Lisfranc reduction device and method of use

Abstract

A fixation system for stabilizing Lisfranc injuries includes one or more implantable fixation devices each having a plurality of tines configured to penetrate respective midfoot bones and one or more bridge sections interconnecting the tines. In some aspects, at least one fixation device includes three or more tines arranged in triangular or polygonal configurations to span anatomical intervals such as the Lisfranc interval, the first and second tarsometatarsal joints, or the medial-middle intercuneiform joint. The tines may include sharpened or reinforced tips and are dimensioned to penetrate bone to a selected depth to maintain reduction and provide multiplanar rigid fixation. Kits including multiple fixation devices of differing sizes or geometric configurations are also disclosed, along with methods for reducing and stabilizing the midfoot by implanting one or more of the fixation devices and closing the surgical incision.

Description

[0001] LISFRANC REDUCTION DEVICE AND METHOD OF USE

[0002] PRIORITY INFORMATION

[0003] This nonprovisional application claims priority to provisional application No 63 / 735,775, entitled “The Lisfranc Reduction Staple,” filed December 18, 2024, by the same inventor(s).

[0004] FIELD OF THE DISCLOSURE

[0005] Aspects of the present disclosure generally relate to medical devices, such as implantable fixation devices.

[0006] BACKGROUND

[0007] A Lisfranc injury denotes a spectrum of injuries to the midfoot involving the TMT (tarsometatarsal) joints and intercuneiform joints which includes the metatarsal bases, cuneiforms, and associated ligamentous complexes These joints are crucial for the stability of the foot and maintenance of the arch of the foot. There are numerous varieties of Lisfranc injuries that can range from purely ligamentous injuries resulting in dislocation or subluxation of the joints to complex fractures involving these joints. Unstable Lisfranc injuries in which the TMT and intercuneiform joints are not properly aligned typically require surgery in order to maintain the stability and structure of the foot.

[0008] One option for operative treatment of Lisfranc injuries is open reduction and internal fixation (ORIF) which involves reduction or alignment of the involved joints with rigid internal fixation using a variety of constructs. In some cases, primary arthrodesis or fusion of these joints is the preferred method depending on the injury pattern and surgeon preference. A major concern with ORIF as opposed to fusion is recurrent displacement of the Lisfranc joints which can lead to midfoot instability and collapse and ultimately a poor outcome for the patient.

[0009] For Lisfranc injuries undergoing ORIF, traditional fixation methods use trans-articular screws to hold the joints in appropriate position. One of the main concerns with this method is damage to the articular surface of joints. To avoid this, many surgeons use a bridge plate construct that crosses over a joint but avoids placing a screw directly across the joint surface. Currently there are bridge plates designed specifically for the Lisfranc joints on the market that are popular as a fixation method. Concerns with this method include potential malreduction or malalignment of the joints and plantar gapping of the joints due to the lack of fixation plantarly. Some surgeons use flexible fixation devices such as strong nonabsorbable suture with metal buttons, but there has been concern for inadequate stability and rigidity with this technique which can lead to recurrent displacement. Many surgeons use a combination of these implants for fixation of Lisfranc injuries and many surgeons also remove the hardware after several months to prevent breakage and irritation Use of a strong construct is imperative in Lisfranc injuries to help prevent recurrent instability and diastasis or widening of the joints However, based on a recent survey of the American Orthopedic Foot and Ankle Society (AOFAS) members regarding management of Lisfranc injuries, there is significant variability in the types of constructs used by surgeons with no clear consensus on ideal implant.

[0010] A staple is a type of orthopedic device that is similar in shape to a regular paper staple but is made of surgical grade stainless steel, titanium or other metals and is used in a variety of procedures for bony fixation. Staples are becoming more popular amongst foot and ankle surgeons particularly for midfoot and hindfoot fusions due to their ease of insertion and excellent continuous compression across joint surfaces Studies have shown shorter operating room time when using staples compared to screw and plate constructs. Staples have not been widely used for fixation of joints without a planned fusion or arthrodesis across the joint and there are no staples designed specifically for fixation of Lisfranc injuries.

[0011] Accordingly, there exists a need for a Lisfranc fixation system and method of use. However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the field of this invention how the shortcomings of the prior art could be overcome.

[0012] The present invention may address one or more of the problems and deficiencies of the prior art discussed above However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.

[0013] BRIEF SUMMARY

[0014] Some implementations of the present invention relate to a fixation device for stabilizing a Lisfranc injury. The fixation device comprises at least three tines configured to penetrate respective midfoot bones, and a plurality of bridge sections interconnecting the tines, with at least one bridge section extending between a pair of the tines. The bridge sections are arranged to span at least one anatomical interval of the midfoot, and at least one tine is configured to penetrate a medial cuneiform while another tine is configured to penetrate a base of a second metatarsal when implanted into a patient.

[0015] In some implementations, the tines and bridge sections may be arranged to form a triangular perimeter, including right-angle or equilateral triangular configurations. Certain versions may include three-or-more-sided perimeters such as diamond-shaped, square-shaped, rectangularshaped, trapezoidal-shaped, or polygonal-shaped arrangements. In some implementations, the tines may be dimensioned to have a length of approximately 10-25 mm or 15-25 mm, may include sharpened or beveled distal tips, and may incorporate reinforced shafts configured to resist bending under an axial insertion load of approximately 50-120 N Additional implementations may include radiopaque or radiolucent markers and may be configured to provide multiplanar rigid fixation across multiple midfoot joints to maintain midfoot reduction.

[0016] Some implementations of the present invention relate to a method of stabilizing a Lisfranc injury. The method comprises creating a surgical incision, performing an open reduction of a patient’s midfoot anatomy to restore alignment of at least the Lisfranc interval, implanting a fixation device comprising at least two tines and a bridge section interconnecting the tines such that at least one tine penetrates a medial cuneiform and at least one tine penetrates a base of a second metatarsal, and closing the surgical incision.

[0017] In some implementations, the method may further include implanting additional tines into one or more targeted midfoot bones, implanting one or more additional fixation devices to stabilize adjacent joints, or selecting a fixation device having a triangular, quadrilateral, or polygonal configuration. The method may also include verifying tine placement using fluoroscopic or radiographic imaging, imaging the patient’s uninjured foot to determine anatomical spacing targets, selecting the fixation device from a kit having multiple sizes or configurations, or orienting additional fixation devices to span different anatomical intervals. Certain implementations may further include penetrating targeted bones to depths between approximately 10-25 mm or 15-25 mm, inserting tines capable of resisting specified axial loading, or positioning tines within approximately 2-6 mm of a central region of the targeted bone.

[0018] Some implementations of the present invention relate to a kit for stabilizing a Lisfranc injury. The kit comprises a plurality of fixation devices, each fixation device including a plurality of tines configured to penetrate respective midfoot bones and at least one bridge section extending between the tines and arranged to span at least one anatomical interval of the midfoot. At least one fixation device of the kit includes at least three tines and a plurality of bridge sections interconnecting the tines, with at least one tine configured to penetrate a medial cuneiform and at least one tine configured to penetrate a base of a second metatarsal when implanted into a patient.

[0019] In some implementations, the fixation devices of the kit may include triangular arrangements (including right-angle or equilateral triangle geometries), four-tine configurations forming diamond, square, rectangular, trapezoidal, or polygonal perimeters, or devices sized as small, medium, or large based on bridge-section lengths ranging from approximately 1.2-3.6 cm. Additional kit implementations may include tines dimensioned at 10-25 mm or 15-25 mm in length, sharpened or beveled distal tips, reinforced shafts, radiopaque or radiolucent markers, or structures configured to provide multiplanar rigid fixation across multiple midfoot joints

[0020] Aspects of the present disclosure generally relate to devices, methods, and kits as substantially described herein and illustrated in the accompanying drawings and specification. In some embodiments, the aspects may include combinations or sub-combinations of any of the foregoing elements, as would be apparent to a person of ordinary skill in the art having the benefit of this disclosure.

