Patent Description:
The disclosed apparatuses, systems, and methods relate to surgical tools. More specifically, the disclosed apparatuses, systems, and methods relate to surgical tools for performing ankle surgery, including total ankle surgery.

The ankle is a joint that acts much like a hinge. The joint is formed by the union of the three bones. The ankle bone is the talus. The top of the talus fits inside a socket that is formed by the lower leg, including the tibia and the fibula. Arthritis, bone degeneration, and/or injury can cause ankle joint deterioration resulting in pain, reduced range of motion, and decreased quality of life. In many cases, physicians recommend ankle replacement surgery with an implant. One example of such an implant is the INBONE™ Total Ankle System available from Stryker, of Memphis, TN, although one of ordinary skill in the art will understand that the disclosure is not limited to such implants. The process of implanting an ankle replacement system typically includes the use of sizing and/or cutting (e.g., drilling and/or resection) guides.

Document <CIT> relates to a patient-specific ankle arthroplasty guide. Document <CIT> relates to a laser-based implant alignment and resection guide systems and related methods.

Document <CIT> relates to an instrument for intra-operative implant templating using fluoroscopy. The instrument comprises a peg and a ring which are used for anterior-posterior alignment.

A surgical guide according to the invention is defined in claim <NUM>. Further embodiments of the invention are set out in the dependent claims. The disclosed guides, systems, and methods provide enhanced durability and have a reduced size, which improves the ability of the surgeon to manipulate the guide during surgery. Further, the disclosed guides, systems, and methods provide enhanced visibility of the surface(s) to be cut during the surgery while reducing the number of components used compared to conventional instrumentation, which yields a more streamlined and efficient method.

As described above, in some embodiments, a surgical guide includes a body has a shape that corresponds to a shape of an implant. In some embodiments, an outer periphery of the body defines the shape that corresponds to the shape of the implant. The body defines an opening and at least one hole that is sized and configured to receive a tool therein. A first alignment feature may be coupled to the body. The first alignment feature is configured to facilitate alignment of the surgical guide with a first anatomic plane.

In some embodiments, the first opening is defined between a first side of the body, a second side of the body, a third side of the body, and a fourth side of the body.

In some embodiments, a second alignment feature extends from the second side of the body and is configured to facilitate alignment of the surgical guide with a second anatomic plane that is different from the first anatomic plane.

In some embodiments, first and second legs may extend from the first side of the body. Each of the first and second legs may define a respective hole that is sized and configured to receive a connection feature of another surgical guide.

In some embodiments, the connection feature includes a dowel.

In some embodiments, at least one of the first and second legs includes at least one step. The at least one step may provide a visual indication as to a location of a surface of a prosthesis to be implanted.

In some embodiments, the first and second legs include a plurality of steps.

In some embodiments, the first and second legs include a beveled surface.

In some embodiments, the first anatomic plane is a sagittal plane, and the second anatomic plane is a frontal plane.

In some embodiments, the first alignment feature includes a first component and a second component. The first component may include an opening, and the second component may include a projection that terminates in a shape that is complementary to a shape of the opening.

In some embodiments, the opening is defined by a block.

In some embodiments, the second alignment feature includes an opening and a projection that terminates in a shape that is complementary to a shape of the opening.

In some embodiments, the projection terminates from a flange that has a cross-sectional geometry to facilitate the coupling of the surgical guide to another surgical tool. In some embodiments the cross-sectional geometry has a trapezoidal shape.

In some embodiments, the at least one hole includes a first hole, a second hole, and a third hole disposed between the first hole and the second hole.

In some embodiments, the first hole is defined by a first bushing that extends from the body, the second hole is defined by a second bushing that extends from the body, and the third hole is defined by a third bushing that extends from the body.

In some embodiments, the body defines at least one slot that is disposed between the opening and the second side. The at least one slot may be sized and configured to receive a tool, including at least one of a depth indicating tool or a blade of a cutting tool.

In some embodiments, at least one of a posterior side or an anterior side of the body includes a notch configured to provide a visual indication of a location of at least one surface of a prosthesis to be implanted when the surgical guide is viewed in a sagittal plane.

In some embodiments, the body includes a joint line indicator.

In some embodiments, the joint line indicator includes at least one projection extending into the opening defined by the body.

In some embodiments, the joint line indicator includes a notch formed in at least one of a posterior side and/or an anterior side of the body.

In some embodiments, a first guide includes a first side, a second side, a third side, and a fourth side. The third and fourth sides extend between the first and second sides. The body defines a first opening between the first side, the second side, the third side, and the fourth side. The body may further define a first hole and a second hole each sized and configured to receive at least one fixation and/or and a cutting tool therein. A first alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a first anatomic plane, and a second alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a second anatomic plane. In some embodiments, the first anatomic plane and the second anatomic plane are the same. In some embodiments, the first anatomic plane and the second anatomic plane are different.

In some embodiments, the first guide includes first and second legs extending from the first side of the first guide body. A gap may be defined between the first leg, the second leg, and the first side of the first guide body.

In some embodiments, the system includes a second guide. The second guide may have a transverse beam that extends between a first arm and a second arm. The second guide may be configured to be coupled to the first guide.

In some embodiments, first and second protrusions extend from the transverse beam of the second guide. The first and second protrusions may be sized and configured to be received in respective connection features defined by the first and second legs of the first guide body for coupling the second guide to the first guide. In some embodiments, each connection feature includes a hole. In some embodiments, each connection feature includes a slot.

In some embodiments, each of the first and second arms of the second guide define at least one connection feature for receiving an elongate radiopaque device therein. In some embodiments, the at least one connection feature includes a hole. In some embodiments, the at least one connection feature includes a slot.

