Blood flow controlling apparatus

• US 20060241745A1
• Filed: 04/19/2006
• Published: 10/26/2006
• Est. Priority Date: 04/21/2005
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto
• Application Number:
  US11/407,582
• Publication Number:
  US 20060241745A1
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 blood flow controlling apparatus, which is configured to be implanted into a blood circulatory system of a patient, comprises an anchoring means, which is arranged to fix the position of the apparatus in the blood circulatory system, and a valve means being connected to the anchoring means. The valve means is configured to be arranged within the blood circulatory system and is configured to be extendable in a direction transverse to blood flow in order to make contact with native tissue when inserted in the blood circulatory system. The valve means is further configured to release said contact as a result of being exposed to blood flow in a permitted direction.

Claims

1. A prosthesis for improving blood flow through a native heart valve within a heart comprising:

an anchoring framework configured to engage tissue associated with the heart and thereby anchor the prosthesis; and

a valve member coupled to the anchoring framework and extending from the anchoring framework so as to be interposed between leaflets of the native heart valve when the anchoring framework is engaged with the tissue;

wherein the valve member has an expanded configuration for contacting at least one leaflet of the native heart valve during a first direction of blood flow and the valve member has a contracted configuration for releasing contact with at least one leaflet of the native heart valve during a second direction of blood flow.

2. The prosthesis of claim 1, wherein the anchoring framework comprises a tissue engagement structure configured to engage ventricular tissue in the heart.

3. The prosthesis of claim 2, wherein the anchoring framework further comprises a connecting member for coupling the valve member to the tissue engagement structure.

4. The prosthesis of claim 1, wherein the anchoring framework is a stent configured for deployment in a body lumen.

5. The prosthesis of claim 1, wherein the valve member is expandable in a direction transverse to the flow of blood for preventing regurgitation through the native heart valve.

6. The prosthesis of claim 1, wherein the valve member comprises an umbrella-shaped flexible flap.

7. The prosthesis of claim 6, wherein the anchoring framework includes an elongated rod extending through a center region of the umbrella-shaped flap.

8. The prosthesis of claim 7, further comprising a plurality of flexible connecting members extending from a peripheral edge of the umbrella-shaped flap and the anchoring framework.

9. An apparatus for restoring function to a mitral valve in a human heart, comprising:

a flow control member; and

an anchor having a first end and a second end, the first end of the anchor being connected to the flow control member, the second end of the anchor having a tissue engagement structure, the anchor having a length such that the flow control member is positioned at least partially within the mitral valve when the tissue engagement structure is engaged with the tissue;

wherein the flow control member is movable between an expanded state to contact at least one leaflet of the mitral valve and thereby substantially prevent blood flow past the mitral valve and a reduced state to thereby allow blood flow past the mitral valve.

10. The apparatus of claim 9, wherein the anchor is elongated between the first and the second ends.

11. The apparatus of claim 10, wherein the flow control member is a flexible umbrella-shaped flap.

12. The apparatus of claim 11, further comprising a plurality of connecting threads extending from a circumference of the umbrella-shaped flap to the anchor.

13. The apparatus of claim 9, wherein the tissue engagement structure includes a framework of struts engageable with an interior surface of the heart.

14. The apparatus of claim 13, wherein the tissue engagement structure comprises a plurality of hooks.

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

introducing a prosthesis into an interior of the heart;

securing one end of the prosthesis to tissue within the heart;

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

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

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

16. The method of claim 15, wherein the securing of one end of the prosthesis in the heart includes extending the one end of the prosthesis at least partially through heart tissue in a left ventricle.

17. The method of claim 15, wherein expanding the prosthesis to contact at least one leaflet of the heart valve includes coapting at least one leaflet of the heart valve with the prosthesis.

18. The method of claim 15, wherein expanding the prosthesis to contact at least one leaflet of the heart valve includes expanding an umbrella-like flexible flap disposed at one end of the prosthesis.

19. The method of claim 18, 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.

20. The method of claim 18, wherein the contracting the prosthesis to substantially allow blood flow includes allowing the umbrella-like flexible flap to collapse.