, curved on the interior surface of the pivoting end <NUM> to form at least one curved region <NUM>. The at least one curved region <NUM> on each of the plurality of teeth <NUM> may form a spherical opening or opening with a circular or round cross-section on the interior surface of the pivoting end <NUM>. The plurality of teeth <NUM> may also include, for example, a projection or extension <NUM> positioned near an end of the pivoting assembly <NUM> and extending into the spherical opening formed by the curved regions <NUM> of the teeth <NUM>. The projections <NUM> provide a retaining surface for coupling the pivoting member <NUM> to the alignment guide <NUM>, as shown in <FIG>, <FIG>, and <FIG>.

The pivoting member <NUM> may include a first end <NUM> and a second end <NUM>, as shown in <FIG>. The terms "pivoting member," "sphere wire," "grip wire," and "alignment wire" may be used interchangeably herein as each essentially refer to a wire including a protrusion. The pivoting member <NUM> may also include a wire portion <NUM> extending from the first end <NUM> to a pivot protrusion or spherical member <NUM>. The pivot protrusion <NUM> may be, for example, spherical or may have a circular or round cross-section and be sized and shaped to match the opening between the plurality of teeth <NUM> of the pivoting end <NUM>. The pivot protrusion <NUM> may rotate within the plurality of teeth <NUM> in the pivoting end <NUM>. The pivoting member <NUM> may also include an insertion end <NUM> and a tapered region <NUM> extendi ng between the pivot protrusion <NUM> and the insertion end <NUM>. The insertion end <NUM> may have a pointed tip for insertion through the skin and into the patient's foot. The pivot protrusion <NUM> allows for the insertion end <NUM> to be inserted into the patient's foot at the desired position and at a desired angle relative to the patient's bone.

As shown in <FIG>, the guide sleeve insert <NUM> may have a body <NUM> with a first end <NUM> and a second end <NUM>. The guide sleeve insert <NUM> may also include a through hole or cannulation <NUM> extending from the first end <NUM> to the second end <NUM>. The guide sleeve insert <NUM> may also include a bone contacting surface <NUM> at the second end <NUM>. The bone contacting surface <NUM> may engage the bone for receiving the guide wire <NUM>. The body <NUM> may be, for example, curved from the first end <NUM> to the second end <NUM>.

With continued reference to <FIG>, the guide wire, k-wire or alignment wire <NUM> may include a first end <NUM> and a second end <NUM>. The guide wire <NUM> may be a straight wire made of a flexible or deformable material, for example, nitinol, to allow the guide wire <NUM> to bend as the wire <NUM> follows the through hole <NUM> through the guide sleeve insert <NUM>. Once inserted into the through hole <NUM>, the guide wire <NUM> may deform to the shape of the guide wire sleeve <NUM>, as shown in <FIG>, and include a first wire portion <NUM> near the first end <NUM> and a second wire portion <NUM> near the second end <NUM>. The guide wire <NUM> may further include a curved portion <NUM> positioned between the first wire portion <NUM> and the second wire portion <NUM>.

The method (not part of the presently claimed invention) of using the bone fixation system <NUM> may include obtaining a bone fixation system <NUM> and making an incision in the patient over the fractured bone. Next, a pivoting member <NUM> may be placed through the skin and into the patient's bone, for example, a fifth metatarsal bone. The pivoting member <NUM> should be placed with the insertion end <NUM> extending through the central axis of the bone. The pivoting member <NUM> may be placed to position the tip or second end <NUM> of the pivoting member <NUM> or the threaded insertion end <NUM> of the pivoting member <NUM> along the axis of the trajectory of the k-wire <NUM> as shown in <FIG>. Once the pivoting member <NUM> is inserted in the desired position, the alignment guide <NUM> may be coupled to the pivoting member <NUM>. The alignment guide <NUM> may be coupled by engaging the pivoting end <NUM> of the alignment guide <NUM> with the pivot protrusion <NUM> of the pivoting member <NUM>. Then, the opening <NUM> of the first end <NUM> of the alignment guide <NUM> may be positioned to align with the central axis of the bone. The first end <NUM> may be aligned prior to or after insertion of the guide sleeve <NUM> into the opening <NUM>. The bone contact surface <NUM> of the second end <NUM> of the guide sleeve <NUM> may then be placed on the patient's bone at the desired entry point for the k-wire <NUM>. After the insertion point has been selected, the k-wire <NUM> may be inserted into the cannulation <NUM> at the first end <NUM> of the guide sleeve <NUM>. The k- wire <NUM> may be guided through the cannulation <NUM> and into the patient's bone, for example, into the central axis and in line with the insertion end <NUM> of the pivoting member <NUM>. After confirming the k-wire <NUM> is in the desired position, the alignment guide <NUM> and pivoting member <NUM> may be removed from the patient. Next, a fastener, for example, fastener <NUM>, as shown in <FIG>, may be inserted over the k-wire <NUM> and into an intramedullary canal of the patient, for example, into the central axis of the fifth metatarsal. Once the fastener (not shown) is inserted into the patient's bone, the k-wire <NUM> may be removed from the patient's bone. Finally, the procedure may be completed and the patient's incision closed.