In some embodiments, the system includes a drill bit that extends from a first end to a second end. The first end may be configured to be coupled to a driving tool, and the second end may include at least one cutting surface. The drill bit may include at least one indicia located along its length at a distance from the second end. The distance of the at least one indicia from the second end may correspond to a length of an implant. The drill bit may be sized and configured to be received in a third hole defined by the first guide body.

In some embodiments, the third hole defined by the first guide body is located between the first hole and the second hole.

In some embodiments, the at least one indicia includes a plurality of indicia. Each indicia of the plurality of indicia may be disposed at a respective distance from the second end of the drill bit. The respective distance may correspond to a respective length of a different implant.

In some embodiments, a method includes coupling a first guide to an adjustment block, aligning a fluoroscope with the first guide in at least one anatomic plane using at least one of a first alignment feature and a second alignment feature of the first guide, and securing the first guide to a tibia once a desired alignment of the first guide has been achieved. In some embodiments, the second guide includes first and second arms that are coupled together a transverse beam.

In some embodiments, a method includes coupling a second guide to the first guide and coupling the second guide to the first guide includes inserting at least one protrusion extending from the transverse beam of the second guide into at least one connection feature of the first guide. In some embodiments, the at least one connection feature of the first guide includes at least one hole defined by the first guide. In some embodiments, the at least one connection feature of the first guide includes at least one slot defined by the first guide.

In some embodiments, a method includes determining a size of an implant to be implanted. The determining may be based at least in part on view of the first guide under fluoroscopy.

In some embodiments, determining the size of the implant includes inserting a drill bit into a hole defined by the first guide and into the tibia, and identifying an indicia disposed along a length of the drill bit.

In some embodiments, a method includes preparing a tibia for resection by inserting a drill into a first corner drill hole defined by the first guide.

In some embodiments, a method includes inserting the drill into a second corner drill hole defined by the first guide.

Further disclosed herein is a surgical guide that includes a body having a shape that corresponds to a shape of an implant to be implanted, wherein the body defines a first opening and at least one hole that is sized and configured to receive a tool, wherein a first alignment feature configured to facilitate alignment of the surgical guide with a first anatomic plane is coupled to the body.

These and other features and advantages of the apparatuses and methods described herein will be more fully disclosed in, or rendered obvious by, the following detailed description of the preferred embodiments, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts.

This description of the exemplary embodiments is to be read in connection with the accompanying drawings, which are to be considered part of the entire written description.

The disclosed guides provide enhanced durability and have a reduced size, which improves the ability of the surgeon to manipulate the guide during surgery. Further, the disclosed guides provide enhanced visibility of the surface(s) to be cut during the surgery while reducing the number of components used compared to conventional instrumentation, which yields a more streamlined and efficient method.

In addition, this description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as "lower," "upper," "horizontal," "vertical," "proximal," "distal," "above," "below," "up," "down," "top" and "bottom," as well as derivatives thereof (e.g., "horizontally," "downwardly," "upwardly," etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as "connected" and "interconnected," refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.

<FIG> illustrate one example of a combination sizing and drill guide <NUM> in accordance with some embodiments. Guide <NUM> includes a body <NUM> extending from an inferior side <NUM> to a superior side <NUM>, as best seen in <FIG>. Body <NUM> further includes opposed sides <NUM>, <NUM> (<FIG>), an anterior side <NUM>, and a posterior side <NUM>, as best seen in <FIG>. The profile of guide <NUM>, such as defined by inferior side <NUM>, superior side <NUM>, and opposed sides <NUM>, <NUM>, which is shown has having a generally trapezoidal shape, may correspond to the profile of a prosthesis component. For example, the profile and/or outer periphery of guide <NUM> defined by inferior side <NUM>, superior side <NUM>, and opposed sides <NUM>, <NUM> may correspond to the tibial and/or talar prosthesis components of a total ankle replacement system, although one of ordinary skill in the art will understand that body <NUM> of guide <NUM> may have a shape that corresponds to other types of implants.

In some embodiments, body <NUM> may be formed from a rigid radiopaque material, such as a surgical grade metal. One of ordinary skill in the art will understand that guide <NUM> may be formed from other materials, such as a combination of radiolucent (e.g., Radel® polyphenylsulfone (PPSU), available from Solvay) and radiopaque (e.g., stainless steel, aluminum, titanium, cobalt, chromium) materials. Guide <NUM> may be machined from a single block of material, molded, or formed using an additive manufacturing process (e.g., Direct Metal Laser Sintered (DMLS), Electron Beam Melting (EBM)).

The inferior side <NUM> may include a pair of spaced apart legs <NUM>, <NUM> that extend inferiorly from body <NUM>. A gap <NUM> is defined between the legs <NUM>, <NUM> and inferior side <NUM>. Gap <NUM> is shown as having a generally rectangular shaped in which its length (e.g., space between legs <NUM>, <NUM>) is greater than its width (e.g., length of legs <NUM>, <NUM>), but it should be understood that gap <NUM> may have a square shape in which the length and width dimensions are equal. Further, one of ordinary skill in the art will understand that gap <NUM> may have other shapes (e.g., arced, triangular, etc.) to facilitate visualization of the underlying bone. In some embodiments, a crossbar (not shown) may extend across gap <NUM>, i.e., from leg <NUM> to leg <NUM>. The crossbar may have a surface (e.g., a lower or inferior surface) that corresponds to a location of a potential resection line (e.g., the location at which a planar surface of a talus is formed) as will be described in greater detail below.

