Expandable epicardial pads and devices and methods for delivery of same

• US 10,610,356 B2
• Filed: 07/19/2017
• Issued: 04/07/2020
• Est. Priority Date: 02/05/2015
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: Vidlund, Robert M., Kovalsky, Igor, Tegels, Zachary J., Ekvall, Craig A.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/654,374
• Publication Number:
  US 20170312077A1
• Time in Patent Office: 993 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 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An apparatus for use in the delivery of a prosthetic mitral valve may include 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.

Claims

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,

the apparatus also including 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,

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.

2. 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.

3. 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 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.

4. The apparatus of claim 3, wherein the dilator member is a balloon inflatable with an inflation medium to move the dilator member to the second configuration.

5. The apparatus of claim 3, 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.

6. 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 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.

7. 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.

8. The method of claim 7, 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 delivery sheath.

9. The method of claim 7, further comprising:

disposing an epicardial pad within the space formed by the dilator member; and

securing the epicardial pad to the apex of the heart.

10. The method of claim 9, further comprising:

prior to disposing the epicardial pad, coupling to the epicardial pad a tether extending from a prosthetic heart valve implanted within the heart, the securing the epicardial pad includes securing the prosthetic valve and tether in position within the heart.

11. The method of claim 9, further comprising:

prior to disposing an epicardial pad within the space formed by the dilator member, inserting the epicardial pad within a lumen defined by the dilator device such that the epicardial pad is in a collapsed configuration; and

prior to the securing the epicardial pad, moving the epicardial pad to an expanded configuration.

12. The method of claim 11, wherein the moving the epicardial pad to the expanded configuration includes moving the epicardial pad outside the lumen of the dilator device such that the epicardial pad assumes a biased expanded configuration.

13. The method of claim 11, wherein the epicardial pad is a balloon, the moving the epicardial pad to the expanded configuration includes inflating the balloon.

14. The method of claim 7, further comprising:

prior to disposing the dilator member outside a distal end of the delivery sheath, retracting a portion of pericardium tissue from a portion of epicardium tissue of the heart,

the disposing the dilator member includes disposing the dilator member within a space formed between the pericardium tissue and the epicardium tissue by the retracting.

15. 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 an epicardial pad disposed within a lumen of the delivery sheath, the epicardial pad being in a collapsed configuration within the lumen of the delivery sheath and having an expanded configuration, the epicardial pad defining an opening and having a tether extending through the opening, the tether being coupled to a prosthetic heart valve implanted within the heart;

disposing the epicardial pad outside a distal end of the delivery sheath and outside the surface of the heart near the apex of the heart; and

securing the epicardial pad in the expanded configuration to the outside surface of the heart to secure the prosthetic heart valve and the tether in a desired position.

16. The method of claim 15, further comprising:

prior to the securing, moving the epicardial pad to the expanded configuration.

17. The method of claim 15, wherein the disposing the epicardial pad outside a distal end of the delivery sheath causes the epicardial pad to automatically assume the expanded configuration.

18. The method of claim 15, further comprising:

prior to disposing the epicardial pad outside a distal end of the delivery sheath, inserting an internal anchor into a ventricle of the heart, the internal anchor being coupled to the epicardial pad; and

securing the internal anchor to an inside surface of the heart.

19. The method of claim 15, further comprising:

inserting an internal anchor into a ventricle of the heart, the internal anchor being coupled to the epicardial pad with sutures;

securing the internal anchor to an inside surface of the heart; and

after the securing the internal anchor, inserting a cutting device into the patient and cutting the sutures and tether.