Cardiac valve repair system and methods of use

• US 10,383,724 B2
• Filed: 04/21/2017
• Issued: 08/20/2019
• Est. Priority Date: 07/19/2010
• Status: Active Grant

• Current Assignee: Bmeye B.V. (Edwards Lifesciences Corporation)
• Original Assignee: Bmeye B.V. (Edwards Lifesciences Corporation)
• Inventors: Seguin, Jacques
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca S
• Application Number:
  US15/494,107
• Publication Number:
  US 20170224479A1
• Time in Patent Office: 851 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

Systems and methods for mitral valve repair having a docking station and a valve implant. The docking station is an anchoring device having a helix structure. The valve implant is made of an expandable frame and a valve, and is radially expandable to a diameter that is at least the same as an expanded diameter of the anchoring device. The method of delivering the docking station and valve implant is performed by inserting the components through device delivery catheters.

Claims

1. A system for mitral valve repair comprising:

a docking station and a valve implant,

wherein the docking station comprises an anchor that comprises a helix structure having at least two turns;

wherein the valve implant comprises an expandable frame and a valve, and the valve implant is radially expandable to at least an external valve diameter that is the same as an internal anchor diameter when the anchor is in an expanded position, and

wherein the system is configured such that, when implanted at a native mitral valve, the docking station and the valve implant will not contact an entire circumference of a native annulus of the native mitral valve.

2. The system of claim 1 wherein the anchor is configured to transition between a delivery state for placement within and delivery by a catheter, and the expanded position, wherein the expanded position is an expanded, helical shaped deployed state.

3. The system of claim 2 wherein the anchor is substantially straight in the delivery state.

4. The system of claim 1 wherein the expandable frame comprises a stent comprising a plurality of interconnected wires, and valve further comprises a valve material comprising a synthetic fabric.

5. The system of claim 1 wherein the expandable frame comprises a stent comprising a plurality of interconnected wires, and the valve further comprises a valve material comprising a treated animal tissue.

6. The system of claim 1 wherein the expandable frame comprises a stent comprising a plurality of interconnected wires, and the valve further comprises a valve material further comprising treated bovine tissue.

7. The system of claim 1 wherein the expandable frame comprises cobalt chromium and is balloon expandable.

8. The system of claim 1 wherein the anchor is configured such that at least one of the at least two turns can be positioned encircling native leaflets of a native mitral valve on a ventricular side of the native leaflets.

9. The system of claim 8 wherein the valve implant is configured such that the valve implant can be secured to the native leaflets by trapping the native leaflets between the valve implant and the anchor.

10. A system, comprising:

an anchor, wherein the anchor comprises a superelastic material configured to transition from an first configuration, in which the anchor is straightened for transvascular delivery to a native heart valve, to a second configuration comprising at least two circular turns;

a replacement valve, wherein the replacement valve comprises an expandable frame and a valve body, and wherein the replacement valve can transition from a collapsed configuration, for transvascular delivery to the native heart valve, to an expanded configuration, wherein the anchor and the replacement valve are configured such that, when delivered to the native heart valve, expansion of the replacement valve from the collapsed configuration to the expanded configuration inside the anchor can trap native leaflets of the native heart valve between the replacement valve and the anchor and thereby secure the replacement valve and the anchor at the native heart valve, and

wherein the replacement valve in the expanded configuration has a diameter smaller than a major axis of the native heart valve.

11. A system, comprising:

an anchor, wherein the anchor comprises a superelastic material configured to transition from an first configuration, in which the anchor is straightened for transvascular delivery to a native heart valve, to a second configuration comprising at least two circular turns;

a replacement valve, wherein the replacement valve comprises an expandable frame and a valve body, and wherein the replacement valve can transition from a collapsed configuration, for transvascular delivery to the native heart valve, to an expanded configuration, wherein the anchor and the replacement valve are configured such that, when delivered to the native heart valve, expansion of the replacement valve from the collapsed configuration to the expanded configuration inside the anchor can trap native leaflets of the native heart valve between the replacement valve and the anchor and thereby secure the replacement valve and the anchor at the native heart valve, and

wherein the at least two circular turns of the anchor in the second configuration and the replacement valve in the expanded configuration each have a diameter smaller than a major axis of the native heart valve.

12. The system of claim 11 wherein the expandable frame comprises a stent comprising a plurality of interconnected wires.

13. The system of claim 11 wherein valve body comprises a valve material comprising a treated animal tissue.

14. The system of claim 11 wherein the expandable frame comprises cobalt chromium and is balloon expandable.

15. The system of claim 11 wherein the anchor is configured such that at least one of the at least two turns is positionable such that it encircles the native leaflets on a ventricular side of the native leaflets.

16. The system of claim 11 wherein, in the expanded configuration, the replacement valve has a first diameter at a first end of the replacement valve, a second diameter at a second end of the replacement valve, and a third diameter between the first end and the second end of the replacement valve, wherein the third diameter is smaller than the first diameter and the second diameter.

17. A system, comprising:

an anchor, wherein the anchor is transitionable between a straightened configuration for transvascular delivery through an opening in a femoral vein to a native heart valve and a deployed configuration comprising at least two circular turns;

a replacement valve, wherein the replacement valve comprises an expandable frame having posts to form commissural points and a valve body, wherein the valve body comprises multiple pieces of animal tissue sewn or bonded together and to the posts that can open to allow blood flow therethrough and close to prevent blood flow therethrough;

wherein the replacement valve can transition from a collapsed configuration, for transvascular delivery through the opening in the femoral vein to the native heart valve, to an expanded configuration;

wherein the anchor can be transvascularly delivered to the native heart valve such that at least one of the at least two circular turns encircles native leaflets of the native heart valve, and the replacement valve is configured such that the replacement valve can be transvascularly delivered to the native heart valve in the collapsed configuration and expanded to the expanded configuration inside the anchor and thereby secure the replacement valve and the anchor at the native heart valve, and

wherein the replacement valve in the expanded configuration is configured to have a diameter smaller than a major axis of the native heart valve, such that native commissural regions of the native heart valve extend radially beyond the replacement valve.

18. The system of claim 17 wherein the at least two circular turns of the anchor in the deployed configuration are configured to have a diameter smaller than a major axis of the native heart valve, such that native commissural regions of the native heart valve extend radially beyond the at least two circular turns of the anchor.

19. A system, comprising:

an anchor, wherein the anchor is transitionable between a straightened configuration for transvascular delivery through an opening in a femoral vein to a native heart valve and a deployed configuration comprising at least two circular turns;

a replacement valve, wherein the replacement valve comprises an expandable frame having posts to form commissural points and a valve body, wherein the valve body comprises multiple pieces of animal tissue sewn or bonded together and to the posts that can open to allow blood flow therethrough and close to prevent blood flow therethrough;

wherein the replacement valve can transition from a collapsed configuration, for transvascular delivery through the opening in the femoral vein to the native heart valve, to an expanded configuration;

wherein the anchor can be transvascularly delivered to the native heart valve such that at least one of the at least two circular turns encircles native leaflets of the native heart valve, and the replacement valve is configured such that the replacement valve can be transvascularly delivered to the native heart valve in the collapsed configuration and expanded to the expanded configuration inside the anchor and thereby secure the replacement valve and the anchor at the native heart valve, and

wherein the at least two circular turns of the anchor in the deployed configuration are configured to have a diameter smaller than a major axis of the native heart valve, such that native commissural regions of the native heart valve extend radially beyond the at least two circular turns of the anchor.