In some embodiments, each leg <NUM>, <NUM> may include one or more holes and/or slots. For example, and as shown in <FIG>, leg <NUM> may define a first hole <NUM> and a second hole <NUM> located above (e.g., superior to) first hole <NUM>, and leg <NUM> may define a first hole <NUM> and a second hole <NUM> located above (e.g., superior to) first hole <NUM>. Holes <NUM>, <NUM>, <NUM>, <NUM> are sized and configured to receive a pin or other engagement feature for coupling another surgical guide to guide <NUM>. For example, holes <NUM>, <NUM>, <NUM>, <NUM> may be sized and configured to receive an engagement feature for coupling an alignment guide, such as an angel wing alignment guide <NUM> described below and illustrated in <FIG>, to the guide <NUM>, although one of ordinary skill in the art will understand that other guides or surgical device may be coupled to guide <NUM> via one or more holes <NUM>, <NUM>, <NUM>, <NUM>. One of ordinary skill in the art will understand that the features could be reversed, where the angel wing alignment guide <NUM> possess holes <NUM>, <NUM> and guide <NUM> defines projections <NUM>-<NUM>, <NUM>-<NUM>.

In some embodiments, one of more of holes <NUM>, <NUM>, <NUM>, <NUM> may be oblong or take the form of slots to facilitate proper alignment and coupling of other tools and guides. For example, in the example illustrated in <FIG>, holes <NUM>, <NUM> are shown having an oblong shape, and it should be appreciated that one or more of the other holes <NUM>, <NUM>, <NUM>, <NUM> or combinations of holes may have other forms and shapes.

Body <NUM> also defines a central opening <NUM> located between inferior side <NUM> and superior side <NUM>. In some embodiments, one or more projections <NUM>-<NUM>, <NUM>-<NUM> extend inwardly into opening <NUM>. Projections <NUM>-<NUM>, <NUM>-<NUM> collectively may be referred to as a "joint-line indicator <NUM>," as they are located to provide a surgeon or other medical professional an indication as to the location of the joint line of a prosthesis that is to be implanted. While projections <NUM>-<NUM>, <NUM>-<NUM> are shown as being pointed or arrow shaped, one of ordinary skill in the art will understand that the projections <NUM>-<NUM>, <NUM>-<NUM> may take other shapes and forms to provide a joint line indicator <NUM>.

In some embodiments, a number of holes are provided adjacent to superior side <NUM> of body <NUM> above opening <NUM>. For example, body <NUM> may define holes <NUM>, <NUM>; holes <NUM>, <NUM>; and hole <NUM>. Holes <NUM>, <NUM> may be referred to as corner drill holes <NUM>, <NUM> and be sized and configured to identify the location of the superior tibial resection intersections. Put another way, the corner drill holes <NUM>, <NUM> are located at the superior medial and lateral corners of the tibial resection. In some embodiments, the corner drill holes <NUM>, <NUM> may be used to guide a surgical tool, such as a drill, to perform work on bone (e.g., drill into bone).

Holes <NUM>, <NUM> are shown as being positioned adjacent to holes <NUM>, <NUM> such that hole <NUM> is located between hole <NUM> and hole <NUM> and hole <NUM> is located between hole <NUM> and hole <NUM>. As will be understood by one of ordinary skill in the art, the position of holes <NUM>, <NUM> could be located in various arrangements to facilitate boney fixation. Holes <NUM>, <NUM> are sized and configured to receive a pin, k-wire, or other fixation device therein. As will be understood by one of ordinary skill in the art, a fixation device may be received within one or both of holes <NUM>, <NUM> to secure guide <NUM> to bone. Hole <NUM> is sized and configured to receive a surgical tool, such as a drill bit, pin, and/or depth gauge, therein. For example, a pin, drill, or other surgical tool may be inserted into hole <NUM> to determine an appropriate length for an implant, as best seen in <FIG>.

In some embodiments, guide <NUM> may include one or more alignment features, including one or more alignment features that extend superiorly from superior side <NUM>. For example, a first alignment feature, which may be a sagittal alignment feature, may extend from superior side <NUM> and include at least a first component <NUM>-<NUM> and a second component <NUM>-<NUM>. In some embodiments, the first component <NUM>-<NUM> takes the form of a block having a circular opening <NUM> (<FIG>), and second component <NUM>-<NUM> takes the form of a projection that terminates in a circular shape <NUM> (<FIG>). As best seen in <FIG>, when viewed from the side and the fluoroscope is properly aligned with the guide <NUM>, the circular shape <NUM> will appear within an approximate center of the circular opening <NUM> defined by the first component <NUM>-<NUM> (e.g., a bullseye). If the fluoroscope is not properly aligned, then the circular shape <NUM> will not appear centered within circular opening <NUM>. Although the first and second components <NUM>-<NUM>, <NUM>-<NUM> are described as including circular shapes and openings, one of ordinary skill in the art will understand that other shapes, which may be complementary to one another, may be used to provide a fluoroscopic alignment check.

In some embodiments, guide <NUM> may include a second alignment feature, which may be a coronal alignment feature and may also extend from superior side <NUM>. Second alignment feature includes a base <NUM> and a flange <NUM> that extends in an anterior direction from base <NUM>. Base <NUM> defines a hole <NUM> that extends entirely through base <NUM>, as best seen in <FIG>. Flange <NUM> extends from base <NUM> in an anterior direction and includes a projection <NUM> along its length. In some embodiments, flange <NUM> has a trapezoidal cross-sectional geometry that is sized and configured to form a dovetail connection with another surgical tool, such as the adjustment block <NUM> with a tool holder <NUM> disclosed in <CIT>, which was incorporated by reference in its entirety above. However, it should be understood that flange <NUM> may have other cross-sectional geometries to facilitate coupling to other surgical tools.

As best seen in <FIG>, projection <NUM> extends from flange <NUM> in an inferior direction and terminates with a circular shape. When a fluoroscope is properly aligned with guide <NUM> in the coronal or frontal plane, projection <NUM> will appear to be disposed within the center of hole <NUM> (e.g., a bullseye) to provide a fluoroscopic alignment check. Although hole <NUM> and projection <NUM> are described and shown as having circular shapes, one of ordinary skill in the art will understand that hole <NUM> and projection <NUM> may have other shapes.

