Patent Description:
<CIT> describes devices and methods for use in fixation of a patient's joints or for fixation of a fracture. The fixation guides disclosed therein provide an orientation for insertion of intramedullary nails through a patient's joint or fracture. An alignment guide, for positioning a guidewire across two bones, is described together with a base member, an alignment member, and a fixation guide. The base member includes a first portion and a second portion with the second portion extending out from the first portion in a relatively perpendicular direction and the first portion including at least one opening. The alignment member including at least one opening, being coupled to the base member, and angled relative to the second portion of the base member. The fixation guide being removably inserted through one of the at least one openings in the first portion of the base member.

The current technology for fusions across two bones utilizes plate and screw fixation that can only be applied on the approach surface. Since the plates are attached outside the fusion zone, the plates will experience bending moments and are limited in their ability to provide uniform compression forces across the fusion site or surfaces. In addition, the plates and screws may create pain due to hardware prominence on the patient's bones. Further, the blood supply to the periosteum may be compromised by attaching a plate to the exterior surface of the bones. Current medial plating systems may experience recurrent hallux valgus and dorsal plating systems may experience plantar gapping over time.

Accordingly, new and improved intramedullary nail alignment guides, fixation guides, devices, and methods which overcome the above-referenced problems and others are needed.

The present invention as defined in the claims is directed toward devices and for use in fixation of a patient's joints or for fixation of a fracture. The disclosed alignment and fixation guides provide an orientation for insertion of intramedullary nails through a patient's joint or fracture. Methods of inserting an intramedullary nail into two bones for fixation of the two bones as described herein are for the purposes of illustration and better understanding of the disclosed and claimed devices, and as surgical methods are not claimed in accordance with the provisions of the EPC.

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 embodiments of the invention 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.

Generally stated, disclosed herein are implants, guides, devices, instruments, and systems for fixing a joint using an intramedullary nail. Further, methods for implanting and removing an intramedullary nail using the implants, guides, devices, instruments and systems are discussed (but these methods not claimed).

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 spirit and 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 an alignment guide system <NUM>. The alignment guide system <NUM> includes an alignment guide or polyaxial targeting guide <NUM>, a pivoting member <NUM>, a guide sleeve insert <NUM>, and a guide wire or k-wire <NUM>. The alignment guide or polyaxial targeting guide <NUM> includes a body <NUM> and a pivot assembly <NUM>. The body <NUM> having a first end <NUM> and a second end <NUM>. The first end <NUM> includes a first opening <NUM> for receiving the guide sleeve insert <NUM>. The first opening <NUM> may extend entirely through the first end <NUM> of the body <NUM> along a longitudinal axis of the alignment guide <NUM>. The second end <NUM> includes a coupling region <NUM> and second openings (not shown) extending through the coupling region <NUM>. The coupling region <NUM> may have a width or thickness smaller than the width or thickness of the rest of the body <NUM>. The second openings may be sized and shaped for receiving fasteners <NUM> to couple the body <NUM> to the pivot assembly <NUM>. The body <NUM> may also have, for example, a curvature or arc as the body extends from the first end <NUM> to the second end <NUM>. The curvature may be positioned, for example, near the distal or first end <NUM> of the alignment guide <NUM>.

As shown in <FIG> and <FIG>, the pivot assembly <NUM> includes a first end <NUM> and a second end <NUM>. The first end <NUM> includes a first slot <NUM> inset into the first end <NUM> for receiving the coupling region <NUM> at the second end <NUM> of the body <NUM>. The second end <NUM> includes a pivot slot <NUM> and a pivoting end <NUM> for receiving the pivoting member <NUM>. As shown in <FIG>, the pivot slot <NUM> may be angled, for example, along the longitudinal axis of the alignment guide <NUM>. The pivot slot <NUM> may be, for example, narrower on the medial side than the lateral side of the alignment guide <NUM>. The pivoting end <NUM> may include, for example, a plurality of teeth, 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 a curved region <NUM>. The curved regions <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 the second end <NUM> 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>.

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 the 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, pivot member, 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> extending between the pivot protrusion <NUM> and the insertion end <NUM>. The insertion end <NUM> may have a pointed tip for insertion into the patient's foot.

As shown in <FIG>, the guide sleeve insert <NUM> may have a first end <NUM> and a second end <NUM>. The guide sleeve insert <NUM> may have a handle portion <NUM> at the first end <NUM> and a shaft <NUM> extending from the handle portion <NUM> to the second end <NUM>. The second end <NUM> may include a channel <NUM> extending into the shaft <NUM>. As shown in <FIG>, the second end <NUM> may also include a contact portion <NUM> for contacting a patient's foot, as shown in <FIG>, <FIG> and <FIG>. The contact portion <NUM> may include, for example, a plurality of protrusions or other textured surface <NUM> to assist with contacting the patient's foot. The guide sleeve insert <NUM> may be, for example, cannulated to allow for insertion of the guide wire <NUM>. The guide wire <NUM> may have a first end <NUM> and a second end <NUM>. The second end <NUM> of the guide wire <NUM> may have a pointed or sharp tip for insertion into a patient's bone.

