ORTHOPEDIC IMPLANTS, INSTRUMENTATION SYSTEMS AND METHODS OF USE

Abstract

The orthopedic implant includes an upper portion, a central portion having a larger lateral dimension than the upper portion, and a lower portion having a larger lateral dimension than the central portion. Additionally, each of the upper portion, central portion, and lower portion may be non-linear and / or curved in at least one plane. The instrument has a body including a housing. The body includes a platform, at least one retention mechanism for retaining the implant on the platform, an adjustment mechanism for adjusting the height of the platform relative to a top surface of the housing, and a lid coupled to the housing, where the top surface of the housing and the lid define a slot configured to receive a cutting instrument.

Description

[Technical field]

[0001] (Related Applications) This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 363,724, filed on April 28, 2022, and entitled "Orthopedic Implants," and U.S. Provisional Patent Application No. 63 / 366,184, filed on June 10, 2022, and entitled "Apparatus and Methods for Biological Implants," the disclosures of which are incorporated by reference in their entireties herein.

[0002] The present disclosure relates to podiatric and orthopedic implants and procedures associated with artificial joint replacements, joint replacements, arthrectomies and / or osteotomies of the foot / ankle joint, and / or procedures incorporating the surrounding bone / soft tissue. [Background technology]

[0003] Many currently available implants, devices and methods for addressing bone, soft tissue and joint trauma (acute and chronic, e.g., defects, gradual deterioration, etc.) do not fully address the needs of patients. Furthermore, many of the currently available implants, devices and methods for addressing joint trauma do not take into account joint anatomical characteristics and associated mechanical and kinematic movement patterns / capacities. Summary of the Invention

[0004] One aspect of the present disclosure is directed to some embodiments of an orthopedic implant, such as a bone plate. The implant includes an upper portion, a central portion having a larger lateral dimension than the upper portion, and a lower portion having a larger lateral dimension than the central portion. The upper portion, central portion, and lower portion may also include at least one fixation opening. The upper portion, central portion, and lower portion may be curved and nonlinear in at least one plane.

[0005] According to certain aspects of the present disclosure, the top portion of the implant includes at least one opening extending from the top surface to the bottom surface and configured to receive a fastener therethrough.

[0006] According to certain aspects of the present disclosure, the central portion does not include an opening.

[0007] According to one aspect of the present disclosure, the lower portion extends from the top surface to the bottom surface and includes at least one opening configured to receive a fastener therethrough.

[0008] According to certain aspects of the present disclosure, the top portion is non-linear and / or curved in at least one plane.

[0009] According to certain aspects of the present disclosure, the central portion is non-linear and / or curved in at least one plane.

[0010] According to certain aspects of the present disclosure, the lower portion is non-linear and / or curved in at least one plane.

[0011] According to one aspect of the present disclosure, the top portion includes a slot extending from the top surface to the bottom surface and configured to receive a fastener therethrough.

[0012] Another aspect of the present disclosure is directed to an orthopaedic surgical instrument. According to one aspect of the present disclosure, the orthopaedic surgical instrument includes a body having a housing. The body further includes a platform configured to receive an implant, at least one retention mechanism configured to hold the implant at least partially on the platform, and an adjustment mechanism configured to adjust the height of at least a portion of the platform relative to a top surface of the housing. The instrument also includes a lid hinged to the housing, the top surface of the housing and the lid defining a cutting slot configured to receive at least a portion of a cutting instrument.

[0013] According to certain aspects of the present disclosure, the implant is a biological graft implant.

[0014] According to one aspect of the present disclosure, the implant has a substantially wedge shape.

[0015] According to certain aspects of the present disclosure, the at least one retention feature includes a pair of retention features configured to contact the implant on opposing sides of the implant.

[0016] According to one aspect of the present disclosure, the lid includes a window coupled to the lid, the window being transparent.

[0017] According to certain aspects of the present disclosure, the instrument includes at least one actuator at least partially disposed within the housing, at least a first portion of the at least one actuator extending laterally through an opening in a sidewall of the housing and at least a second portion of the at least one actuator extending longitudinally through an opening in the plate.

[0018] According to one aspect of the present disclosure, the at least one actuator is a pair of actuators disposed on opposing sides of the housing.

[0019] According to one aspect of the disclosure, each actuator is configured to releasably engage the lid to retain the lid in a closed position.

[0020] According to one aspect of the present disclosure, operation of the actuator disengages the actuator from the lid.

[0021] According to one aspect of the present disclosure, the lid includes a button releasably coupled with the engagement element.

[0022] According to one aspect of the present disclosure, actuation of the button biases an engagement element into contact with the implant to hold the implant in a desired position.

[0023] Another aspect of the present disclosure is directed to a surgical system. The system includes an instrument including a body having a housing, a platform configured to receive a biological implant, at least one retention mechanism configured to hold the biological implant at least partially on the platform, an adjustment mechanism configured to adjust the height of at least a portion of the platform relative to a top surface of the housing, and a lid hinged to the housing, the top surface of the housing and the lid defining a cut slot configured to receive at least a portion of a cutting instrument. The system also includes a first implant configured to be reformed within the housing of the instrument, and a second implant.

