Circumferential ablation device assembly

• US 6,416,511 B1
• Filed: 08/17/2000
• Issued: 07/09/2002
• Est. Priority Date: 05/09/1997
• Status: Expired due to Term

• Current Assignee: Link Spine Group, Inc. (Spinesmith Holdings, LLC)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Ross, Michael Ronald, Lesh, Michael D., Langberg, Jonathan J., Peacock, James C. III
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US09/642,614
• Time in Patent Office: 691 Days
• Field of Search: 600/373, 600/374, 600/375, 600/381, 600/393, 606/27, 606/32, 606/37, 606/40, 606/41, 606/42, 606/45, 606/46, 606/47, 606/48, 606/51, 606/34, 607/99, 607/101, 607/122, 601/2, 128/898
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00994 : combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

This invention is a circumferential ablation device assembly which is adapted to forming a circumferential conduction block in a pulmonary vein. The assembly includes a circumferential ablation element which is adapted to ablate a circumferential region of tissue along a pulmonary vein wall which circumscribes the pulmonary vein lumen, thereby transecting the electrical conductivity of the pulmonary vein against conduction along its longitudinal axis and into the left atrium. The circumferential ablation element includes an expandable member with a working length that is adjustable from a radially collapsed position to a radially expanded position. An equatorial band circumscribes the outer surface of the working length and is adapted to ablate tissue adjacent thereto when actuated by an ablation actuator. The equatorial band has a length relative to the longitudinal axis of the expandable member that is narrow relative to the working length, and is also substantially shorter than its circumference when the working length is in the radially expanded position. A pattern of insulators may be included over an ablation element which otherwise spans the working length in order to form the equatorial band described. The expandable member is also adapted to conform to the pulmonary vein in the region of its ostium, such as by providing a great deal of radial compliance or by providing a taper along the working length which has a distally reducing outer diameter. A linear ablation element is provided adjacent to the circumferential ablation element in a combination assembly which is adapted for use in a less-invasive “maze”-type procedure in the region of the pulmonary vein ostia in the left ventricle.

Claims

1. A tissue ablation device assembly for ablating a region of cardiac tissue in a patient, comprising:

an ablation member, said ablation member having first and second end portions, said ablation member including an ablation element having a length between said first and second end portions of said ablation member, wherein said ablation element is adapted to couple to an ablation actuator; and

an anchor coupled to said first end portion of said ablation member, said anchor including an expandable member that is positionable within a pulmonary vein extending from the left atrial wall of a patient, wherein said expandable member is expandable to a radially expanded condition that is adapted to engage the pulmonary vein;

wherein said ablation element is further adapted to extend along the region of tissue when said expandable member is positioned and engaged within the pulmonary vein in the radially expanded condition.

2. A tissue ablation device assembly as recited in claim 1, wherein said expandable member comprises an inflatable balloon that is adapted to couple to a pressurizeable fluid source and to inflate with fluid from the fluid source to the radially expanded position.

3. A tissue ablation device assembly as recited in claim 1, wherein said anchor further comprises a guidewire tracking member that is adapted to slideably engage and track over a guidewire positioned within the pulmonary vein.

27. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element is adapted to emit a circumferential pattern of energy.

28. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises an electric coil.

29. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises at least one electrode that is adapted to couple to an electrical current source.

30. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises a plurality of electrodes.

31. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises a cryogenic ablation element.

32. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises an ultrasound ablation element.

33. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises a light emitting ablation element.

34. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises a microwave ablation element.

35. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises a thermal ablation element.

36. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, wherein the ablation element comprises a chemical fluid ablation element.

54. A tissue ablation device assembly as recited in any of claims 1, 4, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, or 23, further comprising:

at least one guiding catheter having a proximal end portion, a distal end portion, and a passageway extending along a longitudinal axis between a proximal port along the proximal end portion and a distal port along the distal end portion;

the distal end portion being positionable within the atrium by manipulating the proximal end portion externally of the patient;

wherein the ablation member is adapted to be delivered along the longitudinal passageway and through the distal port to the location when the distal end portion is positioned within the atrium with the external end portion located externally of the patient.

4. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue;

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location; and

a delivery member with a proximal end portion and a distal end portion which cooperates with the anchor and also with the ablation element at least in part to deliver the anchor to the anchoring position and the ablation element along the location by positioning the distal end portion within the atrium with the proximal end portion located externally of the patient.

