Circumferential ablation device assembly

• US 6,254,599 B1
• Filed: 03/22/1999
• Issued: 07/03/2001
• Est. Priority Date: 05/09/1997
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: Lesh, Michael D., Langberg, Jonathan J., Peacock, James C. III, Ross, Michael Ronald
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US09/273,815
• Time in Patent Office: 834 Days
• Field of Search: 600/373, 600/374, 600/375, 600/381, 600/393, 606/32, 606/37, 606/40, 606/41, 606/42, 606/45, 606/46, 606/47, 606/48, 606/34, 606/51, 607/101, 607/122, 607/99, 601/2
• 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 system for ablating a circumferential region of tissue at a location where a single pulmonary vein extends from an atrium in a patient, comprising:

an ablation member with a contact member which is adapted to substantially contact the circumferential region of tissue, and also with an ablation element which is adapted to be ablatively coupled to the circumferential region of tissue when the circumferential ablation member is positioned at the location; and

a delivery assembly that cooperates with the circumferential ablation member and that is adapted to deliver the circumferential ablation member to the location.

2. The tissue ablation device system of claim 1, wherein the contact member comprises a body that is adapted to have a looped geometry which substantially contacts the circumferential region of tissue.

3. The tissue ablation device system of claim 2, wherein

the contact member is adapted to be positioned in a collapsed geometry within a delivery passageway of a delivery catheter and to be delivered through the delivery passageway and into the atrium; and

the contact member is adjustable to the looped geometry when the contact member is positioned externally of the delivery passageway.

4. The tissue ablation device system of claim 2, wherein the looped geometry is sized to engage the pulmonary vein.

5. The tissue ablation device system of claim 1, wherein the contact member is adjustable from a first configuration, which is adapted to be delivered through a delivery passageway of a delivery catheter and into the atrium, to a second configuration which is adapted to contact the circumferential region of tissue.

6. The tissue ablation device system of claim 1, wherein

the delivery assembly comprises a delivery catheter with a proximal end portion and a distal end portion and a delivery passageway extending between a distal port along the distal end portion and a proximal port located proximally of the distal port;

and

the ablation member is adapted to be advanced through the delivery passageway and into the atrium through the distal port.

7. The tissue ablation device system of claim 1, wherein the delivery assembly comprises an elongate body with a proximal end portion and a distal end portion;

and

the ablation member is located at least in part along the distal end portion of the elongate body.

8. The tissue ablation device system of claim 7, wherein the contact member is located at least in part along the distal end portion of the elongate body.

9. The tissue ablation device system of claim 7, wherein the delivery assembly further comprises a tracking member that is located at least in part along the elongate body and that is adapted to slideably engage a guide member seated within the pulmonary vein and to track over the guide member in order to position the circumferential ablation member along the location.

10. The tissue ablation device system of claim 9, further comprising a pulmonary vein guide member that is adapted to be seated within the pulmonary vein and also to be slideably engaged and tracked by the tracking member.

11. The tissue ablation device system of claim 1, wherein the ablation element comprises at least one electrode that is adapted to couple to an electrical current source.

12. The tissue ablation device system of claim 1, wherein the ablation element comprises a plurality of electrodes that are located at least in part along the contact member and that are adapted to couple to an electrical current source.

13. The tissue ablation device system of claim 1, wherein the ablation element comprises a cryogenic ablation element.

14. The tissue ablation device system of claim 1, wherein the ablation element comprises an ultrasound ablation element.

15. The tissue ablation device system of claim 1, wherein the ablation element comprises a light emitting ablation element.

16. The tissue ablation device system of claim 1, wherein the ablation element comprises a microwave ablation element.

17. The tissue ablation device system of claim 1, wherein the ablation element comprises a thermal ablation element.

18. The tissue ablation device system of claim 1, wherein the ablation element comprises a chemical fluid ablation element.

