Tibial osteotomy system, instrument, and related method

Abstract

The present disclosure relates to a tibial osteotomy system. The system includes a base plate configured to interface with a tibia, the base plate including a body having a first pair of openings configured to receive a first pair of stabilizing elements, a first end having a first opening, and a second end having a second opening. The system also includes a measurement arm fixedly coupled to the first end of the base plate through the first opening and having a third opening aligned with the first opening to receive a first screw, and a cutting guide pivotally coupled to the second end of the base plate through the second opening and having a fourth opening aligned with the second opening to receive a second screw therein. The cutting guide also includes a slot, a measurement flag releasably coupled within the slot, and a protrusion configured to receive a second stabilizing element.

Description

Cross - reference to related applications

[0001] This application claims priority based on U.S. Provisional Patent Application No. 63 / 011,737, filed on April 17, 2020, entitled "Tibial Osteotomy System, Instruments, and Related Methods", the disclosure of which is hereby incorporated by reference in its entirety.

Technical Field

[0002] The present disclosure relates to bone and soft - tissue systems, instruments, and related methods. The present disclosure relates to podiatric and orthopedic bone and soft - tissue systems, instruments, and related surgical procedures for repairing and / or correcting soft tissue and / or bone. More specifically, the present disclosure relates to, but is not limited to, instruments, systems, assemblies, and methods for repairing and / or correcting deformities of soft tissue and / or bone, such as bone in the distal tibia.

Background Art

[0003] Deformities at or near the ankle joint can be caused by various conditions and events, such as improperly healed fractures or osteoarthritis. Therefore, in order to realign the anatomical and mechanical axes of the ankle joint, a device such as a bone wedge may be implanted into the tibia. Similarly, in some procedures, the implant may also be removed from the tibia. Deformities in one plane (deformities in the sagittal plane) and two planes (deformities in the sagittal plane and the frontal plane) can both be corrected using tibial osteotomy.

[0004] Typically, a tibial osteotomy (more specifically, a distal tibial osteotomy) is not by guided and measured cutting and planning, but rather is performed by manually making a series of cuts using visual planning, which is generally done preoperatively using X-rays and also intraoperatively using stabilization elements and fluoroscopy techniques. Thus, tibial osteotomy has a high incidence of errors related to the procedure and especially the cutting, as such procedures require a high level of surgeon experience and expertise, as well as correct performance. In particular, in two-plane correction, tibial osteotomy is difficult for the surgeon to perform and thus is often restricted in access for the patients who need it.

[0005] Accordingly, there is a desire for a surgical device that provides guidance for both one-plane and two-plane tibial osteotomies to increase surgeon accuracy and improve the reproducibility of the procedure.

[0006] Thus, there is a need for instruments, implants, systems, assemblies, and methods for tibial osteotomy and other parts of the body of a mammal (e.g., a human) that facilitate accurate surgical procedures that are measurable and have high reproducibility.

[0007] The present disclosure is directed to overcoming these and other deficiencies in the art. SUMMARY OF THE INVENTION

[0008] A first aspect relates to a tibial osteotomy system. The system includes a baseplate having a first end and a second end, a measurement arm coupled to and extending from the first end of the baseplate, and a cut guide coupled to and extending from the second end of the baseplate, the cut guide being translatable relative to the baseplate and the measurement arm.

[0009] In one embodiment, the measurement arm includes a curved shape. In one embodiment, the measurement arm includes a head portion having an opening configured to fixedly couple to a first end of the base plate, and an arm portion extending from the head portion and having a guide portion.

[0010] In one embodiment, the cut guide is pivotally coupled to a second end of the base plate. In one embodiment, the cut guide includes a head portion having an opening configured to pivotally couple to a second end of the base plate, and a body extending from the head portion and having a first arm and a second arm, the first arm and the second arm defining a slot. In one embodiment, the cut guide includes a measurement flag releasably couplable to the slot, and pivoting of the cut guide relative to the measurement arm positions the measurement flag adjacent to the guide portion of the measurement arm. In one embodiment, the slot is configured to receive a blade of a cutting tool. In one embodiment, the cut guide includes a protrusion extending from the body of the cut guide and including at least one opening, the opening of the protrusion being configured to receive a stabilization element.

[0011] In one embodiment, the base plate includes a body portion disposed between a first end and a second end, and the bottom surface of the base plate is configured to interface with the anterior surface of the tibia. In one embodiment, the body portion of the base plate includes a pair of openings configured to receive a pair of stabilization elements, the stabilization elements coupling the base plate to the tibia.

[0012] In one embodiment, the measurement arm is coupled to the first end of the base plate by a first screw, and the cut guide is coupled to the second end of the base plate by a second screw. In one embodiment, the first and second screws are the same. In one embodiment, the first and second screws include a bore extending through the screw along a central axis, the bore being configured to receive a stabilization element.

[0013] The second aspect relates to a tibial osteotomy system. The system includes a baseplate configured to interface with the tibia. The baseplate includes a body having a first pair of openings configured to receive a first pair of stabilization elements, a first end having a first opening, and a second end having a second opening, the first end being disposed opposite the body from the second end. The system also includes a measurement arm fixedly coupled to the first end of the baseplate through the first opening and having a third opening, the third opening and the first opening being aligned to receive a first screw therein. The system also includes a cut guide pivotally coupled to the second end of the baseplate through the second opening and a fourth opening, the fourth opening and the second opening being aligned to receive a second screw therein, the cut guide including a slot, a measurement flag releasably coupled within the slot, and a protrusion including a fifth opening configured to receive a second pair of stabilization elements therethrough.

[0014] In one embodiment, the first screw and the second screw each have a bore configured to be concentric with respect to a central axis, the bore being configured to receive a second pair of stabilization elements. In one embodiment, the second pair of stabilization elements are K-wires. In one embodiment, the first pair of stabilization elements are olive wires. In one embodiment, the measurement arm includes a guide portion having incremental measurement markings. In one embodiment, the measurement flag is coupled within the slot such that pivoting the cut guide positions the measurement flag adjacent to the incremental measurement markings.

