Prosthetic mitral valves and apparatus and methods for delivery of same

Patent metadata

Field	Value
Publication number	US-10786351-B2
Application number	US-201715626607-A
Country	US
Kind code	B2
Filing date	Jun 19, 2017
Priority date	Jan 7, 2015
Publication date	Sep 29, 2020
Grant date	Sep 29, 2020

Abstract

Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when the valve is in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The distal end portion of the delivery sheath is inserted into a left atrium of a heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. In some embodiments, actuation wires are used to assist in the reversion of the outer frame. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

First claim

What is claimed is:

1. An apparatus, comprising:
a prosthetic heart valve including an inner frame and an outer frame coupled to the inner frame at a plurality of coupling joints, the plurality of coupling joints configured to allow the outer frame to be moved relative to the inner frame such that the prosthetic valve can be moved between a first configuration and a second configuration, a plurality of prosthetic valve leaflets being coupled to the inner frame and adapted to allow blood to flow from an inflow end of the prosthetic heart valve toward an outflow end of the prosthetic heart valve but to substantially block blood from flowing from the outflow end of the prosthetic heart valve toward the inflow end of the prosthetic heart valve,
the outer frame having an outer frame coupling portion coupled to the inner frame at the plurality of coupling joints and an outer frame free end portion, the inner frame having an inner frame coupling portion coupled to the outer frame at the plurality of coupling joints and an inner frame free end portion,
the outer frame free end portion and the inner frame free end portion each opening in the same direction toward the inflow end of the prosthetic heart valve when the prosthetic valve is in the first configuration, the outer frame free end portion and the inner frame free end portion opening in opposite directions when the prosthetic valve is in the second configuration, and
a delivery sheath configured to receive the prosthetic heart valve in the second configuration,
wherein the inner frame and the outer frame are each formed of shape memory material so that the inner frame and the outer frame are each compressible and self-expandable,
wherein upon the prosthetic heart valve transitioning from the second configuration to the first configuration, the outer frame is configured to invert relative to the inner frame and the delivery sheath.

2. The apparatus of claim 1 , wherein each coupling joint from the plurality of coupling joints includes a living hinge disposed between the inner frame and the outer frame, the living hinge including a hinge member formed with one of a polymer, a tissue and a superelastic material.

3. The apparatus of claim 2 , wherein the hinge member is coupled to the inner frame and coupled to the outer frame with one or more strands of suture.

4. The apparatus of claim 1 , wherein each coupling joint from the plurality of coupling joints includes a tab disposed on the inner frame interlocked within a slot defined by the outer frame.

5. The apparatus of claim 1 , wherein each coupling joint from the plurality of coupling joints includes at least one strand of suture wrapped through at least one of an opening defined in the inner frame and an opening defined in the outer frame.

6. The apparatus of claim 1 , wherein each coupling joint from the plurality of coupling joints includes a pin disposed through an opening defined by the inner frame and an opening defined by the outer frame.

7. The apparatus of claim 6 , wherein each coupling joint from the plurality of coupling joints further includes an interface element disposed between the inner frame and the outer frame.

8. The apparatus of claim 1 , wherein each coupling joint from the plurality of coupling joints includes at least one tether inserted through at least one opening defined in the inner frame and at least one opening defined in the outer frame.

9. An apparatus, comprising:
a prosthetic heart valve including an inner frame and an outer frame coupled to the inner frame at a plurality of coupling joints, the plurality of coupling joints configured to allow the outer frame to be moved relative to the inner frame such that the prosthetic valve can be moved between a first configuration and a second configuration, the prosthetic valve including a plurality of prosthetic valve leaflets being coupled to the inner frame and adapted to allow blood to flow from an inflow end of the prosthetic heart valve toward an outflow end of the prosthetic heart valve but to substantially block blood from flowing from the outflow end of the prosthetic heart valve toward the inflow end of the prosthetic heart valve,
the outer frame having an outer frame coupling portion coupled to the inner frame at the plurality of coupling joints and an outer frame free end portion, the inner frame having an inner frame coupling portion coupled to the outer frame at the plurality of coupling joints, a first end portion and an inner frame free end portion on an opposite end of the inner frame from the first end portion,
the plurality of coupling joints being disposed between the outer frame free end portion and the first end portion of the inner frame when the prosthetic valve is in the first configuration, the plurality of coupling joints being disposed between the inner frame free end portion and the outer frame free end portion when the prosthetic valve is in the second configuration, the outer frame free end portion and the inner frame free end portion each opening toward the inflow end of the prosthetic heart valve in the first configuration, and
a delivery sheath configured to receive the prosthetic heart valve in the second configuration,
wherein the inner frame and the outer frame are each formed of shape memory material so that the inner frame and the outer frame are each compressible and self-expandable,
wherein upon the prosthetic heart valve transitioning from the second configuration to the first configuration, the outer frame is configured to invert relative to the inner frame and the delivery sheath.

10. The apparatus of claim 9 , wherein each coupling joint from the plurality of coupling joints includes a living hinge disposed between the inner frame and the outer frame, the living hinge including a hinge member formed with one of a polymer, a tissue and a superelastic material.

11. The apparatus of claim 10 , wherein the hinge member is coupled to the inner frame and coupled to the outer frame with one or more strands of suture.

12. The apparatus of claim 9 , wherein each coupling joint from the plurality of coupling joints includes a tab disposed on the inner frame interlocked within a slot defined by the outer frame.

13. The apparatus of claim 9 , wherein each coupling joint from the plurality of coupling joints includes at least one strand of suture wrapped through at least one of an opening defined in the inner frame and an opening defined in the outer frame.

14. The apparatus of claim 9 , wherein each coupling joint from the plurality of coupling joints includes a pin disposed through an opening defined by the inner frame and an opening defined by the outer frame.

15. The apparatus of claim 14 , wherein each coupling joint from the plurality of coupling joints further includes an interface element disposed between the inner frame and the outer frame.

16. The apparatus of claim 9 , wherein each coupling joint from the plurality of coupling joints includes at least one tether inserted through at least one opening defined in the inner frame and at least one opening defined in the outer frame.

17. The apparatus of claim 9 , wherein each coupling joint from the plurality of coupling joints includes at least one tether inserted through at least one of an opening defined in the inner frame or an opening defined in the outer frame, and a living hinge member coupled to the inner frame and coupled to the outer frame.

18. The apparatus of claim 9 , wherein the outer frame includes a first frame portion and a second frame portion, the first frame portion is coupled to t

Assignees

• Tendyne Holdings Inc

Inventors

• Christianson Mark
• Vidlund Zachary
• Vidlund Robert
• Kovalsky Igor
• Peckels William
• Evans Michael
• Perrin Chad
• Otte John F
• Mai Son

Classifications

• A61F2/246

  Devices for obstructing a leak through a native valve in a closed condition · CPC title

• A61F2220/0083

  using hook and loop-type fasteners · CPC title

• A61F2250/0098

  radio-opaque, e.g. radio-opaque markers · CPC title

• A61F2/2457

  Chordae tendineae prostheses · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title