[0024] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with the detailed description, serve to explain the principles of the present invention. It is emphasized that, in accordance with standard industry practice, various features may or may not be drawn to scale. In fact, dimensions of various features may be arbitrarily increased or decreased for clarity of discussion. The drawings are intended to illustrate embodiments of the present disclosure and are not to be construed as limiting the invention. [Brief description of the drawings]

[0025] [Figure 1] FIG. 1 is a front view of an orthopedic implant according to the present disclosure. [Diagram 2] FIG. 2 is a rear view of the orthopedic implant of FIG. 1 in accordance with the present disclosure; [Diagram 3] FIG. 2 is a first side view of the orthopedic implant of FIG. 1 in accordance with the present disclosure; [Figure 4] FIG. 2 is a second side view of the orthopedic implant of FIG. 1 in accordance with the present disclosure; [Diagram 5] FIG. 1 is a front view of an orthopedic implant according to the present disclosure. [Figure 6] FIG. 6 is a rear view of the orthopedic implant of FIG. 5 in accordance with the present disclosure. [Figure 7]FIG. 6 is a first side view of the orthopedic implant of FIG. 5 in accordance with the present disclosure; [Figure 8] FIG. 6 is a second side view of the orthopedic implant of FIG. 5 in accordance with the present disclosure; [Figure 9] FIG. 1 is a front view of an orthopedic implant according to the present disclosure. [Figure 10] FIG. 10 is a rear view of the orthopedic implant of FIG. 9 in accordance with the present disclosure. [Figure 11] FIG. 10 is a first side view of the orthopedic implant of FIG. 9 in accordance with the present disclosure; [Figure 12] FIG. 10 is a second side view of the orthopedic implant of FIG. 9 in accordance with the present disclosure; [Figure 13] FIG. 1 is a front view of an orthopedic implant according to the present disclosure. [Figure 14] FIG. 14 is a rear view of the orthopedic implant of FIG. 13 in accordance with the present disclosure; [Figure 15] FIG. 14 is a first side view of the orthopedic implant of FIG. 13 in accordance with the present disclosure; [Figure 16] FIG. 14 is a second side view of the orthopedic implant of FIG. 13 in accordance with the present disclosure; [Figure 17] FIG. 1 is a front view of an orthopedic implant according to the present disclosure. [Figure 18] FIG. 18 is a rear view of the orthopedic implant of FIG. 17 in accordance with the present disclosure. [Figure 19] FIG. 18 is a first side view of the orthopedic implant of FIG. 17 in accordance with the present disclosure; [Figure 20] FIG. 18 is a second side view of the orthopedic implant of FIG. 17 in accordance with the present disclosure. [Figure 21] FIG. 1 is a front view of an orthopedic implant according to the present disclosure. [Figure 22] FIG. 22 is a rear view of the orthopedic implant of FIG. 21 in accordance with the present disclosure. [Figure 23] FIG. 22 is a first side view of the orthopedic implant of FIG. 21 in accordance with the present disclosure; [Figure 24] FIG. 22 is a second side view of the orthopedic implant of FIG. 21 in accordance with the present disclosure; [Diagram 25] FIG. 1 is a front perspective view of an orthopaedic surgical instrument according to the present disclosure; [Figure 26] FIG. 2 is a front view of the orthopaedic surgical instrument of FIG. 1 in accordance with the present disclosure; [Figure 27] FIG. 26 is a rear view of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure; [Figure 28] FIG. 26 is a first side view of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure; [Figure 29] FIG. 26 is a second side view of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure; [Diagram 30] FIG. 26 is a top view of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure. [Diagram 31] FIG. 26 is a bottom view of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure. [Diagram 32] FIG. 26 is an alternative front perspective view of the orthopedic surgical instrument of FIG. 25 with a transparent lid in accordance with the present disclosure. [Diagram 33] FIG. 26 is a front perspective view of a portion of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure; [Diagram 34] FIG. 26 is a rear view of a portion of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure; [Diagram 35] 26 is a first side view of a portion of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure; [Diagram 36] FIG. 26 is a second side view of the portion of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure; [Figure 37] FIG. 26 is a top view of a portion of the orthopaedic surgical instrument of FIG. 25 in accordance with the present disclosure. [Figure 38] FIG. 26 is a front perspective view of a portion of the orthopedic surgical instrument of FIG. 25 with a transparent housing in accordance with the present disclosure; [Figure 39] FIG. 26 is an alternative front perspective view of a portion of the orthopedic surgical instrument of FIG. 25 with a transparent housing in accordance with the present disclosure. [Diagram 40] FIG. 26 is a top perspective view of a portion of the orthopaedic surgical instrument of FIG. 25 with a transparent housing in accordance with the present disclosure; [Diagram 41] FIG. 26 is an alternative front perspective view of a portion of the orthopedic surgical instrument of FIG. 25 with a transparent housing in accordance with the present disclosure. [Diagram 42] FIG. 26 is a side view of a portion of the orthopaedic surgical instrument system of FIG. 25 with a transparent housing in accordance with the present disclosure. [Diagram 43] FIG. 26 is an alternative side view of a portion of the orthopedic surgical instrument of FIG. 25 with a transparent housing in accordance with the present disclosure; [Diagram 44] FIG. 1 is a perspective view of an orthopaedic surgical instrument according to the present disclosure; [Diagram 45] FIG. 45 is a top perspective view of the orthopaedic surgical instrument of FIG. 44 in accordance with the present disclosure. [Diagram 46] FIG. 45 is a side view of the orthopedic surgical instrument of FIG. 44 with a transparent housing and lid in accordance with the present disclosure; [Figure 47] FIG. 45 is a rear perspective view of the orthopaedic surgical instrument of FIG. 44 in accordance with the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] In this detailed description and in the claims that follow, the words proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior, and inferior are defined by standard usage to designate specific portions or sites of a bone or implant according to the relative placement or directional terms of natural bone. For example, "proximal" refers to the portion of the device or implant closest to the torso and "distal" refers to the portion of the device or implant furthest from the torso. With respect to directional terms, "anterior" means a direction toward the front of the body, "posterior" means a direction toward the back of the body, "medial" means a direction toward the midline of the body, "lateral" means a direction away from the side or midline of the body, "superior" means above another object or structure, and "inferior" means below. Furthermore, with respect to the foot specifically, the term "dorsal" refers to the top of the foot and the term "plantar" refers to the bottom of the foot.

