Translumenally implantable heart valve with formed in place support

• US 7,556,645 B2
• Filed: 05/05/2005
• Issued: 07/07/2009
• Est. Priority Date: 05/05/2004
• Status: Expired due to Fees

• Current Assignee: DFM, LLC (PDL BioPharma, Inc.)
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US11/122,983
• Publication Number:
  US 20060025854A1
• Time in Patent Office: 1,524 Days
• Field of Search: 623/2.1, 623/23.67, 623/1.44, 623/1.37, 623/1.28, 623/1.29, 623 124- 126, 623/2.13, 623/2.14, 623/2.17, 623/2.18, 623/2.11, 623/2.12, 623/2.15, 623/2.16, 623/2.19
• US Class Current: 623/2.1
• 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
• 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
• 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 cardiovascular prosthetic valve includes a cuff having a distal end and a proximal end. An inflatable structure is coupled to the cuff and has at least one inflatable channel that forms a toroidal structure. A valve is coupled to the cuff; the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction. In one arrangement, the distal end of the cuff has a non-circular cross-section with respect to the flow and the non-circular cross-section is configured to affect the performance of an adjacent valve. In another arrangement, the cuff includes an anchor moveable from a first position to a second position. In another arrangement, control wires are coupled to the cuff.

Claims

1. A stentless cardiovascular implant comprising:

a continuous, stentless, annular tubular body, movable from a collapsed tubular configuration for translumenal navigation to a patent tubular configuration having a central lumen for permitting blood flow therethrough following deployment;

a first inflatable annulus and a second inflatable annulus on the body;

a valve coupled to the tubular body;

the valve configured to permit blood flow in a first axial direction through the central lumen and to inhibit blood flow in a second axial direction opposite to the first axial direction; and

at least two inflation tubes that are detachably coupled to the tubular body;

wherein introduction of inflation media into at least one of the first and second annulus holds the tubular body in the patent tubular configuration.

2. A stentless cardiovascular implant as in claim 1, wherein the tubular body comprises a fabric sleeve.

3. A stentless cardiovascular implant as in claim 2, wherein the fabric comprises Dacron®

.

4. A stentless cardiovascular implant as in claim 2, wherein the fabric comprises ePTFE.

5. A stentless cardiovascular implant as in claim 1, wherein the first inflatable annulus is positioned at a first end of the implant and the second inflatable annulus is positioned at a second end of the implant.

6. A stentless cardiovascular implant as in claim 1, further comprising inflatable struts positioned in between the first and second inflatable annulus.

7. A stentless cardiovascular implant as in claim 6, wherein the inflatable struts are in fluid communication with one of the first and second inflatable annulus.

8. A stentless cardiovascular implant as in claim 6, wherein at least one of the first and second inflatable annulus is separately inflatable from the inflatable struts.

9. A stentless cardiovascular implant as in claim 1, wherein at least one of the first and second inflatable annulus is dimensioned to provide a seal to prevent blood from reentering the left ventricle.

10. A stentless cardiovascular implant as in claim 1, wherein the implant has an outside diameter when in the patent tubular configuration within the range of from about 14 mm to about 30 mm.

11. A stentless cardiovascular implant as in claim 1, further comprising three inflatable commissural supports.

12. A stentless cardiovascular implant as in claim 1, wherein the valve comprises a plurality of tissue leaflets.

13. A stentless cardiovascular implant as in claim 12, wherein the tissue comprises pericardium.

14. A stentless cardiovascular implant as in claim 1, wherein the valve comprises polymer leaflets.

15. A stentless cardiovascular implant as in claim 13, wherein the pericardium is decellularized.

16. A stentless cardiovascular implant as in claim 1, comprising three control wires.

17. A stentless cardiovascular implant as in claim 16, further comprising three control wire tubes.

18. A stentless cardiovascular implant as in claim 1, further comprising a valve for retaining inflation media within the inflatable annulus following detachment of the inflation tube.