19. A tissue ablation device system for ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:

a delivery member with a proximal end portion, a distal end portion, a longitudinal axis, and a fluid passageway extending along at least the proximal end portion and which is adapted to be fluidly coupled to a fluid source at a proximal fluid port located along the proximal end portion; and

an expandable member located along the distal end portion with a working length along the longitudinal axis which is adjustable between a radially collapsed position and a radially expanded position wherein the working length has a first portion, a second portion, and an intermediate portion between the first and second portions along the longitudinal axis and which in the radially expanded position has an expanded outer diameter that is sufficient to engage the circumferential region of tissue, wherein in the radially expanded position the system is adapted to allow a volume of fluid within the fluid passageway to be ablatively coupled to only a circumferential area surrounding the intermediate portion, whereby engaging the circumferential region of tissue with the intermediate portion the circumferential region of tissue may be positioned within the circumferential area such that the volume of fluid may be ablatively coupled to the circumferential region of tissue.

20. A tissue ablation device system as in claim 19, further comprising an ablation electrode which is adapted to be electrically coupled to an electrical current source and also to the fluid passageway when the volume of fluid comprises an electrically conductive medium, wherein the intermediate portion is adapted to allow the ablation electrode to be ablatively coupled to the circumferential area via an electrical current flowing at least in part through the electrically conductive medium.

21. A tissue ablation device system as in claim 20, wherein the ablation electrode is located at least in part within the fluid passageway.

22. A tissue ablation device system as in claim 19, wherein the intermediate portion is adapted to allow the volume of fluid to pass from within the fluid passageway and into the circumferential area.

23. A tissue ablation device system as in claim 19, further comprising a pressurizeable source of ablative fluid that is adapted to be fluidly coupled to the fluid passageway via the proximal port, wherein the intermediate portion is adapted to allow a volume of the ablative fluid within the fluid passageway to be ablatively coupled to only the circumferential area.

24. A tissue ablation device system as in claim 19, wherein the expandable member further comprises a balloon wall with an outer surface along the working length, and also comprises an outer wall having an inner surface which is disposed around and circumscribes the balloon wall along the intermediate portion;

the fluid passageway comprises an interior space formed at least in part between the inner and outer surfaces, and the circumferential area surrounds the outer wall along the intermediate portion; and

the system is adapted to allow the volume of fluid within the interior space to be ablatively coupled to the circumferential area through the outer wall.

25. A tissue ablation device system as in claim 19, wherein the expandable member further comprises an expandable balloon with a balloon wall constructed at least in part from a porous membrane along the first, second, and intermediate portions;

the balloon wall defines at least in part an interior space that forms at least a portion of the fluid passageway;

a first shield cooperates with the porous membrane to substantially prevent the volume of fluid within the interior space from being ablatively coupled to a first adjacent area surrounding the first portion;

a second shield cooperates with the porous membrane to substantially prevent the volume of fluid within the interior space from being ablatively coupled to a second adjacent area surrounding the second portion; and

the balloon wall along the intermediate portion is substantially unshielded such that the volume of fluid within the interior space may be ablatively coupled to the circumferential area through at least one pore provided along the porous membrane.

26. The tissue ablation device system of claim 19, further comprising an ultrasound ablation element which cooperates with the expandable member and which in the radially expanded condition is adapted to be ultrasonically coupled to the circumferential area.

27. The tissue ablation device system of claim 19, further comprising an electrode ablation element which cooperates with the expandable member and which in the radially expanded condition is adapted to be electrically coupled to the circumferential area.

28. The tissue ablation device system of claim 19, further comprising a thermal ablation element which cooperates with the expandable member and which in the radially expanded condition is adapted to be thermally coupled to the circumferential area.

29. The tissue ablation device system of claim 19, further comprising a cryogenic ablation element which cooperates with the expandable member and which in the radially expanded condition is adapted to be cryogenically coupled to the circumferential area.

30. The tissue ablation device system of claim 19, further comprising a light emitting ablation element which cooperates with the expandable member and which in the radially expanded condition is adapted to be optically coupled to the circumferential area.

31. The tissue ablation device system of claim 19, further comprising a microwave ablation element which cooperates with the expandable member and which in the radially expanded condition is adapted to be ablatively coupled to the circumferential area.

32. The tissue ablation device system of claim 19, further comprising a chemical ablation element which cooperates with the expandable member and which in the radially expanded condition is adapted to be chemically coupled to the circumferential area.

