Heart valve repair system

• US 8,961,594 B2
• Filed: 05/31/2012
• Issued: 02/24/2015
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Maisano, Francesco, Vanermen, Hugo, Alfieri, Ottavio, Tobis, Idan, Guidotti, Andrea, Denti, Paolo
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/485,145
• Publication Number:
  US 20130325115A1
• Time in Patent Office: 999 Days
• Field of Search: 623/2.17, 623/1.36, 606/108, 606/151
• US Class Current: 623/2.17
• 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 17/0401 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 17/0487 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 2017/00783 Valvuloplasty
• 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 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• 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
• CPC Class Codes: A61F 2230/0006 circular

Abstract

Techniques are described for use with one or more sutures. For some applications, techniques are described for fixedly-coupling two or more sutures to each other. For some applications, such techniques are used for treating a heart valve of a subject. Techniques are also described for treating a heart valve of a subject by coupling leaflets of the heart valve to a support using tissue-piercing elements. Other embodiments are also described.

Claims

1. A method for use with a heart valve of a patient, the heart valve including at least two leaflets, the method comprising:

delivering, to a first side of the heart valve, a support, having a leaflet-engaging side;

delivering, to a second side of the heart valve, a plurality of leaflet-piercing elements, wherein one of the first and the second sides of the heart valve is an upstream side of the heart valve, and the other of the first and the second sides of the heart valve is a downstream side of the heart valve;

piercing the leaflets of the valve, from the second side to the first side of the valve, with the leaflet-piercing elements; and

coupling the support to the leaflets by coupling the leaflet-piercing elements to the support, such that the support overlaps more than one leaflet,

wherein delivering the leaflet-piercing elements comprises delivering, to the second side of the valve, a securing element that includes (1) a core, (2) two or more arms, an inner end of each arm being coupled to the core, and the arms extending radially outward from the core, and (3) the leaflet-piercing elements, coupled to respective outer ends of each arm.

2. The method according to claim 1, wherein delivering the leaflet-piercing elements comprises delivering the leaflet-piercing elements independently of delivering the support.

4. The method according to claim 1, wherein coupling the securing element to the support comprises sandwiching the leaflets between the securing element and the support.

5. The method according to claim 1, wherein coupling the securing element to the support comprises coupling the core to the support, and wherein coupling the core to the support facilitates coupling the leaflet-piercing elements to the support.

6. The method according to claim 1, wherein the core defines a coupling portion, and wherein coupling the securing element to the support comprises coupling the coupling portion of the core to the support.

7. The method according to claim 6, wherein coupling the coupling portion of the core to the support comprises coupling the coupling portion to the support at the first side of the heart valve.

8. The method according to claim 1, wherein delivering the support comprises delivering the support in a compressed configuration, and transitioning the support to an uncompressed configuration in which the support is flat.

9. The method according to claim 1, wherein delivering the support comprises delivering the support in a compressed configuration, and transitioning the support to an uncompressed configuration in which the support is generally circular.

11. The method according to claim 1, wherein delivering the support comprises:

percutaneously delivering the support while the support is in a generally-cylindrical delivery configuration thereof, and

subsequently, deploying the support into a generally flat deployed configuration thereof.

12. The method according to claim 1, wherein coupling the leaflet-piercing elements to the support comprises advancing the leaflet-piercing elements into the support.

13. The method according to claim 1, wherein coupling the leaflet-piercing elements to the support comprises advancing the leaflet-piercing elements through the support.

14. The method according to claim 1, wherein coupling the leaflet-piercing elements to the support comprises coupling the securing element to the support.

15. The method according to claim 6, wherein coupling the coupling portion to the support facilitates the coupling of the leaflet-piercing elements to the support.

16. The method according to claim 6, wherein the support defines an inner perimeter that defines an opening through the support, and wherein coupling the coupling portion of the core to the support comprises securing at least part of the coupling portion within the opening.

17. The method according to claim 7, wherein coupling the coupling portion to the support comprises moving at least part of the coupling portion, from the second side of the heart valve, between the leaflets of the heart valve, to the first side of the heart valve.

18. The method according to claim 1,

wherein the first side of the heart valve is the downstream side of the heart valve,

wherein the second side of the heart valve is the upstream side of the heart valve,

wherein delivering the support to the first side of the heart valve comprises delivering the support to the downstream side of the heart valve, and

wherein delivering the leaflet-piercing elements to the second side of the heart valve comprises delivering the leaflet-piercing elements to the upstream side of the heart valve.

19. The method according to claim 1,

wherein the first side of the heart valve is the upstream side of the heart valve,

wherein the second side of the heart valve is the downstream side of the heart valve,

wherein delivering the support to the first side of the heart valve comprises delivering the support to the upstream side of the heart valve, and

wherein delivering the leaflet-piercing elements to the second side of the heart valve comprises delivering the leaflet-piercing elements to the downstream side of the heart valve.

20. The method of according to claim 1,

wherein delivering the support comprises delivering the support through a catheter, and

wherein delivering the leaflet-piercing elements comprises delivering the leaflet-piercing elements through a delivery sheath distinct from the catheter.

21. The method according to claim 1,

wherein delivering the leaflet-piercing elements comprises delivering the leaflet-piercing elements through a delivering sheath, and

wherein delivering the support comprises advancing the support, while in a compressed configuration, over the delivery sheath.

3. A method for use with a heart valve of a patient, the heart valve including at least two leaflets, the method comprising:

delivering, to a first side of the heart valve, a support that comprises a braided wire mesh and has a leaflet-engaging side;

delivering, to a second side of the heart valve, a plurality of leaflet-piercing elements, wherein one of the first and second sides of the heart valve is an upstream side of the heart valve, and the other of the first and the second sides of the heart valve is a downstream side of the heart valve;

piercing the leaflets of the valve, from the second side to the first side of the valve, with the leaflet-piercing elements; and

coupling the support to the leaflets by coupling the leaflet-piercing elements to the support, such that the support overlaps more than one leaflet.

10. The method according to claim 3, wherein delivering the leaflet-piercing elements comprises delivering, to the second side of the valve, a securing element that includes (1) a core, (2) two or more arms, an inner end of each arm being coupled to the core, and the arms extending radially outward from the core, and (3) the leaflet-piercing elements, coupled to respective outer ends of each arm.

22. The method according to claim 10, wherein delivering the support comprises delivering the support in a compressed configuration, and transitioning the support to an uncompressed configuration in which the support is flat.

23. The method according to claim 10, wherein delivering the support comprises delivering the support in a compressed configuration, and transitioning the support to an uncompressed configuration in which the support is generally circular.

24. The method according to claim 10, wherein delivering the support comprises:

percutaneously delivering the support while the support is in a generally-cylindrical delivery configuration thereof, and

subsequently, deploying the support into a generally flat deployed configuration thereof.

25. The method according to claim 10, wherein coupling the leaflet-piercing elements to the support comprises advancing the leaflet-piercing elements into the support.

26. The method according to claim 10, wherein coupling the leaflet-piercing elements to the support comprises advancing the leaflet-piercing elements through the support.