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US20060265056A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Heart valve prosthesis and methods of manufacture and use

Assignee: Medtronic CV Luxembourg SARL
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Filing: 2006-05-12
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Granted: —
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Expires: 2026-05-12
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Abstract

Abstract A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Inventors

  • 👤 Than Nguyen
  • 👤 Hung Nguyen
  • 👤 Mykim Nguyen
  • 👤 Stanley Komatsu
  • 👤 Robrecht Michiels

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 05:14
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2418; A61F2/2415; A61F2220/00; A61F2220/0025; A61F2220/005; A61F2220/0058; A61F2220/0075; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/001; A61F2230/0028; A61F2230/0054; A61F2230/0063; A61F2230/0067; A61F2230/0073; A61F2230/008; A61F2250/00; A61F2250/0014; A61F2250/0039; Y; Y10; Y10S; Y10S623/00; Y10S623/90

Claims Analysis

Total Claims: 48
Claim 1
Independent Claim 85 words
1 . A valve prosthesis comprising: a self-expanding multi-level frame having a contracted delivery configuration and an expanded deployed configuration, the multi-level frame having in the expanded deployed configuration an enlarged outflow section with a first nominal diameter, a conical inflow section having a second nominal diameter and a constriction region having a third fixed diameter smaller than the first and second nominal diameters; and a valve body affixed to the multi-level frame, the valve body comprising a plurality of leaflets affixed to a skirt.
Claim 2
Dependent Claim 85 words
1 . A valve prosthesis comprising: a self-expanding multi-level frame having a contracted delivery configuration and an expanded deployed configuration, the multi-level frame having in the expanded deployed configuration an enlarged outflow section with a first nominal diameter, a conical inflow section having a second nominal diameter and a constriction region having a third fixed diameter smaller than the first and second nominal diameters; and a valve body affixed to the multi-level frame, the valve body comprising a plurality of leaflets affixed to a skirt.
Claim 3
Dependent Claim 21 words
2 . The valve prosthesis of claim 1 wherein the multi-level frame comprises a cell pattern defined by unequal length zig-zags.
Claim 4
Dependent Claim 27 words
3 . The valve prosthesis of claim 1 wherein the conical section has a proximal end and the conical inflow section flares outward towards the proximal end.
Claim 5
Dependent Claim 40 words
4 . The valve prosthesis of claim 1 wherein adjoining leaflets are affixed together to form commissures and have free edges that define coaptation edges and a center of coaptation, the commissures being longitudinally offset from the center of coaptation.
Claim 6
Dependent Claim 26 words
5 . The valve prosthesis of claim 4 wherein the commissures are affixed to the multi-level frame at a location proximal of the center of coaptation.
Claim 7
Dependent Claim 35 words
6 . The valve prosthesis of claim 5 wherein the multi-level frame comprises a cell pattern and the commissures include flaps that span an entire area of at least one cell of the cell pattern.
Claim 8
Dependent Claim 27 words
7 . The valve prosthesis of claim 4 wherein the commissures and coaptation edges of the leaflets define catenaries that substantially uniformly distribute loads over the leaflets.
Claim 9
Dependent Claim 21 words
8 . The valve prosthesis of claim 7 wherein the catenaries are configured to reduce horizontal loads applied to the commissures.
Claim 10
Dependent Claim 38 words
9 . The valve prosthesis of claim 1 wherein the leaflets are affixed to the skirt at joints, and the joints are affixed to the frame to evenly distribute forces through the valve body to the multi-level frame.
Claim 11
Dependent Claim 26 words
10 . The valve prothesis of claim 9 wherein the multi-level frame further comprises a cell pattern that defines a contour configured to support the joints.
Claim 12
Dependent Claim 36 words
11 . The valve prosthesis of claim 4 wherein each leaflet is individually formed and comprises an enlarged lateral end having a plurality of flaps that are folded over to increase the durability of the commissures.
Claim 13
Dependent Claim 21 words
12 . The valve prosthesis of claim 1 wherein the skirt further comprises a plurality of longitudinally-oriented reinforcing tabs or pleats.
Claim 14
Dependent Claim 20 words
13 . The valve prosthesis of claim 12 wherein the reinforcing tabs or pleats are affixed to the multi-level frame.
Claim 15
Dependent Claim 32 words
14 . The valve prosthesis of claim 12 wherein the skirt further comprises a plurality of end tabs adapted to be affixed to a proximal-most row of cells of the multi-level frame.
Claim 16
Dependent Claim 31 words
15 . The valve prosthesis of claim 1 wherein the leaflets comprise a material selected from one of: porcine, bovine, equine or other mammalian pericardial tissue, synthetic material or polymeric material.
Claim 17
Dependent Claim 41 words
16 . The valve prosthesis of claim 1 wherein the valve body is deployed supra-annularly of a patient's aortic annulus when the valve prosthesis is delivered within a patient's aortic valve and the multi-level frame is in the expanded deployed configuration.
Claim 18
Dependent Claim 27 words
17 . The valve prosthesis of claim 1 wherein the multi-level frame is configured to hold a patient's native valve permanently open in the expanded deployed configuration.
Claim 19
Dependent Claim 27 words
18 . The valve prosthesis of claim 1 wherein the multi-level frame is configured to permit access to a patient's coronary arteries in the expanded deployed configuration.
Claim 20
Dependent Claim 32 words
19 . The valve prosthesis of claim 1 wherein multi-level frame has proximal and distal ends and a plurality of cell patterns that vary in size between the proximal and distal ends.
Claim 21
Dependent Claim 37 words
