Opposing disk device for grasping cardiac valve tissue

• US 10,398,553 B2
• Filed: 11/11/2016
• Issued: 09/03/2019
• Est. Priority Date: 11/11/2016
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Kizuka, Koji J.
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/349,288
• Publication Number:
  US 20180133010A1
• Time in Patent Office: 1,026 Days
• 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 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

The present disclosure relates to repair devices and methods for repair of regurgitant tricuspid valves. A repair method includes positioning a repair device at a tricuspid valve in a collapsed configuration. The repair device includes a proximal disk and a distal disk joined by a neck section. The distal disk is deployed by passing it from the collapsed state to an expanded configuration on a first side of the tricuspid valve. The proximal disk is then deployed by passing it from the collapsed state to an expanded configuration on a second side of the tricuspid valve so as to grasp all three tricuspid valve leaflets between the deployed distal disk and the deployed proximal disk.

Claims

1. A method for repairing a targeted cardiac valve, the method comprising:

positioning a repair device at a targeted cardiac valve, the repair device being moveable between a collapsed configuration and an expanded configuration, the repair device including;

a proximal disk element;

a distal disk element spaced apart from the proximal disk element so as to define a grasping space therebetween for grasping cardiac valve tissue; and

a neck section joining the proximal disk element and the distal disk element, the neck section having a diameter that is smaller than a diameter of the proximal disk element and the distal disk element;

wherein the proximal disk element, the distal disk element, and the neck section are integrally formed as a self-expanding structure

deploying the distal disk element on a first side of targeted cardiac valve tissue to move the distal disk element from the collapsed configuration to the expanded configuration; and

deploying the proximal disk element on a second side of the targeted cardiac valve tissue to move the proximal disk element from the collapsed configuration to the expanded configuration so as to grasp the cardiac valve tissue between the deployed distal disk element and the deployed proximal disk element.

2. The method of claim 1, wherein the targeted cardiac valve is a tricuspid valve, and wherein the targeted cardiac valve tissue includes the leaflets of the tricuspid valve.

3. The method of claim 2, wherein deployment of the proximal disk simultaneously captures the three leaflets of the tricuspid valve between the proximal disk element and the distal disk element.

4. The method of claim 2, wherein the grasping space is sized and shaped to conform to an anatomical shape of the targeted tricuspid valve leaflets.

5. The method of claim 2, wherein the distal disk element is deployed on a ventricular side of the targeted tricuspid valve, and wherein the proximal disk element is deployed on an atrial side of the targeted tricuspid valve.

6. The method of claim 1, wherein the repair device includes a plurality of grip elements configured to enhance engagement of the repair device with the targeted cardiac valve tissue upon deployment of the repair device.

7. The method of claim 1, wherein the repair device is delivered to the targeted cardiac valve through a transjugular approach.

8. The method of claim 1, wherein prior to deployment, the distal disk element and the proximal disk element are maintained in the collapsed configuration by a sheath, and wherein the distal disk element and the proximal disk element are moved to respective expanded configurations by unsheathing the distal section and the proximal section.

9. The method of claim 1, further comprising locking the proximal disk element and the distal disk element in the deployed configuration using a locking mechanism, the locking mechanism including a locking plate, the locking plate including an aperture through which an actuator rod passes, and the locking plate being adjustable between an angled configuration that binds the locking plate against the actuator rod and prevents translation of the actuator rod and a more perpendicular configuration that allows translation of the actuator rod.

10. An interventional device configured for repair of a regurgitant tricuspid valve, the repair device comprising:

a proximal disk element movable between a collapsed configuration and an expanded configuration;

a distal disk element moveable between a collapsed configuration and an expanded configuration, the distal disk element being spaced apart from the proximal disk so as to define a grasping space therebetween for grasping tricuspid valve leaflets when the proximal disk element and the distal disk element are in expanded configurations and are deployed at a tricuspid valve; and

a neck section joining the proximal disk element and the distal disk element, the neck section having a diameter that is smaller than a diameter of the proximal disk element and the distal disk element,

wherein the proximal disk element, the distal disk element, and the neck section are integrally formed as a self-expanding structure.

11. The interventional device of claim 10, wherein the disk elements are maintained in collapsed configurations when constrained but move to the expanded configurations when not constrained.

12. The interventional device of claim 11, wherein the device is formed at least partly of a wireframe nitinol structure.

13. The interventional device of claim 10, further comprising a locking plate configured to selectively bind against an actuator rod coupled to a connection element proximal the proximal disk to prevent translation of the actuator rod.

14. The interventional device of claim 10, further comprising a connection element disposed proximal the proximal disk.

15. The interventional device of claim 14, wherein the connection element is integrally formed with the proximal disk element, the distal disk element, and the neck section.

16. An interventional system configured for repair of a regurgitant tricuspid valve, the repair system comprising:

a delivery system, including;

a sheath;

a delivery catheter disposed within the sheath so as to be translatable within the sheath, the delivery catheter including a connection element disposed at a distal end of the delivery catheter; and

an interventional device, including;

a connection element configured to engage with the connection element of the delivery catheter to detachably couple the interventional device to the delivery catheter;

a proximal disk element movable between a collapsed configuration and an expanded configuration;

a distal disk element moveable between a collapsed configuration and an expanded configuration, the distal disk element being spaced apart from the proximal disk so as to define a grasping space therebetween for grasping tricuspid valve leaflets when the proximal disk element and the distal disk element are in expanded configurations and are deployed at a tricuspid valve;

a neck section joining the proximal disk element and the distal disk element, the neck section having a diameter that is smaller than a diameter of the proximal disk element and the distal disk element;

wherein the proximal disk element, the distal disk element, and the neck section are integrally formed as a self-expanding structure,

wherein the sheath is configured to be retractable relative to the delivery catheter to expose the interventional device and enable the distal disk element and the proximal disk element to move toward the expanded configuration.

17. The interventional system of claim 16, wherein the proximal and distal disk elements are self-expandable such that when housed within the sheath the proximal and distal disk elements are constrained to the collapsed configuration and such that the proximal and distal disk elements self-expand upon retraction of the sheath relative to the interventional device.

18. The interventional system of claim 16, wherein the interventional device further includes a central shaft to which the proximal disk element is attached, the proximal disk element being segmented into three separate proximal grasping elements and the distal disk element being segmented into three separate distal grasping elements.

19. The interventional system of claim 16, wherein the connection element is integrally formed with the proximal disk element, the distal disk element, and the neck section.