Total ankle replacement instruments, assemblies and methods of use

Abstract

The present disclosure relates to an instrument. The instrument includes a handle coupled to a rod and a body configured to receive the rod in a central portion thereof. The instrument also includes a coupling configured to releasably couple to one or more components of an implant. Actuation of the handle drives the rod to actuate a first implant component relative to a second implant component and position the first implant component adjacent to the second implant component.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62 / 705,801, filed July 16, 2020, entitled "Total Ankle Replacement Instrumentation, Assemblies, and Methods of Use," the entire contents of which are incorporated herein by reference.

[0002] (Technical field) The present disclosure relates to soft tissue implant systems, instruments, and related methods. The present disclosure relates to podiatric and orthopedic implants and surgeries related to soft tissue and / or bone repair. More specifically, but not by way of limitation, the present disclosure relates to instruments, implants, devices, systems, assemblies, and methods for soft tissue-to-soft tissue, soft tissue-to-bone, and bone-to-bone joining. [Background technology]

[0003] Many currently available instruments for total ankle replacement surgery do not allow a user to quickly and reliably position (and / or position, reposition, or remove) one or more components of a total ankle replacement system. Summary of the Invention

[0004] The present disclosure is directed to implants, devices and methods for use in maintaining, correcting and / or resurfacing articular surfaces.

[0005] A first aspect of the present disclosure is a system including an implant system having a tibial component, a talar component, and an intermediate component. The system also includes an instrument having a handle portion, a head portion having a releasable coupling mechanism for releasably coupling with the tibial component of the implant system, and a body portion disposed between the handle portion and the head portion.

[0006] According to a first aspect of the present disclosure, the head portion is configured to releasably couple with the intermediate component.

[0007] According to a first aspect of the present disclosure, the tibial component and the medial component can be simultaneously releasably coupled to the head portion of the instrument such that the tibial component is positioned superiorly relative to the medial component.

[0008] According to a first aspect of the present disclosure, the handle portion comprises a grip portion and a threaded rod, at least a portion of the threaded rod extending into and through the body portion of the implant.

[0009] According to a first aspect of the present disclosure, the body portion has complementary threads that receive at least a portion of the threaded rod.

[0010] According to a first aspect of the present disclosure, manipulation of the grip portion actuates a threaded rod along the longitudinal axis of the instrument.

[0011] According to a first aspect of the present disclosure, actuation of a threaded rod along the longitudinal axis repositions the medial component relative to the tibial component in the proximal-distal direction.

[0012] A second aspect of the present disclosure is an instrument comprising a handle coupled to a rod and a body configured to receive the rod in a central portion of the body, and a coupling configured to releasably couple to one or more components of an implant.

[0013] According to a second aspect of the present disclosure, actuation of the handle drives the rod to actuate the first implant component relative to the second implant component and position the first implant component adjacent to the second implant component.

[0014] According to a second aspect of the present disclosure, the coupling portion includes a protrusion configured to engage at least a portion of one or more components of the implant.

[0015] According to a second aspect of the present disclosure, the coupling portion includes an actuator configured to facilitate engagement and disengagement with one or more components of the implant via the protrusion.

[0016] According to a second aspect of the present disclosure, the first implant component is an insert for a total ankle replacement implant.

[0017] According to a second aspect of the present disclosure, the second implant component is a tibial tray for a total ankle replacement implant.

[0018] According to a second aspect of the present disclosure, the rod includes a first thread disposed along the length of the rod.

[0019] According to a second aspect of the present disclosure, the instrument has a second thread disposed within the body, the second thread being complementary to and receiving the first thread, and actuation of the handle causes translation of the rod through the body via the first and second threads.

[0020] According to a second aspect of the present disclosure, the first implant component is releasably coupleable to the second implant component.

[0021] According to a second aspect of the present disclosure, the coupling portion is configured to releasably couple with the second implant component such that the second implant component remains in a fixed position while the first implant component is actuated.

[0022] According to a second aspect of the present disclosure, the coupling portion has a catch and a notch.

[0023] According to a second aspect of the present disclosure, the second implant component has a complementary geometry to the catch and notch to receive the catch on a portion of the second implant component.