Referring now to <FIG>, a fixation guide <NUM> is shown. The fixation guide <NUM> includes an outrigger assembly or frame <NUM> which may be coupled to a compression device <NUM> and an intramedullary nail <NUM>. The frame <NUM> may include a first end <NUM> and a second end <NUM>. The frame <NUM> may include at least one opening <NUM> allowing for visualization through the frame <NUM> with imaging technology, such as x-rays, as seen in <FIG>. The frame <NUM> is ideally made of a material that is strong enough to prevent deformation during surgery, for example, a metal, such as aluminum, a composite, such as carbon fiber, or the like. The frame <NUM> may also be radiolucent to allow for imaging through the frame <NUM> for determining if correct alignment of the nail <NUM> was achieved.

In the embodiment depicted in <FIG>, the outrigger assembly <NUM> includes a base portion <NUM> and a guide portion <NUM>. The base portion <NUM> includes first or lateral arm <NUM> and a second or distal arm <NUM>. The lateral arm <NUM> extends generally perpendicular to the top surface of the base portion <NUM> and angled in a proximal-distal direction. The lateral arm <NUM> includes a first drill hole <NUM> extending through the arm <NUM> in a medial-lateral direction. The distal arm <NUM> extends generally perpendicular to the base portion <NUM> at the distal end and includes a knob opening or first opening <NUM>, a nail attachment opening or second opening <NUM>, and a nail attachment portion or apparatus <NUM>. The nail attachment portion <NUM> includes an end with an inverted two step profile including a first step or first nail attachment segment <NUM> extending a first distance and a second step or second nail attachment segment <NUM> extending a second distance. The first distance is greater than the second distance.

As shown in <FIG> and <FIG>, the base portion <NUM> may also include two locking openings <NUM> for coupling the base portion <NUM> to the guide portion <NUM>. The locking openings <NUM> extend into the base portion <NUM> from a proximal end. In addition, the base portion <NUM> may include two buttons or release buttons <NUM>. The release buttons <NUM> may include a portion that extends into the locking openings <NUM> to couple to the guide portion <NUM>. When depressed the release buttons <NUM> disengage from the guide portion <NUM> and allow for removal of the guide portion <NUM> from the base portion <NUM>.

The guide portion <NUM> includes a second drill hole <NUM> and a third drill hole <NUM>, as shown in <FIG>, <FIG>, and <FIG>. The second and third drill holes <NUM>, <NUM> may each be positioned at different angles relative to the top surface of the guide portion <NUM>. The third drill hole <NUM> may extend from the top surface of the guide portion <NUM> through a projection <NUM> extending away from a bottom surface of the guide portion <NUM>. The guide portion <NUM> may also include two arms <NUM> for engaging the two locking openings <NUM> of the base portion <NUM>. The arms <NUM> may include a base <NUM> coupled to the guide portion <NUM>, a recessed region <NUM> extending away from the base <NUM>, and a locking projection <NUM> extending away from the recessed region <NUM>. The locking projections <NUM> having a diameter or size larger than a diameter or size of the recessed region <NUM>. Multiple guide portions <NUM> may be provided to engage the base portion <NUM> and each guide portion <NUM> may include openings <NUM>, <NUM> that correspond to the position of the openings <NUM>, <NUM> in different size intramedullary nails <NUM>. Alternatively, it is also contemplated that the guide portion <NUM> may include, for example, a plurality of drill holes <NUM>, <NUM> as necessary to secure the intramedullary nail <NUM> across a joint or fracture. The drill holes <NUM>, <NUM> may each include, for example, multiple holes spaced a small distance apart or multiple nested or overlapping holes to correspond to the openings <NUM>, <NUM> in multiple size intramedullary nails <NUM>.

When the arms <NUM> are inserted into the locking openings <NUM> of the base portion <NUM>, the arms <NUM> may extend past the release buttons <NUM>. The release buttons <NUM> may include, for example, an extension member <NUM> extending through and perpendicular to the locking openings <NUM>, as shown in <FIG> and <FIG>. The extension members <NUM> may include, for example, an opening (not shown) that may be aligned with the locking openings <NUM> in the base portion <NUM>. For example, when the release buttons <NUM> are depressed, the openings (not shown) in the extension members <NUM> may be directly aligned with the locking openings <NUM> to allow for the arms <NUM> to be inserted through the openings in the extension members <NUM>. During insertion, once the locking projections <NUM> pass through the openings (not shown) in the release buttons <NUM>, the buttons <NUM> may be released and the extension members <NUM> may engage the recessed regions <NUM> to secure the guide portion <NUM> to the base portion <NUM>. During removal of the guide portion <NUM>, the release buttons <NUM> may be depressed to align the openings in the extension members <NUM> with the locking openings <NUM>. Next, the guide portion <NUM> may be removed from the base portion <NUM> by pulling the guide portion <NUM> until the locking projections <NUM> pass through the openings (not shown) in the extension members <NUM> and out of the locking openings <NUM>.

