Apical closure system

• US 10,575,838 B2
• Filed: 11/17/2016
• Issued: 03/03/2020
• 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): Ton, Martin T
• Application Number:
  US15/354,136
• Publication Number:
  US 20170065263A1
• Time in Patent Office: 1,202 Days
• Field of Search: 606213, 606215, 606219
• 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 for prostheses A61F2210/0014

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 a hole in tissue comprising:

a tissue-attachment portion configured to attach to tissue around a hole, wherein the tissue-attachment portion comprises one or more hooks, barbs, pins, adhesive portions, screws, staples or other elements that are configured to become attached to tissue;

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 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 tissue together and in conjunction with the sealing material disposed within the interior of the collapsible portion is configured to close the hole.

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

3. An apparatus for closing a hole in tissue comprising:

a tissue-attachment portion configured to attach to tissue around a 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 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 tissue together and in conjunction with the sealing material disposed within the interior of the collapsible portion is configured to close the hole, wherein the tissue-attachment portion comprises;

a first tissue-attachment portion configured to couple to tissue around a first side of the hole; and

a second tissue-attachment portion configured to couple to tissue around a second side of the hole.

4. A system for closing a hole in tissue comprising:

a hole-closure device comprising;

a tissue-attachment portion configured to attach to tissue around a hole; and

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

wherein collapse of the collapsible portion from the expanded configuration to the collapsed configuration causes collapse of the tissue-attachment portion;

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

a delivery device comprising;

a shaft configured to maintain the collapsible portion of the hole-closure device in the expanded configuration by extending therethrough, wherein the hole-closure device is in a delivery configuration when mounted on the shaft with the collapsible portion in the expanded configuration; and

a sheath that covers the hole-closure device in the delivery configuration, wherein the sheath is slidable relative to the delivery device and is configured to be removably disposed around the tissue-attachment portion to maintain the tissue-attachment portion in a non-attachment configuration, when the hole-closure device is in the delivery configuration;

wherein upon withdrawal of the sheath from around the tissue-attachment portion, the tissue-attachment portion returns to an attachment configuration; and

wherein upon withdrawal of the shaft from within the collapsible portion, the collapsible portion inwardly collapses from the expanded configuration to the collapsed configuration.

5. The system of claim 4, wherein the delivery device is configured to be used for a transapical procedure conducted via an apical hole, while the hole-closure device is in the delivery configuration and disposed around the delivery device shaft.

6. The system of claim 5, wherein the delivery device comprises a lumen configured to allow passage therethrough of an instrument for use in the transapical procedure.

7. The system of claim 4, wherein the delivery device comprises a lumen configured to allow passage therethrough of an instrument for use in a medical procedure.

8. The system of claim 4, wherein the collapsible portion comprises a sealing material disposed in an interior thereof.

9. The system of claim 4, 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.

10. The system of claim 4, wherein the tissue-attachment portion comprises a shape-memory alloy.

11. The system of claim 4, wherein the tissue-attachment portion comprises a plurality of tissue-attachment elements.

12. The system of claim 4, wherein the tissue-attachment portion comprises a plurality of hooks configured to hook to tissue.

13. The system of claim 4, wherein the tissue-attachment portion comprises:

a first tissue-attachment portion configured to couple to tissue around a first side of the hole; and

a second tissue-attachment portion configured to couple to tissue around a second side of the hole.