Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools

• US 8,858,622 B2
• Filed: 04/24/2012
• Issued: 10/14/2014
• Est. Priority Date: 09/20/2000
• Status: Expired due to Fees

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Machold, Timothy R., Chang, Robert T., Macoviak, John A., Rahdert, David A.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/454,767
• Publication Number:
  US 20120209377A1
• Time in Patent Office: 903 Days
• Field of Search: 623/2.36, 623/2.37, 606/198, 604/500, 604/508
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Claims

1. A device for reshaping a mitral valve annulus composing:

a deployment system comprising a guide wire, a cutting tool, a first catheter, a second catheter,

the first and second catheters each including a guide lumen said guide lumen having a sidewall and a distal opening,

the distal opening of one of the catheters being formed through the side wall, and

a magnetic region formed of magnetic or ferromagnetic materials placed in the vicinity of the distal openings of each guide lumen,

the magnetic or ferromagnetic materials being of sufficient magnetic strength and appropriate polarity and sized and configured to magnetically couple and maintain alignment of the distal opening of the first catheter to the distal opening of the second catheter across a layer of tissue,

the cutting tool sized and configured to pass from the distal opening of one catheter, through said layer of tissue, to the distal opening of the other and create a passageway that will accommodate the passage of the guide wire between the guide lumens of the first and second catheters, said guidewire having sufficient length to extend through both catheters;

a bridging element sized and configured to bridge the left atrium of human heart.

2. The device according to claim 1

wherein the first catheter is sized and configured to be placed within the great cardiac vein within the wall of the left atrium of a human heart, and

the second catheter is sized and configured to enter the interior chamber of the left atrium of a human heart through the fossa ovalis of said human heart, and

the layer of tissue is the tissue between the interior of the great cardiac vein and the chamber of the left atrium of the human heart and the bridging element is sized and configured to be placed between the interior of the great cardiac vein and the fossa ovalis,

said bridging element further includes tensioning means for selectively lengthening or shortening the span of the bridging element, thereby shortening a minor axis of the mitral valve.

3. The device according to claim 1 further comprising a second guide wire, said second guide wire being arranged for deployment of said second catheter.

4. A device according to claim 1

wherein the distal opening of at least one catheter is within the magnetic region of that catheter.

5. A device according to claim 1,

further where the distal opening of the second catheter is also formed through the sidewall of that catheter.

6. A device according to claim 1

wherein the distal opening of each catheter is within the magnetic region of that catheter.

7. A device according to claim 1

wherein the layer of tissue, is a layer of tissue in a beating human heart and magnetic regions are of sufficient strength and configuration to maintain the distal openings of the catheters in alignment across the layer of tissue for sufficient time and with sufficient stability to permit the cutting tool to pierce the layer of tissue and the guide wire to be passed out of the distal opening of one catheter into the distal opening of the other catheter.