Implant for heart valve

• US 10,702,385 B2
• Filed: 02/25/2019
• Issued: 07/07/2020
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hacohen, Gil
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US16/284,331
• Publication Number:
  US 20190183644A1
• Time in Patent Office: 498 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0015 : differing in density or specific weight
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means
• CPC Class Codes: A61F 2250/0071 : breakable or frangible

Abstract

A native heart valve includes a first leaflet and a second leaflet. The first and second leaflets are arranged into a double-orifice by using the implant to couple a middle scallop of the first leaflet to a middle scallop of the second leaflet. Using at least one clip controller, each clip is opened by deflecting an arm of the clip away from a midline of the implant, and each clip is closed by deflecting the arm of the clip back toward the midline. The first and second clips are opened and closed independently of each other. Other embodiments are also described.

Claims

1. A method for use at a native valve of a heart of a subject, the valve including a first leaflet and a second leaflet, the method comprising:

transluminally advancing, to the heart, an implant coupled to a delivery apparatus,

the implant including a first clip and a second clip, the first clip and the second clip fixedly coupled to each other, the first clip including a first-clip arm, and the second clip including a second-clip arm, and

the delivery apparatus including a delivery tube and at least one clip controller disposed within the delivery tube;

advancing the implant out of the delivery tube;

forming the first leaflet and the second leaflet into a double-orifice arrangement by using the implant to couple a middle scallop of the first leaflet to a middle scallop of the second leaflet by, using the clip controller;

opening the first clip by deflecting the first-clip arm;

independently of opening the first clip, opening the second clip by deflecting the second-clip arm;

gripping the first leaflet with the first clip by closing the first clip by deflecting the first-clip arm; and

independently of gripping the first leaflet, gripping the second leaflet with the second clip by closing the second clip by deflecting the second-clip arm;

decoupling the clip controller from the implant; and

withdrawing the delivery apparatus from the subject.

2. The method according to claim 1, further comprising:

subsequently to closing the first clip, locking the first clip, and

subsequently to closing the second clip, locking the second clip.

3. The method according to claim 1, wherein:

the first-clip arm includes a tissue-engaging portion and an other portion, the tissue-engaging portion being articulatably coupled to the other portion, and

closing the first clip by deflecting the first-clip arm comprises closing the first clip by deflecting the first-clip arm independently of an angular disposition of the tissue-engaging portion with respect to the other portion.

4. The method according to claim 1, wherein closing the first clip by deflecting the first clip-arm comprises closing the first clip by deflecting the first clip-arm such that the first clip-arm is in contact with a downstream surface of the first leaflet, and closing the second clip by deflecting the second clip-arm comprises closing the second clip by deflecting the second clip-arm such that the second clip-arm is in contact with a downstream surface of the second leaflet.

5. The method according to claim 1, wherein:

the first clip further includes a first grip,

the second clip further includes a second grip,

closing the first clip comprises closing the first clip by deflecting the first clip-arm toward the first grip, and

closing the second clip comprises closing the second clip by deflecting the first clip-arm toward the second grip.

6. The method according to claim 1, wherein:

the implant includes a first clip-controller interface and a second clip-controller interface,

closing the first clip by deflecting the first clip-arm comprises using the at least one clip controller to operate the first clip-controller interface to deflect the first clip-arm, and

closing the second clip by deflecting the second clip-arm comprises using the at least one clip controller to operate the second clip-controller interface to deflect the second clip-arm.

7. The method according to claim 6, wherein using the at least one clip controller to operate the first clip-controller interface to deflect the first clip-arm comprises using the at least one clip controller to move the first clip-controller interface a first distance such that the first clip-arm moves a second distance, the second distance being more than 1.5 times greater than the first distance.

8. The method according to claim 6, wherein:

opening the first clip by deflecting the first clip-arm comprises using the at least one clip controller to operate the first clip-controller interface to deflect the first clip-arm, and

opening the second clip by deflecting the second clip-arm comprises using the at least one clip controller to operate the second clip-controller interface to deflect the second clip-arm.

9. The method according to claim 6, wherein:

using the at least one clip controller to operate the first clip-controller interface to deflect the first clip-arm comprises using the at least one clip controller to slide the first clip-controller interface with respect to the first clip, and

using the at least one clip controller to operate the second clip-controller interface to deflect the second clip-arm comprises using the at least one clip controller to slide the second clip-controller interface with respect to the second clip.

10. The method according to claim 1, wherein:

opening the first clip by deflecting the first-clip arm comprises opening the first clip by deflecting the first-clip arm laterally;

opening the second clip by deflecting the second-clip arm comprises opening the second clip by deflecting the second-clip arm laterally;

closing the first clip by deflecting the first-clip arm comprises closing the first clip by deflecting the first-clip arm medially; and

closing the second clip by deflecting the second-clip arm comprises closing the second clip by deflecting the second-clip arm medially.