Closure device and method of closing a bodily opening

• US 9,554,783 B2
• Filed: 07/31/2009
• Issued: 01/31/2017
• Est. Priority Date: 02/01/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Inventors: Pavcnik, Dusan, Tekulve, Kurt J.
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US12/533,731
• Publication Number:
  US 20100030259A1
• Time in Patent Office: 2,741 Days
• Field of Search: 606/213.215, 606/139, 606/151, 606/153, 606/157, 606/213, 606215-217, 606/232, 128/898
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor

Abstract

In one embodiment, a device for closing or occluding ASDs and PFOs, or other bodily passageways, includes a circumferential frame, a sheet of biocompatible material attached to the frame, and at least one anchor attached to the sheet of biocompatible material. In another embodiment, the closure device includes a circumferential frame, at least one crossbar extending across and attached to the frame, at least one anchor connected to at least one crossbar; and at least one sheet of biocompatible material (such as ECM material) attached to the frame. The anchor includes at least one grasping member having a structure, such as a wired loop, which is configured for releasable attachment to a delivery release member, which facilitates delivery of a closure device collapsibly disposed in a delivery catheter. Alternatively, one or more anchor end pairs may be connected to a delivery bar enhancing delivery and retrieval of the device.

Claims

1. A closure device comprising:

only one circumferential frame defining a single frame plane;

a first crossbar extending across the frame, the first crossbar having a central portion and terminal crossbar ends connectively linked to separate sites on the frame;

a bar-shaped first anchor containing two terminal first anchor ends and a central portion attached to the central portion of the first cross bar; and

a single sheet of biocompatible material, the sheet of biocompatible material having a periphery attached to the frame,

wherein each of the frame, the first crossbar, and the first anchor comprises at least one flexible, substantially linear structure,

wherein the first anchor is only indirectly connected to the frame via the first crossbar and

wherein the first crossbar is configured to extend in an arc concave to the frame plane when deployed, and wherein the first anchor is configured to extend in an arc convex to the frame plane when deployed.

2. The device of claim 1, wherein the frame comprises one or more coils forming a closed ring.

3. The device of claim 1, wherein the substantially linear structure of each of the frame and the first crossbar comprises a hollow tube or coil, wherein one or more connecting wires extend longitudinally through the frame and the first crossbar, the one or more wires connecting the first crossbar to the frame.

4. The device of claim 1, wherein the substantially linear structure of the first anchor comprises a hollow tube or coil comprising two terminal first anchor ends, wherein an anchor wire extends longitudinally through the first anchor, the anchor wire comprising two terminally disposed grasping members frictionally engaged by the first anchor.

5. The device of claim 1, further comprising a delivery bar comprising a flexible, substantially linear structure comprising at least a tube, coil, bar or wire, the delivery bar joined between the two terminal first anchor ends.

6. The device of claim 1, further comprising:

a second crossbar extending across the frame, the second crossbar having terminal crossbar ends connectively linked to the frame, wherein each terminal crossbar end of the second crossbar is connected to the frame at a site of connection to a terminal crossbar end of the first crossbar;

wherein second crossbar comprises at least one flexible, substantially linear structure in the form of a tube, coil, bar, or wire, and

wherein the second crossbar is configured to extend in an arc concave to the frame plane.

7. The device of claim 6, further comprising a second bar-shaped anchor comprising two terminal second anchor ends, the second anchor comprising a flexible, substantially linear structure, the second anchor configured to extend in an arc convex to the frame plane when deployed, wherein a central portion of the second anchor is connected to a central portion of the second crossbar.

8. The device of claim 7, further comprising a first coupling member connecting the central portion of the first anchor to the central portion of the first crossbar, and a second coupling member connecting the central portion of the second anchor to the central portion of the second crossbar.

9. The device of claim 7, wherein the substantially linear structure of the first anchor comprises a first anchor coil and the substantially linear structure of the second anchor comprises a second anchor coil, wherein one or more anchor wires extend longitudinally through the first and second anchor coils, the one or more anchor wires forming terminally disposed grasping members at each anchor end, each terminally disposed grasping member being frictionally engaged by an anchor coil end.

10. The device of claim 7, further comprising a delivery bar comprising a flexible, substantially linear structure, wherein the delivery bar is joined between a first pair of terminal anchor ends on one delivery bar end and a second pair of terminal anchor ends on a second delivery bar end.

11. The device of claim 7, wherein the substantially linear structure of the delivery bar comprises a delivery bar coil, wherein one or more wires extend longitudinally through the delivery bar coil, the wires connecting the delivery bar to the first and second anchors.

12. The device of claim 1, wherein the biocompatible material is connected to at least a portion of the frame and at least a portion of the first crossbar.

13. The device of claim 1, wherein the biocompatible material comprises ECM material.

14. A closure device comprising:

only one frame, the frame defining a frame plane;

a first crossbar extending across the frame, the first crossbar having terminal crossbar ends connectively linked to separate sites on the frame;

a second crossbar extending across the frame, the second crossbar having terminal crossbar ends connectively linked to separate sites on the frame;

a first anchor containing two terminal first anchor ends;

a second anchor containing two terminal second anchor ends;

a delivery bar joined between a first pair of terminal anchor ends on one delivery bar end and a second pair of terminal anchor ends on a second delivery bar end; and

a sheet of biocompatible material attached to the frame,

wherein the first crossbar is configured to extend in an arc concave to the frame plane when deployed, and wherein the first anchor is configured to extend in an arc convex to the frame plane when deployed, wherein each of the delivery bar, the first anchor, the second anchor, the first crossbar, and the second crossbar comprises a coil and terminally disposed wire loops;

wherein one or more wires interconnect the terminally disposed wire loops of the delivery bar with terminally disposed wire loops of the first and second anchors, and wherein one or more wires interconnect the terminally disposed wire loops of the first and second crossbars with the frame.

15. The device of claim 14, further comprising a first coupling member connecting the central portion of the first anchor to the central portion of the first crossbar, and a second coupling member connecting a central portion of the second anchor to a central portion of the second crossbar.

16. A closure device comprising:

only one circumferential frame;

a first crossbar extending across the frame, the crossbar having terminal crossbar ends connectively linked to separate sites on the frame;

a bar-shaped first anchor containing two terminal anchor ends, wherein a central portion of the first anchor is connected to a central portion of the first crossbar;

a delivery bar connecting the two terminal anchor ends; and

a single sheet of biocompatible material having a periphery attached to the frame,

wherein each of the frame, the first crossbar, the first anchor, and the delivery bar comprises at least one flexible, substantially linear structure in the form of a tube, coil, bar, or wire.

17. The device of claim 16, further comprising a second crossbar and a second anchor, the second anchor comprising two terminal second anchor ends,

wherein the second crossbar extends across the frame, the second crossbar having terminal crossbar ends connectively linked to the frame, wherein each terminal crossbar end of the second crossbar is connected to the frame at a site of connection to a terminal crossbar end of the first crossbar;

wherein a central portion of the second anchor is connected to a central portion of the second crossbar; and

wherein each of the second crossbar and the second anchor comprises at least one flexible, substantially linear structure in the form of a tube, coil, bar, or wire.