Patent ID: 12239550

DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION

Generally stated, disclosed herein are guides, devices, instruments, systems, and methods for maintaining, correcting and/or resurfacing joint surfaces. Further, methods for using the guides, devices, instruments, systems, and methods for maintaining, correcting and/or resurfacing joint surfaces are discussed.

In this detailed description and the following claims, the words proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part or portion of a bone, instrument, 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 devices, systems, instrumentation and methods are described herein with reference to use with the bones of the ankle, the bones of the foot, ankle and lower leg may be used to describe the surfaces, positions, directions or orientations of the devices, systems, instrumentation and methods. Further, the devices, systems, 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 devices, systems, 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 disclosure. For example, the devices, systems, instrumentation and methods, and the aspects, components, features and the like thereof, described herein with respect to the right leg may be mirrored so that they likewise function with the left leg. Further, the devices, systems, instrumentation and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the leg for brevity purposes, but it should be understood that the devices, systems, 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 toFIGS.1-39, the instruments, devices, implants, systems, and methods of using the instruments, devices, implants, and systems for a total ankle replacement (TAR) procedure are shown. The total ankle replacement procedure may include, for example, an alignment procedure, an initial resection procedure, a trialing and chamfer resection procedure, a final trialing and peg preparation procedure, and an implantation procedure.

Referring now toFIGS.1-39, alignment guides for TAR surgery are shown. A first alignment guide or tibia alignment guide100is shown inFIGS.1-28. As shown inFIG.1, the alignment guide or full alignment guide100includes a first translation mechanism or medial-lateral adjustment member110, a second translation mechanism or distal-proximal adjustment member170, a third translation mechanism or varus-valgus adjustment member440, and a tower400coupled to the third translation mechanism440on a first end and the second translation mechanism170on a second end. The second translation mechanism170is movably coupled to the first translation mechanism110by distal-proximal translating members150,160. The third translation mechanism440is moveably coupled to the second translation mechanism170by the tower400. The first and second translation mechanisms110,170may be as described and shown in greater detail in U.S. Provisional Application No. 62/899,703, entitled Joint Replacement Alignment Guides, Systems and Methods of Use and Assembly, which is hereby incorporated by reference in its entirety.

Referring now toFIGS.15-20, the first translation mechanism110includes a housing112, a fastening member, fastener, or screw130received within the housing112, and a coupling member or cap140secured to the fastening member130. The housing112may include a first opening114positioned at a first end and extending into the housing112and a second opening116positioned at a second end and extending into the housing112. The first opening114may be aligned with the second opening116to receive the fastening member130. The housing112may further include a cavity118extending into the housing112from a bottom or distal surface. The cavity118may intersect with the first opening114of the second opening116. The cavity118may also receive a portion of the fastening member130when the first translation member110is assembled. In addition, the housing112may include at least one window120extending from a first side of the housing112into the cavity118. In the depicted embodiment, the at least one window120is two windows120, although alternative numbers of windows120are also contemplated and may include, for example, one or more windows120. The housing112may also include a plurality of dimension markings122positioned along at least a portion of the first side of the housing112. Further, the housing112includes a foot or extension member124extending away from a second side of the housing112. The extension member124may be, for example, positioned near the distal end of the second side of the housing112. As shown inFIG.4, the extension member124may include a first recess126positioned at the first end of the housing112and a second recess128positioned at the second end of the housing112.

With continued reference toFIGS.15-20, the fastening member130may include a shaft portion132and a head portion136. The head portion136may be coupled to a first end of the shaft portion132. The head portion136may also include a drive opening138positioned on the first end of the head portion136opposite the shaft portion132. The drive opening138may be, for example, sized and shaped or configured to receive a driving tool, such as a screw driver, to rotate the fastening member130. The shaft portion132may be, for example, threaded along at least a portion of the shaft132and may include a locking opening134. The locking opening134may be positioned, for example, perpendicular to a longitudinal axis of the fastening member130. The locking opening134may be, for example, sized and shaped or configured to receive a pin or locking member146. As shown inFIGS.15-20, the shaft portion132is threaded from the head portion136toward the second end and includes a non-threaded section near the second end of the shaft portion132. The coupling member140may include a through hole142extending from a first end to a second end. The coupling member140may also include a locking opening144extending from a side of the coupling member140into the through hole142. The locking opening144may be, for example, generally perpendicular to the through hole142. The locking opening144may receive a pin or locking member146to secure the coupling member140to the fastening member130.

