Blood flow controlling apparatus

• US 9,498,330 B2
• Filed: 06/24/2014
• Issued: 11/22/2016
• 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 O.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/313,329
• Publication Number:
  US 20140309732A1
• Time in Patent Office: 882 Days
• US Class Current: 1/1
• 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 a leaflet coaptation member, a connecting member, and an anchor suitable for anchoring the apparatus to the interventricular septum. The leaflet coaptation member coapts with the native mitral valve leaflets during systole when disposed therebetween, thereby reducing mitral valve regurgitation. During diastole, the native leaflets release coaptation with the leaflet coaptation member, permitting blood flow from the left atrium into the left ventricle.

Claims

1. A method for treating a mitral valve in need thereof, the method comprising:

inserting a delivery catheter using a guidewire through a surgical access through a chest of a patient and through a left ventricular wall of a heart into a left ventricle;

advancing, through the delivery catheter and into the left ventricle, a valve member of a repair device in a radially compressed state, the valve member including a plurality of pericardium flaps movable between an open state and a closed state in response to blood flow, the pericardium flaps in close contact with each other, the repair device further comprising an anchor member and a connecting member, the connecting member including a first end-portion and a second end-portion, the first end-portion coupled to the valve member, the connecting member including a flexible section, the anchor member including a disk-shaped element;

positioning the valve portion to contact native leaflets of a mitral valve with the second end-portion of the connecting member extending through the left ventricular wall;

adjusting the flexible section of the connecting member;

contacting the disk-shaped element of the anchor with an external left-ventricular wall at or near an apex of the heart;

securing the disk-shaped element of the anchor member to the second end-portion of the connecting member; and

removing the delivery catheter.

2. The method of claim 1, wherein advancing the valve member including the plurality of pericardium flaps comprises advancing a valve member including a plurality of pericardium flaps arranged side-by-side in a circle.

3. The method of claim 1, wherein advancing the valve member including the plurality of pericardium flaps comprises advancing a valve member including a plurality of pericardium flaps attached to the connecting member.

4. The method of claim 1, further comprising locking the flexible section of the connecting member.

5. The method of claim 1, wherein the disk-shaped element is a first disk-shaped element, the anchor further comprising a second disk-shaped element, the method further comprising:

contacting the second disk-shaped element with an inner left-ventricular wall; and

securing the second disk-shaped element to the second end-portion of the connecting member.

6. A method for treating a mitral valve in need thereof, the method comprising:

advancing, through a left ventricular wall into a left ventricle of a heart, a valve member of a repair device in a radially compressed state, the valve member including a plurality of flaps movable between an open state and a closed state in response to blood flow, the flaps in close contact with each other, the repair device further comprising an anchor member and a connecting member, the connecting member including a first end-portion and a second end-portion, the first end-portion coupled to the valve member, the anchor member including a disk-shaped element;

positioning the valve portion to contact native leaflets of a mitral valve with the second end-portion of the connecting member extending through the left ventricular wall;

contacting the disk-shaped element of the anchor with an external left-ventricular wall at or near an apex of the heart; and

securing the disk-shaped element of the anchor member to the second end-portion of the connecting member.

7. The method of claim 6, wherein advancing, through the left ventricular wall into the left ventricle, the valve member of the repair device further comprises advancing the valve member through a delivery catheter inserted through the left ventricular wall, the method further comprising removing the delivery catheter.

8. The method of claim 6, wherein advancing the valve member including the plurality of flaps comprises advancing a valve member comprising a plurality of pericardium flaps.

9. The method of claim 6, wherein advancing the valve member including the plurality of flaps comprises advancing a valve member comprising a plurality of flaps arranged side-by-side in a circle.

10. The method of claim 6, wherein advancing the valve member including the plurality of flaps comprises advancing a valve member comprising a plurality of flaps attached to the connecting member.

11. The method of claim 6, wherein advancing the valve member including the connecting member comprises advancing a valve member comprising a connecting member including a flexible section.

12. The method of claim 11, further comprising adjusting the flexible section of the connecting member.

13. The method of claim 11, further comprising locking the flexible section of the connecting member.

14. The method of claim 6, wherein the disk-shaped element is a first disk-shaped element, the anchor further comprising a second disk-shaped element, the method further comprising:

contacting the second disk-shaped element with an inner left-ventricular wall; and

securing the second disk-shaped element to the second end-portion of the connecting member.