# US 2021/0330385 A1 · Surgical kit for knee osteotomies and corresponding preoperative planning method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330385 A1 - Document ID: US20210330385A1 - Status: Published application - Kind: A1 - Application number: 16/610,039 - Filed: 2019-08-22 - Published: 2021-10-28 - Earliest claimed: 2018-08-24 - Assignees: Laboratoires Bodycad Inc. - Applicants: Laboratoires Bodycad Inc - Inventors: Jean Robichaud; Hugo Robichaud; Geoffroy River-Sabourin - Web page: https://patentgrep.com/patent/US20210330385A1 ## CPC - A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations - A61B 17/151: {for corrective osteotomy} - A61B 17/1728: {for holes for bone plates or plate screws} - A61B 17/1764: {for the knee} - A61B 17/8028: {Cushions, i.e. elements forming interface between bone plate and bone} - A61B 17/808: {Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms} - A61B 17/8095: {Wedge osteotomy devices} - B33Y 50/02: for controlling or regulating additive manufacturing processes - B33Y 80/00: Products made by additive manufacturing - G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture - G16H 50/50: for simulation or modelling of medical disorders - A61B 17/1604: {Chisels; Rongeurs; Punches; Stamps} - A61B 17/1615: {Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material} - A61B 17/1675: {for the knee} - A61B 17/1735: {for rasps or chisels} - A61B 2017/568: {produced with shape and dimensions specific for an individual patient} - A61B 2034/101: {Computer-aided simulation of surgical operations} - A61B 2034/104: {Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring} - A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones} - A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides} - A61B 2090/036: {abutting on tissue or skin} - A61B 2090/062: {penetration depth} - A61B 2090/067: {for measuring angles} - B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)} - G05B 2219/45171: Surgery drill - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES - G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G) ## Abstract According to an aspect, a preoperative planning method for a high-tibial knee osteotomy procedure is provided. The method includes: a) constructing a 3D model of a patient's bones; b) analyzing the 3D model to select a desired correction angle to apply to the patient's tibia bone to adjust a mechanical axis thereof; c) determining surgical steps required to apply the desired correction angle to the patient's tibia bone; d) designing a patient-specific guide to guide generic surgical tools in performing the surgical steps, the patient-specific guide being designed to conform to the anatomy of the patient's bones based on the 3D model; and e) manufacturing the patient-specific guide designed in step d). A corresponding kit, system and computer readable medium for performing the method are also provided. ## Claims ### Claim 1 A preoperative planning method for a high-tibial knee osteotomy procedure, the method comprising: a) obtaining a 3D model of a patient's bones; b) analyzing the 3D model to select a desired correction angle to apply to the patient's tibia bone to adjust a mechanical axis thereof; c) determining surgical steps required to apply the desired correction angle to the patient's tibia bone; d) designing a patient-specific guide to guide generic surgical tools in performing the surgical steps, the patient-specific guide being designed to conform to the anatomy of the patient's bones based on the 3D model; and e) manufacturing the patient-specific guide designed in d). ### Claim 2 (depends on 1) The method according to claim 1, further comprising designing a patient-specific fixation plate for securing an opening to be formed in the patient's tibia bone during the osteotomy procedure, the patient-specific fixation plate being designed to conform to the anatomy of the patient's tibia bone using the 3D model. ### Claim 3 (depends on 1) The method according to claim 1, wherein designing the patient-specific guide comprises designing a drilling module using the 3D model, to guide insertion of drill bits into the patient's tibia bone at predetermined positions, depths, and/or orientations to weaken the patient's tibia bone in preparation for forming at least one planar cut therein. ### Claim 4 (depends on 3) The method according to claim 3, wherein designing the patient-specific guide comprises designing a cutting module using the 3D model, to guide insertion of an osteotome into the patient's tibia bone at predetermined positions, depths, and/or orientations to form the planar cut in the weakened area. ### Claim 5 (depends on 1) The method according to claim 1, wherein designing the patient-specific guide comprises designing a predrilling module using the 3D model, to guide insertion of drill bits into the patient's tibia bone at predetermined positions, depths, and/or orientations corresponding to the positions, depths and/or orientations of fasteners to be received therein. ### Claim 6 (depends on 1) The method according to claim 1, wherein designing the patient-specific guide comprises designing a security pin guide module using the 3D model, to guide insertion of a security pin into the patient's tibia bone at a predetermined position, depth and/or orientation to protect the tibial plateau of the patient's tibia bone throughout the surgical procedure. ### Claim 7 (depends on 1) The method according to claim 1, wherein designing the patient-specific guide comprises designing an anchor module using the 3D model, for engaging with a spreader tool, the anchor module having separable proximal and distal sections positioned on opposite sides of a planar