US6767362B2
Expired / Lapsed
US
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Minimally-invasive heart valves and methods of use
Assignee: Edwards Lifesciences Corp
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Filing: 2002-06-28
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Granted: 2004-07-27
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Expires: 2022-06-28
Abstract
Abstract Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves may be implanted using a balloon catheter. Preferably, the leaflets of the heart valves are secured to the commissure regions of the expandable stents using a clamping arrangement to reduce stress.
Inventors
- 👤 Stefan Schreck
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:50
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2427; A61F2/243; A61F2/2433; A61F2/2412; A61F2/2418; A61F2/2436; A61F2/2469; A61F2220/00; A61F2220/0008; A61F2220/0016; A61F2220/0025; A61F2220/0075; Y; Y10; Y10S; Y10S623/00; Y10S623/90
Claims Analysis
Total Claims: 16
Claim 1
Independent Claim
209 words
A method of minimally-invasive heart valve replacement surgery on a patient, comprising: providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, and wherein a plurality of prosthetic leaflets are attached to the stent, each leaflet having an approximately semi-circular cusp edge terminating at each end in commissure portions, and a coapting edge extending between the commissure portions, each leaflet being attached to the stent substantially entirely along the cusp edge and at bath commissure portions in a manner that provides continuous support for each leaflet along the cusp edge, with a coapting edge remaining unattached, wherein the stent comprises a wireform defining alternating commissures and arcuate cusps, the cusp edge of each prosthetic leaflet being attached along a wireform cusp, wherein the commissure portions of the prosthetic leaflets terminate in outwardly extending tabs that each attach to a wireform commissure, and wherein tabs from adjacent leaflets are attached together at each of the wireform commissures; storing the stent in an expanded configuration; compressing the stent just prior to implantation; delivering the compressed stent through a tube to a heart valve annulus; and expanding the stent so that the leaflets form a one-way valve at the heart valve annulus.
Claim 2
Independent Claim
209 words
A method of minimally-invasive heart valve replacement surgery on a patient, comprising: providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, and wherein a plurality of prosthetic leaflets are attached to the stent, each leaflet having an approximately semi-circular cusp edge terminating at each end in commissure portions, and a coapting edge extending between the commissure portions, each leaflet being attached to the stent substantially entirely along the cusp edge and at bath commissure portions in a manner that provides continuous support for each leaflet along the cusp edge, with a coapting edge remaining unattached, wherein the stent comprises a wireform defining alternating commissures and arcuate cusps, the cusp edge of each prosthetic leaflet being attached along a wireform cusp, wherein the commissure portions of the prosthetic leaflets terminate in outwardly extending tabs that each attach to a wireform commissure, and wherein tabs from adjacent leaflets are attached together at each of the wireform commissures; storing the stent in an expanded configuration; compressing the stent just prior to implantation; delivering the compressed stent through a tube to a heart valve annulus; and expanding the stent so that the leaflets form a one-way valve at the heart valve annulus.
Claim 3
Dependent Claim
75 words
The method of claim 1 , further including: providing an annular tissue-engaging base, the base being expandable from a collapsed state; connecting the wireform and leaflets to the base to form a heart valve; delivering the heart valve with the connected base in its collapsed state and wireform in its compressed size to an annulus of the patient's heart valve being replaced; and expanding the base into its expanded state in contact with the annulus.
Claim 4
Dependent Claim
20 words
The method of claim 2 , wherein the tissue-engaging base is plastically-expandable from its collapsed state to its expanded state.
Claim 5
Dependent Claim
22 words
The method of claim 3 , including the step of expanding the tissue-engaging base by inflating a balloon within the tissue-engaging base.
Claim 6
Dependent Claim
30 words
The method of claim 1 , wherein the step of delivering the compressed stent through a tube to the annulus is accomplished by passing the valve through the patient's vasculature.
