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US5961549A Expired / Lapsed US ⏱️ 0.0 years remaining

Multi-leaflet bioprosthetic heart valve

Assignee: Edwards Lifesciences Corp
•
Filing: 1997-04-03
•
Granted: 1999-10-05
•
Expires: 2017-04-03
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Abstract

Abstract Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve. One apparatus for testing the leaflets includes a frame for securing the arcuate cusp of the leaflet while the straight coapting edge remains free, to simulate the actual leaflet mounting configuration within the heart valve prosthesis. The frame may include a lower portion having a recess for the leaflet and plurality of receptor holes around the peripheral edge of the recess, and an upper portion having a plurality of needles which extend downward through the leaflet and into the receptor holes and secure the edges of the leaflet.

Inventors

  • 👤 Than Nguyen
  • 👤 Hung Ly Lam
  • 👤 Jianbo Zhou
  • 👤 Carlos M. Romero
  • 👤 Ralph Kafesjian
  • 👤 Xiaoming G. Guo
  • 👤 Van Le Huynh

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 21:01
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/0105; A61M25/0133; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415; A61F2/2472; Y; Y10; Y10S; Y10S623/00; Y10S623/90; Y10S623/909; Y10S623/91; Y10S623/912; Y10S623/913

Claims Analysis

Total Claims: 17
Claim 1
Independent Claim 44 words
A multi-leaflet bioprosthetic heart valve comprising a plurality of leaflets, wherein each of the leaflets has a measured deflection response within 0.030 inches of the other leaflets upon application of a load sufficient to stress each of the leaflets between 300 and 600 kPa.
Claim 2
Dependent Claim 44 words
A multi-leaflet bioprosthetic heart valve comprising a plurality of leaflets, wherein each of the leaflets has a measured deflection response within 0.030 inches of the other leaflets upon application of a load sufficient to stress each of the leaflets between 300 and 600 kPa.
Claim 3
Dependent Claim 27 words
The valve of claim 1, wherein each of the leaflets has a measured deflection rsponse within 0.003 inches of the other leaflets upon application of said load.
Claim 4
Dependent Claim 13 words
The valve of claim 1, wherein the leaflets are made of bovine percardium.
Claim 5
Dependent Claim 10 words
The valve of claim 3, wherein the leaflets are glutaraldehyde-fixed.
Claim 6
Dependent Claim 13 words
The valve of claim 1, wherein there are three leaflets in said valve.
Claim 7
Dependent Claim 25 words
The valve of claim 1, wherein each of the leaflets has an observed intrinsic load test response within a predetermined range of the other leaflets.
Claim 8
Dependent Claim 17 words
The valve of claim 1, wherein the leaflets are made of a matrix having a tissue ingrowth.
Claim 9
Dependent Claim 21 words
The valve of claim 1, wherein the leaflets are made of a substrate on which is formed a cell growth covering.
Claim 10
Dependent Claim 13 words
The valve of claim 1, wherein the leaflets are made of extruded collagen.
Claim 11
Dependent Claim 31 words
The valve of claim 1, wherein a load is applied to each individual leaflet prior to assembly in the valve for a predetermined number of times before observing the deflection response.
Claim 12
Dependent Claim 75 words
The valve of claim 1, wherein a load is applied to each individual leaflet prior to assembly in the valve by mounting the leaflet in a frame so that portions which are to be sutured in the valve are held stationery, and the load is applied to the leaflet in a location adapted to simulate a point at which an average load is applied in operation of the valve, whereupon the deflection response is observed.
Claim 13
Dependent Claim 45 words
A multi-leaflet bioprosthetic heart valve comprising a plurality of bovine pericardium leaflets, wherein each of the leaflets has a measured deflection response of between 0.17 and 0.34 inches upon application of a load sufficient to stress each of the leaflets between 300 and 600 kPa.
Claim 14
Dependent Claim 45 words
A multi-leaflet bioprosthetic heart valve comprising a plurality of bovine pericardium leaflets, wherein each of the leaflets has a measured deflection response of between 0.17 and 0.34 inches upon application of a load sufficient to stress each of the leaflets between 300 and 600 kPa.
Claim 15
Dependent Claim 27 words
The valve of claim 12, wherein each of the leaflets has a measured deflection response within 0.030 inches of the other leaflets upon application of said load.
Claim 16
Dependent Claim 27 words
The valve of claim 13, wherein each of the leaflets has a measured deflection response within 0.003 inches of the other leaflets upon application of said load.
Claim 17
Dependent Claim 41 words
The valve of claim 12, wherein the load is applied to each of the leaflets in a location adapted to simulate a point at which an average load is applied in operation of the valve, whereupon the deflection response is observed.

References Cited (Backward Citations)

US4388735A Cited
EP0133420B1 Cited
US4687483A Cited
US5037434A Cited
US5376110A Cited
US5613982A Cited
US5549666A Cited
US5718012A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2002-10-04 2003-04-05 2003-10-05 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2006-10-04 2007-04-05 2007-10-05 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2010-10-04 2011-04-05 2011-10-05 $7700.00 Window Closed / Lapsed

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