# US 10,441,414 B2 · Method of making a prosthetic valve and valve obtained therewith > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,414 B2 - Document ID: US10441414B2 - Status: Granted - Kind: B2 - Application number: 15/309,003 - Filed: 2015-05-06 - Published: 2017-03-16 - Granted: 2019-10-15 - Earliest claimed: 2014-05-06 - Assignees: Dsm IP Assets B.V. - Applicants: DSM IP Assets B.V. - Inventors: Paul Frederik Grundeman; Jolanda Kluin; Karlien Kristel Boon-Ceelen; Thomas König - Web page: https://patentgrep.com/patent/US10441414B2 ## CPC - A61F 2/2415: {Manufacturing methods} - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable - 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) ## Abstract The present invention provides a method of making a prosthetic valve that can take a first form wherein the valve is open and a second form wherein the valve is closed, the valve comprising a leaflet assembly having at least one leaflet attached to a supporting element, the leaflet having a free margin that can move between a first position wherein the valve takes the first form and a second position wherein the valve takes the second form, the method comprising providing a textile structure, and forming the leaflet assembly from the textile structure, such that a selvedge of the textile structure forms the free margin of the leaflet, wherein the textile structure is made by weaving warp and fill threads into a two-layer woven fabric having two stacked and interconnected layers, the two layers having selvedges at one longitudinal edge, and wherein forming the leaflet assembly comprises connecting two lateral edges of a single piece of the fabric to make a substantially tubular structure wherein the inner layer forms the leaflet and the outer layer forms the supporting element. With this method a prosthetic valve can be made with little process variability and errors, and resulting in a valve with high reliability and durability. The invention also relates to a method of making a leaflet assembly, and to a leaflet assembly and a prosthetic valve obtainable by said methods. ## Claims ### Claim 1 A method of making a prosthetic valve that can take a first form wherein the valve is open and a second form wherein the valve is closed, the valve comprising a leaflet assembly having at least one leaflet attached to a supporting element, the leaflet having a free margin that can move between a first position wherein the valve takes the first form and a second position wherein the valve takes the second form, the method comprising: (i) providing a textile structure having woven warp and fill threads forming a two-layer double weave fabric having two stacked and interconnected layers and crossing threads between the two layers, wherein the two layers have selvedges at one longitudinal edge and a continuous connection at an opposite edge to the one longitudinal edge, and wherein the two-layer woven fabric includes further connections between the two layers which create different sections that pre-define one or more leaflets in a layer; and (ii) forming the leaflet assembly from the textile structure by connecting two lateral edges of a single piece of the fabric to make a substantially tubular structure such that an inner layer forms the leaflet and an outer layer forms the supporting element and such that a selvedge of the textile structure forms the free margin of the leaflet. ### Claim 2 (depends on 1) The method according to claim 1, wherein the prosthetic valve has two or three leaflets. ### Claim 3 (depends on 1) The method according to claim 1, wherein the fabric has a different number of warp threads in each of the two layers to thereby define different lateral widths of the two layers. ### Claim 4 (depends on 1) The method according to claim 1, wherein one layer of the two layers in the fabric has a locally increased increasing the number of fill threads to thereby establish a different length of the one layer relative to another of the two layers. ### Claim 5 (depends on 1) The method according to claim 1, wherein the single piece of fabric is made in a continuous weaving operation as a continuous fabric that is cut into pieces of desired length, and optionally cut edges are stabilized. ### Claim 6 (depends on 1) The method according to claim 1, wherein the fabric contains layers with single layer thickness of 20-200 μm. ### Claim 7 (depends on 1) The method according to claim 1, wherein the warp and fill threads have a linear density of less than 120 dtex. ### Claim 8 (depends on 1) The method according to claim 1, wherein the warp and fill threads have a linear density of between 5 and 30 dtex. ### Claim 9 (depends on 1) The method according to claim 1, wherein the warp and fill threads comprise ultra-high molecular weight polyethylene (UHMWPE) yarn. ### Claim 10 (depends on 1) The method according to claim 1, wherein the prosthetic valve has three leaflets, and wherein the free margin of the leaflets has an excess length, relative to a minimum length needed for closing the valve, of at least 7%. ### Claim 11 (depends on 1) The method according to claim 1, further comprising attaching the leaflet assembly to a stent. ### Claim 12 (depends on 1) A method of making a leaflet assembly for a prosthetic valve as described in claim 1.