IP Library Granted Patent US 10,028,833
Granted Patent B2
US 10,028,833 · App. 14/582,694 · Granted Jul 24, 2018

Tissue fastening systems and methods utilizing magnetic guidance

Inventors: Paul A. Spence (Louisville, KY); Edward I. McNamara (Chelmsford, MA); Mark Maguire (Hillsborough, CA)
Assignee: MITRALIGN, INC.
A61F2/2451A61B17/0401A61F2/2466A61B17/0487A61B2017/00243A61B2017/00783A61B2017/00876A61B2017/0409A61B2017/0414A61B2017/0417A61B2017/0419A61B2017/0464A61B2017/0496A61F2210/009A61F2220/0016A61F2220/0075
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,028,833
App. No.
14/582,694
Granted
Jul 24, 2018
Kind
B2
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 (58)

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 first fastener into the annulus while the first and second magnets are coupled to one another;

wherein the first fastener is delivered with the second catheter and includes a base portion with a loop extending therefrom and the step of placing a second magnet adjacent the annulus comprises passing the second catheter through the aortic valve into the left ventricle so as to position the second magnet against a wall of the left ventricle adjacent the annulus.

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

3. The method of claim 1 , wherein the second catheter includes a main portion that divides at a distal end into a delivery catheter portion and a magnetic guiding portion that carries the second magnet, the delivery catheter portion being configured to carry and deliver the first fastener.

4. The method of claim 1 , further including the step of delivering a T bar anchor using the first catheter such that a portion of the T bar anchor is inserted through the loop of the first fastener delivered with the second catheter.

5. The method of claim 1 , further including the steps of moving positions of the first and second catheters so as to change positions of the first and second magnets which are then magnetically coupled to one another and at least one additional second fastener is into the annulus while the first and second magnets are coupled to one another.

6. The method of claim 5 , wherein the first fastener and the at least one additional second fastener are connected in series to form a daisy chain arrangement.

7. The method of claim 1 , wherein the first fastener is applied into the annulus from the coronary sinus using the first catheter within the coronary sinus while the while the first and second magnets are coupled to one another due to the second catheter being disposed in the left atrium.

8. 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 first fastener into the annulus while the first and second magnets are coupled to one another;

wherein the first catheter includes a pair of first magnets that are arranged such that like first poles are facing each other and the second catheter includes a main portion that divides at a distal end into a delivery catheter portion and a magnetic guiding portion that carries the second magnet with a pole that is opposite to the first pole being disposed at a top of the magnetic guiding portion, the delivery catheter portion being configured to carry and deliver the first fastener.

9. 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 first fastener into the annulus while the first and second magnets are coupled to one another;

wherein the first catheter includes a plurality of first magnets along a length thereof wherein poles of the plurality of first magnets are arranged such that adjacent first magnets are attracted to one another yet are separated from one another by a restraining member that is configured to exert a restraining force.

10. The method of claim 9 , wherein the restraining member comprises an inflattable bladder that is disposed between adjacent first magnets.

11. 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 first fastener into the annulus while the first and second magnets are coupled to one another;

further including a fastener delivery device coupled to the second catheter and configured to secure the first fastener to the annulus, wherein the respective first and second magnets coupled to the first and second catheters are positioned such that the first fastener can pass through the anchor delivery portion into the annulus while the first and second magnets are coupled to one another.

12. The method of claim 11 , wherein said fastener delivery device comprises a steerable catheter portion so as to enable delivery of a fastener to a desired position.

13. The method of claim 11 , 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.

14. The method of claim 11 , 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.

15. The method of claim 14 , wherein said first fastener further comprises a torsion spring member configured to expand after deployment from said catheter portion.

16. The method of claim 15 , wherein said torsion spring member locks against said flexible tensile member upon deployment from said catheter portion.

17. The method of claim 11 , wherein a plurality of fastener delivery devices are coupled to at least one of said first and second catheters and configured to deliver respective fasteners at spaced apart locations along the annulus.

18. The method of claim 17 , 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.

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

extending the distal end of a first catheter into the coronary sinus adjacent the heart valve;

extending the distal end of a second catheter adjacent the annulus of the heart valve and outside the coronary sinus;

magnetically coupling the distal end of the first catheter and the distal end of the second catheter;

deploying a tissue fastener to the tissue adjacent the annulus and proximate the magnetically coupled distal ends of the first and second catheters; and

modifying the annulus of the heart valve using the tissue fastener to reduce the regurgitation of blood through the heart valve;

wherein deploying the tissue fastener to the tissue comprises deploying the tissue fastener through a magnetic material associated with the distal end of one of the first or second catheters.

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

extending the distal end of a first catheter into the coronary sinus adjacent the heart valve;

extending the distal end of a second catheter adjacent the annulus of the heart valve and outside the coronary sinus;

magnetically coupling the distal end of the first catheter and the distal end of the second catheter;

deploying a tissue fastener to the tissue adjacent the annulus and proximate the magnetically coupled distal ends of the first and second catheters; and

modifying the annulus of the heart valve using the tissue fastener to reduce the regurgitation of blood through the heart valve;

wherein deploying the tissue fastener to the tissue comprises deploying the tissue fastener adjacent a magnetic material associated with the distal end of one of the first and second catheters.

21. The method of claim 19 , wherein modifying the annulus comprises applying a force to the tissue fastener.

22. The method of claim 19 , further comprising:

moving the distal end of the first catheter to a location spaced from the deployed tissue fastener;

magnetically coupling the second catheter with the first catheter at the location spaced from the deployed tissue fastener; and

deploying a second tissue fastener to the tissue adjacent the annulus and proximate the magnetically coupled distal ends of the first and second catheters.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2019
From: MITRALIGN, INC.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 048941/0323 →
CHANGE OF ADDRESS Recorded May 21, 2018
From: MITRALIGN, INC.
To: MITRALIGN, INC.
Reel/Frame 046881/0034 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2018
From: SPENCE, PAUL A; MCNAMARA, ED; MAGUIRE, MARK
To: MITRALIGN, INC.
Reel/Frame 045859/0642 →
Continuity (6)
Continuation 10948923 · Sep 24, 2004
Continuation In Part 10689872 · Oct 21, 2003
Provisional Application 60554314 · Mar 18, 2004
Provisional Application 60531855 · Dec 23, 2003
Provisional Application 60420095 · Oct 21, 2002
Related Publication 20150134055A1 · May 14, 2015