Positioning system and method for orienting an ablation element within a pulmonary vein ostium

• US 6,514,249 B1
• Filed: 03/02/2000
• Issued: 02/04/2003
• Est. Priority Date: 07/08/1997
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: OʼSullivan, Martin F., Maguire, Mark A., Carcamo, Edward L., Taylor, Kevin J., Picazo, Guillermo P., Lesh, Michael D., Schaer, Alan K.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/517,472
• Time in Patent Office: 1,069 Days
• Field of Search: 606/41, 606/49-50, 606/27-29, 606/31, 606/37-38, 607/96-99, 607/101-102, 607/116, 607/122, 607/113
• US Class Current: 606/41
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00243 cardiac
• 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: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

This invention relates to a surgical device and method. More particularly, it relates to a tissue ablation device assembly and method using a circumferential ablation member in combination with a position monitoring assembly in order to position the circumferential ablation member along a circumferential region of tissue at a location where a pulmonary vein extends from a left atrium.

Claims

1. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion having a longitudinal axis;

an ablation member along the distal end portion with an ablation element that is adapted to be ablatively coupled to a substantially circumferential area surrounding the longitudinal axis, wherein the substantially circumferential area is adapted to substantially coincide with the substantial portion of the circumferential region of tissue when the ablation member is at the location; and

a position monitoring assembly with a sensor apparatus coupled to the distal end portion and that is adapted to sense a predetermined parameter that provides indicia of the position of the ablation member relative to the location, the position monitoring assembly being substantially rotationally fixed about a longitudinal axis relative to the elongate body.

2. The system of claim 1, wherein said sensor is adapted to couple to a position monitoring circuit that is adapted to monitor at least one aspect of the predetermined parameter sensed by the sensor.

3. The system of claim 2, wherein said position monitoring circuit is adapted to monitor an aspect of the predetermined parameter that comprises a rate of change in the predetermined parameter.

4. The system of claim 3, wherein said position monitoring circuit is adapted to provide a signal that indicates the at least one aspect of the sensed predetermined parameter.

5. The system of claim 4, wherein said signal comprises an input signal to a visual display that visually indicates the at least one aspect of the sensed predetermined parameter.

6. The system of claim 1, wherein the position monitoring assembly further comprises a position detector coupled to said sensor, wherein the position detector is adapted to detect when the ablation member is at the location based upon the sensed predetermined parameter.

7. The system of claim 1, wherein said sensor comprises a temperature sensor that is adapted to sense a predetermined parameter that comprises a temperature value that indicates an ablative coupling between the ablation element and the substantial portion of the circumferential region of tissue.

8. The system of claim 7, wherein the temperature sensor is coupled to the ablation member and is adapted to sense a temperature affected by an ablative coupling between the ablation element and the substantial portion of the circumferential region of tissue;

and

the position monitoring assembly further comprises a temperature monitoring circuit, wherein the temperature sensor is adapted to couple to the temperature monitoring circuit and the temperature monitoring circuit is adapted to provide indicia that the ablation member is at the location based upon the temperature monitored by the temperature sensor.

9. The system of claim 8, wherein the ablation member further comprises an expandable member that is positionable along the location and which is adjustable from a radially collapsed position to a radially expanded position that is adapted to engage the substantial portion of the circumferential region of tissue;

and

said temperature sensor is coupled to said expandable member such that the temperature sensor is adapted to be positioned adjacent to the substantial portion of the circumferential region of tissue when the expandable member is in the radially expandable position at the location.

10. The system of claim 1, wherein said sensor comprises an acoustic wave sensor which is adapted to sense an acoustic wave reflecting from a tissue wall surrounding the distal end portion.

11. The system of claim 10, wherein said sensor comprises an ultrasound sensor which is adapted to sense an acoustic wave which provides indicia of the position of the ablation member relative to a tissue wall along the location.

12. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:

an ablation member with an ablation element;

positioning means for positioning the ablation member along the location;

monitoring means for monitoring a position of the ablation member relative to the location, wherein the monitoring means is adapted to monitor the position of the ablation member without being rotated relative to the ablation member; and

coupling means for ablatively coupling the ablation element to the substantial portion of the circumferential region of tissue when the ablation member is positioned along the location.

13. The system of claim 12, wherein the monitoring means comprises a sensor coupled to the distal end portion for sensing a predetermined parameter that provides indicia of the position of the ablation member relative to the location.

14. The system of claim 13, wherein the monitoring means comprises a means for monitoring a temperature which indicates an ablative coupling between the ablation element and the substantial portion of the circumferential region of tissue.

