PATENT FORAMEN OVALE CLOSURE METHOD

• US 20120197292A1
• Filed: 03/29/2012
• Published: 08/02/2012
• Est. Priority Date: 09/01/2005
• Status: Active Grant

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Chin-Chen, Chao, Grishaber, Randy David B., Kammerer, Gene W., Khan, Isaac John, Park, Jin
• Granted Patent: US 9,861,347 B2
• Time in Patent Office: Days
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• 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 2017/00606 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

The present invention relates to devices for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such closure devices for closing the passageway. The method includes introducing a mechanical closure device into an atrium of the heart and transeptally deploying the closure device across the interatrial septum to provide proximation of the septum secundum and septum primum.

Claims

1. A method to facilitate closure of a PFO in a heart, the heart having an interatrial septum comprised of a septum primum and a septum secundum between a first atrium and a second atrium, the method comprising:

introducing a mechanical closure device into the first atrium of the heart, the closure device having a proximal end portion and a distal end portion, and further comprising a flexible closure line coupled to a proximal expandable anchor and a distal expandable anchor, the proximal and distal expandable anchors each having a plurality of longitudinally oriented legs attached between proximal and distal end rings;

penetrating only the septum primum or the septum secundum from the first atrium to the second atrium in the heart at a first location along the interatrial septum so that at least the distal end portion of the closure device is located in the second atrium;

deploying the distal expandable anchor associated with the closure device into the second atrium;

partially withdrawing the closure device from the second atrium to the first atrium;

deploying the proximal expandable anchor associated with the closure device into the first atrium; and

radially expanding the proximal and distal expandable anchors into a flat shape by tensioning the closure line.

2. The method of claim 1 wherein introducing the mechanical closure device into an atrium of the heart comprises a minimally invasive procedure.

3. The method of claim 2 wherein the minimally invasive procedure is a percutaneous procedure.

4. The method of claim 1 wherein penetrating the interatrial septum comprises piercing the septum.

5. The method of claim 1 wherein penetrating the interatrial septum comprises non-core cutting of the interatrial septum.

6. The method of claim 1 further comprising adjusting the proximal anchor relative to the distal anchor to enhance proximation.

9. The method of claim 1 further comprising assessing the degree of proximation between the septum secundum and septum primum.

10. The method of claim 1 further comprising releasing the closure device from a delivery device.

7. The method of claim 13 wherein adjusting the proximal anchor comprises uni-axially adjusting the proximal anchor relative to a closure line associated with the closure device.

8. The method of claim 14 wherein uni-axially adjusting the proximal anchor comprises incrementally adjusting the proximal anchor relative to the closure line associated with the closure device.