Inverting temporary valve sheath

• US 10,667,909 B2
• Filed: 05/12/2017
• Issued: 06/02/2020
• Est. Priority Date: 05/16/2016
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Weisz, Ety, Kreizer, Mark
• Primary Examiner(s): Lynch, Robert A
• Application Number:
  US15/593,484
• Publication Number:
  US 20170325955A1
• Time in Patent Office: 1,117 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

A percutaneous device including a temporary valve attached to a sheath, the sheath having an inverting section for delivery and removal thereof from a blood vessel. The sheath is inverted for delivery, housing the valve between inverted layers thereof. To deploy said valve, the sheath is everted to position the temporary valve on an outer surface thereof. The temporary valve and sheath are reversibly movable between inverted and deployed configurations. Upon eversion, the temporary valve assumes a radially expanded canopy shape having an outer diameter selected to contact the vessel wall and allow blood flow in only one direction. The temporary valve may be removed by releasing one end of the valve from the sheath, flattening the temporary valve along the longitudinal axis of the sheath. Also provided is a temporary valve system comprising a dilator for inverting and everting the sheath, said dilator being removably connected to the sheath.

Claims

1. A temporary valve device, comprising:

a sheath having a first section and a second section, said first section attached to a distal end of said second section;

a temporary valve having a first valve end and a second valve end, said first valve end fixedly attached to an outer circumference of said first section of the sheath; and

an attachment mechanism detachably connecting said second valve end of said temporary valve to said outer circumference of the first section of the sheath.

2. The device of claim 1, wherein said first section is formed of a braided member.

3. The device of claim 1, wherein said temporary valve is formed with an umbrella shape.

4. The device of claim 3, wherein said temporary valve has an opening extending therethrough.

5. The device of claim 1, wherein said attachment mechanism comprises a plurality of lines connecting said second valve end to said first section.

6. The device of claim 5, wherein first ends of said lines are attached to a rim of said temporary valve.

7. The device of claim 5, wherein first ends of said lines are attached to a position separated from a rim of said temporary valve by a predetermined gap.

8. The device of claim 5, further comprising a plurality of reinforcing ribs coupled to said temporary valve, said ribs being disposed about the temporary valve.

9. The device of claim 8, wherein said ribs are one of embedded in the temporary valve, attached to an inner surface of the temporary valve and attached to an outer surface of the temporary valve.

10. The device of claim 8, wherein said ribs extend from respective first rib ends to respective second rib ends, said first rib ends being separated from said first valve end.

11. The device of claim 10, wherein said second rib ends are one of separated from said second valve end and aligned with said second valve end.

12. The device of claim 10, wherein said second rib ends include attachment rings for attachment to said lines.

13. The device of claim 8, wherein said device includes one of 4 ribs, 8 ribs and 16 ribs.

14. The device of claim 8, wherein said ribs are biased to a radially expanded configuration.

15. The device of claim 5, wherein said lines include loops for attachment to an attachment wire.

16. The device of claim 15, wherein said attachment wire is interwoven through said line loops and said first section, said interwoven portion extending 180 degrees about a circumference of said first section.

17. The device of claim 15, wherein said first section includes a plurality of sheath loops to which the line loops are attached via the attachment wire.

18. The device of claim 1, wherein the temporary valve is invertable.

19. The device of claim 1, wherein said attachment mechanism is one of an attachment wire, string and pin.

20. The device of claim 1, wherein said attachment mechanism couples the temporary valve directly to said first section.

21. A temporary valve device, comprising:

a sheath having a first section and a second section, said first section attached to a distal end of said second section;

a temporary valve attached to an outer surface of said first section, said temporary valve extending from a first valve end to a second valve end;

an attachment mechanism reversibly connecting said temporary valve to said first section; and

a first control wire extending through said valve device and having first and second free ends located outside of said valve device, wherein a proximal retraction of said first and second free ends moves said first section and temporary valve to an inverted delivery configuration.

