Ablation catheter having shape-changing balloon

• US 6,780,183 B2
• Filed: 09/16/2002
• Issued: 08/24/2004
• Est. Priority Date: 09/16/2002
• Status: Expired due to Fees

• Current Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Original Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Inventors: Jimenez, Teodoro S. Jr., Klumb, Pete B.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/244,355
• Publication Number:
  US 20040054367A1
• Time in Patent Office: 708 Days
• Field of Search: 606/27, 606/28, 606/41, 606/192, 606/194, 607/101-105, 604/96.01, 604/102.02, 604/103, 604/103.07, 600/439, 600/459, 600/462, 600/466
• US Class Current: 606/41
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A circumferential ablation catheter is provided that is particularly useful for ablating a circumferential region of tissue in a tubular region of or near the heart, such as a pulmonary vein. The catheter comprises an elongated tubular catheter body having an outer wall, proximal and distal ends, and a lumen extending therethrough. The catheter also comprises a generally tubular inner support member having proximal and distal ends and a lumen extending therethrough. A proximal portion of the inner support member extends into the lumen of the catheter body, and a distal portion of the inner support member extends outside the catheter body. A circumferential ablation element, such as an ultrasound transducer, is mounted on the distal portion of the inner support member outside the catheter body. A moveable tube extends through the lumen of the inner support member and through the catheter body. The moveable tube is longitudinally moveable relative to the inner support member and catheter body and has a distal end that extends beyond the distal end of the inner support member. An inflatable balloon is provided generally in surrounding relation to the circumferential ablation element. The inflatable balloon has a proximal end attached, directly or indirectly, to the distal end of the catheter body and a distal end attached, directly or indirectly, to a portion of the moveable tube that extends beyond the distal end of the inner support member. Longitudinal movement of the moveable tube relative to the catheter body and inner support member causes movement of the distal end of the balloon relative to the proximal end of the balloon to thereby change the length and shape of the expanded balloon.

Claims

1. A circumferential ablation catheter comprising:

an elongated tubular catheter body having an outer wall, proximal and distal ends, and a lumen extending therethrough;

a generally tubular inner support member having proximal and distal ends and a lumen extending therethrough, wherein a proximal portion of the inner support member extends into the lumen of the catheter body and a distal portion of the inner support member extends outside the catheter body;

a circumferential ablation element mounted on the distal portion of the inner support member outside the catheter body;

a moveable tube extending through the lumen of the inner support member and through the catheter body, the moveable tube being longitudinally moveable relative to the inner support member and catheter body and having a distal end extending beyond the distal end of the inner support member; and

an inflatable balloon provided generally in surrounding relation to the circumferential ablation element, the inflatable balloon having a proximal end attached to the distal end of the catheter body and a distal end attached to a portion of the moveable tube that extends beyond the distal end of the inner support member;

wherein longitudinal movement of the moveable tube relative to the catheter body and inner support member causes movement of the distal end of the balloon relative to the proximal end of the balloon to thereby change the length of the balloon.

2. A catheter according to claim 1, wherein the circumferential ablation element comprises an ultrasound ablation element, wherein the ultrasound ablation element is adapted to emit a substantially circumferential pattern of ultrasound energy and to ablatively couple to a substantial portion of a circumferential region of tissue engaged by the inflatable balloon in the radially expanded position when the ultrasound ablation element is coupled to and actuated by an ultrasound ablation actuator.

3. A catheter according to claim 1, wherein the circumferential ablation element comprises an ultrasound transducer.

4. A catheter according to claim 3, wherein the ultrasound transducer is substantially tubular.

5. A catheter according to claim 4, wherein the ultrasound transducer is mounted in surrounding relation to the inner support member with a radial separation between at least a portion of the ultrasound transducer and an outer surface of the inner support member that forms a radial separation region with a gas-filled gap.

6. A catheter according to claim 5, wherein the radial separation region is sealed to substantially prevent fluid from entering from outside of the radial separation region into the gap.

7. A catheter according to claim 3, wherein the ultrasound transducer is adapted to emit a continuous circumferential pattern of ultrasound energy.

8. A catheter according to claim 3, wherein the ultrasound transducer is adapted to emit an acoustic signal at a frequency of between about 5 MHz to about 20 MHz.

9. A catheter according to claim 3, wherein the ultrasound transducer is adapted to emit an acoustic signal at a power level of at least about 20 Watts per centimeter radiator.

10. A catheter according to claim 1, wherein the expanded outer diameter of the inflatable balloon is at least about 1.0 centimeters when in the expanded position.

11. A catheter according to claim 1, wherein the moveable tube has a proximal end that extends out the proximal end of the catheter body.

12. A catheter according to claim 1, wherein the moveable tube has a lumen extending therethrough, wherein the lumen is open at the distal end of the moveable tube.

13. A catheter according to claim 12, wherein the moveable tube has a proximal end that extends out the proximal end of the catheter body and has a luer hub mounted thereon.