[0021] The foregoing description provides an overview of certain features and technical advantages of examples of the present disclosure to facilitate a better understanding of the detailed description that follows. Additional features, variations, and advantages will be described below The concepts and specific examples disclosed herein may be utilized as a basis for modifying or designing other structures or methods to achieve the same or similar purposes as those of the present disclosure. Equivalent constructions, implementations, and variations are considered to fall within the scope of the appended claims Characteristics of the concepts disclosed herein, including their organization, method of operation, and associated advantages, will be further understood from the following description when considered with the accompanying drawings. Each of the figures is provided for illustration and explanation only and is not intended to limit the scope of the claims

[0022] BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The appended drawings are provided to facilitate a more detailed understanding of the features of the present disclosure and to support the following specific description. The disclosure is described below with reference to certain aspects, some of which are illustrated in the appended drawings. It should be understood that the appended drawings depict only illustrative examples of the disclosure and are therefore not to be considered as limiting its scope, as the description may encompass other equally effective implementations. In some instances, the same reference numbers in different drawings may be used to identify the same or similar elements for ease of understanding.

[0024] FIG 1 is a perspective view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0025] FIG 2A is a side elevation view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0026] FIG 2B is a side elevation view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0027] FIG 20 is a side elevation view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0028] FIG 3 is a top plan view of an embodiment of the fixation device in accordance with some aspects of the present invention

[0029] FIG 4 is a top plan view depicting an embodiment of the fixation device, in accordance with some aspects of the present invention, implanted into the anatomy of a patient.

[0030] FIG 5 is a top plan view depicting a pair of fixation devices, in accordance with some aspects of the present invention, implanted into the anatomy of a patient.

[0031] FIG 6 is a perspective view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0032] FIG 7A is a side elevation view of an embodiment of the fixation device in accordance with some aspects of the present invention. FIG 7B is a side elevation view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0033] FIG 70 is a side elevation view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0034] FIG 8 is a top plan view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0035] FIG 9 is a top plan view depicting the fixation device, in accordance with some aspects of the present invention, implanted into the anatomy of a patient.

[0036] FIG 10A is a is a perspective view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0037] FIG 10B is a is a perspective view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0038] FIG 10C is a is a perspective view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0039] FIG 11 is a top plan view depicting multiple fixation devices, in accordance with some aspects of the present invention, implanted into the anatomy of a patient.

[0040] FIG 12 is a perspective view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0041] FIG 13 is a side elevation view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0042] FIG 14 is a top plan view of an embodiment of the fixation device in accordance with some aspects of the present invention.

[0043] FIG 15 is a top plan view depicting the fixation device, in accordance with some aspects of the present invention, implanted into the anatomy of a patient

[0044] FIG 16 is a flowchart of a method in accordance with some aspects of the present invention

[0045] DETAILED DESCRIPTION OF THE INVENTION

[0046] In the following detailed description of the present invention, reference is made to the accompanying drawings, which form a part thereof, and within which are shown by way of illustration specific embodiments by which the invention may be practiced. Numerous specific details are set forth to provide a thorough description of the embodiments of the present invention. It will be appreciated that the embodiments described herein are illustrative and not limiting. Features, functions, elements, and components described in connection with any embodiment may be combined with features, functions, elements, and components of other embodiments, in whole or in part, unless otherwise stated. Likewise, individual features may be implemented independently of other features, or in different combinations, as would be understood by a person of ordinary skill in the art. The invention therefore encompasses all variations, modifications, and equivalents that fall within the scope of the appended claims, including embodiments having any combination of the features described herein. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from the scope of the invention.

[0047] The relevant descriptions of such features may apply equally to the features and related components among all the drawings For example, any suitable combination of the features, and variations of the same, described with components illustrated in FIG. 1 , can be employed with the components of FIG. 2, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereinafter. It should be understood that the figures presented are not meant to be illustrative of actual views of any particular portion of the actual structure or method but are merely idealized representations employed to more clearly and fully depict the present invention defined by the claims below.

[0048] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the context clearly dictates otherwise.

[0049] The phrases “in some embodiments,” “according to some embodiments,” “in the embodiments shown,” “in other embodiments,” and the like generally mean the particular feature, structure, or characteristic following the phrase is included in at least one implementation. In addition, such phrases do not necessarily refer to the same embodiments or different embodiments.

[0050] When language similar to “at least one of A, B, or C” or “at least one of A, B, and C” is used in the specification or claims, the phrase is intended to mean any of the following: (1 ) at least one of A; (2) at least one of B; (3) at least one of C; (4) at least one of A and at least one of B; (5) at least one of B and at least one of C; (6) at least one of A and at least one of C; or (7) at least one of A, at least one of B, and at least one of C.

[0051] All numerical designations, such as measurements, efficacies, physical characteristics, forces, and other designations, including ranges, are approximations which are varied up or down by increments of 1.0 or 0.1 , as appropriate. It is to be understood, even if it is not always explicitly stated that all numerical designations are preceded by the term “approximately.” As used herein, “approximately” refers to being within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined. When an acceptable range is not dictated by the one of ordinary skill in the art, “approximately” refers to ±15% of the numerical when used in connection with particular values; it should be understood that a numerical including an associated range with a lower boundary of greater than zero must be a non-zero numerical, and the term “approximately” should be understood to include only non-zero values in such scenarios Several aspects of a fixation system specifically designed to stabilize the Lisfranc joints will now be described with reference to various implant configurations, instruments, and associated methods of use. The following description sets forth examples of geometries, material selections, and multi-joint spanning arrangements that may be utilized to achieve rigid, multiplanar fixation across the Lisfranc interval and adjacent tarsometatarsal and intercuneiform joints, as well as tools and techniques for implant insertion, reduction, and removal. In some aspects, the fixation device is designed specifically for open reduction and internal fixation of the Lisfranc joints, however, the device may be used for other joints and in other operations

[0052] FIG 1 is a perspective view of an embodiment of the fixation device 100 in accordance with some aspects of the present invention. As depicted, the fixation device 100 includes tines 102 and bridge sections 104. These components are formed from biocompatible metallic materials suitable for orthopedic fixation. The materials may be selected to provide sufficient strength, fatigue resistance, and long-term stability when implanted across the Lisfranc interval or other midfoot joints.

[0053] In some embodiments, the tines 102 and / or the bridge sections 104 are formed from nickeltitanium alloy (Nitinol). Nitinol provides shape-memory and pseudoelastic characteristics that enable the fixation system to exert continuous internal compression across the targeted joint spaces. These properties allow the fixation device 100, when deployed in an appropriate configuration, to maintain stability across, for example, the medial cuneiform to the base of the second metatarsal, the medial-to-middle cuneiform articulation, the second tarsometatarsal joint, the first tarsometatarsal joint, and / or other anatomical locations described herein

[0054] In other embodiments, the tines 102 and / or the bridge sections 104 may be formed from alternative biocompatible metals, including titanium or titanium-based alloys Such materials can also provide the structural rigidity, compatibility with imaging, and implant longevity necessary for stabilization of Lisfranc injuries and related midfoot conditions.

[0055] Additional material variations may be utilized depending on the desired mechanical properties, manufacturing processes, or clinical applications. Non-limiting examples include stainless steel alloys, cobalt-chromium alloys, polymer-metal composites, or other medical-grade materials capable of delivering controlled compression and maintaining joint stability after implantation.

[0056] As provided in Figs. 1-4, in some aspects, the fixation device 100 includes three tines 102a, 102b, and 102c with three bridge sections 104a, 104b, and 104c extending between the tines 102 The interconnecting bridge sections 104a, 104b, and 104c establish three intersections 106a, 106b, 106c. It should be noted that more or less bridge sections 104 may be used in conjunction with the three tines 102.

[0057] The three-tine variations may be in a triangular configuration, which will allow the surgeon to fixate multiple joints with a single implant. However alternative three-tine variations may have a non-triangular shape. Alternative geometries include but are not limited to circular, square, rectangular, trapezoidal, or other polygonal layouts, which may be selected based on patient anatomy, injury pattern, or surgeon preference.