[0027] Similarly, positions or orientations may be used herein with reference to anatomical structures or surfaces. For example, because the present implants, devices, instruments, 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, instruments, and methods. Furthermore, the implants, devices, instruments, and methods disclosed herein, as well as their aspects, components, features, etc., are described with respect to one side of the body for purposes of brevity. However, because the human body is relatively symmetrical or mirrored about a line of symmetry (the midline), it is expressly contemplated herein that the implants, devices, instruments, and methods described and / or illustrated herein, as well as their aspects, components, features, etc., may be changed, altered, modified, reconfigured, or otherwise modified for use or association with another side of the body for the same or similar purposes without departing from the spirit and scope of the present invention. For example, the implants, devices, instruments, and methods described herein with respect to the right foot, as well as their aspects, components, features, etc., may be mirrored to function similarly on the left foot. Additionally, while the implants, devices, instruments, and methods disclosed herein, and their aspects, components, features, etc., are described with respect to the foot for purposes of brevity, it will be understood that the implants, devices, instruments, and methods may also be used with other bones of the body having a similar structure.

[0028] Referring to the drawings, like reference numerals are used throughout the several views to indicate like or similar components, and with particular reference to FIGS. 1-24, an orthopedic implant (e.g., a plate) is shown. The implant is shown to include various portions (e.g., upper, middle, lower, etc.) having various lateral dimensions that may be larger, smaller, or equal to one another. Similarly, the aforementioned portions may also include various thicknesses that may be larger, smaller, or equal to one another. Additionally, the aforementioned portions may be curved and / or non-planar relative to one another to approximate the contours of the adjacent bone surfaces. The illustrated implant may be implemented in combination with other implant components and / or systems, such as wedges of various sizes / shapes, trial instruments corresponding to the wedges, and other instruments common to orthopedic procedures. In some embodiments, the illustrated implant may include a center portion (shown herein as a substantially solid portion, e.g., a portion without openings) configured to span an osteotomy location (where an implant, such as a wedge, may be implanted). The implant may also include an upper portion and a lower portion that include one or more fixation apertures configured to couple the implant to the patient's bone (e.g., tibia) on either side of the osteotomy location to hold the wedge in a desired position (e.g., in the osteotomy location).

[0029] 1-8, an orthopedic implant 10 is shown according to an exemplary embodiment. The illustrated implant 10 is an orthopedic bone plate configured to releasably couple with one or more bones or bone fragments of a patient via one or more fasteners (e.g., screws, etc.). As shown, the implant 10 includes an upper portion 12, a central portion 18, and a lower portion 20. The upper portion 12 and the lower portion 20 are each disposed opposite the central portion 18 relative to one another. As shown, the lower portion 20 has a larger lateral dimension than the central portion 18 and the upper portion 12, which has a larger lateral dimension than the upper portion 12. Moving upward from the lower portion 20 toward the upper portion 12, the implant 10 is shown to taper from a larger to a smaller lateral width.

[0030] The top 12 is shown to include a slot 14 disposed at its top, adjacent a terminal end of the top 12 as shown in the exemplary embodiment of FIGS. 1-8. In some aspects, the slot 14 may be configured to receive a fastener therein and therethrough to facilitate coupling with a bone / bone segment. Additionally, in some aspects, the slot 14 may be configured as a compression slot such that a fastener may be inserted therein and therethrough to couple with and apply a compressive force across one or more bones / bone fragments. The top 12 also includes at least one opening 16 configured to receive a fastener therein and therethrough. As shown in FIGS. 1-8, the at least one opening 16 is a pair of openings adjacent to one another. It should be understood that in some aspects, the implant 10 may be provided in a variety of sizes / lengths and one or more of the slots 14 and / or openings 16 may be disposed around the top 12 accordingly.

[0031] The central portion 18 is shown integral with the upper portion 12 and the lower portion 20, and is further shown to include markings thereon. In some embodiments, the markings may include various sizes, SKUs, or other information associated with the implant 10. As shown in at least FIGS. 3-4, the central portion 18 includes a tapered thickness, with a smaller thickness adjacent the upper portion 12 and a larger thickness adjacent the lower portion 20. As shown, the central portion 18 does not include an opening or slot, however, in some embodiments, the central portion 18 may include one or more features configured to facilitate coupling of the implant 10 with one or more bones / bone fragments. Additionally, in some embodiments, the central portion 10 may be configured to span an osteotomy location within a bone or to span between bone fragments that may include a volume filled by a graft (e.g., a wedge) or other additional implant in some embodiments.

[0032] The lower portion 20 is shown to be integral with the central portion 18 of the implant 10. Additionally, the lower portion 20 is shown to include at least one opening 22 configured to receive a fastener therein and therethrough to facilitate attachment to one or more bones or bone fragments. In some aspects, the openings 22 may be the same as or similar to the openings 16 of the upper portion 12. As shown, the lower portion 20 includes a total of five openings 22 arranged in two offset rows (three in the lower row and two in the upper row). However, in some aspects, the openings 22 may be staggered around the lower portion 22 and may be provided in various numbers. In some embodiments, the lower portion 20 may include slots, such as slots the same as or similar to the slots 14 of the upper portion 12.

[0033] The implant 10 may be provided in various sizes for the upper portion 12, middle portion 18, and lower portion 20 to accommodate various procedures or sizes in a patient's bone / anatomy. For example, in some embodiments, the middle portion 18 may have a length greater or less than that shown relative to the upper portion 12 and lower portion 20. Additionally, in some embodiments, the location, number, and spacing of the slots 14 and openings 16, 22 may be varied depending on the size of the implant 10 and its various portions.