The alignment guide100may also include a first distal-proximal translating member150and a second distal-proximal translating member160, as shown in at leastFIGS.15-20. The first translating member150may include a body152with a first opening or securement opening154positioned at a distal end of the body152. The first opening154may extend through the body152from a first side to a second side. In addition, the first translating member150may include a groove156positioned around the body152between a midpoint of the body152and the proximal end of the body152. The first translating member150may also include a plurality of teeth158extending along at least a portion of the length or in the direction of the longitudinal axis of the body152from the first end to the second end. The first translating member150may also include a plurality of dimension markings159positioned along at least a portion of the length or in the direction of the longitudinal axis of the body152. The second translating member160may include a body162with a first opening or securement opening164positioned at a distal end of the body152. In addition, the second translating member160may include a groove166positioned around the body162between a midpoint of the body162and the proximal end of the body162. The second translating member160may also include a plurality of dimension markings168positioned along at least a portion of the length or in the direction of the longitudinal axis of the body162.

With continued reference toFIGS.15-20, the first translation mechanism110also includes the coupling member240. The coupling member240includes a base242, a securement fastener or telescoping rod knob274received within the coupling member240, and a drive member276rotatably coupled to the base242of the coupling member240. The base242may include a through hole244extending into the base242from a first side. The base242may also include a channel246extending into the base242from a bottom surface. The channel246may include a female dovetail portion or receiving member248. The receiving member248may include a first protrusion250positioned on a first side of the bottom surface and a second protrusion252positioned on a second side of the bottom surface. The channel246may include an opening at the bottom surface that may be, for example, smaller than the width of the interior top surface of the channel246. For example, the channel246may have angled side surfaces as the channel246extends into the base242. In addition, the base242may include at least one window254extending from the first end into the channel246and at least one window254extending from the second end into the channel246. The base242may also include a locking pin opening256extending from the first end to the second end, for example, between the two windows254. The base242may further include an engagement pin opening258extending into the base242from the first end.

A locking member or indicator member260may extend away from a top surface of the base242on the first side, as shown inFIGS.15-20. The locking member260may include a through hole262extending from the first side toward the second side of the base242. In addition, the locking member260may include a pointer264extending away from a top surface of the locking member260. The pointer264may have, for example, a generally triangular shape or alternative shape which terminates in a point. Finally, the locking member260may include a locking pin opening266extending between the first end and the second end and positioned near a top surface of the locking member260. The locking pin opening266may extend through the locking member260, for example, perpendicular or generally perpendicular to the through hole262. A translating protrusion270may also extend away from a top surface of the base242adjacent to the locking member260. The translating protrusion270may include a through hole or threaded hole272extending between the first end and the second end. The locking member260may be spaced apart from the translating protrusion270to form a channel and the channel may be, for example, sized and shaped or configured to receive a side of the housing112.

The securement fastener274may include, for example, a head portion with a drive feature and a shaft portion extending away from a second end of the head portion. The shaft portion may be, for example, threaded along at least a portion of its length. The drive member276may include a shaft278and a first groove280. The first groove280may be, for example, inset into the shaft278and may extend around at least a portion of the circumference of the shaft278. The drive member276may also include a drive shaft282with a drive opening284at a first end of the drive member276. The drive shaft282may have, for example, a diameter smaller than the diameter of the shaft278. In addition, the head portion286may be coupled to the second end of the drive member276and there may be a second groove288positioned between shaft278and the head portion286. The drive member276may further include a locking pin opening290extending through the drive member276and positioned within the second groove288.

