US5531094A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Apparatus for testing prosthetic heart valve hinge mechanism
Assignee: CARBOMEIDCS Inc
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Filing: 1994-11-14
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Granted: 1996-07-02
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Expires: 2014-11-14
Abstract
Abstract An apparatus for proof testing mechanical heart valve prostheses. The apparatus also provides an in vitro test environment simulating in vivo loads, providing a function test. If the heart valve passes the pivot proof test, a function test is performed. The apparatus first directs a pressurized back flow against the tested valve, closing the valve and applying pressure against the leaflet occluders well beyond the maximum functional in vivo load. The heart valve is positioned so that the leaflets assume their "worst-case" position, that is, the heart valve is oriented so that all the necessary play or gap between the leaflet pivots and pivot recesses is subsumed at one location, thus representing the most severe condition that might be experienced with a heart valve in use. The heart valve is loaded by back pressure applied through a working fluid. Pressure transponders detect the pressure on each side of the heart valve, to determine if a valid test has been performed.
Inventors
- 👤 Robert B. More
- 👤 Peter Strzepa
- 👤 Michael J. Mewhort
- 👤 Thomas S. Reventas
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 20:20
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2472
Claims Analysis
Total Claims: 27
Claim 1
Independent Claim
109 words
An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure exceeding 22 psi and being sufficient to provide a selected energy of fracture.
Claim 2
Independent Claim
109 words
An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure exceeding 22 psi and being sufficient to provide a selected energy of fracture.
Claim 3
Independent Claim
114 words
An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for turning said part to selected worse-case orientations, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being sufficient to provide a selected energy of fracture.
Claim 4
Independent Claim
114 words
An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for turning said part to selected worse-case orientations, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being sufficient to provide a selected energy of fracture.
Claim 5
Dependent Claim
18 words
The apparatus according to claim 2 wherein said means for turning comprise a rack and a pinion gear.
Claim 6
Dependent Claim
15 words
The apparatus according to claim 2 further comprising means for sensing said elevated back pressure.
Claim 7
Dependent Claim
20 words
The apparatus according to claim 4 further comprising means for incrementally raising said back pressure to a preselected test pressure.
Claim 8
Dependent Claim
45 words
The apparatus according to claim 5 wherein said means for directing a working fluid comprise means for controlling a rate of flow of said working fluid, and wherein said means for incrementally raising said back pressure comprise means for incrementally raising said rate of flow.
Claim 9
Dependent Claim
29 words
The apparatus according to claim 6 wherein said means for incrementally raising said rate of flow is responsive to said means for sensing to adjust said rate of flow.
Claim 10
Dependent Claim
35 words
The apparatus according to claim 2 further comprising means for selectively applying a pulsatile forward flow of said working fluid through said part of said mechanical heart valve at a systolic pressure of physiologic magnitude.
Claim 11
Dependent Claim
29 words
The apparatus according to claim 8 further comprising a fluid flow compliance and a fluid flow resistance for creating a diastolic pressure between pulses of said pulsatile forward flow.
Claim 12
Dependent Claim
13 words
The apparatus according to claim 2 wherein said back pressure exceeds 22 psi.
Claim 13
Independent Claim
106 words
A method for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said method comprising the steps of holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure exceeding 22 psi and being sufficient to provide a selected energy of fracture.
Claim 14
Independent Claim
106 words
A method for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said method comprising the steps of holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure exceeding 22 psi and being sufficient to provide a selected energy of fracture.
Claim 15
Independent Claim
107 words
A method for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said method comprising the steps of holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, turning said part to selected worse-case orientations, directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being in excess of expected diastolic pressure.
Claim 16
Independent Claim
107 words
A method for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said method comprising the steps of holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, turning said part to selected worse-case orientations, directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being in excess of expected diastolic pressure.
Claim 17
Dependent Claim
19 words
The method according to claim 12 wherein said step of turning comprise inverting said part of said heart valve.
Claim 18
Dependent Claim
13 words
The method according to claim 13 further comprising sensing said elevated back pressure.
Claim 19
Dependent Claim
18 words
The method according to claim 14 further comprising incrementally raising said back pressure to a preselected test pressure.
Claim 20
Dependent Claim
41 words
The method according to claim 15 wherein said step of directing a working fluid comprises controlling a rate of flow of said working fluid, and wherein said step of incrementally raising said beck pressure comprise incrementally raising said rate of flow.
Claim 21
Dependent Claim
29 words
The method according to claim 16 wherein said step of incrementally raising said rate of flow is responsive to said means for sensing to adjust said rate of flow.
Claim 22
Dependent Claim
36 words
The method according to claim 12 further comprising the step of selectively applying a pulsatile forward flow of said working fluid through said part of said mechanical heart valve at a systolic pressure of physiologic magnitude.
Claim 23
Dependent Claim
33 words
The method according to claim 18 further comprising the step of creating a fluid flow compliance and a fluid flow resistance to impose a diastolic pressure between pulses of said pulsatile forward flow.
Claim 24
Dependent Claim
13 words
The method according to claim 12 wherein said back pressure exceeds 22 psi.
Claim 25
Independent Claim
142 words
An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, said means for directing a working fluid comprising means for controlling a rate of flow of said working fluid, means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being sufficient to provide a selected energy of fracture, means for sensing said back pressure, means for incrementally raising said flow rate to attain said elevated back pressure.
Claim 26
Independent Claim
142 words
An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, said means for directing a working fluid comprising means for controlling a rate of flow of said working fluid, means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being sufficient to provide a selected energy of fracture, means for sensing said back pressure, means for incrementally raising said flow rate to attain said elevated back pressure.
Claim 27
Dependent Claim
29 words
The apparatus according to claim 21 wherein said means for incrementally raising said rate of flow is responsive to said means for sensing to adjust said rate of flow.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-07-02 | 2000-01-01 | 2000-07-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-07-02 | 2004-01-01 | 2004-07-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-07-02 | 2008-01-01 | 2008-07-02 | $7700.00 | Window Closed / Lapsed |