Fibular nail system, instrumentation, and surgical methods
Patent Information
- Application Number
- AU2025210663
- Authority / Receiving Office
- AU · AU
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-07-19
- Filing Date
- 2025-01-17
- Publication Date
- 2026-08-27
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
CROSS RELATED APPLICATIONS
[0001] This application claims benefit of priority of U.S. Provisional Application No. 63 / 622,994 filed on January 19, 2024, and entitled “Fibular Nail System, Instrumentation, and Surgical Methods,” and U.S. Provisional Application No. 63 / 673,477 filed on July 19, 2024, and entitled “Fibular Nail System, Instrumentation, and Surgical Methods,” the disclosures of which are hereby incorporated herein by reference in their entirety. TECHNICAL FIELD
[0002] The present disclosure relates to implants, instruments, and surgical methods to be implemented in surgical procedures. The present disclosure relates to podiatric and orthopedic implants, instruments, and surgical methods to be implemented in various procedures of the foot, ankle, or other anatomy. More specifically, but not exclusively, the present disclosure relates to an intramedullary implant, instruments, and associated methodology to be implemented for surgical procedures of the lower extremity, namely the foot and / or ankle. BACKGROUND OF THE INVENTION
[0003] Many currently available surgical implants, instruments, and methods do not completely address the needs of patients. Additionally, many currently available surgical implants, instruments, and methods fail to account for properties of foot and ankle anatomy and accordingly can decrease favorability of the outcome for the patient. SUMMARYOF THE INVENTION
[0004] The present disclosure is directed toward implants, instruments, and surgical methods to be implemented in surgical procedures of the foot and ankle.
[0005] A first aspect of the present disclosure is an implant. The implant includes a first end and a second end separated from the first end by a shaft. The second end includes a dynamic feature that, when actuated, transitions from a first position to a second position.
[0006] According to the first aspect of the present disclosure, the implant includes an inner cavity extending from the first end of the implant to the second end of the implant.
[0007] According to the first aspect of the present disclosure, the implant includes an actuator positioned at least partially within the cavity, wherein the actuator extends from the first end of the implant to the second end of the implant.
[0008] According to the first aspect of the present disclosure, the first end of the implant includes a base, and the base includes an opening at a terminal end of the first end of the implant, wherein the opening is in fluid communication with the cavity.
[0009] According to the first aspect of the present disclosure, the actuator includes an interface at an end of the actuator proximate to the base of the implant, wherein the interface is accessible via the opening and cavity.
[0010] According to the first aspect of the present disclosure, the base includes a first plurality of openings and a second plurality of openings, wherein the first and second plurality of openings extend diametrically through the base and provide fluid communication with the cavity.
[0011] According to the first aspect of the present disclosure, the first plurality of openings includes a threading.
[0012] According to the first aspect of the present disclosure, the first plurality of openings includes a first opening extending diametrically through the base and includes a first central axis, and a second opening extending diametrically through the base and includes a second central axis, wherein the first and second central axes are positioned in planes that form an oblique angle with one another.
[0013] According to the first aspect of the present disclosure, the second plurality of openings includes a third opening extending diametrically through the base and includes a third central axis, and a fourth opening extending diametrically through the base and including a fourth central axis, wherein the third and fourth central axes are substantially parallel to one another.
[0014] According to the first aspect of the present disclosure, the implant includes a transition portion positioned between the base and the shaft, wherein the transition portion includes a tapered diameter which is greatest at a point adjacent to the base and least at a point adjacent to the shaft.
[0015] According to the first aspect of the present disclosure, the transition portion includes a first longitudinal axis and the shaft includes a second longitudinal axis, wherein the first and second longitudinal axes form an oblique angle with one another.
[0016] According to the first aspect of the present disclosure, the dynamic feature includes a plurality of protrusions which extend at least partially outward from the implant.
[0017] According to the first aspect of the present disclosure, wherein the plurality of protrusions include a pair of protrusions, wherein each protrusion of the pair of protrusions is positioned diametrically opposite the second end from one another.
[0018] According to the first aspect of the present disclosure, each protrusion of the pair of protrusions are integral with the second end of the implant.
[0019] According to the first aspect of the present disclosure, the first position includes an outer surface of each of the protrusions substantially level with the outer surface of the implant, and the second position includes the outer surface of each of the protrusions forming an oblique angle relative to the outer surface of the implant.
[0020] According to the first aspect of the present disclosure, the actuator includes a tip at an end opposite of that of the interface, wherein the actuator is translatable along the length of the cavity of the implant.
[0021] According to the first aspect of the present disclosure, the actuator is configured such that when translated within the cavity toward the second end of the implant, the tip of the actuator is configured to contact at least a portion of each of the protrusions within the cavity of the implant and bias each of the protrusions outward.
[0022] A second aspect of the present disclosure is directed to an implant. The implant includes a first end, which includes a first plurality of openings extending diametrically through the first end, a second plurality of openings extending diametrically through the second end, and a first opening positioned at a terminal end of the first end and extending through the first end along a longitudinal axis. The implant also includes a shaft that is integral with the first end and forms an oblique angle relative to the first end and includes a cannulation in fluid communication with the first opening and extending along a length of the shaft. The implant also includes a second end which is integral with the shaft. The second end includes a cannulation in fluid communication with the cannulation of the shaft, and a dynamic feature that includes a first position in which a majority of the dynamic feature is positioned below the outer surface of the implant and a second position in which the dynamic feature extends beyond the outer surface of the implant. The implant also includes an actuator disposed within and extending through the first opening of the first end, the cannulation of the shaft, and into the cannulation of the second end. The actuator includes an interface at a first end that is proximate to the first opening and accessible via the first opening with an actuation instrument, and a tip at a second end opposite the first end configured to contact at least a portion of the dynamic feature within the cannulation of the second end so as to manipulate the dynamic feature from the first position to the second position.