With continued reference toFIGS.15-20, the second translation mechanism, distal-proximal adjustment member, or gearbox170may include a housing172, a coupling fastener or internal-external adjustment screw202, a locking fastener204, a drive member212, an engagement member218, and a locking cap226. The housing172may include a base174with a first extension member or proximal extension member190extending away from a top surface of the base174and a second extension member or distal extension member200extending away from a bottom surface of the base174. The base174may also include a fastener hole176positioned near the second end of the housing172and a fastener hole or locking hole192extending at least partially through the first extension member190from a first side into a coupling hole or recess196. The base174may also include a locking pin hole178positioned between the fastener hole136and the locking hole192. The base174may further include a through hole or alignment pin hole180extending through the base174from a first side to a second side. The through hole180may have, for example, an oval or elliptical shape. The through hole180may be positioned below the fastener hole192. The base174may also include a tool opening182positioned near the first end of the base174. The locking cap opening184may extend into the base174from a second side and engage or overlap with the tool opening182. The locking cap opening184may have, for example, a diameter larger than the diameter of the tool opening182. The locking cap opening184may be, for example, threaded to receive a fastener226. The housing172may also include the cavity186positioned within the base174. The housing172may further include an enlarged opening or keyhole portion188extending through the base174and the distal extension member200. The enlarged opening188may extend from the top surface of the base174into and through the cavity186. In addition, the locking cap opening184may extend from a second side of the base174into the cavity186.

As shown in at leastFIGS.15,19and20, the housing172may also include a locking pin hole194extending through the first extension member190in a medial-lateral direction from the first end toward the second end. The first extension member190may also include the coupling hole196extending into the first extension member190from a superior or top surface. The coupling hole196may be, for example, a circular or a round recess or alternatively shaped recess corresponding to the shape of the stem410of the tower system400. In addition, the first extension member190may also include two threaded recesses198positioned on opposite sides of the coupling hole196. The threaded recesses198may be configured or sized and shaped to receive a first alignment pin206and a second alignment pin208. The alignment pins206,208when inserted may have a portion of the pins206,208extending above the superior or top surface of the first extension member190to engage a bottom surface of the housing340of the coupling member300. The second extension member or distal extension member200may extend away from an inferior or bottoms surface, as well as between the first end and the second end of the base member174. In addition, the cavity186may extend through the base174as well as the second extension member200from a top surface to a bottom surface of the housing172. The cavity186may be positioned near a first end of the housing172. The housing172may also include a through hole187positioned near a second end of the housing172. The through hole187may extend through the base174as well as the second extension member200from the top surface to the bottom surface of the housing172. The cavity186and the through hole187may be, for example, configured or sized and shaped to receive the first translating member150and the second translating member160, respectively.

The second translation mechanism170may also include a coupling fastener or internal external adjustment screw202for engagement with the fastener hole192of the housing172, as shown in at leastFIGS.15-20. In addition, the second translation mechanism170may include a locking fastener204received within the fastener hole176. The fastener hole176extends into the through hole187to enable the locking fastener204to engage the second translating member160and secure the second translating member160at a desired height. The second translation mechanism170may also include a drive member212with a first portion including a drive opening214at a first end and a driveshaft216extending away from the first portion to the second end. The driveshaft216may engage or be received within a through hole224of an engagement member218. The engagement member218may also include a body or shaft220and a plurality of teeth222extending around the circumference of the exterior surface of the body220. The plurality of teeth222may extend along only a portion of the length of the body220between a first end and second end of the engagement member218. The plurality of teeth222may be, for example, configured or sized and shaped to engage the plurality of teeth158of the first translating member150. The through hole224may extend through the body220along the entire length of the engagement member218. The driveshaft216may extend completely through the through hole224to engage the locking cap226. Although not shown, a washer may be positioned between the engagement member218and the locking cap226when assembled with the drive member212. The locking cap226may include a body228and a through hole230extending through the body228from the first end to a second end. The locking cap226may also include recesses or drive features232inset into the first end and the second end of the body228. Further, the locking cap226may include threads234along the exterior circumference between the first end and the second end of the body228. The threads234may be, for example, configured or sized and shaped to engage the locking cap opening184.