[0024] A third aspect of the present disclosure is a method for positioning implant components. The method includes selecting a desired size of a first implant component and a corresponding size of a second implant component, releasably coupling the first and second implant components to a distal end of an insertion instrument, wherein the first implant component is positioned superiorly relative to the second implant component. The method also includes selectively repositioning the second implant component relative to the first implant component, positioning the first and second implant components relative to the patient's tibia, and separating the first and second implant components from the insertion instrument.

[0025] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with the detailed description, serve to explain the principles of the present invention. It is emphasized that, in accordance with standard practice in the industry, various features may or may not be drawn to scale. In fact, the dimensions of various features may be arbitrarily increased or decreased for clarity of discussion. The drawings are for the purpose of illustrating inventive embodiments of the present disclosure and are not to be construed as limiting the invention. [Brief explanation of the drawings]

[0026] [Figure 1] FIG. 1 is a side elevational perspective view of an exemplary instrument for facilitating implantation of an implant system according to the present disclosure. [Figure 2] 2 is a side perspective view of the exemplary instrument of FIG. 1 for facilitating implantation of an implant system according to the present disclosure. FIG. [Figure 3] FIG. 10 is another side perspective view of an alternative embodiment of an exemplary instrument for facilitating implantation of an implant system according to the present disclosure. [Figure 4] 2 is another side view of the exemplary instrument of FIG. 1 for facilitating implantation of an implant system according to the present disclosure. [Figure 5] 2 is a side cross-sectional view of the exemplary instrument of FIG. 1 for facilitating implantation of an implant system according to the present disclosure. [Figure 6] 2 is another cross-sectional side view of the exemplary instrument of FIG. 1 for facilitating implantation of an implant system according to the present disclosure. [Figure 7] 2 is a side cross-sectional view of an end of the exemplary instrument of FIG. 1 for facilitating implantation of an implant system according to the present disclosure. [Figure 8] 2 is a side elevational perspective view of the exemplary instrument of FIG. 1 for facilitating implantation of an implant system with an alternative component according to the present disclosure. FIG. [Figure 9] 9 is an enlarged side elevation perspective view of an end of the exemplary instrument of FIG. 8 for facilitating implantation of an implant system according to the present disclosure. [Figure 10] 9 is an enlarged top view of an end of the exemplary instrument of FIG. 8 for facilitating implantation of an implant system according to the present disclosure. [Figure 11] 9 is an enlarged side view of an end of the exemplary instrument of FIG. 8 for facilitating implantation of an implant system according to the present disclosure. [Figure 12] 9 is an enlarged front view of an end of the exemplary instrument of FIG. 8 for facilitating implantation of an implant system according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0027] In this detailed description and the claims that follow, the terms proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior, and inferior are defined by their standard usage to refer to specific sites or portions of a bone or implant, following terms that refer to the relative placement or orientation of natural bone. For example, "proximal" refers to the portion of the device or implant closest to the torso, and "distal" refers to the portion of the device or implant farthest from the torso. As directional terms, "anterior" refers to a direction toward the front of the body, "posterior" refers to a direction toward the back of the body, "medial" refers to a direction toward the midline of the body, "lateral" refers to a direction toward the side of the body or away from the midline of the body, "up" refers to a direction above another object or structure, and "down" refers to a direction below another object or structure. Furthermore, with respect to the foot specifically, "dorsal" refers to the top of the foot and "plantar" refers to the bottom of the foot.

[0028] Similarly, herein, location or direction may be used with reference to an anatomical structure or surface. For example, the present implants, devices, instruments, and methods are described herein with reference to use on the bones of the foot, and therefore the bones of the foot, ankle, and lower leg may be used to describe the surface, location, direction, or orientation of the implants, devices, instruments, and methods. Furthermore, the implants, devices, instruments, and methods disclosed herein, as well as their aspects, components, features, etc., are described with reference to one side of the body for the sake of brevity. However, because the human body is relatively symmetrical or mirror-imaged with respect to a line of symmetry (the midline), it is expressly intended that the implants, devices, instruments, and methods described and / or illustrated herein, as well as their aspects, components, features, etc., may be altered, changed, modified, reconfigured, or otherwise modified for use on or in association with the opposite side of the body for the same or similar purposes without departing from the spirit and scope of the present invention. For example, implants, devices, instruments, and methods described herein with reference to the right foot, as well as their aspects, components, features, etc., may be reversed to function similarly on the left foot. Additionally, while the implants, devices, instruments, and methods, and aspects, components, features, etc., disclosed herein are described with respect to the foot for simplicity, it should be understood that the implants, devices, instruments, and methods may also be used in other bones of the body having similar structures.