The location of base <NUM> along superior side <NUM> may be varied. For example, while base <NUM> is shown as being positioned along the posterior side <NUM>, it should be understood that base <NUM> may be located closer to or at the anterior side <NUM> along superior side <NUM>. In some embodiments, base <NUM> may define a second hole <NUM> that is aligned with circular opening <NUM> defined by first component <NUM>-<NUM> of the first alignment feature such that second component <NUM>-<NUM> may be visible through both circular opening <NUM> and hole <NUM>, as best seen in <FIG>. However, it should be understood that hole <NUM> may be omitted depending on the relative positioning of the first alignment feature and base <NUM>.

Although the first and second alignment features are described as extending from superior side <NUM> of guide <NUM>, it should be understood that the first and/or second alignment features may be otherwise located on guide <NUM>. For example, one or both of the first and second alignment features may extend from other sides or surfaces of the guide, such as the anterior side <NUM>, the inferior side <NUM> or may be otherwise incorporated into the body <NUM> of guide <NUM>. Additionally or alternatively, the first and/or second alignment features may be positioned on another guide that may be coupled to guide <NUM>. For example, the first, second, and/or additional alignment features could be disposed on or otherwise provided by the angel wing alignment guide <NUM>, which is described in greater detail below.

Referring to <FIG>, it can be seen that the posterior side <NUM> may be angled or include a beveled surface <NUM>. Beveled surface <NUM> may extend away from posterior side <NUM> in an anterior direction to provide clearance for the talus when guide <NUM> is positioned against a tibia. In some embodiments, posterior side <NUM> may include a notch or slot <NUM> that extends inwardly (e.g., in an anterior direction). Notch <NUM> is aligned with the surface of superior side <NUM> and provides a visual indicator as to the upper surface of a prosthesis (not shown) that corresponds to guide <NUM>. For example, guide <NUM> may be provided in one or more sizes, which corresponding to one or more sizes of available implants, such as a tibial implant of a total ankle prosthesis. When guide <NUM> is viewed under fluoroscopy in the sagittal plane, notch <NUM> provides the surgeon with an indication as to where the tibia will be resected and where the upper (e.g., superior) surface of the tibial component of the ankle prosthesis will be located. One or more additional notches may be provided along the posterior side <NUM> to identify the location of the lower (e.g., inferior) surface of the tibial component or talar component or upper (e.g., superior) surface of the talar component, as will be understood by one of ordinary skill in the art. Further, it should be understood that while notch <NUM> is shown being located along the posterior side <NUM> so that the notch is positioned adjacent to bone, other types of visual indicators may be used and placed at other locations on body <NUM> of guide <NUM>.

Guide <NUM> may include other visualization indicators. For example and referring again to <FIG>, legs <NUM>, <NUM> may include one or more steps, such as steps <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, for providing a surgeon with a visual indication as to the location of a lower or upper surface of a prosthesis (e.g., a talar prosthesis). As noted above, in some embodiments, multiple implant sizes may be provided, including sizes having multiple heights, e.g., short and tall heights. Steps <NUM>-<NUM>, <NUM>-<NUM> (collectively, "steps <NUM>") may correspond to a short or chamfer sized implant, and steps <NUM>-<NUM>, <NUM>-<NUM> (collectively, "steps <NUM>") may correspond to a tall or flat-top implant. Further, in some embodiments, a respective surface of steps <NUM> may be coplanar with the inferior surface <NUM>, and steps <NUM> may be coplanar with a crossbar (not shown) that extends between legs <NUM>, <NUM>, if provided.

In some embodiments, the guide <NUM> may include one or more indicia, such as indicia <NUM>-<NUM>, <NUM>-<NUM> (collectively, "indicia <NUM>") located on the anterior side <NUM> (<FIG>), indicia <NUM> located on side <NUM> (<FIG>), and indicia <NUM> located on side <NUM> (<FIG>). One or more of indicia <NUM>, <NUM>, <NUM> may be visible both with or without fluoroscopy. Providing indicia that is visible under fluoroscopy advantageously enables the indicia to be visible on x-rays or other fluoroscopically obtained images so that a surgeon and/or other healthcare professional may be able to compare the relative sizes of the guides and thus assess what size implant should be used with the patient.

Turning now to <FIG>, one example of an angel wing alignment guide <NUM> is illustrated. As noted above and described in greater detail below, the angel wing alignment guide <NUM> may be used in combination with guide <NUM>. Alignment guide <NUM> may have a generally arcuate or "u-shaped" body with a transverse beam <NUM> extending between a first arm <NUM> and a second arm <NUM>. As best seen in <FIG>, the transverse beam <NUM> may include an enlarged area <NUM>, which may have a width that is greater than a width of a remainder of the transverse beam <NUM> and/or a width of arms <NUM>, <NUM>. In some embodiments, one or more dowels or protrusions <NUM>-<NUM>, <NUM>-<NUM> (collectively, "dowels <NUM>" or "protrusions <NUM>") extend from a posterior surface <NUM> of alignment guide <NUM>. Protrusions <NUM> are sized and configured to be received within holes <NUM>, <NUM>, <NUM>, <NUM> defined by the legs <NUM>, <NUM> of guide <NUM> for coupling the alignment guide <NUM> to guide <NUM>. As best seen in <FIG>, one or both of the protrusions <NUM> may include a spring arm, detent, or other coupling mechanism <NUM> for increasing the frictional coupling between the protrusion(s) <NUM> and holes <NUM>, <NUM>, <NUM>, <NUM> and thus between alignment guide <NUM> and guide <NUM>. One of ordinary skill in the art will understand that while the protrusions <NUM> are shown as having a generally circular cross-sectional shape, which a cross section is taken along an axis perpendicular to a longitudinal axis of the protrusions, the protrusions <NUM> may have other cross-sectional shapes, e.g., triangular, rectangular, etc..