[0034] 9-16, an orthopedic implant 50 is shown according to an exemplary embodiment. The illustrated implant 50 is an orthopedic bone plate configured to releasably couple with one or more bones or bone fragments of a patient via one or more fasteners (e.g., screws, etc.). As shown, the implant 50 includes an upper portion 52, a central portion 58, and a lower portion 60. The upper portion 52 and the lower portion 60 are each disposed opposite the central portion 58 relative to one another. As shown, the lower portion 60 has a larger lateral dimension (at its widest point) than the central portion 58 and the upper portion 52, which has a larger lateral dimension (at its widest point) than the upper portion 52. Moving upward from the lower portion 60 toward the upper portion 52, the implant 50 is shown to taper from a larger to a smaller lateral width (considering each portion at its widest point).

[0035] The upper portion 52 is shown to include a slot 54 disposed at its uppermost portion, and as shown in the exemplary embodiment of FIGS. 9-16, the slot 54 is disposed adjacent an end of the upper portion 52. In some aspects, the slot 54 may be configured to receive a fastener therein and therethrough to facilitate coupling with a bone or bone segment. Additionally, in some aspects, the slot 54 may be configured as a compression slot such that a fastener may be inserted therein and therethrough to couple with and apply a compressive force across one or more bones / bone fragments. The upper portion 52 also includes at least one opening 56 configured to receive a fastener therein and therethrough. As shown in FIGS. 9-16, the at least one opening 56 is a pair of openings spaced apart from one another. It should be understood that in some aspects, the implant 50 may be provided in a variety of sizes / lengths and one or more of the slots 54 and / or openings 56 may be disposed around the upper portion 52 accordingly.

[0036] The central portion 58 is shown integral with the upper portion 52 and the lower portion 60, and is further shown to include markings thereon. In some embodiments, the markings may include various sizing, SKU, or other information associated with the implant 50. As shown, the central portion 58 does not include an opening or slot, however, in some embodiments, the central portion 58 may include one or more features configured to facilitate coupling of the implant 50 with one or more bones or bone fragments. Additionally, in some embodiments, the central portion 50 may be configured to span an osteotomy location within a bone, or to span between bone fragments that may include a volume filled by a graft (e.g., a wedge) or other additional implant in some embodiments.

[0037] The lower portion 60 is shown to be integral with the central portion 58 of the implant 50. Additionally, the lower portion 60 is shown to include at least one aperture 62 configured to receive a fastener therein and therethrough to facilitate connection with one or more bones or bone fragments. As shown in FIGS. 9-16, the lower portion 60 has a taper at an end and then widens as it moves toward the central portion 58. In some aspects, the aperture 62 may be the same as or similar to the aperture 56 of the upper portion 52. In some aspects, the aperture 62 may be the same as or similar to the aperture 56 of the upper portion 52. As shown, the lower portion 60 includes a total of three apertures 62 arranged in two offset rows (one in the lower row and two in the upper row). However, in some aspects, the apertures 62 may be staggered with respect to the lower portion 62 and may be provided in various numbers. In some embodiments, the lower portion 60 may include a slot that is the same as or similar to the slot 54 of the upper portion 52, for example.

[0038] Because the implant 50 may be sized to accommodate various procedures or sizes in a patient's bone / anatomy, the upper portion 52, middle portion 58, and lower portion 60 may have various lengths or thicknesses. For example, in some embodiments, the middle portion 58 may have a length greater or less than that shown relative to the upper portion 52 and lower portion 60. Additionally, in some embodiments, the location, number, and spacing of the slots 54 and openings 56, 62 may be altered depending on the size of the implant 50 and its various portions.

[0039] 17-24, an orthopedic implant 70 is shown according to an exemplary embodiment. The illustrated implant 70 is an orthopedic bone plate configured to releasably couple with one or more bones or bone fragments of a patient via one or more fasteners (e.g., screws, etc.). As shown, the implant 70 includes an upper portion 72, a central portion 78, and a lower portion 80. The upper portion 72 and the lower portion 80 are each disposed opposite the central portion 78 relative to one another. As such, the lower portion 80 has a larger lateral dimension than the central and upper portions 78, 72, and the central portion 76 has a larger lateral dimension than the upper portion 72. Moving upward from the lower portion 80 toward the upper portion 72, the implant 70 is shown to taper from a larger to a smaller lateral width.

[0040] The upper portion 72 is shown to include a slot 74 disposed at its uppermost portion, and as shown in the exemplary embodiment of FIGS. 17-24, the slot 74 is disposed adjacent to an end of the upper portion 72. In some aspects, the slot 74 may be configured to receive a fastener therein and therethrough to facilitate coupling with a bone or / bone segment. Additionally, in some aspects, the slot 74 may be configured as a compression slot such that a fastener is inserted therein and therethrough to couple with one or more bones or bone fragments and apply a compressive force across the bone or bone fragments. The upper portion 72 also includes at least one opening 76 configured to receive a fastener therein and therethrough. As shown in FIGS. 17-18, the at least one opening 76 is a pair of openings spaced apart from one another. It should be understood that in some aspects, the implant 70 may be provided in a variety of sizes / lengths, and one or more of the slots 74 and / or openings 76 may be disposed around the upper portion 72 accordingly.

[0041] The central portion 78 is shown integral with the upper and lower portions 72, 80 and is further shown to include markings thereon. In some embodiments, the markings may include various size designations, SKUs, or other information associated with the implant 70. As shown, the central portion 78 does not include an opening or slot, however, in some embodiments, the central portion 78 may include one or more features configured to facilitate coupling of the implant 70 with one or more bones or bone fragments. Additionally, in some embodiments, the central portion 70 may be configured to span an osteotomy location within a bone or to span between bone fragments that may include a volume filled by a graft (e.g., a wedge) or other additional implant in some embodiments.

