US20040186563A1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Minimally-invasive heart valve with cusp positioners
Assignee: Edwards Lifesciences Corp
•
Filing: 2003-03-18
•
Granted: —
•
Expires: 2023-03-18
Abstract
Abstract A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised, or the aortic wall if they are. The support frame may be formed from a flat sheet of Nitinol that is bent into a three-dimensional configuration and heat set. A holder having spring-like arms connected to inflow projections of the valve may be used to deliver, reposition and re-collapse the valve, if necessary.
Inventors
- 👤 Mario Lobbi
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:41
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2427; A61F2/243; A61F2/2412; A61F2/2418; A61F2/2436; A61B; A61B17/00; A61B17/22; A61B17/221; A61F2/95; A61F2/9522; A61F2/9525; A61F2220/00; A61F2220/0008; A61F2220/0016; A61F2220/0025; A61F2220/0066; A61F2220/0075
Claims Analysis
Total Claims: 55
Claim 1
Independent Claim
127 words
1 . A prosthetic heart valve support frame, comprising: a continuous, undulating valve leaflet frame that mimics the natural fibrous structure of an aortic valve, the leaflet frame having three cusp regions alternating with and intermediate three commissure regions, the three cusp regions being positioned at an inflow end of the support frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at an outflow end of the support frame and circumferentially about the flow axis; and three cusp positioners rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp positioner being located at the outflow end of the support frame and intermediate two of the commissure regions of the leaflet frame.
Claim 2
Dependent Claim
127 words
1 . A prosthetic heart valve support frame, comprising: a continuous, undulating valve leaflet frame that mimics the natural fibrous structure of an aortic valve, the leaflet frame having three cusp regions alternating with and intermediate three commissure regions, the three cusp regions being positioned at an inflow end of the support frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at an outflow end of the support frame and circumferentially about the flow axis; and three cusp positioners rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp positioner being located at the outflow end of the support frame and intermediate two of the commissure regions of the leaflet frame.
Claim 3
Dependent Claim
26 words
2 . The heart valve support frame of claim 1 , wherein the leaflet frame and the cusp positioners are formed integrally as a single piece.
Claim 4
Dependent Claim
41 words
3 . The heart valve support frame of claim 2 , wherein the support frame is formed by a process comprising: providing a two-dimensional blank of the support frame; and forming the two-dimensional blank into the three-dimensional heart valve support frame.
Claim 5
Dependent Claim
23 words
4 . The heart valve support frame of claim 1 , wherein the leaflet frame and the cusp positioners are made of Nitinol.
Claim 6
Dependent Claim
36 words
5 . The heart valve support frame of claim 1 , wherein the Nitinol has a martensitic transition temperature of less than about 5° C. and an austenitic transition temperature of more than about 20° C.
Claim 7
Dependent Claim
44 words
6 . The heart valve support frame of claim 1 , wherein each cusp positioner has a U-shape with an apex of the U-shape pointing toward the outflow end of the support frame and two legs of the U-shape pointing toward the inflow end.
Claim 8
Dependent Claim
44 words
7 . The heart valve support frame of claim 6 , wherein each of the two legs of each U-shaped cusp positioner is rigidly fixed to the continuous leaflet frame at a location approximately midway between a cusp region and a commissure region thereof.
Claim 9
Dependent Claim
25 words
8 . The heart valve support frame of claim 6 , further including an anti-migration member rigidly fixed to each cusp positioner and projecting therefrom.
Claim 10
Dependent Claim
26 words
9 . The heart valve support frame of claim 8 , wherein each anti-migration member comprises an elongated section terminating in an enlarged and rounded head.
Claim 11
Dependent Claim
59 words
10 . The heart valve support frame of claim 1 , wherein the support frame further includes three cusp connectors rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp connector being located at the inflow end of the support frame and intermediate two of the cusp regions of the leaflet frame.
Claim 12
Dependent Claim
44 words
11 . The heart valve support frame of claim 10 , wherein each cusp connector has a U-shape with an apex of the U-shape pointing toward the inflow end of the support frame and two legs of the U-shape pointing toward the outflow end.
Claim 13
Dependent Claim
60 words
12 . The heart valve support frame of claim 10 , wherein the leaflet frame, cusp positioners, and cusp connectors are formed integrally as a single piece, and wherein the three cusp positioners and three cusp connectors define a continuous, undulating shape that generally mimics the shape of the leaflet frame but is rotated 60° about the flow axis therefrom.