With continued reference toFIGS.15-20, the coupling member300may include a housing340, an alignment pin housing302, and a securement knob330. The alignment pin housing302is received within a through hole344of the housing340and secured together with a locking pin354. In addition, the securement knob330is received within a through hole or threaded hole318of the alignment pin housing302to secure the coupling member300to a pin, for example, a pin108. The housing340may include a base342with a through hole344. The base342may have, for example, a generally square or rectangular shape, although other shapes are also contemplated. The base342may also include a through hole346extending through the two sides of the base342for receiving a pin354to couple the alignment pin housing302to the base342. The housing340may also include a stem356extending away from an inferior or bottom surface of the base342. The stem356may include a groove358extending around at least a portion of the circumference of the stem356. The stem356may also include a through hole360extending through the stem356. The through hole360may be, for example, configured or sized and shaped to receive a fastener202to secure the housing340to the housing172. The housing340may further include a proximal coupling protrusion350extending away from a superior or top surface of the base342. The coupling protrusion350may include, for example, tabs352extending away from the exterior, side surface of the coupling protrusion350or a pin352extending through the coupling protrusion350to assist with engagement of the coupling member with the tower portion400.

With continued reference toFIGS.15-20, the alignment pin housing302includes a base304, which may be, for example, “L” shaped. The housing302may also include at least one pin hole316extending into the base304from a first side to a second side. As shown, the at least one pin hole316may be, for example, three pin holes316positioned adjacent to each other in a generally linear arrangement. The housing302may also include a through hole318extending through the base304from a first end to a second end. The through hole318may be, for example, positioned perpendicular to the at least one pin hole316. In addition, the housing302may include pin holes322,326for receiving locking pins, such as, pin328to secure the securement knob330and pins (not shown) to the housing302. The pin hole322may extend through the base304from a first end to a second end near a posterior surface. The pin hole326may extend through the base304from a superior surface to an inferior surface and positioned near the second end and the anterior surface.

In addition, the securement knob330includes a head or drive portion332and a stem or shaft334extending away from a bottom surface of the head portion332. The shaft334may include a threaded portion336extending along at least a portion of the length of the shaft334. The threaded portion336may be, for example, configured or sized and shaped to be inserted into the through hole318. The securement knob330may also include a drive feature338inset into the first end of the head332of the knob330.

Referring now toFIGS.21-26, the tower400may include a coupling rod410, which may be received within a tower base420to couple the second translation mechanism170to the third translation mechanism or varus-valgus adjustment member440. The rod410may include a first end412and a second end414. The first end412includes an opening416for coupling to the third adjustment member440. The tower base420may couple to the coupling member300on a distal end. The tower base420may include a coupling opening424for receiving the proximal coupling protrusion350and a securement pin opening430on a first end for receiving the tabs352of the coupling member300. The second end of the tower base420may include a securement protrusion with an opening422extending into the base420along the longitudinal axis of the base420. The second end may also include a first or threaded opening426and a second opening428for coupling the tower base420to the third translation mechanism440. The threaded opening426may be, for example, sized and shaped or configured to receive a knob432. The knob432may be, for example, the same or similar to knob520.

The third translation mechanism440may include a housing450with a first opening452at a first end, a second opening454at a second end and a cavity456extending into the housing450from a bottom surface and engaging or overlapping the through hole created by the first and second openings452,454. The third translation mechanism440may also include a fastening member470, a cap442, and a knob520. The fastening member470, which may be the same or similar to fastening member130, which will not be described again here, in detail, for brevity sake. The fastening member470may include a shaft portion472and a head portion476, which may be the same or similar to the shaft portion132and the head portion136of the fastening member130. The head portion476may include a drive opening478, which may be the same or similar to the drive opening138. The shaft portion472may include a locking opening474, which may be the same or similar to the locking opening134. The coupling member442may be the same or similar to the coupling member140. The coupling member442may include a through hole444and a locking opening446, which may be the same or similar to the through hole142and locking opening144. The locking opening446may receive a pin or locking member, such as the pin or locking member146, to secure the coupling member442to the fastening member470.

