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

• US 9,498,331 B2
• Filed: 03/16/2015
• Issued: 11/22/2016
• Est. Priority Date: 09/20/2000
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Chang, Robert T., Macoviak, John A., Rahdert, David A., Machold, Timothy R.
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US14/659,157
• Publication Number:
  US 20150182337A1
• Time in Patent Office: 617 Days
• US Class Current: 1/1
• 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 system for treating a human or animal heart, the system comprising:

an implant sized and configured for placement partially within a left atrium, said implant comprising a bridging element, an anterior bridge stop, and a posterior bridge stop, said posterior bridge stop in the form of an elongate structure,

a guide wire of sufficient length and sufficiently small diameter for deployment in an intravascular path that has a length that is greater than a length from a first vascular access site into the heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, and

a connector to connect an end of the implant to one end of the guide wire with sufficient gripping strength to enable an operator to pull the implant along at least a portion of the intravascular path into the heart chamber.

2. A system according to claim 1

wherein the bridging 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.

3. The system of claim 1 wherein the elongate structure forms a T-shaped structure with said bridging element.

4. The system of claim 1 wherein the elongate structure is a stent.

5. The system of claim 1 wherein the elongate structure is curved.

6. The system of claim 5 wherein the curvature of the elongate structure generally conforms to a curvature of an inside of a typical human Great Cardiac Vein.

7. A system for treating a human or animal heart, the system comprising:

an implant sized and configured for placement partially within a heart chamber, said implant comprising a bridging element, an anterior bridge stop, and a posterior bridge stop;

a guide wire;

a connector to connect an end of the implant to one end of the guide wire with sufficient gripping strength to enable an operator to pull the implant along at least a portion of an intravascular path into the heart chamber;

a first catheter having a first lumen therethrough and a first distal end region, said first distal end region having a first magnetic head, said first magnetic head comprising a permanent magnet having a lumen at least partially therethrough and a first orifice therein through the side wall of said first magnetic head, said first orifice of sufficient diameter for said guidewire to pass therethrough and said lumen in the first magnetic head in communication with the lumen in said first catheter; and

a second catheter having a second lumen therethrough and a second distal end region, said second distal end region having a second magnetic head, said second magnetic head comprising a permanent magnet having a lumen therein, said lumen in said second magnetic head in communication with the lumen in said second catheter, said first and second magnetic heads of sufficient strength and of orientation of polarity when brought in proximity to each other they align said first and second orifice so that the guide wire may pass through one orifice into the other.

8. A system according to claim 7 wherein the strength and polarity of said first magnetic head and said second magnetic head are sufficient to align and temporarily hold said first and said second orifice while separated by a width of human tissue.

9. A system according to claim 8 wherein the width of tissue is the width of tissue between the interior of the left atrium and the interior of the great cardiac vein.

10. A system according to claim 7 wherein the lumen of the second catheter is open at an end of the second catheter and the orifice in the second magnetic head is located on a terminus of the second catheter and surrounds, in whole or in part, the lumen of the second catheter such that when said first magnetic head and said second magnetic head are magnetically attached, the magnetic heads are generally perpendicular.

11. A system according to claim 7 said first magnetic head is located at a tip of said first catheter.

12. A system according to claim 7 wherein said first orifice in the first magnetic head communicates with a ramp between said first orifice and the lumen in the first magnetic head.

13. An implant according to claim 7 wherein said posterior bridge stop is an elongate member and forms a T shaped structure with said bridging element.

14. An implant according to claim 13 wherein said elongate member is curved.

15. An implant according to claim 14 wherein said elongate member has a curvature that approximates a curvature of an inside of a typical human Great Cardiac Vein.

16. An implant according to claim 7 wherein said posterior bridge stop is a stent.