[0015] The third aspect relates to a method of preparing the tibia for a tibial osteotomy. The method includes providing a tibial osteotomy system including a baseplate, a measurement arm fixedly coupled to the baseplate, and a cutting guide pivotally coupled to the baseplate and releasably coupled within a slot, the cutting guide including a measurement flag. The method further includes coupling the baseplate to the tibia, pivoting the cutting guide so that the measurement flag is disposed adjacent to the measurement arm, removing the measurement flag from the slot, and positioning a cutting tool such that a cutting edge of the cutting tool is disposed within the slot of the cutting guide and adjacent to the tibia.

[0016] These and other objects, features, and advantages of the aspects disclosed herein will become apparent from the following detailed description of the various aspects of the invention in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0017] The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate embodiments of the invention and, together with the detailed description, serve to explain the principles of the invention. It is emphasized that various features may or may not be drawn to scale in accordance with standard industry practice. In fact, the dimensions of the various features may be arbitrarily increased or decreased for clarity of discussion. The drawings are for the purpose of illustrating embodiments of the invention disclosed herein and are not to be construed as limiting the invention.

[0018]

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[0019] In this detailed description and the following claims, the terms proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by their standard usage to indicate a particular part or portion of a bone or implant according to the relative placement or directionality terms of the natural bone. For example, "proximal" means the part of the device or implant closest to the torso, and "distal" indicates the part of the device or implant farthest from the torso. As directional terms, "anterior" is the direction towards the front side of the body, "posterior" is the direction towards the back side of the body, "medial" is the direction towards the midline of the body, "lateral" is the direction towards the side of the body or away from the midline of the body, "superior" is above another object or structure, and "inferior" means the direction towards the bottom. Further specifically with respect to the foot, "dorsal" refers to the top of the foot and "plantar" refers to the bottom of the foot.

[0020] Similarly, position or orientation may be used herein with reference to an anatomical structure or surface. For example, since implants, devices, instruments, and methods are described herein with reference to use with the bones of the foot, terms such as foot, ankle, and lower leg bones may be used to describe the surface, position, orientation, or alignment of implants, devices, instruments, and methods. Further, the implants, devices, instruments, and methods, and aspects, components, features, etc. disclosed herein are described with respect to one side of the body for purposes of brevity. However, since the human body is relatively symmetric or mirror-image about a line of symmetry (midline), the implants, devices, instruments, and methods, and aspects, components, features, etc. described and / or illustrated herein may be modified, varied, altered, reconfigured, or otherwise changed for use or relevance on the opposite side of the body for the same or similar purposes without departing from the spirit and scope of the invention. For example, implants, devices, instruments, and methods, and aspects, components, features, etc. described herein with respect to the right foot may be mirrored so that they function similarly on the left foot. Further, while the implants, devices, instruments, and methods, and aspects, components, features, etc. disclosed herein are described with respect to the foot for purposes of brevity, it should be understood that the implants, devices, instruments, and methods may be used with other bones of the body having a similar structure.

[0021] Generally, disclosed herein are instruments, components, systems, assemblies, and methods for correcting and / or repairing soft tissue and / or bone. The instruments, components, systems, assemblies, and methods disclosed herein may be used to perform a tibial osteotomy. In some applications, the instruments, components, systems, assemblies, and methods disclosed herein may be implemented in performing a tibial osteotomy on the distal portion of the tibia (referred to herein as a distal tibial osteotomy). The instruments, components, systems, assemblies, and methods may be exemplified and described in the context of a distal tibial osteotomy in this disclosure, but the instruments, components, systems, assemblies, and methods may be similarly employed or adapted without undue experimentation for performing other procedures, such as a tibial osteotomy on an alternative portion of the tibia. Further, the instruments, components, systems, assemblies, and methods may be equally employed for correcting and / or repairing any other tissue and / or bone segment or portion of other parts of a mammalian (e.g., human) body, such as the musculoskeletal components of the foot and ankle joint, but are not limited thereto.

[0022] Referring to the drawings, throughout several figures, like reference numerals are used to indicate like or similar components, and in particular, referring to FIGS. 1-18, an exemplary embodiment of a tibial osteotomy system 100 for correcting and / or repairing a portion of a tibia (or other bone and / or soft tissue) in a tibial osteotomy procedure is shown. In FIGS. 19-27, alternative exemplary embodiments of a tibial osteotomy system for correcting and / or repairing a portion of a tibia (or other bone and / or soft tissue) in a tibial osteotomy procedure according to this disclosure are illustrated.

[0023] Referring to FIGS. 1-18, a tibial osteotomy system, guide, device, or instrument is shown as osteotomy system 100. In some embodiments, tibial osteotomy system 100 may be implemented to facilitate osteotomy or other procedures on the tibia and / or surrounding bone and / or soft tissue, such as, for example, musculoskeletal components of the foot and / or ankle. As shown in FIGS. 1, 3, and 13-18, osteotomy system 100 is disposed on the distal portion of tibia 102 (where tibia 102 is adjacent to fibula 104). Osteotomy system 100 is configured to facilitate tibial osteotomy, which for simplicity is referred to herein as distal tibial osteotomy. However, in some applications, osteotomy system 100 may be implemented in facilitating tibial osteotomy on portions of tibia 102 other than the distal portion. In distal tibial osteotomy, osteotomy guide 100 is configured to couple to patient's tibia 102 to secure osteotomy system 100 and prevent displacement or other movement of osteotomy system 100 relative to the distal portion of tibia 102. In distal tibial osteotomy, osteotomy system 100 facilitates distal tibial osteotomy by allowing one or more surgeons to perform the necessary cuts on tibia 102 and / or otherwise manipulate tibia 102, fibula 104, or other portions of the foot and / or ankle, and by facilitating alignment of tibia 102.

