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

• US 7,338,514 B2
• Filed: 06/01/2001
• Issued: 03/04/2008
• Est. Priority Date: 06/01/2001
• Status: Expired due to Term

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ressemann, Thomas V., Blaeser, David J., Keith, Peter T., Wahr, Dennis W.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/870,813
• Publication Number:
  US 20020183787A1
• Time in Patent Office: 2,468 Days
• Field of Search: None
• US Class Current: 606/213
• 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 method of delivering a closure device to a patent foramen ovale in a heart, comprising:

advancing a catheter into the right atrium of the heart;

advancing the catheter through the patent foramen ovale into the left atrium of the heart;

deploying a first anchor of the closure device in the left atrium;

withdrawing the catheter into the right atrium of the heart;

deploying a second anchor of the closure device in the right atrium, wherein deploying the second anchor includes deploying a flexible elongate member passing through the second anchor and having a first end connected to the first anchor; and

positioning the second anchor, wherein positioning the second anchor includes moving the second anchor along the flexible elongate member toward the septum secundum by advancing a positioning catheter connected to the second anchor, and wherein advancing the positioning catheter includes inflating a balloon in contact with a releasable fixation mechanism of the closure device.

2. The method of claim 1, further comprising positioning the first anchor within the left atrium prior to deploying the second anchor.

3. The method of claim 2, wherein positioning the first anchor includes pivoting the first anchor with respect to the flexible elongate member.

4. The method of claim 3, wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum.

5. The method of claim 3, wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum and the septum secundum.

6. The method of claim 3, wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum and to bring the septum primum into sealing contact with the septum secundum.

7. The method of claim 3, further including testing the effectiveness of the positioning of the first anchor prior to deploying the second anchor.

8. The method of claim 1, wherein withdrawing the catheter into the right atrium of the heart includes deploying a flexible elongate member having a first end connected to the first anchor into the patent foramen ovale.

9. The method of claim 1, wherein deploying the second anchor in the right atrium includes deploying the second anchor a substantial distance away from the septum secundum, such that the second anchor does not contact the septum secundum as it is deployed.

10. The method of claim 1, wherein deploying the second anchor includes expanding the second anchor from a delivery configuration to a deployed configuration.

11. The method of claim 1, further comprising positioning the second anchor.

12. The method of claim 1, further comprising sealingly contacting the septum secundum with the second anchor.

13. The method of claim 12, further comprising fixing the second anchor to the flexible elongate member subsequent to sealingly contacting the septum secundum.

14. The method of claim 13, wherein fixing the second anchor includes deflating the balloon in contact with the releasable fixation mechanism of the closure device.

15. The method of claim 14, wherein fixing the second anchor further includes piercing the flexible elongate member with at least one pin of the releasable fixation mechanism.

16. The method of claim 15, further comprising severing the flexible elongate member adjacent the second anchor after fixing the second anchor to the flexible elongate member.