22. A percutaneous temporary valve system, comprising:

a sheath having a first section and a second section, said first section attached to a distal end of said second section;

a temporary valve having a first valve end and a second valve end, wherein said first valve end is fixedly attached to an outer circumference of said first section of the sheath and said second valve end is detachably connected to the outer circumference of said first section of the sheath; and

a dilator for insertion through said valve device, said dilator having a nosecone at a distal end thereof.

23. The system of claim 22, further comprising a first wire having first and second free ends located outside of said valve device, wherein a proximal retraction of said first and second free ends moves said first section and temporary valve to an inverted delivery configuration.

24. The system of claim 23, wherein said first wire is woven through said dilator, out of a distal dilator opening thereof and through said first section at an attachment point.

25. The system of claim 24, wherein the dilator comprises a reduced diameter waist distally of said distal opening.

26. The system of claim 24, further comprising a second wire connected to said dilator, said second wire including wire loops for receiving said first wire.

27. The system of claim 26, further comprising a third wire coupled to said first section, said third wire controlling inversion and eversion of the first section independently of a position of said dilator.

28. The system of claim 26, wherein said temporary valve comprises a plurality of lines connecting said second valve end to said first section.

29. The system of claim 28, further comprising an attachment wire, wherein said lines include looped free ends for attachment to said first section via said attachment wire.

30. The system of claim 22, wherein said first section is formed of a braided member.

31. The system of claim 22, wherein said temporary valve is invertable.

32. A temporary valve device, comprising:

a sheath having a first section and a second section, said first section attached to a distal end of said second section;

an invertible temporary valve having a first valve end and a second valve end, said first valve end fixedly attached to an outer circumference of said first section of the sheath and said second valve end detachably connected to said outer circumference of said first section of the sheath; and

wherein said temporary valve is reversibly movable between an inverted delivery configuration and a deployed canopy configuration, wherein, in said delivery configuration, said first section is inverted into said second section and wherein in said deployed configuration, said first section is moved distally out of said second section to permit radial expansion of said temporary valve.

33. The device of claim 32, wherein said first section is formed of a braided member.

34. The device of claim 32, wherein said temporary valve is formed with an umbrella shape having an opening extending therethrough to house a delivery device.

35. The device of claim 32, wherein said temporary valve has a diameter which increases from a proximal end to a distal end.

36. The device of claim 32, wherein said temporary valve comprises a plurality of lines connecting said second valve end to said first section.

37. The device of claim 36, wherein first ends of said lines are attached to a rim of said temporary valve.

38. The device of claim 36, wherein first ends of said lines are attached to a position separated from a rim of said temporary valve by a predetermined gap.

39. The device of claim 36, further comprising an attachment wire, wherein said lines include line loops are free ends thereof for attachment to said first section via said attachment wire.

40. The device of claim 39, wherein said attachment wire is interwoven through said line loops and said first section, said interwoven portion extending 180 degrees about a circumference of said first section.

41. The device of claim 40, wherein said first section includes a plurality of sheath loops to which the line loops are attached via the attachment wire.

42. The device of claim 36, wherein said lines are removably attached to said first section.

43. The device of claim 32, further comprising a plurality of reinforcing ribs coupled to said temporary valve, said ribs being symmetrically disposed about the temporary valve.

44. The device of claim 43, wherein said ribs are one of embedded in the temporary valve, attached to an inner surface of the temporary valve, and attached to an outer surface of the temporary valve.

45. The device of claim 43, wherein said ribs extend from respective first rib ends to respective second rib ends, said first rib ends being separated from said first valve end.

46. The device of claim 45, wherein said second rib ends are one of separated from said second valve end and aligned with said second valve end.

47. The device of claim 45, wherein said second rib ends include attachment rings for attachment to said lines.

48. The device of claim 43, wherein said device includes one of 8 ribs and 16 ribs.

49. The device of claim 43, wherein said ribs are biased to a radially expanded configuration.

50. The device of claim 32, further comprising a first control wire extending through said valve device and having first and second free ends located outside of said valve device, wherein a proximal retraction of said first and second free ends moves said sheath and temporary valve to said inverted delivery configuration.