[0023] A third aspect of the present disclosure is directed to a corresponding surgical method. The surgical method includes creating a volume that extends proximally from a distal-most portion of a fibula of a patient, placing a template over at least a portion of the fibula of the patient, wherein the template includes at least one marking indicative of sizing of an intramedullary implant, and determining a desired size of the intramedullary implant. The surgical method also includes obtaining an intramedullary implant of the desired size, coupling an alignment instrument with a first end of the intramedullary implant, and inserting the intramedullary implant within the volume in the fibula of the patient. The surgical method also includes engaging a first instrument with an internal feature of the intramedullary implant so as to manipulate a dynamic feature of the intramedullary implant from a first position to a second position, wherein the intramedullary implant has a greater lateral geometry in the second position than in the first position, and drilling, using the alignment instrument, one or more holes in the fibula of the patient, wherein the one or more holes in the fibula correspond to the position of one or more openings disposed within the intramedullary implant. The surgical method further includes coupling at least one fastener with the one or more openings of the intramedullary implant via the one or more holes in the fibula of the patient, decoupling the alignment instrument from the intramedullary implant, and releasably coupling an end cap with the first end of the intramedullary implant. BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the detailed description herein, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating preferred embodiments and are not to be construed as limiting the invention. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. The foregoing and other objects, features and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:
[0025] FIG. 1 is a side view of an exemplary orthopedic implant, in accordance with the present disclosure;
[0026] FIG. 2 is an alternate side view of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0027] FIG. 3 is a perspective, front view of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0028] FIG. 4 is a side view of a rear or distal portion of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0029] FIG. 5 is an alternate side view of the rear or distal portion of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0030] FIG. 6 is a rear perspective view of the rear portion of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0031] FIG. 7 is a side view of a front or proximal portion of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0032] FIG. 8 is an alternate rear view of the front or proximal
[0033] portion of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0034] FIG. 9 is a front perspective view of the front portion of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0035] FIG. 10 is a side cross-sectional view of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0036] FIG. 11 is an enlarged, cross-sectional side view of the rear or distal portion of the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0037] FIG. 12 is an enlarged, cross-sectional side view of the front or proximal portion of the exemplary orthopedic implant of FIG. 1 in an initial state, in accordance with the present disclosure;
[0038] FIG. 13 is an enlarged, cross-sectional side view of the front portion of the exemplary orthopedic implant of FIG. 1 in a biased state, in accordance with the present disclosure;
[0039] FIG. 14 is an enlarged, cross-sectional side view of the front portion of the exemplary orthopedic implant of FIG. 1 in an actuated state, in accordance with the present disclosure;
[0040] FIG. 15 is a front view of components of a system for implementation with the orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0041] FIG. 16 is a side view of components of the system of FIG. 15 for implementation with the orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0042] FIG. 17 is a step of a surgical method which may be implemented in conjunction with the components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0043] FIG. 18 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0044] FIG. 19 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0045] FIG. 20 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0046] FIG. 21 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0047] FIG. 22 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0048] FIG. 23 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0049] FIG. 24 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0050] FIG. 25 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0051] FIG. 26 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0052] FIG. 27 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0053] FIG. 28 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0054] FIG. 29 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0055] FIG. 30 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0056] FIG. 31 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0057] FIG. 32 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0058] FIG. 33 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0059] FIG. 34 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0060] FIG. 35 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0061] FIG. 36 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0062] FIG. 37 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0063] FIG. 38 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0064] FIG. 39 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0065] FIG. 40 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0066] FIG. 41 is a step of the surgical method which may be implemented in conjunction with components of the system of FIG. 15 and / or the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0067] FIG. 42 is a front view of one configuration of the components of the system of FIG. 15 which may be implemented in conjunction with the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0068] FIG. 43 is a side view of the configuration FIG. 42 of the components of the system of FIG. 15 which may be implemented in conjunction with the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0069] FIG. 44 is an alternate front view of the configuration of FIG. 42 of the components of the system of FIG. 15 which may be implemented in conjunction with the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0070] FIG. 45 is a front view of another configuration of the components of the system of FIG. 15 which may be implemented in conjunction with the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0071] FIG. 46 is a side view of the configuration of FIG. 45 of the components of the system of FIG. 15 which may be implemented in conjunction with the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0072] FIG. 47 is a front view of the configuration of FIG. 45 of the components of the system of FIG. 15 which may be implemented in conjunction with the exemplary orthopedic implant of FIG. 1, in accordance with the present disclosure;
[0073] FIG. 48 is a side view of an exemplary front end or proximal portion of the exemplary orthopedic implant of FIG. 1 in an initial state, in accordance with the present disclosure;
[0074] FIG. 49 is a side, perspective view of the exemplary front end or proximal end portion of FIG. 48 of the exemplary orthopedic implant of FIG. 1 in a biased state, in accordance with the present disclosure; and
[0075] FIG. 50 is a side, perspective view of the pair of wings of the exemplary proximal end portion of FIG. 47 of the exemplary orthopedic implant of FIG. 1 in an actuated state, in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0076] In this detailed description and the following claims, the words proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part or portion of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, “proximal” means the portion of a device or implant nearest the torso, while “distal” indicates the portion of the device or implant farthest from the torso. As for directional terms, “anterior” is a direction towards the front side of the body, “posterior” means a direction towards the back side of the body, “medial” means towards the midline of the body, “lateral” is a direction towards the sides or away from the midline of the body, “superior” means a direction above and “inferior” means a direction below another object or structure. Further, specifically in regards to the foot, the term “dorsal” refers to the top of the foot and the term “plantar” refers to the bottom of the foot.
[0077] Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current implants, devices, instrumentation, and methods are described herein with reference to use with the bones of the foot, the bones of the foot, ankle and lower leg may be used to describe the surfaces, positions, directions or orientations of the implants, devices, instrumentation and methods. Further, the implants, devices, instrumentation, and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the implants, devices, instrumentation, and methods, and the aspects, components, features and the like thereof, described and / or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the invention. For example, the implants, devices, instrumentation, and methods, and the aspects, components, features and the like thereof, described herein with respect to the right foot may be mirrored so that they likewise function with the left foot. Further, the implants, devices, instrumentation, and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the foot for brevity purposes, but it should be understood that the implants, devices, instrumentation, and methods may be used with other bones of the body having similar structures.
[0078] Referring now to FIGS. 1-50, an orthopedic implant system 1000 and components thereof are shown, according to an exemplary embodiment. The system 1000 and the components thereof, which may include one or more implants and / or instruments commonly implemented in orthopedic surgical procedures, may be implemented according to a surgical method shown in at least FIGS. 17-41. It should be understood that, in some aspects, the system 1000 may include duplicates of one or more components, wherein one or multiple of the components are implemented in conjunction with the system 1000. Further, it should be understood that in implementing the system 1000, one or more of the components of the system 1000 may be omitted.
[0079] Referring now to at least FIGS. 1-14 and 47-50, the system 1000 is shown to include an implant 102, according to an exemplary embodiment. The implant 102 is shown to be an intramedullary nail and is further shown to be a fibular intramedullary nail. The implant 102 is configured to be implanted, by a physician, within an intramedullary canal of a fibula of a patient. The implant 102 may then be secured within the canal of the fibula using one or more additional implants, for example screws, k-wires or other fasteners, as well as one or more features of the implant 102 itself. Further, in placing the implant 102 within the fibula of the patient, a physician may implement one or more components of the system 1000, for example various instruments, according to the steps of the surgical method as shown and described with respect to FIGS. 17-41. As shown, the implant 102 has a substantially elongated geometry with a cylindrical geometry along at least a portion of the length thereof. Further, in some aspects the implant 102 may have varying diameters along the length of the implant, where tapered geometries may transition from a first diameter to a second diameter.
