US6287338B1
Expired / Lapsed
US
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Pre-stressing devices incorporating materials subject to stress softening
Assignee: Sorin Group Italia SRL
•
Filing: 1999-03-10
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Granted: 2001-09-11
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Expires: 2019-03-10
Abstract
Abstract A method and apparatus for pre-stressing devices incorporating materials subject to stress softening is disclosed, as well as the resulting device. The method includes fabricating a heart valve with an inflow side and an outflow side. At least a portion of the heart valve includes a material subject to stress softening. The material experiences stress when a pressure differential occurs between the inflow side and the outflow side of the valve. The method includes creating a stress in the material prior to implantation in order to stabilize the stress/strain response of the material prior to implantation.
Inventors
- 👤 Edward J. Sarnowski
- 👤 Riyad E. Moe
- 👤 Donald W. James
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 21:07
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415
Claims Analysis
Total Claims: 29
Claim 1
Independent Claim
69 words
A method for manufacturing a prosthetic heart valve, comprising the steps of: fabricating a heart valve, the valve having an inflow side and an outflow side, at least a portion of the heart valve comprising an elastomer material subjected to stress softening, the material experiencing stress when a pressure differential occurs between the inflow side and the outflow side; and creating the stress in the material prior to use.
Claim 2
Independent Claim
69 words
A method for manufacturing a prosthetic heart valve, comprising the steps of: fabricating a heart valve, the valve having an inflow side and an outflow side, at least a portion of the heart valve comprising an elastomer material subjected to stress softening, the material experiencing stress when a pressure differential occurs between the inflow side and the outflow side; and creating the stress in the material prior to use.
Claim 3
Dependent Claim
35 words
The method of claim 1 where creating a pressure differential comprises raising the stress to the point where the material subject to stress softening experiences the stress that it is expected to experience in use.
Claim 4
Dependent Claim
36 words
The method of claim 2 , wherein creating a pressure differential comprises raising the stress to the point where the material subject to stress softening experiences more stress that it is expected to experience in use.
Claim 5
Dependent Claim
10 words
The method of claim 1 further comprising removing the stress.
Claim 6
Dependent Claim
18 words
The method of claim 4 further comprising cyclically creating and removing the stress a predefined number of times.
Claim 7
Dependent Claim
22 words
The method of claim 1 wherein creating the stress comprises applying pressure to the outflow side of the valve with a fluid.
Claim 8
Dependent Claim
11 words
The method of claim 6 wherein the fluid is a gas.
Claim 9
Dependent Claim
11 words
The method of claim 6 wherein the fluid is a liquid.
Claim 10
Dependent Claim
16 words
The method of claim 1 wherein creating the stress comprises applying a weight to the valve.
Claim 11
Dependent Claim
20 words
The method of claim 9 wherein applying a weight comprises applying a weight to the outflow side of the valve.
Claim 12
Dependent Claim
20 words
The method of claim 9 wherein applying a weight comprises applying a weight to the inflow side of the valve.
Claim 13
Dependent Claim
16 words
The method of claim 1 wherein creating the stress comprises applying a vacuum to the valve.
Claim 14
Dependent Claim
13 words
The method of claim 1 wherein creating the stress comprises accelerating the valve.
Claim 15
Dependent Claim
13 words
The method of claim 1 wherein creating the stress comprises vibrating the valve.
Claim 16
Dependent Claim
23 words
The method of claim 1 wherein creating the stress comprises applying a static head of fluid to the outflow side of the valve.
Claim 17
Dependent Claim
22 words
The method of claim 1 wherein creating the stress comprises pumping fluid into a chamber on the outflow side of the valve.
Claim 18
Dependent Claim
23 words
The method of claim 1 wherein creating the stress comprises pumping fluid out of the chamber on the inflow side of the valve.
Claim 19
Dependent Claim
25 words
The method of claim 1 wherein creating the stress comprises creating a pressure differential between the inflow side and the outflow side of the valve.
Claim 20
Dependent Claim
28 words
The method of claim 1 wherein the valve has an annular portion supporting three leaflets, further comprising supporting the annular portion of the valve when creating the stress.
Claim 21
Dependent Claim
25 words
The method of claim 19 wherein supporting the annular portion of the valve comprises placing an annular collar inside the annular portion of the valve.
Claim 22
Independent Claim
39 words
A method for manufacturing, a heart valve, the heart valve having at least a portion that includes an elastomer material subject to stress softening comprising the steps of: pre-stressing the elastomer material subject to stress softening prior to use.
Claim 23
Independent Claim
39 words
A method for manufacturing, a heart valve, the heart valve having at least a portion that includes an elastomer material subject to stress softening comprising the steps of: pre-stressing the elastomer material subject to stress softening prior to use.
Claim 24
Dependent Claim
32 words
The method of claim 21 , wherein pre-stressing comprises subjecting the portion of the object comprising the material subject to stress softening to the stress it is expected to experience in use.
Claim 25
Dependent Claim
24 words
The method of claim 21 , wherein pre-stressing comprises subjecting the material to more stress than the material is expected to experience in use.
Claim 26
Independent Claim
89 words
A method for pre-stressing a tri-leaflet heart valve to meet a performance requirement, the method comprising the steps of: providing the heart valve having an inflow side and an outflow side, the heart valve comprising an elastomer portion subject to stress softening; creating a stress in the elastomer portion by providing a pressure differential between the inflow side and the outflow side; repeating a predetermined number of cycles; raising the stress to a predetermined amount; and lowering the stress to cause the heart valve to meet the performance requirement.
Claim 27
Independent Claim
89 words
A method for pre-stressing a tri-leaflet heart valve to meet a performance requirement, the method comprising the steps of: providing the heart valve having an inflow side and an outflow side, the heart valve comprising an elastomer portion subject to stress softening; creating a stress in the elastomer portion by providing a pressure differential between the inflow side and the outflow side; repeating a predetermined number of cycles; raising the stress to a predetermined amount; and lowering the stress to cause the heart valve to meet the performance requirement.
Claim 28
Dependent Claim
15 words
The method of claim 24 wherein the predetermined number of cycles is less than 100.
Claim 29
Dependent Claim
16 words
The method of claim 24 wherein the predetermined number of cycles is between 25 and 75.
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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) | 2004-09-10 | 2005-03-12 | 2005-09-11 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-09-10 | 2009-03-12 | 2009-09-11 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-09-10 | 2013-03-12 | 2013-09-11 | $7700.00 | Window Closed / Lapsed |