Energy based devices and methods for treatment of patent foramen ovale

• US 6,939,348 B2
• Filed: 10/02/2003
• Issued: 09/06/2005
• Est. Priority Date: 03/27/2003
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Cierra, Inc. (Terumo Corporation)
• Inventors: Alegandro, Jose, Deem, Mark E., Malecki, William, Gifford, Hanson, Horne, Kenneth, Francis, Dan
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/679,245
• Publication Number:
  US 20040193147A1
• Time in Patent Office: 705 Days
• Field of Search: 606 27- 31, 606/41, 606 47- 50, 606/213, 607/101, 607/102, 607/122, 128/898
• US Class Current: 606/41
• 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 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: C08L 2201/12 : Shape memory

Abstract

Methods and apparatus for treatment of patent foramen ovale (PFO) provide for applying energy to tissues adjacent the PFO with a catheter device to substantially close the PFO acutely. Apparatus generally includes a catheter device having at least one energy transmission member at or near its distal end configured to apply energy to PFO tissues to acutely, substantially close the PFO. Applied energy may be monoploar or bipolar radiofrequency energy or any other suitable energy, such as laser, microwave, ultrasound, resistive heating or the like. Some embodiments of a catheter device further include one or more tissue apposition members near the distal end for helping bring PFO tissues together, such as a PFO covering member, a vacuum applying member and/or the like. PFO closure via energy-based approaches of the invention may help prevent stroke, treat migraine headache, and possibly treat or prevent other medical conditions.

Claims

1. A method of treating a patent foramen ovale in a heart, the method comprising:

advancing a catheter device for treating the patent foramen ovale to a position in the heart which does not extend through the patent foramen ovale; and

applying energy to tissues adjacent the patent foramen ovale with the catheter device to substantially close the patent foramen ovale.

2. A method as in claim 1, further comprising engaging a distal structure on the catheter device against a right atrial side of the patent foramen ovale to bring the tissues at least partially together.

3. A method as in claim 2, wherein the tissues are brought together before applying the energy.

4. A method as in claim 2, further comprising holding the tissues together while applying the energy.

5. A method as in claim 4, further comprising holding the tissues together after the energy has been applied.

6. A method as in claim 1, further comprising cooling the tissues after the energy has been applied.

7. A method as in claim 2, wherein engaging the distal structure comprises contacting the tissues with a tissue covering member adjacent a distal end of the catheter device.

8. A method as in claim 7, wherein contacting the tissues with the tissue covering member causes blood pressure in a left atrium of the heart to bring the tissues at least partially together.

9. A method as in claim 8, further comprising applying vacuum force to the tissues with the time covering member to bring the tissues at least partially together.

10. A method as in claim 1, further comprising cooling the tissues after the energy has been applied.

11. A method as in claim 1, further comprising:

bringing the tissues at least partially together, using the catheter device; and

holding the tissues together while applying the energy and while cooling the tissues.

12. A method as in claim 1, wherein advancing the catheter comprises positioning a distal end of the catheter in a right atrium of the heart.

13. A method as in claim 1, wherein advancing comprises advancing the catheter over a guidewire extending through the patent foramen ovale, the method further comprising removing the guidewire from the patent foramen ovale so that nothing remains in the patent foramen ovale before applying the energy to the tissue.

14. A method as in claim 1, wherein applying energy comprises applying at least one of radiofrequency energy, cryogenic energy, resistive heat energy, ultrasound energy, microwave energy and laser energy.

15. A method as in claim 14, wherein at least one of monopolar radiofrequency energy and bipolar radiofrequency energy is applied.

16. A method as in claim 14, wherein applying energy comprises energizing a single conductive member of the catheter device.

17. A method as in claim 14, wherein applying energy comprises energizing multiple conductive members of the catheter device.

18. A method as in claim 1, wherein applying energy comprises denaturing collagen in the tissues.

19. A method as in claim 1, further comprising monitoring an amount of energy applied to the tissues.

20. A method as in claim 19, wherein monitoring the amount of energy comprises monitoring a temperature of the tissues.

21. A method as in claim 19, wherein monitoring the amount of energy comprises monitoring an impedance of the tissues.

22. A method as in claim 19, further comprising determining when a sufficient amount of energy has been applied to the tissues to substantially close the patent foramen ovale.

23. A method as in claim 22, further comprising discontinuing the application of energy when the sufficient amount of energy has been applied.

24. A method as in claim 1, further comprising directly visualizing the patent foramen ovale and the tissues using at least one visualization device coupled with the catheter device.