Involuted endovascular valve and method of construction

• US 20050240262A1
• Filed: 05/05/2003
• Published: 10/27/2005
• Est. Priority Date: 05/03/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: White, Jennifer K.
• Granted Patent: US 7,331,993 B2
• Time in Patent Office: Days
• US Class Current: 623/2.120
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents

Abstract

A prosthetic tri-leaflet valve formed by involuting a portion of a tubular structure inside itself. The valve can be made by a method comprising providing a tubular segment in which three equidistant longitudinal incisions are made in one end of the tube creating three flaps which are involuted, i.e., folded, in toward the inside of the tube and the edges of the flaps secured to the inner wall of the tube to form leaflets. The tube can be formed of a single sheet of synthetic, organic or biological material and can be solid, woven, braided or the like. A braided configuration permits the valve to be annularly compressed and delivered to the site using a minimally invasive delivery mechanism, then expanded at the implantation site.

Claims

1. A method of forming a prosthetic valve, comprising:

a. providing a tube of material having an inner wall, an outer wall, a diameter “

d”

, a height “

h” and

a wall thickness “

t”

;

b. cutting three longitudinal incisions from one end in said material about 120 degrees apart to form three flaps, each said flap having a first edge, a second edge generally parallel to said first edge, and a bottom edge;

c. involuting each said flap within said tube; and

,

d. attaching each said fist edge and second edge of each involuted flap to said inner wall of said tube.

2. The method of claim 1, wherein said three longitudinal incisions have a length “

L”

, such that L= 1/2 h−

2 t, where “

h”

is the cylinder height and “

t”

is the thickness of said tube.

3. The method of claim 1, wherein said height “

h”

is approximately equal to the diameter of the recipient aortic annulus diameter “

A”

.

4. The method of claim 1, wherein the edges of each flap are cut to be rounded off along their free edge to create concave shaped leaflets.

5. The method of claim 1, wherein scallop shaped segments of said tube wall are removed between commissures.

6. The method of claim 1, wherein said attaching is achieved by suturing.

7. The method of claim 1, wherein said tube is comprises a generally rectangular sheet of material that has two opposing sides joined together.

8. (canceled)

9. An autologous valve formed by a process, comprising:

a. providing a tube of material having an inner wall, an outer wall, a diameter “

a”

, a height “

b” and

a wall thickness “

t”

;

b. cutting three longitudinal incisions from one end in said material about 120 degrees apart to form three flaps, each said flap having a first edge, a second edge generally parallel to said first edge, and a bottom edge;

c. involuting each said flap within said tube; and

,

d. attaching each said first edge and second edge of each involuted flap to said inner wall of said tube.

10. A method of converting a tube into a valve, comprising:

a. providing a tube of material having an inner wall, an outer wall, a diameter “

a”

, a height “

b” and

a wall thickness “

t”

;

b. cutting three longitudinal incisions from one end in said material about 120 degrees apart to form three flaps, each said flap having a first edge, a second edge generally parallel to said first edge, and a bottom edge;

c. involuting each said flap within said tube; and

,

d. attaching each said first edge and second edge of each involuted flap to said inner wall of said tube.

11. A endovascular valve, comprising:

a. a flexible tube having a first end and a second end, an inner wall and an outer wall;

b. a plurality of leaflets formed from a portion of said first end by making a plurality of longitudinal incisions in said downstream end to form a plurality of flaps, each flap having a first edge and second edge, involuting said flaps toward said inner wall and securing said first edge and second edge of each flap to said inner wall of said tube.