Apical closure system

• US 9,526,483 B2
• Filed: 07/11/2011
• Issued: 12/27/2016
• Est. Priority Date: 07/15/2010
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Tuval, Yossi
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/179,727
• Publication Number:
  US 20120016411A1
• Time in Patent Office: 1,996 Days
• Field of Search: 606/151, 606/213, 606/215, 606/219
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

Aspects of the present invention provide apparatuses and methods for closing an apical hole in a heart of a subject, including a hole-closure device that includes a tissue-attachment portion configured to attach to cardiac tissue around the apical hole, and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly inside the apical hole.

Claims

1. An apparatus for closing an apical hole in a heart of a subject, the apparatus comprising a hole-closure device that comprises:

a tissue-attachment portion configured to attach to cardiac tissue around an apical hole;

a ring-shaped collapsible portion coupled to the tissue-attachment portion and being at least partially formed from a shape-memory material to be configured to close the apical hole by collapsing inwardly to assume a collapsed state from an expanded state; and

a sealing material disposed within an interior of the collapsible portion and configured to seal a center of the collapsible portion when the collapsible portion is in the collapsed state,

wherein collapse of the collapsible portion causes collapse of the tissue-attachment portion, and

wherein collapse of the tissue-attachment portion is configured to draw the cardiac tissue together and in conjunction with the sealing material disposed within the interior of the collapsible portion is configured to close the apical hole.

2. The apparatus of claim 1, further comprising a sheath configured to be removably disposed around the tissue-attachment portion,

wherein the tissue-attachment portion is maintained in a non-attachment configuration when the sheath is disposed around the tissue-attachment portion, and

wherein the tissue-attachment portion transitions to an attachment configuration in response to withdrawal of the sheath from around the tissue-attachment portion.

3. The apparatus of claim 2, wherein the tissue-attachment portion is in a straightened state when in the non-attachment configuration, and

wherein the tissue-attachment portion defines a U-shape when in the attachment configuration.

4. The apparatus of claim 1, wherein the tissue-attachment portion comprises a shape-memory alloy that is configured to assume a U-shape when the tissue-attachment portion is not constrained.

5. The apparatus of claim 1, wherein the hole-closure device comprises a plurality of tissue-attachment portions.

6. The apparatus of claim 1, wherein the tissue-attachment portion comprises:

a proximal tissue-attachment portion disposed at a proximal end of the hole-closure device and configured to couple to extracardiac tissue around the apical hole; and

a distal tissue-attachment portion disposed at a distal end of the hole-closure device and configured to couple to intracardiac tissue around the apical hole.

7. The apparatus of claim 1, wherein the tissue-attachment portion comprises a plurality of tissue-attachment elements.

8. The apparatus of claim 7, wherein the tissue-attachment elements comprise hooks configured to hook to the cardiac tissue around the apical hole.

9. An apparatus for closing an apical hole in a heart of a subject, the apparatus comprising:

a hole-closure device that comprises,

a tissue-attachment portion configured to attach to cardiac tissue around an apical hole, and

a collapsible portion coupled to the tissue-attachment portion and configured to close the apical hole by collapsing inwardly, the collapsible portion having an expanded state and a collapsed state,

wherein collapse of the collapsible portion from the expanded state to the collapsed state causes collapse of the tissue-attachment portion, and

wherein collapse of the tissue-attachment portion draws the cardiac tissue together to close the apical hole;

a delivery device; and

a sheath that covers the hole-closure device in a delivery configuration, wherein the sheath is slidable relative to the delivery device, and

wherein in the delivery configuration the hole-closure device is disposed around the delivery device to be held in the expanded state by the delivery device extending therethrough, and wherein in the delivery configuration the tissue-attachment portion is held in a straightened, non-attachment state between the delivery device and the sheath, and

wherein upon proximal withdrawal of the sheath from covering the tissue-attachment portion of the hole-closure device, the tissue-attachment portion returns to an outwardly curved attachment state for attaching to cardiac tissue around the apical hole, and wherein upon proximal withdrawal of the delivery device from within the collapsible portion of the hole-closure device, the collapsible portion inwardly collapses from the expanded state to the collapsed state.

10. The apparatus of claim 9, wherein the delivery device is configured to be used for a transapical procedure conducted via the apical hole, while the hole-closure device is disposed around the delivery device.

11. The apparatus of claim 10, wherein the delivery device comprises a catheter configured to allow passage therethrough of an instrument for use in the transapical procedure.

12. A method for closing an apical hole in a heart of a subject, comprising:

inserting a hole-closure device into the apical hole, while a collapsible portion of the hole-closure device is in an expanded state, the collapsible portion having a sealing material disposed in an interior thereof, wherein inserting the hole-closure device into the apical hole comprises inserting a delivery device into the apical hole, the hole-closure device being disposed around the delivery device such that the collapsible portion is held in the expanded state thereby;

attaching a tissue-attachment portion of the hole-closure device to cardiac tissue around the apical hole; and

closing the apical hole, by collapsing the collapsible portion of the hole-closure device into a collapsed state, wherein withdrawing the delivery device from the collapsible portion of the hole-closure device causes the collapsible portion to assume the collapsed state from the expanded state,

wherein collapse of the collapsible portion causes the sealing material to seal a center of the hole-closure device and causes collapse of the tissue-attachment portion, and

wherein collapse of the tissue-attachment portion is configured to draw the cardiac tissue together and in conjunction with the sealing material disposed within the interior of the collapsible portion is configured to close the apical hole.

13. The method of claim 12, wherein attaching the tissue-attachment portion of the hole-closure device to the cardiac tissue around the apical hole comprises removing a sheath from around the tissue-attachment portion.

14. The method of claim 12, further comprising attaching a plurality of tissue-attachment portions of the hole-closure device to the cardiac tissue around the apical hole.

15. The method of claim 12, wherein attaching the tissue-attachment portion of the hole-closure device to the cardiac tissue around the apical hole comprises:

attaching a proximal tissue-attachment portion disposed at a proximal end of the hole-closure device to extracardiac tissue around the apical hole; and

attaching a distal tissue-attachment portion disposed at a distal end of the hole-closure device to intracardiac tissue around the apical hole.

16. The method of claim 12, wherein attaching the tissue-attachment portion of the hole-closure device to the cardiac tissue around the apical hole comprises attaching a plurality of tissue-attachment elements of the hole-closure device to the cardiac tissue around at least one end of the apical hole.

17. The method of claim 16, wherein attaching the tissue-attachment elements to the cardiac tissue comprises hooking hooks to the cardiac tissue around the apical hole.

18. The method of claim 12, further comprising using the delivery device for a transapical procedure conducted via the apical hole, while the hole-closure device is disposed around the delivery device.

19. The method of claim 18, wherein using the delivery device comprises passing an instrument therethrough that is for use in the transapical procedure.