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

• US 20080091264A1
• Filed: 09/21/2007
• Published: 04/17/2008
• Est. Priority Date: 11/26/2002
• Status: Abandoned Application

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Scott, David, Chang, Robert, Machold, Timothy, Tholfsen, David, Rahdert, David
• Application Number:
  US11/903,472
• Publication Number:
  US 20080091264A1
• Time in Patent Office: Days
• US Class Current: 623/2.1
• 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• 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 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/1132 : End-to-end connections
• CPC Class Codes: A61B 2017/1135 : End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 : Side-to-side connections, e.g. shunt or X-connections
• 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 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2002/30668 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61M 2025/09175 : having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 : Guide wires

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. An implant system comprising

a first catheter,

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 an operative component between the guide lumens of the first and second catheters.

2. A system according to claim 1

wherein the first catheter includes an elongated shaft having a distal end, and a head carried at the distal end in which the distal opening is formed, the head including the magnetic or ferromagnetic material.

3. A system according to claim 2

wherein the head includes a distal magnetic portion, a center magnetic portion and a proximal magnetic portion.

4. A system according to claim 3

wherein the distal magnetic portion has a first end and a second end, the first end having a first magnetic polarity and the second end having a second opposite magnetic polarity;

the center magnetic portion has a first end and a second end, the first end having a first magnetic polarity and the second end having a second opposite magnetic polarity;

the proximal magnetic portion has a first end and a second end, the first end having a first magnetic polarity and the second end having a second opposite magnetic polarity; and

the magnetic polarity of the first ends of the distal magnetic portion, the center magnetic portion and the proximal magnetic portion is the same.

5. A system according to claim 4

wherein the distal magnetic portion is arranged such that the first end is adjacent the center magnetic portion;

and

the proximal magnetic portion is arranged such that the first end is adjacent the center magnetic portion.

6. A system according to claim 5

wherein the head includes opposite first and second side surfaces,

wherein the distal opening is formed on the first side surface of the head, and

wherein the center magnetic portion is arranged such that the first end is located on the first side surface of the head.

7. A system according to claim 6

wherein the second catheter includes an elongated shaft having a distal end, and a head carried at the distal end in which the distal opening is formed, the head including the magnetic or ferromagnetic material.

8. A system according to claim 7

wherein the second catheter magnetic portion has a first end with a first magnetic polarity and a second end with a second opposite magnetic polarity, the magnetic portion arranged such that the second end adjacent the distal end of the second catheter.

9. A system according to claim 8

wherein the magnetic polarity of the first end of the second catheter magnetic portion is the same as the magnetic polarity of the first end of the center magnetic portion.

10. A system according to claim 1

wherein the operative component comprises a first guide wire.

11. A system according to claim 10

wherein the first guide wire has a first stretched configuration and a second unstretched configuration.

12. A system according to claim 11

wherein the first guide wire is configured to adopt a coiled configuration when the first guide wire is in its unstretched configuration.

13. A system according to claim 10

wherein the first catheter distal opening includes a ramped portion, said ramped portion being sized and configured to guide the first guide wire into the second catheter distal opening.

14. A system according to claim 10

wherein the second catheter distal opening is formed with a funnel, said funnel being sized and configured to receive the first guide wire from the first catheter distal opening.

15. A system according to claim 9

wherein the distal end of the first catheter head is sized and configured for rotation relative to the elongated shaft.

16. A system according to claim 15

wherein a first retaining structure is coupled to the first catheter head and a second retaining structure is coupled to the elongated shaft, the first retaining structure being engagable with the second structure to limit the rotation of the first catheter head relative to the elongated shaft.

17. A system according to claim 16 wherein the first retaining structure comprises a pin and the second retaining structure comprises a plate including a partial circumferential slot.

19. A method comprising

providing an implant system as defined in claim 1,

deploying the first and second catheters,

magnetically coupling the distal opening of the first catheter to the distal opening of the second catheter, and

passing a operative component between the guide lumens of the first and second catheters.

18. An implant system comprising

a first catheter,

a second catheter,

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

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 an operative component between the guide lumens of the first and second catheters, and

a region of at least one of the first and second catheters adjacent the magnetic or ferromagnetic materials being sized and configured for rotation during the magnetic coupling.

20. A method comprising

providing an implant system as defined in claim 18,

deploying the first and second catheters,

magnetically coupling the distal opening of the first catheter to the distal opening of the second catheter, and

passing a operative component between the guide lumens of the first and second catheters.