Implanting a valve prosthesis in body channels

• US 20030109924A1
• Filed: 07/23/2002
• Published: 06/12/2003
• Est. Priority Date: 12/31/1996
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Cribier, Alain
• Granted Patent: US 7,846,203 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the stenotic aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface. The valve prosthesis can be delivered percutaneously, surgically, or endoscopically.

Claims

1. A method of surgically or endoscopically implanting a valve prosthesis, which comprises the steps of:

(a) surgically or endoscopically providing access to a patient'"'"'s vasculature;

(b) advancing a first balloon dilatation catheter having distal and proximal ends and having a deflated first dilatation balloon adjacent the catheter distal end into the patient'"'"'s vasculature to position said first dilatation balloon within to a stenotic valve and annulus;

(c) inflating said first dilatation balloon to dilate the stenotic valve;

(d) deflating said first dilatation balloon and withdrawing said deflated balloon in the proximal direction;

(e) advancing a second dilatation catheter having distal and proximal ends and having a second deflated dilatation balloon adjacent the catheter distal end, wherein said second balloon has a valve prosthesis arranged circumferentially around said second dilatation balloon, into the patient'"'"'s vasculature to position said second dilatation balloon and said valve prosthesis adjacent to the previously dilated stenotic valve;

(f) inflating said second dilatation balloon to cause said valve prosthesis to adhere to said aortic valve and annulus; and

(g) deflating said second dilatation balloon and withdrawing said second catheter in the proximal direction.

2. The method of claim 1, wherein prior to step (b), a guidewire having a distal end is advanced distally into the patient'"'"'s vasculature until the guidewire distal end is adjacent or distal to the stenotic valve.

3. The method of claim 2, wherein in steps (b) and (e) the first and second balloon catheters, respectively, are advanced over the guidewire.

4. The method of claim 1, wherein in step (c) the first dilatation balloon is inflated to a high pressure.

5. The method of claim 4, wherein the pressure is greater than 4 atm.

6. The method of claim 4, wherein the first dilatation balloon is inflated maximally up to the balloon'"'"'s bursting point.

7. The method of claim 4, wherein the inflation lasts only a few seconds.

8. The method of claim 1, wherein inflating the dilatation balloon in step (c) tests the stenotic aortic valve for efficacy of the procedure and creates an aperture in the valve.

9. The method of claim 1, wherein in step (f) the second dilatation balloon is inflated to a high pressure.

10. The method of claim 9, wherein the second dilatation balloon is inflated to a pressure less than the pressure to which the first dilatation balloon is inflated.

11. The method of claim 9, wherein the pressure is less than 4 atm and does not damage the valve prosthesis.

12. The method of claim 9, wherein the inflation lasts only a few seconds.

13. The method of claim 1, wherein the valve prosthesis needs only a light pressure for its own expansion.

14. The method of claim 1, wherein the patient'"'"'s vasculature is accessed surgically and a thoracotomy is performed.

15. The method of claim 1, wherein the patient'"'"'s vasculature is accessed endoscopically.

16. The method of claim 15, wherein the IV is introduced through a trocar or cannula.

17. The method of claim 1, wherein an artery is accessed.

18. The method of claim 1, wherein a vein is accessed.

19. The method of claim 1, wherein the valve is an aortic valve.

20. The method of claim 1, wherein the subclavian artery is accessed.

21. The method of claim 1, wherein no cardiopulmonary bypass is used.