[0042] The lower portion 80 is shown to be integral with the central portion 78 of the implant 70. Additionally, the lower portion 80 is shown to include at least one aperture 82 configured to receive a fastener therein and therethrough to facilitate attachment to one or more bones / bone fragments. As shown, the lower portion 80 includes a pair of lobes extending therefrom at the termini of the lower portion 80, with an aperture 82 disposed within each lobe in the exemplary embodiment of FIGS. 17-24. In some aspects, the apertures 82 may be the same as or similar to the apertures 76 of the upper portion 72. As shown, the lower portion 80 includes a total of three apertures 82 arranged in two offset rows (two in the lower row and one in the upper row). However, in some aspects, the apertures 82 may be staggered with respect to the lower portion 82 and may be provided in various numbers. In some embodiments, the lower portion 80 may include a slot, such as a slot that is the same as or similar to the slot 74 of the upper portion 72.

[0043] Because the implant 70 may be sized to accommodate various procedures or sizes in a patient's bone / anatomy, the upper portion 72, middle portion 78, and lower portion 80 may have correspondingly different sizes. For example, in some embodiments, the middle portion 78 may have a length greater or less than that shown relative to the upper portion 72 and lower portion 80. Additionally, in some embodiments, the location, number, and spacing of the slots 74 and openings 76, 82 may be varied depending on the size of the implant 70 and its various portions.

[0044] 25-43, an orthopedic surgical instrument 100 system and its components are shown in accordance with various aspects of the present disclosure. In some aspects, the instrument 100 may be a component of a surgical kit or a larger surgical system provided to a physician. For example, the instrument 100 may be a component of a kit / system that includes, but is not limited to, one or more biological implants (e.g., implantable implants such as bone wedges), various fixation options and corresponding fasteners (e.g., plates, intramedullary (IM) nails, screws, etc.), and various other instruments common to orthopedic surgical procedures. In some aspects, a surgical kit may include one or more of the instruments 100, and various embodiments of the instruments 100 may, for example, have various sizes, shapes, and other geometries and may be configured to accommodate biological implants of various sizes, shapes, and other geometries.

[0045] The instrument 100 is shown to include a body 102 having a housing 104. As shown, the housing 104 is configured to have a substantially cubic or box-like shape, although in some aspects the housing 104 may have alternative shapes. The housing 104 includes a pair of side surfaces 106 separated by a front surface 108 and a back surface 110, the side surfaces 106 being configured as a first set of parallel planes, the front surface 106 and the back surface 110 being configured as a second set of parallel planes, the first and second sets of parallel planes being substantially perpendicular to one another. The body 102 is further shown to include a plate 122 located in a plane that is substantially perpendicular to and above the planes of the side surfaces 106, the front surface 108, and the back surface 110. The plate 122 may be integral with one or more of the aforementioned side surfaces of the housing 104, or may be releasably coupled to one or more components of the body 102 and / or the housing 104 via one or more fasteners 120, as shown in the exemplary embodiment herein. In some aspects, the fasteners 120 are received through one or more openings in the plate 122 and may be further configured to be received within one or more features of the body 102 and / or housing 104 (e.g., bores or other openings having threads complementary to the shape of the fasteners 120) that are configured complementary to the shape of the fasteners 120. As shown, the fasteners 122 include, for example, a common Phillips-style interface configured to facilitate manipulation (e.g., installation or removal) via similar Phillips-style instruments, although in various embodiments the fasteners 122 may include one or more alternative shapes (e.g., flat head, hexalobe, Torxx, etc.).

[0046] The instrument 100 is further shown to include a lid 112 configured to be hinged (in some embodiments, releasably) to the top of the housing 104 via a pair of hinges 114. However, in some aspects, the lid 112 may be hinged to the plate 122 and / or the housing 104. The illustrated lid 112 is configured to be manipulated from an open position to a closed position (and from the closed position to the open position) about the hinges 114, and the range of motion of the lid 112 may be pivotal movement about a longitudinal axis extending through each of the hinges 114. Additionally, the lid 112 is shown to be coupled to a protrusion extending from the platform 122 (but may extend from the housing 104) via one or more fasteners 126, which may be the same as or similar to the fasteners 120 (or may include one or more of those of the alternative embodiments described with respect to the fasteners 120), as shown. The range of motion of the lid 112 may be constrained by the protrusion when in engagement with the protrusion, i.e., the range of motion of the lid 112 may be, for example, at least 90 degrees (but may be more or less), between the top surface of the plate 122 (at least a portion of the bottom surface of the lid is in contact with at least a portion of the top surface of the plate, the "closed" position) and the surface of the protrusion located closest to the front surface 108 of the housing 104 (at least a portion of the top surface of the lid is in contact with at least a portion of the surface of the protrusion, the "open" position). In some embodiments, the lid 112 may include a range of motion of about 180 degrees, or more. The rear surface 110 of the housing 104 is shown to include at least one recess 118 configured to receive at least a portion of the lid 112 when in the "open" position, as defined above. Thus, when in the “open” position, the recess 118 may receive a portion of the lid 112 coupled to the hinge 114 and / or a portion adjacent to the portion of the lid 112 coupled to the hinge 114 to prevent the range of motion of the lid 112 from being limited in the maximum “open” position by a mechanical stop including at least a portion of the lid 112 contacting at least a portion of the rear surface 110 of the housing 104.

