Expandable Epicardial Pads And Devices And Methods For Delivery Of Same

Patent metadata

Field	Value
Publication number	US-2020179111-A1
Application number	US-202016788382-A
Country	US
Kind code	A1
Filing date	Feb 12, 2020
Priority date	Feb 5, 2014
Publication date	Jun 11, 2020
Grant date	—

Abstract

Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

First claim

What is claimed is:

1 . An apparatus, comprising:
an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart, the prosthetic heart valve having a tether extending therefrom and outside the heart when the prosthetic heart valve is disposed within the heart, the epicardial pad defining a lumen configured to receive the tether therethrough, the epicardial pad being movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter, the epicardial pad configured to be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart, wherein the epicardial pad is a balloon.

2 . The apparatus of claim 1 , wherein the balloon is configured to be inflated by an inflation medium to move the epicardial pad to the second configuration.

3 . The apparatus of claim 1 , wherein the balloon is configured to be inflated by an inflation medium to move the epicardial pad to a third configuration in which the epicardial pad is expanded,
the epicardial pad configured to be moved from the third configuration to the second configuration in which the epicardial pad is collapsed inwardly to form a cup shape.

4 . The apparatus of claim 1 , wherein the balloon includes an inflation lumen through which an inflation medium can be communicated to and from the balloon.

5 . The apparatus of claim 4 , wherein the inflation lumen is defined by the balloon.

6 . The apparatus of claim 4 , wherein the inflation lumen is defined by an inflation line separate from the balloon and in fluid communication with an interior of the balloon.

7 . An apparatus, comprising:
an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart, the prosthetic heart valve having a tether extending therefrom and outside the heart when the prosthetic heart valve is disposed within the heart, the epicardial pad defining a lumen configured to receive the tether therethrough, the epicardial pad being movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter, the epicardial pad configured to be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart, wherein the epicardial pad includes a spiral member.

8 . The apparatus of claim 7 , wherein the spiral member has an elongated and radially compressed shape when in the first configuration, and has an axially compressed shape with coils of the spiral member being collapsed upon each other when in the second configuration.

9 . The apparatus of claim 7 , wherein the spiral member has a plurality of coils, the spiral member having an elongated and radially compressed shape when in the first configuration, and having an axially compressed shape with the plurality of coils being collapsed upon each other when in the second configuration, the epicardial pad having a third configuration in which the spiral member is biased into an expanded shape when not constrained within a lumen of a delivery sheath.

10 . The apparatus of claim 7 , wherein the spiral member has an elongated and radially compressed shape when in the first configuration, and has an axially compressed shape with coils of the spiral member being collapsed upon each other when in the second configuration, the epicardial pad further including a locking member configured to maintain the epicardial pad in the second configuration.

11 . The apparatus of claim 10 , wherein the locking member is positioned at a proximal end portion of the spiral member.

12 . The apparatus of claim 10 , wherein the locking member defines a lumen configured to receive a portion of a delivery device therethrough.

13 . The apparatus of claim 10 , wherein the locking member includes a collapsible tubular sock portion.

14 . The apparatus of claim 13 , wherein the sock portion is formed of a mesh or fabric material.

15 . The apparatus of claim 13 , wherein the sock portion is moveable from a first configuration during delivery of the epicardial pad to a second configuration during deployment of the epicardial pad, the sock portion having a first length in the first configuration greater than a second length in the second configuration.

16 . The apparatus of claim 15 , wherein the sock portion is at least partially collapsed upon itself in the second configuration of the sock portion.

17 . The apparatus of claim 15 , wherein the sock portion is configured to engage at least some of the coils of the spiral member when the spiral member is in the second configuration.

18 . The apparatus of claim 7 , wherein the spiral member is formed of a shape-memory material.

19 . The apparatus of claim 7 , wherein the spiral member is at least partially covered with a polyester material.

20 . An apparatus, comprising:
a delivery sheath defining a first lumen; a dilator device defining a second lumen and being movably disposed within the first lumen of the delivery sheath, the dilator device including an elongate member and an expandable member disposed at a distal end of the elongate member, the expandable member having a collapsed configuration and an expanded configuration, the dilator device being in the collapsed configuration when disposed within the first lumen; and an epicardial pad having a collapsed configuration and an expanded configuration, the epicardial pad configured to be disposed within the second lumen when in the collapsed configuration, the epicardial pad configured to be disposed against an outside surface of a heart when in the expanded configuration, the dilator member of the dilator device configured to dilate tissue associated with the outside surface of the heart when moved from its collapsed configuration to its expanded configuration such that a space is formed in which the epicardial pad can be disposed, wherein the epicardial pad is a balloon inflatable with an inflation medium to move the epicardial pad to the expanded configuration.

Assignees

• Tendyne Holdings Inc

Inventors

• Vidlund Robert M
• Kovalsky Igor
• Tegels Zachary J
• Ekvall Craig A

Classifications

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2250/0098

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

• A61F2220/0041

  using additional screws, bolts, dowels or rivets, e.g. connecting screws · CPC title