The compression device <NUM> slidingly mates with the nail attachment portion <NUM>, as shown in <FIG>. The compression device <NUM> includes a compression member <NUM>, a bolt <NUM>, and an engagement fastener <NUM>. As best seen in <FIG> and <FIG>, the compression member <NUM> has a base <NUM> with a top end <NUM> and a bottom end <NUM>. The compression member <NUM> also includes a protrusion <NUM> at the bottom end <NUM>. A first opening <NUM> is near the top end <NUM> for receiving bolt <NUM>. The first opening <NUM> is threaded to mate with a threaded end <NUM> of bolt <NUM>. A second opening <NUM> is near the bottom end <NUM> and passes through the base <NUM> and protrusion <NUM>. The second opening <NUM> is slidingly engaged with the nail attachment portion <NUM>. The proximal end of the compression member <NUM> is angled from a point between the top and midline of the protrusion <NUM> to approximately a midpoint <NUM> of the bottom end <NUM> of the base <NUM> of the compression member <NUM>. The angled portion of the protrusion <NUM> may include teeth or a texture surface <NUM> for engaging a patient's bone. The angled portion may have an angle that, for example, mimics or corresponds to the angle of the bone it contacts.

As depicted, after the compression member <NUM> is slid over nail attachment portion <NUM>, the compression member <NUM> may be secured to the base <NUM> using the bolt <NUM>, as shown in <FIG>. The threaded end <NUM> of bolt <NUM> is inserted into first opening <NUM> and the threaded end <NUM> mates with the threads of the first opening <NUM>. The bolt <NUM> may also include a stop member (not shown). The stop member (not shown) prevents bolt <NUM> from passing through first opening <NUM>. The bolt <NUM> may also include a drive opening in the head portion <NUM> for rotating the bolt <NUM> to engage and disengage from the compression member <NUM>. Alternatively, a torque indicating or limiting driver (not shown) including, for example, a torque meter may be used to turn the bolt <NUM>.

An alternative compression member <NUM> is also contemplated. The alternative compression member <NUM> may include a force gauge (not shown) to directly measure the compressive force. The force gauge (not shown) may include gauge indicators or markings (not shown) positioned along the longitudinal axis of the base <NUM> to show the compressive force being applied.

As shown in <FIG> and <FIG>, the engagement fastener <NUM> includes a knob <NUM> coupled to a shaft <NUM>. The shaft <NUM> includes a drive opening <NUM> at a first end and a threaded portion <NUM> at a second end. Although the threaded portion <NUM> is shown as only including threads on a portion of the shaft <NUM>, it is also contemplated that the shaft <NUM> could be threaded along its entire length. The drive opening <NUM> may be, for example, hexagonal, square, Phillips or another multi-lobed configuration for coupling with an insertion instrument. The shaft <NUM> is inserted through the nail attachment opening <NUM> and the threaded end <NUM> couples to the intramedullary nail <NUM> to secure the fixation guide <NUM> to the nail <NUM>.

Referring now to <FIG> and <FIG>, the intramedullary nail <NUM> includes a body <NUM> with a closed end <NUM>, a fastening end <NUM>, and openings <NUM>, <NUM>, <NUM>. The openings <NUM>, <NUM>, <NUM> may be, for example, three openings disposed on independent planes and angularly spaced apart relative to each other. By placing the three openings <NUM>, <NUM>, <NUM> at opposing angles oblique to the longitudinal axis of the nail <NUM>, the amount of longitudinal and rotational movement of the nail <NUM> is limited. It is also contemplated that the intramedullary nail <NUM> may include any number of openings <NUM>, <NUM>, <NUM> as may be necessary to secure the nail <NUM> to a patient's bones. The fastening end <NUM> includes an insertion opening <NUM> and an engagement opening <NUM>. The insertion opening <NUM> is a threaded opening along a longitudinal axis in the center of the nail <NUM> parallel to the exterior surface of the nail <NUM>. The insertion opening <NUM> is used to secure the nail <NUM> to the nail attachment portion <NUM> using an engagement fastener <NUM>, such as a thumb screw. The engagement opening <NUM> may include a central axis that is generally transverse the longitudinal axis of the nail <NUM>. The engagement fastener <NUM> is inserted through opening <NUM> and passes through the nail attachment portion <NUM> before being screwed into the insertion opening <NUM> to secure nail <NUM> to the nail attachment portion <NUM>.