[0058] A triangular shaped fixation device 100 can be used to span and stabilize multiple joints with a single implant. The multiplanar rigid fixation provided by the staple helps to prevent recurrent instability across joints and allows for easy insertion.

[0059] In some aspects, the staple size and shape will be designed specifically to span the Lisfranc interval 10 from the medial cuneiform 12 to the base of the second metatarsal 14. Moreover, it can be designed specifically to span various combinations of the second TMT 16 joint between the base of the second metatarsal 14 and the intermediate / middle cuneiform 18, the medial- middle intercuneiform joint 20 between the medial cuneiform 12 and the intermediate / middle cuneiform 18 and / or the first TMT joint 22 between the base of the first metatarsal 24 and the medial cuneiform 12.

[0060] The size, length, and shape of the bridge sections 104 and tines 102 may be determined based on the anatomical spacing of the Lisfranc joint 10 so that the fixation device 100 appropriately matches the depth, width, and geometry of the involved joints and bones. In some embodiments, the overall geometry of the fixation device 100 corresponds to the expected spacing of the bones in their anatomically correct position, such as the spacing present prior to injury or the spacing restored after the joints are reduced to their natural alignment. The dimensions of the fixation device 100 may further depend on patient-specific factors, including age, bone density, bone thickness, height, weight, or anatomical measurements obtained through medical imaging.

[0061] In some embodiments, the bridge sections 104 are adjustable in length, which allows the surgeon to extend or retract the bridge section to match the anatomical spacing of the targeted midfoot interval. In various implementations, the adjustable bridges may include sliding, telescoping, ratcheting, or other length-varying mechanisms suitable for altering length.

[0062] In some embodiments as exemplified in Figs. 2B and 2C, one or more of the bridge sections 104 of the fixation device may be formed with a slope or curvature configured to improve anatomical conformity when the fixation device 100 is implanted The slope or curvature may represent a collective three-dimensional contour of the bridge sections 104 as an assembly as depicted, or it may be defined along an individual bridge section 104. In certain implementations, each bridge section 104 may have a unique slope or curvature, or only selected bridge sections 104 may incorporate such features, to accommodate the complex geometry of the midfoot. Providing non-planar bridge sections 104 helps ensure that the device 100 follows the natural triangular arrangement of the midfoot joints and reduces the likelihood of hardware prominence or soft-tissue irritation after implantation. This is particularly useful at the first tarsometatarsal (TMT) joint and the medial cuneiform, where the medial cuneiform is anatomically lower and exhibits a drop-off relative to adjacent structures. In these regions, a planar bridge profile can cause the device to sit proud of the bone surface, whereas a depth contour, slope, or curvature along the bridges allows the device to rest in a more anatomically congruent orientation. In some embodiments, the resulting bridge assembly may occupy a non- planar orientation that is tailored to the sloped and variably elevated surfaces of the medial and middle cuneiforms and adjacent metatarsal bases.

[0063] In some embodiments, a three-tine version of the fixation device 100 includes a set of bridge sections 104 that intersect the three tines 102 at approximately 90-degree angles, forming a generally planar construct similar to that shown in FIG 2A Providing the tines 102 in a substantially perpendicular arrangement relative to the bridge sections 104 can simplify insertion trajectories and may facilitate stable seating of the implant 100 when the midfoot surfaces being spanned are relatively planar.

[0064] In other embodiments, one or more of the angles between the tines 102 and the adjacent bridge sections 104 may be altered from 90 degrees to introduce a controlled slope or elevation change across the three-tine assembly, as exemplified in FIGs 2B Adjusting these angles allows the collective bridge geometry to assume a non-planar orientation that better reflects the anatomical drop-off between the medial cuneiform, the first TMT joint, and the base of the second metatarsal. In some implementations, each bridge section 104 may incorporate a distinct curvature as exemplified in FIG. 2C so that the bridge assembly collectively forms an anatomical arc, matching the natural sloped contour of the medial midfoot.

[0065] In certain embodiments, altering the tine-to-bridge angles provides vertical or oblique offsets among the tine entry points, enabling the fixation device 100 to rest more congruently against bone surfaces that differ in height, inclination, or curvature. By allowing the bridge sections 104 to follow this sloped anatomical profile, the device 100 may reduce the risk of hardware prominence, soft-tissue irritation, or dorsal impingement that could otherwise occur when planar fixation constructs are applied across non-uniform joint elevations.

[0066] In various embodiments, the angular adjustments and curvatures of the three bridge sections 104 may be fixed, selectively adjustable during manufacturing, or provided in multiple preconfigured options as part of a surgical kit. This enables a surgeon to select a construct whose collective slope, curvature, or contour best aligns with a patient’s midfoot anatomy, thereby improving implant fit, reducing prominence, and optimizing fixation stability across the Lisfranc interval and adjacent joints.

[0067] In some aspects, the penetration depth of the tines 102 and / or the length of the tines 102 is between approximately 10 mm and 25 mm In some aspects, the tines have a penetration depth and / or length of approximately 15-25 mm. In some embodiments, the penetration depth of the tines 102 is at least approximately 10 mm to ensure sufficient cancellous bone purchase for stable fixation. In some embodiments, the penetration depth of the tines 102 is less than or equal to approximately 25 mm to avoid breaching the far cortex or extending into adjacent joint spaces. The penetration depth of the tines 102 may be determined based on a patient’s age, bone thickness, bone density, height, weight, or anatomical measurements derived from medical imaging

[0068] As best depicted in FIG. 3, in some aspects, the bridge sections 104 may establish a rightangle triangular configuration Such a configuration may facilitate spanning multiple anatomical intervals while providing predictable geometric relationships between the tines 102. In some embodiments, the right-angle geometry enables one bridge section to function as a primary load-bearing span while the remaining bridge sections maintain fixation across adjacent joints, thereby supporting multiplanar stability during reduction and healing.

[0069] Based on this right-angle triangular arrangement, the length of bridge section 104a may be between approximately 1.5 cm and 3.0 cm. This range corresponds to the span of the second TMT joint 16 and permits tine 102a to be implanted into the base of the second metatarsal 14 and tine 102b to be implanted into the intermediate cuneiform 18. In some embodiments, each tine is positioned generally near the center of the respective bone or within a predetermined distance, such as approximately 2-6 mm, from the cortical perimeter to optimize fixation strength.

[0070] Similarly, the length of bridge section 104b may be between approximately 1.2 cm and 2 5 cm to span the medial-middle intercuneiform joint 20 and ensure placement of tine 102b within the intermediate cuneiform 18 and tine 102c within the medial cuneiform 12. In some embodiments, tine placement is maintained within approximately 2-6 mm of the central region of each bone or within a predefined safe zone based on anatomical imaging.

[0071] The length of bridge section 104c may be between approximately 1.8 cm and 3.2 cm to correspond to the span of the Lisfranc interval 10 This allows tine 102a to be implanted into the base of the second metatarsal 14 and tine 102c to be implanted into the medial cuneiform 12. In some embodiments, each tine is positioned within approximately 2-6 mm of the anatomical center of the targeted bone or another predetermined region selected to maximize fixation stability.

[0072] Referring now to FIG. 5, in some aspects, multiple fixation devices 100 may be employed to further stabilize one or more joints. For example, the depicted multi-system approach includes a pair of fixation devices 100 each having their respective bridge sections 104 arranged in an equilateral configuration with bridge sections 104c in a parallel or generally parallel relation. The tines 102a from each device can be implanted into the base of the second metatarsal 14, the tines 102c from each device can be implanted into the medial cuneiform 12, and the tines 102b are diagonally opposed with one implanted into the base of the first metatarsal 24 and the other implanted into the intermediate cuneiform 18.