Claim 7
Dependent Claim
34 words
The method of claim 5 , wherein the step of delivering the compressed stent through a tube to the annulus is accomplished by passing the valve through a catheter introduced into a peripheral artery.
Claim 8
Dependent Claim
45 words
The method of claim 6 , wherein the step of delivering the compressed stent through a tube to the annulus is accomplished by passing the valve through a catheter introduced into the femoral artery and advanced through the iliac artery, abdominal aorta and aortic arch.
Claim 9
Dependent Claim
30 words
The method of claim 1 , wherein the step of delivering the compressed stent through a tube to the annulus is accomplished via a minimally-invasive port in the patient's chest.
Claim 10
Dependent Claim
68 words
The method of claim 1 , wherein the tabs from adjacent leaflets extend outward between spaced wires of the wireform commissure, and wherein inserts are provided around which the adjacent leaflet tabs wrap and are secured, the inserts being size larger than the distance that the wires of the wireform commissure are spaced apart so as to maintain the leaflet tabs on the outside of the wireform commissure.
Claim 11
Independent Claim
194 words
A method of minimally-invasive heart valve replacement surgery on a patient, comprising: providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, the stent defining a plurality of upstanding commissures and a plurality of arcuate cusps, one cusp each between adjacent commissures, wherein a plurality of prosthetic leaflets are attached to the stent along the cusps and commissures in a manner that provides continuous support for each leaflet along the stern cusps, wherein the stent and leaflets are configured to be radially compressed, wherein the stent comprises a wireform, and wherein the prosthetic leaflets each have a cusp edge attached along a wireform cusp, and the prosthetic leaflets each have a pair of commissure portions terminating in outwardly extending tabs that each attach to a wireform commissure, wherein tabs from adjacent leaflets are attached together at each of the wireform commissures; storing the stent in an expanded configuration; compressing the stent just prior to implantation; delivering the compressed stent through a tube to a heart valve annulus; and expanding the stent so that the leaflets form a one-way valve at the heart valve annulus.
Claim 12
Independent Claim
194 words
A method of minimally-invasive heart valve replacement surgery on a patient, comprising: providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, the stent defining a plurality of upstanding commissures and a plurality of arcuate cusps, one cusp each between adjacent commissures, wherein a plurality of prosthetic leaflets are attached to the stent along the cusps and commissures in a manner that provides continuous support for each leaflet along the stern cusps, wherein the stent and leaflets are configured to be radially compressed, wherein the stent comprises a wireform, and wherein the prosthetic leaflets each have a cusp edge attached along a wireform cusp, and the prosthetic leaflets each have a pair of commissure portions terminating in outwardly extending tabs that each attach to a wireform commissure, wherein tabs from adjacent leaflets are attached together at each of the wireform commissures; storing the stent in an expanded configuration; compressing the stent just prior to implantation; delivering the compressed stent through a tube to a heart valve annulus; and expanding the stent so that the leaflets form a one-way valve at the heart valve annulus.
Claim 13
Dependent Claim
75 words
The method of claim 4 , further including: providing an annular tissue-engaging base, the base being expandable from a collapsed state; connecting the stent and leaflets to the base to form a heart valve; delivering the heart valve with the connected base in its collapsed state and stent in its compressed size to an annulus of the patient's heart valve being replaced; and expanding the base into its expanded state in contact with the annulus.
Claim 14
Dependent Claim
68 words
The method of claim 10 , wherein the tabs from adjacent leaflets extend outward between spaced wires of the wireform commissure, and wherein inserts are provided around which the adjacent leaflet tabs wrap and are secured, the inserts being size larger than the distance that the wires of the wireform commissure are spaced apart so as to maintain the leaflet tabs on the outside of the wireform commissure.