[0029] The presently disclosed devices, implants, systems, assemblies, and related methods for maintaining, correcting, and / or resurfacing articular surfaces may be similar to, or include at least one feature or aspect of, the implants, systems, assemblies, and related methods disclosed in the following documents, all of which are incorporated herein by reference: International PCT application number PCT / US2019 / 29009, filed April 24, 2019, Title: Implant, method of use, and assembly International PCT application number PCT / US2019 / 64741, filed December 12, 2019, Title: Implant system and method of use International PCT Application No. PCT / US2019 / 66336, filed December 13, 2019, Title: Patient-specific device and method of use; International PCT Application No. PCT / US2019 / 66408, filed December 13, 2019, Title: Artificial joint replacement alignment guide, system, and methods of use and assembly International PCT Application No. PCT / US2019 / 66149, filed December 13, 2019, Alignment Device and Method of Use in Total Ankle Replacement Surgery; International PCT Application No. PCT / US2019 / 66393, filed December 13, 2019, Title: Artificial joint replacement alignment guide, system, and methods of use and assembly U.S. Provisional Patent Application No. 62 / 898,615, filed September 11, 2019, entitled: Resection Guide, Sweep Reamer, and Method of Use in Total Ankle Replacement Surgery; International PCT Application No. PCT / US2019 / 66398, filed December 13, 2019, Title: Distractor with removable paddle, impaction device, and method of use in total ankle replacement surgery; International PCT application number PCT / US2019 / 65025, filed December 6, 2019, title: Test insert assembly; U.S. Provisional Patent Application No. 62 / 899,460, filed September 12, 2019, Title: Total Ankle Replacement Method; International PCT Application No. PCT / US2019 / 66404, filed December 13, 2019, Title: Instruments, guides and related methods for total ankle replacement. Similarly, the presently disclosed devices, implants, systems, assemblies, and related methods for maintaining, correcting, and / or resurfacing articular surfaces may include one or more devices (e.g., one or more inserter and / or implanter devices) disclosed in the following documents, all of which are incorporated herein by reference: International PCT application number PCT / US2019 / 29009, filed April 24, 2019, Title: Implant, method of use, and assembly International PCT application number PCT / US2019 / 64741, filed December 12, 2019, Title: Implant system and method of use International PCT Application No. PCT / US2019 / 66336, filed December 13, 2019, Title: Patient-specific device and method of use; International PCT Application No. PCT / US2019 / 66408, filed December 13, 2019, Title: Artificial joint replacement alignment guide, system, and methods of use and assembly International PCT Application No. PCT / US2019 / 66149, filed December 13, 2019, Alignment Device and Method of Use in Total Ankle Replacement Surgery; International PCT Application No. PCT / US2019 / 66393, filed December 13, 2019, Title: Artificial joint replacement alignment guide, system, and methods of use and assembly U.S. Provisional Patent Application No. 62 / 898,615, filed September 11, 2019, entitled: Resection Guide, Sweep Reamer, and Method of Use in Total Ankle Replacement Surgery; International PCT Application No. PCT / US2019 / 66398, filed December 13, 2019, Title: Distractor with removable paddle, impaction device, and method of use in total ankle replacement surgery; International PCT application number PCT / US2019 / 65025, filed December 6, 2019, title: Test insert assembly; U.S. Provisional Patent Application No. 62 / 899,460, filed September 12, 2019, Title: Total Ankle Replacement Method; International PCT Application No. PCT / US2019 / 66404, filed December 13, 2019, Title: Instruments, guides and related methods for total ankle replacement.

[0030] Referring to the drawings, wherein the same reference numerals are used throughout the several views to indicate like or similar components, and with particular reference to Figures 1-6, an exemplary embodiment of an instrument 100 (e.g., an inserter, insertion instrument, etc.) for positioning and / or repositioning a device, implant, or portion thereof adjacent to one or more articular surfaces (e.g., between two articular surfaces, in contact with one or more articular surfaces, etc.) is shown.

[0031] 1-7 illustrate an exemplary instrument, designated as an inserter 100, for positioning, positioning, or repositioning one or more components of a system used in a total ankle replacement procedure in accordance with the present disclosure. The inserter 100 positions and positions devices, implants, and / or portions of a system used in a total ankle replacement adjacent one or more articular surfaces of a patient.