[0080] The implant 102 is shown to include a first end 104 substantially opposite a second end 106, according to an exemplary embodiment. The first end 104 is shown to include a base 108 extending from a terminal end of the implant 102 (at the first end 104) to a transition 120. As shown, the transition 120 includes a tapered geometry along at least a portion of the length thereof, wherein the transition 120 is positioned between the base 108 and a shaft 122. The shaft 122 is shown to have a cylindrical geometry (similar to that of the base 108), but with a lesser cross-sectional diameter than that of the base 108 (and thus the cross-sectional diameter along the transition 120 decreases when moving from the base 108 to the shaft 122).
[0081] The base 108 is shown to include a first set of openings 110 (e.g., openings 110) and a second set of openings 112 (e.g., openings 112). The openings 110, which are shown, for example, to include three openings, but may also include a greater or lesser number of opening(s) are positioned between the terminal end of the first end 104 of the implant 102 and the transition 120. Similarly, the openings 112, which are shown, for example, to include two openings, but may also include a greater or lesser number of opening(s) are positioned between the transition 120 and the openings 110. The openings 110, 112 are shown to extend diametrically through the implant 102 so as to create fluid communication therebetween. As shown, the openings 110 and 112 may be positioned variously about the circumference of the implant 102 both relative to each other and to the other set of openings. The openings 110 are shown to be threaded openings, whereas the openings 112 are shown to be threadless. However, in some aspects the openings 110, 112 may be threaded or unthreaded, or some combination of threaded and unthreaded openings.
[0082] Further, the openings 110, 112 are shown to be in fluid communication with one another (e.g., the openings 110 with the other openings 110 and with the openings 112, and vice-versa), as each of the openings 110, 112 are in fluid communication with a cavity 118 extending along a longitudinal axis of the base 108 from the terminal end of the first end 104. As shown, the cavity 118 is shown to have a substantially cylindrical geometry. The cavity 118, which extends along the length of the base 108 and the transition 120, is shown to be in fluid communication with a cavity 124 of the shaft portion 122 so as to form a continuous cavity extending from the terminal end of the first end 104 into the shaft 122.
[0083] The terminal end of the first end 104 of the implant 102 is shown to be open to the cavity 118 and is further shown to include notches 114 which may facilitate coupling with an end cap 144 (as shown in FIG. 41). The end cap 144 may include notches complimentary to the notches 114 as well as a threading complimentary to threading 116 positioned within the cavity 118 at the terminal end of the first end 104 (and adjacent to the notches 114). In coupling the end cap 144 with the implant 102, the end cap 144 may engage with one or both of the notches 114 and / or the threading 116 so as to close off the cavity 118 at the terminal end of the first end 104.
[0084] The implant 102 is shown to include an actuator 128 disposed within the cavities 118, 124 and extending along the length of the shaft 122 to a terminal point positioned within a cavity 142 (which is in fluid communication with the cavities 118, 124) of the second end 106 of the implant 102. As shown, the actuator 128 has a substantially cylindrical geometry along at least a portion of its length, although in some aspects the actuator 128 may include alternate geometries. The actuator 128 is shown to include an interface 130, which is shown to be a hex-drive feature but may be alternate interfaces in some embodiments, positioned at a terminal end of the actuator 128 and positioned within the cavity 118 within the transition 120. Further, the actuator 128 includes a threading 132 along at least a portion of its length, which is complimentary to a threading 126 disposed within the cavity 124 along at least a portion of the length of the interior surface of the shaft 122. Accordingly, a physician may insert an appropriate instrument with a complimentary interface to that of the interface 130 (along the longitudinal axis of the body 108) within the cavity 118 such that the instrument (for example, the instrument 362 as shown in at least FIG. 33) engages with the interface 130. The physician may then manipulate the instrument 362 (e.g., rotate) so as to drive rotation of the actuator 128 along the threading 126 so as to translate the actuator 128 along the length of the shaft 122 within the cavity 124 and toward the second end 106 of the implant 102.
[0085] The second end 106 of the implant 102 is shown to be integral with the shaft 122 (which is in turn integral with the transition 120 and the base 108) and is further shown to have a cross-sectional geometry (and diameter) of substantially the same size as the shaft 122. The second end 106 is shown to terminate in a tip 136 positioned at a terminal end of the second end 106, wherein the tip 106 has a substantially rounded geometry (e.g., a blunt tip). In some aspects, the tip 136 may be coupled with and / or releasably couplable with the shaft 122 such that in assembling the implant 102, the tip 136 and the shaft 122 may be coupled with one another. The cavity 124 of the shaft 122 is shown to be in fluid communication with the cavity 142 of the second end 106, where the cavity 142 extends along the longitudinal axis of the second end 106 toward the tip 136 (but does not extend to the terminal end of the tip 136 and thus does not provide fluid communication to the exterior portion of the tip 136).
[0086] The second end 106 is further shown to include a pair of wings 138, which are positioned diametrically opposite the circumference of the second end 106 from one another. In some aspects, the second end 106 may include alternate numbers of wings, for example a single wing or three or more wings. The wings 138 are shown to be integral with the second end 106 and are positioned such that they protrude from a portion of the second end 106 between the wings 138 and the tip 136 in a direction at least partially toward the shaft 122. The wings 138 are integral with the second end 106 at a point between the wings 138 and the tip 136 of the second end 106. Further, the wings 138 are shown to protrude at least partially in a lateral direction, for example at an oblique angle relative to the longitudinal axis of the second end 106. Accordingly, the wings 138 may be biased toward the longitudinal axis of the second end 106 such that at least a portion of one or both of the wings 138 is positioned within the cavity 142 of the second end 106. The wings 138 are also shown to include a texture 140 positioned on an outer surface thereof, which is shown in at least FIGS. 12-14 as a collection of ridges (e.g., a serration, ribs, etc.) running in a direction perpendicular to that of the longitudinal axis of the second end 106. In some aspects, the texture 140 may have an alternate configuration, for example ridges extending in a different direction, a collection of protrusions arranged in a pattern, or other possible textural arrangements. As shown, the wings 138 further include a substantially angled surface on an interior portion thereof (angled relative to the longitudinal axis of the second end 106) at the end of the wings 138 closest to the shaft 122.
