# US 10,441,415 B2 · Heart valves with increased effective orifice area > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,415 B2 - Document ID: US10441415B2 - Status: Granted - Kind: B2 - Application number: 14/488,728 - Filed: 2014-09-17 - Published: 2015-03-26 - Granted: 2019-10-15 - Earliest claimed: 2013-09-20 - Assignees: Edwards Lifesciences Corporation - Applicants: Edwards Lifesciences Corporation - Inventors: Derrick Johnson; Van Le Huynh; Qinggang Zeng - Web page: https://patentgrep.com/patent/US10441415B2 ## CPC - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)} - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2210/00: Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof - A61F 2250/006: modular - A61F 2310/00389: The prosthesis being coated or covered with a particular material - 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 A prosthetic heart valve for implant in a human. The valve includes a wireform with undulating inflow cusps and outflow commissure posts to which flexible leaflets attach and coapt in a flow area. Each leaflet may drape over the top of the wireform in the cusp area, but have tabs that each extend underneath the wireform at the commissure posts to be secured along with a tab of an adjacent leaflet. The prosthetic heart valve may also be a dual-wire wireform, with the leaflets sandwiched therebetween. One wireform may be larger than the other, with the leaflets extending over the smaller wireform. The smaller wireform may have commissures that bend radially outward from the larger wireform to provide structure to which the leaflet tabs attach. ## Claims ### Claim 1 A prosthetic heart valve, comprising: a first undulating wireform comprising an elongated rod-like structure having a peripheral shape continuously alternating around a central axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end; a second undulating wireform comprising an elongated rod-like structure having a peripheral shape continuously alternating around the axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end, wherein the first and second wireforms are separate elements, wherein the cusps and commissures of the two wireforms are circumferentially aligned around the axis with the aligned cusps positioned adjacent to one another while the commissures of the first wireform are shorter in height than the commissures of the second wireform, and wherein the heart valve has no rigid annular components; and wherein the heart valve has no rigid annular components; and a plurality of flexible leaflets having outer edges secured at the cusps of the first and second undulating wireforms, wherein the cusps of the first wireform are located axially below the cusps of the second wireform and the outer edges of the flexible leaflets are secured therebetween. ### Claim 2 (depends on 1) The heart valve of claim 1, wherein both the first wireform and second wireform are covered with fabric and wherein the flexible leaflets have commissure tabs that extend outward through the inverted U-shaped commissures of the second fabric-covered wireform and are secured to cloth tabs extending from the fabric covering on the second wireform. ### Claim 3 (depends on 1) The heart valve of claim 1, wherein a cross-sectional shape through the first wireform is dissimilar from a cross-sectional shape through the second wireform. ### Claim 4 (depends on 1) The heart valve of claim 1, wherein both the first wireform and second wireform are covered with fabric and the outer edges of the flexible leaflets are secured between the respective cusps with sutures. ### Claim 5 (depends on 1) The heart valve of claim 1, wherein the flexible leaflets each have commissure tabs that extend outward through the commissures of the second wireform and are secured to cloth tabs extending from a cloth covering on the second wireform. ### Claim 6 (depends on 5) The heart valve of claim 5, wherein an assembly of the leaflet commissure tabs and cloth tabs on adjacent portions of each commissure of the second cloth-covered wireform is rolled or folded and sewn together outside of that commissure. ### Claim 7 (depends on 1) The heart valve of claim 1, wherein both the first wireform and second wireform are covered with fabric and a cloth tab on one of the wireforms encompasses a small piece of silicone ribbon at least at the cusps thereof to provide a sewing ring. ### Claim 8 (depends on 1) The heart valve of claim 1, wherein the cusps of both wireforms curve in an inflow direction and the commissures of the second wireform define upstanding commissure posts with inverted U-shapes projecting in an outflow direction, and the commissures of the first wireform are about one half the height of the commissures of the second wireform. ### Claim 9 (depends on 1) The heart valve of claim 1, wherein both the first wireform and second wireform are separately covered with fabric and then joined with sutures with outer edges of the flexible leaflets sandwiched therebetween. ### Claim 10 (depends on 1) The heart valve of claim 1, wherein both the first wireform and second wireform are formed of the same material. ### Claim 11 A prosthetic heart valve, comprising: a first undulating wireform comprising a preformed wire having a peripheral shape continuously alternating around a central axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end; a second undulating wireform comprising a preformed wire having a peripheral shape continuously alternating around the axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end, wherein the first and second wireforms are separate elements; wherein the cusps and commissures of the two wireforms are circumferentially aligned around the axis with the aligned cusps positioned adjacent to one another while the commissures of the first wireform are shorter in height than the commissures of the second wireform, and wherein the heart valve has no rigid annular components; and wherein the heart valve has no rigid annular components; and a plurality of flexible leaflets having outer edges secured at the cusps of the first and second undulating wireforms, wherein the second wireform is located axially above the first wireform with no axially overlapping portions. ### Claim 12 (depends on 11) The heart valve of claim 11, wherein both the first wireform and second wireform are covered with fabric and the outer edges of the flexible leaflets are secured between the respective cusps with sutures. ### Claim 13 (depends on 11) The heart valve of claim 11, wherein the cusps of both wireforms curve in an inflow direction and the commissures of the second wireform define upstanding commissure posts with inverted U-shapes projecting in an outflow direction, and the commissures of the first wireform are about one half the height of the commissures of the second wireform. ### Claim 14 (depends on 11) The heart valve of claim 11, wherein both the first wireform and second wireform are formed of the same material. ### Claim 15 (depends on 11) The heart valve of claim 11, wherein both the first wireform and second wireform are separately covered with fabric and then joined with sutures with outer edges of the flexible leaflets sandwiched therebetween. ### Claim 16 (depends on 11) The heart valve of claim 11, wherein the flexible leaflets each have commissure tabs that extend outward through the commissures of the second wireform and are secured to cloth tabs extending from a cloth covering on the second wireform. ### Claim 17 (depends on 16) The heart valve of claim 16, wherein an assembly of the leaflet commissure tabs and cloth tabs on adjacent portions of each commissure of the second cloth-covered wireform is rolled or folded and sewn together outside of that commissure. ### Claim 18 (depends on 11) The heart valve of claim 11, wherein both the first wireform and second wireform are covered with fabric and a cloth tab on one of the wireforms encompasses a small piece of silicone ribbon at least at the cusps thereof to provide a sewing ring. ### Claim 19 (depends on 11) The heart valve of claim 11, wherein the first and second undulating wireforms are cloth-covered, and the outer edges of the flexible leaflets are sandwiched between the cusps of the first and second wireforms. ### Claim 20 (depends on 11) The heart valve of claim 11, wherein the cusps of both wireforms curve in an inflow direction and the commissures of the second wireform define upstanding commissure posts with inverted U-shapes projecting in an outflow direction, and the first wireform has truncated commissures of about one half the height of the commissures of the second wireform.