[0032] As shown in FIGS. 1-6 , the inserter 100 includes a handle portion 102, a body portion 104, and a head portion 110. The handle portion 102 is shown coupled to a rod 105, which extends into a first portion 108 of the body portion 104. The handle 102 includes a grip portion 109 configured to extend outwardly from the handle 102. In some embodiments, the grip portion 109 may be configured to interface with one or more instruments during at least a portion of a total ankle replacement procedure. The grip portion 109 may also be configured to be grasped and / or manipulated by a physician during at least a portion of a total ankle replacement procedure. As shown, the grip portion 109 has multiple protrusions that are offset from one another by approximately 90 degrees. In alternative embodiments, the gripping portion 109 may have more or fewer protrusions than the four shown, and the protrusions may be variously spaced around the handle 102 (e.g., the gripping portions 109 may be equally spaced from one another or unevenly spaced from one another). In some embodiments, the handle 102 may include additional and / or alternative geometries to that shown in FIG. 1 . For example, the handle 102 may include a continuous protrusion extending entirely around the handle 102 with an opening located in a central portion of the handle 102 (e.g., as shown in FIG. 3 ). In some embodiments, the inserter may have multiple handles that can be releasably coupled to the rod 105. This may provide different gripping portions 109 for contacting multiple physicians and / or other instruments. In alternative embodiments of the inserter 100, the handle 102 and its gripping portion 109 may be integral with the rod 105.

[0033] The handle 102 is shown coupled to a rod 103, which is further coupled to a body portion 104 of the inserter 100. The rod 103 is received by an opening 106 in a first end 108 of the body portion 104. The geometry of the opening 106 is complementary to the geometry of the rod 103. For example, the illustrated rod 103 has a substantially cylindrical geometry, and the opening 106 is substantially circular / cylindrical. The rod 103 has threads 105 disposed along the length of the rod 103, the threads 105 being configured to contact (interlock) with one or more components of the body portion 104. In some embodiments, the opening 106 has threads therein that are complementary to the threads 105, thereby receiving the threads 105 of the rod 103 such that the rod 103 can translate (move parallel) along the central axis of the opening 106. In some embodiments, the threads 105 may be received by an alternate component of the body portion 104. For example, the head portion 110 of the body portion 104 may have complementary threads configured to receive at least a portion of the threads 105 of the rod 103. In some embodiments, manipulation of the handle 102 by a user (e.g., a physician) (e.g., twisting / rotating the threaded rod 103, pushing the plunger, etc.) may cause the threads 105 to contact one or more complementary geometries (e.g., opposing threads of the opening 106, etc.) to translate the rod 103 and further actuate one or more components of the inserter 100, such as a component of the head portion 110. Additionally, manipulation of the handle 102 (e.g., rotating, thereby translating the rod 103) may translate one or more components of an implant 200 used in a total ankle replacement. For example, rotating the handle 102 of the inserter 100 can translate one or more components of the implant 200 toward or away from the body portion 104 of the inserter 100, thereby allowing the components to be positioned, positioned, repositioned, coupled, or manipulated.In some embodiments, the rod 103 may be translatable between one or more predetermined positions, which may be located between the handle 102 and the head 110 (e.g., at various points along the body 104 of the inserter 100). Additionally, the predetermined positions may have locking elements such that the rod 103 may be retained in one or more predetermined positions.

[0034] The body portion 104 includes a central portion 107 disposed between the first end 108 and the head portion 110. The central portion 107 may have one or more openings, as shown in FIG. 1, along its length. In some embodiments, the openings in the central portion 107 may be configured to allow a user to view the rod 103 as it translates through the body portion 104. This translation is driven by rotation of the handle 102, and this translation causes the threads 105 of the rod 103 to contact one or more components of the body portion 104 (e.g., complementary threads in the openings 106 and / or the head portion 110). In some embodiments, the central portion 107 may have openings disposed on one or more sides of the body portion 104, but may also have one or more sides without openings. For example, in one embodiment, the central portion 107 may have one or more openings disposed only on lateral sides of the body portion 104 of the inserter 100. Conversely, in additional embodiments, central portion 107 may have one or more openings located only on the top and / or bottom surfaces of inserter body portion 104 (e.g., as shown in FIG. 3 ). In some embodiments, central portion 107 may have one or more lateral protrusions therefrom (e.g., adjacent openings 106) configured to accommodate a user and / or an instrument implemented in combination with inserter 100.