In some embodiments, arm <NUM> includes one or more holes <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> (collectively, "holes <NUM>"), and arm <NUM> includes one or more holes <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> (collectively, "holes <NUM>"). Holes <NUM>, <NUM> are sized and configured to receive a dowel, pin, rod, or other elongate radiopaque device. The elongate radiopaque device may be coupled to the alignment guide <NUM> to provide a surgeon with an approximation of an axis of a tibial implant that is to be implant such that the surgeon can assess the proper location of a cutting and/or reaming guide with a mechanical and/or anatomic axis of the patient. Although plural holes are shown in <FIG> to provide the surgeon with multiple locations at which the alignment rod may be positioned, it should be understood that a single hole may be provided, or one or more slots may be provided along the longitudinal axes of the arms <NUM>, <NUM> to provide the surgeon with the ability to provide near continuous adjustment of the location of such an alignment rod.

As noted above, the alignment guide <NUM> may include one or more alignment features, such as the sagittal and/or coronal alignment features discussed above. For example, the first and second components <NUM>-<NUM>, <NUM>-<NUM> of the first alignment feature may be provided along the arms <NUM>, <NUM> and/or transverse beam <NUM>. Additionally or alternatively, the base <NUM> and/or flange <NUM> of the second alignment feature may be provided along arms <NUM>, <NUM> and/or transverse beam <NUM>, as will be understood by one of ordinary skill in the art.

<FIG> illustrate one example of alignment guide <NUM> coupled to guide <NUM>. More particularly, in <FIG>, the protrusions <NUM> of alignment guide <NUM> are disposed within holes <NUM>, <NUM> of guide <NUM>. In some embodiments, a surface (e.g., a bottom or top surface) of one or more of arms <NUM>, <NUM> may be aligned with steps <NUM> when protrusions <NUM> of alignment guide <NUM> are disposed within holes <NUM>, <NUM> of guide <NUM>. As such, the surface(s) of arms <NUM>, <NUM> may provide a visual indication of a location of an inferior surface of an implant (e.g., a talar implant) and/or a location at which a talus will be resected.

<FIG> illustrate another example of alignment guide <NUM> coupled to guide <NUM>. More particularly, in <FIG>, the protrusions <NUM> of alignment guide <NUM> are disposed within holes <NUM>, <NUM> of guide <NUM>. In some embodiments, a surface (e.g., a bottom or top surface) of one or more of arms <NUM>, <NUM> may be aligned with steps <NUM> when protrusions <NUM> of alignment guide <NUM> are disposed within holes <NUM>, <NUM> of guide <NUM>. As such, the surface(s) of arms <NUM>, <NUM> may provide a visual indication of a location of an inferior surface of an implant (e.g., a talar implant) and/or a location at which a talus will be resected.

Turning now to <FIG>, one example of a drill bit <NUM> that may be used with guide <NUM> is illustrated. Drill bit <NUM> extends from a first end <NUM>, which may also be referred to as a "coupling end" or a "trailing end," to a second end <NUM>, which may also be referred to as a "drilling end" or a "leading end. " Coupling end <NUM> may include one or more flats <NUM> or other surfaces that facilitate engagement with a power system or hand tool as will be understood by one of ordinary skill in the art. Leading end <NUM> may include one or more threads or cutting elements <NUM> to facilitate a drilling operation. Drill bit <NUM> may further include one or more grooves or other indicia <NUM> disposed along a length of the drill bit <NUM>. For example, indicia <NUM> may include numerals and/or letters in addition to grooves, as will be understood by one of ordinary skill in the art. In some embodiments, the one or more indicia <NUM> is located between an approximate middle of drill bit <NUM> and a proximal end of cutting element(s) <NUM>.

<FIG> illustrates one example of the drill bit <NUM> disposed within hole <NUM> defined by guide <NUM>. In use, one or more of the indicia <NUM> are visible when the assemblage of the guide <NUM> and drill bit <NUM> are viewed in the sagittal plane under fluoroscopy. The indicia <NUM> identify a depth of the tip of the drill bit <NUM>, which may correspond to a length of a prosthesis component. For example, in some embodiments, the indicia correspond to a length of a tibial tray of a total ankle prosthesis, such as the tibial tray of the INBONE™ total ankle prosthesis.

<FIG> illustrate another example of a sizing and drill guide <NUM> in accordance with some embodiments. Guide <NUM> includes a body <NUM> extending from an inferior side <NUM> to a superior side <NUM>, as best seen in <FIG>. Body <NUM> further includes opposed sides <NUM>, <NUM> (<FIG>), an anterior side <NUM>, and a posterior side <NUM>, as best seen in <FIG>. The profile of guide <NUM>, such as defined by inferior side <NUM>, superior side <NUM>, and opposed sides <NUM>, <NUM>, which is shown as having a generally trapezoidal shape, may correspond to the profile of a prosthesis component. For example, the profile of guide <NUM> defined by inferior side <NUM>, superior side <NUM>, and opposed sides <NUM>, <NUM> may correspond to the tibial and/or talar prosthesis components of a total ankle replacement system, although one of ordinary skill in the art will understand that body <NUM> of guide <NUM> may have a shape that corresponds to other types of implants.

In some embodiments, body <NUM> may be formed from a rigid radiopaque material, such as a surgical grade metal. One of ordinary skill in the art will understand that guide <NUM> may be formed from other materials, such as a combination of radiolucent (e.g., Radel® polyphenylsulfone (PPSU), available from Solvay) and radiopaque (e.g., stainless steel, aluminum, titanium, cobalt, chromium) materials. Guide <NUM> may be machined from a single block of material, molded, or formed using an additive manufacturing process (e.g., DMLS, EBM).