Claim 14
Dependent Claim
24 words
13 . The heart valve support frame of claim 1 , wherein the cusp positioners flare outwardly from the rest of the support frame.
Claim 15
Dependent Claim
178 words
14 . A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having three cusp regions intermediate three commissure regions, the three cusp regions being positioned at an inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at an outflow end of the leaflet frame and circumferentially about the flow axis; three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions; and three cusp positioners rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp positioner being located at the outflow end of the leaflet frame and intermediate two of the commissure regions of the leaflet frame.
Claim 16
Dependent Claim
178 words
14 . A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having three cusp regions intermediate three commissure regions, the three cusp regions being positioned at an inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at an outflow end of the leaflet frame and circumferentially about the flow axis; three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions; and three cusp positioners rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp positioner being located at the outflow end of the leaflet frame and intermediate two of the commissure regions of the leaflet frame.
Claim 17
Dependent Claim
42 words
15 . The heart valve of claim 14 , wherein each cusp positioner has a U-shape with an apex of the U-shape pointing toward the outflow end of the leaflet frame and two legs of the U-shape pointing toward the inflow end.
Claim 18
Dependent Claim
42 words
16 . The heart valve of claim 15 , wherein each of the two legs of each U-shaped cusp positioner is rigidly fixed to the continuous leaflet frame at a location approximately midway between a cusp region and a commissure region thereof.
Claim 19
Dependent Claim
23 words
17 . The heart valve of claim 15 , further including an anti-migration member rigidly fixed to each cusp positioner and projecting therefrom.
Claim 20
Dependent Claim
57 words
18 . The heart valve of claim 14 , wherein the heart valve further includes three cusp connectors rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp connector being located at the inflow end of the leaflet frame and intermediate two of the cusp regions of the leaflet frame.
Claim 21
Dependent Claim
42 words
19 . The heart valve of claim 18 , wherein each cusp connector has a U-shape with an apex of the U-shape pointing toward the inflow end of the leaflet frame and two legs of the U-shape pointing toward the outflow end.
Claim 22
Dependent Claim
58 words
20 . The heart valve of claim 19 , wherein the leaflet frame, cusp positioners, and cusp connectors are formed integrally as a single piece, and wherein the three cusp positioners and three cusp connectors define a continuous, undulating shape that generally mimics the shape of the leaflet frame but is rotated 60° about the flow axis therefrom.
Claim 23
Dependent Claim
30 words
21 . The heart valve of claim 18 , wherein an inflow periphery of the heart valve is defined along the alternating and rigidly fixed cusp regions and cusp connectors.
Claim 24
Dependent Claim
45 words
22 . The heart valve of claim 21 , wherein the inflow periphery has an external fabric covering, and wherein the heart valve further includes a fabric panel defining an exterior surface of the heart valve between each pair of cusp positioner and cusp connector.
Claim 25
Dependent Claim
43 words
23 . The heart valve of claim 14 , wherein the leaflet frame has a fabric covering along substantially its entire length, the fabric covering defining a flange, wherein the arcuate cusp edges of the flexible leaflets attach to the fabric covering flange.
Claim 26
Dependent Claim
46 words
24 . The heart valve of claim 23 , wherein the fabric covering flange projects generally outward from the leaflet frame and the cusp edges of the flexible leaflets extend radially outward past and underneath the leaflet frame and are sewn to the fabric covering flange.
Claim 27
Dependent Claim
58 words
25 . The heart valve of claim 14 , wherein each flexible leaflet has a pair of tabs extending on either side of its free edge, wherein two tabs of adjacent flexible leaflets meet and pass together to the outside of the adjacent commissure region of the leaflet frame and are attached thereto using sutures through the tabs.
Claim 28
Dependent Claim
191 words
26 . A collapsible prosthetic heart valve, comprising: a continuous, collapsible leaflet frame having three U-shaped cusp regions intermediate three U-shaped commissure regions, the three cusp regions being positioned at an inflow end of the leaflet frame and circumferentially about a flow axis defined within the leaflet frame, the three commissure regions being positioned at an outflow end of the leaflet frame and circumferentially about the flow axis; a cloth covering extending around the leaflet frame; and three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shape commissure region, diverge on the outside of commissure region, and are attached to the leaflet frame on the outside of the commissure region.
