# US 12,365,141 B2 · Process for the production of a 4D medical device and 4D medical device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,365,141 B2 - Document ID: US12365141B2 - Status: Granted - Kind: B2 - Application number: 16/950,559 - Filed: 2020-11-17 - Published: 2021-05-20 - Granted: 2025-07-22 - Earliest claimed: 2019-11-18 - Assignees: 3D Medlab - Applicants: 3D Medlab - Inventors: Gaël Volpi; Donatien Campion; Marie Fischer - Web page: https://patentgrep.com/patent/US12365141B2 ## CPC - B29C 64/393: for controlling or regulating additive manufacturing processes - A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07) - A61F 2/90: characterised by a net-like or mesh-like structure - B22F 3/24: After-treatment of workpieces or articles {(B22F3/1146 takes precedence)} - B33Y 10/00: Processes of additive manufacturing - B33Y 50/02: for controlling or regulating additive manufacturing processes - B33Y 80/00: Products made by additive manufacturing - G16H 30/20: for handling medical images, e.g. DICOM, HL7 or PACS - A61F 2240/002: Designing or making customized prostheses - A61F 2250/0092: Means for cleaning prostheses - B22F 10/36: of energy beam parameters - B22F 10/60: Treatment of workpieces or articles after build-up - B22F 10/80: Data acquisition or data processing - B33Y 50/00: Data acquisition or data processing for additive manufacturing - G16H 30/40: for processing medical images, e.g. editing - 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) - 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) - B22F: WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER (making alloys by powder metallurgy C22C); APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER - 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 ## Abstract The subject matter described herein relates to a process suitable for the production of an implantable medical device by means of a 3D printer. The process includes identifying an intended implant area for the medical device, collecting, in a non-invasive manner, a set of physiological data corresponding to the local anatomy of said intended implant area of the patient, noninvasively taking measurements from the set of physiological data of the patient with the aid of an analysis tool, and adding the characteristics of the medical device, which are specific to additive manufacturing, to thus generate a 3D model of the medical device to be produced. The process further includes exporting the 3D model of the medical device to be produced to the 3D printer suitable for printing a shape-memory material in which the parameters of the 3D printer are adapted to the geometry of the medical device. ## Claims ### Claim 1 A process for producing a medical device by means of a three-dimensional (3D) printer, said medical device being intended to be implanted in the body of a patient, comprising the following steps: identifying an intended implant area for the medical device, collecting, with the aid of an acquisition means and in a non-invasive manner, a set of physiological data corresponding to local anatomy of said intended implant area of the patient, taking measurements, with the aid of analysis tools and in a non-invasive manner, from the set of physiological data of the patient, adding characteristics of the medical device, which are specific to additive manufacturing, to thus generate a 3D model of the medical device to be produced, the process then comprising the following step: exporting the 3D model of the medical device to be produced to the 3D printer suitable for printing a shape-memory material in which parameters of the 3D printer are adapted to a geometry of the medical device; and 3D printing, using the 3D printer, the shape memory material, and according to the 3D model, the medical device, wherein the medical device comprises an implantable vascular device having dimensions customized to the patient based on the measurements, and the shape memory material is configured to alternate between two crystallographic states by varying a temperature of the shape memory material, and the method further comprises modifying a transition temperature of the shape memory material that causes the shape memory material to transition between the two crystallographic states and thereby change an opening temperature of the implantable vascular device. ### Claim 2 (depends on 1) The process according to claim 1, wherein taking the measurements from the set of physiological data of the patient comprises the step of: measuring distances between two anatomical parts. ### Claim 3 (depends on 1) The process according to claim 1, wherein taking the measurements from the set of physiological data of the patient comprises the step of: obtaining an anatomical shape. ### Claim 4 (depends on 1) The process according to claim 1, wherein the set of physiological data is presented in the form of patient images extracted from a DICOM (Digital Imaging and Communication in Medicine) file, from a scanner or from a scintigraphy scan. ### Claim 5 (depends on 1) The process according to claim 1, wherein the set of physiological data comprises mechanical properties of a tissue in said intended implant area of the patient. ### Claim 6 (depends on 1) The process according to claim 1, wherein the characteristics of the medical device, which are specific to additive manufacturing, comprise lattice structures. ### Claim 7 (depends on 1) The process according to claim 1, wherein the characteristics of the medical device, which are specific to additive manufacturing, comprise a customization of thickness of the medical device depending on stresses which will be applied to said medical device. ### Claim 8 (depends on 1) The process according to claim 1, wherein a geometric landmark is added to a shape of the medical device in order to be able to verify axial positioning. ### Claim 9 (depends on 1) The process according to claim 1, wherein the shape-memory material mainly comprises nickel and titanium. ### Claim 10 (depends on 9) The process according to claim 9, wherein the shape-memory material comprises an alloy with 55.4% nickel and 44.6% titanium, by weight. ### Claim 11 (depends on 1) The process according to claim 1, wherein the shape-memory material is in the form of a powder whose particle sizing is between 1 micrometer and 100 micrometers. ### Claim 12 (depends on 1) The process according to claim 1, wherein the 3D printer comprises an energy source that allows melting of a material, in a local manner. ### Claim 13 (depends on 12) The process according to claim 12, wherein the energy source is controlled in terms of speed and power, with values of between 1 mm/s and 10,000 mm/s and of between 1 W and 5000 W, respectively. ### Claim 14 (depends on 12) The process according to claim 12, wherein said energy source comprises a laser, including a YAG, yttrium or CO2 laser. ### Claim 15 (depends on 1) The process according to claim 1, comprising, after 3D printing the medical device, applying a post-processing step to the medical device to enhance geometric conformity or avoid deformations of the medical device. ### Claim 16 (depends on 15) The process according to claim 15, wherein the post-processing step comprises sanding, microbeading, shot-peening, passivation, electroplating, static chemical deposition, dynamic chemical deposition, polishing, heat treatment or chemical machining. ### Claim 17 (depends on 1) The process according to claim 1, wherein the medical device is a stent. ### Claim 18 (depends on 1) A computer program comprising computer program code means that make it possible to perform the steps according to claim 1 when said program is run on a computer.