Anti-reflux prosthesis

• US 9,358,095 B2
• Filed: 10/22/2013
• Issued: 06/07/2016
• Est. Priority Date: 10/24/2012
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: McHugo, Vincent
• Primary Examiner(s): SWEET, THOMAS
• Assistant Examiner(s): Bissing, Daniel
• Application Number:
  US14/060,338
• Publication Number:
  US 20140114433A1
• Time in Patent Office: 959 Days
• Field of Search: 623/23.64, 623/23.65, 623/23.68
• US Class Current: 1/1
• 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 2/2412 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 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines

Abstract

A prosthesis and a method for controlling flow through a bodily lumen in a first direction and a second direction are provided. The prosthesis includes a body having a proximal portion, a distal portion and a body lumen extending therethrough. The prosthesis also includes a first valve for controlling flow through the body lumen in a first direction where the first valve forms a first opening in the prosthesis. The prosthesis includes a second valve for controlling flow through the body lumen in a second direction where the second valve includes a portion that contacts the body in a closed configuration and the portion is spaced apart from the body in an open configuration to form the second opening. The first opening is positioned apart from the second opening and the second opening opens in response to a higher pressure than the first opening.

Claims

1. A prosthesis for controlling flow through a bodily lumen, the prosthesis comprising:

a body having a proximal portion, a distal portion and a body lumen extending therethrough;

a first valve for controlling flow through the body lumen in a first direction, the first valve forming a first opening in the prosthesis; and

a second valve for controlling flow through the body lumen in a second direction, the second valve comprising a tubular member that at least partially coextends longitudinally and circumferentially with the body, an outer wall of the second valve being sized and shaped to fit against at least a portion of an inner wall of the body, the second valve having a portion that contacts the body in a closed configuration and the portion is spaced apart from the body in an open configuration to form a second opening;

wherein the first opening is positioned apart from the second opening; and

the second opening opens in response to a higher pressure than the first opening.

2. The prosthesis of claim 1, wherein the first valve is connected to the second valve and the first opening is positioned distal to the second valve.

3. The prosthesis of claim 1, wherein the first valve is connected to the body and extends distally from the body.

4. The prosthesis of claim 1, wherein the second valve is positioned at least partially within the body.

5. The prosthesis of claim 1, wherein a portion of the second valve extends distal to the distal portion of the body.

6. The prosthesis of claim 1, wherein the second valve is positioned within the body and a distal end of the second valve is proximal to a distal end of the body.

7. The prosthesis of claim 1, wherein the first valve comprises an asymmetrically tapered portion.

8. The prosthesis of claim 1, wherein the body comprises a higher radial force than the second valve.

9. The prosthesis of claim 1, wherein a diameter of the tubular member is greater than a diameter of the body.

10. The prosthesis of claim 1, wherein the cross-section shape of the body at the second valve is circular or oval.

11. The prosthesis of claim 1, further comprising an anti-migration collar connected to the body and extending radially away from the body.

12. The prosthesis of claim 1, wherein the second valve is partially connected to the body at a connection portion that extends partially around the body.

13. The prosthesis of claim 12, wherein the connection portion is about 180°

around the body or less.

18. The prosthesis of claim 1, wherein the first valve comprises a sleeve valve.

19. The prosthesis of claim 1, wherein the second valve, the body or both the second valve and the body comprise a woven material.

20. The prosthesis of claim 18, wherein the second valve, the body or both the second valve and the body comprise a woven material.

14. A method of controlling flow through a bodily lumen in a first direction and a second direction, the method comprising:

positioning a body of a prosthesis within the bodily lumen, the prosthesis including a first valve and a second valve, the first valve for controlling flow through the body lumen in a first direction, the first valve forming a first opening in the prosthesis and the second valve for controlling flow through the body lumen in a second direction, the second valve comprising a tubular member that at least partially coextends longitudinally and circumferentially with the body, an outer wall of the second valve being sized and shaped to fit against at least a portion of an inner wall of the body, the second valve having a portion that contacts the body in a closed configuration and the portion is spaced apart from the body in an open configuration to form a second opening;

opening the first valve in response to the flow in the first direction; and

opening the second valve in response to the flow in the second direction where a pressure required to open the second valve is greater than a pressure required to open the first valve, the first valve being closed in the absence of the flow in the first direction and the second valve being closed in the absence of flow in the second direction at the higher pressure.

15. The method of claim 14, comprising providing the body having a higher radial force than the second valve.

16. The method of claim 14, comprising providing the first valve with a structure to prevent the first valve from everting in response to the flow in the second direction at the higher pressure.

17. The method of claim 14, comprising positioning the second valve against an opening in the body to form a closed configuration for the second valve.