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1. (WO2019042961) TISSUE-ENGINEERED MEDICAL DEVICE
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Pub. No.: WO/2019/042961 International Application No.: PCT/EP2018/073076
Publication Date: 07.03.2019 International Filing Date: 28.08.2018
IPC:
A61L 27/18 (2006.01) ,A61L 27/34 (2006.01) ,A61L 27/36 (2006.01) ,A61L 27/38 (2006.01) ,A61L 27/50 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
L
METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27
Materials for prostheses or for coating prostheses
14
Macromolecular materials
18
obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
L
METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27
Materials for prostheses or for coating prostheses
28
Materials for coating prostheses
34
Macromolecular materials
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
L
METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27
Materials for prostheses or for coating prostheses
36
containing ingredients of undetermined constitution or reaction products thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
L
METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27
Materials for prostheses or for coating prostheses
36
containing ingredients of undetermined constitution or reaction products thereof
38
Animal cells
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
L
METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27
Materials for prostheses or for coating prostheses
50
Materials characterised by their function or physical properties
Applicants:
UNIVERSITÄT ZÜRICH [CH/CH]; Prorektorat VNW Rämistrasse 71 8006 Zürich, CH
Inventors:
HOERSTRUP, Simon P.; CH
EMMERT, Maximilian Y.; CH
BAAIJENS, Frank; NL
DRIESSEN-MOL, Anita; NL
Agent:
PESTALOZZI, Deborah; CH
Priority Data:
17189221.904.09.2017EP
Title (EN) TISSUE-ENGINEERED MEDICAL DEVICE
(FR) DISPOSITIF MÉDICAL OBTENU PAR GÉNIE TISSULAIRE
Abstract:
(EN) The present invention concerns a tissue-engineered medical device, as well as a method for the production said medical device, comprising the following steps: providing a polymer scaffold comprising a mesh comprising polyglycolic acid, and a coating comprising poly-4-hydroxybutyrate; application of a cell suspension containing preferably human cells to the polymer scaffold; placement of the seeded polymer scaffold in a bioreactor and mechanical stimulation by exposure to a pulsatile flux of incremental intensity, thereby forming an extracellular matrix; mounting of the graft on a conduit stabilizer and incubation in cell culture medium; decellularisation of the graft in a washing solution; nuclease treatment of the graft; and rinsing of graft. The invention further comprises and various steps of quality control of the tissue-engineered medical device.
(FR) La présente invention concerne un dispositif médical obtenu par génie tissulaire, ainsi qu'un procédé de production dudit dispositif médical, comprenant les étapes suivantes: la fourniture d'un échafaudage polymère comprenant une maille comprenant de l'acide polyglycolique, et un revêtement comprenant du poly-4-hydroxybutyrate; l'application d'une suspension cellulaire contenant de préférence des cellules humaines à l'échafaudage polymère; la mise en place de l'échafaudage polymère ensemencé dans un bioréacteur et une stimulation mécanique par exposition à un flux pulsatile d'intensité incrémentielle, formant ainsi une matrice extracellulaire; le montage du greffon sur un stabilisateur de conduit et l'incubation dans un milieu de culture cellulaire; la décellularisation du greffon dans une solution de lavage; le traitement par nucléase du greffon; et le rinçage du greffon. L'invention comprend en outre diverses étapes de contrôle de qualité du dispositif médical obtenu par génie tissulaire.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)