The engagement opening <NUM> of the nail <NUM> may be a threaded opening that passes through the exterior surface of nail <NUM> to secure the nail <NUM> to the bone using a fastener, such as a locking screw <NUM>. The locking screw <NUM> is depicted in <FIG> and includes a head <NUM> with a drive opening (not shown) and a threaded shank <NUM>. The drive opening (not shown) may be, for example, a Phillips opening, a flat head opening, a hexagonal opening, or other multi-lobed configuration. The threaded shank <NUM> is designed to engage the patient's bone at the distal end and the threads (not shown) in the engagement opening <NUM> to secure the nail <NUM> in place inside the patient's bones.

The nail <NUM> may also include a fastening end <NUM> with a shape that corresponds to the shape of the end of the nail attachment portion <NUM> to create a tight fit between the nail <NUM> and the attachment portion <NUM>. As depicted in <FIG>, the fastening end <NUM> may have a two-step profile including a first step or first fastening segment <NUM> and a second step or second fastening segment <NUM>. When the nail <NUM> is secured to the outrigger assembly <NUM> the first fastening segment <NUM> aligns with second nail attachment segment <NUM> and second fastening segment <NUM> aligns with first nail attachment segment <NUM>. The engagement fastener <NUM> may then be inserted to secure the nail <NUM> to the outrigger assembly <NUM>. The step profiles of the nail <NUM> and the nail attachment portion <NUM> provide additional stability to the nail <NUM> during insertion into the patient's bone and prevent nail <NUM> from rotating during insertion of the pegs and screws.

The fixation guide <NUM> may be used with at least one guide system <NUM>, as shown in <FIG>. The guide system <NUM> may be used for insertion of pegs or locking screws <NUM> through the intramedullary nail <NUM>. The pegs <NUM> may include a head portion <NUM> with a drive opening (not shown) and a threaded shaft <NUM>. The guide system <NUM> may include an obturator <NUM>, drill guide <NUM>, and a screw guide <NUM>. The guide system <NUM> may also include a pin guide <NUM>, as shown in <FIG>. The obturator <NUM> may include a handle portion <NUM> coupled to a first end of a shaft portion <NUM> and a tip <NUM> at the second end of the shaft portion <NUM>. The drill guide <NUM> may include a grip portion <NUM> at a first end of a shaft portion <NUM>. The drill guide <NUM> may also include a cannulation <NUM> extending from the first end to the second end of the shaft portion <NUM>. The cannulation <NUM> may be, for example, sized to receive the obturator <NUM>. In addition, the drill guide <NUM> may include teeth <NUM> at the second end for engagement with the patient's bones. The screw guide <NUM> may include a grip portion <NUM> at a first end of the shaft portion <NUM>. The screw guide <NUM> may also include a cannulation <NUM> extending from the first end to the second end of the shaft portion <NUM>. The cannulation <NUM> may be, for example, sized to receive the drill guide <NUM>. In addition, the screw guide <NUM> may include teeth <NUM> at the second end for engagement with the patient's bone.

The fixation guide <NUM> may also include a locking guide <NUM>, as shown in <FIG>. The locking guide <NUM> may be used for insertion of a locking screw <NUM> into the intramedullary nail <NUM>. The locking guide <NUM> may include a grip portion <NUM> at a first end of a shaft portion <NUM>. The locking guide <NUM> may also include a cannulation <NUM> extending from the first end to the second end of the shaft portion <NUM>. The cannulation <NUM> may be, for example, sized to receive a drill bit or k-wire drill (not shown) for drilling an opening in the bone for insertion of the locking screw <NUM>. The k-wire drill (not shown) may be used for both drilling the opening in the bone and as a pin for temporary fixation. In addition, the locking guide <NUM> may include threads <NUM> at the second end for engagement with the end of the intramedullary nail <NUM>.

Another embodiment of a fixation guide <NUM> is shown in <FIG>. The fixation guide <NUM> includes an outrigger assembly or frame <NUM> which may be coupled to a compression device <NUM> and an intramedullary nail <NUM>. The frame <NUM> may include a first end <NUM> and a second end <NUM>. The frame <NUM> may also include at least one opening <NUM> allowing for visualization through the frame <NUM> with imaging technology, such as x-rays, as seen in <FIG>. The frame <NUM> is ideally made of a material that is strong enough to prevent deformation during surgery, such as a metal, while also being radiolucent to allow for imaging through the frame <NUM> to determine if correct alignment of the nail <NUM> was achieved. The frame <NUM> may be made of, for example, carbon fiber.

