Circumferential ablation device assembly

• US 6,117,101 A
• Filed: 11/25/1998
• Issued: 09/12/2000
• Est. Priority Date: 07/08/1997
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson), Regents of the University of California (University of California)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson), Regents of the University of California (University of California)
• Inventors: Lesh, Michael D., Diederich, Chris J., Peacock, James C. III, Ross, Michael R.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US09/199,736
• Time in Patent Office: 657 Days
• Field of Search: 606/15, 606/32, 606/40, 606/41, 606/45, 606/46, 606/47, 606/48, 607/96, 607/99, 607/122, 600/373, 600/374, 600/381, 600/471, 604/101, 604/22
• US Class Current: 604/22
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

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. A cylindrical ultrasound transducer is provided on an inner member within the balloon and forms the circumferential ablation member by emitting a radial ultrasound signal which is circumferential to the transducer and highly collimated to the transducer'"'"'s length. The circumferential ultrasound signal sonically couples to the balloon'"'"'s outer skin to form the circumferential ablation element that is adapted to ablate a circumferential path of tissue engaged to the balloon.

Claims

1. A tissue ablation device assembly for 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 elongate body with a proximal end portion and a distal end portion, the distal end portion having proximal and distal sections;

an expandable member including a proximal end and a distal end coupled to the proximal and distal sections of the distal end portion, respectively, the expandable member being adjustable between a radially collapsed condition and a radially expanded condition with an expanded outer diameter which is adapted to engage the substantial portion of the circumferential region of tissue; and

an ultrasound ablation element secured to the distal section at a fixed position within the expandable member, wherein the ultrasound ablation element is adapted to emit a substantially circumferential pattern of ultrasound energy and to ablatively couple to the substantial portion of the circumferential region of tissue engaged by the expandable member in the radially expanded condition when the ultrasound ablation element is coupled to and actuated by an ultrasound ablation actuator.

2. The assembly of claim 1, wherein the expanded outer diameter of the expandable member is at least 1.0 centimeters when in the expanded condition.

3. The assembly of claim 1, wherein the expanded outer diameter of the expandable member is at least 2.0 centimeters when in the expanded condition.

4. The assembly of claim 1, wherein the expanded outer diameter of the expandable member is between about 1.0 centimeter and about 2.5 centimeter when in the expanded condition.

5. The assembly of claim 1, wherein the distal end portion of the elongated body comprises a plurality of tubular members.

6. The assembly of claim 1, wherein the ultrasound ablation element comprises a substantially tubular ultrasound transducer that is mounted onto and surrounds the distal end portion at the fixed position.

7. The assembly of claim 6, wherein the distal end portion has an outer surface, and the ultrasound transducer is mounted onto the distal end portion with a radial separation between at least a portion of the ultrasound transducer and the outer surface of the distal end portion that forms a radial separation region with a gas-filled gap.

8. The assembly of claim 7, wherein the radial separation region is sealed to substantially prevent fluid from entering from outside of the radial separation region into the gap.

9. The assembly of claim 7, further comprising a support member being positioned within the radial separation region and bridging between the distal end portion of the elongated body and the tubular ultrasound transducer to thereby support at least in part the tubular ultrasound transducer around the distal end portion of the elongated body.

10. The assembly of claim 9, wherein the support member comprises a substantially elastomeric material.

11. The assembly of claim 7, wherein the distal end portion of the elongated body comprises a plurality of ridges that are spaced apart such that a plurality of said radial separation regions is formed within the spaces between the ridges and between tubular ultrasound transducer and the distal end portion.

12. The assembly of claim 6, wherein the tubular ultrasound transducer comprises a piezoceramic material and has an electrically conductive inner surface and an electrically conductive outer surface, and the assembly further comprising a first electrical lead with a distal end portion electrically coupled to the electrically conductive inner surface and a second electrical lead with a distal end portion electrically coupled to the electrically conductive outer surface, wherein each of the first and second electrical leads also has a proximal end portion terminating along the proximal end portion of the elongate body, and wherein the proximal end portions of the electrical leads are adapted to couple to an electrical current source.

13. The assembly of claim 1, wherein the ultrasound ablation element comprises an array of circumferentially spaced ultrasound transducer panels.

14. The assembly of claim 13, wherein each ultrasound transducer panel is adapted to be individually actuated, such that each ultrasound transducer panel is adapted to be ablatively couple to the substantial portion of the circumferential region of tissue.