33. A tissue ablation device system for ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

a circumferential ablation member with an ablation element which is adapted to be ablatively coupled to the circumferential region of tissue when the circumferential ablation member is positioned along the location; and

a delivery assembly cooperating with the circumferential ablation member and which is adapted to deliver the circumferential ablation member to the location, wherein the delivery assembly comprises a delivery member having a proximal end portion and a distal end portion with a tracking member which is adapted to slidably engage a guide member seated within the pulmonary vein and to track over the guide member such that the circumferential ablation member may be positioned at the location.

34. The tissue ablation device system of claim 33, wherein the tracking member further comprises a tracking passageway extending between a distal port along the distal end portion of the delivery member and a proximal port located along the delivery member proximally of the distal port, the tracking passageway being adapted to receive and slideably engage the guide member through the distal and proximal ports and along the tracking passageway.

35. The tissue ablation device system of claim 34, wherein the proximal port is located along the distal end portion of the delivery member.

36. The tissue ablation device system of claim 34, wherein the proximal port is located along the proximal end portion of the delivery member and is adapted to be positioned externally of the patient when the circumferential ablation member is positioned at the location.

37. The tissue ablation device system of claim 36, further comprising a pulmonary vein guide member which is adapted to be seated within the pulmonary vein and to be moveably engaged and tracked by the tracking member.

38. The tissue ablation device system of claim 37, wherein the pulmonary vein guide member comprises a guidewire which is adapted to have a shaped, steerable distal tip.

39. The tissue ablation device system of claim 37, wherein the guidewire has an outer diameter from about 0.018 inches to about 0.035 inches.

40. The tissue ablation device system of claim 33, wherein the delivery assembly further comprises at least one guiding catheter which has an internal passageway which is adapted to slideably receive the circumferential ablation member and the delivery member and also to deliver the circumferential ablation member into the atrium.

41. The tissue ablation device system of claim 33, wherein the ablation element further comprises an electrode ablation element.

42. The tissue ablation device system of claim 33, wherein the ablation element further comprises an ultrasound ablation element.

43. The tissue ablation device system of claim 33, wherein the ablation element further comprises a thermal ablation element.

44. The tissue ablation device system of claim 33, wherein the ablation element further comprises a light emitting ablation element.

45. The tissue ablation device system of claim 33, wherein the ablation element further comprises a microwave ablation element.

46. The tissue ablation device system of claim 33, wherein the ablation element further comprises a chemical ablation element.

47. A tissue ablation device system for ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

a circumferential ablation member with an ablation element which is adapted to ablatively couple to the circumferential region of tissue when the circumferential ablation member is positioned along the location; and

a delivery member with a proximal end portion and a distal end portion, wherein the circumferential ablation member is located at least in part along the distal end portion and is adapted to be delivered to the location at least in part with the delivery member,

wherein the system is adapted to allow a volume of blood to flow from the pulmonary vein, across the location, and into the atrium when the circumferential ablation member is positioned along the location and the ablation element is ablatively coupled to the circumferential region of tissue.

48. The tissue ablation device system of claim 47, further comprising a perfusion member cooperating with the circumferential ablation member and also with the delivery member and having a perfusion passageway extending between a distal port located distally of the circumferential ablation member and a proximal port located proximally of the circumferential ablation member,

wherein the perfusion passageway is adapted to allow blood to flow through the distal port, along the perfusion passageway, and out the proximal port while the ablation element is ablatively coupled to the circumferential region of tissue.

49. The tissue ablation device assembly as in claim 47, wherein the circumferential ablation member additionally includes an expandable member cooperating with the ablation element and which is adapted to substantially engage the circumferential region of tissue when the ablation element is ablatively coupled to the circumferential region of tissue.

50. The tissue ablation device assembly of claim 47, wherein the ablation element further comprises an electrode ablation element.

51. The tissue ablation device assembly of claim 47, wherein the ablation element further comprises an ultrasound ablation element.

52. The tissue ablation device assembly of claim 47, wherein the ablation element further comprises a thermal ablation element.

53. The tissue ablation device assembly of claim 47, wherein the ablation element further comprises a light emitting ablation element.

54. The tissue ablation device assembly of claim 47, wherein the ablation element further comprises a microwave ablation element.

55. The tissue ablation device assembly of claim 47, wherein the ablation element further comprises a chemical ablation element.