As shown in <FIG>, the frame <NUM> includes a base portion <NUM> and a guide portion <NUM>. The base portion <NUM> may be as described above with reference to <FIG>, which will not be described again here for brevity sake. The guide portion <NUM> includes a second drill hole <NUM> and a third drill hole <NUM>, as shown in <FIG>, <FIG> and <FIG>. The second and third drill holes <NUM>, <NUM> may each be positioned at different angles relative to the top surface of the guide portion <NUM>. The third drill hole <NUM> may extend from the top surface of the guide portion <NUM> through a projection <NUM> extending away from a bottom surface of the guide portion <NUM>. Multiple guide portions <NUM> may be provided to engage the base portion <NUM> and each guide portion <NUM> may include openings <NUM>, <NUM> that correspond to the position of the openings <NUM>, <NUM> in different size intramedullary nails <NUM>. Alternatively, it is also contemplated that the guide portion <NUM> may include, for example, a plurality of drill holes <NUM>, <NUM> as necessary to secure the intramedullary nail <NUM> across a joint or fracture. The drill holes <NUM>, <NUM> may each include, for example, multiple holes spaced a small distance apart or multiple nested or overlapping holes to correspond to the openings <NUM>, <NUM> in multiple size intramedullary nails <NUM>.

The guide portion <NUM> may also include an alignment arm <NUM>, as shown in <FIG>. The alignment arm <NUM> has a first end <NUM> and a second end <NUM>. The first end <NUM> may be coupled or secured to a bottom surface of the guide portion <NUM>. The second end <NUM> may include a pivoting end <NUM> for receiving the pivoting member <NUM>. The pivoting end <NUM> may include, for example, a plurality of teeth, 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 a curved region <NUM>, as shown in <FIG> and <FIG>. The 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 shape formed by the curved regions <NUM> may, for example, match the shape of the pivot protrusion <NUM> of the pivoting member <NUM>. The plurality of teeth <NUM> may also include, for example, a projection or extension <NUM> positioned near the plantar end of the alignment arm <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 arm <NUM>, as shown in <FIG>. The pivoting member <NUM> is of the type described above with reference to <FIG>, which will not be described again here for brevity sake.

As shown in <FIG> and <FIG>, the guide portion <NUM> may include two arms <NUM> for engaging the two locking openings <NUM> of the base portion <NUM>. The arms <NUM> may include a base <NUM> coupled to the guide portion <NUM>, a recessed region <NUM> extending away from the base portion <NUM>, and a locking projection <NUM> extending away from the recessed region <NUM>. The locking projections <NUM> having a diameter or size larger than a diameter or size of the recessed region <NUM>. The arms <NUM> are configured to engage the locking openings <NUM> in the base portion <NUM>. When the arms <NUM> are inserted into the locking openings <NUM> of the base portion <NUM>, the arms <NUM> may extend past the release buttons <NUM>. The release buttons <NUM> may be of the type described above with reference to <FIG> and <FIG> and will not be described again here for brevity sake. In addition, when the release buttons <NUM> are depressed, the openings (not shown) in the extension members <NUM> may be directly aligned with the locking openings <NUM> to allow for the arms <NUM> to be inserted through the openings in the extension members <NUM>. During insertion, once the locking projections <NUM> pass through the openings (not shown) in the release buttons <NUM>, the buttons <NUM> may be released and the extension members <NUM> may engage the recessed regions <NUM> to secure the guide portion <NUM> to the base portion <NUM>. During removal of the guide portion <NUM>, the release buttons <NUM> may be depressed to align the openings in the extension members <NUM> with the locking openings <NUM>. Next, the guide portion <NUM> may be removed from the base portion <NUM> by pulling the guide portion <NUM> until the locking projections <NUM> pass through the openings (not shown) in the extension members <NUM> and out of the locking openings <NUM>.

The compression device <NUM> may be of the type described above with reference to <FIG>, which will not be described again here for brevity sake. In addition, the engagement fastener <NUM>, as shown in <FIG>, may be of the type described above with reference to <FIG> and <FIG>. Thus, the fixation guide <NUM> may be assembled in the same way as described above, which will not be described again here for brevity sake.

The surgical method for inserting an intramedullary nail <NUM> into a patient's foot <NUM> across a joint is shown in <FIG>. As shown in <FIG>, the method may include preparing a patient's joint for insertion of an intramedullary nail <NUM>. The method may also include using an alignment guide system to insert a k-wire across the patient's joint <NUM> and removing the alignment guide system from the joint <NUM>. The method may further include drilling over the k-wire to form a cavity for the intramedullary nail <NUM> and securing the intramedullary nail to a fixation guide device <NUM>. Next, the method may include inserting the intramedullary nail into the cavity <NUM> and inserting at least one first peg into a closed end of the intramedullary nail <NUM>. In addition, the method may include using the fixation guide device to compression the joint <NUM> and inserting at least one second peg into a fixation end of the intramedullary nail <NUM>. Further, the method may include detaching and removing the fixation guide device <NUM> and inserting a fastening screw into the fastening end of the intramedullary nail <NUM>.