One or more slots <NUM>-<NUM>, <NUM>-<NUM> (collectively, "slots <NUM>") may be defined by body <NUM> adjacent to the inferior side <NUM>. Slots <NUM> extend from the anterior side <NUM> of body <NUM> to the posterior side <NUM> of body <NUM> and are sized and configured to receive a resection level indicator and/or blade of a cutting instrument, such as a saw. In some embodiments, slots <NUM> are aligned with one another such that a longitudinal axis defined by slot <NUM>-<NUM> is collinear with a longitudinal axis defined by slot <NUM>-<NUM>, although it should be understood that slots <NUM> may be otherwise arranged with respect to one another. As best seen in <FIG>, the posterior side <NUM> may include one or more notches <NUM>, which are aligned with slots <NUM>, and one or more notches <NUM>, which are aligned with the superior surface <NUM> of body <NUM>. The one or more notches <NUM> provide a surgeon or other medical professional with a visual indication as to the location of the slots <NUM>, which may correspond to the location of a bone resection and/or an inferior surface of an implant based on the positioning of the guide <NUM> when guide <NUM> is viewed under fluoroscopy in the sagittal plane. Similarly, the one or more notches <NUM> may provide a surgeon or other medical professional with a visual indication as to the location of the superior surface of the body <NUM>, which may correspond to a superior surface of an implant, such as the tibial implant of a total ankle prosthesis.

Body <NUM> may also define a central opening <NUM> located between inferior side <NUM> and superior side <NUM> and between opposed sides <NUM>, <NUM>. In some embodiments, one or more projections <NUM>-<NUM>, <NUM>-<NUM>, which collectively may be referred to as "projections <NUM>" or "joint-line indicator <NUM>," extend inwardly into opening <NUM>. Projections <NUM> are located along body <NUM> to provide a surgeon or other medical professional a visual indication as to the location of the joint line of a prosthesis, such as a total ankle prosthesis, that is to be implanted when viewed in the frontal plane. While projections <NUM> are shown as being pointed or arrow shaped, one of ordinary skill in the art will understand that the projections <NUM> may take other shapes and forms to provide a joint line indicator <NUM>. As best seen in <FIG>, the anterior side <NUM> and posterior side <NUM> may respectively include notches <NUM>, <NUM>, which are aligned with joint-line indicator <NUM>. Notches <NUM>, <NUM> provide a surgeon or other medical professional with a visual indication as to the location of the joint line when guide <NUM> is viewed under fluoroscopy in the sagittal plane.

Referring again to <FIG> and <FIG>, a number of holes may be provided adjacent to the superior side <NUM> of body <NUM> above opening <NUM>. For example, body <NUM> may define corner drill holes <NUM>-<NUM>, <NUM>-<NUM> (collectively, "holes <NUM>" or "corner drill holes <NUM>") and a central hole <NUM>. Corner drill holes <NUM> may be sized and configured to receive a drill bit and/or to identify a location of where a drill is used to prepare the corners of a tibial resection. Put another way, the corner drill holes <NUM> are located at the superior medial and lateral corners of the tibial resection. Hole <NUM> may be sized and configured to receive a surgical tool, such as a drill bit, pin, and/or depth gauge, therein. For example, a pin, drill, or other surgical tool may be inserted into hole <NUM> to determine an appropriate length for an implant, as best seen in <FIG> and <FIG>. In some embodiments, holes <NUM>, <NUM> may be formed in portions of body <NUM> that extend from anterior side <NUM> to form bushings <NUM>, <NUM>, <NUM>. It should be understood that body <NUM> may define additional holes, such as holes to receive fixation elements (e.g., pins, k-wires, or any other suitable device) therein for securing the guide <NUM> to bone or other tissue.

Guide <NUM> may also include one or more alignment features. For example, guide <NUM> may include a first alignment feature, which may be a sagittal alignment feature, and a second alignment feature, which may be a coronal alignment feature. First alignment feature may extend superiorly from superior side <NUM> and include a first component <NUM>-<NUM> and a second component <NUM>-<NUM>. In some embodiments, the first component <NUM>-<NUM> takes the form of a block having a circular opening <NUM> (<FIG>), and component <NUM>-<NUM> takes the form of a projection that terminates in a circular shape <NUM> (<FIG>). As best seen in <FIG>, when viewed from the side and the fluoroscope is properly aligned with the guide <NUM>, the circular shape <NUM> will appear within an approximate center of the circular opening <NUM> defined by the first component <NUM>-<NUM> to form a fluoroscopic check (e.g., a bullseye). If the fluoroscope is not properly aligned, then the circular shape <NUM> will not appear centered within circular opening <NUM>. Although the first and second components <NUM>-<NUM>, <NUM>-<NUM> are described as including circular shapes and openings, one of ordinary skill in the art will understand that other shapes may be used to provide a fluoroscopic alignment check.

Second alignment feature may include a base <NUM> and a flange <NUM> that extends in an anterior direction from base <NUM>. Base <NUM> defines a hole <NUM> that extends entirely through base <NUM>, as best seen in <FIG>. Flange <NUM> extends from base <NUM> in an anterior direction and includes a projection <NUM> along its length. In some embodiments, flange <NUM> has a trapezoidal cross-sectional geometry that is sized and configured to form a dovetail connection with another surgical tool, such as the adjustment block <NUM> with a tool holder <NUM> disclosed in <CIT>, which was incorporated by reference in its entirety above. However, it should be understood that flange <NUM> may have other cross-sectional geometries to facilitate coupling to other surgical tools. As best seen in <FIG>, projection <NUM> extends from flange <NUM> in an inferior direction and terminates with a circular shape. When a fluoroscope is properly aligned with guide <NUM> in the coronal or frontal plane, projection <NUM> will appear to be disposed within the center of hole <NUM> (e.g., a bullseye) to provide a fluoroscopic alignment check. Although hole <NUM> and projection <NUM> are described and shown as having circular shapes, one of ordinary skill in the art will understand that hole <NUM> and projection <NUM> may have other shapes.