[0073] In some embodiments, one or more additional support sections may extend between the bridge sections 104 of each fixation device 100 to further enhance structural rigidity and load distribution across the construct. These support sections may be configured to resist torsional, shear, and / or bending forces that develop during weightbearing or joint reduction and may thereby improve the overall stability of the fixation device 100. In certain aspects, the support sections may be oriented to interconnect adjacent bridge sections 104 to form supplemental cross-bracing geometries that reinforce the device. The support sections may have any suitable cross-sectional profile or material composition and may be dimensioned to maintain the reduction of the Lisfranc interval 10, the first TMT joint 22, the second TMT joint 16, or other associated joints during postoperative healing

[0074] As illustrated in Figs 6-9, the bridge sections 104 may be arranged to form an oblique triangular configuration in some embodiments, while in other embodiments the bridge sections 104 may collectively define an equilateral triangular geometry. Each of these configurations may be selected to accommodate variations in patient anatomy, joint spacing, or surgical approach. In certain aspects, one or more additional support sections may extend between the bridge sections 104 to enhance construct rigidity, resist multidirectional loading, and maintain reduction across the Lisfranc interval 10 and adjacent joints. Such support sections may be positioned to create supplemental bracing, distribute forces more evenly across the implant, or reinforce specific spans based on the anatomical features being stabilized.

[0075] The sizing of the bridge sections 104 forthe oblique or equilateral triangular configurations may be generally equal to or similar to the sizing described in connection with the right-angle triangular arrangement. However, alternative lengths of one or more bridge sections 104 are also contemplated to accommodate anatomical variation or the specific joints being spanned. For example, the length of bridge section 104a may be between approximately 1.4 cm and 2 8 cm, which corresponds to the anatomical span across the Lisfranc interval 10 and permits tine 102a to be implanted into the base of the second metatarsal 14 and tine 102b to be implanted into the base of the first metatarsal 24. In some embodiments, each tine is positioned near the central region of the corresponding bone or within a predetermined distance, such as approximately 2-6 mm from the cortical perimeter, to optimize fixation strength while maintaining adequate bone purchase.

[0076] The length of bridge section 104b may be between approximately 1.3 cm and 2.6 cm. This range is suitable for spanning the first TMT joint 22 and permits tine 102b to be implanted into the first metatarsal 24 and tine 102c to be implanted into the medial cuneiform 12. In some embodiments, each tine is positioned generally near the central region of the respective bone or within a predetermined distance, such as approximately 2-6 mm from the cortical perimeter, to achieve stable fixation while avoiding cortical breach or interference with adjacent joint surfaces.

[0077] The length of bridge section 104c may be between approximately 1.8 cm and 3.2 cm. This range corresponds to the anatomical span of the Lisfranc interval 10 and permits tine 102a to be implanted into the base of the second metatarsal 14 and tine 102c to be implanted into the medial cuneiform 12. In some embodiments, tine placement is maintained within approximately 2-6 mm of the anatomic center of each targeted bone or within another predetermined positioning tolerance selected to maximize bone purchase, implant stability, and postoperative joint reduction integrity

[0078] In some embodiments, as illustrated in FIG. 7A, the bridge sections 104 may intersect the respective tines 102 at approximately 90-degree angles, resulting in a generally planar construct. Such a perpendicular arrangement can facilitate straightforward insertion trajectories and may be suitable for stabilizing joint intervals that occupy similar elevations or planar relationships across the midfoot

[0079] In other embodiments, as exemplified in FIG. 7B, one or more of the bridge sections 104 may be sloped relative to the plane established in FIG. 7A. The introduction of a slope or elevation change along one or more bridge sections 104 allows the obtuse triangular frame to assume a non-planar orientation that better reflects the anatomical drop-off between the medial cuneiform, intermediate cuneiform, and adjacent metatarsal bases. In these embodiments, the angles between the tines 102 and the respective bridge sections 104 may also be altered from 90 degrees, such that the tines 102 extend obliquely to match the anatomical entry trajectories required for bones of differing heights or inclinations.

[0080] Adjusting the bridge slope and tine angles as shown in FIG 7B provides vertical and oblique offsets among the various tine entry points, thereby enabling the fixation device 100 to seat more congruently against bone surfaces that are not coplanar. This can substantially reduce the risk of hardware prominence, dorsal impingement, or soft-tissue irritation that might otherwise occur if a planar obtuse triangular construct were forced to span anatomical intervals characterized by non-uniform elevations or sloped contours.

[0081] In still other embodiments, the obtuse triangular configuration may include curved bridge sections 104, as depicted in FIG. 7C. Each bridge section 104 may incorporate a unique curvature, or only selected bridge sections 104 may be curved, to create a collective three- dimensional contour that follows the natural, arcuate geometry of the midfoot. Providing curved bridges allows the fixation device 100 to more precisely match the convexity or concavity of the underlying joints, including the sloped surfaces of the medial cuneiform and adjacent tarsometatarsal articulations.

[0082] In some embodiments, the curved or sloped bridge sections 104 of FIG. 7C may be combined with altered tine angles to produce a multi-planar construct tailored to the irregular anatomy of the Lisfranc complex. By enabling variation in both bridge curvature and tine orientation, the obtuse triangular device may conform more naturally to the triangular and variably elevated joint configuration of the medial midfoot, thereby improving implant fit and reducing the likelihood of postoperative hardware prominence.

[0083] In various embodiments, the planar, sloped, and curved versions of the obtuse triangular fixation device may be provided as separate pre-configured options in a surgical kit, or may be manufactured with selectively adjustable bridge-to-tine angles or customizable curvature profiles. Such options allow a surgeon to select a construct whose geometry best aligns with the patient-specific anatomy encountered intraoperatively.

[0084] Referring now to FIGs. 10-11, in some aspects, the present invention includes a two-tine fixation device 200. In this configuration, a single bridge section 204 extends between two tines 202a and 202b to span a selected anatomical interval. In certain embodiments, one or more additional bridge sections or supplemental supports may be incorporated to increase structural rigidity, distribute loads across multiple planes, or adapt the device for use in joints with greater variability in spacing or alignment.

[0085] The bridge section 204 and the tines 202 may be provided in a range of sizes depending on the intended implant location. In some embodiments, the lengths of the bridge section 204 may correspond to the same anatomical spans described in connection with the three-tine configurations. For example, a two-tine device spanning the first TMT joint 22, the second TMT joint 16, or the Lisfranc interval 10 may utilize bridge lengths between approximately 1.3 cm and 3.2 cm, and tine depths between approximately 10 mm and 25 mm, or 15 mm and 25 mm in some implementations, similar to the measurements described for the three-tine embodiments. These dimensions may be selected to ensure proper placement within the central region of the targeted bones or within a predetermined distance, such as 2-6 mm from the cortical perimeter.

[0086] In some embodiments, a two-tine version of the fixation device includes a bridge section that intersects the pair of tines at approximately a 90-degree angle, as illustrated in FIG. 10A. Configuring the tines and the bridge in a perpendicular arrangement can facilitate predictable insertion trajectories and may simplify placement when the anatomical surfaces being spanned lie in a relatively planar relationship

[0087] In other embodiments, the angle between the tines and the bridge section is intentionally altered from 90 degrees to introduce a slope or elevation change along the length of the bridge, as shown in FIG. 10B. Adjusting this angle allows the bridge to assume a non-planar orientation that more closely follows the natural contours of the midfoot, including the downward slope of the medial cuneiform and the variable elevation of the first tarsometatarsal joint.

[0088] In some embodiments, the altered angle provides a vertical or oblique offset between the two tine entry points, enabling the implant to seat flush against bones that do not share a common height or planar surface. This geometry reduces the risk of hardware prominence by preventing the bridge from projecting outward when spanning bones of differing elevations In certain implementations, the angle adjustment may be uniform along the bridge or may be combined with additional curvature or contouring so that the bridge transitions smoothly between the respective bone surfaces.

[0089] In various embodiments, the angle between the tines and the bridge may be fixed, selectively adjustable during manufacturing, or provided in multiple pre-set configurations within a kit, allowing a surgeon to select a device whose bridge slope best corresponds to the patient’s anatomy.