[0087] The second end 106 is also shown to include a pin 146 positioned within the cavity 142 at a point along the longitudinal axis of the second end 106 between the pair of wings 138. As shown in at least FIGS. 12-14, the pin 146 has a substantially cylindrical geometry and extends diametrically across the cavity 142 within the second end 106 of the implant 102. However, in some aspects the pin 146 may have alternate geometries, positions, or may include multiple pins 146. In some aspects, an interior surface of each of the wings 138 may have a curved portion (e.g., a cutout) on an inner surface thereof configured to accommodate the geometry of the pin 146 when one or both of the wings 138 have been biased at least partially into the cavity 142 (e.g., as shown in FIG. 13). However, it should be understood by one skilled din the art that the natural position of the wings 138 is that which is shown in FIG. 12, where both of the wings 138 protrude from the second end 106 (and the cavity 142) at an oblique angle relative to the longitudinal axis of the second end 106.
[0088] The actuator 128 is shown to include a tip 134 positioned at an end opposite the interface 130, as shown in at least FIGS. 12-14. The tip 134 includes a substantially angled geometry terminating at a point, with the threading 132 of the actuator 128 extending along the length of the actuator and terminating at a point adjacent the angled geometry of the tip 134.
[0089] As shown in FIG. 13, the actuator 128 may be translated along the longitudinal axis of the shaft 122 (which is coaxial with the longitudinal axis of the second end 106) via the threading 132 of the actuator and the threading 126 of the shaft 122 such that the actuator 128 and tip 134 thereof are received within the cavity 142 of the second end 106. When the wings 138 are in an inward-biased position such as that of FIG. 13, the angled portion of the tip 134 contacts the inner, angled surface of each of the wings 138. As the actuator 128 is translated further into the cavity 142 of the second end 106, the tip 134 biases each of the wings 138 laterally (e.g., outward from the cavity 142) such that the wings 138 extend beyond the outer surface of the second end 106 of the implant 102. The actuator 128 may be advanced into the cavity 142 until the tip 134 contacts the pin 146, at which point the actuator 128 may not be advanced any further and, accordingly, the wings 138 are biased as far laterally as possible. In some aspects, the instrument 362 may include a torque limiting feature such that the actuator 128 cannot be advanced beyond a certain point within the cavity 142 if the wings 138 encounter a resistance external to the implant 102, the further biasing of the wings 138 would not exceed the threshold of the torque limiting feature of the instrument 362.
[0090] Referring now to FIGS. 15-16 and 42-47, an outrigger 150 and components thereof are shown adjacent the implant 102 and the fibula 202 and tibia 204 of a patient, according to an exemplary embodiment. The outrigger 150 is shown to be releasably couplable with the first end 104 of the implant 102 and guide implantation of the implant 102 as well as fixation of the implant 102 once the implant 102 has been placed within the fibula 202 of the patient. The outrigger as shown in FIGS. 15-16 may be implemented in conjunction with various drill guides, screw guides, k-wires, drills, screws (and / or other implants / fasteners), and other instruments common to orthopedic surgical procedures.
[0091] The outrigger 150 is shown to include a lower portion 152 and an upper portion 164, which are releasably couplable with one another via a coupling 166. As shown, the coupling 166 includes a threaded knob mechanism which threadably couples the lower and upper portions 152, 164, although in some aspects other coupling devices may be implemented (e.g., a ball detent, dovetail grooves, etc.). In some aspects, the outrigger may be provided to the physician in a coupled configuration, such as that shown in FIGS. 15-16 and 45-47. However, the outrigger 150 may also be provided to the physician in a decoupled configuration, for example that shown in FIGS. 42-44. Further, the physician may desire to manipulate the upper and lower portions 152, 164 from a coupled to decoupled configuration (or vice versa) based on personal preference, access to anatomy, or other various reasons.
[0092] The lower portion 152 of the outrigger 150 is shown to include a first end 154 opposite the lower portion 152 from a second end 156. The first end 154 is releasably couplable with the base 108 of the implant 102 via a coupling 158. The coupling 158 may include a threaded portion disposed at a terminal end of the first end 154 configured to interface with the threading 116 of the base 108. Further, the coupling 158 may include a geometry complimentary to that of the base 108, which may include one or more notches configured to interface / engage with the notches 114 of the base 108. The lower portion 152 is shown to have a substantially J-shaped geometry, where the lower portion 152 includes a substantial curvature between the first and second ends 154, 156. The second end 156 is shown to include a coupling feature configured to accommodate the coupling 166 of the upper portion 164 such that the upper and lower portions 152, 164 may be releasably coupled with one another. Accordingly, the coupling feature of the second end 156 may include a threading disposed in an opening or other bore, with the threading complimentary to that of the coupling 166.
[0093] The upper portion 164 of the outrigger 150 is shown to be positioned superior (e.g., above) relative to the lower portion 152 when the two components are in a coupled configuration, as shown in FIGS. 15-16. The upper portion 164 includes a central portion 168 which is shown to include a substantially elongated geometry. A lower portion of the central portion 168 is shown to engage with the second end 156 of the lower portion 152 such that the coupling 166 (which is disposed on a lower portion of the central portion 168) may releasably couple the two components together. The central portion 168 is further shown to include a pair of extensions 170, 180 extending laterally and from opposite sides of an upper portion of the central portion 168. As shown, the extensions 170, 180 extend in substantially opposite directions (but in some aspects, not 180-degree opposite directions) along an arcuate path sharing a common radius (e.g., along an arc which may form a portion of a circumference of a circle with its vertex positioned along a longitudinal axis of the implant 102 and / or a portion of the fibula 202 in which the implant 102 may be positioned). Each of the extensions 170, 180 are shown to include a substantially square or rectangular geometry.
[0094] The first extension 170 is shown to include a set of openings 174 and a set of openings 176, with the openings 174 positioned directly below and having parallel axes to the openings 176. Each of the openings 174, 176 are shown to extend from a front side of the upper portion 164 (e.g., the side with the coupling 166) through to a rear side of the upper portion 164. As shown, each of the openings 174, 176 include three scalloped openings (e.g., overlapping circular openings) arranged horizontally. However, in some aspects the openings 174, 176 may include alternate numbers of openings, or alternate arrangements of those openings to that shown in at least FIGS. 15-16. The second extension 180 is shown to include a set of openings 184 and a set of openings 186, with the openings 184 positioned directly below and having parallel axes to the openings 186. Each of the openings 184, 186 are shown to extend from a front side of the upper portion 164 (e.g., the side with the coupling 166) through to a rear side of the upper portion 164. As shown, the each of the openings 184, 186 include three scalloped openings (e.g., overlapping circular openings) arranged horizontally. However, in some aspects the openings 184, 186 may include alternate numbers of openings, or alternate arrangements of those openings to that shown in at least FIGS. 15-16.
[0095] Each of the extensions 170, 180 are shown to include a protrusion 172, 182 extending downward from a bottom portion of the respective extension. Each of the protrusions 172, 182 are shown to include a rounded geometry, but may include alternate geometries in some aspects. As shown, the protrusions 172, 182 each include a pair of openings 178, 188 (respectively) extending therethrough from a front surface through to a rear surface. The openings 178 of the protrusion 172 are shown to be arranged vertically, as are the openings 188 of the protrusion 182.
