Devices, systems, and methods for reshaping a heart valve annulus

• US 7,691,144 B2
• Filed: 03/25/2005
• Issued: 04/06/2010
• Est. Priority Date: 10/01/2003
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/089,940
• Publication Number:
  US 20050222488A1
• Time in Patent Office: 1,838 Days
• Field of Search: 604/95.04, 601/14, 601/49, 605/85, 604/33, 604/34, 604/35, 605/08, 623/2.36, 623/2.37, 606/191, 606/192, 606/194, 606/198
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00876 magnetic
• 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0012 : for adjusting elasticity, flexibility, spring rate or mechanical tension

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 of implanting a bridge element within a left atrium comprising

deploying a guide wire in an intravascular path that extends from a first vascular access site into a right atrium through a vena cava, from the right atrium through an interatrial septum into the left atrium, from the left atrium into and through a great cardiac vein into the right atrium, and from the right atrium through a vena cava to a second vascular access site that is different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site,

coupling the bridge element to one end of the guide wire,

pulling on the other end of the guide wire to pull the bridge element along at least a portion of the intravascular path into the left atrium, and

placing the bridge element in tension between the great cardiac vein and the interatrial septum.

3. A method according to claim 1 or 2

wherein the bridge element comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.

4. A method according to claim 1 or 2

wherein the bridge element is coupled to the second end of the guide wire, and

wherein the first end of the guide wire is pulled to pull the bridge element along at least a portion of the intravascular path through the great cardiac vein and into the left atrium.

5. A method according to claim 1 or 2

wherein placing the bridge element in tension includes securing a posterior bridge stop to the bridge element to abut against venous tissue within the great cardiac vein.

6. A method according to claim 1 or 2

wherein placing the bridge element in tension includes securing an anterior bridge stop to the bridge element to abut against tissue on the interatrial septum within the right atrium.

7. A method according to claim 6

wherein placing the bridge element in tension includes securing a posterior bridge stop to the bridge element to abut against venous tissue within the great cardiac vein.

8. A method according to claim 1 or 2

wherein placing the bridge element in tension includes adjusting tension on the bridge element to achieve a desired therapeutic result.

9. A method according to claim 8

wherein the desired therapeutic result is reducing mitral valve regurgitation.

2. A method of implanting a bridge element within a left atrium comprising

deploying a guide wire in an intravascular path that extends from a first vascular access site into a right atrium through an IVC, from the right atrium through an interatrial septum into the left atrium, from the left atrium into and through a great cardiac vein into the right atrium, and from the right atrium through a SVC to a second vascular access site that is different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site,

coupling the bridge element to one end of the guide wire,

pulling on the other end of the guide wire to pull the bridge element along at least a portion of the intravascular path into the left atrium, and

placing the bridge element in tension between the great cardiac vein and the interatrial septum.