[0047] A portion of the lid disposed between the hinge joint between the lid 112 and the hinge 114 cooperates with a portion of the top surface of the plate 122 adjacent the rear surface 110 of the housing 104 to define an opening 116 (see FIG. 34). Additionally, the opening 116 may be disposed substantially below the fastener 120. As shown in FIGS. 25-47, and more specifically in FIG. 34, the opening 116 is an elongated opening having a substantially rectangular shape, although the opening 116 may have a variety of alternative geometries, shapes, sizes, and locations relative to the instrument 100 and its components in alternative embodiments. The opening 116 (e.g., a slot, etc.) is shown configured to receive at least a portion of an instrument therein, such as, for example, the distal end of a cutting instrument (not shown) common to surgical procedures including, but not limited to, a sagittal saw or a reciprocating saw (which may or may not be included in a system / kit with the instrument 100 and / or biological implant). In some embodiments, the opening 116 may be obstructed by at least a portion of the top surface of the lid 112 when the lid 112 is in the “open” position, but is configured to receive at least a portion of a cutting instrument when in the “closed” position.

[0048] The instrument 100 is further shown to include a platform 124 disposed within and releasably coupled to at least a portion of the housing 104. Moreover, the platform 124 is disposed substantially below the plate 122. As shown at least in FIG. 38 , the platform is hinged (in some embodiments, releasably) to the housing 104 (which may include at least one of the plate 122 and / or the back surface 110 of the housing 104) via a pair of hinges 140. The hinge connection between the platform 124 and the hinges 140 may be configured to permit movement of the platform 124 in a pivotal manner (in a manner similar to that described above with reference to the lid 112) about a longitudinal axis extending through each of the hinges 140.

[0049] The sides 106 of the housing 104 are shown to include a pair of slots 130, with a single slot 130 disposed on each of the sides 106 and disposed substantially opposite one another. As shown, the slots 130 have a substantially upright curved shape, but in some embodiments may have another shape. Additionally, the instrument 100 is shown to include a pair of actuators 128 releasably coupled to the platform 124 at its lateral portions and extending laterally from the platform 124 through the slots 130 to a point disposed outside the housing 104. Each of the actuators 128 is shown to include a knob portion disposed laterally relative to the side 106 and a shaft portion extending toward the platform 124, the shaft portion being received within an opening in the platform 124. The platform 124 is shown to include a recess in its central region configured to at least partially retain at least a portion of the implant 144 (not shown, but disposed beneath a biological implant 144, referred to hereinafter as "implant 144," which may include a bone wedge or other biological / graft implant having various sizes, shapes, and geometries). A shaft portion of each actuator 128 may extend through an opening in the platform 124 (each actuator 128 on either side of the platform 124) such that the actuator 128 protrudes into the volume of the recess in the platform 124. The actuator 128 may include a narrowed tip (e.g., pointed to facilitate retention) at an end opposite the knob, the tip configured to contact a portion of the implant 144 when disposed within the recess. Thus, the user may operate the actuators 128 synchronously or independently such that the tips of the actuators contact the implant 144 and retain the implant 144 within the recess in the platform 124 (which may include retention based on friction and / or retention as a result of a small recess formed in the implant 144 from the tip of the actuator 128).When the tip of the actuator 128 is in a desired position relative to the platform 124 and implant 144, the user may manipulate (e.g., rotate, actuate, etc.) a knob portion of the actuator 128 to "lock" the actuator in the desired position to facilitate continued retention of the implant 144. When the actuator 128 contacts and thus retains the implant 144 within the recess of the platform 124 (or when the shaft portion of the actuator is disposed within the opening of the platform 124), any range of motion of the platform 124 may be constrained by a mechanical stop that exists between the actuator 128 and the upper / lower limits of the slot 130. It should be noted that the contact point between the tip of the actuator 128 and the implant 144 may be located below the upper surface of the platform 124 and / or plate 122 such that a cutting instrument inserted into the opening 116 will not contact the actuator 128 (due to the physical barrier of the plate 122 and / or platform 124).

[0050] The front surface 108 of the housing 104 is configured to include a slot 134 having a substantially upright shape (but may have alternative shapes in some embodiments) as shown in FIGS. 25-26, 32-33, 38-39, and 41. Additionally, the instrument 100 is shown to include an adjustment mechanism 132 including a threaded member 136 and a locking member 138, where the locking member 138 is configured to extend (through an interlocking connection or integral configuration) from a lateral portion of the front portion of the platform 124 (e.g., the opposite side of the platform relative to the hinge 140). The threaded member 136 is shown to extend from the platform 124 toward and through the slot 134 in the front surface 108 such that the end of the threaded member 136 opposite the platform 124 is located outside of the housing 104. Additionally, as shown and described herein, the end of threaded member 136 opposite platform 124 includes a knob portion configured to facilitate manipulation (via coupling or integral connection) of adjustment mechanism 132, which includes threaded member 136, as well as platform 124 regarding the pivotal range of motion described above with reference to hinge 140. In some embodiments, the knob portion of threaded member 136 may be releasably coupleable with threaded member 136.

[0051] The locking member 138 is shown to include the same and / or similar shape as a washer or nut, with the threaded member 136 received through a central opening in the locking member 138, which is disposed exterior to the housing 104 but adjacent its front surface 108. In some embodiments, the locking member 138 is configured to receive an end of the threaded member 136 opposite the platform 124 after the knob portion is separated and the knob portion is recoupled after the threaded member 136 is received within the opening in the locking member 138. The knob portion may be configured to have a lateral shape that is larger than the shape of the opening in the locking member 138 to facilitate retention of the locking member 138 between the front surface 108 and the knob portion.

