Device and method for improving heart valve function

• US 10,213,305 B2
• Filed: 11/27/2017
• Issued: 02/26/2019
• Est. Priority Date: 05/18/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto, Alon, David
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): Lauer, Christina
• Application Number:
  US15/823,445
• Publication Number:
  US 20180078362A1
• Time in Patent Office: 456 Days
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

The invention is a method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is preferably configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.

Claims

1. A blood-flow controlling device for treating a mitral or tricuspid valve in need thereof, the device comprising:

a blood-flow blocking portion comprising an elongate structure with a substantially cylindrical portion, a portion of the blood-flow blocking portion disposable between leaflets of a native mitral or tricuspid valve and fillable with blood;

a flexible, elongate body portion passing inside of the blood-flow blocking portion, the blood-flow blocking portion slidable up and down the body portion;

an anchor portion disposed on a distal end of the elongate body portion, the anchor portion engageable with heart tissue at or adjacent a heart apex, the anchor portion comprising a tubular body and a plurality of pointed, elongated prongs emanating from a distal end of the tubular body, the plurality of elongated prongs self-expandable from a compressed configuration, in which the plurality of elongated prongs extend distally, and an expanded configuration, in which the plurality of elongated prongs are deflected radially outward relative to a center of the tubular body;

an anchor delivery catheter for delivering the anchor portion having a distal end sheath that maintains the plurality of elongated prongs in the compressed configuration; and

a locking catheter slidable along the elongate body portion,

wherein the locking catheter is operable to lock the blood-flow blocking portion to the elongate body portion, preventing sliding therebetween.

2. The blood-flow controlling device of claim 1, wherein the blood-flow blocking portion further comprises a bendable lumen through which the elongate body portion extends, the locking catheter operable to deform the bendable lumen to lock the blood-flow blocking portion to the elongate body portion.

3. The blood-flow controlling device of claim 2, wherein the bendable lumen is within a bendable tube extending from a proximal end of the blood-flow blocking portion, the bendable tube being plastically deformable to lock the blood-flow blocking portion to the elongate body portion.

4. The blood-flow controlling device of claim 1, wherein the blood-flow blocking portion is dimensioned for positioning between leaflets of the native mitral valve.

5. The blood-flow controlling device of claim 1, wherein the blood-flow blocking portion is dimensioned for positioning between leaflets of the native tricuspid valve.

6. The blood-flow controlling device of claim 1, wherein the anchor delivery catheter includes an expandable balloon positioned around a portion of the distal end sheath, the expandable balloon being expandable during delivery of the anchor portion so as to assist in advancement thereof by preventing entanglement of the anchor portion with chordae tendinae and other sub-valvular structures.

7. The blood-flow controlling device of claim 1, wherein the anchor portion further comprises a coupling member to which a connector at the distal end of the elongate body portion is couplable.

8. The blood-flow controlling device of claim 1, further including a leash extending from a proximal end of the blood-flow blocking portion that is configured to anchor in tissue and restrain unwanted movement of the blood-flow blocking portion.

9. A blood-flow controlling device for treating a mitral or tricuspid valve in need thereof, the device comprising:

a blood-flow blocking portion comprising an elongate structure, a portion of the blood-flow blocking portion disposable between leaflets of a native mitral or tricuspid valve and fillable with blood;

a flexible, elongate body portion passing inside of the blood-flow blocking portion, the blood-flow blocking portion slidable up and down the body portion; and

an anchor portion disposed on a distal end of the elongate body portion, the anchor portion engageable with heart tissue at or adjacent a heart apex;

an anchor delivery catheter for delivering the anchor portion having a distal end sheath from which the anchor portion is expelled; and

a locking catheter slidable along the elongate body portion,

wherein the locking catheter is operable to lock the blood-flow blocking portion to the elongate body portion, preventing sliding therebetween.

10. The blood-flow controlling device of claim 9, wherein the blood-flow blocking portion comprises a substantially cylindrical portion.

11. The blood-flow controlling device of claim 9, wherein the anchor portion comprises an inner anchor plate and an outer anchor plate.

12. The blood-flow controlling device of claim 9, wherein the anchor portion comprises a tubular body and a plurality of pointed, elongated prongs emanating from a distal end of the tubular body, the plurality of elongated prongs self-expandable from a compressed configuration, in which the plurality of elongated prongs extend distally, and an expanded configuration, in which the plurality of elongated prongs are deflected radially outward relative to a center of the tubular body.

13. The blood-flow controlling device of claim 9, wherein the anchor portion further comprises a coupling member to which a connector at the distal end of the elongate body portion is couplable.

14. The blood-flow controlling device of claim 9, wherein the blood-flow blocking portion further comprises a bendable lumen through which the elongate body portion extends, the locking catheter operable to deform the bendable lumen to lock the blood-flow blocking portion to the elongate body portion.

15. The blood-flow controlling device of claim 14, wherein the bendable lumen is within a bendable tube extending from a proximal end of the blood-flow blocking portion, the bendable tube being plastically deformable to lock the blood-flow blocking portion to the elongate body portion.

16. The blood-flow controlling device of claim 9, wherein the blood-flow blocking portion is dimensioned for positioning between leaflets of the native mitral valve.

17. The blood-flow controlling device of claim 9, wherein the blood-flow blocking portion is dimensioned for positioning between leaflets of the native tricuspid valve.

18. The blood-flow controlling device of claim 9, wherein the anchor portion comprises a plurality of elongated prongs self-expandable from a compressed configuration, and the anchor delivery catheter distal end sheath maintains the plurality of elongated prongs in the compressed configuration.

19. The blood-flow controlling device of claim 18, wherein the anchor delivery catheter includes an expandable balloon positioned around a portion of the distal end sheath, the expandable balloon being expandable during delivery of the anchor portion so as to assist in advancement thereof by preventing entanglement of the anchor portion with chordae tendinae and other sub-valvular structures.

20. The blood-flow controlling device of claim 9, further including a leash extending from a proximal end of the blood-flow blocking portion that is configured to anchor in tissue and restrain unwanted movement of the blood-flow blocking portion.