Medical stent with a valve and related methods of manufacturing

• US 6,790,237 B2
• Filed: 10/09/2001
• Issued: 09/14/2004
• Est. Priority Date: 10/09/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Stinson, Jonathan S.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/972,054
• Publication Number:
  US 20030069646A1
• Time in Patent Office: 1,071 Days
• Field of Search: 623/23.7, 623/1.26, 623/1.24, 623/1.13, 623/2.14, 623/2.16, 623/2.18, 623/23.68, 623/2.12, 623/2.17, 623/2.19
• 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 esophageal stent having a valve, comprising:

a generally tubular body formed of braided wires and 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 formed of non-braided wires extended from the braided wires 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.

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

3. The medical esophageal stent according to claim 2, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

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

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

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

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

8. The medical esophageal stent according to claim 1, wherein the extended wires forming the valve are curled inwards.

9. The medical esophageal stent according to claim 1, wherein the extended wires forming the valve have a straight portion and a bend inwards at a predetermined location of the extended wires.

10. The medical esophageal stent according to claim 1, wherein the extended wires forming the valve are curled so that middle portions of the extended wires converge toward each other.

11. The medical esophageal stent according to claim 1, wherein the predetermined condition is a passage of food from the esophagus into the stomach.

12. The medical esophageal stent according to claim 1, wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

13. A medical stent having a valve, comprising:

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

a normally closed valve formed of non-braided wires extended from the braided wires 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.

14. The medical stent according to claim 13, wherein at least a portion of the tubular body and valve is provided with a covering.

15. The medical stent according to claim 14, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

16. The medical stent according to claim 13, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the valve.

17. The medical stent according to claim 13, wherein the valve is a one-way valve.

18. The medical stent according to claim 13, wherein the extended wires forming the valve are curled inwards so as to form generally convex shapes relative to an interior of the valve.

19. The medical stent according to claim 13, wherein the extended wires forming the valve have a straight portion and a bend inwards at a predetermined location of the extended wires.

20. The medical stent according to claim 13, wherein the extended wires forming the valve are curled so that middle portions of the extended wires converge toward each other.

21. The medical stent according to claim 13, wherein the stent is an esophageal stent being sized and configured to be placed in an esophagus of a patient.

22. The medical stent according to claim 13, wherein the stent is configured to be placed in an esophagus of a patient, and wherein the predetermined condition is a passage of food from the esophagus into the stomach.

23. The medical stent according to claim 13, wherein the stent is configured to be placed in an esophagus of a patient, and wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

24. A medical stent having a valve, comprising:

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

a normally closed valve formed of non-braided wires extended from the braided wires of the tubular body, the non-braided wires being curled inwardly so as to form wires having a convex shape relative to an interior of the valve, 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.

25. The medical stent according to claim 24, wherein at least a portion of the tubular body and valve is provided with a covering.

26. The medical stent according to claim 25, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

27. The medical stent according to claim 24, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the valve.

28. The medical stent according to claim 24, wherein the valve is a one-way valve.

29. The medical stent according to claim 24, wherein the stent is configured to be placed in an esophagus of a patient, and wherein the predetermined condition is a passage of food from the esophagus into the stomach.

30. The medical stent according to claim 24, wherein the stent is configured to be placed in an esophagus of a patient, and wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

31. A medical esophageal stent having a valve, comprising:

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

a normally closed valve formed of non-braided wires extended from the braided wires of the tubular body, the non-braided wires being curled inwardly so as to form wires having a convex shape relative to an interior of the valve, 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.

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

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

34. The medical esophageal stent according to claim 31, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the valve.

35. The medical esophageal stent according to claim 31, wherein the predetermined condition is a passage of food from the esophagus into the stomach.

36. The medical esophageal stent according to claim 31, wherein the predetermined condition is a passage of food from the esophagus into the stomach.

37. The medical esophageal stent according to claim 31, wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

38. A medical esophageal stent having a valve, comprising:

a generally tubular body formed of braided wires and 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 formed integral to the distal end portion 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 valve is made of an elastomeric material.

39. The medical esophageal stent according to claim 38, wherein the tubular body has a generally tapered body.

40. The medical esophageal stent according to claim 38, wherein at least a portion of the tubular body and valve is provided with a covering.

41. The medical esophageal stent according to claim 40, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

42. The medical esophageal stent according to claim 38, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the valve.

43. The medical esophageal stent according to claim 38, wherein the predetermined condition is a passage of food from the esophagus into the stomach.

44. The medical esophageal stent according to claim 38, wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.

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

46. The medical esophageal stent according to claim 38, wherein the opening includes at least one slit.

47. A medical stent having a valve, comprising:

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

a normally closed valve formed integral to the distal end portion of the tubular body, the valve including a valved end having an opening when the valve is in a normally closed position,

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

48. The medical stent according to claim 47, wherein the tubular body has a generally tapered body.

49. The medical stent according to claim 47, wherein the tubular body is sized and configured to be placed in an esophagus of a patient.

50. The medical stent according to claim 47, wherein the valve is formed of non-braided wires extended from the braided wires of the tubular body.

51. The medical stent according to claim 50, wherein the non-braided wires are curled inwardly so as to form wires having a convex shape relative to an interior of the valve.

52. The medical stent according to claim 50, wherein the non-braided wires forming the valve have a straight portion and a bend inwards at a predetermined location of the extended wires.

53. The medical stent according to claim 50, wherein the non-braided wires forming the valve are curled so that middle portions of the extended wires converge toward each other.

54. The medical stent according to claim 50, wherein at least a portion of the tubular body and valve is provided with a covering.

55. The medical stent according to claim 54, wherein the material for the covering is selected from a group of polyurethane, polytetrafluoroethylene, and silicone.

56. The medical stent according to claim 47, wherein the predetermined condition is a predetermined pressure difference between an upstream and a downstream of the valve.

57. The medical stent according to claim 47, wherein the valve is made of an elastomeric material.

58. The medical stent according to claim 57, wherein the elastomeric valve is a gasket valve.

59. The medical stent according to claim 57, wherein the opening includes at least one slit.

60. The medical stent according to claim 47, wherein the stent is configured to be placed in an esophagus of a patient, and wherein the predetermined condition is a passage of food from the esophagus into the stomach.

61. The medical stent according to claim 47, wherein the stent is configured to be placed in an esophagus of a patient, and wherein the predetermined condition is a vomiting of a stomach content from the stomach to the esophagus.