[0052] The anterior surface is shown to include a set of markings 142 disposed adjacent the slot 134. As shown, the markings 142 include numerical markings that increase at regular intervals as one moves downward from the top to the bottom of the slot 134. In some embodiments, the markings may include indications of distance measurements (e.g., mm, inches, etc.) or angle measurements (e.g., degrees, etc.) and may increase / decrease when moving from top to bottom or bottom to top along the slot 134. Thus, the adjustment mechanism 132 is configured such that the threaded member 136 may be manipulated within a range of motion defined by the slot 134 when the locking member 138 is not in contact with the anterior surface 110 (and thus is in an "unlocked" position). Such manipulation of the threaded member 136 is configured to drive the aforementioned pivoting of the platform 124, such that the upward or downward movement of the threaded member 136 within the slot 134 adjusts the amount or thickness of the implant 144 that extends above the upper surface of the plate 122. Once threaded member 136 is positioned adjacent to the desired markings 142, locking member 138 may be actuated along threaded member 136 (via threads on the inner surface of the opening) until a surface of locking member 138 contacts outer surface 110, thereby holding threaded member 136 in the desired position adjacent to the desired markings 142. In some embodiments, adjustment mechanism 132 may be configured as an infinite adjustment mechanism (e.g., threaded member 136 may be held in a position between two of the markings 142 by locking member 138), or as a finite adjustment mechanism (e.g., adjustment mechanism and / or housing 104 include slots or other features that allow threaded member 136 to be locked only by locking member 138 adjacent each of the markings 142).

[0053] The instrument 100 and its components, as well as other components of the surgical kit / system, including but not limited to those shown and described herein, may be performed by a clinician either pre-operatively or intra-operatively according to the methods subsequently described herein. However, it should be noted that the methods are exemplary and in no way limiting. Furthermore, one or more steps of the methods may be omitted, repeated, performed in a different order than described, or substituted with various other steps. Furthermore, the components performed in performing the methods may differ from those shown and described herein, including, for example, the implant 144 and cutting instruments / tools common to surgical procedures. It should be understood that the equipment and components described with reference to the methods below are exemplary and may differ in some embodiments.

[0054] In some embodiments, the clinician may be provided with the instrument 100, which may be a component of a kit or system, or may obtain the instrument 100 prior to the surgical procedure. Any kit / system may include at least one implant 144 (e.g., a biological implant) and at least one cutting instrument in addition to the device 100. Pre-operatively or intra-operatively, the clinician may determine a desired size of the at least one implant 144. If performed pre-operatively, various medical images may be incorporated into this determination. Alternatively, if performed intra-operatively, various implant sizing trials (which may be included in the system / kit with the instrument 100 and at least one implant 144) may be placed and removed within the patient's cavity until a desired size of the at least one implant 144 is determined based on the fit of the sizing trials. Any desired size of the at least one implant 144 may correspond to one or more of height measurements, angle measurements, or other measurements that may correspond to the markings 142 on the instrument 100. The clinician may then place at least one implant, one implant 144 at a time, into the recess of the platform 124 and adjust the actuator 128 so that the implant 144 is held in the desired position within the recess of the platform 124. The clinician may then manipulate the locking member 138 to an "unlocked" position and manipulate the threaded member 136 to be positioned adjacent to one of the markings 142 corresponding to the desired size, angle, and / or other implant parameters. The clinician may then manipulate the locking member 138 to a "locked" position to hold the threaded member 136 (and thus the implant 144 and platform 124) in the desired position. The clinician may then close the lid 112 of the instrument 100 to expose the opening 116. The clinician may then insert a cutting instrument into the slot 116 and manipulate the instrument along the length of the slot 116, cutting the implant 144 along a plane parallel to the top surface of the plate and placing it directly above it. When the lid 112 is in the closed position, debris from the incision is retained within the device 100 .The clinician may then open the lid 112 and, once the clinician has determined that cutting of the implant 144 is complete, adjust the actuator 128 so that the implant 144 can be removed from the instrument 100. The clinician may then check the size (and / or shape, and / or configuration, etc.) of the implant 144 to ensure that it corresponds to the desired size / shape / angle, etc., before implanting the implant 144 in the patient. In some embodiments, the aforementioned method may be repeated if the implant 144 is not of the desired dimensional or angular parameters, or if the clinician's desired parameters have changed, or if a second implant 144 is required for the procedure.

[0055] 44-47, an exemplary embodiment illustrates the instrument 100 with alternative components selected from those shown and described with reference to FIGS. 25-43. The instrument 100 illustrated in FIGS. 44-47 is illustrated to include a lid 212 that is different from the lid 112 illustrated in FIGS. 25-43, where the lid 212 is compatible with the instrument 100 and its various components and associated methods. The lid 212 is illustrated to include an open center portion covered by a window 214 that is variously positioned relative to the lid 212 and releasably coupled to the lid 212 by a fastener 216 that extends through the window 214 and into the lid 212. As illustrated, the window 214 is a solid, transparent piece that is configured to cover the implant 144 when placed on the platform 124. The lid 212 is further illustrated to include a button 218 that extends from a bottom surface of the window 214 to a top surface thereof. The button 218 is further shown to include an engaging element 220 coupled thereto and disposed on the opposite side of the window 214 from the button 218, and a resilient member disposed therebetween. As shown, the resilient member is a spring, although in some embodiments the resilient member may include other common resilient elements. Actuation (e.g., pushing, depressing, etc.) of the button 218 above the top surface of the window 214 urges the engaging element downward toward the implant 144 to contact the implant 144 and hold the implant 144 in a desired position while a cutting instrument is inserted through the opening 116 and manipulated to reshape the implant 144.