[0024] At least as shown in FIGS. 1-3, the bone resection system 100 is shown to include a base plate 112, a cut guide 122, and a measurement arm 132. As shown in FIGS. 1 and 3, the base plate 112 is configured to conform to the curve of the distal portion of the tibia 102. The base plate 112 is shown to couple to the cut guide 122 and the measurement arm 132 via a pair of coupling devices shown as a first screw 124 and a second screw 126. In some embodiments, the first screw 124 and the second screw 126 may be the same as the screw 400 as shown in FIGS. 7-9. The screw 400, which may be the same as and / or similar to the first and second screws 124, 126, includes a head 412 having an interface 412. The screw 400 also includes a bore 424 that extends along a central axis through the screw 400 (e.g., thus cannulating the screw 400). Further, the screw 400 includes a stem 420, and the stem includes a thread 422 along at least a portion of the stem 420.

[0025] As shown in FIGS. 1-3, the first screw 124 and the second screw 126 are shown to include an interface 127 that may be the same as and / or similar to the interface 412 as shown in FIGS. 8-9. The interfaces 127 of the first screw 124 and the second screw 126 may be configured to accommodate the same tool, or may be configured to accommodate a plurality of tools. Further, the interface 127 may be the same as and / or similar to the interface 412 of the screw 400. In some embodiments, the interface 127 of the first screw 124 may be the same as the second screw 126, for example, a Torx screw drive (e.g., a hexagonal star pattern as shown in FIG. 3) or a hex screw drive (as shown in FIG. 1). Both the first screw 124 and the second screw 126 define a bore 129 (e.g., cannulated) that is disposed about the central axes of the first and second screws 124, 126. The bore 129 extends along the entire length of the central axes of the first and second screws 124, 126 and establishes fluid communication through the first and second screws 124, 126 along the central axes. In some embodiments, the bore 129 may be configured to be concentric with the central axes of the first and second screws 124, 126. Further, the bores 129 of the first and second screws 124, 126 are configured to receive a stabilization member, such as a K-wire. In some embodiments, such a stabilization member may be disposed on the tibia 102 before the bore 129 receives the stabilization member (e.g., while coupling the base plate 112, cut guide 122, and measurement arm 132, the screws 124, 126 may be disposed over the stabilization member. Alternatively, the screws 124, 126 may be disposed on top of the front surface of the tibia 102 such that the stabilization member can be inserted through the screws 124, 126 and moved into the tibia 102 from front to back.

[0026] The first screw 124 is shown to facilitate the coupling of the base plate 112 and the measurement arm 132, and the bottom surface of the measurement arm 132 is configured to interface with the upper surface of the base plate 112. The second screw 126 is shown to facilitate the coupling of the base plate 112 and the cut guide 122, and the bottom surface of the cut guide 122 interfaces with the upper surface of the base plate 112. In some embodiments, the first screw 124 and the second screw 126 may have the same and / or similar sizes and dimensions. For example, the first screw 124 may be adapted for coupling the base plate 112 and the cut guide 122, while the second screw 126 may be adapted for coupling the base plate 112 and the measurement guide 132. Both the first and second screws 124, 126 are configured to facilitate coupling such that one or both of the coupling members can be translated relative to the other coupling member.

[0027] In some embodiments, the osteotomy system 100 may include one or more base plates 112 of various sizes and / or curvatures to accommodate various dimensions and shapes of the tibia 102. Continuing with the previous example, one or more base plates 112 of the osteotomy system 100 may be compatible with and thus configured to couple / interface with the cut guide 122 and the measurement arm 132 via other components of the osteotomy system 100, such as the first and second screws 124, 126. In some embodiments, the osteotomy system 100 may include base plates 112 configured to accommodate tibia dimensions of patients of different sizes and ages. For example, the osteotomy system 100 may include three base plates 112 configured to accommodate small (e.g., pediatric), medium (e.g., average adult), and large (e.g., large adult) tibia dimensions.

[0028] As shown in FIGS. 4-5, base plate 112 includes a first opening 222 and a second opening 232, the first opening 222 including a first threading 224 therein, and the second opening 232 including a second threading 234 therein. The first opening 222 is disposed at a first end 220 of the base plate 112, while the second opening 232 is disposed at a second end 230 of the base plate 112 on the opposite side of the first end (and the first opening 222). In some embodiments, the first opening 222 and the second opening 232 may be of the same and / or similar size (e.g., radius, depth, etc.) to provide compatibility with a common coupling device (e.g., the first and / or second screws 124, 126).

[0029] Base plate 112 is shown to include a body 210 disposed between a first opening 222 and a second opening 232, as shown in FIGS. 1-5. The body 210 is shown to have a substantially curved shape to facilitate interfacing with the physiological shape of the anterior portion of the tibia 102. In some embodiments, the osteotomy system 100 may include one or more embodiments of the base plate 112, and different embodiments of the base plate 112 may include slight variations to the body 210 to best interface with the patient's tibia 102. For example, an alternative embodiment of the base plate 112 may include an elongated body 210 and / or a slightly different curvature of the body 210 (and correspondingly, the relative positions of the first opening 222 and the second opening 232 will vary slightly). In some embodiments, the body 210, and thus the base plate 112, may further include a curvature configured to accommodate the anterior surface of the tibia 102 such that the bottom surface of the base plate 112 is also curved (e.g., such that the base plate 112 begins to wrap around the curvature of the anterior portion of the tibia 102 when interfacing). Additionally, the osteotomy system 100 may include one or more base plates 112 configured to accommodate different sizes, shapes, and / or curvatures of the tibia 102.

[0030] The body 210 of the pair of openings 116 disposed between the first opening 222 and the second opening 232 is shown in FIGS. 1-5. In some embodiments, the pair of openings 11 may be of equal size so as to accommodate common hardware (e.g., the same hardware may be used in both of the pair of openings 116). For example, as shown in FIGS. 1-3 and FIGS. 13-18, each opening of the pair of openings 116 is configured to accommodate an olive wire 114. The olive wire 114 is received into and through the pair of openings 116 when the base plate 112 interferes with the front surface of the tibia 102. Further, a portion of the olive wire 114 is inserted into the front portion of the distal tibia 102 until the stopper 115 of each of the olive wires 114 contacts the upper surface of the base plate 112 adjacent to the pair of openings 116. The stopper 115 is disposed along each of the olive wires 114 and includes a lateral dimension that is substantially larger than that of each of the pair of openings 116 so as to define the depth to which the olive wire 114 can be inserted into the tibia 102 (from the front). In some embodiments, the pair of openings 116 may be sized to receive one or more calibers of the olive wire 114. For example, a base plate configured to be used with a smaller tibia 102 (e.g., a child) may include smaller caliber openings 116 configured to receive a smaller caliber olive wire 115. Similarly, the pair of openings 116 may be sized to receive a larger caliber of the olive wire 115 for use with a larger tibia 102 (e.g., a larger adult).