[0035] The inserter head 110 is configured to interface (e.g., have complementary / positioned geometries) with one or more components of an implant 200 (see FIGS. 4-6 ) used in a total ankle replacement procedure. Additionally, the head 110 is shown with a locking mechanism 112 disposed on its upper surface, which is translatable by a user between a locked and an unlocked position. In some embodiments, at least as shown in FIGS. 1-2 , the locking mechanism 112 can be translated between a locked and an unlocked position within the slot 113. For example, the locking mechanism 112 can be in the unlocked position when the locking mechanism 112 is located at the end of the slot 113 closest to the center portion 107 of the body, and in the locked position when the locking mechanism 112 is located at the end of the slot 113 farthest from the center portion 107. By translating the locking mechanism 112 from a locked position to an unlocked position (and vice versa), a user can prepare the instrument 100 to releasably couple and separate one or more components of the implant 200.

[0036] When the locking mechanism 112 is in the unlocked position, as shown in FIG. 2 , the locking mechanism 112 may be compressed to release (e.g., separate from the instrument) one or more other components of the total ankle replacement system. As shown in the exemplary embodiment of FIGS. 1-2 , the top surface of the head portion 110 may include instructions 111. The instructions 111 may provide text and / or directional indicators identifying locked and unlocked positions / or directions, as well as instructions regarding compressing the locking mechanism 112 to couple / discouple with the implant 200 and / or its components. Such coupling and separation of the components of the implant 200 allows a user to position, position, and reposition the components of the implant 200 within a joint or adjacent one or more articular surfaces during a total ankle replacement procedure. In alternative embodiments, the locking mechanism 112 may include other locking mechanisms in addition to or in place of the sliding locking mechanism 112 shown in FIGS. 1-2 . 3, the locking mechanism 112 may have a bolt action latching feature configured to allow a user to manipulate a portion of the locking mechanism 112 such that the combination of the locking mechanism 112 and the head 110 physically prevents translation of the rod 103 (and subsequent movement of any other components, such as components of the implant 200).

[0037] The head 110 is shown having a protrusion 114 extending from the top of the head 110. The protrusion 114 extends in a direction substantially opposite the handle 102. The protrusion 114 is configured to have a complementary geometry with one or more components of the implant 200, thereby allowing the components of the implant 200 to be releasably coupled to the protrusion 114 of the instrument 100. As shown in FIGS. 4-5 , the protrusion 114 has a protrusion 116 extending from the protrusion 114 in a direction substantially opposite the handle 102 (e.g., the protrusion 116 extends from the protrusion 114 in substantially the same direction as the protrusion 114 extends from the head 110). The protrusion 116 has a catch 118 disposed at an end opposite the protrusion 114. The catch defines a recess 119. The recess 119 is configured to facilitate coupling with the implant 200 and its components and positioning / repositioning of the implant 200 and its components.

[0038] 4-6, insert 202 (e.g., a component of implant 200) is shown positioned adjacent a bottom surface of protrusion 114. In some embodiments, insert 202 may be releasably coupled to or interface with protrusion 114. For example, insert 202 may abut one or more surfaces of head 110 and / or protrusion 114 of head 110 to prevent movement of insert 202, at least in the general direction of handle 102. In some embodiments, insert 202 may be positioned adjacent an articular surface or another portion of implant 200 (e.g., a talar component) on an underside of insert 202 and in contact with a bottom surface of protrusion 114 on an upper side of insert 202.

[0039] The protrusion 116, including the catch 118 and its recess 119, is configured to mate with the tibial tray 204, as shown in FIGS. 4-6. The tibial tray 204 is configured to mate with the head portion 110 (and the protrusion 116) via the catch 118 and the recess 119. As shown in FIG. 7, the catch 118 and the recess 119 defined by the catch 118 are configured to releasably mate with a complementary geometry of the tibial tray 204. For example, the catch 118 may contact and be received by a complementary recess disposed on the tibial tray 204, while the tibial tray 204 may simultaneously have a catch configured to contact and be received by the recess 119 defined by the catch 118. As further shown in FIG. 7, the protrusion 116 (including the catch 118 and the recess 119) has a negative angle to prevent movement of the tibial tray 204 when the tibial tray 204 is inserted into the implant. The negative angle of the protrusion 116 is configured on the upper surface of the protrusion 116 and may be flush with the horizontal (e.g., parallel to the horizontal) or may extend at an angle below the horizontal (e.g., a negative angle). Thus, the negative angle formed by the protrusion 116 also forms an angle of 90 degrees or more with adjacent portions of the protrusion 114. In some embodiments, the protrusion 116 may have a negative angle of up to 90 degrees below the horizontal to secure and retain various different aspects of the tibial tray 204 and / or other components of the implant 200.

