Tissue fastening systems and methods utilizing magnetic guidance

• US 20050125011A1
• Filed: 01/31/2005
• Published: 06/09/2005
• Est. Priority Date: 04/24/2001
• Status: Abandoned Application

• Current Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Sansoucy, Michael R., Bruszewski, Walter, Spence, Paul A., McNamara, Ed, Maguire, Mark
• Application Number:
  US10/949,133
• Publication Number:
  US 20050125011A1
• Time in Patent Office: Days
• US Class Current: 606/144
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• 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 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic

Abstract

Catheter based systems and methods for securing tissue including the annulus of a mitral valve. The systems and methods employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Claims

1. A method of modifying an annulus of a heart valve to reduce regurgitation of blood through the valve, comprising:

applying first and second fasteners on opposite sides of the annulus through at least one catheter thereby holding heart tissue between the first and second fasteners,

applying third and fourth fasteners on opposite sides of the annulus through at least one catheter thereby holding heart tissue between the third and fourth fasteners,

coupling the first and second fasteners together and the third and fourth fasteners together using at least one flexible tensile member, and

reducing the distance between adjacent ones of at least two of the first, second, third and fourth fasteners by applying tension to the flexible tensile member thereby shortening the circumferential length of the annulus.

2. The method of claim 1, wherein the first, second, third, and fourth fasteners include at least one magnet.

3. The method of claim 1, wherein the first, second, third, and fourth fasteners include at least one mechanical fastening element.

4. The method of claim 1, wherein the first, second, third, and fourth fasteners include at least one mechanical fastening element and at least one magnet.

5. The method of claim 1, further comprising:

using at least one magnet delivered through a catheter to guide at least one of the fasteners into position.

6. The method of claim 5, further comprising:

removing the magnet after guiding the fastener or fasteners into position.

7. The method of claim 5, wherein said at least one fastener is delivered through the magnet.

8. The method of claim 1, wherein the first, second, third and fourth fasteners are delivered by the same catheter device.

9. The method of claim 1, wherein the first, second, third and fourth fasteners are delivered by at least two different catheter devices.

10. The method of claim 1, wherein reducing the distance between adjacent ones of at least two of the first, second, third and fourth fasteners further comprises:

reducing the distance between each of the first, second, third and fourth fasteners.

11. A catheter system for modifying an annulus of a heart valve to reduce regurgitation of blood through the valve, the system comprising:

a catheter having at least one lumen,

first and second fasteners coupled together by an elongate flexible member such that said first fastener is movable along the elongate flexible member to a position closer to said second fastener,

an actuation device coupled in a releasable manner to said elongate flexible member and adapted to pull the elongate flexible member to thereby reduce the distance between said first and second fasteners, and

a coupling capable of securing the flexible tensile member in a locked position relative to said first and second fasteners.

12. The system of claim 11, wherein said first and second fasteners further comprise magnets.

13. The system of claim 11, wherein said first and second fasteners further comprise mechanical fasteners having projections configured to penetrate heart tissue.

14. The system of claim 11, wherein said coupling further comprises a crimpable member.

15. The system of claim 11, wherein said coupling further comprises a portion of said first fastener.

16. The system of claim 11, wherein said first and second fasteners are further coupled together by a length adjustable member configured to allow the distance between said first and second fasteners to be shortened as said actuation mechanism pulls said flexible tensile member.

17. The system of claim 16, wherein said length adjustable member includes first and second telescoping portions coupled together.

18. The system of claim 16, wherein said length adjustable member includes a generally accordion-shaped section.

19. The system of claim 11, further comprising:

at least one fastener driving portion configured to drive the first and second fasteners into the annulus.

20. The system of claim 19, wherein the fasteners driving portion further comprises a spring operated member at a distal end of said catheter.

21. The system of claim 11, further comprising a third fastener in the form of a pledget coupled with said flexible tensile member, wherein said first and second fasteners are adapted to be on one side of the annulus and said pledget is adapted to be on an opposite side of the annulus to trap tissue therebetween.

22. The system of claim 11, further comprising:

a first magnet coupled to a distal end of said first catheter.

23. The system of claim 22, further comprising:

a second catheter configured to be directed into a coronary sinus proximate to the annulus, and

a second magnet coupled to said second catheter and configured magnetically couple with said first magnet.

24. A catheter adapted to be positioned over at least two flexible tensile members anchored to tissue within a patient, comprising:

a distal support portion,

a locking device carried by said distal support portion in a manner allowing said locking device to be released onto the two flexible tensile members, and further adapted to be locked onto the two flexible tensile members such that the flexible tensile members cannot move axially with respect to each other thereby fixing the lengths of the flexible tensile members distal to said locking device.

25. The catheter of claim 24, wherein said locking device further comprises a crimp.

26. The catheter of claim 25, further comprising:

a compression device at said distal support portion, said compression device having at least one movable portion configured to apply compression to said crimp and thereby lock said crimp onto the flexible tensile members.

27. The catheter of claim 24, further comprising:

a cutting device at said distal support portion configured to cut the flexible tensile members.

28. The catheter of claim 27, wherein said cutting device is coupled to an RF energy source.