14. A catheter according to claim 1, further comprising a distal tubing mounted on the distal end of the moveable tube and having a proximal end to which the distal end of the balloon is attached.

15. A catheter according to claim 14, further comprising one or more electrodes mounted on the distal tubing.

16. A catheter according to claim 15, further comprising a tip electrode mounted on the distal tubing, the tip electrode having proximal and distal ends and an open passage extending therethrough.

17. A catheter according to claim 16, wherein the moveable tube has a lumen extending therethrough and a distal end positioned within the open passage of the tip electrode, wherein the lumen of the moveable tube is open at the distal end of the moveable tube, whereby fluid can pass through the moveable tube and out the distal end of the tip electrode.

18. A catheter according to claim 14, further comprising an elastic tubing having a proximal end attached to the distal end of the inner support member and a distal end attached to the proximal end of the distal tubing proximal to the position at which the distal end of the balloon is attached to the distal tubing.

19. A catheter according to claim 18, wherein the elastic tubing comprises silicone.

20. A catheter according to claim 1, wherein the inner support member is longitudinally moveable relative to the catheter body and moveable tube, whereby longitudinal movement of the inner support member relative to the catheter body and moveable tube causes longitudinal movement of the circumferential ablation element relative to the catheter body and moveable tube.

21. A catheter according to claim 20, wherein the proximal end of the inner support member extends out the proximal end of the catheter body.

22. A catheter according to claim 1, wherein the catheter body comprises a proximal region having a single lumen and a distal region having a plurality of lumens.

23. A catheter according to claim 1, further comprising means for deflecting the distal end of the catheter body.

24. A catheter according to claim 23, wherein the deflecting means comprises:

a puller wire extending through a lumen of the catheter body, said puller wire being fixedly attached at its distal end at or near the location of deflection; and

a control handle for moving the puller wire longitudinally relative to the catheter body to thereby cause deflection.

25. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue in a tubular region of or near the heart of a patient, comprising:

introducing into a patient a catheter according to claim 1, wherein the circumferential ablation element comprises an ultrasound ablation element coupled to an acoustic energy driver;

contacting a substantial portion of the circumferential region of tissue with at least a portion of the inflatable balloon, such that the ultrasound ablation element is positioned to deliver a substantially circumferential pattern of ultrasound energy through the inflatable balloon to the substantial portion of the circumferential region of tissue; and

actuating the acoustic energy driver to ablatively couple the ultrasound ablation element to the substantial portion of the circumferential region of tissue via the inflatable balloon.

26. A method according to claim 25, wherein contacting at least the substantial portion of the circumferential region of tissue comprises expanding the inflatable balloon to radially engage the substantial portion of the circumferential region of tissue.

27. A method according to claim 26, wherein expanding the inflatable balloon comprises introducing an ultrasonically transparent inflation fluid to an inner region of the inflatable balloon.

28. A method according to claim 27, wherein the ultrasonically transparent inflation fluid comprises a radiopaque dye.

29. A method according to claim 26, further comprising longitudinally moving moveable tube relative to the catheter body to move the distal end of the balloon distally relative to the proximal end of the balloon.

30. A method according to claim 29, wherein the moveable tube is moved longitudinally after the balloon is expanded.

31. A method according to claim 25, wherein the moveable tube has a lumen extending therethrough, wherein the lumen is open at the distal end of the moveable tube, and further wherein the catheter is introduced over a guidewire that extends through the lumen of the moveable tube.

32. A method according to claim 25, wherein the catheter further comprises a distal tubing mounted on the distal end of the moveable tube and having a proximal end to which the distal end of the balloon is attached, wherein one or more electrodes are mounted on the distal tubing.

33. A method according to claim 32, further comprising mapping electrical activity in the tubular region of or near the heart using the one or more electrodes.

34. A catheter according to claim 25, wherein the inner support member is longitudinally moveable relative to the catheter body and moveable tube, the method further comprising longitudinally moving the inner support member relative to the catheter body and moveable tube to affect longitudinal movement of the circumferential ablation element relative to the catheter body and moveable tube.

35. A method according to claim 25, further comprising ablatively coupling the ultrasound ablation element to the substantial portion of the circumferential region of tissue at a location where cardiac tissue extends along the pulmonary vein.

36. A method according to claim 25, further comprising ablatively coupling the ultrasound ablation element to the substantial portion of the circumferential region of tissue at a location where cardiac tissue extends along an ostium of the pulmonary vein.

37. A method according to claim 25, further comprising ablatively coupling the ultrasound ablation element to the substantial portion of the circumferential region of tissue at a location along the atrial wall and surrounding an ostium of the pulmonary vein.

38. A method according to claim 25, further comprising actuating the ultrasound ablation element to emit the substantially circumferential pattern of ultrasound energy at a frequency ranging from about 5 MHz to about 20 MHz.

39. A method according to claim 25, wherein the entire circumferential region of tissue is ablatively coupled to the ultrasound ablation element.