Nonstented temporary valve for cardiovascular therapy

• US 7,320,704 B2
• Filed: 05/05/2005
• Issued: 01/22/2008
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: DFM, LLC (PDL BioPharma, Inc.)
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/122,768
• Publication Number:
  US 20060020332A1
• Time in Patent Office: 992 Days
• Field of Search: 623 21- 236
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30672 : temporary
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0059 : temporary
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

A method of treating a patient utilizes a temporary valve. In one embodiment, an inflatable structure of a temporary valve is inflated at a cardiovascular site in fluid communication with a native valve. At least a portion of the native valve is removed translumenally. A prosthetic valve is deployed to compliment or replace a native valve. The temporary valve is removed.

Claims

1. A temporary heart valve catheter, for enabling minimally invasive procedures on a valve in a beating heart, comprising:

an elongate, flexible catheter body, having a proximal end and a distal end;

a valve on the distal end, the valve comprising an inflatable structure; and

at least one link between the catheter and the valve to prevent detachment of the valve from the catheter.

2. A temporary heart valve catheter as in claim 1, further comprising a tubular body, the tubular body supported by the inflatable structure, the valve further comprising a valve mechanism coupled to the tubular body, the valve mechanism configured to permit blood flow in a first axial direction through the tubular body and to inhibit blood flow in a second axial direction opposite to the first axial direction.

3. A temporary heart valve catheter as in claim 2, wherein the tubular body comprises a fabric sleeve.

4. A temporary heart valve catheter as in claim 3, wherein the fabric comprises Dacron®

.

5. A temporary heart valve catheter as in claim 3, wherein the fabric comprises ePTFE.

6. A temporary heart valve catheter as in claim 1, wherein the inflatable structure comprises a first inflatable annulus and a second inflatable annulus.

7. A temporary heart valve catheter as in claim 6, wherein the first inflatable annulus is positioned at a first end of the valve and the second inflatable annulus is positioned at a second end of the valve.

8. A temporary heart valve catheter as in claim 7, further comprising inflatable struts positioned in between the first and second inflatable annulus.

9. A temporary heart valve catheter as in claim 8, wherein the inflatable struts are in fluid communication with one of the first and second inflatable annulus.

10. A temporary heart valve catheter as in claim 8, wherein at least one of first and second inflatable annulus is separately inflatable from the inflatable struts.

11. A temporary heart valve catheter as in claim 1, wherein the implant has an outside diameter when in the tubular configuration within the range of from about 18 mm to about 38 mm.

12. A temporary heart valve catheter as in claim 1, wherein the inflatable structure comprises at least three inflatable commissural supports.

13. A temporary heart valve catheter as in claim 1, wherein the valve comprises a plurality of tissue leaflets.

14. A temporary heart valve catheter as in claim 13, wherein the tissue comprises pericardium.

15. A temporary heart valve catheter as in claim 14, wherein the pericardium is decellularized.

16. A temporary heart valve catheter as in claim 1, wherein the valve comprises polymer leaflets.

17. A temporary heart valve catheter as in claim 1, wherein the elongate, flexible catheter body comprises an outer sheath in which the valve is stored in a collapsed state for delivery.

18. A temporary heart valve catheter as in claim 1, further comprising a guidewire extending through the elongate, flexible catheter body and the valve on the distal end of the elongate, flexible catheter body.

19. A temporary heart valve catheter as in claim 1, further comprising at least one inflation tube coupled to the inflation structure.

20. A temporary heart valve catheter as in claim 19, further comprising a valve for retaining inflation media within the inflation structure.

21. A temporary heart valve catheter of claim 1, wherein the inflatable structure comprises a first inflatable ring at a proximal end of the inflatable structure, a second inflatable ring at a distal end of the inflatable structure, and an inflatable intermediate support in between the first and second inflatable rings.

22. A temporary heart valve catheter of claim 21, wherein the intermediate support comprises a zig-zag configuration.

23. A temporary heart valve catheter of claim 1, further comprising an inflatable structure valve on the inflatable structure for preventing escape of media used to inflate the inflatable structure.

24. A temporary heart valve catheter of claim 1, further comprising at least one moveable occluder that controls the flow of blood through the inflatable structure.

25. A temporary heart valve catheter of claim 24, wherein the occluder comprises tissue.

26. A temporary heart valve catheter of claim 24, wherein the occluder comprises a synthetic leaflet.

27. A temporary heart valve catheter of claim 24, wherein the occluder comprises a mechanical valve.

28. A temporary heart valve catheter of claim 27, wherein the mechanical valve comprises a single leaflet valve.

29. A temporary heart valve catheter of claim 27, wherein the mechanical valve comprises a bileaflet valve.

30. A temporary heart valve catheter of claim 1, wherein the inflatable structure comprises an inflatable cuff comprising at least one inflatable channel that forms, at least in part, a distal inflatable toroidal structure and a proximal inflatable toroidal structure, the inflatable cuff also comprising a waist that extends between the distal inflatable toroidal structure and the proximal inflatable toroidal structure.

31. A temporary heart valve catheter of claim 30, further comprising a valve member coupled to the inflatable cuff, the valve member configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction.

32. A temporary heart valve catheter of claim 31, wherein the valve member comprises tissue.

33. A temporary heart valve catheter of claim 31, wherein the valve member comprises a synthetic leaflet.

34. A temporary heart valve catheter of claim 31, wherein the valve member comprises a mechanical valve.

35. A temporary heart valve catheter of claim 1, wherein the inflatable structure comprises a flexible cuff having a distal end and a proximal end;

at least one inflatable channel that forms a toroidal structure;

a valve member mounted to the cuff;

the valve member configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction; and

at least one anchor that is moveable between a first position in which the anchor extends in a radial direction to engage an adjacent anatomical structure and a second position in which the anchor has a reduced radial profile.

36. A temporary heart valve catheter of claim 1, further comprising an embolic protection device coupled to the valve.