Referring now to <FIG>, the method may be described in greater detail. For example, the method may include making an incision over a joint, for example, a medial or dorsomedial incision over a first tarsometatarsaljoint. Then, tissue dissection may be performed to expose the joint. Optionally, the cartilage may be resected and removed from the joint, then subchondral bone preparation may be performed. The cartilage resection may be performed, for example, using a cut guide <NUM>, as shown in <FIG>. The cut guide <NUM> may include a body or base member <NUM> The body <NUM> may include at least one first slot <NUM> on a first side of the body <NUM> and at least one second slot <NUM> on a second side of the body <NUM>. The cut guide <NUM> may also include a fin or paddle <NUM> extending from a bottom surface of the body <NUM>. The fin <NUM> is sized and shaped to fit into a joint between two bones, for example, the metatarsal and cuneiform bones. The bottom surface of the body <NUM> may be, for example, anatomically curved to mate with the surface of the dorsal surface of the patient's bones. The guide <NUM> may also include a first arm <NUM> extending from a first end of the body <NUM> and a second arm <NUM> extending from a second end of the body <NUM>. The first arm <NUM> may extend in a proximal direction while the second arm <NUM> may extend in a distal direction. The first arm <NUM> may have a bottom surface <NUM>, which may be anatomically curved to correspond to the patient's bones. The first arm <NUM> may also include at least one hole <NUM> for securing the cut guide <NUM> to a first bone for cutting a portion of the first bone. The second arm <NUM> may include at least one hole <NUM> for securing the cut guide <NUM> to a second bone for cutting a portion of the second bone. If a bone graft or implant (not shown) is needed to restore length to the patient's toe after the resection, the bone graft or implant (not shown) may then be inserted into the joint. The bone graft or implant (not shown) may be, for example, shaped to match the shape of the adjacent bones <NUM>, <NUM>.

The method may also include inserting a k-wire <NUM>, for example, through the metatarsal bone <NUM> and into the medial cuneiform bone <NUM> across the first tarsal-metatarsal joint, as shown in <FIG>. The k-wire <NUM> may be placed from plantar medial distal to dorsal lateral proximal. Next, a pivoting member or sphere wire <NUM> may be obtained and placed at the proximal plantar medial aspect of the medial cuneiform <NUM>, as shown in <FIG>. Then, the pivoting end <NUM> of the alignment guide <NUM> may be coupled to the pivoting protrusion <NUM> of the pivoting member <NUM>. Once coupled the alignment guide <NUM> may pivot about the pivoting protrusion <NUM> of the pivoting member <NUM>.

Referring now to <FIG>, an optional nail positioning guide <NUM> is shown. The nail positioning guide <NUM> may be used to assist with placement of a k-wire <NUM>. The nail positioning guide <NUM> may include a base <NUM> and a handle <NUM> extending away from a top surface of the base <NUM> near the first end. The first end of the base <NUM> also includes a projection or leg <NUM> extending from a bottom surface of the base <NUM>. The base <NUM> may also include at least one alignment opening <NUM> near the first end and an alignment marking <NUM> extending at least partially between the first end and the second end. The method may optionally include inserting the projection <NUM> into the central lateral aspect of the first tarsal-metatarsal joint. Once the projection <NUM> is inserted into the joint, the at least one alignment opening <NUM> is positioned on the patient's bone <NUM> at the desired start position for the k-wire <NUM>. Next, a pilot hole may be formed in the patient's bone <NUM> through the at least one alignment opening <NUM> for appropriately lining up the k-wire for insertion.

Next, if not already coupled to the pivoting member <NUM>, the alignment guide <NUM> may be coupled to the pivoting member <NUM>, as shown in <FIG>. A guide sleeve insert <NUM> may then be inserted into the first opening <NUM> in the distal end of the guide <NUM> and placed into contact with the patient's bone <NUM>. The trajectory of the guide sleeve insert <NUM> is then aligned for the desired starting position of the k-wire <NUM>, which matches the desired trajectory of the nail <NUM>. If the nail positioning guide <NUM> was used, the distal end of the guide sleeve insert <NUM> may be aligned to the pivot hole in the bone <NUM>. Specifically, the channel <NUM> of the guide sleeve insert <NUM> may be aligned over the pivot hole in the bone <NUM>. Then, the k-wire <NUM> may be inserted through the guide sleeve insert <NUM> and into the patient's bone <NUM> until it contacts the pivoting protrusion <NUM> of the pivoting member <NUM> or reaches the proximal plantar aspect of the medial cuneiform <NUM>. Placement of the k-wire <NUM> may then be confirmed using fluoroscopy. Once the desired placement of the k-wire <NUM> is achieved, the sleeve insert <NUM> may be removed from the k-wire <NUM> and guide <NUM> removed from the pivoting member <NUM>. After the sleeve insert <NUM> and guide <NUM> are removed, the length of the k-wire <NUM> may be measures with a nail depth gauge (not shown).