[0096] The central portion 168 is further shown to include one or more openings disposed thereon and extending from the front surface through to the rear surface. As shown, the central portion 168 includes a pair of openings 190 positioned opposite a projection from one another, with the projection extending just above the top of the extensions 170, 180 and positioned there between. As shown, the openings 190 are substantially oblong (e.g., not perfectly circular), although in some aspects the openings 190 may be alternate geometries. The central portion 168 is also shown to include a pair of openings 192 positioned centrally on the central portion 168 and having substantially the same geometry of the openings 190. The openings 192 are shown to be positioned closer to one another than the openings 190 such that at least a portion of each of the openings 192 is positioned at least partially between the openings 190 relative to the width of the central portion 168. The central portion 168 is also shown to include an opening 194 having a substantially circular geometry and positioned below and at least partially between (relative to the width of the central portion 168) the openings 192. Further, the central portion 168 is also shown to include an opening 196 positioned directly below the opening 194 and having a smaller, yet still circular geometry. It should be understood by one skilled in the art that one or more of the openings of the central portion 168 as shown and described herein may have an alternate, size, geometry, position, or quantity to that shown in the exemplary embodiment of FIGS. 15-16.
[0097] Referring now to FIGS. 17-41, an exemplary surgical method is shown, according to an exemplary embodiment. As shown, the exemplary surgical method includes components of the system 1000, however in some aspects other systems may be used according to the same or a similar surgical method. Further, in performing the exemplary surgical method of FIGS. 17-41, one or more steps may be omitted, duplicated, or performed in an alternate order to that shown. Further, in some aspects instrumentation common to orthopedic procedures, for example powered drills and drivers, may be implemented in conjunction with the components of the system 1000.
[0098] Referring now to FIG. 17, the step of implant sizing is shown, according to an exemplary embodiment. The system 1000 is shown to include an implant sizing template (template 302) which is configured to be positioned above / over the fibula 202 of the patient, as shown in FIG. 17. The system 1000 further includes a handle 304 which is releasably couplable with the template 302. As shown in FIG. 17, the physician may manipulate the template 302 using the handle 304 so as to position the template 302 over the fibula 202 of the patient. The template 302 is further shown to include a set of markings 308 indicative of the length and diameter of various sizes of implants (for example, each marking corresponds to a length and / or diameter of an implant 102 in millimeters). Further, the template 302 also includes a set of markings 306 positioned at the opposite end of the template 302 from the marking 308. The markings 306 are indicative of various sizes of end caps 144 for the implant 102 (e.g., with each marking corresponding to a size / length of an end cap 144 in millimeters). The template 302 is shown to include an angle along a length thereof, with the angle corresponding to the angle between the transition 120 and the shaft 122 of the implant 102. The physician may position the template 302 as shown in FIG. 17 and determine a size (e.g., length and diameter) of a desired implant 102 as well as a size of the end cap 144.
[0099] Referring now to FIG. 18, the step of positioning a guide is shown, according to an exemplary embodiment. The system 1000 is shown to include a guide 310, which is pivotably coupled with a handle 312. As shown, the guide 310 has a geometry similar to that of a “hook plate” which is commonly used in orthopedic surgical procedures of the foot and ankle including, for example, the fibula 202. The guide 310 may be positioned such that a “hooked” portion at a first end of the guide 310 engages with a distal-most portion of the fibula 202. In order to achieve a desired position, the handle 312 may be pivoted 360-degrees relative to the guide 310. For example, the physician may manipulate the handle 312 relative to the guide 310 based on handedness of the physician or the orientation of the affected fibula of the patient.
[0100] Referring now to FIG. 19, the step of positioning a drill guide is shown, according to an exemplary embodiment. The guide 310 is further shown to include a guide 314, which extends from a distal-most end (e.g., hooked end) of the guide 310. The guide 314 is configured to receive a k-wire therein and guide the k-wire along a trajectory into the distal-most end of the fibula 202 as the k-wire moves proximally. In the step 19, the physician may manipulate the guide 310 (and / or the handle 312) to position the guide 314 along a desired trajectory relative to the fibula 202. In some aspects, the physician may utilize fluoroscopy to visualize the trajectory of the guide 314 and the corresponding k-wire.
[0101] Referring now to FIG. 20, the step of coupling the guide 310 with the fibula 202 of the patient is shown, according to an exemplary embodiment. The guide 310 is shown to include a pair of openings 316 positioned between an end of the guide 310 opposite the “hooked” end and the guide 312, with the openings 316 extending from the top surface of the guide 310 through to the bottom surface. Accordingly, the physician may place, for example, an olive wire 318 through one or both of the openings 316 to secure the guide 310 in the desired position relative to the fibula 202.
[0102] FIG. 21 is further shown to include the step of placing a k-wire 320 in the distal portion of the fibula 202 using the guide 314 of the guide 310, according to an exemplary embodiment. In some aspects, the k-wire 320 may be placed using fluoroscopy such that the physician may monitor the trajectory and depth of the k-wire 320 as it progresses into the distal fibula 202 and moves proximally. The physician may ensure that the k-wire 320 does not exit the fibula 202 at any point. In some aspects, the physician may ensure that the k-wire 320 progresses past and identified fracture in the distal portion of the fibula 202 before stopping the progress of the k-wire 320.
[0103] Referring now to FIG. 21, the step of removing the guide 310 is shown, according to an exemplary embodiment. In the step of FIG. 21, the physician may remove one or more olive wires 318 placed through openings 316 of the guide 310 so as to releasably couple the guide 310 with the fibula 202. In removing the guide 310, the physician may slide the guide 314 in a distal direction over the k-wire 320 so as not to interfere with the trajectory and placement of the k-wire 320 within the distal fibula 202. It should be understood that the physician may implement fluoroscopy in order to ensure proper placement of the k-wire 320 in the distal fibula 202 prior to removal of the guide 310.
[0104] Referring now to FIG. 22, the step of placing a parallel k-wire to the k-wire 320 is shown, according to an exemplary embodiment. In some aspects, the physician may place the k-wire 320 as shown in FIG. 21 along a desired trajectory but biased in the anterior or posterior direction relative to the ideal placement. The physician may implement a parallel wire guide 321 in order to place a second k-wire adjacent and parallel to the k-wire 320, with the second k-wire then remaining in the distal fibula 202 of the patient and the original k-wire 320 removed. It should be understood that the step of FIG. 22 may not be performed in all surgical procedures and thus may be omitted by the physician.