15. The assembly of claim 14, wherein each of the circumferentially spaced ultrasound transducer panels in the array comprises a piezoceramic material, and further comprising a plurality of actuating lead assemblies, each of the actuating lead assemblies being coupled to a corresponding one of the ultrasound transducer panels in the array and also adapted to couple to an electrical current source.

16. The assembly of claim 1, wherein the ultrasound ablation element is adapted to ablatively couple simultaneously to the substantial portion of the circumferential region of tissue.

17. The assembly of claim 1, wherein the ultrasound ablation element is adapted to emit a continuous circumferential pattern of ultrasound energy whereby the entire circumferential region of tissue is ablated.

18. The assembly of claim 1, wherein the ultrasound ablation element is adapted to emit an acoustic signal at a frequency of between about 5 MHz to about 20 MHz.

19. The assembly of claim 1, wherein the ultrasound ablation element is adapted to emit an acoustic signal at a power level of at least about 20 Watts per centimeter radiator.

20. The assembly of claim 1, wherein the elongate body further comprises a tracking member that is adapted to slideably engage and track over a guide member positioned within the pulmonary vein.

21. The assembly of claim 1, further comprising at least one or more electrodes located along the distal end portion of the elongated body and disposed so as to contact tissue, said electrodes adapted to deliver and/or sense electrical signals to and from the tissue.

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 in a patient, comprising:

providing an ultrasound ablation element coupled to an acoustic energy driver, and coupled to and fixed within a tissue coupling assembly, wherein the ultrasound ablation element is fixed within the tissue coupling assembly;

contacting the substantial portion of the circumferential region of tissue with at least a portion of the tissue coupling assembly, such that the ultrasound ablation element is positioned to deliver a substantially circumferential pattern of ultrasound energy through the tissue coupling assembly 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 tissue coupling assembly.

23. The method of claim 22, wherein contacting at least the substantial portion of the circumferential region of tissue comprises expanding an expandable member of the tissue coupling assembly to radially engage the substantial portion of the circumferential region of tissue.

24. The method of claim 23, wherein expanding the expandable member comprises inflating the expandable member, which is configured as a balloon and includes a balloon wall, with an ultrasonically transmissive inflation fluid such that at least a portion of the balloon wall contacts the substantial portion of the circumferential region of tissue;

and

ablatively coupling the ultrasound ablation element to the substantial portion of circumferential region of tissue involves allowing the substantially circumferential pattern of ultrasound energy to pass through the ultrasonically transmissive inflation fluid and across the balloon wall where in contact with the substantial portion of the circumferential region of tissue.

25. The method of claim 24, wherein inflating the expandable member comprises increasing the diameter of the expandable member to at least 1 cm.

26. The method of claim 25, wherein inflating the expandable member comprises increasing the diameter of the expandable member to at least 2 cm.

27. The method of claim 23, further comprising ablatively coupling the circumferential ultrasound ablation element to the substantial portion of the circumferential region of tissue at the location where cardiac tissue extends along the pulmonary vein.

28. The method of claim 23, further comprising ablatively coupling the circumferential ultrasound ablation element to the substantial portion of the circumferential region of tissue at the location where cardiac tissue extends along an ostium of the pulmonary vein.

29. The method of claim 23, further comprising ablatively coupling the circumferential ultrasound ablation element to the substantial portion of the circumferential region of tissue at the location along the atrial wall and surrounding an ostium of the pulmonary vein.

30. The method of claim 23, further comprising:

providing the ultrasound ablation element with an array of individual ultrasound transducer panels positioned about a circumference; and

separately actuating the array of individual ultrasound transducer panels to emit a plurality of discrete radially directed patterns of ultrasound energy that collectively ablatively couple to a substantial portion of the circumferential region of tissue.

31. The method of claim 23, further comprising actuating the ultrasound ablation element to emit the substantially circumferential pattern of ultrasound energy at a power level of at least 20 Watts.

32. The method of claim 23, further comprising actuating the ultrasound ablation element to emit the substantially circumferential pattern of ultrasound energy at a frequency of between about 5 MHz to about 20 MHz.

33. The method of claim 23 additionally involving diagnosing the patient with a focal origin of atrial arrhythmia in the pulmonary vein prior to actuating the acoustic energy driver.

34. The method of claim 23, wherein the entire circumferential region of tissue is ablatively coupled to the ultrasound ablation element.

35. The method of claim 34, wherein contacting the substantial portion of the circumferential region of tissue comprises contacting the portion of the tissue coupling assembly with the entire circumferential region of tissue.