[0090] The orientation of the two-tine fixation device 200 may be more variable than that of the three- tine or four-tine configurations to accommodate anatomical differences among patients, variations in joint spacing, or specific requirements to maintain reduction The device may be oriented along multiple axes, rotated to align with a particular joint line, or positioned obliquely to counteract instability patterns or directional forces encountered during reduction and postoperative loading. This flexibility allows the two-tine configuration to be adapted for use in a wide range of midfoot fixation scenarios

[0091] In some embodiments, as depicted in FIG. 11 , multiple two-tine fixation devices 200 may be implanted in combination to achieve different stability objectives across the midfoot. Each two- tine device may be oriented to span a distinct anatomical interval, such as the Lisfranc interval 10, the first TMT joint 22, or the second TMT joint 16, or the medial-middle intercuneiform joint 20, thereby allowing the surgeon to tailor construct stiffness, compression vectors, and multiplanar support according to the specific injury pattern. By selecting the orientation and placement of each two-tine device independently, the surgeon may create a composite fixation system that delivers targeted stabilization along multiple axes, compensates for asymmetric ligamentous injury, or reinforces a primary reduction obtained with a separate implant.

[0092] Referring nowto FIGs. 12-15, in some aspects, the fixation device 300 includes four tines 302 connected by four or more bridge sections 304. The four-tine configuration may be utilized to span and stabilize multiple joints simultaneously with a single implant. In some embodiments, this configuration provides enhanced multiplanar rigidity due to the closed-loop geometry formed by the bridge sections 304, thereby improving resistance to translational, rotational, and shear forces acting across the Lisfranc interval 10 and adjacent articulations. The increased structural continuity of the four-tine design may reduce the likelihood of recurrent instability, maintain reduction of the midfoot complex, and facilitate efficient insertion during surgical procedures.

[0093] In certain aspects, the fixation device 300 may be provided in a diamond or generally diamondshaped configuration to span four anatomical intervals or joints. Alternative geometries are also contemplated, including but not limited to circular, square, rectangular, trapezoidal, or other polygonal layouts, which may be selected based on patient anatomy, injury pattern, or surgeon preference. Each geometric variant may offer distinct mechanical advantages, such as optimized force distribution, enhanced bracing across multiple planes, or improved compatibility with specific joint orientations within the midfoot

[0094] As provided in FIG. 15, fixation device 300 includes a first tine 302a implanted into the base of the second metatarsal 14 and a second tine 302b implanted into the intermediate cuneiform 18 with bridge section 304a spanning the second TMT joint 16; a third tine 302c implanted into the medial cuneiform 12 with a second bridge section 304b spanning across the medial-middle intercuneiform joint 20; a fourth tine 302d implanted in the base of the first metatarsal 24 with a third bridge 304c spanning between the first TMT joint 22; and a fourth bridge 304d spanning between the Lisfranc interval 10. Collectively, the tines 302 and the bridge sections 304 stabilize the patient’s anatomy about the Lisfranc interval 10, the second TMT joint 16, the first TMT joint 22, and the Lisfranc interval 10.

[0095] In this manner, the length of bridge section 304a may be between approximately 1.5 cm and 3 0 cm This range is suitable for spanning the second TMT joint 16 and for permitting tine 302a to be implanted into the base of the second metatarsal 14 while tine 302b is implanted into the intermediate cuneiform 18. In some embodiments, the tines 302 are positioned generally near the anatomical center of each respective bone or within a predetermined distance, such as approximately 2-6 mm from the cortical perimeter, to optimize fixation strength and maintain proper reduction.

[0096] The length of bridge section 304b may be between approximately 1.2 cm and 2.5 cm. This dimension corresponds to the anatomical span of the medial-middle intercuneiform joint 20 and permits tine 302b to be implanted into the intermediate cuneiform 18 and tine 302c into the medial cuneiform 12. In some aspects, tine placement is maintained within approximately 2-6 mm of the bone’s central region or within another predetermined tolerance established to enhance joint stability during postoperative loading.

[0097] The length of bridge section 304c may be between approximately 1.3 cm and 2.7 cm. This range is suitable for spanning the first TMT joint 22 while allowing tine 302d to be implanted into the base of the first metatarsal 24 and tine 302c into the medial cuneiform 12. In certain embodiments, each tine is positioned within approximately 2-6 mm of the desired anatomical centerline or other target zone based on imaging or intraoperative evaluation

[0098] The length of bridge section 304d may be between approximately 1.4 cm and 2.8 cm. This range corresponds to the anatomical span of the Lisfranc interval 10 and permits tine 302a to be implanted into the base of the second metatarsal 14 and tine 302d into the base of the first metatarsal 24. In some embodiments, tine positioning is controlled within approximately 2-6 mm of the bone’s central axis or another predetermined safe zone to ensure stability and avoid cortical violation.

[0099] As illustrated in the figures provided, a four-tine diamond-shaped configuration of the fixation device 100 may include bridge sections 104 that intersect the respective tines 102 at approximately 90-degree angles, forming a generally planar quadrilateral perimeter This perpendicular arrangement may be suitable for stabilizing anatomical intervals whose corresponding bone surfaces lie in a relatively common plane.

[0100] Although not illustrated in the drawings, in some embodiments the diamond-shaped configuration may incorporate tine-to-bridge angles other than 90 degrees. Similar to the obtuse triangular embodiments shown in FIGs. 7B and 7C, the tines 102 of the diamond-shaped device may extend at oblique or angled orientations relative to the adjacent bridge sections 104. Providing such angled tine arrangements may be beneficial when the diamond-shaped construct is positioned across bone surfaces that differ in height, inclination, or anatomical orientation.

[0101] In other embodiments, the one or more bridge sections 104 of the diamond-shaped device may be sloped relative to one another, allowing the construct to assume a non-planar orientation tailored to the complex three-dimensional geometry of the midfoot. Sloped bridge sections 104 may permit the device 100 to span anatomical intervals that include the downward slope of the medial cuneiform, the elevation changes at the first and second tarsometatarsal joints, or other irregular joint contours.

[0102] In still other embodiments, also not depicted in the drawings, the bridge sections 104 of the diamond-shaped perimeter may include curvature along individual bridge segments or curvature expressed collectively across the assembly. Each bridge section 104 may have a unique curvature, or only selected portions of the perimeter may be curved, to produce an anatomical arc or multi-directional contour that more accurately matches the underlying bone surfaces. Such curved bridge profiles may reduce the risk of hardware prominence by enabling the diamond-shaped construct to rest more fully against sloped or variably elevated joints of the midfoot.

[0103] These unillustrated variations of the diamond-shaped device may incorporate combinations of angled tines, sloped bridge sections, and curved bridge sections, analogous to the geometries shown for the obtuse triangular configuration in FIGs. 7A-7C. Accordingly, although only the planar diamond-shaped configuration is shown in the figures, the scope of the disclosure encompasses multi-planar, contoured, and curvature-bearing versions of the four-tine device as described herein

[0104] In some aspects, fixation devices may incorporate more than four tines arranged in any suitable geometric configuration to span additional joints, accommodate severe or complex injury patterns, or provide enhanced multiplanar rigidity.

[0105] In some aspects, one or more of the tines 102, 202, or 302 may be sharpened or otherwise formed with a tapered or beveled distal tip to facilitate controlled penetration into cortical and cancellous bone. The tines may additionally be reinforced along their length to withstand the forces encountered during insertion without plastically deforming. In certain embodiments, the tines possess a bending stiffness sufficient to resist deformation under an axial insertion load of at least approximately 50-120 N, and more specifically exhibit a flexural strength of at least approximately 800-1300 MPa as measured according to standard small-implant three-point bend testing. Such mechanical characteristics ensure that the tine maintains alignment and trajectory during insertion into the medial cuneiform, intermediate cuneiform, or metatarsal bases. In some aspects, the tine cross-section may be thickened, ribbed, or otherwise reinforced, or may include a hardened or work-hardened distal segment configured to penetrate cortical bone while reducing insertion torque and minimizing the risk of bending or tip deflection. In some aspects, the distal tip of each tine may be formed in a geometry configured to facilitate efficient penetration of cortical and cancellous bone Suitable geometries include, but are not limited to, chisel-shaped tips, tapered conical tips, beveled tips, trocar-point tips having three or more cutting facets, or a generally triangular cutting profile. The selected geometry may be chosen to reduce insertion force, improve cutting efficiency, and maintain a controlled trajectory during implantation. In certain embodiments, multi-facet geometries such as a trocar or quadfacet tip may improve purchase in denser regions of the medial cuneiform 12, intermediate cuneiform 18, or metatarsal bases 14, 24 by promoting predictable cortical penetration and reducing the likelihood of cortical skiving or lateral displacement.

