TEMPORARY VALVE AND FILTER ON GUIDE CATHETER

• US 20150342717A1
• Filed: 06/01/2015
• Published: 12/03/2015
• Est. Priority Date: 05/30/2014
• Status: Abandoned Application

• Current Assignee: Cardiac Valve Solutions LLC
• Original Assignee: Brian A. Biancucci, Michael J. O'Donnell
• Inventors: O'DONNELL, Michael J., BIANCUCCI, Brian A.
• Application Number:
  US14/727,042
• Publication Number:
  US 20150342717A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/015 Stop means therefor
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A temporary valve and a filtration device can be added to a delivery catheter or guide catheter to improve hemodynamics and provide embolic protection. Both the valve and filter can mount onto the outer diameter of a delivery or guide catheter, which offers several distinct advantages. First, the inner lumen of the delivery or guide catheter remains unaffected, thereby allowing the standard procedure steps to take place without any changes or interruptions, or with minimal changes or interruptions.

Claims

1. A temporary valve system, the system comprising:

a guide catheter having an inner diameter and an outer diameter and a proximal end and a distal end; and

a valve mounted around an outer distal portion of the guide catheter, the valve made of a thin and flexible material and comprising a conical distal section and a conical proximal section, the conical distal section of the valve tapering towards the distal end of the guide catheter and the conical proximal section of the valve tapering towards the proximal end of the guide catheter, the conical proximal section of the valve having a plurality of openings, the valve configured to adopt a collapsed configuration against the guide catheter when fluid flows over the valve from the distal end of the guide catheter to the proximal end of the guide catheter, the valve configured to adopt an expanded configuration when fluid flows over the valve from the proximal end of the guide catheter to the distal end of the guide catheter.

2. The temporary valve system of claim 1, further comprising a filter disposed on the guide catheter proximally to the distal section of the valve, the filter configured to remain in an open configuration when the valve is in either the expanded configuration or the collapsed configuration.

3. The temporary valve system of claim 1, wherein the valve comprises a one-piece construction with no rigid components.

4. The temporary valve system of claim 1, comprising a strutless valve wherein the conical distal section is unsupported by struts.

5. The temporary valve system of claim 2, wherein the filter comprises a support structure configured to support the filter in the open configuration.

6. The temporary valve system of claim 3, wherein the support structure comprises one or move of:

a ring and a plurality of struts.

7. The temporary valve system of claim 3, wherein the support structure is made of a metal or shape memory metal.

8. The temporary valve system of claim 2, wherein the filter has a conical or bell-shaped shaped geometry.

9. The temporary valve system of claim 2, wherein the filter and valve are nested together.

10. The temporary valve system of claim 2, wherein the filter is slidably disposed on the guide catheter.

11. The temporary valve system of claim 2, further comprising a sheath that is slidably disposed over the guide catheter, valve, and filter.

12. The temporary valve system of claim 2, wherein the filter comprises one or more control wires that extend to the proximal end of the guide catheter, the one or more control wires configured to collapse and expand the filter.

13. The temporary valve system of claim 1, wherein the distal section of the valve is attached to the guide catheter with a distal end sleeve, the distal end sleeve having an inner diameter that matches the outer diameter of the guide catheter, and wherein the proximal section of the valve is attached to the guide catheter with a proximal end sleeve, the proximal end sleeve having an inner diameter that matches the outer diameter of the guide catheter.

14. The temporary valve system of claim 1, wherein the proximal section of the valve is longer than the distal section of the valve.

15. The temporary valve system of claim 1, wherein the proximal section of the valve is about twice as long as the distal section of the valve.

16. The temporary valve system of claim 1, wherein the proximal section of the valve is tapered at an angle between about 30 to 60 percent of the angle of the taper of the distal section of the valve.

17. The temporary valve system of claim 1, wherein the valve is slidably disposed on the guide catheter.

18. The temporary valve system of claim 2, wherein the valve and filter are supported by a common frame, the common frame comprising a first plurality of struts for supporting the filter and a second plurality of struts for supporting the valve.

19. The temporary valve system of claim 18, wherein the first plurality of struts for supporting the filter have free ends that are configured to open up to an expanded configuration, and wherein the second plurality of struts for supporting the valve have ends that remain proximate the guide catheter.

