Energy based devices and methods for treatment of anatomic tissue defects

• US 7,293,562 B2
• Filed: 06/21/2004
• Issued: 11/13/2007
• Est. Priority Date: 03/27/2003
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Cierra, Inc. (Terumo Corporation)
• Inventors: Deem, Mark E., Malecki, William, Gifford, Hanson, Horne, Kenneth, Francis, Dan, Alejandro, Jose
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/873,348
• Publication Number:
  US 20050021016A1
• Time in Patent Office: 1,240 Days
• Field of Search: 606 27- 31, 606/41, 606 48- 50, 606/213, 128/898
• US Class Current: 128/898
• 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 anatomic defects in human tissues, such as patent foramen ovale (PFO), atrial or ventricular septal defects, left atrial appendage, patent ductus arteriosis, blood vessel wall defects and certain electrophysiological defects, involve positioning a distal end of an elongate catheter device at the site of the anatomic defect, engaging tissues at the site of the anatomic defect to bring the tissues together, and applying energy to the tissues with the catheter device to substantially close the anatomic defect acutely. Apparatus generally includes an elongate catheter having a proximal end and a distal end, a vacuum application member coupled with the distal end for engaging tissues at the site of the anatomic defect and applying vacuum to the tissues to bring them together, and at least one energy transmission member coupled with the vacuum application member for applying energy to tissues at the site of the anatomic defect to substantially close the defect acutely.

Claims

1. A method of treating an anatomic defect in human tissue, the method comprising:

positioning a distal end of an elongate catheter device at the site of the anatomic defect, wherein positioning the distal end comprises advancing the catheter device intravascularly over a guidewire extending into or through the anatomic defect;

engaging tissues at the site of the anatomic defect to bring the tissues together; and

applying energy to the tissues with the catheter device to substantially close the anatomic defect acutely,

and wherein the anatomic defect is selected from the group consisting of a patent foramen ovale, an atrial septal defect, a left atrial appendage and a ventricular septal defect.

2. A method as in claim 1, wherein advancing the catheter device over the guidewire positions the distal end in a substantially centered position over the anatomic defect.

3. A method as in claim 1, further comprising removing the guidewire from the anatomic defect after it is substantially closed.

4. A method as in claim 1, further comprising removing the guidewire from the anatomic defect before it is substantially closed.

5. A method as in claim 1, wherein the guidewire extends asymmetrically through the anatomic defect.

6. A method as in claim 1, wherein positioning the distal end further comprises expanding an expandable member on the on the guidewire to adjust the position of the guidewire relative to the anatomic defect.

7. A method as in claim 1, wherein positioning further comprises actively steering the distal portion of the catheter device.

8. A method as in claim 1, further comprising visualizing at least one of the distal portion and the anatomic defect during the positioning step.

9. A method as in claim 8, wherein visualizing comprises viewing the anatomic defect directly with an endoscopic device coupled with the catheter device.

10. A method as in claim 8, wherein visualizing comprises viewing at least one radiopaque marker of material on the distal portion, using a radiographic visualization device.

11. A method as in claim 8, wherein visualizing comprises using a technique selected from the group consisting of transesophageal echocardiogram, intracardiac echocardiography, MRI, fluoroscopy, ultrasound and direct vision.

12. A method as in claim 1, wherein positioning comprises forming a seal between the distal end of the elongate catheter device and the tissues.

13. A method as in claim 1, wherein engaging the tissues at the site of the anatomic defect comprises applying a vacuum force.

14. A method as in claim 13, wherein applying the vacuum force comprises:

collecting vacuum force in a reservoir coupled with the catheter; and

applying the collected vacuum force as an impulse to the tissues.

15. A method as in claim 13, further comprising:

passing fluid out of the distal end of the catheter device to provide irrigation; and

suctioning the fluid back into the catheter device using the applied vacuum.

16. A method as in claim 15, further comprising monitoring the suctioned fluid to determine the blood content of the fluid.

17. A method as in claim 15, further comprising monitoring a flow rate of fluid from a fluid supply reservoir into the catheter to determine whether a seal has been formed.

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

positioning a distal end of an elongate catheter device adjacent the patent foramen ovale;

engaging tissues of the patent foramen ovale by applying a vacuum at a first pressure through the catheter device to bring the tissues together; and

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

19. A method as in claim 18, further comprising passing fluid out of the distal end of the catheter device at a second pressure to contact the tissues, wherein the first pressure is sufficiently greater than the second pressure to hold the tissues together and draw the passed fluid back into a lumen of the catheter device.

20. A method as in claim 19, further comprising monitoring the fluid drawn back into the catheter device to determine if the fluid contains blood.

21. A method as in claim 19, farther comprising monitoring a flow rate of fluid from a fluid supply reservoir into the catheter to determine whether a seal has been formed.

22. A method as in claim 19, farther comprising flushing the lumen and the distal end of the catheter device to prevent accumulation of blood therein.

23. A method as in claim 18, farther comprising passing fluid out of the distal end of the catheter device at a second pressure to contact the tissues, wherein the first pressure and the second pressure are approximately equal.

24. A method as in claim 18, wherein applying the vacuum forms a seal between the distal end of the catheter device and the tissues.