The location of base <NUM> along superior side <NUM> may be varied. For example, while base <NUM> is shown as being positioned along the posterior side <NUM>, it should be understood that base <NUM> may be located closer to or at the anterior side <NUM> of body <NUM>. In some embodiments, base <NUM> may define a second hole <NUM> that is aligned with circular opening <NUM> defined by first component <NUM>-<NUM> of the first alignment feature such that second component <NUM>-<NUM> may be visible through both circular opening <NUM> and hole <NUM>, as best seen in <FIG>. However, it should be understood that hole <NUM> may be omitted depending on the relative positioning of the first alignment feature and base <NUM>.

Although the first and second alignment features are described as extending from superior side <NUM> of guide <NUM>, it should be understood that the first and/or second alignment features may be otherwise located on guide <NUM>. For example, one or both of the first and second alignment features may extend from other sides or surfaces of guide <NUM>, such as the anterior side <NUM>, the inferior side <NUM> or may be otherwise incorporated into the body <NUM> of guide <NUM>.

In some embodiments, the guide <NUM> may include one or more indicia, such as indicia <NUM>-<NUM>, <NUM>-<NUM> (collectively, "indicia <NUM>") located on anterior side <NUM>, indicia <NUM> located on side <NUM> (<FIG>), and indicia <NUM> located on side <NUM> (<FIG>). One or more of indicia <NUM>, <NUM>, <NUM> may be visible both with or without fluoroscopy. Providing indicia that is visible under fluoroscopy advantageously enables the indicia to be visible on x-rays or other fluoroscopically obtained images so that a surgeon and/or other healthcare professional may be able to compare the relative sizes of the guides and thus assess what size implant should be used with the patient.

<FIG> and <FIG> illustrate one example of the drill bit <NUM> disposed within hole <NUM> defined by guide <NUM> and a saw blade <NUM> disposed within one of the slots <NUM>. As discussed above with respect to guide <NUM>, the indicia <NUM> of drill bit <NUM> are visible when viewed in the sagittal plane under fluoroscopy. The indicia <NUM> identify a depth of the tip of the drill bit, which may correspond to a length of a prosthesis component.

Although guides <NUM>, <NUM> are described separately and with some different features, it should be understood that guides <NUM>, <NUM> may be modified to include additional features, including features from the other guide. For example, guide <NUM> may be modified to include legs <NUM>, <NUM> and/or a posterior surface having a taper or bevel <NUM>, as described above with respect to guide <NUM>. Additionally or alternatively, guide <NUM> may be modified to include one or more of notches <NUM>, <NUM> to provide visualization queues to a surgeon or other medical professional.

The guides described herein may be used by a surgeon or other medical professional to assess a size of a prosthesis to be implanted into a patient. In some embodiments, the guides may also be used to perform corner drilling in order to prepare a tibia for resection and receipt of a prosthesis. While the following description is provided with reference to the guide <NUM> illustrated in <FIG>, it should be understood that the following description of one example of a method of using guide <NUM> is applicable to guide <NUM>, as well as other guides in accordance with the present disclosure.

In some embodiments, guide <NUM> is coupled to another surgical tool previously placed on a tibia TB of a patient. For example and as illustrated in <FIG>, guide <NUM> may be coupled to the tool holder <NUM> of adjustment block <NUM> disclosed in in <CIT>, which is secured to the tibia TB by pins P1, P2. In some embodiments, flange <NUM>, which may have a trapezoidal shape, is received between the rails of tool holder <NUM> to form a dovetail connection. The position of guide <NUM> may be adjusted using adjustment block <NUM>, as described in <CIT>.

The position of guide <NUM> may be adjusted in order to assess the sizing and/or alignment of guide <NUM> relative to the tibia TB and/or talus TS. For example, profile of the guide, such as provided by the inferior side <NUM>, superior side <NUM>, and opposed sides <NUM>, <NUM>, which may correspond to a profile of a tibial implant, may be used to assess whether the size of the corresponding implant is appropriate for the patient in the frontal plane and/or sagittal plane. Sizing of the implant in the sagittal plane may be performed by a surgeon or other medical professional with the assistance of one or more notches <NUM> and/or alignment guide <NUM>, which may be located on guide <NUM> such that they correspond to the superior side <NUM> and/or inferior side <NUM>. Such assessment may be performed using fluoroscopy. In order to ensure that the fluoroscope is properly aligned with guide <NUM>, one or more of the first and second alignment features may be used to ensure proper alignment of the fluoroscope and guide <NUM>.

For example, the first alignment feature, which may be a sagittal alignment feature, may be used by checking that shape <NUM> of the second component <NUM>-<NUM> appears within an approximate center of opening <NUM> defined by the first component <NUM>-<NUM>. If the fluoroscope is not properly aligned, then shape <NUM> will not appear centered within opening <NUM>. Additionally or alternatively, the second alignment feature, which may be a coronal alignment feature, may be used to check proper alignment between the fluoroscope and the coronal or frontal plane. For example, when a fluoroscope is properly aligned with guide <NUM> in the coronal or frontal plane, projection <NUM> will appear to be disposed within the center of the hole <NUM>.