[0031] When coupled to the cut guide 122 as shown in FIGS. 1-3 and 13-18, the first opening 222 is configured to receive the first screw 124, where the first screw 124 is also received by the opening 125 of the cut guide 122. With the cut guide 122 disposed on the base plate 112 such that the opening 125 of the cut guide 122 is aligned with the first opening 222 of the base plate 112, the second screw 126 is received by both the opening 125 of the cut guide 122 and the first opening 222 of the base plate 112. Accordingly, the second screw 126 includes a thread 422 as shown in FIGS. 8-9, configured to interface with the threading 224 of the first opening 222. In some embodiments, the opening 125 of the cut guide 122 also includes a thread configured to interface with the threading 422 of the second screw 126. When coupled to the base plate 112 via the second screw 126 such that the second screw 126 is received by the first opening 222 of the base plate 112 and the opening 125 of the cut guide 122, the cut guide 112 is configured to be translatable relative to the base plate 112 in the sagittal plane relative to the patient. For example, the cut guide 122 may be translatable about a point of attachment (e.g., the second screw 126 received by the first opening 222 of the base plate 112 and the opening 125 of the cut guide 112) such that the cut guide 122 extends over the tibia 102 from the point of attachment.

[0032] The cutting guide 122 is shown in FIGS. 1-3 and 13-18 in a state of being coupled to the base plate 112, and is further shown independently in FIG. 6. The cutting guide 122 is shown to include a head portion 310 and a body portion 320 extending from the head portion 310. The body portion 320 includes an upper arm 322 and a lower arm 324, and the upper and lower arms 322, 324 define a slot 130 extending toward the head portion 310 along the length of the body portion. The body portion 320 includes a protrusion 121 extending therefrom, and the protrusion 121 includes a first opening 123. In some embodiments, the protrusion 121 is configured to extend at an angle substantially orthogonal to the body portion 320. The first opening 123 is configured at the distal end of the protrusion 121 (e.g., opposite the end where the protrusion 121 contacts the body portion 320). As shown in FIGS. 1 and 13-18, it is configured to receive a stabilizing element shown as the K-wire 118. The first opening 123 may have a substantially circular shape, or may have other alternative shapes to accommodate other K-wires / stabilizing elements. Further, the dimensions of the first opening 123 may be configured to accommodate K-wires 118 of various sizes / bores. In some embodiments, the cutting guide 122 may include a second opening 326 along a portion of the protrusion 121, and the second opening 326 is configured to accommodate one or more tools and / or stabilizing members.

[0033] The bone resection system 100 can also include one or more cut guides 122 configured to accommodate a two-plane correction performed by one or more surgeons during a distal tibia bone resection. This two-plane correction provided by the cut guide 122 is provided to the patient in the anterior frontal plane (i.e., the coronal plane) such that when the cut guide 122 is translated superiorly to the tibia 102 in the sagittal plane, the cut guide 122 is positioned closer to or further from the anterior surface of the tibia 102. In some embodiments, the one or more cut guides 122 may be configured to facilitate a two-plane correction performed in set incremental measurements. For example, a cut guide 122 as shown in FIG. 3 includes a marking 131 of "2" indicating that the cut guide 122 is configured to provide a two-plane correction twice in the anterior frontal plane. One or more cut guides 122 of the bone resection system 100 may be configured to facilitate an incremental two-plane correction in the anterior frontal plane in the range of minus 6 degrees to 6 degrees. For example, the bone resection system 100 may include seven cut guides 122 that facilitate two-plane corrections of minus 6 degrees, minus 4 degrees, minus 2 degrees, 0 degrees, 2 degrees, 4 degrees, and 6 degrees.

[0034] The measurement arm 132 is configured to be coupled to the base plate 112 in the same manner as the cut guide 112. As shown in FIGS. 1-3, 10-12, and 13-18, the measurement arm 132 includes a head 133 having an opening 138. The opening 138 of the measurement arm 132 is configured to be the same as and / or similar to the opening 125 of the cut guide 122. As shown in FIGS. 1-3 and FIGS. 13-18, the opening 138 of the measurement arm 132 is configured to receive a first screw 124. Further, the opening 138 of the measurement arm 132 is configured to have the same and / or similar dimensions as the second opening 232 of the base plate 112. In the coupling with the base plate 112, the measurement arm 132 is disposed on the base plate 112 such that the bottom surface of the measurement arm 132 interfaces with the upper surface of the base plate 112. Further, the opening 138 of the measurement arm 132 is disposed with respect to the second opening 232 of the base plate such that the first screw 124 can be received by the opening 138 of the measurement arm 132 and the second opening 232 of the base plate, thus facilitating the coupling. As shown in FIGS. 4-5, the second opening 232 includes a second thread 234 configured to facilitate the coupling and retention of the first screw 124 by interfacing with the corresponding threading 422 of the first screw 124 (as shown in FIGS. 8-9). In some embodiments, the measurement arm 132 may be coupled to the base plate 112 via a second screw 126 and the first screw 124. For example, the opening 138 of the measurement arm 132 and the opening 125 of the cut guide 122 may be configured to have the same and / or similar dimensions (e.g., radius, depth, etc.) to accommodate a common coupling device such as the first and second screws 124, 126.

[0035] As shown in FIGS. 1-3 and 13-18 in combination with the base plate 112 and also shown independently in FIGS. 10-12, the measurement arm 132 includes a head portion 133 and an arm portion 134 extending from the head portion 133. As shown in FIGS. 10-12, the head portion includes a "protuberance" 512 extending from a protrusion 510 disposed on the bottom surface of the measurement arm 132. The protuberance 512 is shown to engage with the bore 236 of the base plate 112 as shown in FIGS. 4-5. Thus, the engagement of the protuberance 512 and the bore 236 prevents movement / translation of the measurement arm 132 relative to the base plate 112. The arm portion 134 is shown to have a curved shape such that when the base plate 112 (and the bottom surface of the base plate 112 interferes with the front surface of the tibia 102) is coupled, the curve of the arm portion 134 curves towards the inner portion of the tibia 102.