[0105] Referring now to FIG. 23, the step of positioning a tissue protector 322 over the k-wire 320 is shown, according to an exemplary embodiment. Once the physician has confirmed proper placement of the k-wire 320, the physician may position the tissue protector 322 over the k-wire 320 such that the tip of the tissue protector 322 is positioned adjacent to the distal fibula 202 (such that the k-wire 320 has been received at least partially in / through the tissue protector 322).
[0106] Referring now to FIG. 24, the step of reaming the distal fibula 202 is shown, according to an exemplary embodiment. The physician may implement a reamer 324, which is sized to be received within the tissue protector 322 and includes a cannulation to accommodate the k-wire 320, so as to ream into the distal fibula 202 in a proximal direction. In some aspects, the physician may perform this step of the surgical method under fluoroscopy to monitor the proximal progression of the reamer 324. Once the reamer 324 has reached the proximal-most point of the k-wire 320, the physician may remove the reamer 324 as well as the k-wire 320 and tissue protector 322 from the incision adjacent to the distal fibula 202 of the patient.
[0107] Referring now to FIG. 25, the step of reaming through a curved reaming guide 328 is shown, according to an exemplary embodiment. In performing the step of FIG. 25, the physician may obtain a curved reaming guide 328 from the system 1000 and position at least a portion of the curved reaming guide 328 within the void of the distal fibula that was created in the step of FIG. 24. The physician may then use a flexible reamer 330 and place the flexible reamer 330 within the curved reaming guide 328, advancing the flexible reamer 330 to the proximal-most point of the void created in the step of FIG. 24. The physician may then advance the flexible reamer 330, under power, proximally into the fibula 202 to a desired depth based on the desired implant selected in the step of FIG. 17. Once the flexible reamer 330 has reached a desired depth, the physician may remove the flexible reamer 330 and the curved reaming guide 328 from the fibula 202 of the patient.
[0108] Referring now to FIG. 26, the step of reaming the fibula 202 is shown, according to an exemplary embodiment. In performing the step of FIG. 26, the physician may advance the flexible reamer 330 in a larger size than the step of FIG. 25 into the proximal fibula 202 so as to expand the volume (e.g., increase the diameter) created in step of FIG. 25. The step of FIG. 26 may be repeated by the physician (with progressively larger flexible reamers 330) until the volume in the proximal fibula 202 is large enough to accommodate the selected size of the implant 102 (as selected in the step of FIG. 17).
[0109] Referring now to FIG. 27, the step of coupling the outrigger 150 with the implant 102, and inserting the implant 102 within the volume of the fibula 202 is shown, according to an exemplary embodiment. In some aspects, the physician may elect to couple only the lower portion 152 of the outrigger 150 with the implant 102, which may leave more space for the manipulation of various instrumentation. However, in some aspects, the physician may elect to implement the outrigger 150 in its coupled state to facilitate placement of the implant 102 within the fibula 202. In some aspects, the step of FIG. 27 may include coupling the implant 102 with the first end 154 of the outrigger 150, which may include threadably engaging the coupling 158 of the first end with the threading 116 and complementary notches 114 of the base 108 of the implant 102 such that the implant 102 is releasably coupled with the outrigger 150.
[0110] Referring now to FIG. 28, the step of aligning and releasably coupling the outrigger 150 with an anterior portion of the fibula 202 is shown, according to an exemplary embodiment. It should be understood that some steps of the surgical method, for example that of FIG. 28, may vary slightly depending on the anatomy of the patient. Such steps are shown and described herein with reference to the left fibula 202 of the patient, however these steps may be completed in a complementary manner for a right fibula 202 of the patient. The step of FIG. 28 may also include assembling a drill guide 356 (which may include a drill sleeve placed at least partially within a screw sleeve), and inserting a drill guide construct (which includes the drill guide 356) into and through one of the openings 178 or 188, depending on the anatomy of the patient (e.g., the openings 178 are marked “L” and the openings 188 are marked “R”). The drill guide construct may also include a curved wire guide 352, which is placed through the opening 178 (as shown) that is not occupied by the drill guide 356.
[0111] Referring now to FIGS. 29-30, the step of coupling the outrigger 150 with a posterior portion of the fibula 202 is shown, according to an exemplary embodiment. The step of FIGS. 28-29 may also include placing a k-wire 354 into and through the wire guide 352 and into an anterior portion of the fibula 202 so as to releasably couple the outrigger 150 with the fibula 202. An additional drill guide construct (absent the drill guide) may be placed within the openings 188 (as shown), such that a second wire guide 352 may be placed and a second k-wire 354 inserted there through (and subsequently coupled with a posterior portion of the fibula 202. It should be understood that the k-wires 354 placed in the steps of FIGS. 28-29 are aligned by the wire guides 352 so as to miss the implant 102 within the fibula 202 and secure the outrigger 150 by coupling with anterior and posterior portions of the fibula 202 (with the implant 102 positioned therebetween, as shown in FIG. 30).
[0112] Referring now to FIGS. 31-32, the step of releasably coupling the outrigger 150 with the tibia 204 of the patient is shown, according to an exemplary embodiment. The step of FIGS. 31-32 may include a reduction of the fibula 202 (relative to a fracture) by the physician, and subsequent securing of the fibula 202 in the desired reduced position. Accordingly, the step of FIGS. 31-32 may include positioning a wire guide 358 within one of the openings 190 (e.g., on the anterior side of the fibula 202, depending on the anatomy of the patient’s fibula) and positioning a k-wire 360 therethrough and into the anterior portion of the tibia 204.
[0113] Referring now to FIGS. 33-35, the step of actuating the dynamic feature of the implant 102 is shown, according to an exemplary embodiment. The step of FIG. 32 includes inserting, through the opening in the terminal end of the base 108 of the implant 102, a shaft 366 of the instrument 362. The terminal end of the shaft included an engagement feature (e.g., a hex drive feature) that is complimentary to the interface 130 of the actuator 128. Accordingly, the physician may manipulate a handle 364 of the instrument 362 so as to translate the actuator in the proximal direction (e.g., toward the tip 136) until either a) the instrument 362 reaches a torque limit and can no longer drive the actuator 128 further proximally (e.g., as a result of the wings 138 being pressed against the interior of the fibula 202), or b) the tip 134 of the actuator 128 contacts the pin 146. Accordingly, the translation of the actuator 128 causes the tip 134 to contact inner surfaces of each of the wings 138, which have been biased into the cavity 142 by the inner walls of the volume created in the fibula 202. Accordingly, the wings 138 are biased from their position in which the outer surfaces are substantially level (e.g., parallel with) the outer surface of the implant 102, to an expanded position in which the wings 138 protrude beyond the outer surface of the implant 102 (thus to a state in which the implant 102 has a greater lateral dimension than when the wings 138 are positioned with their outer surfaces level to the outer surface of the implant 102). The texture 140 of the wings 138 is configured to engage with the interior of the fibula 202 (e.g., the walls that define the volume that was reamed in previous steps) so as to retain the proximal portion (e.g., the second end 106) of the implant 102 in the desired position in the proximal portion of the fibula 202.