The fastening member470may be inserted through the first opening452, cavity456, and second opening454and extend at least partially beyond the second end. The portion of the fastening member470extending out of the second end of the housing450may couple to the cap442. The third translation mechanism440may be coupled to the base420by a hinge member480,490. The first hinge member480may include a base482with an opening488extending through the base482from a first end to a second end. The opening488may be, for example, sized and shaped or configured to receive a portion of the fastening member470. The first hinge member480may also include a coupling protrusion484with a through hole486extending through the coupling protrusion484from a first end to a second end. The second hinge member490may include a first arm member494and a second arm member496extending toward a superior end of the second hinge member490. The first arm member494is spaced apart from and parallel to the second arm member496forming a channel498between the arm members494,496. The channel498may receive the coupling protrusion484of the first hinge member480of the third translation mechanism440. A fastener510may be inserted through the first arm member494, the coupling protrusion484, and the second arm member496to rotatably couple the first hinge member480to the second hinge member490.

The third translation mechanism440may allow the user to adjust the varus-valgus alignment as it rotates about the hinge members480,490. The third translation mechanism440may also include a proximal protrusion458extending away from a superior or top surface of the housing450. The proximal protrusion458includes an opening extending into the protrusion458from the superior surface. The opening may receive a locking knob520.

As shown inFIGS.23-26, the locking knob520may include a head or drive portion522and a stem or shaft526extending away from a bottom surface of the head portion522. The shaft526may include a threaded portion528extending along at least a portion of the length of the shaft526. The threaded portion528may be, for example, configured or sized and shaped to be inserted into the opening in the proximal protrusion458. The locking knob520may also include a drive feature524inset into the first end of the head522of the knob520.

The first translation mechanism110may be assembled by, for example, inserting the translating protrusion270into the channel246of the base242. The securement fastener274may be inserted through, for example, the through hole262to engage the first side of the housing112. In addition, the drive member276may be inserted into the through hole244and an engagement pin (not shown) may be inserted through the engagement pin hole258until the engagement pin engages the groove288in the drive member276. Then, the fastening member130may be inserted into the first opening114, through the cavity118and the through hole272of the translating protrusion270, and a portion of the fastening member130may extend out of the second opening116. The through hole142of the coupling member140may receive the portion of the fastening member130extending out of the second opening116. In addition, a pin146may be inserted into the locking opening144of the coupling member140and through the locking opening134of the fastening member130to retain the threaded portion of the shaft portion132within the cavity118of the housing112.

Next, a distal end of the first translating member150may be inserted into the first recess126and a locking pin or locking member148may be inserted through the extension member124and the first opening154to secure the first translating member150to the extension member124of the housing112. The distal end of the second translating member160may be inserted into the second recess128and a locking pin148may be inserted through the extension member124and second opening164to secure the second translating member160to the extension member124of the housing112. Then, the second translation mechanism170may be aligned with and slid onto the translating members150,160. The first translating member150may be received within the cavity186of the housing172and a plurality of teeth158may engage the plurality of teeth222of the engagement member218to allow for the housing172to translate with respect to the coupled first translation mechanism110and coupling member240. The engagement member218will be positioned within the cavity186. The drive member212will be coupled to the engagement member218to allow for rotation of the drive member212from a first side to be translated to rotation of the engagement member218. The locking cap226may also be inserted into the locking cap opening184to engage the second end of the drive member212and retain the engagement member218within the cavity186. Further, the second translating member160may be inserted into the through hole187when the locking fastener204is positioned in an unlocked or first position. In use the locking fastener204may be moved to secure the second translating member160when the desired proximal distal position is achieved in a locked or second position.

Referring now toFIGS.27-28, the alignment guide100is positioned on a patient's tibia102with at least two pins108and aligned with the ankle joint106to allow for a TAR procedure to be performed on the tibia102and the talus104. At least one first pin108may be positioned at the distal end of the alignment guide100and extend through at least one of the first translation mechanism110and the second translation mechanism170and a second pin108(not shown) may be inserted through the third translation mechanism300. Once positioned on the tibia102, the first translation mechanism110may be used to achieve medial-lateral adjustment, the second translation mechanism170may be used to achieve distal-proximal adjustment, and the third translation mechanism440may be used to achieve varus-valgus adjustment. The surgical method may be as described in greater detail in U.S. Provisional Application No. 62/899,460, entitled Total Ankle Replacement Surgical Method, which is hereby incorporated by reference in its entirety.

