Fixed anchor and pull mitral valve device and method

• US 9,408,695 B2
• Filed: 01/17/2008
• Issued: 08/09/2016
• Est. Priority Date: 01/30/2002
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mathis, Mark L., Nieminen, Gregory D., Reuter, David G.
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US12/016,054
• Publication Number:
  US 20080140191A1
• Time in Patent Office: 3,127 Days
• Field of Search: 623/2.1, 623 236- 237
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• 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 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• 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
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A device affects the mitral valve annulus geometry of a heart. The device includes a first anchor configured to be positioned within and anchored to the coronary sinus of the heart adjacent the mitral valve annulus within the heart and a second anchor configured to be positioned within the coronary sinus of the heart proximal to the first anchor and adjacent the mitral valve annulus within the heart. The second anchor, when deployed, anchors against distal movement and is moveable in a proximal direction. The device further includes a connecting member having a fixed length permanently attached to the first and second anchors. As a result, when the first and second anchors are within the coronary sinus with the first anchor anchored in the coronary sinus, the second anchor may be displaced proximally to affect the geometry of the mitral valve annulus and released to maintain the effect on the mitral valve geometry.

Claims

1. A method of minimally-invasively treating mitral valve regurgitation, the method comprising:

advancing a delivery device to a patient'"'"'s coronary sinus, the delivery device comprising a catheter;

advancing an intraluminal cardiac device in a collapsed configuration through a lumen of the catheter into the coronary sinus with the delivery device releasably secured to a proximal end of the intraluminal cardiac device, the intraluminal cardiac device comprising a distal expandable anchor, a proximal expandable anchor, and a fixed length connecting member extending between the distal and proximal expandable anchors, wherein advancing the intraluminal cardiac device comprises advancing the intraluminal cardiac device with the distal and proximal expandable anchors in collapsed delivery configurations, wherein at least one of the proximal and distal anchors comprises first and second arm segments that extend from one end of the device toward the connecting member and the other anchor when in the collapsed configuration;

retracting the catheter proximally within the coronary sinus to cause the distal expandable anchor to self-expand within the coronary sinus;

anchoring the distal expandable anchor against movement in the coronary sinus;

while maintaining the proximal expandable anchor within the catheter to prevent self-expansion of the proximal expandable anchor, pulling proximally on the catheter and the intraluminal cardiac device such that the connecting member is disposed on an inside curve of the coronary sinus so as to change the geometry of the mitral valve annulus and bring the leaflets of the mitral valve closer together, thereby reducing undesirable blood flow regurgitation back through the mitral valve during the heart cycle;

while maintaining the intraluminal cardiac device in place, retracting the catheter proximally within the coronary sinus to cause the proximal expandable anchor to self-expand within the coronary sinus;

anchoring the proximal expandable anchor against movement within the coronary sinus to substantially secure the mitral valve annulus in the changed geometry,

whereby anchoring the anchor comprising the first and second arm segments causes the first and second arm segments to extend radially outwardly and fix against the wall of the coronary sinus such that the first and second arm segments extend away from one another toward the connector, and meet one another at a location axially spaced from the one end of the device; and

releasing the proximal end of the intraluminal device and withdrawing the catheter from the coronary sinus.

2. The method of claim 1 wherein the distal anchor comprises the first and second arms segments and the one end comprises the distal end, such that upon anchoring of the distal anchor the first and second arm segments extend away from one another at the distal end of the device, proximally toward the connector, and meet one another at a location proximal to the distal end.

3. The method of claim 1 wherein the proximal anchor comprises the first and second arms segments and the one end comprises the proximal end, such that upon anchoring of the proximal anchor the first and second arm segments extend away from one another at the proximal end of the device, distally toward the connector, and meet one another at a location distal to the proximal end.

4. The method of claim 1 wherein, when the distal and proximal anchor are anchored in the coronary sinus, the first and second arm segments meet one another and engage the coronary sinus wall at a location in the coronary sinus across from the connecting member that is disposed on the inside curve of the coronary sinus.

5. A method of minimally-invasively treating mitral valve regurgitation, the method comprising:

advancing a device within a catheter to a patient'"'"'s coronary sinus, the device comprising a distal expandable anchor, a proximal expandable anchor, and a fixed length connecting member extending between the distal and proximal expandable anchors;

anchoring the distal expandable anchor against the coronary sinus wall in a configuration in which first and second arms of the distal expandable anchor extend away from one another at a distal end of the device, proximally towards the connector, and meet one another at a location proximal to the distal end of the device; and

anchoring the proximal expandable anchor against the coronary sinus wall in a configuration in which first and second arms of the proximal expandable anchor extend away from one another at a proximal end of the device, distally towards the connector, and meet one another at a location distal to the proximal end of the device.