PFO closure devices and related methods of use

• US 7,976,564 B2
• Filed: 05/06/2002
• Issued: 07/12/2011
• Est. Priority Date: 05/06/2002
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Grudem, Jerome K. Jr., Phillips, Joel D., Hackett, Steven S., Olson, Scott A., Christianson, Mark R., Ressemann, Thomas V., Blaeser, David J., Keith, Peter T., Wahr, Dennis W.
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US10/138,565
• Publication Number:
  US 20030208232A1
• Time in Patent Office: 3,354 Days
• Field of Search: 606/213, 606215-217, 606222-225, 606/159
• US Class Current: 606/216
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence

Abstract

Devices and methods for sealing a passageway formed by a patent foramen ovale (PFO track) in the heart are provided. One method includes providing an abrading device to the PFO track and abrading the tissue within the PFO track. The abraded tissue forming the PFO track is then held together under pressure, either via lowering right atrial pressure or via applying suction to the septum primum to pull it into apposition against the septum secundum. After a sufficient period of time, the pressure is released and the abraded tissue heals to form a robust seal over the PFO track. Additionally, several devices are provided which can be placed into the PFO track to apply adhesive to the walls of the PFO track. The devices may or may not be left within the PFO track. If the devices are not left within the PFO track, the walls of the PFO track, covered with adhesive, are brought into apposition with one another and adhered together. If the device is left within the PFO track, the device is flattened from an expanded configuration to a flattened configuration, and the walls of the PFO track, adhering to the outer surface of the device, are pulled toward each other as the device flattens. The device may also include interior structure to hold the device in a flattened configuration.

Claims

1. A method of sealing a passageway between a septum primum and a septum secundum in a heart, comprising:

abrading the passageway;

after abrading the passageway, advancing a delivery catheter into the right atrium;

advancing a collapsed anchor and suture assembly out of the delivery catheter;

passing the collapsed anchor and suture assembly through the tissue of the septum secundum without passing the delivery catheter through the tissue of the septum secundum by puncturing the tissue of the septum secundum with at least two tines of the collapsed anchor;

after passing the collapsed anchor and suture assembly through the tissue of the septum secundum, passing the collapsed anchor and suture assembly through the tissue of the septum primum without passing the delivery catheter through the tissue of the septum primum by puncturing the tissue of the septum primum with the at least two tines; and

expanding the collapsed anchor to a deployed state to secure the suture through the tissue of the septum secundum and the tissue of the septum primum by allowing the at least two tines to self-expand after passing through the tissue of the septum secundum and the tissue of the septum primum.

2. The method of claim 1, wherein advancing the anchor and suture assembly includes advancing a support tube surrounding a suture of the anchor and suture assembly.

3. The method of claim 2, wherein passing the anchor and suture assembly through the tissue of the septum secundum and through the tissue of the septum primum includes passing the support tube surrounding the suture through the tissue of the septum secundum and through the tissue of the septum primum.

4. The method of claim 1, further comprising moving a locking device along a portion of the suture extending between the septum secundum and the delivery catheter.

5. The method of claim 4, wherein moving the locking device includes moving the locking device until the locking device is adjacent the septum secundum and the suture is taut.

6. The method of claim 5, further comprising cutting the suture between the locking device and the delivery catheter.

7. A method of sealing a passageway between a septum primum and a septum secundum in a heart, comprising:

introducing a traumatizing device configured to cause trauma to tissue forming the passageway to be sealed;

causing trauma to tissue forming opposed wall portions of the passageway with the traumatizing device;

after causing the trauma, introducing a suture delivery system adjacent the tissue forming one wall portion of the passageway, the suture delivery system including at least one suture lumen, a suture disposed in the suture lumen and a collapsed anchor;

advancing the suture and the collapsed anchor through the septum secundum and through the septum primum by puncturing the septum secundum and the septum primum with at least two tines of the collapsed anchor; and

expanding the collapsed anchor to a deployed state to secure the suture through the septum secundum and the septum primum by allowing the at least two tines to self-expand after passing through the septum secundum and the septum primum.

8. The method of claim 7, wherein causing trauma to tissue includes denuding endothelium forming the opposed wall portions of the passageway.

9. The method of claim 8, wherein denuding endothelium forming the opposed wall portions of the passageway includes contacting the opposed wall portions with a device configured to abrade the tissue.

10. The method of claim 7, further comprising forcing portions of the traumatized walls of the passageway against one another.

11. The method of claim 10, wherein forcing portions of the traumatized walls of the passageway against one another includes pulling the passageway closed with the suture.

12. The method of claim 7, further comprising withdrawing the traumatizing device prior to introducing the suture delivery system.