A cannulated drill bit (not shown) of a drill may then be inserted over the k-wire <NUM> and drilled into the bones <NUM>, <NUM> until the pivoting member <NUM> is contacted. Once an opening is drilled over the k-wire <NUM>, the pivoting member <NUM> may be removed from the patient's bone <NUM>. Next, a fixation guide <NUM> may be obtained and assembled including selecting and attaching a guide portion <NUM> that corresponds to the measured size of the inserted nail <NUM>. The nail <NUM> may also be coupled to the fixation guide <NUM>. The engagement fastener <NUM> is then inserted into the guide <NUM> and coupled to the selected nail <NUM>. The nail <NUM> may be coupled to the guide <NUM> by turning the engagement fastener <NUM> in a clockwise direction to thread the engagement fastener <NUM> into the inside of the nail <NUM>. Then the assembled alignment guide <NUM> may be inserted into the drilled hole, as shown in <FIG>. The nail <NUM> may be inserted until the contoured piece on the frame <NUM> is flush with the dorsal aspect of the first metatarsal. Fluoroscopy may then be used to confirm the size of the nail <NUM> and the placement of the nail. The pivoting member <NUM> may then be removed.

Referring now to <FIG> and <FIG>, an obturator <NUM> may be inserted into the drill guide <NUM> and the drill guide <NUM> may be inserted into a screw guide <NUM>. The assembled guide system <NUM> may then be inserted into the second drill hole <NUM>, as shown in <FIG>. A pin guide system <NUM> may then be inserted into the third drill hole <NUM>. The pin guide system <NUM> may include a screw guide <NUM>, a k-wire guide <NUM> sized to fit inside of the screw guide <NUM>, and a k-wire <NUM> sized to fit within the k-wire guide <NUM>. The k-wire <NUM> may be inserted through the k-wire guide <NUM>, into the patient's bone <NUM> and through an opening <NUM> in the nail <NUM>, as shown in <FIG>. Next, the obturator <NUM> may be removed from the drill guide <NUM> and a drill bit (not shown) or k-wire drill may be inserted through the drill guide <NUM> to drill into the patient's bone <NUM>. Then, the drill guide <NUM> may be removed from the screw guide <NUM> and a depth gauge (not shown) is inserted through the screw guide <NUM> to measure for selecting a first threaded peg <NUM>. The selected threaded peg <NUM> may then be inserted through the screw guide <NUM> into the bone <NUM> through the opening <NUM> in the nail <NUM>, as shown in <FIG>. After the threaded peg <NUM> is inserted the screw guide <NUM> may be removed from the fixation guide <NUM>.

Next, the k-wire <NUM> and k-wire guide <NUM> may be removed from the screw guide <NUM> in the third drill hole <NUM>. A drill guide (not shown), such as guide <NUM>, may then be inserted into the screw guide <NUM>. A drill bit (not shown) may then be inserted through the drill guide (not shown) to drill into the patient's bone <NUM>. The drill guide (not shown) may then be removed from the screw guide <NUM> and depth gauge (not shown) may be inserted through the screw guide <NUM> to measure for selecting a second threaded peg <NUM>. The selected threaded peg <NUM> may be inserted through the screw guide <NUM> into the bone <NUM> through the opening <NUM> in the nail <NUM>, as shown in <FIG>. Once the threaded pegs <NUM> are inserted through the nail openings <NUM>, <NUM>, the screw guides <NUM> may be removed from the second and third drill holes <NUM>, <NUM>. Then, the temporary fixator or k-wire <NUM> may be removed from across the joint.

With continued reference to <FIG>, a solid driver <NUM> may be used to tighten the bolt <NUM> of the fixation guide <NUM> to translate the compression member <NUM> creating compression across the arthrodesis site. Compression is created between the medial cuneiform bone <NUM> secured to the nail <NUM> with pegs <NUM> and the compression member <NUM> contacting and translating the metatarsal bone <NUM> into closer contact with the medial cuneiform bone <NUM>, as shown in <FIG>. The compression member <NUM> pushes the metatarsal bone <NUM> into contact with the medial cuneiform bone <NUM> along the longitudinal axis of the nail <NUM>. The compression device <NUM> provides controlled compression across the fusion joint to produce the proper surface contact stress between the metatarsal bone <NUM> and medial cuneiform bone <NUM> to promote osteosynthesis and enable proper healing. The protrusion <NUM> of the compression device <NUM> includes a convex surface for applying a central axis force and contact compression to bones having different topographical morphologies of bone. The end of the protrusion <NUM> is angled for oblique contact with the patient's bone and the teeth or textured surface <NUM> provide a gripping surface to assist with gripping the bone during compression of the joint.

Once the desired compression is achieved across the joint, a third peg <NUM> may be inserted through the nail opening <NUM>, as shown in <FIG>. The third peg <NUM> may be inserted by, for example, inserting a coupled obturator <NUM>, drill guide <NUM> and screw guide <NUM> through the first drill hole <NUM> of the fixation guide <NUM>. The obturator <NUM> may then be removed from the drill guide <NUM> and a drill bit (not shown) may be inserted through the drill guide <NUM> to drill into the patient's bone <NUM>. Then, the drill guide <NUM> may be removed from the screw guide <NUM> and a depth gauge (not shown) may be inserted through the screw guide <NUM> to measure for selecting the third threaded peg <NUM>. The selected threaded peg <NUM> may then be inserted through the screw guide <NUM> into the bone <NUM> through the opening <NUM> in the nail <NUM>, as shown in <FIG> and <FIG>. After the threaded peg <NUM> is inserted the screw guide <NUM> may be removed from the fixation guide <NUM>.

