Prosthesis having a sleeve valve

• US 20080208314A1
• Filed: 02/22/2007
• Published: 08/28/2008
• Est. Priority Date: 02/22/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Skerven, Gregory J.
• Granted Patent: US 8,221,505 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 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
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets

Abstract

Disclosed is a pressure sensitive prosthesis that includes a tubular member having a passageway extending therethrough and a sleeve attached about one end of the tubular member. The sleeve functions as a one-way valve to permit fluid flowing through the sleeve lumen in a first, distal direction and under a first pressure, while collapsing in response to fluid flowing in a second direction when the pressure thereof exceeds that of the first direction or pressure. One aspect of the invention includes a first opening and a second opening configured for allowing fluid flow from the passage to the lumen in the first direction.

Claims

1. A prosthesis for placement in a patient for controlling fluid flow through a passageway, the prosthesis comprising:

a tubular stent having a proximal portion, a distal portion, and a passage extending longitudinally therethrough, the distal portion comprising a first opening through a sidewall thereof; and

a sleeve extending from the distal portion of the tubular stent, the sleeve having a lumen extending longitudinally therethrough and communicating with the passage of the tubular stent, the, sleeve permitting the passage of a fluid through the lumen in a first direction in response to the fluid applying a first pressure to the sleeve in the first direction, the sleeve being collapsible so as to substantially close the lumen in response to a fluid applying a second pressure to the sleeve in a second direction;

wherein at least a portion of a proximal portion of the sleeve extends over an outer surface of the stent and is affixed thereto at a sleeve connection position and the first opening is distal to the sleeve connection position; and

wherein the sleeve is normally closed in the absence of fluid applying the first pressure to the sleeve in the first direction.

2. The prosthesis of claim 1, wherein the distal end portion further comprises a second opening in a distal end of the stent.

3. The prosthesis of claim 2, wherein the first opening and the second opening are spaced apart.

4. The prosthesis of claim 2, wherein the first opening and the second opening are contiguous.

5. The prosthesis of claim 2, wherein the first opening comprises a first flow axis extending through the first opening and the second opening comprises a second flow axis extending through the second opening, wherein the first and second flow axes are non-parallel.

6. The prosthesis of claim 1, wherein the first opening is configured for permitting fluid flow in the first direction to flow laterally from the passage into the lumen.

7. The prosthesis of claim 2, further comprising a third opening through the sidewall of the distal portion of the stent.

8. The prosthesis of claim 1, wherein the stent is non-expanding.

9. The prosthesis of claim 1, wherein the stent comprises at least one retention member for retaining the prosthesis in a body passageway.

10. The prosthesis of claim 9, wherein the at least one retention member comprises a radially extending flap.

11. The prosthesis of claim 9, wherein the at least one retention member comprises a pigtail loop.

12. The prosthesis of claim 1, wherein the sleeve is formed from a polymeric material.

13. The prosthesis of claim 1, wherein the sleeve comprises expanded polytetrafluoroethylene.

14. The prosthesis of claim 1, wherein the sleeve has a thickness between about 0.001 inch to about 0.01 inch.

15. The prosthesis of claim 1, wherein the sleeve comprises a modification for increasing resistance to being inverted through the stent in response to the second pressure.

16. A prosthesis for placement in a patient comprising:

a tubular stent having a passage extending longitudinally therethrough, a side wall opening and a distal end opening connected to the passage; and

a sleeve extending from a distal end portion of the tubular stent and having a lumen extending longitudinally therethrough and communicating with the passage of the tubular stent, the sleeve permitting the passage of a fluid through the lumen in a first direction in response to the fluid applying a first pressure to the sleeve in the first direction, the sleeve being collapsible so as to substantially close the lumen in response to a fluid applying a second pressure to the sleeve in a second direction;

wherein the side wall opening comprises a first flow axis extending through the side wall opening and the distal end opening comprises a second flow axis extending through the second opening.

17. The prosthesis of claim 16, wherein at least a portion of a proximal portion of the sleeve extends over an outer surface of the stent and is affixed thereto at a sleeve connection position.

18. The prosthesis of claim 17, wherein the side wall opening and the distal end opening are positioned distal to the sleeve connection position.

19. A prosthesis for placement in a patient for controlling fluid flow through a passageway, the prosthesis comprising:

a tubular stent having a proximal end, a distal portion, and a passage extending longitudinally therethrough, the distal portion having a first opening and a second opening; and

a sleeve extending from the distal portion of the tubular stent, the sleeve having a lumen extending longitudinally therethrough and communicating with the passage of the tubular stent, the sleeve permitting the passage of a fluid through the lumen in a first direction in response to the fluid applying a first pressure to the sleeve in the first direction, the sleeve being collapsible so as to substantially close the lumen in response to a fluid applying a second pressure to the sleeve in a second direction;

wherein the passage comprises a closed tubular conduit between the proximal end and the first opening.