Tissue fastening systems and methods utilizing magnetic guidance

• US 20050267571A1
• Filed: 09/24/2004
• Published: 12/01/2005
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Bruszewski, Walter, Spence, Paul A., McNamara, Ed, Maguire, Mark
• Granted Patent: US 7,431,726 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2017/0458 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: 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: Y10S 623/904 : Heart

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 reducing regurgitation of blood through a heart valve having annulus, the annulus positioned apart from a coronary sinus at least at one location, comprising:

fastening the coronary sinus to the annulus to bring the annulus closer to the coronary sinus at least at the one location, and

modifying the annulus so as to reduce regurgitation of blood through the heart valve.

2. The method of claim 1, wherein fastening the coronary sinus further comprises:

inserting a first guide element into the coronary sinus,

directing a second guide element adjacent to the annulus,

securing the first and second guide elements together, and

applying a fastener between the annulus and the coronary sinus.

3. The method of claim 2, wherein securing the first and second guide elements together further comprises temporarily magnetically attracting the first and second guide elements together while applying the fastener.

4. The method of claim 2, further comprising:

using the same catheter device to direct the second guide element and apply the fastener.

5. The method of claim 1, further comprising:

applying a second fastener to the annulus,

coupling the first and second fasteners together, and

reducing the distance between the first and second fasteners to shorten the circumferential length of the annulus.

6. The method of claim 5, further comprising:

applying the first and second fasteners through the same catheter device.

7. The method of claim 6, further comprising:

serially applying the first and second fasteners through one lumen in a catheter device.

8. The method of claim 6, further comprising:

applying the first and second fasteners through different lumens of the same catheter device.

9. The method of claim 5, wherein at least one flexible tensile member is used to couple the first and second fasteners together and reducing the distance between the first and second fasteners further comprises applying tension to the flexible tensile member.

10. The method of claim 1, wherein modifying the annulus further comprises:

fastening a flexible fabric to the annulus and shortening the circumferential length of the flexible fabric.

11. The method of claim 1, wherein modifying the annulus further comprises:

connecting at least two fasteners to the coronary sinus at spaced apart locations,

coupling a flexible tensile member to the two fasteners, and

tensioning the flexible tensile member to reduce the distance between the two fasteners.

12. The method of claim 1, wherein the coronary sinus lies above the annulus at least at the one location and fastening the coronary sinus to the annulus further comprises moving the coronary sinus downward to a position more adjacent to the annulus at least at the one location.

13. A method of modifying the spatial relationship between a coronary sinus and an annulus of a heart valve, the coronary sinus lying at least partially apart from the annulus at least at one location, comprising:

applying a fastener through the annulus and into the coronary sinus, and

using at least the applied fastener to bring the coronary sinus closer to the annulus at least at the one location.

14. The method of claim 13, wherein using at least the applied fastener to bring the coronary sinus closer to the annulus further comprises:

moving the coronary sinus downwardly to a position adjacent the annulus at least at the one location.

15. The method of claim 13, further comprising:

temporarily anchoring the coronary sinus to the annulus at least at the one location while applying the fastener.

16. The method of claim 15, wherein temporarily anchoring the coronary sinus to the annulus further comprises moving the coronary sinus and annulus together with magnetic elements at least at the one location.

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

delivering a first fastener through a catheter into the coronary sinus,

delivering a second fastener through a catheter to at least one of two locations, the two locations being;

     1) generally above the annulus in the left atrium, and

     2) generally below the annulus in the left ventricle,

securing the first and second fasteners to the annulus, and

reducing the distance between the first and second fasteners thereby reducing the circumferential length of the annulus.

18. The method of claim 17, wherein the second the fastener is delivered to a location above the annulus in the left atrium of the heart.

19. The method of claim 17, wherein the second fastener is delivered to a location below the annulus in the left ventricle of the heart.

20. The method of claim 17, further comprising:

connecting a flexible tensile member between the first and second fasteners, and

shortening the distance between the first and second fasteners to modify the annulus.

21. The method of claim 20, further comprising:

locking the flexible tensile member into position with respect to the fasteners by applying a crimp member to the flexible tensile member through a catheter.

22. The method of claim 17, further comprising:

holding the first and second fasteners in spaced apart positions while securing the first and second fasteners to heart tissue at the two locations, and

biasing the first and second fasteners toward each other to reduce the distance between the first and fasteners.

23. The method of claim 22, wherein biasing the first and second fasteners further comprises:

magnetically attracting the first and second fasteners in a direction toward one another.

24. The method of claim 23, wherein biasing the fasteners further comprises:

spring biasing at least one of the first and second fasteners in a direction toward the other.

25. The method of claim 22, wherein pressurized air is used to hold the first and second fasteners in the spaced apart positions.

26. The method of claim 17, further comprising:

using radio frequency energy to form an aperture in the heart tissue in order to deliver the first and second fasteners to the two locations.

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

delivering respective magnets through at least one catheter to at least two of three locations adjacent the annulus, the three locations being

     1) within the coronary sinus,

     2) generally above the annulus in the left atrium, and

     3) generally below the annulus in the left ventricle,

magnetically coupling the delivered magnets to trap tissue therebetween, and

reducing the circumferential length of the annulus with the respectively delivered magnets.

28. The method of claim 27, further comprising:

delivering a plurality of spaced apart magnets into each of the two positions, and

modifying the annulus by reducing the distance between the spaced apart magnets.

29. The method of claim 27, wherein at least one of the magnets delivered to each location further includes a mechanical fastening element configured to penetrate tissue, and the method further comprises:

driving the fastening elements into the tissue at each location to secure the magnets to the tissue.