# US 12,004,946 B2 · Prosthetic valve with improved washout > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,946 B2 - Document ID: US12004946B2 - Status: Granted - Kind: B2 - Application number: 17/178,802 - Filed: 2021-02-18 - Published: 2021-06-17 - Granted: 2024-06-11 - Earliest claimed: 2017-06-07 - Assignees: Edwards Lifesciences Corporation - Applicants: Edwards Lifesciences Corporation - Inventors: Kyle W Colavito; Dustin V Dienno; Logan R Hagaman; Cody L Hartman; Sudeep Sastry - Web page: https://patentgrep.com/patent/US12004946B2 ## CPC - 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 2/2475: {Venous valves} - A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable - A61F 2230/0095: Saddle-shaped - A61F 2250/0014: having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis - B01D 71/36: Polytetrafluoroethylene - 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) - B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28) ## Abstract Described embodiments are directed toward prosthetic valves having a support structure and at least one leaflet. The leaflet comprises means for allowing fluid that is behind the leaflet to pass through to the front of the leaflet when the leaflet is not in the closed position. The prosthetic valve includes a leaflet moveable between an open position that permits antegrade flow through the prosthetic valve and a closed position that prevents regurgitant flow through the prosthetic valve, the leaflet having an aperture or gap, or a separation of portions of the leaflet to allow a flow or exchange of fluid between a front and back of the leaflet, when the leaflet is not in the closed position. ## Claims ### Claim 1 A method for treating a native valve of a human patient, the method comprising: implanting at or adjacent to a location of the native valve a prosthetic valve comprising a plurality of leaflets, each leaflet having a first outflow free edge, wherein each leaflet is moveable between an open position that permits antegrade flow through the prosthetic valve and a closed position wherein the first outflow free edges of adjacent leaflets coapt with each other to prevent regurgitant flow through the prosthetic valve, each leaflet having a gap to allow a flow or exchange of fluid between a front and a back of the respective leaflet when the respective leaflet is not in the closed position, the prosthetic valve further comprising a support structure, wherein each leaflet is coupled to the support structure, wherein each leaflet includes a first leaflet component and a second leaflet component, wherein the first leaflet component is upstream of the second leaflet component, wherein the-gap for the flow or exchange of fluid between the front and the back of the respective leaflet is disposed between the first and second leaflet components when the respective leaflet is not in the closed position, wherein the second leaflet component comprises the first outflow free edge of the respective leaflet and an inflow free edge unattached to the support structure, wherein the plurality of leaflets comprise three leaflets each having the first and second leaflet components, and wherein the first outflow free edges of the three leaflets coapt in a tricuspid arrangement. ### Claim 2 (depends on 1) The method of claim 1, wherein the first leaflet component and the second leaflet component partially overlap. ### Claim 3 (depends on 2) The method of claim 2, wherein the first leaflet component comprises a first overlap region and the second leaflet component comprises a second overlap region, wherein the first and second overlap regions are in sealing engagement with one another when the respective leaflet is in the closed position. ### Claim 4 (depends on 3) The method of claim 3, wherein the first overlap region extends from a second outflow free edge of the first leaflet component and the second overlap region extends from the inflow free edge of the second leaflet component. ### Claim 5 (depends on 1) The method of claim 1, wherein the first leaflet component has a higher bending stiffness than the second leaflet component. ### Claim 6 (depends on 1) The method of claim 1, wherein the first and second leaflet components overlap and define an overlap region which tapers in width towards the support structure. ### Claim 7 (depends on 1) The method of claim 1, wherein a shape of each leaflet and a corresponding attachment region to a support structure is parabolic. ### Claim 8 (depends on 1) The method of claim 1, wherein each leaflet comprises a porous polymer membrane and a material present in pores of the porous polymer membrane such that the respective leaflet is impermeable. ### Claim 9 (depends on 8) The method of claim 8, wherein the porous polymer membrane is expanded polytetrafluoroethylene. ### Claim 10 (depends on 9) The method of claim 9, wherein the material present in the pores is an elastomer or an elastomeric material or a non-elastomeric material. ### Claim 11 (depends on 9) The method of claim 9, wherein the material present in the pores is a TFE/PMVE copolymer. ### Claim 12 (depends on 1) The method of claim 1, wherein each leaflet comprises a biological tissue. ### Claim 13 A method for reducing incidents of thrombus or reducing thrombus formation, the method comprising: implanting at or adjacent to a location of the native valve a prosthetic valve comprising a plurality of leaflets, the prosthetic valve further comprising a support structure, wherein each leaflet is coupled to the support structure, wherein each leaflet includes a first leaflet component and a second leaflet component, wherein the first leaflet component is upstream of the second leaflet component, wherein the second leaflet component has an outflow edge and an inflow edge and the first leaflet component has an outflow edge and an inflow edge, wherein the leaflets are moveable between an open position that permits antegrade flow through the prosthetic valve and a closed position in which the outflow edges of the second leaflet components coapt with each other to prevent regurgitant flow through the prosthetic valve, wherein when the leaflets are in the open position, antegrade blood can flow through a gap between the first and second leaflet components of each leaflet, wherein the plurality of leaflets comprise three leaflets each having the first and second leaflet components, and wherein the first outflow free edges of the three leaflets coapt in a tricuspid arrangement. ### Claim 14 (depends on 13) The method of claim 13, wherein the first leaflet component and the second leaflet component partially overlap. ### Claim 15 (depends on 14) The method of claim 14, wherein the first leaflet component comprises a first overlap region along the outflow edge of the first leaflet component and the second leaflet component comprises a second overlap region along the inflow edge of the second leaflet component, wherein the first and second overlap regions are in sealing engagement with one another when the respective leaflet is in the closed position. ### Claim 16 (depends on 15) The method of claim 15, wherein the first overlap region extends from the outflow edge of the first leaflet component and the second overlap region extends from the inflow edge of the second leaflet component. ### Claim 17 (depends on 13) The method of claim 13, wherein the first leaflet component has a higher bending stiffness than the second leaflet component. ### Claim 18 (depends on 13) The method of claim 13, wherein the first and second leaflet components overlap and define an overlap region which tapers in width towards the support structure. ### Claim 19 (depends on 13) The method of claim 13, wherein a shape of each leaflet and a corresponding attachment region to a support structure is parabolic. ### Claim 20 (depends on 13) The method of claim 13, wherein each leaflet comprises a porous polymer membrane and a material present in pores of the porous polymer membrane such that the respective leaflet is impermeable. ### Claim 21 (depends on 20) The method of claim 20, wherein the porous polymer membrane is expanded polytetrafluoroethylene. ### Claim 22 (depends on 21) The method of claim 21, wherein the material present in the pores is an elastomer or an elastomeric material or a non-elastomeric material. ### Claim 23 (depends on 21) The method of claim 21, wherein the material present in the pores is a TFE/PMVE copolymer. ### Claim 24 (depends on 13) The method of claim 13, wherein each leaflet comprises a biological tissue. ### Claim 25 (depends on 1) The method of claim 1, wherein, when each leaflet is in the closed position, the gap between the first and second leaflet components of the respective leaflet is closed to prevent the flow or exchange of fluid between the front and the back of the respective leaflet. ### Claim 26 (depends on 13) The method of claim 13, wherein, when each leaflet is in the closed position, the gap between the first and second leaflet components of the respective leaflet is closed to prevent the flow or exchange of fluid between the front and the back of the respective leaflet.