[0114] Referring now to FIG. 36, the step of drilling into the fibula 202 to provide a hole for distal fixation is shown, according to an exemplary embodiment. In some aspects, the step of FIG. 37 may include assembling a drill guide 368 prior to positioning the drill guide 368 within the opening 194, which is positioned on the central portion 168 of the outrigger 150. The physician may implement a drill 369 similar to those used in other orthopedic surgical procedures, for example a 2mm drill, and drill into the lateral portion of the fibula 202 using fluoroscopy to guide the drill 369. The drill 369 may have length markings along a shaft thereof to indicate drilling depth relative to the outrigger 150. In some aspects, the physician may drill into the fibula 202 and then place a depth gauge within the drilled hole to evaluate the depth of the fibula that the drill 369 has reached. The physician may also drill and measure the depth iteratively while using fluoroscopy to visualize the position of the drill 369 relative to the fibula 202 and the implant 102 .
[0115] Referring now to FIG. 37, the step of coupling a fastener implant 372 (for example screw 372) with the implant 102 is shown, according to an exemplary embodiment. The step of FIG. 37 may include the physician determining a desired size / length of screw 372, and then subsequently loading the screw 372 on a driver 370. The driver 370 and the screw 372 may then be loaded into a screw guide, which is inserted into and through the opening 194 such that the screw 372 is aligned with the middle opening 110 of the three openings 110. The driver 370 may then be manipulated so as to threadably engage the screw 372 with the opening 110, with the physician advancing the screw 372 until a marking on a shaft of the driver 372 is positioned flush with a rear portion of the screw sleeve.
[0116] Referring now to FIG. 38, the step of coupling an additional fastener implant 372 (for example screw 372) with the implant 102 is shown, according to an exemplary embodiment. The step of FIG. 38 may include the physician removing the posterior k-wire 354 from the fibula 202. The physician may then place a drill guide, the same as or similar to the drill guide 356, in the appropriate hole to target the distal-most of the openings 110. This step may also include the physician determining a desired size / length of screw 372, and then subsequently loading the screw 372 on the driver 370. The driver 370 and the screw 372 may then be loaded into a screw guide 374, which is inserted into and through the appropriate opening of the openings 188 such that the screw 372 is aligned with the distal-most opening 110 of the three openings 110. The driver 370 may then be manipulated so as to threadably engage the screw 372 with the opening 110, with the physician advancing the screw 372 until a marking on a shaft of the driver 370 is positioned flush with a rear portion of the screw sleeve.
[0117] The step of FIG. 38 may also include the physician removing the anterior k-wire 354 from the fibula 202. The physician may then place a drill guide, the same as or similar to the drill guide 356, in the appropriate hole to target the proximal-most of the openings 110. This step may also include the physician determining a desired size / length of screw 372, and then subsequently loading the screw 372 on the driver 370. The driver 370 and the screw 372 may then be loaded into the screw guide 374, which is inserted into and through the appropriate opening of the openings 178 such that the screw 372 is aligned with the proximal-most opening 110 of the three openings 110. The driver 370 may then be manipulated so as to threadably engage the screw 372 with the opening 110, with the physician advancing the screw 372 until a marking on a shaft of the driver 370 is positioned flush with a rear portion of the screw sleeve.
[0118] Referring now to FIG. 39, the step of placing syndesmotic fixation is shown, according to an exemplary embodiment. The step of FIG. 39 may include assembling a drill guide 376 and placing the drill guide 376 in the appropriate opening of the openings 186 (based on the desired trajectory) such that the drill guide 376 abuts the posterior portion of the fibula 202. The step of FIG. 39 may then include drilling an opening in the fibula 202 that corresponds to the most proximal-most of the openings 112, which may be done under fluoroscopy to monitor position of the drill relative to the implant 102 and the fibula 202. The physician may then obtain the driver 370 and couple the driver 370 with an implant fastener 378 (implant 378) and position the implant 378 adjacent to the fibula 202 and the proximal-most of the openings 112. The driver 370 may then be manipulated so as to threadably engage the implant 378 with the opening 112, with the physician advancing the implant 378 until the implant 378 reaches the desired depth (which may be confirmed using fluoroscopy).
[0119] Referring now to FIG. 40, the step of placing additional syndesmotic fixation is shown, according to an exemplary embodiment. The step of FIG. 40 (which may be similar to the step of FIG. 39) may include assembling the drill guide 376 and placing the drill guide 376 in the appropriate opening of the openings 176 (based on the desired trajectory) such that the drill guide 376 abuts the anterior portion of the fibula 202. The step of FIG. 40 may then include drilling an opening in the fibula 202 that corresponds to the most distal of the openings 112, which may be done under fluoroscopy to monitor position of the drill relative to the implant 102 and the fibula 202. The physician may then obtain the driver 370 and couple the driver 370 with an additional implant fastener 378 (implant 378) and position the implant 378 adjacent to the fibula 202 and the distal-most of the openings 112. The driver 370 may then be manipulated so as to threadably engage the implant 378 with the opening 112, with the physician advancing the implant 378 until the implant 378 reaches the desired depth (which may be confirmed using fluoroscopy).
[0120] Referring now to FIG. 41, the step of coupling the end cap 144 with the implant 102 is shown, according to an exemplary embodiment. In performing the step of FIG. 41, the physician may engage the end cap 144 with a driver or other similar instrument to facilitate threadably coupling the end cap 144 with the threading 116 of the base 108 of the implant 102. The end cap 144 may then be rotated so as to engage a complimentary threading of the end cap 144 with the threading 116 of the base 108. In some aspects, the step of FIG. 41 may also include removal of the k-wire 360, thus decoupling the outrigger 150 from the tibia 204 and allowing the outrigger 150 to be decoupled from the implant 102 such that the end cap 144 may be placed.
[0121] Referring now to FIGS. 48-50, an alternate embodiment of the tip 136 of the implant 102 is shown, according to an exemplary embodiment. In some aspects, the tip 136 of FIGS. 48-50 may be implemented in place of the tip 136 as shown and described with reference to at least FIGS. 1-14 as a component of the implant 102 and the system 100. For example, the tip 136 of FIGS. 48-50 may be similarly coupled, welded, attached, or otherwise engaged with the implant 102 at or near the second end 106.
