Expandable epicardial pads and devices and methods for delivery of same

Patent metadata

Field	Value
Publication number	US-2017312077-A1
Application number	US-201715654374-A
Country	US
Kind code	A1
Filing date	Jul 19, 2017
Priority date	Feb 5, 2015
Publication date	Nov 2, 2017
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.

2 . The apparatus of claim 1 , wherein the epicardial pad is a balloon 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 epicardial pad is a balloon 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 epicardial pad includes a frame member and a covering coupled to the frame member, the frame member being formed with a shape memory material such that the epicardial pad is biased into the second configuration when not constrained within a lumen of a delivery sheath.

5 . The apparatus of claim 1 , wherein the epicardial pad includes a spiral member having an elongated and radially compressed shape when in the first configuration, and having an axially compressed shape with coils of the spiral member being collapsed upon each other when in the second configuration.

6 . The apparatus of claim 1 , wherein the epicardial pad includes a spiral member having 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.

7 . The apparatus of claim 1 , wherein the epicardial pad includes a spiral member having an elongated and radially compressed shape when in the first configuration, and having 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.

8 . The apparatus of claim 1 , further comprising:
an internal anchor coupleable to the epicardial pad, the internal anchor configured to be disposed within a ventricle of the heart when the epicardial pad is disposed against the outside surface of the heart to secure the prosthetic valve and tether in a desired position within the heart.

9 . The apparatus of claim 8 , wherein the internal anchor is coupleable to the epicardial pad with sutures that extend through an opening in the apex of the heart, the internal anchor and epicardial pad configured to close the opening.

10 . 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.

11 . The apparatus of claim 10 , wherein the delivery sheath further includes a retractor portion disposed at a distal end portion of the delivery sheath, the retractor portion configured to separate a portion of pericardium tissue from a portion of epicardium tissue of the heart.

12 . The apparatus of claim 10 , wherein the epicardial pad defines a lumen configured to receive therethrough a tether extending from a prosthetic heart valve, the apparatus further comprising:
an internal locator member movably disposable within the second lumen of the dilator device and movably disposable through the lumen of the epicardial pad, the internal locator member defining a lumen configured to receive therethrough the tether, the internal locator member having a collapsed configuration and an expanded configuration, the internal locator member configured to be inserted into the ventricle of the heart when in the collapsed configuration and moved to the expanded configuration within the ventricle of the heart to help position the epicardial pad against an outside surface of the heart.

13 . The apparatus of claim 10 , wherein the dilator member is a balloon inflatable with an inflation medium to move the dilator member to the second configuration.

14 . The apparatus of claim 10 , wherein the epicardial pad is a balloon inflatable with an inflation medium to move the epicardial pad to the expanded configuration.

15 . The apparatus of claim 10 , wherein the epicardial pad includes a frame member and a covering coupled to the frame member, the frame member being formed with a shape memory material such that the epicardial pad is biased into the expanded configuration when unconstrained within the second lumen.

16 . A method, comprising:
disposing a distal end portion of a delivery sheath outside a surface of a heart near an apex of the heart, the delivery sheath having a dilator device movably disposed within a lumen of the delivery sheath, the dilator device including an elongate member and a dilator member disposed at a distal end portion of the elongate member, the dilator member being movable from a collapsed configuration when disposed within the lumen of the delivery sheath and an expanded configuration; after disposing a distal end portion of a delivery sheath outside a surface of a heart, disposing the dilator member of the dilator device outside a distal end of the delivery sheath; and moving the dilator member to the expanded configuration such that tissue associated with the surface of the heart is dilated from pressure exerted on the tissue by the dilator member and a space is formed to receive an epicardial pad device.

17 . The method of claim 16 , further comprising:
after the moving the dilator member to the expanded configuration, moving the dilator to the collapsed configuration; and disposing the dilator member within the lumen of the deliver

Assignees

• Tendyne Holdings Inc

Inventors

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

Classifications

• A61F2/2457 Primary

  Chordae tendineae prostheses · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2230/0093

  Umbrella-shaped, e.g. mushroom-shaped · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2250/0063

  Nested prosthetic parts · CPC title