[0036] Further, the arm portion 134 is shown to include a guide portion 136. The guide portion 136 includes an angular measurement (e.g., 0 degrees to 15 degrees). With the base plate 112 coupled to the tibia 102 via the olive wire 114 and the measurement arm 132 coupled to the base plate 112 (and the protuberance 512 / bore 236 preventing their relative movement), the cut guide 122 can be pivoted (by the second screw 126) about the coupling point. The guide portion 136 of the measurement arm 132 is arranged such that the operation of the cut guide 122 aligns the central portion of the slot 122 and facilitates measurement using the guide portion 136. As shown in FIGS. 13-17, the slot 130 of the cut guide 122 is configured to removably receive the measurement flag 140.

[0037] The measurement flag 140 is configured to facilitate the measurement of the angle of the slot 130 of the cutting guide 122 with respect to the angle perpendicular to the midline of the tibia 102. For example, as shown in FIG. 14, the measurement flag 140 (and thus the slot 130 of the cutting guide 122) is adjacent to the 0-degree marking 610 of the guide portion 136 of the measurement arm 132. This 0-degree position corresponds to the orientation of the measurement flag 140 (and thus the slot 130) that is orthogonal to the midline of the tibia 102 (where the midline of the tibia 102 intersects the cross-section). Thus, the cutting guide 122 can be manipulated (e.g., translated, pivoted) such that the measurement flag 140 identifies various angle measurements along the anterior surface of the tibia 102 with respect to the 0-degree position. For example, FIG. 15 shows the measurement flag 140 adjacent to the 5-degree marking 612, and thus shows an angle 5 degrees above the 0-degree marking 610. Similarly, FIG. 16 shows the measurement flag 140 adjacent to the 10-degree marking 614, and thus shows an angle 10 degrees above the 0-degree marking 610. FIG. 17 shows the measurement flag 140 adjacent to the 15-degree marking 616, and thus shows an angle 15 degrees above the 0-degree marking 610. In some embodiments, the guide portion 136 may include measurement values greater than 15 degrees (e.g., up to 90 degrees). Further, the increment of the markings on the guide portion 136 may be other than 5 degrees (e.g., 2 degrees, 10 degrees, etc.). In the embodiments shown in FIGS. 1-18, the manipulation of the cutting guide 122 and its components occurs with the other components of the osteotomy system 100 in a fixed position (e.g., the cutting guide 122 is the only component that moves relative to the tibia 102).

[0038] As shown in FIGS. 13-17, the stabilization element shown as the K-wire 118 was repositioned within the tibia 102 as the cut guide 122 was operated over a 15-degree range measured on the guide portion 136 of the measurement arm 132. As shown in FIGS. 1-3 and 18, the measurement flag 140 can be removed from the slot 130 of the cut guide 122. Thus, removal of the cut guide 122 facilitates marking and / or cutting of the tibia 102 by one or more surgeons. For example, the surgeon may manipulate the cut guide 122 so that measurements can be taken using the measurement flag 140 at positions 610 (0 degrees) and 614 (10 degrees). Next, as shown in FIG. 18, the surgeon may introduce a cutting tool shown as a sagittal saw 620 such that its blade 622 is disposed within the slot 130. Thus, the surgeon can then make one or more cuts with the blade 622 disposed within the cut guide 122 to ensure that the tibia 102 is cut at the desired angle (10 degrees in this example). In some embodiments, the slot 130 is arranged such that an angle correction guide is provided on the anterior surface to facilitate the procedure of one or more surgeons when making one or more cuts of the tibia 102.

[0039] Accurate cutting using the osteotomy system 100 facilitates cutting and / or removal of the distal portion of the tibia 102 at an angle desired by the surgeon. In some embodiments, the surgeon can place an implant of equivalent angular measurement within the void left after removal of the distal portion of the tibia 102 as a result of the cut made within the slot 130 of the cut guide 122. In some embodiments, the placement of the osteotomy system 100 on the patient's tibia 102 can be incomplete (e.g., there is a small gap between the bottom surface of the base plate 112 and the anterior surface of the tibia 102). Thus, as with surgical procedures, the measurements taken using the cut guide 122 (and its components) as well as the measurement arm 132 can include a small amount of error. For example, in some embodiments, such measurements can include an error of less than one degree.

[0040] As shown in FIGS. 19-27, an alternative embodiment of the osteotomy system 100 is shown. In some embodiments, the osteotomy system shown includes one or more components that are the same as and / or similar to those shown in the osteotomy system 100. For example, some alternative embodiments may include components that are the same as and / or similar to the base plate 112, the cut guide 122, and the measurement arm 132. Further, some embodiments may implement the same and / or similar coupling mechanisms, such as screws having a bore (e.g., cannulated). The alternative embodiments shown in FIGS. 19-27 include systems that may be implemented when performing a tibial osteotomy, such as a distal tibial osteotomy.

