Valve prosthesis for implantation in body channels

• US 20050251251A1
• Filed: 05/27/2005
• Published: 11/10/2005
• 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 7,585,321 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 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 and is provided with strut members that create stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state.

Claims

1. A method of replacing a stenotic prosthetic valve, comprising:

advancing a first balloon dilatation catheter having distal and proximal ends and having a deflated first dilatation balloon adjacent said catheter distal end into a patient'"'"'s vasculature to position said first dilation balloon within a first stenotic prosthetic valve;

inflating said first dilatation balloon to dilate said first prosthetic valve;

deflating said first dilation balloon and withdrawing said deflated balloon in a proximal direction;

advancing a second dilatation catheter having distal and proximal ends and having a second deflated dilatation balloon adjacent said catheter distal end, wherein said second balloon has a second prosthetic valve arranged circumferentially around said second dilatation balloon, into the patient'"'"'s vasculature to position said second dilatation balloon and said second prosthetic valve within said first prosthetic valve;

inflating said second dilatation balloon to cause said second prosthetic valve to expand within said first prosthetic valve; and

deflating said second dilatation balloon and withdrawing said second catheter in a proximal direction.

2. The method of claim 1, further comprising advancing a guidewire having a distal end into the patient'"'"'s vasculature until a distal portion of said guidewire is adjacent or distal to said first prosthetic valve.

3. The method of claim 2, wherein said first and second balloon catheters, respectively, are advanced over said guidewire.

4. The method of claim 1, wherein said first balloon is inflated to a higher pressure than said second balloon.

5. The method of claim 4, wherein said first balloon is inflated to a pressure of greater than 4 atmospheres.

6. The method of claim 4, wherein said first balloon is inflated maximally up to a bursting point of said first balloon.

7. The method of claim 4, wherein said first balloon is inflated for only a few seconds.

8. The method of claim 1, wherein inflation of said first balloon tests said first prosthetic valve for efficacy and dilates said first prosthetic valve.

9. A method of replacing a first prosthetic valve, comprising:

providing a dilatation catheter having distal and proximal ends and a deflated dilatation balloon adjacent said catheter distal end;

disposing a second prosthetic valve over said deflated balloon;

advancing said dilatation catheter and said second prosthetic valve into a patient'"'"'s vasculature;

positioning said second prosthetic valve within the first prosthetic valve;

inflating said dilatation balloon to expand said second prosthetic valve within said first prosthetic valve; and

deflating said dilatation balloon and withdrawing said dilatation catheter in a proximal direction, wherein said second prosthetic valve is implanted within the first prosthetic valve.

10. A method of replacing the function of a first prosthetic valve, comprising:

providing a self-expanding prosthetic valve comprising a frame and a valvular structure;

providing an elongate sheath having proximal and distal end portions and a lumen extending therethrough;

collapsing said self-expanding prosthetic valve and inserting said prosthetic valve within said lumen along said distal end portion of said elongate sheath;

advancing said elongate sheath into a patient'"'"'s vasculature to position said distal end portion of said elongate sheath adjacent said first prosthetic valve;

ejecting said self-expanding prosthetic valve from said distal end portion of said sheath such that said self-expanding prosthetic valve expands within said first prosthetic valve for replacing a valvular function of said first prosthetic valve; and

withdrawing said sheath from the patient'"'"'s vasculature.

11. The method of claim 10, wherein said self-expanding prosthetic valve is made of a shape memory material.

12. The method of claim 11, wherein a portion of said first prosthetic valve is removed before ejecting said self-expanding prosthetic valve.