Further although not shown, the alignment guide100may be coupled to various resection guides. The resection guides and resection instruments may be as described in greater detail in U.S. Provisional Application No. 62/898,615, entitled Resection Guides, Sweeping Reamers, and Methods for Use in Total Ankle Replacement, which is hereby incorporated by reference in its entirety. In addition, the alignment guide100may be used with additional instruments for the TAR procedure. The alignment guide100may be used with, for example, other alignment instruments such as a joint line pointer and additional alignment instruments, which are described in greater detail in U.S. Provisional Application No. 62/899,655, entitled Alignment Instruments and Methods for Use in Total Ankle Replacement, which is hereby incorporated by reference in its entirety.

Referring now toFIGS.29-39, another alignment guide or tibia alignment guide600is shown. The second alignment guide600may include components that are the same or similar to the first alignment guide100, described in greater detail above. As shown inFIG.29, the alignment guide or full alignment guide600includes a first translation mechanism or medial-lateral adjustment member110, a second translation mechanism or distal-proximal adjustment member170, a third translation mechanism or varus-valgus adjustment member300, and a tower620coupled to the third translation mechanism440on a first end and the second translation mechanism170on a second end. The second translation mechanism170is movably coupled to the first translation mechanism110by distal-proximal translating members150,160. The third translation mechanism440is moveably coupled to the second translation mechanism170by the tower620. The first and second translation mechanisms110,170may be as described and shown in greater detail in U.S. Provisional Application No. 62/899,703, entitled Joint Replacement Alignment Guides, Systems and Methods of Use and Assembly, which is hereby incorporated by reference in its entirety.

The tower620may be, for example, similar to the tower420, as described in greater detail with respect to guide100and which will not be described again here for brevity sake. The tower620may include, for example, more windows or openings632, as shown inFIGS.29-34, than included in tower420. Although not shown, the tower620also includes a first or threaded opening426and a second opening428for coupling the tower base620to the third translation mechanism440. The threaded opening426may be, for example, sized and shaped or configured to receive a knob530. The knob530may be, for example, the similar to knob432. The knob530may include a head or drive portion532and a stem or shaft534extending away from a bottom surface of the head portion532, as shown inFIG.36. The shaft534may include a threaded portion536extending along at least a portion of the length of the shaft534. The threaded portion536may be, for example, configured or sized and shaped to be inserted into the opening426in the tower620. The locking knob530may also include a drive feature538inset into the first end of the head532of the knob530. The locking knob530may further include at least one opening652extending into the head portion532from an exterior surface. The at least one opening652may be, for example, one or more openings652positioned around the circumference of the head portion532. If two openings652are positioned on alternative sides of the head portion532, the two openings652may form a through hole extending across the entire head portion532. The at least one opening652may be, for example, sized and shaped or configured to receive a tool to assist with rotating the knob530. The locking knob530may also include a recess654extending into the head portion532from a superior or top surface.

The alignment guide600may also include an alternative locking knob520and an alternative securement knob330. As shown inFIGS.29-35, the alternative locking knob520also includes at least one opening650extending into the head portion522from an exterior surface. The at least one opening650may be, for example, one or more openings650positioned around the circumference of the head portion522. If two openings650are positioned on alternative sides of the head portion522, the two openings650may form a through hole extending across the entire head portion522. The at least one opening652may be, for example, sized and shaped or configured to receive a tool to assist with rotating the knob530. The locking knob530may also include a recess654extending into the head portion532from a superior or top surface, as shown inFIG.36.

The alternative securement knob330also includes at least one opening666extending into the head portion332from an exterior surface, as shown inFIG.39. The at least one opening666may be, for example, one or more openings666positioned around the circumference of the head portion332. If two openings666are positioned on alternative sides of the head portion332, the two openings666may form a through hole extending across the entire head portion332. The at least one opening666may be, for example, sized and shaped or configured to receive a tool to assist with rotating the knob330.

The alignment guide600may also include an alternative head portion640of the fastening mechanism470and an alternative cap442. As shown inFIG.38, the head portion640of the fastening mechanism470may include a drive feature642extending into the head portion640from a first end. The head portion640may also include grooves644positioned around the circumference of the head portion640. As shown inFIG.37, the alternative cap442may also include grooves644positioned around the circumference of the head portion442. The alignment guide600further includes a plurality of dimension markings464positioned along at least a portion of the first side of the housing450between the first end and the second end.

