Blood Flow Controlling Apparatus

• US 20130090728A1
• Filed: 06/22/2012
• Published: 04/11/2013
• Est. Priority Date: 04/21/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto
• Granted Patent: US 8,758,432 B2
• Time in Patent Office: Days
• US Class Current: 623/2.12
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2418 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A method for reducing regurgitation in a mitral valve using a blood flow controlling apparatus. The blood flow controlling apparatus comprises an anchoring means, preferably arranged to anchor the apparatus to a wall of the left ventricle. The blood flow controlling apparatus further comprises a valve means configured to expand in a direction transverse to blood flow. The valve means is preferably positioned within a native mitral valve and expands for making contact with the mitral valve leaflets during ventricular systole, thereby preventing blood from regurgitating back through the mitral valve into the left atrium. When blood flows from the left atrium to the left ventricle during ventricular diastole, the valve means collapses for allowing blood to pass freely through the mitral valve.

Claims

1. A method for reducing regurgitation in a mitral valve, the method comprising:

percutaneously inserting a mitral valve flow improvement device in a compressed state into a heart, the mitral valve flow improvement device comprising an upstream end and a downstream end;

a flexible prosthetic mitral valve leaflet at the upstream end;

a tissue penetrating anchor at the downstream end;

a connecting member extending axially therebetween, an upstream end thereof encircled by and coupled to the prosthetic mitral valve leaflet; and

a plurality of flexible extending members extending from a rim of the mitral valve leaflet to the connecting member;

anchoring the tissue penetrating anchor in a wall of the left ventricle with the prosthetic mitral valve leaflet disposed in a gap between native mitral valve leaflets;

releasing the mitral valve flow improvement device from the compressed state; and

permitting the prosthetic mitral valve leaflet to alternate between an open state and a closed state, wherein

blood flow from the left ventricle towards the left atrium expands the prosthetic mitral valve leaflet into the closed state in which the prosthetic mitral valve leaflet is umbrella-shaped, the plurality of flexible extending members limiting an upstream movement and expansion thereof, an upstream face of the prosthetic mitral valve leaflet contacts the native mitral valve leaflets in their closed positions, coapting therewith, thereby improving a seal of the mitral valve and reducing regurgitation therethrough, and

blood flow through the mitral valve from a left atrium into the left ventricle collapses the prosthetic mitral valve leaflet into the open state in which the prosthetic mitral valve leaflet is collapsed towards the connecting member, reducing a reduced radial cross section thereof and at least partially releasing contact with the native mitral valve leaflets in their open positions, thereby facilitating blood flow therearound.

2. The method of claim 1, wherein percutaneously inserting a mitral valve flow improvement device comprises percutaneously inserting the mitral valve flow improvement device into a left atrium through a right atrium and an interatrial septum.

3. The method of claim 1, wherein percutaneously inserting a mitral valve flow improvement device comprising a prosthetic mitral valve leaflet comprises percutaneously inserting a mitral valve flow improvement device comprising a prosthetic mitral valve leaflet, wherein a cross-sectional shape of the prosthetic mitral valve leaflet in the closed state is at least one of circular, oval, or rectangular.

4. The method of claim 1, wherein anchoring the tissue penetrating anchor in a wall of the left ventricle comprises engaging opposite sides of the wall of the left ventricle with disk-shaped elements.

5. The method of claim 1, wherein anchoring the tissue penetrating anchor in a wall of the left ventricle with the prosthetic mitral valve leaflet disposed in a gap between native mitral valve leaflets comprises anchoring the tissue penetrating anchor in a wall of the left ventricle with the prosthetic mitral valve leaflet disposed asymmetrically between native mitral valve leaflets.

6. A method for restoring function to a mitral valve in a human heart, comprising:

introducing a prosthesis into an interior of the heart;

securing one end of the prosthesis to tissue within a left ventricle of the heart;

positioning an opposite end of the prosthesis between opposing leaflets of the mitral valve;

expanding the prosthesis so as to place the prosthesis into contact with at least one leaflet of the mitral valve and thereby substantially prevent blood flow through the mitral valve in a first direction; and

contracting the prosthesis so as to substantially allow blood flow through the mitral valve in a second direction.

7. The method of claim 7, wherein the securing of one end of the prosthesis in the left ventricle includes extending the one end of the prosthesis at least partially through heart tissue in the left ventricle.

8. The method of claim 7, wherein expanding the prosthesis to contact at least one leaflet of the mitral valve includes coapting at least one leaflet of the mitral valve with the prosthesis.

9. The method of claim 7, wherein expanding the prosthesis to contact at least one leaflet of the mitral valve includes expanding an umbrella-like flexible flap disposed at one end of the prosthesis.

10. The method of claim 9, further comprising securing a periphery of the flexible flap to the prosthesis with a plurality of flexible connecting members extending between the periphery of the flexible flap and the prosthesis.

11. The method of claim 9, wherein the contracting the prosthesis to substantially allow blood flow includes allowing the umbrella-like flexible flap to collapse.

12. A method for treating regurgitation in a mitral valve comprising:

disposing a flexible flap between native leaflets of a mitral valve in a heart,

wherein

the flap collapses in response to blood flow through the mitral valve from a left atrium into a right ventricle, at least partially releasing contact with at least one native leaflet of the mitral valve in an open position, thereby facilitating blood flow therearound, and

the flap expands into parachute shape in response to blood flow from the left ventricle towards the left atrium, a surface of the flap coapting with at least one native leaflet of the mitral valve in a closed position, thereby improving a seal of the mitral valve and reducing regurgitation therethrough.

13. The method of claim 12, further comprising anchoring the flexible flap to a wall of the heart.

14. The method of claim 13, wherein anchoring the flexible flap to a wall of the heart comprises anchoring the flexible flap to a wall of a left ventricle.

15. The method of claim 12, further comprising inserting the flexible flap into the heart percutaneously.

16. The method of claim 12, wherein disposing a flexible flap between native leaflets of a mitral valve in a heart comprises disposing the flexible flap asymmetrically between native leaflets of the mitral valve in the heart.

17. The method of claim 12, wherein the flap at least partially releasing contact with at least one native leaflet of the mitral valve in an open position comprises the flap at least partially releasing contact with two native leaflets of the mitral valve in their open positions.

18. The method of claim 12, wherein a surface of the flap coapting with at least one native leaflet of the mitral valve in a closed position comprises the surface of the flap coapting with two native leaflets of the mitral valve in their closed positions.