A guide <NUM> may be coupled to the guide <NUM> while determining the size and/or alignment of an implant. For example, one or more protrusions <NUM> may be inserted into holes <NUM>, <NUM> or holes <NUM>, <NUM> defined by legs <NUM>, <NUM> to couple alignment guide <NUM> to guide <NUM>, as shown in <FIG>. As noted above, in some embodiments, a surface (e.g., a bottom or top surface) of one or more of arms <NUM>, <NUM> may be aligned with steps <NUM> when protrusions <NUM> of alignment guide <NUM> are disposed within holes <NUM>, <NUM> of guide <NUM>. As such, the surface(s) of arms <NUM>, <NUM> may provide a visual indication of a location of an inferior surface of an implant (e.g., a talar implant) and/or a location at which a talus will be resected. In some embodiments, a surface (e.g., a bottom or top surface) of one or more of arms <NUM>, <NUM> may be aligned with steps <NUM> when protrusions <NUM> of alignment guide <NUM> are disposed within holes <NUM>, <NUM> of guide <NUM>. As such, the surface(s) of arms <NUM>, <NUM> may provide a visual indication of a location of an inferior surface of an implant (e.g., a talar implant) and/or a location at which a talus will be resected. Further, an elongate radiopaque device may be inserted into one or more of the holes or slots <NUM>, <NUM> defined by the arms <NUM>, <NUM> of guide <NUM> to assess the alignment of guide <NUM> with an axis of the tibia TB (e.g., a mechanical and/or anatomic axis).

When the size and desired location of the implant has been determined, guide <NUM> may be secured to the tibia TB by placing one or more pins P3, P4 in holes <NUM>, <NUM>, as shown in <FIG>. With guide <NUM> secured to tibia TB, drill bit <NUM> may be advanced into the tibia TB guided by hole <NUM>, as illustrated in <FIG>. Drill bit <NUM> may be advanced until it reaches the posterior surface of tibia TB. The location of the drill bit <NUM> may be determined using fluoroscopy as will be understood by one of ordinary skill in the art. Further, the length of the implant (e.g., anterior-to-posterior dimension) may be determined based on the visible indicia <NUM> located along the length of drill bit <NUM>.

In some embodiments, once the size of the implant has been determined, guide <NUM> is used to drill the corners for the tibial resection. For example, a drill <NUM> may be inserted into corner drill holes <NUM>, <NUM> and into the tibia TB, as shown in <FIG>. Once the corner holes have been drilled, guide <NUM> may be removed from its engagement with the tibia TB and/or adjustment block <NUM>. The tibia and talus may be further prepared using any suitable surgical technique, including the technique disclosed in <CIT>, which was incorporated by reference above.

The disclosed guides, systems, and methods provide enhanced durability and have a reduced size, which improves the ability of the surgeon to manipulate the guide during surgery. Further, the disclosed guides, systems, and methods provide enhanced visibility of the surface(s) to be cut during the surgery while reducing the number of components used compared to conventional instrumentation, which yields a more streamlined and efficient method.

As described above, in some embodiments, a surgical guide includes a body having a shape that corresponds to a shape of an implant to be implanted. The body defines a first opening and at least one hole that is sized and configured to receive a tool therein. A first alignment feature is configured to facilitate alignment of the surgical guide with a first anatomic plane.

In some embodiments, an outer periphery of the body defines the shape that corresponds to the shape of the implant.

In some embodiments, the body includes a first side, a second side, a third side, and a fourth side, and the first opening is defined by the first side, the second side, the third side, and the fourth side.

In some embodiments, a second alignment feature is coupled to the body and is configured to facilitate alignment of the surgical guide with a second anatomic plane that is different from the first anatomic plane.

In some embodiments, the projection terminates from a flange that has a cross-sectional geometry to facilitate the coupling of the surgical guide to another surgical tool. In some embodiments, the cross-sectional geometry is trapezoidal.

In some embodiments, the body defines at least one slot that is disposed between the opening and the second side. The at least one slot may be sized and configured to receive a tool, including a depth indicating tool or a blade of a cutting tool.

In some embodiments, a first guide includes a first guide body having a first side, a second side, a third side, and a fourth side. The third and fourth sides extend between the first and second sides. The body defines a first opening between the first side, the second side, the third side, and the fourth side. The body may further define a first hole and a second hole each sized and configured to receive a fixation tool and/or and a cutting tool therein. A first alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a first anatomic plane, and a second alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a second anatomic plane. In some embodiments, the first anatomic plane and the second anatomic plane are the same. In some embodiments, the first anatomic plane and the second anatomic plane are different.

In some embodiments, a method includes coupling a first guide to an adjustment block, aligning a fluoroscope with the first guide in at least one anatomic plane using at least one of a first alignment feature and a second alignment feature of the first guide, coupling a second guide, and securing the first guide to a tibia once a desired alignment of the first guide has been achieved. In some embodiments, the second guide includes first and second arms that are coupled together by a transverse beam.

In some embodiments, coupling the second guide to the first guide includes inserting at least one protrusion extending from the transverse beam of the second guide into at least one connection feature of the first guide. In some embodiments, the at least one connection feature of the first guide includes at least one hole defined by the first guide. In some embodiments, the at least one connection feature of the first guide includes at least one slot defined by the first guide.

Claim 1:
A surgical guide (<NUM>), comprising:
a body (<NUM>) having a shape that corresponds to a shape of an implant to be implanted, the body (<NUM>) defining a first opening (<NUM>) and at least one hole (<NUM>, <NUM>, <NUM>) that is sized and configured to receive a tool therein; and
a first alignment feature (<NUM>-<NUM>, <NUM>-<NUM>) coupled to at least one side of the body (<NUM>) and configured to facilitate alignment of the surgical guide (<NUM>) with a first anatomic plane, and
wherein the first alignment feature (<NUM>-<NUM>, <NUM>-<NUM>) includes a first component (<NUM>-<NUM>) and a second component (<NUM>-<NUM>), the first component including a second opening (<NUM>), and the second component (<NUM>-<NUM>) includes a projection that terminates in a shape (<NUM>) that is complementary to a shape of the second opening.