# US 11,986,415 B2 · Production of a custom medical splint or brace for immobilization of a selected region of a patient's body part > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,986,415 B2 - Document ID: US11986415B2 - Status: Granted - Kind: B2 - Application number: 17/266,222 - Filed: 2019-08-06 - Published: 2021-09-30 - Granted: 2024-05-21 - Earliest claimed: 2018-08-06 - Assignees: Swibrace SA - Applicants: Swibrace SA - Inventors: Frédéric Schuind - Web page: https://patentgrep.com/patent/US11986415B2 ## CPC - A61F 5/0118: {for the arms, hands or fingers} - A61F 5/05825: {Strips of substantially planar form} - A61F 5/05866: {for wrists, hands, fingers or thumbs} - B29C 33/3842: {Manufacturing moulds, e.g. shaping the mould surface by machining} - B29C 33/40: Plastics, e.g. foam or rubber - B29C 51/36: specially adapted for vacuum forming {, Manufacture thereof} - A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques} - B29C 51/00: Shaping by thermoforming {, i.e. shaping sheets or sheet like preforms after heating}, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor {(blow moulding of tubular preforms B29C49/00, deforming of tubular or hollow preforms B29C67/0014)} - B29C 51/421: {of preforms, specially adapted for thermoforming (preheating sheets in general B29B13/023; B29C51/427 takes precedence)} - B29K 2875/00: Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as mould material - B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)} - B33Y 80/00: Products made by additive manufacturing - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES - 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 ## Abstract A method of producing a custom medical device including a splint or brace for immobilization of a selected region of a patient's body part. The custom medical device is produced in accordance with the following operations: (a) production of a three-dimensional mold of a portion of the patient's body part including the selected region onto which the desired medical device is to be placed; (b) definition of a three-dimensional shape of the desired medical device covering the selected region; (c) generation of a two-dimensional template corresponding to the defined three-dimensional shape, and which corresponds to unfolding in a two-dimensional plane of the three-dimensional shape of the desired medical device; (d) production of at least one plate of moldable material in accordance with the two-dimensional template of the desired medical device; and (e) molding of the plate of moldable material onto the three-dimensional mold to shape the desired medical device. ## Claims ### Claim 1 A method of producing a custom medical splint or brace for immobilization of a selected region of a patient's body part, comprising the following steps: producing a three-dimensional mold of a portion of the patient's body part comprising the selected region of the patient's body part onto which a desired medical splint or brace is to be placed; after the producing the three-dimensional mold of the portion of the patient's body part, defining a three-dimensional shape of the desired medical splint or brace covering the selected region of the patient's body part onto which the desired medical splint or brace is to be placed; generating a two-dimensional template of the desired medical splint or brace corresponding to the defined three-dimensional shape, wherein the two-dimensional template corresponds to unfolding in a two-dimensional plane of the three-dimensional shape of the desired medical splint or brace; producing at least one plate of moldable material in accordance with the two-dimensional template of the desired medical splint or brace; and molding the plate of moldable material onto the three-dimensional mold to shape the desired medical splint or brace. ### Claim 2 (depends on 1) The method according to claim 1, wherein the plate of moldable material is made of a thermoformable material, which is heated to an activation temperature prior to molding thereof onto the three-dimensional mold. ### Claim 3 (depends on 2) The method according to claim 2, wherein the three-dimensional mold is made of a material having a melting point that exceeds the activation temperature of the thermoformable material. ### Claim 4 (depends on 3) The method according to claim 3, wherein the three-dimensional mold is made of polyurethane. ### Claim 5 (depends on 1) The method according to claim 1, wherein the three-dimensional mold is produced on the basis of a three-dimensional digital model of the portion of the patient's body part. ### Claim 6 (depends on 5) The method according to claim 5, wherein the three-dimensional digital model of the portion of the patient's body part is a three-dimensional digital model of a portion of a patient's limb, and wherein the three-dimensional digital model of the portion of the patient's limb is generated by three-dimensional imaging of the portion of the patient's limb onto which the splint or brace is to be placed or a mirrored image of a corresponding portion of the patient's contralateral limb. ### Claim 7 (depends on 5) The method according to claim 5, wherein the three-dimensional mold is produced at least partly by milling on a CNC milling machine. ### Claim 8 (depends on 7) The method according to claim 7, wherein the three-dimensional mold is produced from a standardized pre-processed block of material matching a given population of patients, wherein the standardized pre-processed block is subjected to milling. ### Claim 9 (depends on 5) The method according to claim 5, wherein the three-dimensional mold is produced at least partly by additive manufacturing. ### Claim 10 (depends on 9) The method according to claim 9, wherein the three-dimensional mold is produced from a standardized pre-processed block