[0040] As shown in FIGS. 4-5 , the tibial tray 204 may be coupled to the inserter 100 (via the protrusions 116, catches 118, and recesses 119). At the same time, the insert 202 is positioned below the underside of the head portion 110 (e.g., the upper surface of the insert 202 is adjacent to at least a portion of the underside of the head portion 110). A user may actuate the handle 102 (e.g., twist, rotate, push toward the body portion 104, etc.) to translate the rod 103 through the center of the body portion 104 toward the head portion 110. Translation of the rod 103 through the body portion 104 may contact or otherwise translate the insert 202 in a general direction opposite the opening 106 in the body portion 104, thereby positioning at least a portion of the insert 202 adjacent to and / or directly below at least a portion of the tibial tray 204. As the insert 202 translates, it moves from anterior to posterior relative to the tibial tray 204 (e.g., the tibial tray 204 is coupled to the protrusion 116, catch 118, and recess 119 at the anterior portion of the tibial tray 204). Thus, the insert 202 is positioned below (e.g., inferiorly) the anterior portion of the tibial tray 204, and then, as the insert 202 is translated by the rod 103, it is positioned below the posterior portion of the tibial tray 204. In some embodiments, the upper surface of the insert 202 may abut and engage with the lower surface of the tibial tray 204. The insert 202 and / or the tibial tray 204 may include one or more components (e.g., complementary geometries, engagement features, etc.) to facilitate interface between the two components. For example, the tibial tray 204 may have one or more grooves configured to receive, accommodate, and retain one or more elongated grooves of the insert 202 (or vice versa).

[0041] The tibial tray 204 is configured to remain releasably coupled to the inserter 100 as the insert 202 translates. The protrusions 116, catches 118, and recesses 119 are configured to contact and couple with the tibial tray 204 so that the tibial tray 204 is held in a set position while the insert 202 is translated by actuation of the handle 102 (driving the rod 103). For example, the top surface of the insert 202 may contact the tibial tray 204 as the insert 202 translates in a direction substantially opposite the opening 106. This contact between the insert 202 and the tibial tray 204 may apply a force to the tibial tray 204 in a direction substantially the same as or similar to the translation of the insert 202 (e.g., the direction opposite the opening 106). However, because the tibial tray 204 is retained by the protrusions 116, catches 118, and recesses 119, the insert 202 may be positioned relative to the tibial tray 204 as desired. In some aspects, the tibial tray 204 and the insert 202 may have complementary geometries configured to contact and facilitate releasable coupling. Thus, as the tibial tray 204 is held by the protrusions 116, catches 118, and recesses 119, the geometries and / or other coupling features may contact and the insert 202 may be positioned as desired relative to the tibial tray 204 while the tibial tray 204 remains in a set position.

[0042] Referring to FIG. 6 , translation of the rod 103 via actuation of the handle 102 may be defined within a specific range of motion. For example, the rod 103 may be configured to have a length such that contact between the handle 102 and the body portion 104 (the portion adjacent the opening 106) places the insert 202 in a desired position beneath the tibial tray 204. Additionally, the tibial tray 204 and / or the insert 202 may have a shape that accommodates a releasable connection between these two components, and the connection may have one or more geometries / components configured to prevent further translation of the rod 103. As shown in FIG. 6 , once the insert 202 is positioned above the tibial tray 204, these two components may be inserted into a prepared joint cavity using the inserter 100. In some embodiments, the tibial tray 204 and the insert 202 may be manipulated to contact / connect with other components of the implant 200 and / or the patient's joint during a total ankle replacement procedure. In some embodiments, the tibial tray 204 and / or insert 202 may be separated from the inserter 100 prior to implantation into the patient or coupling with other devices / instruments performed in a total ankle replacement procedure. In some embodiments, the tibial tray 204 may be positioned adjacent to the prepared tibial surface using the inserter 100, and when the desired position within the joint space is achieved, the tibial tray 204 and / or insert 202 are simultaneously separated from the inserter.