[0106] In some embodiments, the distal tip of one or more tines may be angulated relative to the longitudinal axis of the tine to control penetration trajectory and optimize engagement within the targeted bone. The angulation may be oriented medially, laterally, dorsally, or plantarly depending on the desired insertion path. Such angulation may direct the tine toward the anatomical center of the bone, avoid encroachment on adjacent joint spaces, or compensate for natural curvature or irregularity of the medial cuneiform, intermediate cuneiform, or metatarsal bases. In certain aspects, angled tips may also reduce the risk of cortical blowout or deviation when encountering harder cortical bone regions.

[0107] In some aspects, one or more of the tines may include a surface treatment or coating configured to enhance bone penetration, reduce insertion torque, or improve resistance to wear. Suitable treatments may include electropolishing, grit blasting followed by polishing, titanium nitride (TiN) coating, diamond-like carbon (DLC) coating, or other biocompatible surface-hardening processes. These treatments may reduce surface friction during insertion, improve penetration efficiency at the distal tip, and enhance the durability of the tine during repeated loading or micromotion at the bone-implant interface

[0108] In some aspects, one or more components of the fixation device are or include a radiolucent or radiopaque marker to facilitate visualization under fluoroscopy or other medical imaging modalities. The entire device may be radiolucent or radiopaque. Alternatively, a marker may be positioned on one or more tines, on one or more bridge sections, or at another strategic location on the implant, and may be constructed of any suitable imaging-compatible material

[0109] In some aspects, the present invention includes a kit having a plurality of fixations devices with different configurations and / or sizes Lisfranc injuries have significant variability and the plurality of fixation devices with differing sizes and / or configurations enables a surgeon to select the most appropriate implant based on the specific injury pattern. The continuous compression provided by each device helps prevent recurrent diastasis and keep the joints reduced appropriately while the multiplanar aspect of the multi-tine constructs enhance stability across the affected joints.

[0110] In some aspects, the kit includes fixation devices offering variability in shape or orientation. Such shapes may include those described herein, including right-angle triangular, oblique triangular, equilateral triangular, diamond, rectangular, trapezoidal, or other polygonal configurations suitable for the targeted anatomy.

[0111] In some aspects, the kit includes fixation devices 100 offered in two orthree primary sizes (e.g. , small, medium, and large) to account for variability in patient anatomy. Additional or intermediate sizes are also contemplated to provide finer granularity in device selection. For example, size ranges for small devices may include bridge lengths between approximately 1 2 cm and 2 2 cm; size ranges for medium devices may include bridge lengths between approximately 1 .8 cm and 3.0 cm; and size ranges for large devices may include bridge lengths between approximately 2.4 cm and 3.6 cm. Intermediate and alternative size options are also contemplated to further refine implant selection according to patient-specific anatomy and surgical preference.

[0112] In some embodiments, the kit further includes one or more sizing templates configured to assist a surgeon in selecting an implant of appropriate size for a given patient anatomy. The templates may define the geometric outline of a corresponding fixation device and may be provided without tines in order to simplify intraoperative positioning and trialing In some aspects, the kit includes one or more templates corresponding to each variation of the implant.

[0113] In some embodiments, one or more of the templates includes a bridge section with an adjustable length, which allows the surgeon to extend or retract the bridge section to match the anatomical spacing of the targeted midfoot interval. In various implementations, the adjustable bridge section may include sliding, telescoping, ratcheting, or other length-varying mechanisms suitable for determining the proper implant configuration.

[0114] The present invention further includes a method of treating a Lisfranc injury. The method may include one or more of the steps described herein, including those enumerated below. In some aspects, the method includes performing open reduction and internal fixation of one or more Lisfranc-associated joints.

[0115] As shown in FIG. 16, and in accordance with some aspects of the present invention, a method of treating a Lisfranc injury may include one or more of the steps described herein. In some implementations, the method begins with performing an open reduction of the patient’s anatomy at step 402 to restore proper alignment of the Lisfranc interval 10 and associated tarsometatarsal and intercuneiform joints.

[0116] Following reduction, the method may include implanting a fixation device at step 404 such that at least one tine penetrates the medial cuneiform 12 and at least one other tine penetrates the base of the second metatarsal 14. This placement may be selected to stabilize the Lisfranc interval 10 and to maintain the anatomical relationship re-established during reduction

[0117] In some embodiments, the method may further include step 405 of implanting a tine into the intermediate cuneiform 18 and / or the first metatarsal 24. These placements may be used when employing two-tine, three-tine, four-tine, or multi-tine fixation devices, that are configured to span additional anatomical intervals, such as the second TMT joint 16, the first TMT joint 22, or the Lisfranc interval 10. Step 405 may include implanting a tine into one or more alternative anatomical features to stabilize the patient’s anatomy.

[0118] The method may further include closing the surgical wound after implantation of the fixation device or devices at step 406. In some aspects, the closure may be performed using sutures, staples, adhesive strips, or any suitable wound-closure technique selected according to the surgeon’s preference and the patient’s anatomy. The closure step may also include layered soft-tissue approximation to restore anatomical planes and support postoperative healing

[0119] In some implementations, the fixation device selected for implantation may be any of the variations described herein, including two-tine, three-tine, four-tine, or multi-tine configurations, as well as variants having right-angle triangular, oblique triangular, equilateral triangular, diamond, trapezoidal, or other polygonal arrangements of bridge sections.

[0120] The method may further include imaging the patient’s injured foot and the contralateral uninjured foot to determine an ideal or acceptable range of anatomical spacings for one or more of the Lisfranc interval 10, the first TMT joint 22, the second TMT joint 16, the intermetatarsal joint 26, and the medial-middle intercuneiform joint 20. This information may be used to select an appropriate device size or configuration and to confirm proper joint reduction

[0121] The method may include measuring one or more anatomical features, such as bone thickness, joint spacing, or cuneiform-metatarsal alignment, to determine the appropriate length of bridge sections and penetration depth of tines for the selected fixation device. Such measurements may be derived from preoperative imaging, intraoperative imaging, direct visualization, or navigation-assisted assessment. In addition, the measurements may be derived from the anatomy of the patient’s non-injured foot.

[0122] In some aspects, the method may include stabilizing or addressing additional joints or bones beyond those specifically described, depending on the patient’s injury pattern, anatomical considerations, or surgeon preference These may include but are not limited to adjacent tarsal articulations, extended metatarsal spans, or supporting structures that contribute to midfoot stability.

[0123] The following provides an overview of some aspects of the present disclosure:

[0124] Aspect 1. A fixation device for stabilizing a Lisfranc injury comprising at least three tines configured to penetrate respective midfoot bones and a plurality of bridge sections interconnecting the tines, with at least one bridge section extending between a pair of the tines, the bridge sections being arranged to span at least one anatomical interval of the midfoot, and at least one tine being configured to penetrate a medial cuneiform and another tine being configured to penetrate a base of a second metatarsal when implanted into a patient

[0125] Aspect 2. The fixation device of Aspect 1, wherein the tines and bridge sections form a triangular perimeter. Aspect 3. The fixation device of Aspect 2, wherein the triangular perimeter defines a right-angle triangle.

[0126] Aspect 4. The fixation device of Aspect 3, wherein the right-angle triangle includes a hypotenuse bridge section configured to span the Lisfranc interval when implanted.

[0127] Aspect 5. The fixation device of Aspect 2, wherein the triangular perimeter defines an equilateral triangle

[0128] Aspect 6. The fixation device of Aspect 1 , wherein the tines comprise four tines interconnected by bridge sections forming a diamond, square, rectangular, trapezoidal, or polygonal configuration

[0129] Aspect 7. The fixation device of Aspect 1 , wherein each tine is dimensioned to penetrate a target bone to a depth between approximately 10 mm and 25 mm.

