CA2422009A1 - Flexible heart valve having moveable commissures - Google Patents

Flexible heart valve having moveable commissures Download PDF

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Publication number
CA2422009A1
CA2422009A1 CA002422009A CA2422009A CA2422009A1 CA 2422009 A1 CA2422009 A1 CA 2422009A1 CA 002422009 A CA002422009 A CA 002422009A CA 2422009 A CA2422009 A CA 2422009A CA 2422009 A1 CA2422009 A1 CA 2422009A1
Authority
CA
Canada
Prior art keywords
valve
cusp
support structure
heart valve
insert member
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002422009A
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French (fr)
Other versions
CA2422009C (en
Inventor
Dongbu Cao
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2422009A1 publication Critical patent/CA2422009A1/en
Application granted granted Critical
Publication of CA2422009C publication Critical patent/CA2422009C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A flexible prosthetic tissue-type heart valve having commissures that are substantially decoupled from a cusp support structure. The valve includes three leaflets having arcuate cusp edges and opposed free edges, with outwardly-directed attachment tabs therebetween. A cusp support structure in either one or more pieces attaches to the leaflet cusp edges. Three commissures are each formed partly with an axially-extending insert member t o which two adjacent leaflet tabs attach. An inverted V-shaped clip maintains close contact between the adjacent leaflet tabs and provides a stress- relieving clamping action in conjunction with the insert member. The insert member attaches about its lower end to base sections of the cusp support structure, or to an intermediate sewing ring, so that the commissures may pivot about the cusp support structure. The sewing band is scalloped and enables attachment of the valve along the scalloped aortic root so as to couple the valve to the natural motion of the aorta. Increased vibrational damping results from this biomechanical coupling.

Claims (16)

1. A heart valve for implantation in an annulus of a heart having commissures on an outflow cod adapted to move in conformity with an anatomical wall structure adjacent the annulus, the heat valve comprising:
three leaflets made of a biocompatible and compliant material, each leaflet having a mended cusp edge opposite a free edge, and a pair of generally oppositely-directed tabs separating the cusp edge and flee edge;
a cusp support structure generally defining a ring and a valve axis and having three rounded each adapted to conform to the cusp edge of the leaflets, the cusp edge of each leaflet being attached to a different rounded section of the cusp support structure so that the three leaflets are arranged generally evenly about the valve axis, the attached leaflet cusp edges and rounded sections together defining valve cusps curving toward an inflow end of the valve;
three valve commissure posts disposed between the valve cusps and projecting generally axially toward an outflow end of the valve, the commissure posts being defined by two adjacent leaflet tabs, a generally axially extending insert member, and as inverted V-shaped clip positioned radially inward from the insert member , the adjacent leaflet tabs being juxtaposed to radially outward with respect to the axis through the inverted V-shaped clip and being wrapped around and secured to the insert member, an inflow end of each commissure post being generally pivotally coupled with respect to the cusp support structure so as to permit both radially inward and outward movement thereof, the valve commissure posts being attachable to the anatomical wall structure; and a sewing band slug to follow the valve cusps and being attached therealong, the sewing band providing a platform for implanting the heart valve such that the valve cusps ere attachable adjacent the annulus.
2. The heart valve of claim 1, win the valve is sized for implantation in an aortic annulus, wherein the anatomical wall structure is the aorta.
3. The heart valve of claim 1, wherein the cusp support structure comprises a one-piece ring.
4. The heart valve of claim 3, wherein the cusp support structure comprises the rounded sections curved toward the inflow end of the valve and connected by commissure base sections about which the valve commissure posts pivot.
5. The heart valve of claim 4, wherein the cusp support structure comprises a relatively rigid rod-like element having a fabric covering, the valve commissure posts being to the cusp support structure using sutures-through the fabric covering.
6. The heart valve of claim 4, wherein the inflow end of the insert member of each commissure post is bifurcated and straddles the associated commissure base section.
7. The heart valve of claim 6, wherein each commissure base section is circular in cross-section, and wherein the divergent legs of the bifurcated inflow end of the associated insert member are sutured together to capture the commissure base section therebetween.
8. The heart valve of claim 1, wherein the cusp support structure comprises three separate pieces arranged generally evenly about the valve axis to define the ring.

16~
9. The heart valve of claim 8, wherein each piece of the cusp support structure comprises a relatively rigid rod-like element having a fabric covering, the sewing band attaching to the valve cusps using sutures through the fabric covering of each piece of the cusp support structure, and wherein the inflow end of each commissure post is pivotally attached to a portion of the sewing band that bridges one of three gaps defined between the three separate pieces of the cusp support structure.
10. The heart valve of claim 8, wherein each piece of the cusp support structure is made of a pre-formed biocompatible fabric having a radially outward tab to which the cusp edge of a leaflet attaches.
11. The heart valve of claim 8, wherein the three separate pieces of the cusp support structure are coupled by six highly compliant connector sections attached between adjacent ends of the rounded sections and V-shaped clips.
12. The heart valve of claim 11, wherein the connector sections are made of fabric.
13. The heart valve of claim 11, wherein the connector sections are made of an elastomer.
14. The heart valve of claim 1, wherein each V-shaped clip is formed of a flexible material adapted to flex apart during an open cycle of the valve wherein fluid flow through the valve causes the free edges of adjacent leaflet tabs to separate.
15. The heart valve of claim 14, further including a fabric covering around each V-shaped clip that extends around the associated insert member and permits suture attachment of the clip to the insert.
16. The heart valve of claim 1, wherein the three leaflets each have a concave free edge.
CA002422009A 2000-09-22 2001-09-14 Flexible heart valve having moveable commissures Expired - Lifetime CA2422009C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/668,660 2000-09-22
US09/668,660 US6461382B1 (en) 2000-09-22 2000-09-22 Flexible heart valve having moveable commissures
PCT/US2001/028729 WO2002024118A1 (en) 2000-09-22 2001-09-14 Flexible heart valve having moveable commissures

Publications (2)

Publication Number Publication Date
CA2422009A1 true CA2422009A1 (en) 2002-03-28
CA2422009C CA2422009C (en) 2009-12-01

Family

ID=24683245

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002422009A Expired - Lifetime CA2422009C (en) 2000-09-22 2001-09-14 Flexible heart valve having moveable commissures

Country Status (7)

Country Link
US (3) US6461382B1 (en)
EP (1) EP1328215B1 (en)
AT (1) ATE310469T1 (en)
AU (2) AU9090801A (en)
CA (1) CA2422009C (en)
DE (1) DE60115273T2 (en)
WO (1) WO2002024118A1 (en)

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AU9090801A (en) 2002-04-02
EP1328215B1 (en) 2005-11-23
US20030014105A1 (en) 2003-01-16
US7179290B2 (en) 2007-02-20
DE60115273D1 (en) 2005-12-29
ATE310469T1 (en) 2005-12-15
AU2001290908B2 (en) 2005-06-02
EP1328215A1 (en) 2003-07-23
DE60115273T2 (en) 2006-08-10
US6461382B1 (en) 2002-10-08
US20050096739A1 (en) 2005-05-05
CA2422009C (en) 2009-12-01
WO2002024118A1 (en) 2002-03-28

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