Claim 29
Dependent Claim
191 words
26 . A collapsible prosthetic heart valve, comprising: a continuous, collapsible leaflet frame having three U-shaped cusp regions intermediate three U-shaped commissure regions, the three cusp regions being positioned at an inflow end of the leaflet frame and circumferentially about a flow axis defined within the leaflet frame, the three commissure regions being positioned at an outflow end of the leaflet frame and circumferentially about the flow axis; a cloth covering extending around the leaflet frame; and three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shape commissure region, diverge on the outside of commissure region, and are attached to the leaflet frame on the outside of the commissure region.
Claim 30
Dependent Claim
86 words
27 . The prosthetic heart valve of claim 26 , further comprising three cusp positioners rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp positioner being located at the outflow end of the support frame and intermediate two of the commissure regions of the leaflet frame, each cusp positioner having a U-shape with an apex of the U-shape pointing toward the outflow end of the leaflet frame and two legs of the U-shape pointing toward the inflow end.
Claim 31
Dependent Claim
57 words
28 . The heart valve of claim 26 , wherein the heart valve further includes three cusp connectors rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp connector being located at the inflow end of the leaflet frame and intermediate two of the cusp regions of the leaflet frame.
Claim 32
Dependent Claim
30 words
29 . The heart valve of claim 28 , wherein an inflow periphery of the heart valve is defined along the alternating and rigidly fixed cusp regions and cusp connectors.
Claim 33
Dependent Claim
43 words
30 . The heart valve of claim 26 , wherein the leaflet frame has a fabric covering along substantially its entire length, the fabric covering defining a flange, wherein the arcuate cusp edges of the flexible leaflets attach to the fabric covering flange.
Claim 34
Dependent Claim
46 words
31 . The heart valve of claim 30 , wherein the fabric covering flange projects generally outward from the leaflet frame and the cusp edges of the flexible leaflets extend radially outward past and underneath the leaflet frame and are sewn to the fabric covering flange.
Claim 35
Dependent Claim
131 words
32 . A method of implanting a prosthetic aortic heart valve, comprising: providing a collapsible prosthetic heart valve having a collapsible leaflet frame defined by three cusp regions on an inflow end of the valve intermediate three commissure regions on an outflow end of the valve, the valve further including three cusp positioners on the outflow end and intermediate the three commissure regions; collapsing the prosthetic heart valve within a delivery tube; advancing the prosthetic heart valve within the delivery tube to an aortic annulus; expelling the prosthetic heart valve from the delivery tube by relative movement therebetween; expanding the prosthetic heart valve; and positioning the prosthetic heart valve such that the cusp positioners contact the two coronary and one non-coronary sinuses of the ascending aorta without blocking the coronary ostia.
Claim 36
Dependent Claim
131 words
32 . A method of implanting a prosthetic aortic heart valve, comprising: providing a collapsible prosthetic heart valve having a collapsible leaflet frame defined by three cusp regions on an inflow end of the valve intermediate three commissure regions on an outflow end of the valve, the valve further including three cusp positioners on the outflow end and intermediate the three commissure regions; collapsing the prosthetic heart valve within a delivery tube; advancing the prosthetic heart valve within the delivery tube to an aortic annulus; expelling the prosthetic heart valve from the delivery tube by relative movement therebetween; expanding the prosthetic heart valve; and positioning the prosthetic heart valve such that the cusp positioners contact the two coronary and one non-coronary sinuses of the ascending aorta without blocking the coronary ostia.
Claim 37
Dependent Claim
40 words
33 . The method of claim 32 , further including: connecting a holder having flexible members to the commissure regions of the prosthetic heart valve and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.
Claim 38
Dependent Claim
35 words
34 . The method of claim 33 , further including: connecting flexible members of the holder to the cusp positioners and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.
Claim 39
Dependent Claim
25 words
35 . The method of claim 33 , further including utilizing the flexible members to rotate the prosthetic heart valve during the step of positioning.
Claim 40
Dependent Claim
25 words
36 . The method of claim 33 , further including utilizing the flexible members to re-collapse the prosthetic heart valve after the step of expanding.