Next, as shown in <FIG>, the fixation guide <NUM> may be removed from the patient's foot <NUM>. The fixation guide <NUM> may be removed by turning the knob <NUM> of the engagement fastener <NUM>. As the knob <NUM> is turned counterclockwise, the threaded portion <NUM> of the engagement fastener <NUM> disengages the insertion opening <NUM> in the nail <NUM>. Then, the fixation guide <NUM> may be removed from the patient's foot <NUM>, as shown in <FIG>. Next, a locking guide <NUM> may be placed into the insertion opening <NUM> of the nail <NUM>, as shown in <FIG>. A drill bit or k-wire drill <NUM> may then be used to drill an opening through the metatarsal <NUM>. A depth gauge (not shown) may be inserted through the locking guide <NUM> to measure the size locking screw <NUM> needed, as shown in <FIG>. Then, the depth gauge (not shown) and locking guide <NUM> may be removed and the locking screw <NUM> may be inserted through the nail opening <NUM> using a driver <NUM>, as shown in <FIG>. The locking screw <NUM> is inserted into the metatarsal <NUM> and the placement and size are then confirmed using fluoroscopy.

The method may further include a removal or revision procedure. The removal procedure may include removing the locking screw <NUM> from the intramedullary nail <NUM> using the driver <NUM>, as shown in <FIG>. Next, a fixation guide <NUM> may be selected include the guide portion <NUM> that corresponds to the nail <NUM> being removed. The frame <NUM> of the fixation guide <NUM> may be coupled to the nail <NUM> and the guide portion <NUM> may be inserted and locked to the frame <NUM>, as shown in <FIG>. An engagement fastener <NUM> may then be inserted into the frame <NUM> and turned to thread into the insertion opening <NUM> in the nail <NUM>. Once the fixation guide <NUM> is secured to the nail <NUM>, a screw guide <NUM> may be inserted into the second drill hole <NUM>, as shown in <FIG>. A driver <NUM> may then be inserted into the cannulation <NUM> of the screw guide <NUM> and inserted into the head of the first peg <NUM>. The driver <NUM> may be rotated to remove the first peg <NUM> from the nail opening <NUM> and out through the screw guide <NUM>. Next, the screw guide <NUM> may be removed from the second drill hole <NUM> and inserted into the third drill hole <NUM>. The driver <NUM> may then be inserted through the screw guide <NUM> and inserted into the head of the second peg <NUM>. Next, the second peg <NUM> may be removed from the nail opening <NUM> and out through the screw guide <NUM>. The screw guide <NUM> may then be removed from the third drill hole <NUM> and inserted into the first drill hole <NUM>. The driver <NUM> may then be inserted through the screw guide <NUM> and inserted into the head of the third peg <NUM>. Next, the third peg <NUM> may be removed from the nail opening <NUM> and out through the screw guide <NUM>. Finally, a slaphammer <NUM> may be attached to the engagement fastener <NUM> of the fixation guide <NUM>. Then the slaphammer <NUM> may be used to back the nail <NUM> out of the patient's foot <NUM>.

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 fixation system, comprising:
an alignment guide system (<NUM>) for forming an opening across a joint, the alignment guide system (<NUM>) comprising:
an alignment wire (<NUM>);
a targeting guide (<NUM>) with a first end and a second end, the targeting guide (<NUM>) comprising:
a body (<NUM>) with a first end (<NUM>) and a second end (<NUM>);
a first opening (<NUM>) positioned at the first end (<NUM>) of the body (<NUM>);
a pivot assembly (<NUM>) with a first end (<NUM>) and a second end (<NUM>),
wherein the first end of the pivot assembly (<NUM>) is configured to couple with a coupling region (<NUM>) positioned at the second end (<NUM>) of the body (<NUM>) of the targeting guide (<NUM>), the pivot assembly (<NUM>) comprising:
a slot (<NUM>) inset into the first end (<NUM>) and configured to receive the coupling region (<NUM>) of the body (<NUM>);
a pivoting end (<NUM>) positioned at the second end (<NUM>) of the pivot assembly (<NUM>) and configured to receive and rotatably engage the alignment wire (<NUM>); and
a pivot slot (<NUM>) positioned at the second end (<NUM>) of the pivot assembly (<NUM>), wherein the pivot slot (<NUM>) is configured to
receive the alignment wire (<NUM>);
a guide sleeve insert (<NUM>) engaging the first opening (<NUM>) in the first end (<NUM>) of the body (<NUM>) of the targeting guide (<NUM>); and
a fixation guide device (<NUM>, <NUM>) for inserting an intramedullary nail into the opening.