Claim 15
Independent Claim
183 words
A method of minimally-invasive heart valve replacement surgery on a patient, comprising: providing an annular tissue-engaging base, the base being expandable from a collapsed state; providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, the stent defining a plurality of upstanding commissures and a plurality of arcuate cusps, one cusp each between adjacent commissures, wherein a plurality of prosthetic leaflets are attached to the stent along the cusps and commissures in a manner that provides continuous support for each leaflet along the stent cusps, wherein the stent and leaflets are configured to be radially compressed; storing the stent in an expanded configuration; compressing the stent just prior to implantation; connecting the stent to the base to form a heart valve; delivering the heart valve with the connected base in its collapsed state and stent in its compressed size through a tube to a heart valve annulus; and expanding the base into its expanded state in contact with the heart valve annulus and the stent so that the leaflets form a one-way valve.
Claim 16
Independent Claim
183 words
A method of minimally-invasive heart valve replacement surgery on a patient, comprising: providing an annular tissue-engaging base, the base being expandable from a collapsed state; providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, the stent defining a plurality of upstanding commissures and a plurality of arcuate cusps, one cusp each between adjacent commissures, wherein a plurality of prosthetic leaflets are attached to the stent along the cusps and commissures in a manner that provides continuous support for each leaflet along the stent cusps, wherein the stent and leaflets are configured to be radially compressed; storing the stent in an expanded configuration; compressing the stent just prior to implantation; connecting the stent to the base to form a heart valve; delivering the heart valve with the connected base in its collapsed state and stent in its compressed size through a tube to a heart valve annulus; and expanding the base into its expanded state in contact with the heart valve annulus and the stent so that the leaflets form a one-way valve.
References Cited (Backward Citations)
US3755823A
Cited
US3839741A
Cited
US4084268A
Cited
US4056854A
Cited
EP0103546B1
Cited
US4477930A
Cited
US4506394A
Cited
US5067957A
Cited
US4592340A
Cited
US4960424A
Cited
EP0362113B1
Cited
SU1621912A1
Cited
US4994077A
Cited
US5840081A
Cited
US6168614B1
Cited
US5411552A
Cited
EP0532678B1
Cited
US5571174A
Cited
US5397351A
Cited
US5545214A
Cited
US5370685A
Cited
US5486193A
Cited
US5674279A
Cited
US5163953A
Cited
US5332402A
Cited
US5682906A
Cited
DE4316971A1
Cited
US5549665A
Cited
US5545209A
Cited
US6092529A
Cited
US5728153A
Cited
US5607465A
Cited
US5612885A
Cited
US5489296A
Cited
US6350282B1
Cited
US5531785A
Cited
US5554185A
Cited
US5582607A
Cited
WO1996019159A1
Cited
US5855603A
Cited
US5824064A
Cited
US5716417A
Cited
WO1996040006A1
Cited
WO1997009949A1
Cited
WO1997009947A1
Cited
US5716399A
Cited
US5716370A
Cited
EP0804911A2
Cited
WO1997046177A1
Cited
US5855601A
Cited
US5669919A
Cited
US5695515A
Cited
EP0850607A1
Cited
US20010007956A1
Cited
US5928281A
Cited
US5957949A
Cited
US5984959A
Cited
WO1999030646A1
Cited
US20010002445A1
Cited
WO1999033414A1
Cited
US6569196B1
Cited
US5980570A
Cited
US5935163A
Cited
WO1999053869A1
Cited
US6074418A
Cited
WO1999056665A1
Cited
US20020026238A1
Cited
US6336937B1
Cited
WO2000041652A1
Cited
US6338740B1
Cited
WO2000044313A1
Cited
WO2000045874A1
Cited
US6425916B1
Cited
WO2000047139A1
Cited
WO2000048533A1
Cited
US6264691B1
Cited
EP1057460A1
Cited
EP1088529A2
Cited
US20010021872A1
Cited
WO2001052775A1
Cited
WO2001054625A1
Cited
WO2001056512A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2007-07-27 | 2008-01-26 | 2008-07-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2011-07-27 | 2012-01-26 | 2012-07-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2015-07-27 | 2016-01-26 | 2016-07-27 | $7700.00 | Window Closed / Lapsed |