[0041] Referring now to FIG. 19, there is shown an osteotomy system 200 according to an exemplary embodiment. The osteotomy system 200 is shown to include a surgical guide 202 coupled (removably, pivotably, or otherwise) to a base 204. In some aspects, the base may include a semi-circular shape (e.g., a quarter-circle shape as shown in FIG. 19), and the pivot point and / or coupling portion of the surgical guide 202 and the base 204 may be disposed substantially near the center point of the circle and / or semi-circle. The surgical guide 202 is shown to include a body 206, the body including a pair of bores 208 that extend substantially across the height of the body 206, and a first cut slot 210 and a second cut slot 212 that are disposed substantially parallel to each other and adjacent to the pair of bores 208. In some aspects, the pair of bores 208 may be configured to receive a coupling element, such as a K-wire, for coupling and / or stabilizing the surgical guide to the patient's tibia. The first and second cut slots 210, 212 extend through the body 206 such that a cutting instrument can be received therein. In some aspects, the body 206 may include a first protrusion 209 and a second protrusion 211 disposed at its opposing ends. Further, in some aspects, one or more of the first and second protrusions 209, 211 may be configured to align with at least a portion of an arcuate portion 220 of the base 204, the arcuate portion extending between a first base member 216 and a second base member 218 that form a substantially right angle. In some aspects, the arcuate portion 220 may include measurement marks 222, and the pivoting of the surgical guide 202 relative to the base 204 may be measured based on the alignment of one or more of the first and second protrusions 209, 211 with the measurement marks 222, which are disposed thereon. Further, the base 204 is shown to include a pair of openings 224 configured to facilitate coupling to various musculoskeletal structures (e.g., the tibia) of the patient via a K-wire or other coupling element.

[0042] Referring now to FIG. 20, an osteotomy system 300 according to an exemplary embodiment is shown. The osteotomy system 300 is shown to include a base 302 coupled to a musculoskeletal structure 308 via a coupling element 306 (e.g., a K-wire, a stabilization wire, etc.) received within an opening 303 variably disposed in the base 302. Further, the base 302 is shown to be coupled (removably, pivotably, or otherwise) to a surgical guide 304. In some aspects, the base may include a substantially L-shaped configuration (e.g., including one or more legs), and the coupling portion of the surgical guide 304 and the base 302 is substantially disposed near one of the L-shaped legs. The surgical guide 304 is shown to include a body 305 having a coupling portion 307, and a cut guide 310 (or a portion thereof) may be received within the coupling portion 307 in a dovetail coupling mechanism. The cut guide 310 may include a recess 311 that is the same as and / or similar to the coupling portion 307, and the recess may be configured to receive at least a portion of an insert 312 (e.g., an extension 313 having a dovetail coupling). The insert 312 includes a base 313 from which a bump 314 extends, and the bump 314 includes a cut slot 316 configured to receive at least a portion of a cutting instrument. In the osteotomy system 300, one or more cut guides that are the same as and / or similar to the cut guide 310 may be removably coupled and / or detached from the surgical guide 304 to address various situations (size, three-dimensional shape, etc.). Similarly, one or more inserts that are the same as and / or similar to the insert 312 may be removably coupled / detached from the recess 311.

[0043] Referring now to FIGS. 21 - 23, there is shown an osteotomy system 400 according to an exemplary embodiment. The osteotomy system 400 is shown to include a base 402 having a substantially semi - circular shape, the base 402 including a bore 404 disposed therein and configured to receive a stabilization element 406 therethrough, promoting stabilization and being releasably coupled to one or more musculoskeletal structures. The osteotomy system 400 is further shown to include a surgical guide 408 configured to be releasably coupled to at least one of the stabilization elements 406 via a coupling mechanism 409 (e.g., an extension having a bore complementary to the stabilization element 406), and the surgical guide 408 is adapted to pivot with respect to the coupling mechanism 409. The surgical guide 408 is shown to include a cut guide 414 releasably coupled to the surgical guide 408 via a base 410 of the surgical guide 408. The base 410 is shown to include a recess in which at least a portion of the cut guide 414 can be positioned and / or coupled. The cut guide 414 includes an extension 412 having a slot 416 disposed therein (the slot 416 having a substantially elongated shape). The extension 412 may be configured such that when the surgical guide 408 (and components coupled thereto) is pivoted about the coupling mechanism 409 (e.g., defining a circular pivot path), the distal most end of the extension 412 is adjacent to at least a portion of the base 402. The cut guide 414 is shown to be releasably coupled to the surgical guide 408 such that one or more cut guides identical and / or similar to the cut guide 414 can be exchanged within the surgical guide 408. The surgical guide 408 includes an actuator 420 disposed on its upper portion and configured to releasably hold the cut guide 414 within at least a portion of the surgical guide 408 (to facilitate releasable coupling). The actuator 420 includes an interval mark 422 disposed thereon and configured to indicate actuation of the actuator 420 (e.g., with respect to rotational actuation). The actuator 420 also includes a coupling mechanism 424 disposed in its central portion and configured to couple the actuator 420 to the surgical guide 408.

[0044] Referring now to FIG. 24, a bone resection system 500 according to an exemplary embodiment is shown. The bone resection system 500 is shown to include a base 502 having a substantially semi-circular shape, the base 502 including a bore 504 disposed therein and configured to receive a stabilization element therethrough, to facilitate stabilization and to be releasably coupled to one or more musculoskeletal structures. The bone resection system 500 is further shown to include a surgical guide 508 configured to be releasably coupled to at least one of the stabilization elements via a coupling mechanism, the surgical guide 508 being pivotable about the coupling mechanism. The surgical guide 508 includes an extension 510 having a substantially curved shape, the extension 510 including a recess 511 (which may extend through the extension 511 in some embodiments). The surgical guide 508 is shown to include a first actuator 520 disposed substantially above the surgical guide 508, where the first actuator 520 may be operated (e.g., rotated) to translate the surgical guide 508 relative to the coupling point with the base 502 such that the surgical guide 508 pivots about the coupling point. In some aspects, a spacer 519 may be disposed between the surgical guide 508 and the first actuator 520. The first actuator 520 includes a texture 518 on its outer edge to facilitate gripping when rotating the first actuator 520, and is shown to include a coupling mechanism 522 configured to couple the first actuator to the surgical guide 508 and the spacer 519. The bone resection system 500 further includes a cut guide 514 coupled to (e.g., releasably, pivotably, etc.) a portion of the base 502. The cut guide 514 is shown to include an extension 512 having a slot 516 disposed therein, the slot 516 having a substantially elongated shape and being configured to receive at least a portion of a cutting instrument.The cutting guide 514 is further shown to include a second actuator 524 configured to be rotated (e.g., operated) such that rotation of the actuator 524 drives a pivotal movement of the cutting guide 514 about a point of attachment to the base 502. The actuator 524 further includes a coupling mechanism 526 configured to couple the actuator 524 to the cutting guide 514 and the base 502.

