Patent US2238863A successfully refreshed from Google Patents.
US5769780A
Expired / Lapsed
US
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Method of manufacturing natural tissue valves having variably compliant leaflets
Assignee: Edwards Lifesciences Corp
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Filing: 1997-10-09
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Granted: 1998-06-23
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Expires: 2017-10-09
Abstract
Abstract Variably compliant natural tissue valve leaflets and vascular bioprosthetics incorporating variably compliant leaflets are provided along with methods for their manufacture. The variably compliant leaflets are fixed with the leaflet base section under greater pressure than the leaflet tip section rendering them relatively stiff along the leaflet base section and more flexible at the leaflet tip section. The radially variable flexing characteristics of the valve leaflets promote even distribution of mechanical stress on the valve assembly during the cardiac cycle leading to improved hemodynamic performance while retarding the calcification of the leaflet tissue.
Inventors
- 👤 Cary Hata
- 👤 Roger Tu
- 👤 Hsing-Wen Sung
- 👤 Shih-Hwa Shen
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 19:01
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415; A61F2/2475; Y; Y10; Y10S; Y10S623/00; Y10S623/901; Y10S623/915
Claims Analysis
Total Claims: 39
Claim 1
Independent Claim
125 words
A process for fixing a natural tissue valve prosthesis having improved hemodynamic characteristics and resistance to calcification, said process comprising: (a) obtaining a mammalian natural tissue valve assembly having a circumferential annular margin and one or more valve leaflets pivotally attached to said circumferential annular margin, each of said one or more valve leaflets including a leaflet base section adjacent to said circumferential annular margin and a leaflet tip section disposed radially therefrom; (b) subjecting each of said leaflet base sections of said one or more valve leaflets to a higher pressure than each of said leaflet tip sections on the same side of the valve leaflet; and (c) contacting each of said sections of said pressurized natural tissue valve assembly with a fixing agent.
Claim 2
Dependent Claim
125 words
A process for fixing a natural tissue valve prosthesis having improved hemodynamic characteristics and resistance to calcification, said process comprising: (a) obtaining a mammalian natural tissue valve assembly having a circumferential annular margin and one or more valve leaflets pivotally attached to said circumferential annular margin, each of said one or more valve leaflets including a leaflet base section adjacent to said circumferential annular margin and a leaflet tip section disposed radially therefrom; (b) subjecting each of said leaflet base sections of said one or more valve leaflets to a higher pressure than each of said leaflet tip sections on the same side of the valve leaflet; and (c) contacting each of said sections of said pressurized natural tissue valve assembly with a fixing agent.
Claim 3
Dependent Claim
38 words
The process of claim 1 wherein each of said leaflet base sections comprises from approximately 5% to approximately 80% of the length of each of said one or more valve leaflets measured radially from said circumferential annular margin.
Claim 4
Dependent Claim
23 words
The process of claim 1 wherein said fixing agent is selected from the group consisting of polyepoxy compounds, glutaraldehyde, formaldehyde and combinations thereof.
Claim 5
Dependent Claim
20 words
The process of claim 2 wherein said fixing agent is a polyepoxy compound and said polyepoxy compound is glycerol-polyglycidyl ether.
Claim 6
Dependent Claim
24 words
The process of claim 1 wherein said tissue valve assembly is selected from the group consisting of tri-leaflet valve assemblies and bileaflet valve assemblies.
Claim 7
Dependent Claim
27 words
The process of claim 1 wherein said pressure is applied intermittently to said valve leaflet while said natural tissue valve assembly is contacted with said fixing agent.
Claim 8
Dependent Claim
16 words
The process of claim 1 wherein said natural tissue valve assembly is a porcine valve assembly.
Claim 9
Dependent Claim
19 words
The process of claim 1 wherein said pressure is derived from contact force applied by a soft porous material.
Claim 10
Dependent Claim
81 words
A process for fixing a natural tissue valve leaflet having improved hemodynamic characteristics and resistance to calcification, said process comprising: (a) providing a natural tissue valve leaflet having a leaflet base section and a leaflet tip section disposed adjacent thereto; (b) subjecting said leaflet base section to a higher pressure than said leaflet tip section on the same side of the valve leaflet; and (c) contacting each of said sections of said pressurized natural tissue valve leaflet with a fixing agent.
Claim 11
Dependent Claim
81 words
A process for fixing a natural tissue valve leaflet having improved hemodynamic characteristics and resistance to calcification, said process comprising: (a) providing a natural tissue valve leaflet having a leaflet base section and a leaflet tip section disposed adjacent thereto; (b) subjecting said leaflet base section to a higher pressure than said leaflet tip section on the same side of the valve leaflet; and (c) contacting each of said sections of said pressurized natural tissue valve leaflet with a fixing agent.
Claim 12
Dependent Claim
23 words
The process of claim 9 wherein said fixing agent is selected from the group consisting of polyepoxy compounds, glutaraldehyde, formaldehyde and combinations thereof.
Claim 13
Dependent Claim
21 words
The process of claim 10 wherein said fixing agent is a polyepoxy compound and said polyepoxy compound is a glycerol-polyglycidyl ether.
Claim 14
Dependent Claim
30 words
The process of claim 8 wherein said natural tissue valve leaflet is derived from tissue selected from the group consisting of pericardial tissue, fascia lata membrane, and dura mater membrane.
Claim 15
Dependent Claim
36 words
The process of claim 1, wherein step (b) includes the step of retaining said leaflet base sections and said leaflet tip sections in separate chambers during the application of higher pressure to said leaflet base sections.
Claim 16
Dependent Claim
36 words
The process of claim 7, wherein step (b) includes the step of retaining said leaflet base sections and said leaflet tip sections in separate chambers during the application of higher pressure to said leaflet base sections.