5. An apparatus as recited in claim 4, wherein said delivery member comprises an elongate body.

6. An apparatus as recited in claim 5, wherein said elongate body has a longitudinal axis, wherein said ablation element has a length located along the longitudinal axis of the elongate body, and wherein said anchor is located along the elongate body generally distal to the ablation element relative to the longitudinal axis.

7. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator and to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue; and

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location;

said anchor comprising an expandable member that is constructed to expand to a sufficient outer diameter to engage a wall of the pulmonary vein at the anchoring position;

wherein the expandable member comprises an inflatable balloon.

8. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator and to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue; and

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location;

said anchor comprising an expandable member that is constructed to expand to a sufficient outer diameter to engage a wall of the pulmonary vein at the anchoring position;

wherein the expandable member includes a central axis configured to be substantially aligned with and extend along a central longitudinal axis of the pulmonary vein when the expandable member is anchored at the anchoring position and the ablation element extends proximally from the expandable member off center from the central axis.

9. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator and to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue; and

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location;

wherein the ablation element has a length and is constructed to ablatively couple to a region of tissue that extends from the location and along a wall of the atrium.

10. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator and to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue; and

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location;

wherein the ablation element is moveable relative to the anchor so as to be repositionable at multiple positions along a circumferential path that corresponds to a circumferential region of tissue at the location.

11. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator and to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue;

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location; and

a stylet;

wherein the ablation element is located along the stylet and the stylet is adapted to position the ablation element along the location for ablation.

12. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator and to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue; and

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location;

wherein the ablation element comprises an electrical ablation element with at least one electrode which is adapted to couple to an electrical current source.

13. An apparatus as recited in claim 12, when the ablation element comprises a plurality of said electrodes which are spaced along the distal end portion to form a linear ablation element.

14. A tissue ablation device assembly for treating atrial arrhythmia in a patient, comprising:

an ablation element that is constructed to couple to an ablation actuator and to be positioned along a region of tissue at least in part at a location where a pulmonary vein extends from an atrium in order to ablate the tissue;

an anchor that is coupled to the ablation element and is constructed to be positioned within the pulmonary vein to engage a pulmonary vein wall at an anchoring position along the pulmonary vein such that the ablation element is substantially secured along the location; and

an ablation actuating assembly which is constructed to couple to and actuate the ablation element.

15. A tissue ablation device assembly, comprising:

a delivery member having a proximal end portion, a distal end portion and a longitudinal axis;

a radially extendable member that comprises an expandable member;

the radially extendable member being adapted to engage a pulmonary vein;

the radially extendable member being disposed along the distal end portion of the delivery member; and

an ablation element coupled to the distal end portion;

the ablation element being adapted to be positioned at a location where a pulmonary vein extends from an atrium;

the ablation element being adapted to ablate a region of cardiac tissue at the location.

16. A tissue ablation device assembly, comprising:

a delivery member having a proximal end portion, a distal end portion and a longitudinal axis;

a radially extendable member;

the radially extendable member being adapted to engage a pulmonary vein;

the radially extendable member being disposed along the distal end portion of the delivery member; and

an ablation element coupled to the distal end portion;

the ablation element being adapted to be positioned at a location where a pulmonary vein extends from an atrium and being adapted to ablate a region of cardiac tissue at the location;

wherein the ablation element is disposed proximal of the expandable member relative to the longitudinal axis of the delivery member.

17. A tissue ablation device assembly, comprising:

a delivery member having a proximal end portion, a distal end portion and a longitudinal axis;

a radially extendable member;

the radially extendable member being adapted to engage a pulmonary vein;

the radially extendable member being disposed along the distal end portion of the delivery member; and

an ablation element coupled to the distal end portion;

the ablation element being adapted to be positioned at a location where a pulmonary vein extends from an atrium and being adapted to ablate a region of cardiac tissue at the location;

wherein the ablation element is disposed within the expandable member.

18. A tissue ablation device assembly, comprising:

a delivery member having a proximal end portion, a distal end portion and a longitudinal axis;

a radially extendable member;

the radially extendable member being adapted to engage a pulmonary vein and is disposed along the distal end portion of the delivery member; and

an ablation element coupled to the distal end portion;

the ablation element being adapted to be positioned at a location where a pulmonary vein extends from an atrium and being adapted to ablate a region of cardiac tissue at the location;

wherein the ablation element is disposed proximal of the expandable member relative to the longitudinal axis of the delivery member.

19. A tissue ablation device assembly, comprising:

an ablation member adapted to be positioned within a vessel having a lumen having a diameter of greater than 1.5 centimeters and to ablate a circumferential region of tissue of the vessel of a sufficient depth so as to form a conduction block that circumscribes the vessel and thereby blocks conduction along a length of the vessel;

wherein the ablation member further comprises an ablation element.

