Implantable valve system

• US 20040059411A1
• Filed: 03/27/2003
• Published: 03/25/2004
• Est. Priority Date: 10/26/2000
• Status: Active Grant

• Current Assignee: Ernst Peter Strecker
• Original Assignee: Ernst Peter Strecker
• Inventors: Strecker, Ernst Peter
• Granted Patent: US 7,156,872 B2
• Time in Patent Office: Days
• US Class Current: 623/1.23
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

An implantable valve having a valve element or leaflet and a base that is attachable to a vessel wall using a connector such as a screw, pin or a staple. The valve can be implanted using a catheter to position the valve in a desired location and drive the connector into the vessel wall. The valve can be used as a venous valve to control blood flow within the veins, arteries, heart or the aorta of a patient.

Claims

1. A body lumen valve comprising:

a base;

a valve element connected to the base such that the valve moves relative to the base between an open position and a closed position; and

a connector that attaches the base to a lumen surface region.

2. The valve of claim 1 wherein the valve element comprises a rim formed of a flexible material.

3. The valve of claim 1 wherein the valve element comprises at least one valve.

4. The valve of claim 1 wherein the valve further comprises a second connector.

5. The valve of claim 1 wherein the connector comprises a pin, a screw or a staple.

6. The valve of claim 1 wherein the valve element further comprises a leaflet attached to a frame.

7. The valve of claim 1 wherein the valve element and the base comprise a unitary structure having a hinge such that the valve element rotates relative to the base at the hinge.

8. The valve of claim 1 wherein the valve element comprises a substantially circular member having a soft peripheral rim.

9. The valve of claim 1 wherein the valve element has a thickness in a range between 0.2 mm and 3.0 mm, and a diameter in a range between 2 mm and 25 mm.

10. The valve of claim 1 wherein the valve element comprises a mesh.

11. The valve of claim 10 wherein the mesh comprises tissue.

12. The valve of claim 1 wherein tissue cells are cultured onto the valve element prior to implantation into a surgical site.

13. The valve of claim 11 wherein tissue cells adhere to the mesh after implantation into a surgical site.

14. A valve and delivery catheter kit comprising:

a valve having a base, a valve element connected to the base and a connector to attach the base to a vessel wall such that the valve element moves relative to the base between an open position and a closed position; and

a delivery catheter having a driver and a guide such that the driver attaches the connector to the vessel wall.

15. The kit of claim 14 wherein the driver comprises a flexible core.

16. The kit of claim 14 wherein the guide comprises a cable.

17. The kit of claim 14 further comprising a sheath that encloses at least a portion of the catheter.

18. The kit of claim 14 wherein the catheter further comprises a catheter connector that connects a distal end of the catheter to the valve.

19. The kit of claim 14 wherein the catheter comprises a double lumen catheter.

20. The kit of claim 14 wherein the guide bends a distal end of the catheter.

21. A method of attaching a valve to a vessel wall comprising:

providing a delivery catheter and a valve having a rotating valve element;

inserting the delivery catheter and valve into a vessel; and

attaching the valve to the vessel wall with the catheter.

22. The method of claim 21 wherein the valve is attached to a vessel wall at a surface region of the vessel wall having a surface area of less than 1 mm².

23. The method of claim 21 further comprising actuating a driver within the catheter to insert the connector into the vessel wall.

24. The method of claim 21 further comprising a guide in the catheter that positions a distal end of the catheter relative to the vessel wall.

28. The valve of claim 23 wherein the tube shaped tube further comprises a crease portion.

25. A valve comprising:

a base;

a connector that attaches the base to a lumen surface region; and

a tubular wall attached to the base, the tubular wall having a distal end with a distal opening and a proximal end with a proximal opening such that fluid flow from the distal end to the proximal end forces the tubular wall into an open position and fluid flow from the proximal end to the distal end forces the tubular wall into a closed position.

26. The valve of claim 25 wherein the tube comprises a wedge shaped tube.

27. The valve of claim 25 wherein the tube comprises a curve shaped tube.

29. The valve of claim 25 wherein the tube is formed of a silicone material.

30. The valve of claim 25 wherein the wall comprises a thin portion at the proximal end of the valve and a thick portion at the distal end of the valve.

31. The valve of claim 25 wherein the proximal opening comprises a rim.

32. The valve of claim 25 wherein the proximal opening comprises at least one reinforcement member.

33. The valve of claim 25 wherein the valve comprises a radially expanding region.

34. The valve of claim 33 wherein the radially expanding region comprises an overlapping portion.

35. The valve of claim 33 wherein the radially expanding region comprises a longitudinal fold.

36. The valve of claim 25 wherein the valve further comprises a concave curved portion.

37. The valve of claim 25 wherein the valve further comprises a kink portion.

38. An implantable venous valve comprising:

a base;

a connector that attaches the base to a lumen surface region;

a leaflet; and

a hinge connecting the base to the leaflet such that the leaflet moves relative to the base between an open position and a closed position.

39. The valve of claim 38 wherein the leaflet comprises an oval shape.

40. The valve of claim 38 wherein the leaflet comprises a rim and a center portion, the rim being thinner than the center portion.

41. The valve of claim 38 wherein the leaflet comprises a concave shape.

42. The valve of claim 38 wherein the valve comprises a frame.

43. The valve of claim 42 wherein the frame comprises a metal filament.

44. The valve of claim 38 wherein the valve is formed of a silicone material.

45. The valve of claim 38 wherein the valve further has a fabric material connecting the leaflet and the base.

46. The valve of claim 38 wherein a frame is located between a first layer and a second layer of the leaflet.

47. The valve of claim 38 wherein the leaflet comprises a mesh.

48. The valve of claim 47 wherein the mesh comprises a surface formed of cells.

49. The valve of claim 48 wherein the cells are cultured onto the mesh.

50. The valve of claim 48 wherein the cells adhere to the mesh after implantation into a surgical site.

51. A delivery catheter for an intralumenal valve comprising:

a sheath;

a catheter mounted within the sheath, the catheter having a valve to be delivered within a body lumen; and

a cannula attached to the catheter, the cannula having an aperture that delivers a fluid to a site.

52. The catheter of claim 51 wherein the fluid comprises a contrast material.

53. The catheter of claim 51 wherein the fluid comprises an adhesive.

54. The catheter of claim 51 wherein the cannula comprises a stopper that adjusts the position of the aperture.

55. A method for attaching a valve to a tissue surface comprising:

providing a valve having a base with a chamber formed between the base and a tissue surface;

providing a catheter attached to a cannula, the cannula having an aperture;

securing the valve to a catheter;

inserting the valve into a body with the catheter;

placing the valve against a tissue surface within the body; and

applying an adhesive through the aperture in the cannula to the chamber to attach the valve to the tissue surface.

56. The method of claim 55 further comprising detaching the catheter from the valve.

57. The method of claim 55 further comprising delivering a contrast medium to the attachment site through the aperture of the cannula.

58. The method of claim 55 further comprising inserting the catheter into a body lumen.

59. The method of claim 55 further comprising inserting the catheter into a vascular lumen.

60. The method of claim 55 further comprising attaching the base to the tissue surface with a connector.