Process and device for the treatment of atrial arrhythmia

• US 6,251,109 B1
• Filed: 01/20/1999
• Issued: 06/26/2001
• Est. Priority Date: 06/27/1997
• Status: Expired due to Term

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: Daig Corporation (Abbott Laboratories Incorporated)
• Inventors: Hassett, James A., Swartz, John F., Bednarek, Michael C.
• Primary Examiner(s): Leubecker, John P.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/233,337
• Time in Patent Office: 888 Days
• Field of Search: 604/93, 604/100, 604/21, 606/41, 606/45, 606/49, 606/198, 607/96, 607/98, 607/101, 607/102, 607/116, 607/119, 607/122
• US Class Current: 606/45
• 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00238 porous
• CPC Class Codes: A61B 2018/00255 arranged one inside another
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1437 whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A process for the treatment of atrial arrhythmia by use of ablation procedures including circumferential ablation of vessels, particularly pulmonary veins, associated with the left atrium of the heart. Also medical devices for such process including a pair of balloons secured to a catheter with one balloon located within the other balloon and an ablation catheter located within one of the balloons, which devices are used for the formation of a circumferential ablation lesion in the pulmonary vein.

Claims

1. A medical device for ablation within a vessel associated with a human heart comprising

an ablation catheter,

a first, outer balloon, secured to the catheter to seal the vessel and substantially prevent the flow of blood through the vessel,

a second, inner balloon, secured to the catheter at a location within the first outer balloon,

an introduction system secured to the catheter to introduce a conductive media inside the first outer balloon,

an ablating element secured to the catheter within the first outer balloon, and

a plurality of balloon openings provided in an outside surface of the first, outer balloon.

2. The medical device of claim 1 wherein the ablating element comprises a ring electrode.

3. The medical device of claim 1 wherein the ablating element comprises a coil electrode.

4. The medical device of claim 1 wherein the introduction system comprises a lumen which extends through the catheter into a media introduction opening in the catheter located within the first outer balloon.

5. The medical device of claim 1 wherein the balloon openings extend around a circumference of the first, outer balloon.

6. The medical device of claim 5 wherein the balloon openings are located on a distal portion of the first, outer balloon.

7. The medical device of claim 2 wherein the ring electrode is secured to the catheter at a location within the outer balloon but outside of the inner balloon.

8. The medical device of claim 3 wherein the coil electrode is secured to the catheter at a location within the outer balloon but outside of the inner balloon.

9. The medical device of claim 1 further comprising a lumen in the catheter including a distal opening in the catheter, which distal opening is located distal from the first and second balloons.

10. The medical device of claim 2 wherein the ring electrode emits radiofrequency energy.

11. The medical device of claim 3 wherein the coil electrode emits radiofrequency energy.

12. The medical device of claim 1 wherein the conductive media is a conductive saline solution.

22. The medical device of claim 1

wherein the ablating element comprises an electrode, and

wherein the electrode is secured to the ablation catheter at a location within the outer balloon, but outside of inner balloon.

13. A medical device for ablation within a vessel associated with a human heart comprising

an introducer with a proximal and a distal end and a lumen passing through the introducer from its proximal to its distal end,

an ablation catheter inserted within the lumen of the introducer,

a first, outer balloon, secured to the catheter to seal the vessel and substantially prevent the flow of blood through the vessel,

a second, inner balloon, secured to the catheter at a location within the first outer balloon,

an introduction system secured to the catheter within the first outer balloon,

an ablating element secured to the catheter located within the first outer balloon, and

a plurality of balloon openings provided in an outside surface of the first outer balloon.

14. The medical device of claim 13 wherein the ablating element comprises a ring electrode.

15. The medical device of claim 13 wherein the ablating element comprises a coil electrode.

16. The medical device of claim 13 wherein the plurality of balloon openings are provided in a line in the outside surface of the first outer balloon.

17. The medical device of claim 16 wherein the balloon openings extend around a circumference of the first, outer balloon.

18. The medical device of claim 16 wherein the balloon openings are located on a distal portion of the first, outer balloon.

19. The medical device of claim 14 wherein the ring electrode is secured to the catheter at a location within the outer balloon but outside of the inner balloon.

20. The medical device of claim 15 wherein the coil electrode is secured to the catheter at a location within the outer balloon but outside of the inner balloon.

21. A process for ablation of tissue within a vessel of a human comprising

introducing an ablation catheter into the vessel, wherein the ablation catheter comprises an extended catheter, a first, outer balloon, secured to the catheter, and a second inner balloon, secured to the catheter and located inside the first outer balloon,

sealing the vessel to prevent substantially the flow of blood through the vessel by use of the first outer balloon,

introducing a conductive media within the first outer balloon through a lumen in the catheter,

passing the conductive media through balloon openings in an outside surface of the first outer balloon,

conducting energy from an electrode secured to the catheter by use of the conductive media through the balloon openings in the outer balloon to the tissue, and

ablating the tissue to form a circumferential ablation lesion.