20. The temporary valve system of claim 2, wherein the valve and filter are concentrically disposed over the guide catheter.

21. A temporary valve system, the system comprising:

a guide catheter having an inner diameter and an outer diameter and a proximal end and a distal end;

a valve mounted around an outer distal portion of the guide catheter, the valve made of a thin and flexible material and comprising a conical distal section and a conical proximal section, wherein the conical distal section of the valve is unsupported by struts and tapers towards the distal end of the guide catheter, and wherein the conical proximal section of the valve tapers towards the proximal end of the guide catheter, the conical proximal section of the valve having a plurality of openings, the valve configured to adopt a collapsed configuration against the guide catheter when fluid flows over the valve from the distal end of the guide catheter to the proximal end of the guide catheter, the valve configured to adopt an expanded configuration when fluid flows over the valve from the proximal end of the guide catheter to the distal end of the guide catheter; and

a filter disposed on the guide catheter proximally to the distal section of the valve, the filter configured to remain in an open configuration when the valve is in either the expanded configuration or the collapsed configuration.

22. A method of providing a temporary valve to a blood vessel, the method comprising:

inserting a guide catheter into the blood vessel, the guide catheter having a valve mounted on an outer distal portion of the guide catheter, the valve made of a thin and flexible material and comprising a conical distal section and a conical proximal section, wherein the conical distal section is unsupported by struts and tapers towards the distal end of the guide catheter and wherein the conical proximal section of the valve tapers towards the proximal end of the guide catheter, the proximal section of the valve having a plurality of openings, the valve configured to adopt a collapsed configuration against the catheter when a fluid flows over the valve from the distal end of the guide catheter to the proximal end of the guide catheter, the valve configured to adopt an expanded configuration when the fluid flows over the valve from the proximal end of the guide catheter to the distal end of the guide catheter;

advancing the distal end of the guide catheter to the ascending aorta;

positioning the valve in the aorta; and

deploying the valve.

23. The method of claim 22, further comprising filtering blood passing past the guide catheter with a filter disposed on the guide catheter proximally to the distal section of the valve, the filter configured to remain in an open configuration when the valve is in either the expanded configuration or the collapsed configuration.

24. The method of claim 23, further comprising positioning the filter between the aortic root and brachiocephalic trunk.

25. The method of claim 22, wherein deploying the valve further comprises retracting a sleeve disposed over the guide catheter and the valve.

26. The method of claim 22, further comprising collapsing the valve by advancing a sleeve over the guide catheter and the valve.

27. The method of claim 22, wherein positioning the valve further comprises positioning the valve between the aortic root and the brachiocephalic trunk.

28. The method of claim 22, wherein positioning the valve further comprises positioning the valve in the descending aorta.

29. The method of claim 23, further comprising manipulating one or more control wires to deploy the filter.

30. The method of claim 22, further comprising deploying a valve excision device through the catheter and removing a cardiac valve.

31. The method of claim 22, further comprising deploying a replacement valve through the catheter.

32. A temporary filter system, the system comprising:

a guide catheter having an inner diameter and an outer diameter and a proximal end and a distal end;

a filter mounted around an outer distal portion of the guide catheter;

a sheath that is slidably disposed over the guide catheter and configured to slide distally to collapse the filter into a closed configuration and slide proximally to allow the filter to expand into an open configuration around the outer diameter of the guide catheter; and

a support structure configured to support the valve in the open configuration.

33. The temporary filter system of claim 32, wherein the support structure is a ring.

34. The temporary filter system of claim 32, wherein the support structure is a plurality of struts.

35. The temporary filter system of claim 32, wherein the support structure is made of a metal or shape memory metal.

36. The temporary filter system of claim 32, wherein the filter has a conical shaped geometry.

37. The temporary filter system of claim 32, wherein the filter has a bell shaped geometry.

38. The temporary filter system of claim 32, wherein the filter is slidably disposed on the guide catheter.

39. The temporary filter system of claim 32, wherein the filter comprises one or more control wires that extend to the proximal end of the guide catheter, the one or more control wires configured to collapse and expand the filter.