Claim 17
Dependent Claim
22 words
The process of claim 1, wherein the leaflet base sections are subjected to a pressure created by contact with a solid body.
Claim 18
Dependent Claim
17 words
The process of claim 15, wherein the solid body is an exterior surface of a pressure bladder.
Claim 19
Dependent Claim
51 words
A process as in claim 1, further including positioning a rigid tube adjacent an outflow side of the valve leaflets, the tube being concentric with and spaced inwardly from the annular margin, wherein said step of subjecting comprises applying said higher pressure to the leaflet base sections outside of said tube.
Claim 20
Dependent Claim
26 words
A process as in claim 17, wherein the higher pressure is applied to said leaflet base sections by inflating a bladder positioned outside of the tube.
Claim 21
Dependent Claim
44 words
A process as in claim 18, wherein the natural tissue valve assembly being fixed is a tri-leaflet valve, and the process further includes providing three discrete bladders outside of the tube adjacent each leaflet for applying the higher pressure to said leaflet base sections.
Claim 22
Dependent Claim
25 words
A process as in claim 1, further comprising mounting the natural tissue valve prosthesis on a surrounding stent support prior to said step of subjecting.
Claim 23
Dependent Claim
22 words
The process of claim 9, wherein the leaflet base sections are subjected to a pressure created by contact with a solid body.
Claim 24
Dependent Claim
17 words
The process of claim 21, wherein the solid body is an exterior surface of a pressure bladder.
Claim 25
Dependent Claim
51 words
A process as in claim 9, further including positioning a rigid tube adjacent an outflow side of the valve leaflets, the tube being concentric with and spaced inwardly from the annular margin, wherein said step of subjecting comprises applying said higher pressure to the leaflet base sections outside of said tube.
Claim 26
Dependent Claim
26 words
A process as in claim 23, wherein the higher pressure is applied to said leaflet base sections by inflating a bladder positioned outside of the tube.
Claim 27
Dependent Claim
44 words
A process as in claim 24, wherein the natural tissue valve assembly being fixed is a tri-leaflet valve, and the process further includes providing three discrete bladders outside of the tube adjacent each leaflet for applying the higher pressure to said leaflet base sections.
Claim 28
Dependent Claim
25 words
A process as in claim 9, further comprising mounting the natural tissue valve prosthesis on a surrounding stent support prior to said step of subjecting.
Claim 29
Dependent Claim
129 words
A process for fixing a natural tissue valve prosthesis having an annular margin and a plurality of leaflets extending generally radially inwardly from the margin, comprising: securing the margin from movement; positioning a tubular member concentrically within the margin and in contact with the leaflets on a downstream side thereof so as to bias the leaflets into a closed position, the tubular member being sized smaller than the margin so that a base section of each leaflet is exposed on the downstream side between the margin and tubular member and a tip section of each leaflet is disposed within the tubular member; and subjecting the base section of the leaflets to a higher pressure than the tip section while contacting the natural tissue valve prosthesis with a fixing agent.
Claim 30
Dependent Claim
129 words
A process for fixing a natural tissue valve prosthesis having an annular margin and a plurality of leaflets extending generally radially inwardly from the margin, comprising: securing the margin from movement; positioning a tubular member concentrically within the margin and in contact with the leaflets on a downstream side thereof so as to bias the leaflets into a closed position, the tubular member being sized smaller than the margin so that a base section of each leaflet is exposed on the downstream side between the margin and tubular member and a tip section of each leaflet is disposed within the tubular member; and subjecting the base section of the leaflets to a higher pressure than the tip section while contacting the natural tissue valve prosthesis with a fixing agent.
Claim 31
Dependent Claim
23 words
The process of claim 27, wherein the leaflet base sections are subjected to said higher pressure created by contact with a solid body.
Claim 32
Dependent Claim
27 words
A process as in claim 28, wherein the higher pressure is applied to said leaflet base sections by inflating a bladder positioned outside of the tubular member.
Claim 33
Dependent Claim
45 words
A process as in claim 29, wherein the natural tissue valve assembly being fixed is a tri-leaflet valve, and the process further includes providing three discrete bladders outside of the tubular member adjacent each leaflet for applying the higher pressure to said leaflet base section.
Claim 34
Dependent Claim
35 words
A process as in claim 27, wherein the tubular member includes three axial cutouts for receiving commissures of the natural tissue valve leaflets, and concave portions between the cutouts for contacting and biasing the leaflets.
Claim 35
Dependent Claim
38 words
A process as in claim 27, wherein the higher pressure is applied to said leaflet base sections by filling a closed space adjacent each base section with a compressible material and compacting the material against the base sections.
Claim 36
Dependent Claim
52 words
A process as in claim 27, wherein the natural tissue valve prosthesis includes a natural tubular wall portion extending on the downstream side of the annular margin, and wherein a pressure source is positioned between the tubular member and tubular wall portion to subject the leaflet base sections to the higher pressure.
Claim 37
Dependent Claim
34 words
A process as in claim 33, wherein the higher pressure is applied to the leaflet base sections by inflating a bladder positioned outside of the tubular member and inside of the tubular wall portion.
Claim 38
Dependent Claim
18 words
A process as in claim 34, further including subjecting the leaflet base sections to an intermittent higher pressure.
Claim 39
Dependent Claim
25 words
A process as in claim 27, further comprising mounting the natural tissue valve prosthesis on a surrounding stent support prior to said step of subjecting.
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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) | 2001-06-22 | 2001-12-22 | 2002-06-23 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-06-22 | 2005-12-22 | 2006-06-23 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-06-22 | 2009-12-22 | 2010-06-23 | $7700.00 | Window Closed / Lapsed |