Claim 41
Dependent Claim
54 words
37 . The method of claim 32 , wherein the prosthetic heart valve is expanded in a location that is inferior to a final implant position such that the cusp positioners contact the surrounding aortic annulus, and the step of positioning comprises displacing the valve in a superior direction to a final implant position.
Claim 42
Dependent Claim
65 words
38 . The method of claim 37 , wherein the cusp positioners are flared outward to define a circle about a flow axis of the valve greater than a circle about the flow axis defined by the three commissure regions, and wherein the step of displacing the valve in a superior direction causes the outwardly flared cusp positioners to be channeled into perspective coronary sinuses.
Claim 43
Dependent Claim
54 words
39 . The method of claim 32 , wherein the collapsible leaflet frame is formed of a shape memory alloy having an austenitic transition temperature less than body temperature, and wherein the step of collapsing is done with the material of the leaflet frame at a temperature at or below its martensitic transition temperature.
Claim 44
Dependent Claim
47 words
40 . The method of claim 39 , wherein the step of collapsing is done in conjunction with immersing the prosthetic heart valve in an ice bath to reduce the temperature of the material of leaflet frame to less than or equal to its martensitic transition temperature.
Claim 45
Dependent Claim
70 words
41 . The method of claim 32 , wherein the collapsible leaflet frame is formed of a shape memory alloy having a memory condition in its expanded state, and wherein the step of expanding the prosthetic heart valve comprises both permitting self-expansion of the valve to an intermediate diameter and then using a physical expander to increase the diameter of the valve to the memory condition of the leaflet frame.
Claim 46
Dependent Claim
52 words
42 . A method of implanting a collapsible prosthetic heart valve, comprising: providing a self-expanding valve comprised of a material displaying hysteresis in the elastic or superelastic region; permitting the valve to self-expand to a first diameter; and assisting the valve with a physical expander to further expand to a second diameter.
Claim 47
Dependent Claim
52 words
42 . A method of implanting a collapsible prosthetic heart valve, comprising: providing a self-expanding valve comprised of a material displaying hysteresis in the elastic or superelastic region; permitting the valve to self-expand to a first diameter; and assisting the valve with a physical expander to further expand to a second diameter.
Claim 48
Dependent Claim
59 words
43 . The method of claim 42 , wherein the prosthetic heart valve includes a collapsible leaflet frame formed of a shape memory alloy having an austenitic transition temperature less than body temperature, and further including a step of collapsing the valve with the material of the leaflet frame at a temperature at or below its martensitic transition temperature.
Claim 49
Dependent Claim
47 words
44 . The method of claim 43 , wherein the step of collapsing is done in conjunction with immersing the prosthetic heart valve in an ice bath to reduce the temperature of the material of leaflet frame to less than or equal to its martensitic transition temperature.
Claim 50
Dependent Claim
15 words
45 . The method of claim 42 , wherein the physical expander is a balloon.
Claim 51
Dependent Claim
140 words
46 . The method of claim 42 , wherein the prosthetic heart valve has a collapsible leaflet frame defined by three cusp regions on an inflow end of the valve intermediate three commissure regions on an outflow end of the valve, the valve further including three cusp positioners on the outflow end and intermediate the three commissure regions, the method further including: collapsing the prosthetic heart valve within a delivery tube; advancing the prosthetic heart valve within the delivery tube to an aortic annulus; expelling the prosthetic heart valve from the delivery tube by relative movement therebetween; expanding the prosthetic heart valve by the steps of permitting self-expansion and assisting further expansion; and positioning the prosthetic heart valve such that the cusp positioners contact the two coronary and one non-coronary sinuses of the ascending aorta without blocking the coronary ostia.
Claim 52
Dependent Claim
40 words
47 . The method of claim 46 , further including: connecting a holder having flexible members to the commissure regions of the prosthetic heart valve and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.
Claim 53
Dependent Claim
35 words
48 . The method of claim 47 , further including: connecting flexible members of the holder to the cusp positioners and utilizing the flexible members to perform the step of positioning the prosthetic heart valve.
Claim 54
Dependent Claim
25 words
49 . The method of claim 47 , further including utilizing the flexible members to rotate the prosthetic heart valve during the step of positioning.
Claim 55
Dependent Claim
25 words
50 . The method of claim 47 , further including utilizing the flexible members to re-collapse the prosthetic heart valve after the step of expanding.
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