Referring now to <FIG>, another insertion guide <NUM> is shown (not part of the presently claimed invention). The insertion guide <NUM> includes a handle <NUM>, a guide member <NUM>, and a curvature adjustment member <NUM>. The handle <NUM> may include a first end <NUM> opposite the second end <NUM> and a first surface <NUM> opposite a second surface <NUM>. The handle <NUM> may also include a first opening <NUM> positioned near the first end <NUM>. In addition, the handle <NUM> may include an alignment member <NUM> at the second end <NUM> of the handle <NUM>. The handle <NUM> may also include a neck portion <NUM> connecting the body of the handle <NUM> with the alignment member <NUM>. The handle <NUM> may further include a second opening <NUM> positioned in the neck portion <NUM> of the insertion guide
<NUM>. The second end <NUM> may also include an alignment hole <NUM> extending through the alignment member <NUM> and the guide member <NUM>. The guide member <NUM> may be coupled to the second surface <NUM> of the alignment member <NUM> below the alignment hole <NUM>. The handle <NUM> may also include a depression or finger engagement surface <NUM> positioned on the first surface <NUM> of the handle <NUM> near the neck portion <NUM>.

As shown in <FIG>, <FIG>, the guide member <NUM> may include a plurality of guide member segments <NUM> coupled together on at least one side. The guide member <NUM> may also include a pulling member <NUM> coupled to and extending through the guide member segments <NUM>. A first end of the pulling member <NUM> may be coupled to the curvature adjustment member <NUM>. The guide member <NUM> may also include a tip <NUM> at an end opposite the end of the guide member <NUM> coupled to the alignment member <NUM>. In addition, the guide member <NUM> may include a bone contacting surface <NUM> extending from the tip <NUM> toward the alignment member <NUM>. The bone contacting surface <NUM> may be, for example, curved or angled to correspond to the shape of the portion of the bone that will be contacted.

The curvature adjustment member <NUM> of the guide member <NUM> may include a tab <NUM> at a first end, as shown in <FIG>, <FIG>, <FIG>. The tab <NUM> may extend through the first opening <NUM> in the handle <NUM>. The curvature adjustment member <NUM> may also include a neck <NUM> at a second end of the member <NUM>. The neck <NUM> may extend through the second opening <NUM> in the handle <NUM>. The curvature adjustment member <NUM> may further include a coupling section <NUM> extending from the neck <NUM> and positioned above the top surface <NUM> of the alignment member <NUM>. The curvature adjustment member <NUM> also includes a locking member and/or fine adjustment member <NUM>. The member <NUM> may include a projection or shaft <NUM> that engages an opening (not shown) in the coupling section <NUM>. The member <NUM> may be turned to lock the curvature adjustment member <NUM> to the alignment member <NUM> of the handle <NUM>. By locking the curvature adjustment member <NUM>, the selected curvature of the guide member <NUM> is secured. In addition, the member <NUM> may be used to make fine or small adjustments of the curvature of the guide member <NUM>.

A method (not part of the presently claimed invention) of using the insertion guide <NUM> may include determining the desired curvature of the guide member <NUM> and pressing the tab <NUM> to activate the pulling member <NUM>. The tab <NUM> may be depressed until the desired curvature is created in the guide member <NUM> by the pulling member <NUM>. Once the desired curvature is achieved, the locking member <NUM> may be tightened to secure the curvature adjustment member <NUM> and in turn secure the curvature of the guide member <NUM>. If necessary, the locking member <NUM> may be loosened or tightened to provide for additional fine tuning of the curvature of the guide member <NUM>. After the desired curvature of the guide member <NUM> is set, the insertion guide <NUM> may be aligned with the patient's bone and a k-wire, such as, flexible or deformable k-wire <NUM>, <NUM> may be inserted through the alignment hole <NUM> and into the patient's bone. The position of the k-wire (not shown) may then be confirmed and if in the desired position, a fastener, such as, fastener <NUM> as shown in <FIG>, may be inserted over the k-wire (not shown) and into the patient's bone, as described in greater detail above. After the fastener is inserted into the patient's bone, the k-wire (not shown) may be removed from the patient. Finally, the procedure may be completed and the incision closed.

It will be further understood that the terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has", and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises," "has," "includes," or "contains" one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that "comprises," "has," "includes," or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

Claim 1:
A bone fixation system (<NUM>), comprising:
an insertion guide (<NUM>), comprising:
a handle member (<NUM>) having a first end (<NUM>) and a second end (<NUM>), the handle member (<NUM>) comprising:
a body (<NUM>) disposed at the first end (<NUM>) of the handle member (<NUM>); and
an alignment member (<NUM>) extending from a portion of the body (<NUM>) to the second end (<NUM>) of the handle member (<NUM>), wherein the body (<NUM>) is wider than the alignment member (<NUM>), and wherein the alignment member (<NUM>) forms an oblique first angle (β) relative to the body (<NUM>); and
a guide member (<NUM>) coupled to the second end (<NUM>) of the handle member (<NUM>), wherein the guide member (<NUM>) is curved, wherein the guide member (<NUM>) has a bone contacting surface (<NUM>) on a distal end of the guide member (<NUM>), and wherein the bone contacting surface (<NUM>) is curved to match a portion of an exterior surface of a metatarsal bone (<NUM>);
a guide wire (<NUM>), wherein the guide member (<NUM>) has a through hole (<NUM>) for receiving the guide wire (<NUM>); and
a fastener (<NUM>) with a cannulation (<NUM>) for receiving the guide wire (<NUM>).