[0056] The device 100 shown in FIGS. 44-47 further includes alternative components configured to engage the housing 104 and / or other components of the device 100, such as the lid 212. The housing 104 is shown to include a pair of actuators 222 disposed on an upper portion of the side 106 of the housing 104, the actuators disposed adjacent the front surface 108 of the housing 104. As shown in FIG. 46, the actuators 222 extend into the housing 104 and extend upwardly through an opening in the plate 122 such that a portion of the actuator 222 is located above the plate 122 and adjacent portions of the lid 212. The actuators 222 are shown to include a substantially curved or hooked shape at an upper portion thereof configured to engage a portion of the lid 212 to hold the lid 212 in a closed position. Additionally, actuation (e.g., pushing, squeezing, etc.) of the actuators 222 causes the curved / hooked upper portion to disengage from the lid 212, thus allowing the lid 212 to be opened by a user.

[0057] Additionally, the threaded member 136 is shown to include an indicator 240 disposed concentrically relative to the threaded member 136. As shown, the indicator 240 is substantially washer-shaped, having an open circular central portion into which a length of the threaded member 136 may be received and positioned, as shown in FIGS. 44-47. Thus, upon actuation of the threaded member 136, the indicator 240 is positioned adjacent to one or more markings 142 on the housing 104, thus indicating a height or angle measurement corresponding to the current position of the threaded member 136. As shown, the indicator 240 may be rotatable relative to the threaded member 136 such that a pointed portion of the indicator 240 may be manipulated from the left side of the slot 134 to the right side, or vice versa.

[0058] In some embodiments, one or more of implants 10, 50, and / or 70 may be provided in a surgical system along with instrument 100 and implant 144. For example, after a clinician performs the aforementioned process of reshaping implant 144 using instrument 100, implant 144 may be placed in a volume within a bone or between bone fragments created by an osteotomy or other surgical procedure. One of implants 10, 50, 70 may then be coupled to the bone or bone fragments using orthopedic fasteners (e.g., screws) such that a portion of implant 10, 50, 70 (e.g., central portion 18, 58, 78) is positioned adjacent to implant 144, thus retaining implant 10, 50, 70 within the aforementioned volume.

[0059] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural unless the context clearly indicates otherwise. It will be further understood that the terms "comprise" (and any form of comprising, 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 apparatus that "comprises," "has," "includes," or "contains" one or more steps or elements includes those one or more steps or elements, but is not limited to having only those one or more steps or elements. Similarly, a method step or apparatus element that "comprises," "has," "includes," or "contains" one or more features includes those one or more features, but is not limited to having 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 be configured in a way not described.

[0060] The present invention has been described with reference to preferred embodiments. It will be understood that the architectural and operational embodiments described herein are illustrative of multiple possible arrangements for providing the same general features, characteristics, and general system operations. Modifications and alterations will occur to others upon reading and understanding the foregoing detailed description. It is intended that the present invention be construed as including all such modifications and alterations.

Claims

1. The top and a central portion having a larger lateral dimension than said upper portion; a lower portion having a greater lateral dimension than said central portion.

2. The orthopedic implant of claim 1 , wherein the top portion extends from a top surface to a bottom surface and has at least one opening configured to receive a fastener.

3. The orthopedic implant of claim 2 , wherein the central portion is a solid structure.

4. The orthopedic implant of claim 3 , wherein the lower portion extends from a top surface to a bottom surface and has at least one opening configured to receive a fastener.

5. The orthopedic implant of claim 1 , wherein the top portion is non-linear and / or curved in at least one plane.

6. The orthopedic implant of claim 1 , wherein the central portion is non-linear and / or curved in at least one plane.

7. The orthopedic implant of claim 1 , wherein the lower portion is non-linear and / or curved in at least one plane.

8. The orthopedic implant of claim 1 , wherein the top portion has a slot extending from a top surface to a bottom surface and configured to receive a fastener.

9. a body having a housing; The body includes: a platform configured to receive the implant; at least one retention mechanism configured to retain the implant at least partially on the platform; an adjustment mechanism configured to adjust a height of at least a portion of the platform relative to an upper surface of the housing; and a lid hinged to the housing, the top surface of the housing and the lid defining a slot configured to receive at least a portion of a cutting instrument.

10. The orthopaedic surgical instrument of claim 9 , wherein the implant is a biologic graft implant.

11. The orthopaedic surgical instrument of claim 10 , wherein the implant has a substantially wedge shape.

12. The orthopaedic surgical instrument of claim 9 , wherein the at least one retention feature comprises a pair of retention features configured to contact the implant on opposing sides of the implant.

13. the lid having a window coupled to the lid; The orthopaedic surgical instrument of claim 9 , wherein the window is transparent.

14. further comprising at least one actuator disposed at least partially within the housing; At least a first portion of the at least one actuator extends laterally through an opening in a sidewall of the housing; The orthopaedic surgical instrument of claim 13 , wherein at least a second portion of the at least one actuator extends longitudinally through an opening in the plate.

15. The orthopaedic surgical instrument of claim 14 , wherein the at least one actuator is a pair of actuators located on opposing sides of the housing.

16. The orthopaedic surgical instrument of claim 15 , wherein each actuator is configured to releasably engage the lid to retain the lid in a closed position.

17. The orthopaedic surgical instrument of claim 16 , wherein actuation of the actuator disengages the actuator from the lid.

18. The orthopaedic surgical instrument of claim 17 , wherein the lid has a button releasably coupled with an engagement element.

19. The orthopaedic surgical instrument of claim 18 , wherein actuation of the button biases the engaging element into contact with the implant to hold the implant in a desired position.

20. Equipped with equipment, The device includes a body having a housing; The body includes: a platform configured to receive a biological implant; at least one retention mechanism configured to retain the biological implant at least partially on the platform; an adjustment mechanism configured to adjust a height of at least a portion of the platform relative to an upper surface of the housing; a lid hinged to the housing, the top surface of the housing and the lid defining a slot configured to receive at least a portion of a cutting instrument; The device comprises: a first implant configured to be reformed within the housing of the device; and a second implant.

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