20 . The valve prosthesis of claim 1 wherein the constriction region comprises a plurality of cell patterns configured to provide a pre-determined radius of curvature for a transition from the constriction region to the outflow section.
Claim 22
Dependent Claim 15 words
21 . The valve prosthesis of claim 1 wherein the skirt comprises a synthetic material.
Claim 23
Dependent Claim 19 words
22 . The valve prosthesis of claim 21 wherein the skirt has a tubular shape in an undeformed configuration.
Claim 24
Dependent Claim 22 words
23 . The valve prosthesis of claim 22 wherein skirt is configured in conical frustum shape formed by deforming the synthetic material.
Claim 25
Dependent Claim 26 words
24 . The valve prosthesis of claim 23 wherein the conical frustum shape is formed by creating a plurality of longitudinally-oriented pleats in the synthetic material.
Claim 26
Dependent Claim 21 words
25 . The valve prosthesis of claim 1 wherein the skirt comprises two or more individual panels of animal pericardial material.
Claim 27
Dependent Claim 21 words
26 . The valve prosthesis of claim 1 wherein the skirt comprises two or more conjoined panels of animal pericardial material.
Claim 28
Dependent Claim 60 words
27 . A valve prosthesis comprising: a valve body comprising a plurality of leaflets affixed to a skirt, adjoining leaflets affixed together to form commissures and having free edges that define coaptation edges and a center of coaptation, wherein the commissures are longitudinally offset from the center of coaptation and define catenaries that substantially uniformly distribute loads over the leaflets.
Claim 29
Dependent Claim 60 words
27 . A valve prosthesis comprising: a valve body comprising a plurality of leaflets affixed to a skirt, adjoining leaflets affixed together to form commissures and having free edges that define coaptation edges and a center of coaptation, wherein the commissures are longitudinally offset from the center of coaptation and define catenaries that substantially uniformly distribute loads over the leaflets.
Claim 30
Dependent Claim 21 words
28 . The valve prosthesis of claim 27 wherein the catenaries are configured to reduce horizontal loads applied to the commissures.
Claim 31
Dependent Claim 36 words
29 . The valve prosthesis of claim 27 wherein each leaflet is individually formed and comprises an enlarged lateral end having a plurality of flaps that are folded over to increase the durability of the commissures.
Claim 32
Dependent Claim 21 words
30 . The valve prosthesis of claim 27 wherein the skirt further comprises a plurality of longitudinally-oriented reinforcing tabs or pleats.
Claim 33
Dependent Claim 31 words
31 . The valve prosthesis of claim 27 wherein the leaflets comprise a material selected from one of: porcine, bovine, equine or other mammalian pericardial tissue, synthetic material or polymeric material.
Claim 34
Dependent Claim 45 words
32 . The valve prosthesis of claim 27 wherein the valve prosthesis further comprises a self-expanding frame, the leaflets are affixed to the skirt at joints, and the joints are affixed to the frame to evenly distribute forces through the valve body to the frame.
Claim 35
Dependent Claim 25 words
33 . The valve prothesis of claim 32 wherein the frame further comprises a cell pattern that defines a contour configured to support the joints.
Claim 36
Dependent Claim 28 words
34 . The valve prosthesis of claim 30 wherein the valve prosthesis further comprises a self-expanding frame and the reinforcing tabs or pleats are affixed to the frame.
Claim 37
Dependent Claim 23 words
35 . The valve prosthesis of claim 27 further comprising a self-expanding frame having a contracted delivery configuration and an expanded deployed configuration.
Claim 38
Dependent Claim 20 words
36 . The valve prosthesis of claim 35 wherein the frame comprises a cell pattern defined by unequal length zig-zags.
Claim 39
Dependent Claim 25 words
37 . The valve prosthesis of claim 35 wherein the commissures are affixed to the frame at a location proximal of the center of coaptation.
Claim 40
Dependent Claim 34 words
38 . The valve prosthesis of claim 35 wherein the frame comprises a cell pattern and the commissures include flaps that span an entire area of at least one cell of the cell pattern.
Claim 41
Dependent Claim 31 words
39 . The valve prosthesis of claim 35 wherein the skirt further comprises a plurality of end tabs adapted to be affixed to a proximal-most row of cells of the frame.
Claim 42
Dependent Claim 40 words
40 . The valve prosthesis of claim 35 wherein the valve body is deployed supra-annularly of a patient's aortic annulus when the valve prosthesis is delivered within a patient's aortic valve and the frame is in the expanded deployed configuration.
Claim 43
Dependent Claim 26 words
41 . The valve prosthesis of claim 35 wherein the frame is configured to hold a patient's native valve permanently open in the expanded deployed configuration.
Claim 44
Dependent Claim 26 words
42 . The valve prosthesis of claim 35 wherein the frame is configured to permit access to a patient's coronary arteries in the expanded deployed configuration.
Claim 45
Dependent Claim 31 words
43 . The valve prosthesis of claim 35 wherein frame has proximal and distal ends and a plurality of cell patterns that vary in size between the proximal and distal ends.
Claim 46
Dependent Claim 52 words
44 . The valve prosthesis of claim 35 wherein the frame has, in the expanded deployed configuration, an enlarged outflow section with a first nominal diameter, a conical inflow section having a second nominal diameter and a constriction region having a third fixed diameter smaller than the first and second nominal diameters.
Claim 47
Dependent Claim 26 words
45 . The valve prosthesis of claim 44 wherein the conical section has a proximal end and the conical section flares outward towards the proximal end.
Claim 48
Dependent Claim 37 words
46 . The valve prosthesis of claim 44 wherein the constriction region comprises a plurality of cell patterns configured to provide a pre-determined radius of curvature for a transition from the constricted region to the outflow section.

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