[0043] When releasing the tibial tray 204 and / or insert 202 from the inserter 100, the user / physician may refer to instructions 111 provided on one or more surfaces of the inserter. As shown in FIG. 1 , the instructions 111 are located on the top surface of the head portion 110 adjacent the locking mechanism 112. Further to the embodiment shown in FIG. 1 , the instructions 111 may indicate that the tibial tray 204 (which may be coupled with the insert 202) may be released from the inserter 100 by applying downward pressure to the locking mechanism 112. Thus, when the desired positioning of the tibial tray 204 and insert 202 is achieved, the physician can release (e.g., separate) the tibial tray 204 and / or insert 202 from the instrument by depressing the locking mechanism 112. Once released, the handle 102 and rod 103 can be returned to the position shown in FIG. 1 by actuating the handle in the opposite manner to the previous actuation of the insert 202 (e.g., rotating in the opposite direction, retracting the plunger in the opposite direction to that which was pushed, etc.).

[0044] Referring now to FIGS. 8-12, an inserter 100 is shown in a configuration similar to that shown in the embodiment of FIGS. 1-7, but may include alternative components. In some embodiments, the inserter 100 of FIGS. 8-12 may include one or more components identical or similar to the inserter 100 of FIGS. 1-7, including, for illustrative purposes only, the handle portion 102, the body portion 104, and the head portion 110 (and their components). The inserter 100 is shown to include a protrusion 216. The protrusion 216 is disposed at a distal portion of the head portion 110 and extends distally therefrom. As shown, the protrusion 216 is positioned in the same and / or similar location as the protrusion 116 as previously shown and described herein. The protrusion 216 may have a pin or other resilient member positioned adjacent to (or above / dorsally of) a rigid member, which may be identical and / or similar to) the protrusion 116. The protrusion 216 is configured to releasably couple with a tibial tray of an ankle arthroplasty system, such as the tibial tray 204 of the implant 200 as shown and described above (although the protrusion 216 may also facilitate releasably coupling with one or more other components of the ankle arthroplasty system). For example, the tibial tray 204 may have a recess (e.g., a bore, a recess, an opening, etc.) configured to receive at least a portion of the protrusion 216 (which may include a resilient member and / or a rigid member) such that the protrusion 216 may be releasably coupled with the tibial tray 204.

[0045] The inserter 100 may include a locking mechanism the same as and / or similar to the locking mechanism 112 (e.g., retention mechanism, actuatable and releasable coupling mechanism, etc.) as shown and described above to retain the tibial tray 204 when the tibial tray 204 is releasably coupled with the projections 216. For example, the locking mechanism 112 may have one or more actuators (e.g., buttons, etc.) that actuate one or more components of the inserter 100. The locking mechanism 112 may, for example, manipulate a resilient member of the projections 216 relative to a rigid member to facilitate releasable coupling and / or decoupling of the tibial tray 204. When implanting the implant 200, the physician releasably couples the tibial tray 204 to the inserter 100 via the protrusions 216 (and may simultaneously or otherwise releasably couple other implant components to the inserter 100), positions the tibial tray 204 as desired, and actuates the locking mechanism 112 to release the tibial tray 204 from the protrusions 216, thereby placing the tibial tray 204 in the desired position. Operation of the locking mechanism 112 may depress, extend, withdraw, or otherwise actuate at least a portion of the protrusions 216 (e.g., a resilient member relative to a rigid member), thereby initiating the releasable coupling of the tibial tray 204 and / or the separation of the tibial tray 204 from the inserter 100. Upon positioning the tibial tray 204 as desired, the physician may manipulate one or more other portions of the inserter 100, such as the gripping portion 109, to actuate at least a portion of the rods 105 and / or 103. This allows the tibial tray 204 to be translated along the longitudinal axis of the inserter 100.

[0046] It should be noted that components, features, and other aspects of the inserter 100 as shown in one or more of Figures 1-12 may be interchangeable between one or more of the embodiments shown and described herein. That is, for example, the inserter 100 as shown in Figure 1 may be modified to include one or more of the features and / or components as shown and described in Figures 8-12. Additionally, the inserter 100 as shown and described herein may be modified to accommodate one or more components of an implant system that may comprise, for example, a total ankle arthroplasty system, which is incorporated by reference herein.