[0130] Aspect 8. The fixation device of Aspect 1 , wherein each tine includes a sharpened or beveled distal tip and a reinforced shaft configured to resist bending under an axial insertion load of at least approximately 50-120 N.

[0131] Aspect 9. The fixation device of Aspect 1 , further comprising a radiopaque or radiolucent marker positioned on one or more of the tines or bridge sections

[0132] Aspect 10. The fixation device of Aspect 1 , wherein the tines and bridge sections are dimensioned and arranged to provide multiplanar rigid fixation across multiple midfoot joints simultaneously to maintain reduction following a Lisfranc injury.

[0133] Aspect 11. A method of stabilizing a Lisfranc injury comprising creating a surgical incision, performing an open reduction of a patient’s midfoot anatomy, implanting a fixation device comprising at least two tines and a bridge section interconnecting the tines such that at least one tine penetrates a medial cuneiform and at least one tine penetrates a base of a second metatarsal, and closing the surgical incision

[0134] Aspect 12. The method of Aspect 11, further comprising implanting an additional tine into at least one of an intermediate cuneiform or a first metatarsal

[0135] Aspect 13. The method of Aspect 11, further comprising implanting one or more additional fixation devices to stabilize one or more of a first tarsometatarsal joint, a second tarsometatarsal joint, a medial-middle intercuneiform joint, or a Lisfranc interval.

[0136] Aspect 14 The method of Aspect 11 , wherein the fixation device comprises a two-tine, three- tine, four-tine, or multi-tine configuration having one or more bridge sections sized to span at least one anatomical interval of the midfoot.

[0137] Aspect 15. The method of Aspect 11, further comprising verifying the position of the fixation device using fluoroscopic or radiographic imaging.

[0138] Aspect 16 The method of Aspect 11, further comprising imaging the patient’s uninjured foot to determine an anatomical spacing target for one or more midfoot joints. Aspect 17 The method of Aspect 11 , further comprising selecting the fixation device from a kit including a plurality of devices of different sizes or geometric configurations.

[0139] Aspect 18 The method of Aspect 11 , further comprising implanting a fixation device having a triangular configuration formed by at least three tines interconnected by a plurality of bridge sections.

[0140] Aspect 19 The method of Aspect 18, wherein the triangular configuration defines a right-angle triangle.

[0141] Aspect 20 The method of Aspect 19, wherein a hypotenuse bridge section spans the Lisfranc interval when implanted

[0142] Aspect 21. The method of Aspect 18, wherein the triangular configuration defines an equilateral triangle.

[0143] Aspect 22. The method of Aspect 11 , wherein the fixation device comprises four tines interconnected by bridge sections arranged to form a diamond, square, rectangular, trapezoidal, or polygonal configuration.

[0144] Aspect 23. The method of Aspect 11 , wherein implanting the fixation device comprises penetrating one or more targeted bones to a depth between approximately 10 mm and 25 mm.

[0145] Aspect 24 The method of Aspect 11 , further comprising inserting a tine having a sharpened or beveled distal tip and a reinforced shaft configured to resist bending under an axial insertion load of at least approximately 50-120 N.

[0146] Aspect 25. The method of Aspect 11, further comprising positioning at least one tine within approximately 2-6 mm of a central region of a targeted bone

[0147] Aspect 26 The method of Aspect 11 , further comprising orienting a second fixation device to span a different anatomical interval than the first fixation device to provide multidirectional stabilization.

[0148] Aspect 27 A kit for stabilizing a Lisfranc injury comprising a plurality of fixation devices, each fixation device including a plurality of tines configured to penetrate respective midfoot bones and at least one bridge section extending between the tines and arranged to span at least one anatomical interval of the midfoot, and wherein at least one fixation device includes at least three tines and a plurality of bridge sections interconnecting the tines, with at least one tine configured to penetrate a medial cuneiform and at least one tine configured to penetrate a base of a second metatarsal.

[0149] Aspect 28 The kit of Aspect 27, wherein at least one fixation device has a triangular perimeter.

[0150] Aspect 29 The kit of Aspect 28, wherein the triangular perimeter defines a right-angle triangle.

[0151] Aspect 30 The kit of Aspect 29, wherein the right-angle triangle includes a hypotenuse bridge section configured to span the Lisfranc interval when implanted. Aspect 31 The kit of Aspect 28, wherein the triangular perimeter defines an equilateral triangle.

[0152] Aspect 32. The kit of Aspect 27, wherein at least one fixation device comprises four tines interconnected by bridge sections forming a diamond, square, rectangular, trapezoidal, or polygonal configuration.

[0153] Aspect 33. The kit of Aspect 27, wherein the tines of at least one fixation device are each dimensioned to penetrate a target bone to a depth between approximately 10 mm and 25 mm.

[0154] Aspect 34. The kit of Aspect 27, wherein at least one fixation device includes tines having a sharpened or beveled distal tip and a reinforced shaft configured to resist bending under an axial insertion load of at least approximately 50-120 N

[0155] Aspect 35 The kit of Aspect 27, wherein at least one fixation device includes a radiopaque or radiolucent marker positioned on a tine or bridge section

[0156] Aspect 36 The kit of Aspect 27, wherein at least one fixation device provides multiplanar rigid fixation across multiple midfoot joints to maintain reduction of the patient’s anatomy.

[0157] Aspect 37. The kit of Aspect 27, wherein at least one fixation device is a small-sized device having one or more bridge sections with lengths between approximately 1.2 cm and 2.2 cm.

[0158] Aspect 38 The kit of Aspect 27, wherein at least one fixation device is a medium-sized device having one or more bridge sections with lengths between approximately 1.8 cm and 3.0 cm.

[0159] Aspect 39. The kit of Aspect 27, wherein at least one fixation device is a large-sized device having one or more bridge sections with lengths between approximately 2.4 cm and 3.6 cm.

[0160] Aspect 40 The kit of Aspect 27, wherein the plurality of bridge sections, of at least one fixation device, collectively define a curved profile configured to conform to a non-planar anatomical contour of the midfoot

[0161] Aspect 41 The kit of Aspect 27, wherein the plurality of bridge sections, of at least one fixation device, collectively define a sloped orientation

[0162] Aspect 42 The kit of Aspect 27, wherein at least one of the tines, of at least one fixation device, extends from a corresponding bridge section at an angle other than 90 degrees to accommodate bone surfaces that differ in height or inclination.

[0163] Aspect 43 The fixation device of Aspect 1 , wherein the plurality of bridge sections collectively define a curved profile configured to conform to a non-planar anatomical contour of the midfoot.

[0164] Aspect 44 The fixation device of Aspect 1 , wherein the plurality of bridge sections collectively define a sloped orientation.

[0165] Aspect 45. The fixation device of Aspect 1 , wherein at least one of the tines extends from a corresponding bridge section at an angle otherthan 90 degrees to accommodate bone surfaces that differ in height or inclination. Aspect 46 The method of Aspect 11 , wherein the plurality of bridge sections collectively define a curved profile configured to conform to a non-planar anatomical contour of the midfoot

[0166] Aspect 47 The method of Aspect 11 , wherein the plurality of bridge sections collectively define a sloped orientation.

[0167] Aspect 48. The method of Aspect 11, wherein at least one of the tines extends from a corresponding bridge section at an angle otherthan 90 degrees to accommodate bone surfaces that differ in height or inclination.

[0168] The foregoing disclosure provides illustration and description but is not intended to be exhaustive or to limit the Aspects to the precise forms disclosed Modifications and variations may be made in light of the above disclosure or may be acquired from practice of the Aspects. The following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.

Claims

What is claimed is:1 . A fixation device for stabilizing a Lisfranc injury, comprising: at least three tines configured to penetrate respective midfoot bones; and a plurality of bridge sections interconnecting the tines, with at least one bridge section extending between a pair of the tines; wherein the bridge sections are arranged to span at least one anatomical interval of the midfoot; and wherein at least one tine is configured to penetrate a medial cuneiform and another tine is configured to penetrate a base of a second metatarsal when implanted into a patient.

