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

• US 8,163,013 B2
• Filed: 09/23/2010
• Issued: 04/24/2012
• Est. Priority Date: 10/01/2001
• Status: Expired due to Term

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Machold, Timothy R., Chang, Robert T., Macoviak, John A., Rahdert, David A.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/924,219
• Publication Number:
  US 20110015730A1
• Time in Patent Office: 579 Days
• Field of Search: 606/191, 606/192, 606/194, 606/198, 606/108, 600/114, 600/585, 600/433, 600/434, 600/435, 623/2.36, 623/2.37
• 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
• 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 method for reshaping a mitral valve annulus comprising

providing a bridging element sized and configured for deployment through an intravascular path on or over a guide wire, the bridging element having a posterior region, an anterior region, and an intermediate region between the posterior and anterior regions,

providing a deployment system comprising a guide wire, a cutting tool, a first catheter, and a second catheter, the first and second catheters each including a guide lumen having a distal opening, and magnetic or ferromagnetic materials placed adjacent the distal openings of both guide lumens, the magnetic or ferromagnetic materials being sized and configured to magnetically couple the distal opening of the first catheter to the distal opening of the second catheter in an alignment that accommodates passage of the guide wire between the guide lumens of the first and second catheters,

deploying the first catheter through an intravascular path that extends from a first vascular access point into a right atrium of a heart, and from the right atrium through the fossa ovalis into a left atrium of a heart at a first location superior to the anterior annulus of the mitral valve,

deploying the second catheter through an intravascular path that extends from a second vascular access point different than the first vascular access point into a great cardiac vein at a second location superior to a posterior annulus of a mitral valve, the first location being more superior relative to the mitral valve annulus than the second location,

magnetically coupling the distal opening of the first catheter in the left atrium to the distal opening of the second catheter within the great cardiac vein through left arterial wall and great cardiac vein venous tissues separating the first catheter and the second catheter,

deploying the cutting tool through an intravascular path to penetrate the tissues separating the magnetically coupled distal openings,

passing the guide wire through the penetrated tissues from the guide lumen of one of the first and second catheters into the guide lumen of the other one of the first and second catheters,

deploying the bridging element over or on the guide wire into an orientation in which (i) the anterior region of the bridging element is located outside the left atrium at the first location within the right atrium, (ii) the posterior region of the bridging element is located outside the left atrium at the second location within the great cardiac vein, and (iii) wherein the intermediate region of the bridging element spans the left atrium above the mitral valve annulus between the second location and the first location generally in a posterior-to-anterior and inferior-to-superior direction, and

adjusting the tension of the bridging element to selectively lengthen or to selectively shorten the span of the intermediate region of the bridging element within the left atrium to apply upward and inward forces to the posterior region of the mitral valve annulus to shorten a minor axis of the mitral valve annulus.

2. A method according to claim 1

wherein passing the guide wire includes passing the guide wire entirely through the guide lumens of the both first and catheters so that the guide wire extends through an intravascular path from the first vascular access site to the second vascular access site.

3. A method according to claim 2

further including withdrawing the first and second catheters over the guide wire.

4. A method according to claim 1

wherein the first catheter is deployed from the first vascular access site over the guide wire,

wherein the second catheter is deployed from the second vascular access over another guide wire, and

wherein passing the guide wire includes passing the guide wire at least partially into the guide lumen of second catheter.

5. A method according to claim 4

further including withdrawing the first catheter over the guide wire, and withdrawing the second catheter over the other guide wire.

6. A method according to claim 1

wherein deploying the cutting tool includes passing the cutting tool through the guide lumen of the first catheter.

7. A method according to claim 1

wherein deploying the cutting tool includes passing the cutting tool through the guide lumen of the second catheter.

8. A method according to claim 1

wherein the cutting tool includes an interior lumen,

wherein deploying the cutting tool includes passing the cutting tool through the guide lumen of one of the first and second catheters, and

wherein passing the guide wire comprises passing the guide wire through the interior lumen of the cutting tool into the guide lumen of the other one of the first and second catheters.

9. A method according to claim 1

wherein the cutting tool comprises a distal element on the guide wire operative to penetrate tissue,

wherein deploying the cutting tool includes advancing the distal element of the guide wire to penetrate the tissues by initially passing the guide wire through the guide lumen of one of the first and second catheters, and

wherein passing the guide wire comprises continuing to pass the guide wire through the penetrated tissues into the guide lumen of the other one of the first and second catheters.