CA2518867A1 - Prosthetic valve that permits retrograde flow - Google Patents

Prosthetic valve that permits retrograde flow Download PDF

Info

Publication number
CA2518867A1
CA2518867A1 CA002518867A CA2518867A CA2518867A1 CA 2518867 A1 CA2518867 A1 CA 2518867A1 CA 002518867 A CA002518867 A CA 002518867A CA 2518867 A CA2518867 A CA 2518867A CA 2518867 A1 CA2518867 A1 CA 2518867A1
Authority
CA
Canada
Prior art keywords
medical device
implantable medical
leaflet
support frame
opening
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
CA002518867A
Other languages
French (fr)
Other versions
CA2518867C (en
Inventor
Thomas A. Osborne
Brian C. Case
Mark W. Bleyer
Ram H. Paul, Jr.
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.)
Cook Inc
Original Assignee
Cook Incorporated
Thomas A. Osborne
Brian C. Case
Mark W. Bleyer
Ram H. Paul, Jr.
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 Cook Incorporated, Thomas A. Osborne, Brian C. Case, Mark W. Bleyer, Ram H. Paul, Jr. filed Critical Cook Incorporated
Publication of CA2518867A1 publication Critical patent/CA2518867A1/en
Application granted granted Critical
Publication of CA2518867C publication Critical patent/CA2518867C/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
    • A61F2/2475—Venous 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
    • 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
    • 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
    • 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
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • 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
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0026—Angular shapes trapezoidal
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0095—Saddle-shaped

Abstract

A prosthetic valve for regulating fluid flow through a body vessel is provided. The valve includes an expandable support frame and a valve leaflet, and includes at least one opening that permits a controlled amount of retrograde flow through the valve when the valve is in a closed configuration.

Claims (28)

1. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising:
a support frame having radially compressed and radially expanded configurations; and at least one leaflet having first and second edges and being moveable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction, the first edge attached to the support frame and the second edge being free of the support frame;
wherein a portion of the support frame and the second edge of the at least one leaflet cooperatively define an opening that permits a controlled amount of fluid flow in the second, opposite direction.
2. The implantable medical device according to claim 1, wherein the support frame is a self expandable support frame.
3. The implantable medical device according to claim 2, wherein the support frame is formed of a nickel-titanium alloy.
4. The implantable medical device according to claim 1, wherein the at least one leaflet is formed of a bioremodellable material.
5. The implantable medical device according to claim 4, wherein the bioremodellable material comprises an extracellular matrix material.
6. The implantable medical device according to claim 4, wherein the bioremodellable material comprises small intestine submucosa.
7. The implantable medical device according to claim 1, further comprising at least one suture attaching the first edge of the at least one leaflet to the support frame.
8. The implantable medical device according to claim 1, wherein the at least one leaflet comprises first and second leaflets.
9. The implantable medical device according to claim 1, wherein the total open area of the opening is less than the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.
10. The implantable medical device according to claim 1, wherein the total open area of the opening is less than about 50% of the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.
11. The implantable medical device according to claim 1, wherein the total open area of the opening is less than about 25% of the cross-sectional area of said body vessel at a desired point of treatment.
12. The implantable medical device according to claim 1, further comprising a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.
13. An implantable medical device that provides a valve for regulating fluid flow through a body vessel comprising:
an expandable support frame; and at least one leaflet attached to the support frame, the at least one leaflet being formed of a bioremodellable material and moveable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction;

wherein the support frame and the at least one leaflet cooperatively define an opening that permits a controlled amount of fluid flow in the second, opposite direction.
14. The implantable medical device according to claim 13, wherein the bioremodellable material comprises an extracellular matrix material.
15. The implantable medical device according to claim 13, wherein the bioremodellable material comprises small intestine submucosa.
16. The implantable medical device according to claim 13, further comprising a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.
17. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising;
an expandable support frame; and at least one leaflet attached to the support frame, the at least one leaflet being formed of a bioremodellable material and movable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction, the at least one leaflet defining an opening that permits a controlled amount of quid flow in the second, opposite direction.
18. The implantable medical device according to claim 17, wherein the bioremodellable material comprises an extracellular matrix material.
19. The implantable medical device according to claim 17, wherein the bioremodellable material comprises small intestine submucosa.
20. The implantable medical device according to claim 17, wherein the opening is substantially square, substantially triangular, substantially ovoid, or teardrop-shaped.
21. The implantable medical device according to claim 17, further comprising a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.
22. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising;
an expandable support frame;
a first leaflet formed of a bioremodellable material and having first and second edges, the first edge attached to the support frame, the first leaflet defining a first opening; and a second leaflet formed of a bioremodellable material and having third and fourth edges, the third edge attached to the support frame and the fourth edge cooperating with the second edge of the first leaflet to define a valve aperture having open and closed configurations, the second leaflet defining a second opening;
wherein the first and second openings permit a controlled amount of fluid flow through said medical device when the valve aperture is in the closed configuration.
23. The implantable medical device according to claim 22, wherein the bioremodellable material comprises an extracellular matrix material.
24. The implantable medical device according to claim 22, wherein the bioremodellable material comprises small intestine submucosa.
25. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising:
a support frame;
26 at least one leaflet attached to the support frame and being moveable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction, the leaflet defining an opening that permits a controlled amount of fluid flow in the second, opposite direction; and a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.
26. The implantable medical device according to claim 25, wherein the at least one leaflet is formed of a bioremodellable material.
27. The implantable medical device according to claim 26, wherein the bioremodellable material comprises an extracellular matrix material.
28. The implantable medical device according to claim 26, wherein the bioremodellable material comprises small intestine submucosa.
CA2518867A 2003-03-12 2004-03-10 Prosthetic valve that permits retrograde flow Expired - Lifetime CA2518867C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US45424903P 2003-03-12 2003-03-12
US60/454,249 2003-03-12
US48813803P 2003-07-16 2003-07-16
US60/488,138 2003-07-16
PCT/US2004/007219 WO2004080352A1 (en) 2003-03-12 2004-03-10 Prosthetic valve that permits retrograde flow

Publications (2)

Publication Number Publication Date
CA2518867A1 true CA2518867A1 (en) 2004-09-23
CA2518867C CA2518867C (en) 2011-09-20

Family

ID=32994554

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2518867A Expired - Lifetime CA2518867C (en) 2003-03-12 2004-03-10 Prosthetic valve that permits retrograde flow

Country Status (8)

Country Link
US (2) US7402171B2 (en)
EP (2) EP1603492B1 (en)
JP (1) JP4624984B2 (en)
AT (1) ATE452601T1 (en)
AU (2) AU2004220576B2 (en)
CA (1) CA2518867C (en)
DE (1) DE602004024766D1 (en)
WO (1) WO2004080352A1 (en)

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