15. The system of claim 13, wherein the monitoring means comprises a means for monitoring a distance between the ablation member and a tissue wall along the location.

16. The system of claim 15, wherein the monitoring means comprises a means for monitoring an acoustic wave reflected from the tissue wall.

17. The system of claim 13, wherein the monitoring means comprises a means for optically visualizing a relative position of a tissue wall along the location with respect to the ablation member.

18. The system of claim 13, wherein the coupling means comprises a shaped member with a shape that is adapted to contact the substantial portion of the circumferential region of tissue, and wherein the ablation element is located at least in part along the shaped member.

19. The system of claim 18, wherein the shaped member comprises an expandable member that is adjustable between a radially collapsed position and a radially expanded position with an expanded outer diameter that is sufficient to engage the circumferential region of tissue.

20. The system of claim 19, wherein the expandable member comprises an inflatable balloon which is adapted to be fluidly coupled to a pressurizeable fluid source and to inflate to the radially expanded position with a volume of pressurized fluid from the pressurizeable fluid source.

21. A system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion;

means for ablating the substantial portion of the region of tissue; and

means for sensing a position of said ablation means relative to an ostium of the pulmonary vein along the atrium.

22. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, using a sensor that is rotationally fixed relative to the ablation member to monitor a parameter that provides indicia of a position of the ablation member relative to the location; and

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue.

23. The method of claim 22, further comprising monitoring said parameter by:

emitting an acoustic signal from an acoustic emitter located along the distal end portion and toward a tissue wall adjacent the distal end portion, and sensing a reflected acoustic signal from a tissue wall adjacent the distal end portion using an acoustic sensor also located along the distal end portion.

24. The method of claim 23, wherein the acoustic sensor comprises an ultrasound transducer, and further comprising sensing the reflected acoustic signal by operating the ultrasound transducer in a mode which is adapted to sense an ultrasound signal reflected from a tissue wall adjacent the distal end portion.

25. The method of claim 22, wherein the acoustic emitter comprises an ultrasound transducer and the acoustic signal comprises an ultrasound signal, and further comprising emitting the acoustic signal by operating the ultrasound transducer in a mode which emits the ultrasound signal from the distal end portion.

26. The method of claim 22, further comprising detecting when the ablation member is at the location based upon said monitored parameter.

27. The method of claim 26, further comprising detecting when the ablation member is at the location by detecting a change in an ultrasound signal reflecting from a tissue wall adjacent to the distal end portion.

28. A method for positioning an ablation apparatus in a pulmonary vein ostium, comprising:

using an ultrasonic sensor to measure a distance from said sensor to a tissue wall; and

determining a position of an ablation member with respect to said tissue wall based on a position of said ablation member with respect to said sensor.

29. A method for determining proper position of an expandable member in a pulmonary vein ostium, comprising:

advancing the expandable member with the expandable member having a constant diameter; and

measuring a Doppler shift in a fluid flowing past said expandable member.

30. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion having a longitudinal axis;

an ablation member along the distal end portion with an ablation element that is adapted to be ablatively coupled to a substantially circumferential area surrounding the longitudinal axis, wherein the substantially circumferential area is adapted to substantially coincide with the substantial portion of the circumferential region of tissue when the ablation member is at the location; and

a position monitoring assembly with a sensor coupled to the distal end portion that is adapted to sense a predetermined parameter for providing indicia of the position of the ablation member relative to the location, the sensor being adapted to couple to a position monitoring circuit that monitors an aspect of the predetermined parameter that comprises a rate of change in the predetermined parameter and provides an audio signal that audibly indicates the sensed predetermined parameter.

31. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion having a longitudinal axis;

an ablation member along the distal end portion with an ablation element that is adapted to be ablatively coupled to a substantially circumferential area surrounding the longitudinal axis, wherein the substantially circumferential area is adapted to substantially coincide with the substantial portion of the circumferential region of tissue when the ablation member is at the location; and

a position monitoring assembly with a flow sensor coupled to the distal end portion and adapted to sense a level of blood flow around the ablation member for providing indicia of the position of the ablation member relative to the location.

32. The system of claim 31, wherein said flow sensor is adapted to sense a predetermined parameter that comprises a velocity of blood flowing around the ablation member.

33. The system of claim 32, wherein said sensor comprises a Doppler flow sensor which is located along the distal end portion.

34. The system of claim 33, wherein the circumferential ablation member comprises an expandable member located along the distal end portion, and the Doppler flow sensor is located within the expandable member.

35. The system of claim 33, wherein the Doppler flow sensor is located distally of the ablation member.

44. The system of claim 33, further comprising a controller coupled to the common ultrasound transducer and which is adapted to alternate modes of operating the common ultrasound transducer between the first and second modes.

36. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion having a longitudinal axis;

an ablation member along the distal end portion with an ablation element that is adapted to be ablatively coupled to a substantially circumferential area surrounding the longitudinal axis, wherein the substantially circumferential area is adapted to substantially coincide with the substantial portion of the circumferential region of tissue when the ablation member is at the location; and

a position monitoring assembly with a pressure sensor coupled to the distal end portion and adapted to sense a fluid pressure at a predetermined location relative to the ablation member for providing indicia of the position of the ablation member relative to the location.

37. The system of claim 36, wherein the ablation member comprises an expandable member located along the distal end portion, and the pressure sensor is located within the expandable member.

38. The system of claim 36, wherein the pressure sensor is located distally of the ablation member.

39. The system of claim 36, wherein the pressure sensor comprises:

a passageway extending between a distal port located along the distal end portion and a proximal port located along the proximal end portion of the elongate body;

a substantially non-compressible fluid located within the passageway; and

a pressure transducer coupled to the passageway.

40. The system of claim 36, wherein the ablation member comprises an expandable member that is adjustable between a radially collapsed position and a radially expanded position, wherein in the radially expanded position along the location the expandable member is adapted to substantially occlude blood flow between the pulmonary vein and the atrium;

and

the pressure sensor is positioned to sense a pressure adjacent to the expandable member that is characteristic of the expandable member being adjusted to the radially expanded position along the location.

41. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion having a longitudinal axis;

an ablation member along the distal end portion with an ablation element that is adapted to be ablatively coupled to a substantially circumferential area surrounding the longitudinal axis, wherein the substantially circumferential area is adapted to substantially coincide with the substantial portion of the circumferential region of tissue when the ablation member is at the location; and

a position monitoring assembly comprising a plurality of individual ultrasound transducers spaced circumferentially about the distal end portion, the ultrasound transducers being adapted to sense an acoustic wave reflecting from a tissue wall surrounding the distal end portion for providing indicia of the position of the ablation member relative to the location.

42. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion having a longitudinal axis;

an ablation member along the distal end portion with an ablation element that is adapted to be ablatively coupled to a substantially circumferential area surrounding the longitudinal axis, wherein the substantially circumferential area is adapted to substantially coincide with the substantial portion of the circumferential region of tissue when the ablation member is at the location; and

a position monitoring assembly comprising a first ultrasound transducer adapted to sense an acoustic wave reflecting from a tissue wall surrounding the distal end portion for providing indicia of the position of the ablation member relative to the location, and wherein the ablation element comprises a second ultrasound transducer.

43. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion having a longitudinal axis;

an ablation member along the distal end portion with an ablation element that is adapted to be ablatively coupled to a substantially circumferential area surrounding the longitudinal axis, wherein the substantially circumferential area is adapted to substantially coincide with the substantial portion of the circumferential region of tissue when the ablation member is at the location; and

a position monitoring assembly with an acoustic wave sensor adapted to sense an acoustic wave reflecting from a tissue wall surrounding the distal end portion, and wherein the ablation element and the acoustic wave sensor comprise a common ultrasound transducer which is adapted to be operated both in a first mode as an ultrasound ablation element and also in a second mode as an ultrasound sensor.

45. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:

an ablation member with an ablation element;

a tracking member adapted to slideably engage and track over a guide member positioned within the pulmonary vein for positioning the ablation member along the location;

monitoring means for monitoring a position of the ablation member relative to the location; and

coupling means for ablatively coupling the ablation element to the substantial portion of the circumferential region of tissue when the ablation member is positioned along the location.

46. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:

an ablation member with an ablation element;

positioning means for positioning the ablation member along the location;

a detection means coupled to the distal end portion for sensing a predetermined parameter that provides indicia of the position of the ablation member relative to the location for detecting when the ablation member is positioned at the location; and

coupling means for ablatively coupling the ablation element to the substantial portion of the circumferential region of tissue when the ablation member is positioned along the location.

47. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:

an ablation member with an ablation element;

positioning means for positioning the ablation member along the location;

a sensor coupled to the distal end portion for monitoring a velocity of a volume of blood flowing past the ablation member for providing indicia of the position of the ablation member relative to the location; and

coupling means for ablatively coupling the ablation element to the substantial portion of the circumferential region of tissue when the ablation member is positioned along the location.

