Prosthetic valve delivery system with independently-movable capsule portions

• US 10,463,487 B2
• Filed: 07/23/2018
• Issued: 11/05/2019
• Est. Priority Date: 02/05/2015
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hariton, Ilia, Harari, Boaz
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US16/042,028
• Publication Number:
  US 20180338830A1
• Time in Patent Office: 470 Days
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• 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

Abstract

Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a method of releasing a valve from a delivery capsule in a heart may be provided. The method may include moving a distal capsule portion of the delivery capsule a first distance in the heart in a first direction. Such movement may release ventricular anchoring legs of the valve from the capsule, The method may also include moving a proximal capsule portion of the delivery capsule a second distance in a second direction in the heart. The first direction may be opposite the second direction. Such movement may release atrial anchoring arms of the valve from the capsule. The method may also include moving the distal capsule portion a third distance in the first direction in the heart, to thereby release an annular valve body of the valve from the capsule.

Claims

1. A method of releasing a valve from a delivery capsule in a heart, the method comprising:

advancing the delivery capsule into the heart, the delivery capsule comprising a distal capsule portion and a proximal capsule portion, wherein the distal capsule portion and the proximal capsule portion are held together to retain the valve between the distal capsule portion and proximal capsule portion during the advancement of the delivery capsule into the heart;

moving the distal capsule portion a first distance in the heart in a first direction to release ventricular anchoring legs of the valve from the delivery capsule;

moving the proximal capsule portion a second distance in a second direction in the heart, opposite the first direction, to release atrial anchoring arms of the valve from the delivery capsule; and

after the release of the ventricular anchoring legs and the atrial anchoring arms from the delivery capsule, moving the distal capsule portion a third distance in the first direction in the heart to release an annular valve body of the valve from the delivery capsule.

2. The method of claim 1, wherein the first direction is a ventricular direction and the second direction is an atrial direction.

3. The method of claim 1, further comprising:

prior to movement of the distal capsule portion the third distance in the first direction, moving the released ventricular anchoring legs in the second direction.

4. The method of claim 1, further comprising:

prior to movement of the distal capsule portion the third distance in the first direction, positioning the released ventricular anchoring legs to engage tissue on a ventricular side of a native atrioventricular valve.

5. The method of claim 1, further comprising:

prior to movement of the distal capsule portion the third distance in the first direction, positioning the released atrial anchoring arms to engage tissue on an atrial side of a native atrioventricular valve.

6. The method of claim 1, wherein release of the ventricular anchoring legs from the delivery capsule occurs prior to release of the atrial anchoring arms from the delivery capsule.

7. The method of claim 1, wherein the valve body remains constrained within the distal capsule portion during movement of the distal capsule portion the first distance in the first direction and during movement of the proximal capsule portion the second distance in the second direction.

8. The method of claim 1,

wherein movement of the distal capsule portion the first distance in the first direction causes terminal ends of the ventricular anchoring legs to deflect radially outward relative to the valve body;

and

wherein movement of the proximal capsule portion the second distance in the second direction causes terminal ends of the atrial anchoring arms to deflect radially outward relative to the valve body.

9. The method of claim 1, wherein movement of the distal capsule portion the third distance in the first direction causes radial expansion of the valve body.

10. The method of claim 1, wherein movement of the distal capsule portion the third distance in the first direction releases the valve from the delivery capsule.

11. The method of claim 1, wherein movement of the distal capsule portion the third distance in the first direction causes a longitudinal distance between the atrial anchoring arms and the ventricular anchoring legs to be reduced.

12. The method of claim 1, wherein movement of the distal capsule portion the third distance in the first direction causes a diameter defined by terminal ends of the atrial anchoring arms to be enlarged and causes a diameter defined by terminal ends of the ventricular anchoring legs to be enlarged.

13. The method of claim 1, wherein release of the atrial anchoring arms from the delivery capsule occurs when the proximal capsule portion is in an atrium of the heart.

14. The method of claim 1, wherein release of the valve body from the delivery capsule occurs when the distal capsule portion is in a ventricle of the heart.

15. The method of claim 1, wherein release of the valve body from the delivery capsule anchors the valve in a native atrioventricular valve.

16. The method of claim 15, wherein tissue of the native atrioventricular valve is clamped between the ventricular anchoring legs and the atrial anchoring arms upon release of the valve body from the delivery capsule.

17. The method of claim 1, wherein an opening of the distal capsule portion and an opening of the proximal capsule portion are held together to enclose the valve within the delivery capsule during the advancement of the delivery capsule into the heart.

18. The method of claim 1, wherein an outer diameter of the distal capsule portion is equal to an outer diameter of the proximal capsule portion.

19. The method of claim 1, wherein the distal capsule portion is configured to retain at least a portion of the atrial anchoring arms during the advancement of the delivery capsule into the heart.

20. A method of releasing a valve from a delivery capsule in a heart, the method comprising:

moving a distal capsule portion of the delivery capsule a first distance in the heart in a first direction to release ventricular anchoring legs of the valve from the delivery capsule;

moving a proximal capsule portion of the delivery capsule a second distance in a second direction in the heart, opposite the first direction, to release atrial anchoring arms of the valve from the delivery capsule; and

moving the distal capsule portion a third distance in the first direction in the heart to release an annular valve body of the valve from the delivery capsule,

wherein release of the ventricular anchoring legs from the delivery capsule occurs after release of the atrial anchoring arms from the delivery capsule.