cur to be formed in the patient's bone during the surgical procedure. ### Claim 8 (depends on 1) The method according to claim 1, wherein designing the patient-specific guide comprises designing a validator module for validating an opening to be formed in the patient's tibia bone during the surgical procedure based on its expected shape according to the 3D model. ### Claim 9 (depends on 8) The method according to claim 8, wherein designing the validator module comprises determining internal and exterior surface contours of the patient's tibia bone in and/or around the opening using the 3D model and configuring abutment surfaces of the validator module to conform to the surface contours. ### Claim 10 (depends on 1) The method according to claim 1 further comprising designing a patient-specific fixation plate using the 3D model, to secure an opening to be formed in the patient's tibia bone during the surgical procedure. ### Claim 11 (depends on 10) The method according to claim 10, wherein designing the patient-specific fixation plate comprises virtually opening the patient's tibia bone using the 3D model to determine an expected shape and contour of the patient's tibia bone and providing the patient-specific fixation plate with a shape and contour corresponding to the expected shape and contour of the patient's tibia bone. ### Claim 12 (depends on 10) The method according to claim 10, wherein designing the patient-specific fixation plate further comprises determining an expected shape and contour of the opening to be formed in the patient's bone using the 3D model and providing the patient-specific fixation plate with a wedge having surfaces and contours corresponding to the expected shape and contour of the opening to be formed in the patient's bone. ### Claim 13 A computer system configured to: a) receive a 3D model of a patient's bones; b) analyze the 3D model to select a desired correction angle to apply to the patient's tibia bone to adjust a mechanical axis thereof; c) determine surgical steps required to apply the desired correction angle to the patient's tibia bone; d) design a patient-specific guide to guide generic surgical tools in performing at least one of the surgical steps, the patient-specific guide being designed to conform to the anatomy of the patient's bones using the 3D model; and e) transmit instructions to a manufacturing device to manufacture the patient-specific guide designed in step d). ### Claim 14 (depends on 13) The computer system according to claim 13, further comprising a user interface device for receiving commands from a user to select the desired correction angle, design the patient-specific guide, and/or design a patient-specific fixation plate. ### Claim 15 A non-transitory computer-readable medium having instructions stored thereon which, when executed by the computer, cause the computer to perform the steps of: a) receiving a 3D model of a patient's bones; b) analyzing the 3D model to select a desired correction angle to apply to the patient's tibia bone to adjust a mechanical axis thereof; c) determining surgical steps required to apply the desired correction angle to the patient's tibia bone; d) designing a patient-specific guide to guide generic surgical tools in performing the surgical steps, the patient-specific guide being designed to conform to the anatomy of the patient's bones using the 3D model; and e) transmitting instructions to a manufacturing device to manufacture the patient-specific guide designed in step d). ### Claim 16 A surgical kit for performing a high-tibial knee osteotomy, the surgical kit comprising a plurality of generic tools, and at least one patient-specific guide configured to cooperate with the generic tools to guide the same in performing steps of the high-tibial knee osteotomy procedure as determined according to a preoperative plan. ### Claim 17 (depends on 16) The surgical kit according to claim 16, wherein the generic tools comprise a plurality of calibrated drill bits, further wherein the at least one patient-specific guide comprises at least one drill module conforming to the patient's tibia bone and configured to guide the calibrated drill bits to predetermined positions, depths and/or orientations in the patient's tibia bone. ### Claim 18 (depends on 16) The surgical kit according to claim 16, wherein the generic tools comprise one or more osteotomes, further wherein the at least one patient-specific guide comprises at least one cutting module conforming to the patient's tibia bone and configured to guide the one or more osteotomes to predetermined positions, depths and/or orientations in the patient's tibia bone. ### Claim 19 (depends on 16) The surgical kit according to claim 16, wherein the generic tools comprise a plurality of calibrated drill bits, further wherein the at least one patient-specific guide comprises at least one predrilling module conforming to the patient's tibia bone and configured to guide the calibrated drill bits to predetermined positions, depths and/or orientations in the patient's tibia bone corresponding to planned positions, depths and/or orientations of fixation plate fasteners. ### Claim 20 (depends on 16) The surgical kit according to claim 16, wherein the generic tools comprise a plurality of fasteners having different sizes and/or lengths, further wherein the kit comprises at least one patient-specific fixation plate conforming to the patient's tibia bone, and having fastener apertures of different sizes formed therein at different positions and/or orientations, for receiving corresponding ones of the plurality of fasteners, and guiding them to predetermined depths, positions and/or orientations in the patient's tibia bone.