Tissue fastening systems and methods utilizing magnetic guidance

• US 20050119734A1
• Filed: 09/24/2004
• Published: 06/02/2005
• Est. Priority Date: 10/21/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Spence, Paul A., McNamara, Ed, Maguire, Mark
• Granted Patent: US 8,979,923 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• 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
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• 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 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• 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: A61B 2017/0649 : Coils or spirals
• 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
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

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 applying a fastener to an annulus of a heart valve, comprising:

placing a first magnet in a coronary sinus using a first catheter,

placing a second magnet adjacent the annulus, outside of the coronary sinus, using a second catheter,

magnetically coupling the first and second magnets, and

applying a fastener into the annulus while the first and second magnets are coupled.

2. The method of claim 1, wherein a single catheter device is used to apply the fastener and place the second magnet adjacent the annulus.

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

a first catheter,

a first magnet coupled with said first catheter in such a manner that said first catheter is operative to deliver said first magnet adjacent to the annulus,

a second catheter,

a second magnet coupled with said second catheter in such a manner that said second catheter is operative to deliver said second magnet adjacent to the annulus, and

a fastener delivery device coupled to at least one of said first and second catheters and configured to secure a first fastener to the annulus.

4. The system of claim 3, wherein said fastener delivery device comprises a steerable catheter portion so as to enable delivery of a fastener to a desired position.

5. The system of claim 4, wherein said fastener delivery device is coupled at predetermined angle relative to an axis of magnetic attraction between said first and second magnets.

6. The system of claim 3, further comprising a plurality of fastener delivery devices coupled to at least one of said first and second catheters and configured to deliver respective fasteners at spaced apart locations along the annulus.

7. The system of claim 6, further comprising the plurality of fasteners coupled together with at least one flexible tensile member such that said flexible tensile member is capable of drawing the fasteners together and thereby reducing the circumferential length of the annulus.

8. The system of claim 3, wherein said fastener delivery device further comprises a catheter portion, and further comprising:

an RF powered element extendable from within said catheter portion and operable to form an aperture in the annulus for insertion of the fastener.

9. The system of claim 3, wherein at least one of said first and second catheters is coupled with an inflatable member configured to stabilize said fastener delivery device adjacent the annulus.

10. The system of claim 3, wherein said fastener delivery device is a catheter portion, and further comprising:

said first fastener coupled with a flexible tensile member and received within said catheter portion, said first fastener and flexible tensile member deployable through said catheter portion.

11. The system of claim 10, wherein said first fastener further comprises a torsion spring member configured to expand after deployment from said catheter portion.

12. The system of claim 11, wherein said torsion spring member locks against said flexible tensile member upon deployment from said catheter portion.

13. The system of claim 10, further comprising:

a second fastener coupled with said flexible tensile member, at least one of said first and second fasteners movable along and then lockable to said flexible tensile member thereby allowing a distance between said first and second fasteners to be shortened and locked resulting in a shortening of the circumferential length of the annulus.

14. A catheter adapted to be a guide element placed within a vessel, comprising:

a distal support portion, and

first and second magnets carried on said distal support portion, said first and second magnets positioned in spaced apart relation such that a gap is formed between said first and second magnets and repelling poles face each other, whereby a circumferential virtual magnetic pole emanates around the gap between said first and second magnets.