[0047] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit 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 dictates otherwise. The terms "comprise," "include," "comprises," "comprising," and any form of "have," such as "have," "has," "having," "include," "include," "included," and any form of "contain," such as "contain," "contains," "containing," and any form of "contain," are understood to be open-ended, relating verbs. Consequently, a method or apparatus that "comprises," "has," "includes," or "contains" one or more steps or elements may possess one or more of those steps or elements, but is not limited to possessing only those one or more steps or elements. Similarly, a method step or apparatus element 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, an apparatus or structure that is configured in a particular way is configured in at least that way, but may also be configured in ways not recited.

[0048] The present disclosure has been described with reference to preferred embodiments. It will be understood that the structural and operational embodiments described herein are illustrative of multiple possible configurations for providing the same general features, characteristics and general system operation. Modifications and alterations will occur to others upon reading, understanding and understanding the foregoing detailed description. It is intended that the present disclosure be construed as including all such modifications and alterations.

Claims

1. The implant system and a device; the implant system includes a tibial component, a talar component, and an intermediate component; The device comprises: a handle portion coupled to the rod; a head portion having a releasable coupling mechanism configured to releasably couple to the tibial component; and a body portion disposed between the handle portion and the head portion, the head portion is releasably coupleable to an intermediate component; the coupling mechanism has a protrusion extending from a top portion of the coupling mechanism; the protrusion has a projection configured to engage at least a portion of the tibial component; The protrusion is a catch disposed at an end of the protrusion; a notch defined by the catch and configured to mate with the tibial component; an engagement portion provided on a lower surface of the protrusion, The engagement portion is slidably coupled to the intermediate component, and the rod abuts the intermediate component to translate the intermediate component relative to the coupling mechanism.

2. The system of claim 1 , wherein the tibial component and the medial component are simultaneously releasably coupleable to the head portion of the instrument such that the tibial component is positioned superiorly relative to the medial component.

3. The handle portion of the instrument includes a grip portion and a threaded rod as the rod; The system of claim 1 , wherein at least a portion of the threaded rod extends into and through the body of the instrument.

4. The system of claim 3 , wherein the body of the instrument has complementary threads that receive at least a portion of the threaded rod.

5. The system of claim 4 , wherein manipulation of the gripping portion actuates the threaded rod along the longitudinal axis of the instrument.

6. The system of claim 5, wherein actuation of the threaded rod along the longitudinal axis repositions the medial component relative to the tibial component in a proximal-distal direction.

7. a handle coupled to the rod; a body portion having a first end and a head portion; a coupling portion; the body portion is configured to receive the rod at a central portion of the body portion; the coupling portion is configured to releasably couple to one or more components of an implant system; the coupling portion has a protrusion extending from an upper portion of the coupling portion; the protrusion has a projection configured to engage at least a portion of a first implant component of the one or more components of the implant system; The protrusion is a catch disposed at an end of the protrusion; a notch defined by the catch and configured to mate with the first implant component of the one or more components of the implant system; an engagement portion provided on a lower surface of the protrusion, the engagement portion slidably couples with a second implant component of the one or more components of the implant system, and the rod abuts the second implant component to translate the second implant component relative to the coupling portion.

8. 8. The instrument of claim 7, wherein actuation of the handle moves the rod to actuate the second implant component relative to the first implant component and position the second implant component adjacent to the first implant component.

9. The instrument of claim 7 , wherein the coupling comprises an actuator configured to facilitate engagement and disengagement with at least one of the one or more components of the implant system.

10. The instrument of claim 8 , wherein the second implant component is an insert for a total ankle replacement implant.

11. The instrument of claim 8 , wherein the first implant component is a tibial tray for a total ankle replacement implant.

12. The instrument of claim 7 , wherein the rod has a first thread disposed along the length of the rod.

13. a second thread disposed within the body; the second thread is complementary to and receives the first thread; The instrument of claim 12, wherein actuation of the handle causes translation of the rod through the body portion via the first thread and the second thread.

14. The instrument of claim 8 , wherein the second implant component is releasably coupleable with the first implant component.

15. 9. The instrument of claim 8, wherein the coupling portion is configured to releasably couple with the first implant component such that the first implant component remains in a fixed position while the second implant component is actuated.

16. The instrument of claim 15, wherein the first implant component has a complementary geometry to the catch and the notch to receive the catch on a portion of the first implant component.

Images