Closure devices, related delivery methods and tools, and related methods of use

• US 9,078,630 B2
• Filed: 05/17/2010
• Issued: 07/14/2015
• Est. Priority Date: 06/01/2001
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wahr, Dennis W., Blaeser, David J., Keith, Peter T., Ressemann, Thomas V.
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): Kapoor, Sidharth
• Application Number:
  US12/781,573
• Publication Number:
  US 20100234882A1
• Time in Patent Office: 1,884 Days
• Field of Search: 606/213, 606/215, 606/216, 606/217, 606/218, 606/219, 606/151, 606/153, 606/157, 606/139, 606/232, 227/1, 227/175.1, 227/179.1, 227/181.1, 227/26, 227/28, 227/29, 227/30, 227/31, 227/19
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00351 Heart

Abstract

A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor. Preferably, the elongate member is flexible.

Claims

1. A device for sealing a passageway in a human heart, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor deployable from a collapsed state to an expanded state, the first anchor having an open structure that permits blood to pass through the first anchor when the first anchor is in the expanded state;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor deployable from a collapsed state to an expanded state, the second anchor having a covering for occluding blood flow through the second anchor when the second anchor is in the expanded state;

an elongate member adapted to extend through the passageway and connect the first and second anchors; and

a locking element positionable on the elongate member;

wherein the second anchor is movable along the elongate member relative to the first anchor, wherein the locking element is movable along the elongate member towards the second anchor to secure the location of the second anchor on the elongate member, and wherein the locking element is arranged to engage the outer surface of the elongate member so as to permit movement of the locking element along the elongate member towards the second anchor but resist movement of the locking element along the elongate member away from the second anchor, whereby the locking element is configured to resist movement of the second anchor away from the first anchor along the elongate member.

2. The device of claim 1, wherein the passageway is a patent foramen ovale.

3. The device of claim 1, wherein the first anchor includes a plurality of arms radiating from a central hub of the first anchor.

4. The device of claim 1, wherein the second anchor includes a plurality of arms radiating from a central hub of the second anchor.

5. The device of claim 1, wherein the elongate member is flexible.

6. The device of claim 1, wherein the first anchor pivots relative to the elongate member.

7. The device of claim 1, wherein the second anchor pivots relative to the elongate member.

8. The device of claim 1, wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

9. The device of claim 1, wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.

10. The device of claim 1, wherein the second anchor includes a plurality of arms, and wherein the covering spans between its plurality of arms.

11. The device of claim 10, wherein the first anchor includes a plurality of arms, and wherein the first anchor does not include structure spanning between its plurality of arms.

12. The device of claim 5, wherein the elongate member is sufficiently flexible to conform to a shape of the passageway.

13. The device of claim 1, wherein the elongate member is a braided structure.

14. The device of claim 1, wherein the elongate member is a multifilar structure.

15. The device of claim 1, wherein the elongate member is configured to permanently connect the first and second anchors implanted in the heart.

16. The device of claim 1, wherein at least a portion of the elongate member is configured to remain implanted in the heart with the device.

17. The device of claim 1, wherein the elongate member has a first end fixedly connected to the first anchor.

18. The device of claim 1, wherein the locking element is tubular.

27. The device of claim 1, wherein the locking element is movable along the elongate member to a position engaging the second anchor, whereby the locking element resists movement of the second anchor away from the first anchor.

29. The device of claim 1, wherein the elongate member has a substantially smooth outer surface, and wherein the locking element includes a plurality of projecting grips arranged to engage the outer surface of the elongate member so as to permit movement of the locking element along the elongate member towards the second anchor but resist movement of the locking element along the elongate member away from the second anchor.

31. The device of claim 1, wherein the covering of the second anchor comprises a porous material having a porosity sufficient to encourage ingrowth of tissue.

19. A method of sealing a passageway in a heart, comprising:

deploying a first anchor from a collapsed state to an expanded state, the first anchor having an open structure that permits blood to pass through the first anchor when the first anchor is in the expanded state;

positioning the first anchor in the expanded state against a first portion of body tissue proximate a first end of the passageway;

deploying a second anchor from a collapsed state to an expanded state, the second anchor having a covering for occluding blood flow through the second anchor when the second anchor is in the expanded state, the second anchor being movable along an elongate member relative to the first anchor, the elongate member extending through the passageway and connecting the first and second anchors;

positioning the second anchor in the expanded state against a second portion of body tissue proximate a second end of the passageway; and

moving a locking element along the elongate member towards the second anchor to secure the location of the second anchor on the elongate member, the locking element being arranged to engage the outer surface of the elongate member so as to permit movement of the locking element along the elongate member towards the second anchor but resist movement of the locking element along the elongate member away from the second anchor, whereby the locking element is configured to resist movement of the second anchor away from the first anchor along the elongate member.

20. The method of claim 19, wherein the passageway is a patent foramen ovale.

21. The method of claim 19, wherein moving the locking element along the elongate member towards the second anchor comprises moving the locking element to a position proximate the second anchor, whereby the locking element resists movement of the second anchor away from the first anchor.

22. The method of claim 21, further comprising severing the elongate member adjacent the second anchor.

23. The method of claim 19, wherein the second anchor includes a plurality of arms, and wherein the covering spans between its plurality of arms.

24. The method of claim 23, wherein the first anchor includes a plurality of arms, and wherein the first anchor does not include structure spanning between its plurality of arms.

25. The method of claim 20, wherein the elongate member is sufficiently flexible to conform to a shape of the patent foramen ovale.

26. The method of claim 19, further comprising moving the second anchor along the elongate member towards the first anchor prior to moving the locking element along the elongate member towards the second anchor.

28. The method of claim 19, wherein moving the locking element along the elongate member towards the second anchor comprises moving the locking element to a position engaging the second anchor, whereby the locking element resists movement of the second anchor away from the first anchor.

30. The method of claim 19, wherein the elongate member has a substantially smooth outer surface, and wherein the locking element includes a plurality of projecting grips arranged to engage the outer surface the outer surface of the elongate member so as to permit movement of the locking element along the elongate member towards the second anchor but resist movement of the locking element along the elongate member away from the second anchor.

32. The device of claim 19, wherein the covering of the second anchor comprises a porous material having a porosity sufficient to encourage ingrowth of tissue.