[0045] Referring now to FIG. 25, there is shown an osteotomy system 600 according to an exemplary embodiment. The osteotomy system 600 is shown to include a base 602 having a substantially semi-circular shape, the base 602 including a bore (not shown) disposed in the base and configured to receive a stabilization element 606 therethrough, to facilitate stabilization and to be releasably coupled to one or more musculoskeletal structures. The osteotomy system 600 is further shown to include a surgical guide 608 configured to be releasably coupled to at least one of the stabilization elements 606 via a coupling mechanism, the surgical guide 608 being pivotable relative to the coupling mechanism. The surgical guide 608 includes an extension 610 having a substantially curved shape, the extension 610 including a recess 611 (which may extend through the extension 611 in some embodiments). The surgical guide 608 is shown to include an actuator 618 disposed substantially above the surgical guide 608, where the actuator 618 may be operated (e.g., rotated) to position the surgical guide 608 about the point of attachment to the base 602 such that the surgical guide 608 pivots about the point of attachment. The actuator 618 is shown to include a texture on its outer edge to facilitate gripping when rotating the actuator 618. The osteotomy system 600 further includes a cut guide 614 coupled (e.g., releasably, pivotably, etc.) to a portion of the base 602. The cut guide 614 is shown to include an extension 612 having a slot 616 disposed therethrough (which may be open at the distal portion of the extension 612), the slot 616 having a substantially elongated shape and being configured to receive at least a portion of a cutting instrument. Further, the cut guide 614 includes a protrusion 615 extending from a position adjacent the slot 616 and having a bore 617, the bore 617 being configured to receive a stabilization element (e.g., the same and / or similar to the stabilization element 606) to hold the cut guide 614 in a stationary position during one or more cuts.The cutting guide 614 is further shown to include an actuator 618 (the same as and / or similar to those described previously) configured to be rotated (e.g., actuated), and the rotation of the actuator 618 is adapted to drive a pivotal movement of the cutting guide 614 about a point of attachment to the base 602.

[0046] Referring now to FIG. 26, an osteotomy system 700 according to an exemplary embodiment is shown. The osteotomy system 700 is shown to include a base 702 having a substantially semi-circular shape (e.g., less than a full circle), the base 702 including a bore (not shown) disposed in the base and configured to receive a stabilization element 706 therethrough to facilitate stabilization and releasably coupled to one or more musculoskeletal structures. The osteotomy system 700 is further shown to include a surgical guide 708 configured to releasably couple to at least one of the stabilization elements 706 via a coupling mechanism, and the surgical guide 708 is pivotable about the coupling mechanism. The surgical guide 708 includes an extension 710 having a substantially curved shape, the extension 710 including a protrusion 711 disposed on the extension 710 and extending from a side surface of the extension 710. In some aspects, the protrusion 711 may be positioned at intervals corresponding to angle or arc measurements when operated on a component of the osteotomy system 700. The surgical guide 708 includes an actuator 718 disposed substantially above the surgical guide 708, and the actuator 718 may be operated (e.g., rotated) to position the surgical guide 708 about a point of attachment to the base 702 such that the surgical guide 708 pivots about the point of attachment. The actuator 718 is shown to include a texture on its outer edge to facilitate gripping when rotating the actuator 718. In some aspects, the surgical guide 708 may include a bore 709 in which a stabilization element 706 may be disposed to fix the surgical guide 708 in a stationary position (e.g., after being operated to a desired position). The osteotomy system 700 further includes a cut guide 714 coupled to a portion of the base 702 (e.g., releasably, pivotably, etc.). The cut guide 714 is shown to include an extension 712 having a slot 716 disposed therein (which may be open at a distal portion of the extension 712), the slot 716 having a substantially elongated shape and configured to receive at least a portion of a cutting instrument.Furthermore, the cutting guide 714 extends from a position adjacent to the slot 716 and includes a protrusion 715 having a bore 717, the bore 717 being configured to receive a stabilizing element (e.g., the same as and / or similar to the stabilizing element 706) to hold the cutting guide 714 in a stationary position during the execution of one or more cuttings. The cutting guide 714 is further shown to include a coupling element 720 including an interface 722 (e.g., torx, hex, etc.) configured to couple the cutting guide 714 to a portion of the base 702, and is adapted to facilitate pivoting of the cutting guide 714 about the point of attachment to the base 702.

[0047] Referring now to FIG. 27, an osteotomy system 800 according to an exemplary embodiment is shown. The osteotomy system 800 is shown to include a base 802 having a substantially semi-circular shape (e.g., less than a full circle), the base 802 including a bore (not shown) disposed in the base 802 and configured to receive a stabilization element 806 therein, to facilitate stabilization and to be releasably coupled to one or more musculoskeletal structures. The osteotomy system 800 is further shown to include a surgical guide 808 configured to be releasably coupled to at least one of the stabilization elements 806 via a coupling mechanism such that the surgical guide 808 can pivot about the coupling mechanism. The surgical guide 808 includes an extension 810 having a substantially curved shape, the extension 810 including a protrusion 811 disposed on the extension 810 and extending from a side surface of the extension 810. In some aspects, the protrusion 811 can be positioned at intervals corresponding to measurements of an angle or an arc when being manipulated relative to components of the osteotomy system 800. The surgical guide 808 is shown to include a coupling element 820 including an interface 822 (e.g., a torx, a hex, etc.) configured to couple a cut guide 814 to a portion of the base 802 so as to facilitate pivoting of the cut guide 814 about a point of attachment to the base 802. In some aspects, the surgical guide 808 may also include a hole (not shown) in which the stabilization element 806 can be disposed to fix the surgical guide 808 in a stationary position (e.g., after being manipulated to a desired position). The osteotomy system 800 further includes a cut guide 814 coupled to a portion of the base 802 (e.g., releasably, pivotably, etc.). The cut guide 814 is shown to include an extension 812 having a slot 816 disposed therethrough (which may be an open end at a distal portion of the extension 812), the slot 816 having a substantially elongated shape and being configured to receive at least a portion of a cutting instrument.Furthermore, the cut guide 814 extends from a position adjacent to the slot 816 and includes a protrusion 815 having a bore 817, and the bore 817 can be configured to receive a stabilization element (e.g., the same as and / or similar to the stabilization element 806) to hold the cut guide 814 in a stationary position during the execution of one or more cuts. The cut guide 814 is further shown to include an additional coupling element 820 (the same as and / or similar to those described previously) configured to couple the cut guide 814 to a part of the base 802, facilitating the pivoting of the cut guide 814 about the point of attachment to the base 802.

