Medical stent with a valve and related methods of manufacturing

• US 7,354,455 B2
• Filed: 08/05/2004
• Issued: 04/08/2008
• Est. Priority Date: 10/09/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Stinson, Jonathan S.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/911,650
• Publication Number:
  US 20050065614A1
• Time in Patent Office: 1,342 Days
• Field of Search: 623/1.13, 623/1.24, 623/2.18, 623/23.68
• US Class Current: 623/23.68
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets

Abstract

Medical stents having valves and their methods of manufacture are disclosed. The valve may be basket-shaped and formed integral to a medical stent to prevent undesirable backflow across the valve. The valve can be formed by converting the braided wires of the stent, by providing elastomeric material onto a mold or fixture to form an elastomeric valve, or by attaching a gasket valve. The valve is normally closed but configured to allow easy opening in response to a predetermined condition.

Claims

1. A medical stent having an elastomeric valve, comprising:

a generally tubular body formed of braided wires having a proximal end portion and a distal end portion; and

a normally closed valve made of an elastomeric material and formed integral to the distal end portion of the braided wires, the elastomeric valve having a generally convex outer surface in a normally closed position and is substantially radially symmetric about a longitudinal axis of the tubular body,

wherein the elastomeric valve is sufficiently rigid so as to substantially maintain a predetermined shape,

wherein the elastomeric valve is configured to open in response to a predetermined condition,

wherein the elastomeric valve includes an opening when the valve is in the normally closed position, and

wherein said opening is located at a distal end of the valve.

2. The medical stent according to claim 1, wherein the elastomeric valve is basket-shaped.

3. The medical stent according to claim 1, wherein the elastomeric valve is a gasket valve.

4. The medical stent according to claim 1, wherein at least a portion of the tubular body is provided with a covering.

5. The medical stent according to claim 4, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

6. The medical stent according to claim 1, wherein at least a portion of the elastomeric valve is provided with a covering.

7. The medical stent according to claim 6, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

8. The medical stent according to claim 7, wherein at least a portion of the tubular body is provided with a covering and a material for the covering in the tubular body is the same as the material for the covering in the elastomeric valve.

9. The medical stent according to claim 1, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the elastomeric valve.

10. The medical stent according to claim 1, wherein the elastomeric valve is a one-way valve.

11. The medical stent according to claim 1, wherein the opening includes at least one slit.

12. The medical stent according to claim 1, wherein the stent is configured to be placed in an esophagus of a patient.

13. The medical stent according to claim 12, wherein the predetermined condition is a passage of food from the esophagus into the stomach.

14. The medical stent according to claim 12, wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

15. The medical stent according to claim 1, wherein the tubular body has a generally tapered body.

27. The medical stent according to claim 1, wherein the elastomeric valve lacks wires.

16. A medical esophageal stent having an elastomeric valve, comprising:

a generally tubular body having a proximal end portion and a distal end portion, the tubular body being sized and configured to be placed in an esophagus of a patient; and

a normally closed valve made of an elastomeric material and formed integral to the distal end portion of the tubular body, the valve having a generally convex outer surface and is substantially radially symmetric about a longitudinal axis of the tubular body wherein the valve is configured to open in response to a predetermined condition,

wherein a valved end of the valve includes an opening when the valve is in a normally closed position, and

wherein the opening lacks a cover for closing the opening.

17. The medical esophageal stent according to claim 16, wherein at least a portion of the tubular body and valve is provided with a covering.

18. The medical esophageal stent according to claim 17, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

19. The medical esophageal stent according to claim 16, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the valve.

20. The medical esophageal stent according to claim 16, wherein the predetermined condition is a passage of food from the esophagus into the stomach.

21. The medical esophageal stent according to claim 16, wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

22. The medical esophageal stent according to claim 16, wherein the valve is a one-way valve.

23. The medical esophageal stent according to claim 16, wherein the tubular body has a generally tapered body.

24. The medical esophageal stent according to claim 16, wherein the elastomeric valve is a gasket valve.

25. The medical esophageal stent according to claim 16, wherein the opening includes at least one slit.

26. The medical esophageal stent according to claim 16, wherein the elastomeric valve is basket-shaped.

28. The medical esophageal stent according to claim 16, wherein the tubular body comprises a plurality of flexible wires.

29. The medical esophageal stent according to claim 16, wherein the tubular body comprises an elongate body having a length greater than a diameter of the elongate body.

44. The medical esophageal stent according to claim 16, wherein the body is formed of braded wires and the valve is fixedly attached to the braided wires.

30. A medical stent having an elastometric valve, comprising:

a generally tubular, radially flexible body having a proximal end portion and a distal end portion; and

a normally closed valve made of an elastometric material and formed integral to the distal end portion of the tubular body, the elastometric valve having a generally convex outer surface,

wherein the valve is configured to open in response to a predetermined condition,

wherein a valve end of the valve includes an opening when the valve is in a normally closed position, and

wherein the opening lacks a cover for closing the opening.

31. The medical stent according to claim 30, wherein at least a portion of the tubular body and valve is provided with a covering.

32. The medical stent according to claim 31, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

33. The medical stent according to claim 30, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the valve.

34. The medical stent according to claim 30, wherein the predetermined condition is a passage of food from the esophagus into the stomach.

35. The medical stent according to claim 30, wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

36. The medical stent according to claim 30, wherein the valve is a one-way valve.

37. The medical stent according to claim 30, wherein the tubular body has a generally tapered body.

38. The medical stent according to claim 30, wherein the elastomeric valve is a gasket valve.

39. The medical stent according to claim 30, wherein the opening includes at least one slit.

40. The medical stent according to claim 30, wherein the elastomeric valve is basket-shaped.

41. The medical stent according to claim 30, wherein the tubular body comprises a plurality of flexible wires.

42. The medical stent according to claim 30, wherein the tubular body comprises an elongate body having a length greater than a diameter of the elongate body.

43. The medical stent according to claim 30, wherein the tubular body is sized and configured to be placed in an esophagus of a patient.

45. The medical stent according to claim 30, wherein the body is formed of braded wires and the valve is fixedly attached to the braided wires.