48. A tissue ablation system for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:

an ablation member with an ablation element;

positioning means for positioning the ablation member along the location;

a sensor coupled to the distal end portion for monitoring a pressure at a predetermined location with respect to the ablation member for providing indicia of the position of the ablation member relative to the location; and

coupling means for ablatively coupling the ablation element to the substantial portion of the circumferential region of tissue when the ablation member is positioned along the location.

49. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring a parameter that provides indicia of a position of the ablation member relative to the location;

coupling an ultrasound ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue;

monitoring the parameter by emitting an acoustic signal from an acoustic emitter located along the distal end portion, and sensing a reflected acoustic signal from a tissue wall adjacent the distal end portion using an acoustic sensor also located along the distal end portion; and

ablating the substantial portion of the circumferential region of tissue by actuating the ultrasound ablation element to emit an ultrasound signal which is adapted to ablatively couple to the substantial portion of the circumferential region of tissue.

50. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring a parameter that provides indicia of a position of the ablation member relative to the location;

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue; and

monitoring the parameter by emitting an acoustic signal from an acoustic emitter located along the distal end portion wherein the acoustic emitter and ablation element both comprise a common ultrasound transducer;

emitting the acoustic signal by operating the common ultrasound transducer in a first mode that emits a first ultrasound signal toward the tissue wall and that is adapted to be reflected by the tissue wall and toward the acoustic sensor for ultrasound imaging; and

ablating the substantial portion of the circumferential region of tissue by operating the common ultrasound transducer in a second mode that emits a second ultrasound signal that ablatively couples to the circumferential region of tissue.

51. The method of claim 50, wherein the common ultrasound transducer also forms at least in part the acoustic sensor, and further comprising sensing the acoustic signal by operating the common ultrasound transducer in a third mode that senses the reflected ultrasound signal from the tissue wall.

52. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring a parameter that provides indicia of a position of the ablation member relative to the location;

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue; and

monitoring said parameter by emitting an acoustic signal from an acoustic emitter located along the distal end portion wherein the acoustic emitter and ablation element both comprise a common ultrasound transducer;

sensing the acoustic signal by operating the common ultrasound transducer in a first mode that senses the acoustic signal; and

ablating the substantial portion of the circumferential region of tissue by operating the common ultrasound transducer in a second mode that emits a second ultrasound signal that is adapted to ablatively couple to the circumferential region of tissue.

53. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring a parameter that provides indicia of a position of the ablation member relative to the location;

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue; and

monitoring the parameter by emitting an acoustic signal from an acoustic emitter located along the distal end portion wherein the acoustic emitter and ablation element both comprise a common ultrasound transducer;

emitting the acoustic signal by operating the common ultrasound transducer in a first mode that emits a first ultrasound signal toward the tissue wall and that is adapted to be reflected by the tissue wall and toward the acoustic sensor for ultrasound imaging;

sensing the acoustic signal by operating the common ultrasound transducer in a first mode that senses the acoustic signal; and

ablating the substantial portion of the circumferential region of tissue by operating the common ultrasound transducer in a second mode that emits a second ultrasound signal that ablatively couples to the circumferential region of tissue.

54. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring the position of the ablation member by sensing a level of blood flow around the ablation member for providing indicia of a position of the ablation member relative to the location; and

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue.

55. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring the position of the ablation member by sensing a pressure at a desired location relative to the ablation member for providing indicia of a position of the ablation member relative to the location; and

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue.

56. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring a parameter that provides indicia of a position of the ablation member relative to the location;

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue; and

detecting when the ablation member is located along the location by detecting a change in a level of blood flow around the ablation member.

57. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring a parameter that provides indicia of a position of the ablation member relative to the location;

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue; and

detecting when the ablation member is located along the region of tissue by energizing the ablation element to emit a pattern of energy; and

detecting a change in temperature along said pattern while the ablation element is energized.

58. A method for treating atrial arrhythmia by ablating a substantial portion of a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

providing an ablation member with an ablation element that is adapted to couple to an ablation actuator and to ablatively couple to a substantial portion of the circumferential region of tissue when the ablation member is positioned along the location;

delivering the ablation member to the location;

while delivering the ablation member to the location, monitoring a parameter that provides indicia of a position of the ablation member relative to the location;

coupling an ablation element provided along the ablation member to the substantial portion of the circumferential region of tissue; and

detecting when the ablation member is located along the region of tissue by detecting a change in pressure at a predetermined location relative to the ablation element while the ablation member is being positioned along the region of tissue.

59. A method for determining proper expansion of an expandable member in a pulmonary vein ostium, comprising:

expanding the expandable member at a fixed position in the pulmonary vein; and

measuring a Doppler shift in a fluid flowing past said expandable member.