Needle apparatus for closing septal defects and methods for using such apparatus

• US 8,747,483 B2
• Filed: 11/16/2012
• Issued: 06/10/2014
• Est. Priority Date: 09/07/2001
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Promed, Inc.
• Inventors: Ginn, Richard S.
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US13/679,945
• Publication Number:
  US 20130072966A1
• Time in Patent Office: 571 Days
• Field of Search: 606/213
• US Class Current: 623/23.72
• 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 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture

Abstract

Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient'"'"'s vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Claims

1. A method of treating a patent foramen ovale in a heart of a human patient, the patent foramen ovale (PFO) having a first tissue flap that partially overlaps a second tissue flap with an opening therebetween, the method comprising:

advancing a catheter through the patient'"'"'s vasculature and into a right atrium of the heart, the catheter having a needle associated therewith;

advancing a distal end of the needle from the right atrium, through the first tissue flap, then through the second tissue flap and into a left atrium of the heart, wherein advancement of the needle creates a first hole in the first tissue flap and a second hole in the second tissue flap to allow the first tissue flap to be held to the second tissue flap; and

holding the first tissue flap in contact with the second tissue flap.

2. The method of claim 1, further comprising introducing the catheter to the patient'"'"'s vasculature through a percutaneous entry site prior to advancing the catheter through the patient'"'"'s vasculature.

3. The method of claim 2, wherein the percutaneous entry site is in a peripheral vessel.

4. The method of claim 3, wherein advancing the catheter through the patient'"'"'s vasculature includes advancing the catheter through the peripheral vessel and a vena cava.

5. The method of claim 1, wherein a handle device is provided on a proximal end of the catheter.

6. The method of claim 1, further comprising holding the first tissue flap in contact with the second tissue flap with an implantable device.

7. The method of claim 6, wherein the implantable device comprises the needle, a filament coupled to the needle, and a locking device.

8. The method of claim 1, wherein the distal end of the needle is advanced using a pusher member.

9. The method of claim 1, further comprising advancing a proximal end of the needle into the first tissue flap.

10. The method of claim 9, further comprising advancing the proximal end of the needle through the second tissue flap into the left atrium.

11. The method of claim 1, further comprising holding the first tissue flap in contact with the second tissue flap with the needle in the left atrium.

12. The method of claim 11, wherein a filament is coupled to the needle, the method further comprising attaching a locking element to the filament in the right atrium such that the first tissue flap is held to the second tissue flap.

13. The method of claim 1, wherein the needle is coupled with an element that is biased to transition from a stressed state to an unstressed state.

14. The method of claim 1, wherein the catheter is an outer catheter and the needle is slidable from within the outer catheter.

15. The method of claim 1, wherein the first tissue flap is held in contact with the second tissue flap while a structure extends through the first and second holes.

16. The method of claim 1, wherein holding the first tissue flap in contact with the second tissue flap comprises closing the opening of the PFO.

17. The method of claim 1, further comprising pivoting the needle while the needle is in the left atrium.

18. The method of claim 1, further comprising advancing the catheter through the patient'"'"'s vasculature until a distal end of the catheter is disposed adjacent the first tissue flap.

19. The method of claim 1, wherein the catheter is a delivery catheter.

20. The method of claim 1, wherein the catheter is slidably coupled with a pusher member.