[0122] The tip 136 as shown in FIGS. 48-50, includes a pair of wings 138 extending from a central portion (e.g., base, body, etc.) of the tip 136 and having a geometry the same as and / or similar to that of the wings 138 shown and described with reference to FIGS. 1-14. A distal-most portion of the wings 138 (closest the terminal end thereof) is shown to include a texture 140 disposed on an outer surface of at least a portion of the distal-most portion of the wings 138. As shown in FIGS. 48-50, the texture may include a geometric pattern, for example ridges, which may have a variable height along the length of the texture 140 (or which may provide the texture 140 with a variable height along a length thereof). The texture 140 may also include one or more curved / valley features positioned between pointed / peak features, with said features disposed along at least a portion of the distal portion of the wings 138. As shown in the side view of FIG. 48, the texture 140 may include one or more curved or fishhook-shaped geometries curving away from a surface of the wings 136 and terminating in an upward pointed geometry.
[0123] The terminology used herein for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. 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.
[0124] 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 instruments, guides, implants, plates, and / or systems as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative components or features, 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 components or features to provide a similar function for the intended purpose. In addition, the instruments, guides, implants, plates, and / or systems may include more or fewer components or features than the embodiments as described and illustrated herein. For example, the components and features of various implant materials, branching, apertures, etc. may be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Further, the steps of the surgical method associated with the system 1000 shown and described with reference to FIGS. 17- 41 may be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Accordingly, this detailed description of the currently preferred embodiment of the system 1000 and implant 102 is to be taken as illustrative, as opposed to limiting of the disclosure.
[0125] The implant and system have been described with reference to the preferred embodiments. It will be understood that the 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 implant and system are to be construed as including all such modifications and alterations.
Claims
1. An implant, comprising:a first end;a second end separated from the first end by a shaft, wherein the second end comprises:a dynamic feature that, when actuated, transitions from a first position to a second position.
2. The implant of claim 1, wherein the implant comprises an inner cavity extending from the first end of the implant to the second end of the implant.
3. The implant of claim 2, further comprising:an actuator positioned at least partially within the cavity, wherein the actuator extends from the first end of the implant to the second end of the implant.
4. The implant of claim 3, wherein the first end of the implant comprises a base, wherein the base comprises:an opening at a terminal end of the first end of the implant, wherein the opening is in fluid communication with the cavity.
5. The implant of claim 4, wherein the actuator comprises an interface at an end of the actuator proximate to the base of the implant, wherein the interface is accessible via the opening and cavity.
6. The implant of claim 5, wherein the base comprises:a first plurality of openings; anda second plurality of openings, wherein the first and second plurality of openings extend diametrically through the base and provide fluid communication with the cavity.
7. The implant of claim 6, wherein the first plurality of openings comprise a threading.
8. The implant of claim 7, wherein the first plurality of openings comprise:a first opening extending diametrically through the base and comprising a first central axis; anda second opening extending diametrically through the base and comprising a second central axis, wherein the first and second central axes are positioned in planes that form an oblique angle with one another.
9. The implant of claim 8, wherein the second plurality of openings comprise:a third opening extending diametrically through the base and comprising a third central axis; anda fourth opening extending diametrically through the base and comprising a fourth central axis, wherein the third and fourth central axes are substantially parallel to one another.
10. The implant of claim 4, further comprising:a transition portion positioned between the base and the shaft, wherein the transition portion comprises a tapered diameter which is greatest at a point adjacent to the base and least at a point adjacent to the shaft.
11. The implant of claim 10, wherein the transition portion comprises a first longitudinal axis and the shaft comprises a second longitudinal axis, wherein the first and second longitudinal axes form an oblique angle with one another.
12. The implant of claim 11, wherein the dynamic feature comprises a plurality of protrusions which extend at least partially outward from the implant.
13. The implant of claim 11, wherein the plurality of protrusions comprises a pair of protrusions, wherein each protrusion of the pair of protrusions are positioned diametrically opposite the second end from one another.
14. The implant of claim 13, wherein each protrusion of the pair of protrusions are integral with the second end of the implant.
15. The implant of claim 14, wherein a first position comprises an outer surface of each of the pair of protrusions being substantially level with the outer surface of the implant, and asecond position comprises the outer surface of each of the pair of protrusions forming an oblique angle relative to the outer surface of the implant.
16. The implant of claim 15, wherein the actuator comprises a tip at an end opposite that of the interface, wherein the actuator is translatable along the length of the cavity of the implant.
17. The implant of claim 16, wherein the actuator is configured such that when translated within the cavity toward the second end of the implant, the tip of the actuator contacts at least a portion of each of the protrusions within the cavity of the implant and move each of the pair of protrusions outward.
18. The implant of claim 17, wherein each of the pair of protrusions comprises a texture disposed on at least a portion of the outer surface thereof.
19. An implant comprising:a first end, comprising:a first plurality of openings extending diametrically through the first end;a second plurality of openings extending diametrically through the second end; a first opening positioned at a terminal end of the first end and extendingthrough the first end along a longitudinal axis;a shaft, wherein the shaft is integral with the first end and forms an oblique angle relative to the first end, the shaft comprising:a cannulation in fluid communication with the first opening and extending along a length of the shaft; anda second end, wherein the second end is integral with the shaft, the second end comprising:a cannulation in fluid communication with the cannulation of the shaft; anda dynamic feature comprising a first position in which a majority of the dynamic feature is positioned below an outer surface of the implant and a second position in which the dynamic feature extends beyond the outer surface of the implant; andan actuator disposed within and extending through the first opening of the first end, the cannulation of the shaft, and into the cannulation of the second end, wherein the actuator comprises:an interface at a first end closest to the first opening and accessible via the first opening with an actuation instrument; anda tip at a second end opposite the first end configured to contact at least a portion of the dynamic feature within the cannulation of the second end so as to manipulate the dynamic feature from the first position to the second position.
20. A surgical method, comprising:creating a volume extending proximally from a distal-most portion of a fibula of a patient;placing a template over at least a portion of the fibula of the patient, wherein the template comprises at least one marking indicative of sizing of an intramedullary implant;determining a desired size of an intramedullary implant;obtaining an intramedullary implant of the desired size;coupling an alignment instrument with a first end of the intramedullary implant;inserting the intramedullary implant within the volume of the fibula of the patient;engaging a first instrument with an internal feature of the intramedullary implant so as to manipulate a dynamic feature of the intramedullary implant from a first position to a second position, wherein the intramedullary implant has a greater lateral geometry in the second position than in the first position;drilling, using the alignment instrument, one or more holes in the fibula of the patient, wherein the one or more holes in the fibula correspond to the position of one or more openings of the intramedullary implant;coupling at least one fastener with the one or more openings of the intramedullary implant via the one or more holes in the fibula of the patient;decoupling the alignment instrument from the intramedullary implant; andreleasably coupling an end cap with the first end of the intramedullary implant.