2. The device of claim 1, wherein the at least three tines and the plurality of bridge sections are arranged to form a perimeter with a triangular configuration.3 The device of claim 2, wherein the triangular configuration establishes rightangle triangle.

4. The device of claim 3, wherein the right-angle triangle includes a hypotenuse bridge section that is configured to span the Lisfranc interval when implanted into the patient.

5. The device of claim 2, wherein the triangular configuration establishes an equilateral triangle.

6. The device of claim 1, wherein the at least three tines comprise four tines, and the bridge sections interconnect the tines to form a diamond, square, rectangular, trapezoidal, or polygonal configuration.

7. The device of claim 1, wherein the at least three tines are each dimensioned to penetrate a target bone to a depth between approximately 10 mm and 25 mm8. The device of claim 1, wherein the at least three tines each include a sharpened or beveled distal tip and a reinforced shaft configured to resist bending under an axial insertion load of at least approximately 50-120 N.

9. The device of claim 1 , further comprising a radiopaque or radiolucent marker positioned on one or more of the tines or bridge sections.

10. The device of claim 1 , wherein the tines and the bridge sections are dimensioned and arranged to provide multiplanar rigid fixation across multiple midfoot joints simultaneously when implanted in the patient, thereby maintaining reduction of the patient’s midfoot anatomy following a Lisfranc injury.

11. The device of claim 1, wherein the plurality of bridge sections collectively define a curved profile configured to conform to a non-planar anatomical contour of the midfoot.

12. The device of claim 1, wherein the plurality of bridge sections collectively define a sloped orientation.

13. The device of claim 1 , wherein at least one of the tines extends from a corresponding bridge section at an angle other than 90 degrees to accommodate bone surfaces that differ in height or inclination.14 A method of stabilizing a Lisfranc injury, comprising: creating a surgical opening; performing an open reduction of a patient’s midfoot anatomy to restore alignment of at least the Lisfranc interval; implanting a fixation device comprising at least two tines and a bridge section interconnecting the tines, such that at least one tine penetrates a medial cuneiform and at least one tine penetrates a base of a second metatarsal; and closing the surgical opening.

15. The method of claim 14, further comprising implanting an additional tine into at least one of an intermediate cuneiform or a first metatarsal.

16. The method of claim 14, further comprising implanting one or more additional fixation devices to stabilize one or more of a first tarsometatarsal joint, a second tarsometatarsal joint, a medial-middle intercuneiform joint, or a Lisfranc interval.

17. The method of claim 14, wherein the fixation device comprises a two-tine, three-tine, four-tine, or multi-tine configuration having one or more bridge sections sized to span at least one anatomical interval selected from the Lisfranc interval, the first tarsometatarsal joint, the second tarsometatarsal joint, the medial-middle intercuneiform joint, and the Lisfranc interval.

18. The method of claim 14, further comprising verifying the position of the fixation device using fluoroscopic or radiographic imaging.

19. The method of claim 14, further comprising imaging the patient’s uninjured foot to determine an anatomical spacing target for the Lisfranc interval, the first tarsometatarsal joint, the second tarsometatarsal joint, the intermetatarsal joint, or the medial-middle intercuneiform joint.20 The method of claim 14, further comprising selecting the fixation device from a kit including a plurality of devices of different sizes or geometric configurations21. The method of claim 14, wherein implanting the fixation device comprises implanting a device having a triangular configuration formed by at least three tines interconnected by a plurality of bridge sections.

22. The method of claim 21 , wherein the triangular configuration defines a rightangle triangle.

23. The method of claim 22, wherein a hypotenuse bridge section spans the Lisfranc interval when the fixation device is implanted.

24. The method of claim 21 , wherein the triangular configuration defines an equilateral triangle25. The method of claim 14, wherein implanting the fixation device comprises implanting a device having four tines interconnected by bridge sections arranged to form a diamond, square, rectangular, trapezoidal, or polygonal configuration.

26. The method of claim 14, wherein implanting the fixation device comprises penetrating one or more targeted bones to a depth between approximately 10 mm and 25 mm.

27. The method of claim 14, wherein implanting the fixation device comprises inserting at least one tine having a sharpened or beveled distal tip and a reinforced shaft configured to resist bending under an axial insertion load of at least approximately 50-120 N.28 The method of claim 14, wherein implanting the fixation device comprises positioning at least one tine within approximately 2-6 mm of a central region of a targeted bone.

29. The method of claim 14, further comprising orienting a second fixation device to span at least one different anatomical interval than the first fixation device to provide multidirectional stabilization30. The method of claim 14, wherein the plurality of bridge sections collectively define a curved profile configured to conform to a non-planar anatomical contour of the midfoot.

31. The method of claim 14, wherein the plurality of bridge sections collectively define a sloped orientation.32 The method of claim 14, wherein at least one of the tines extends from a corresponding bridge section at an angle other than 90 degrees to accommodate bone surfaces that differ in height or inclination.

33. A kit for stabilizing a Lisfranc injury, comprising: a plurality of fixation devices, wherein each fixation device includes a plurality of tines configured to penetrate respective midfoot bones and at least one bridge sectionextending between the plurality of tines and arranged to span at least one anatomical interval of the midfoot; at least one of the plurality of fixation devices including: at least three tines; and a plurality of bridge sections interconnecting the tines; wherein at least one tine of the plurality of fixation devices is configured to penetrate a medial cuneiform and at least one tine is configured to penetrate a base of a second metatarsal when implanted in a patient.

34. The kit of claim 33, wherein at least one of the plurality of fixation devices has a triangular perimeter.

35. The kit of claim 34, wherein at least one of the plurality of fixation devices has a right-angle triangular perimeter.36 The kit of claim 34, wherein the right-angle triangle includes a hypotenuse bridge section configured to span the Lisfranc interval when the at least one fixation device is implanted.

37. The kit of claim 34, wherein at least one of the plurality of fixation devices has an equilateral triangular perimeter.

38. The kit of claim 34, wherein the triangular perimeter defines an equilateral triangle.

39. The kit of claim 33, wherein the at least one fixation device comprises four tines, and the bridge sections interconnect the tines to form a diamond, square, rectangular, trapezoidal, or polygonal configuration.

40. The kit of claim 33, wherein the tines of the at least one fixation device are each dimensioned to penetrate a target bone to a depth between approximately 10 mm and 25 mm.

41. The kit of claim 33, wherein the at least one fixation device includes tines having a sharpened or beveled distal tip and a reinforced shaft configured to resist bending under an axial insertion load of at least approximately 50-120 N.

42. The kit of claim 33, wherein the at least one fixation device includes a radiopaque or radiolucent marker positioned on one or more of the tines or bridge sections.

43. The kit of claim 33, wherein the tines and the bridge sections of the at least one fixation device are dimensioned and arranged to provide multiplanar rigid fixation across multiple midfoot joints simultaneously when implanted in the patient, thereby maintaining reduction of the patient’s midfoot anatomy following a Lisfranc injury.

44. The kit of claim 33, wherein the at least one fixation device is a small-sized device having one or more bridge sections with lengths between approximately 1.2 cm and 2.2 cm.

45. The kit of claim 33, wherein the at least one fixation device is a medium-sized device having one or more bridge sections with lengths between approximately 1.8 cm and 3.0 cm.

46. The kit of claim 33, wherein the at least one fixation device is a large-sized device having one or more bridge sections with lengths between approximately 2.4 cm and 3.6 cm.

47. The kit of claim 33, wherein the plurality of bridge sections, of at least one fixation device, collectively define a curved profile configured to conform to a non- planar anatomical contour of the midfoot. The kit of claim 33, wherein the plurality of bridge sections, of at least one fixation device, collectively define a sloped orientation.

48. The kit of claim 33, wherein at least one of the tines, of at least one fixation device, extends from a corresponding bridge section at an angle other than 90 degrees to accommodate bone surfaces that differ in height or inclination

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