In addition, the alignment guide600may further include a locking knob665. The locking knob665may be inserted into an opening (not shown) in housing450. The opening may be positioned near a second end of the housing450. The locking knob665may extend into at least one of the second opening454or cavity456to engage the fastening member470. The locking knob665may, for example, engage the fastening member470to prevent further rotation once the desired position is achieved.

The above disclosure describes a portion of a total ankle replacement (TAR) procedure and the devices used in that procedure. Additional understanding of the TAR procedure may be found in U.S. Provisional Application No. 62/779,436 filed Dec. 13, 2018 and entitled Joint Replacement Systems and Methods of Use and Assembly, International Application No. PCT/US2019/029009 filed Apr. 24, 2019 and entitled Implants and Methods of Use and Assembly, U.S. Provisional Application No. 62/779,092 filed Dec. 13, 2018 and entitled Instruments, Guides and Related Methods for Total Ankle Replacement, International Application No. PCT/US2019/066404 filed Dec. 13, 2019 and entitled Instruments, Guides and Related Methods for Total Ankle Replacement, U.S. Provisional Application No. 62/890,611 filed Aug. 22, 2019 and entitled Patient Specific Instruments and Methods of Use, International Application No. PCT/US2019/066336 filed Dec. 13, 2019 and entitled Patient Specific Instruments and Methods of Use, U.S. Provisional Application No. 62/899,703 filed Sep. 12, 2019 and entitled Joint Replacement Alignment Guides, Systems and Methods of Use and Assembly, International Application No. PCT/US2019/066408 filed Dec. 13, 2019 and entitled Joint Replacement Alignment Guides, Systems and Methods of Use and Assembly, U.S. Provisional Application No. 62/899,655 filed Sep. 12, 2019 and entitled Alignment Instruments and Methods for Use in Total Ankle Replacement, International Application No. PCT/US2019/066149 filed Dec. 13, 2019 and entitled Alignment Instruments and Methods for Use in Total Ankle Replacement, U.S. Provisional Application No. 62/899,740 filed Sep. 12, 2019 and entitled Joint Replacement Alignment Guides, Systems and Methods of Use and Assembly, U.S. Provisional Application No. 62/898,615 filed Sep. 11, 2019 and entitled Resection Guides, Sweeping Reamers, and Methods for Use in Total Ankle Replacement, International Application No. PCT/US2019/064948 filed Dec. 6, 2019 and entitled Resection Guides, Sweeping Reamers, and Methods for Use in Total Ankle Replacement, U.S. Provisional Application No. 62/898,854 filed Sep. 11, 2019 and entitled Distractors Having Attachable Paddles, Impaction Devices, and Methods for Use in Total Ankle Replacement, International Application No. PCT/US2019/066398 filed Dec. 13, 2019 and entitled Distractors Having Attachable Paddles, Impaction Devices, and Methods for Use in Total Ankle Replacement, U.S. Provisional Application No. 62/899,646 filed Sep. 12, 2019 and entitled Trial Insert Assembly, International Application No. PCT/US2019/065025 filed Dec. 6, 2019 and entitled Trial Insert Assembly, U.S. Provisional Application No. 62/899,460 filed Sep. 12, 2019 and entitled Total Ankle Replacement Surgical Method, International Application No. PCT/US2019/066409 filed Dec. 13, 2019 and entitled Total Ankle Replacement Surgical Method, which are each hereby incorporated herein in their entireties.

As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present disclosure without departing from the scope of the disclosure. The components of the implants as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the implants may include more or fewer components or features than the embodiments as described and illustrated herein. For example, the components and features ofFIGS.1-28andFIGS.29-39may be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Specifically, alignment guides100,600may be used in alternative combinations as would be modified or altered by one of skill in the art. Accordingly, this detailed description of the currently-preferred embodiments is to be taken in an illustrative, as opposed to limiting of the disclosure.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. 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.

The disclosure has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the disclosure be construed as including all such modifications and alterations.