20. A tissue ablation device assembly as in claim 19, wherein the ablation member comprises an ablation element, and the ablation member is adapted to position the ablation element generally at a central position at the location relative to a lumenal axis of the pulmonary vein.

21. A tissue ablation device assembly as in claim 19, wherein the ablation member includes a conductive fluid delivery source which is adapted to occupy at least a portion of a space between the ablation element and the region of tissue.

22. A tissue ablation device assembly as in claim 19, wherein the ablation member comprises an ablation element which is adapted to contact the region of tissue.

23. A tissue ablation device assembly for ablating a circumferential region of tissue at a location where a pulmonary vein extends from a left atrium, comprising:

a circumferential ablation member having an energy emitting ablation element and an expandable member, the expandable member having a working length along a longitudinal axis of the circumferential ablation member that is adjustable between a radially collapsed position and a radially expanded position in which an outer diameter of the working length of the expandable member is sufficient to engage the pulmonary vein; and

a delivery member which cooperates with the circumferential ablation member and which is constructed to position the circumferential ablation member along the location, the circumferential ablation member being configured to guide substantially all of the emitted energy along a radial flow path in only a single circumferential pattern between the energy emitting ablation element and the circumferential region of tissue, the circumferential pattern having a longitudinal dimension smaller than the working length.

24. A tissue ablation device assembly as in claim 23, wherein the energy emitting ablation element comprises an electrode ablation element.

25. A tissue ablation device assembly as in claim 24, herein the delivery member directly supports the ablation electrode element.

26. A tissue ablation device assembly as in claim 23, wherein the expandable member comprises an inflatable balloon that is adapted to couple to a pressurizeable fluid source and to expand with fluid from the fluid source to the radially expanded position.

37. A method for treating atrial arrhythmia by forming a lesion at a location where a pulmonary vein extends from an atrium in a patient, comprising:

delivering an expandable contact member to the location;

expanding the contact member so as to engage a substantially circumferential area of tissue;

delivering an ablation element to the location, the ablation element being adapted to ablatively couple to a region of cardiac tissue adjacent to at least a portion of the substantially circumferential area of tissue; and

actuating the ablation element to ablate the region of cardiac tissue.

38. The method of claim 37, wherein providing an ablation element involves providing an ablation element that is coupled to the contact member such that when the contact member is expanded to engage the substantially circumferential area of tissue, the ablation element is simultaneously positioned at the location.

39. The method of claim 38, wherein the contact member and the ablation element comprise at least part of an inflatable member, and expanding the contact member involves inflating the inflatable member.

40. The method of claim 39, wherein actuating the ablation element ablatively couples the ablation element to substantially the entire circumferential region of cardiac tissue adjacent to the substantially circumferential area of tissue.

41. The method of claim 37 further involving providing a conductive media between the ablation element and the region of cardiac tissue.

42. The method of claim 37, wherein the contact member comprises an inflatable balloon, and expanding the contact member involves inflating the balloon.

43. The method of claim 37, wherein actuating the ablation element ablatively couples the ablation element to substantially the entire circumferential region of cardiac tissue adjacent to the substantially circumferential area of tissue.

44. The method of claim 37, wherein actuating the ablation element discharges an electrical current.

45. The method of claim 44 further involving providing a conductive media between the ablation element and the region of cardiac tissue.

46. The method of claim 37, wherein actuating the ablation element discharges thermal energy.

47. The method of claim 37, wherein actuating the ablation element absorbs thermal energy.

48. The method of claim 37, wherein actuating the ablation element discharges ultrasound energy.

49. The method of claim 37, wherein actuating the ablation element discharges microwave energy.

50. The method of claim 37, wherein actuating the ablation element discharges light energy.

51. A method for treating atrial arrhythmia by forming a lesion at a location where a pulmonary vein extends from an atrium in a patient, comprising:

delivering a contact member to the location;

engaging the contact member with a substantially circumferential area of tissue at the location; and

ablating a region of cardiac tissue while the contact member engages the circumferential area of tissue at the location.

52. The method of claim 51, wherein ablating a region of cardiac tissue involves positioning an ablation element at the location near the contact member.

53. An medical device system for treating atrial arrhythmia by forming a lesion at a location where a pulmonary vein extends from an atrium in a patient, comprising:

a contact member adapted to contact a substantially circumferential area of tissue at the location; and

an ablation element adapted to ablation a region of cardiac tissue while the contact member contacts the substantially circumferential area of tissue.