Nonstented heart valves with formed in situ support

• US 7,534,259 B2
• Filed: 05/05/2005
• Issued: 05/19/2009
• 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): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/123,210
• Publication Number:
  US 20060020327A1
• Time in Patent Office: 1,475 Days
• Field of Search: 623 21- 22
• 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 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

An implantable prosthetic valve having an in situ formable support structure and methods of deploying such a valve are disclosed. In one arrangement, the valve has a base and at least one flow occluder. A first flexible component which is incapable of retaining the valve at a functional site in the arterial vasculature extends proximally of the base of the valve. A second flexible component which is incapable of retaining the valve at a functional site in the arterial vasculature extends distally of the base of the valve. At least one rigidity component combines with at least one of the first and second flexible components to impart sufficient rigidity to the first or second components to retain the valve at the site.

Claims

1. A method of in situ formation of a prosthetic valve support at a site of a native valve, comprising the steps of:

providing a prosthetic valve, attached to a flexible support component which is incapable of retaining the prosthetic valve at a functional site in the arterial vasculature, the support component extending both proximally and distally of the base of the native valve;

positioning the prosthetic valve at the site such that the flexible support component spans the site of the native valve; and

supplementing the flexible support component to increase the rigidity of the support component sufficiently to retain the prosthetic valve at the site.

2. A method of in situ formation of a prosthetic valve support as in claim 1, wherein the supplementing step comprises introducing inflation media into the support component.

3. A method of in situ formation of a prosthetic valve support as in claim 1, wherein the supplementing step comprises introducing an elongate flexible filament into the support component.

4. A method of in situ formation of a prosthetic valve support as in claim 2, additionally comprising the step of increasing the viscosity of the inflation media following introduction into the support component.

5. A method of in situ formation of a prosthetic valve support as in claim 1, additionally comprising the step of removing the native valve prior to supplementing the flexible support component.

6. A method of in situ formation of a prosthetic valve support as in claim 1, additionally comprising the step of debulking the native valve prior to supplementing the flexible support component.

7. A method of in situ formation of a prosthetic valve support as in claim 1, additionally comprising the step of performing a balloon valvuloplasty on the native valve prior to supplementing the flexible support component.

8. A method of in situ formation of a prosthetic valve support as in claim 1, wherein the step of positioning the valve at the site comprises translumenally advancing the prosthetic valve over an aortic arch.

9. A method of in situ formation of a prosthetic valve support as in claim 1, wherein the step of positioning the valve comprises using a trans apical approach.

10. A method of in situ formation of a prosthetic valve support as in claim 1, wherein the step of positioning the valve comprises using a transeptal approach.

11. A method of in situ formation of a prosthetic valve support as in claim 1, further comprising manipulating the position of the prosthetic valve before the step of supplementing the flexible support component.

12. A method of in situ formation of a prosthetic valve support as in claim 11, wherein the step of manipulating the position of the prosthetic valve comprises using three control wires.

13. A method of in situ formation of a prosthetic valve support as in claim 12, additionally comprising the step of permitting perfusion through the prosthetic valve during the manipulating the position step.

14. A method of in situ formation of a prosthetic valve support as in claim 1, additionally comprising the step of permitting perfusion through the prosthetic valve during the step of supplementing the flexible support component.

15. A method of in situ formation of a prosthetic valve support as in claim 1, additionally comprising the step of placing a temporary valve downstream from the native valve.

16. A method of in situ formation of a prosthetic valve support as in claim 1, additionally comprising the step of placing an embolic filter downstream from the native valve.

17. A method of in situ formation of a prosthetic valve support as in claim 1, wherein the prosthetic valve is functional prior to the step of supplementing the flexible support component to increase the rigidity of the support component sufficiently to retain the valve at the site.

18. A method of in situ formation of a prosthetic valve support at a site of a native valve, comprising the steps of:

providing a prosthetic valve, attached to a flexible support component which is incapable of retaining the valve at a functional site in the arterial vasculature, the support component extending both proximally and distally of the base of the native valve;

positioning the valve at the site such that the flexible support component spans the native valve; and

supplementing the flexible support component to increase the rigidity of the support component sufficiently to retain the valve at the site, wherein the supplementing step comprises introducing inflation media into the support component, and

increasing the viscosity of the inflation media following introduction into the support component.

19. A method of in situ formation of a prosthetic valve support as in claim 18, additionally comprising the step of removing the native valve prior to supplementing the flexible support component.

20. A method of in situ formation of a prosthetic valve support as in claim 18, additionally comprising the step of debulking the native valve prior to supplementing the flexible support component.

21. A method of in situ formation of a prosthetic valve support as in claim 18, additionally comprising the step of performing a balloon valvuloplasty on the native valve prior to supplementing the flexible support component.

22. A method of in situ formation of a prosthetic valve support as in claim 18, wherein the step of positioning the valve at the site comprises translumenally advancing the prosthetic valve over an aortic arch.

23. A method of in situ formation of a prosthetic valve support as in claim 18, wherein the step of positioning the valve comprises using a trans apical approach.

24. A method of in situ formation of a prosthetic valve support as in claim 18, wherein the step of positioning the valve comprises using a transeptal approach.

25. A method of in situ formation of a prosthetic valve support as in claim 18, further comprising manipulating the position of the prosthetic valve before the step of supplementing the flexible support component.

26. A method of in situ formation of a prosthetic valve support as in claim 25, wherein the step of manipulating the position of the prosthetic valve comprises using three control wires.

27. A method of in situ formation of a prosthetic valve support as in claim 26, additionally comprising the step of permitting perfusion through the prosthetic valve during the manipulating the position step.

28. A method of in situ formation of a prosthetic valve support as in claim 18, additionally comprising the step of permitting perfusion through the prosthetic valve during the step of supplementing the flexible support component.

29. A method of in situ formation of a prosthetic valve support as in claim 18, additionally comprising the step of placing a temporary valve downstream from the native valve.

30. A method of in situ formation of a prosthetic valve support as in claim 18, additionally comprising the step of placing an embolic filter downstream from the native valve.

31. A method of in situ formation of a prosthetic valve support as in claim 18, wherein the prosthetic valve is functional prior to the step of supplementing the flexible support component to increase the rigidity of the support component sufficiently to retain the valve at the site.