[0048] The osteotomy system 100 described herein, as well as those shown in alternative embodiments (described herein), includes components configured to be directly attached to the tibia, allowing one or more surgeons to accurately measure angles with a sagittal saw for opening and closing a wedge osteotomy. Further, the base plate 112 is configured to accommodate the metaphyseal flare of the tibia. Additionally, a plurality of cut guides (e.g., cut guide inserts) enable correction in the anterior plane. The osteotomy system 100 is also configured (e.g., may be radiopaque) to fluoroscopically visualize the osteotomy site prior to cutting the bone. The osteotomy system 100 can also be assembled and disassembled to facilitate cleaning and sanitation procedures and can be used for tibial osteotomy on a patient's right and / or left leg (e.g., right and / or left tibia). In some embodiments, the osteotomy system and / or its components can be 3D printed using a variety of materials (e.g., various polymers, metals, stainless steel, other metal alloys, etc.) having known biocompatibility.

[0049] The terms used in this specification are for the purpose of describing particular embodiments only and are not intended to limit the present invention. As used in this specification, singular expressions are intended to include plural forms as well, unless the context clearly indicates otherwise. It will be further understood that expressions such as "comprising", "having", "consisting of", "including" and their derivatives are open-ended inclusive verbs. As a result, a method or device that "comprises", "has", "consists of", or "includes" one or more steps or elements holds those one or more steps or elements, but is not limited to holding only those one or more steps or elements. Similarly, steps of a method or elements of a device that "comprise", "have", "consist of", or "include" one or more features own those one or more features, but are not limited to owning only those one or more features. Further, a device or structure configured in a certain way is at least configured in that way, but may also be configured in ways not described.

[0050] The present invention has been described with reference to preferred embodiments. It will be understood that the embodiments of the structures and operations described herein are examples of a plurality of possible arrangements for providing the same general features, characteristics, and general system operations. Modifications and changes will occur to others upon reading and understanding the above detailed description. The present invention is intended to be construed as including all such modifications and changes.

Claims

1. A tibial osteotomy system, comprising: A base plate including a first end and a second end; A measuring arm for measuring the angle of cutting and removing the distal part of the tibia; The measuring arm is coupled to and extends from the first end of the base plate; The tibial osteotomy system further includes: A cut guide coupled to and extending from the second end of the base plate; The cut guide is translatable relative to the base plate and the measuring arm; The cut guide is pivotally coupled to the second end of the base plate; The cut guide includes: A head portion including an opening configured to pivotally couple to the second end of the base plate; A body extending from the head portion and having a first arm and a second arm; The first arm and the second arm define a slot; The system further includes a measuring flag releasably coupled to the slot, wherein pivoting of the cut guide relative to the measuring arm positions the measuring flag adjacent to the guide portion of the measuring arm; A tibial osteotomy system.

2. The measuring arm has a curved shape; The tibial osteotomy system according to claim 1.

3. The measuring arm includes: A head portion including an opening configured to fixedly couple to the first end of the base plate; An arm portion extending from the head portion including a guide portion; The tibial osteotomy system according to claim 2.

4. The slot is configured to receive a cutting tool blade; The tibial osteotomy system according to claim 1.

5. The cut guide further includes a protrusion extending from the body of the cut guide and having at least one opening, the opening of the protrusion being configured to receive a stabilization element; The tibial osteotomy system according to claim 1.

6. The base plate includes a body portion disposed between the first end and the second end, and the bottom surface of the base plate is configured to interface with the anterior surface of the tibia; The tibial osteotomy system according to claim 1.

7. The body of the base plate includes a pair of openings configured to receive a pair of stabilization elements, the stabilization elements coupling the base plate to the tibia; The tibial osteotomy system according to claim 6.

8. The measuring arm is coupled to the first end of the base plate by a first screw, and the cut guide is coupled to the second end of the base plate by a second screw; The tibial osteotomy system according to claim 1.

9. The first and second screws are similarly configured. The tibial osteotomy system according to claim 8.

10. The first and second screws each have a bore extending through the screw along a central axis, and the bore is configured to receive a stabilization element. The tibial osteotomy system according to claim 8.

11. A tibial osteotomy system, The system comprises a base plate configured to interface with the tibia, The base plate includes a body having a first pair of openings configured to receive a first pair of stabilization elements, a first end including the first opening, a second end including the second opening, the first end being on the opposite side of the second end, The system also includes a measuring arm for measuring the angle of cutting and removal of the distal portion of the tibia, The measuring arm includes a measuring arm fixedly coupled to the first end of the base plate through the first opening and further including a third opening, the third opening and the first opening being aligned to receive a first screw therein, The system also includes a cut guide pivotally coupled to the second end of the base plate through the second opening and the fourth opening, the fourth opening and the second opening being aligned to receive a second screw therein, The cut guide further includes a slot, a measuring flag releasably coupled within the slot, a protrusion including a fifth opening, The fifth opening is configured to receive a second stabilization element therethrough. Tibial osteotomy system.

12. The first screw and the second screw each include a bore configured concentrically with respect to a central axis, The bore is configured to receive a second pair of stabilization elements. The tibial osteotomy system according to claim 11.

13. The second pair of stabilization elements are K-wires. The tibial osteotomy system according to claim 12.

14. The first pair of stabilization elements are olive wires. The tibial osteotomy system according to claim 11.

15. The measuring arm includes a guide portion, The guide portion includes incremental measurement markings. The tibial osteotomy system according to claim 11.

16. The measuring flag is coupled within the slot such that pivoting the cut guide positions the measuring flag adjacent to the incremental measurement markings. The tibial osteotomy system according to claim 15.

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