Prosthetic heart valve devices with tethered anchors and associated systems and methods

• US 10,265,172 B2
• Filed: 04/18/2017
• Issued: 04/23/2019
• Est. Priority Date: 04/29/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Krivoruchko, Mike
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/489,889
• Publication Number:
  US 20170312078A1
• Time in Patent Office: 735 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 2017/0417 T-fasteners
• 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• 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

Abstract

Prosthetic heart valve devices with tethered anchors and associated systems and methods are disclosed herein. A heart valve device configured in accordance with embodiments of the present technology can include, for example, a valve support for carrying a prosthetic valve. The valve support can be configured to be implanted at an annulus of a native mitral valve. The device can further include at least one elongated flexible member extending from the valve support in a ventricular direction, and an anchor coupled to the valve support via the elongated flexible member. The anchor can be shaped to wrap around an exterior area of an apical portion of the heart. In addition, the anchor can inhibit retrograde migration of the valve support.

Claims

1. A heart valve device for implantation in a native mitral valve of a heart, the heart valve device comprising:

a valve support for carrying a prosthetic valve having a plurality of leaflets, wherein the valve support comprises a frame portion that supports the prosthetic valve, and wherein the valve support is configured to be implanted at an annulus of the native mitral valve;

at least one elongated flexible member extending from the valve support in a ventricular direction, wherein the elongated flexible member connects to one of the leaflets of the prosthetic valve; and

an anchor coupled to the valve support via the elongated flexible member, wherein the anchor is shaped to wrap around an exterior area of an apical portion of the heart, and wherein the anchor is configured to inhibit retrograde migration of the valve support.

2. The heart valve device of claim 1 wherein:

the elongated flexible member is configured to extend through an opening in the apical portion of the heart to connect to the anchor; and

the anchor comprises a material configured to cover and seal the opening in the apical portion of the heart.

3. The heart valve device of claim 1 wherein the elongated flexible member comprises a first elongated flexible member and a second elongated flexible member, and wherein the first elongated flexible member connects to a first region of the anchor and the second elongated flexible member connects to a second region of the anchor spaced apart, the first region being spaced apart from the second region.

4. The heart valve device of claim 1 wherein the elongated flexible member is a tether that restricts movement between the valve support and the anchor.

5. The heart valve device of claim 1 wherein the anchor comprises a semi-rigid frame and a non-permeable material on the frame.

6. The heart valve device of claim 1 wherein the anchor comprises a self-expandable frame having a conformal concave shape, the anchor being configured to self-expand to attach to the apical portion of the heart.

7. The heart valve device of claim 1 wherein the anchor is sized and shaped to contract around the apical portion of the heart to lessen left ventricle dilation.

8. The heart valve device of claim 1 wherein the anchor comprises a mesh basket configured to conform to the apical portion of the heart.

9. The heart valve device of claim 1 wherein the elongated flexible member is adjustable in length.

10. The heart valve device of claim 1 wherein:

the elongated flexible member is one of a plurality of elongated flexible members connected to the frame portion at a plurality of spaced apart connection sites around a circumference of the frame portion;

the plurality of elongated flexible members are sized to extend from the leaflets through an opening in the apical portion of the heart to connect to the anchor; and

the anchor comprises a self-expandable material having a concave shape corresponding to the apical portion of the heart and configured to cover and seal the opening in the apical portion of the heart.

11. A heart valve device for implantation in a native valve of a heart, the heart valve device comprising:

a valve support comprising a frame portion configured to support a prosthetic valve having a plurality of leaflets;

an anchor having a surface area configured to attach and conform to an exterior portion of the heart downstream of the native valve; and

a plurality of elongated flexible members connecting the valve support to the anchor, wherein the elongated flexible members connect to the leaflets of the prosthetic valve.

12. The heart valve device of claim 11 wherein:

the valve support is sized and shaped to be implanted in a native annulus of a native mitral valve; and

the anchor is configured to attach to an apical portion of the heart proximate to a left ventricle of the heart.

13. The heart valve device of claim 11 wherein the anchor comprises a self-expandable material, and wherein the anchor self-expands to a convex shape.

14. The heart valve device of claim 11 wherein the elongated flexible members are flexible lines connected between the valve support and the anchor.

15. The heart valve device of claim 11 wherein the anchor comprises a woven basket having a cup-shape configured to grip the apical portion of the heart.

16. A heart valve device for implantation in a native valve of a heart, the heart valve device comprising:

a valve support comprising a frame portion for carrying a prosthetic valve with a plurality of leaflets, wherein the valve support is configured to be implanted at an annulus of the native valve;

an anchor comprising a mesh structure having a concave shape when expanded, wherein the mesh structure is configured to conform to an exterior portion of an apical region of the heart; and

at least one elongated flexible member connecting the valve support to the anchor, wherein the elongated flexible member connects to at least one of the leaflets of the prosthetic valve.

17. The heart valve device of claim 16 wherein the mesh structure is made of nitinol.