of material matching a given population of patients, wherein the standardized pre-processed block is subjected to additive manufacturing. ### Claim 11 A method of producing a custom medical splint or brace for immobilization of a selected region of a patient's body part comprising the following steps: producing a three-dimensional mould of a portion of the patient's body part comprising the selected region of the patient's body part onto which a desired medical splint or brace is to be placed; defining a three-dimensional shape of the desired medical splint or brace covering the selected region of the patient's body part onto which the desired medical splint or brace is to be placed, wherein the three-dimensional shape of the desired medical splint or brace is defined by applying support material onto the three-dimensional mold covering the selected region where the desired medical splint or brace is to be placed and delimiting the three-dimensional shape of the desired medical splint or brace by means of the support material, generating a two-dimensional template of the desired medical splint or brace corresponding to the defined three-dimensional shape, wherein the two-dimensional template corresponds to unfolding in a two-dimensional plane of the three-dimensional shape of the desired medical splint or brace, wherein the two-dimensional template is generated by removing the support material with the three-dimensional shape delimited thereon from the three-dimensional mold and flattening the support material to cause unfolding of the three-dimensional shape in the two-dimensional plane, producing at least one plate of mouldable material in accordance with the two-dimensional template of the desired medical splint or brace; and moulding the plate of mouldable material onto the three-dimensional mould to shape the desired medical splint or brace. ### Claim 12 A method of producing a custom medical splint or brace for immobilization of a selected region of a patient's body part, comprising the following steps: producing a three-dimensional mould of a portion of the patient's body part comprising the selected region of the patient's body part onto which a desired medical splint or brace is to be placed; defining a three-dimensional shape of the desired medical splint or brace covering the selected region of the patient's body part onto which the desired medical splint or brace is to be placed, wherein the three-dimensional shape of the desired medical splint or brace is defined in a digital environment by delimiting the three-dimensional shape of the desired medical splint or brace onto a three-dimensional digital model of the portion of the patient's body part corresponding to the three-dimensional mold, generating a two-dimensional template of the desired medical splint or brace corresponding to the defined three-dimensional shape, wherein the two-dimensional template corresponds to unfolding in a two-dimensional plane of the three-dimensional shape of the desired medical splint or brace, wherein the two-dimensional template is generated by digitally processing the three-dimensional shape to unfold the three-dimensional shape in the two-dimensional plane, producing at least one plate of mouldable material in accordance with the two-dimensional template of the desired medical splint or brace; and moulding the plate of mouldable material onto the three-dimensional mould to shape the desired medical splint or brace. ### Claim 13 (depends on 1) The method according to claim 1, wherein the three-dimensional mold is provided with a base member designed to support the three-dimensional mold in a substantially vertical configuration. ### Claim 14 (depends on 1) The method according to claim 1, wherein molding of the plate of moldable material onto the three-dimensional mold is carried out entirely by hand. ### Claim 15 (depends on 1) The method according to claim 1, wherein molding of the plate of moldable material onto the three-dimensional mold is carried out under vacuum. ### Claim 16 (depends on 15) The method according to claim 15, wherein the plate of moldable material is roughly molded onto the three-dimensional mold, wherein the three-dimensional mold is placed, together with the molded plate of moldable material, into a vacuum bag, and wherein vacuum is applied to the vacuum bag to cause final molding of the plate of moldable material onto the three-dimensional mold. ### Claim 17 (depends on 16) The method according to claim 16, wherein the vacuum bag has a custom shape conforming to the shape of the desired medical splint or brace to prevent or reduce formation of wrinkles during application of vacuum to the vacuum bag. ### Claim 18 (depends on 1) The method according to claim 1, further comprising the step of forming one or more apertures or cut-outs in the plate of moldable material. ### Claim 19 (depends on 18) The method according to claim 18, wherein the step of forming one or more apertures or cut-outs in the plate of moldable material is carried out prior to molding on the three-dimensional mold. ### Claim 20 (depends on 1) The method according to claim 1, wherein the medical splint or brace is produced by molding of a single plate of moldable material. ### Claim 21 (depends on 1) The method according to claim 1, wherein the medical splint or brace is produced by molding of a single plate of thermoformable material. ### Claim 22 (depends on 1) The method according to claim 1, wherein the medical splint or brace is configured to act as an external immobilization device placed around the selected region of the patient's body part. ### Claim 23 (depends on 1) The method according to claim 1, wherein the medical splint or brace is configured to act as an implantable immobilization device placed in the selected region of the patient's body part.