US7399315B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Minimally-invasive heart valve with cusp positioners
Assignee: Edwards Lifesciences Corp
•
Filing: 2003-03-18
•
Granted: 2008-07-15
•
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 M. Iobbi
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 01:25
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: 19
Claim 1
Independent Claim
244 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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 2
Dependent Claim
244 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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 3
Dependent Claim
40 words
The heart valve of claim 1 , wherein each of the two legs of each U-shaped cusp positioner is rigidly fixed to the collapsible leaflet frame at a location approximately midway between a cusp legion and a commissure region thereof.
Claim 4
Dependent Claim
21 words
The heart valve of claim 1 , further including an anti-migration member rigidly fixed to each cusp positioner and projecting therefrom.
Claim 5
Dependent Claim
292 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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; 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 6
Dependent Claim
292 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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; 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 7
Dependent Claim
56 words
The heart valve of claim 4 , 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 8
Dependent Claim
282 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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; wherein the fabric covering flange projects generally outwardly from the leaflet frame, and the cusp edges of the flexible leaflets extend radially outwardly past and underneath the leaflet frame, and are sewn to the fabric covering flange.
Claim 9
Dependent Claim
282 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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; wherein the fabric covering flange projects generally outwardly from the leaflet frame, and the cusp edges of the flexible leaflets extend radially outwardly past and underneath the leaflet frame, and are sewn to the fabric covering flange.
Claim 10
Dependent Claim
260 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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 11
Dependent Claim
260 words
A collapsible prosthetic heart valve, comprising: a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the 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 integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve; 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 12
Dependent Claim
229 words
A collapsible prosthetic heart valve, comprising: a continuous, collapsible leaflet frame shaped for implantation within a defective native heart valve, the frame having a periphery defined by only three U-shaped cusp regions intermediate three U-shaped commissure regions, the three U-shaped 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 U-shaped cusp regions defining at least a portion of a terminal end of the leaflet frame, the three U-shaped 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 U-shaped cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the U-shaped commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shaped commissure region, diverge on the outside of U-shaped commissure region, and are attached to the leaflet frame on the outside of the U-shaped commissure region.
Claim 13
Dependent Claim
229 words
A collapsible prosthetic heart valve, comprising: a continuous, collapsible leaflet frame shaped for implantation within a defective native heart valve, the frame having a periphery defined by only three U-shaped cusp regions intermediate three U-shaped commissure regions, the three U-shaped 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 U-shaped cusp regions defining at least a portion of a terminal end of the leaflet frame, the three U-shaped 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 U-shaped cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the U-shaped commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shaped commissure region, diverge on the outside of U-shaped commissure region, and are attached to the leaflet frame on the outside of the U-shaped commissure region.
Claim 14
Dependent Claim
292 words
A collapsible prosthetic heart valve, comprising: a continuous, collapsible leaflet frame having a periphery defined by only three U-shaped cusp regions intermediate three U-shaped commissure regions, the three U-shaped 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 U-shaped cusp regions defining at least a portion of a terminal end of the leaflet frame, the three U-shaped 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; 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 U-shaped cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the U-shaped commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shaped commissure region, diverge on the outside of U-shaped commissure region, and are attached to the leaflet frame on the outside of the U-shaped commissure region; 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, 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 15
Dependent Claim
292 words
A collapsible prosthetic heart valve, comprising: a continuous, collapsible leaflet frame having a periphery defined by only three U-shaped cusp regions intermediate three U-shaped commissure regions, the three U-shaped 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 U-shaped cusp regions defining at least a portion of a terminal end of the leaflet frame, the three U-shaped 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; 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 U-shaped cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the U-shaped commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shaped commissure region, diverge on the outside of U-shaped commissure region, and are attached to the leaflet frame on the outside of the U-shaped commissure region; 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, 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 16
Dependent Claim
55 words
The heart valve of claim 8 , 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 17
Dependent Claim
28 words
The heart valve of claim 10 , wherein an inflow periphery of the heart valve is defined along the alternating and rigidly fixed cusp regions and cusp connectors.
Claim 18
Dependent Claim
41 words
The heart valve of claim 8 , 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 19
Dependent Claim
44 words
The heart valve of claim 12 , 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.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2011-07-15 | 2012-01-14 | 2012-07-15 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2015-07-15 | 2016-01-14 | 2016-07-15 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2019-07-15 | 2020-01-14 | 2020-07-15 | $7700.00 | Window Closed / Lapsed |