Tissue ablation device and method of use

• US 5,971,983 A
• Filed: 05/09/1997
• Issued: 10/26/1999
• Est. Priority Date: 05/09/1997
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Lesh, Michael D.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US08/853,861
• Time in Patent Office: 900 Days
• Field of Search: 606/41, 606/45, 606/46, 606/47, 600/585, 600/373-375, 600/377, 607/101, 607/122, 604/96, 604/101, 604/104, 604/264, 604/280
• US Class Current: 606/41
• 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

Abstract

A tissue ablation device creates long linear lesions along a body space wall of an animal, and primarily between adjacent pulmonary vein ostia in a left atrial wall. An ablation element includes first and second ends that are bordered by first and second anchors. The anchors are adapted to secure the ablation element ends at predetermined first and second locations along the body space wall such that the ablation element is adapted to ablate an elongate region of tissue between those locations. The anchors may be guidewire tracking members, each including a bore adapted to receive and track over a guidewire, and may anchor within adjacent pulmonary vein ostia when the engaged guidewires are positioned within the respective veins. Stop members may be provided on the guidewires and may be adapted for positioning the relative anchors or for forcing the anchors to fit snugly within the vein ostia. A conduit passageway through the catheter houses a stiffening stylet which may be advanced into the region of the ablation element in order to impart a shape to that element to conform it to a predetermined region of anatomy, or to stiffen the underlying catheter in order to advance the assembly into remote anatomy.

Claims

1. A tissue ablation device assembly, comprising:

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

an ablation member located at least in part along the distal end portion of the elongate body with a first end portion, a second end portion located proximally of the first end portion, and an ablation element between the first and second end portions;

a first anchor located at least in part along the first end portion wherein the first anchor is adapted to be positioned at least in part within a first pulmonary vein extending from the left atrial wall of a left atrium in a patient in a patient; and

a second anchor located at least in part along the second end portion wherein the second anchor is adapted to be positioned at least in part within a second pulmonary vein extending from the left atrial wall.

2. The tissue ablation device assembly of claim 1, wherein the first anchor comprises a first guidewire which is positionable within the first pulmonary vein and also a first guidewire tracking member which is located at least in part along the first end portion and is adapted to moveably engage the first guidewire and to track over the first guidewire when the first guidewire is positioned within the first pulmonary vein.

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

the assembly further comprises a longitudinal axis;

the first guidewire tracking member comprises a first guidewire passageway extending along the elongate body between a first distal port located along the distal end portion and a first proximal port located along the elongate body proximally of the first distal port, the first guidewire passageway being adapted to slideably receive the first guidewire through the first distal and proximal ports; and

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

4. The tissue ablation device assembly of claim 2, wherein the second anchor comprises a second guidewire which is positionable within the second pulmonary vein and also a second guidewire tracking member which is located at least in part along the second end portion and is adapted to moveably engage the second guidewire.

5. The tissue ablation device assembly of claim 4, wherein

the assembly further comprises a longitudinal axis;

the first guidewire tracking member comprises a first guidewire passageway extending along the elongate body between a first distal port located along the distal end portion and a first proximal port located along the elongate body proximally of the first distal port, the first guidewire passageway being adapted to slideably receive the first guidewire through the first distal and proximal ports; and

the second guidewire tracking member comprises a second guidewire passageway extending along the elongate body between a second distal port located proximally of the first distal port along the elongate body and a second proximal port located proximally of the second distal port along the elongate body, the second guidewire passageway being adapted to slideably receive the second guidewire through the second distal and proximal ports.

6. The tissue ablation device assembly of claim 5, wherein the ablation element is located along the distal end portion between the first and second distal ports.

7. The tissue ablation device assembly of claim 1, wherein

the first anchor comprises an anchoring region formed along the first end portion and which is adapted to have a shape which is positionable within the first pulmonary vein.

8. The assembly of claim 7, wherein the first anchor further comprises a guidewire tracking member located at least in part along the anchoring region and which is adapted to moveably engage a guidewire positioned within the first pulmonary vein and to track over the guidewire into the first pulmonary vein.

9. The assembly of claim 7, wherein

the anchoring region is a first anchoring region;

and

the second anchor comprises a second anchoring region formed along the second end portion and which is adapted to have a second shape that is positionable within the second pulmonary vein.

10. The assembly of claim 9, wherein

the first anchor further comprises a first guidewire tracking member located at least in part along the first anchoring region and which is adapted to moveably engage a first guidewire positioned within the first pulmonary vein and to track over the first guidewire until the first guidewire tracking member is positioned at least in part within the first pulmonary vein;

and

the second anchor further comprises a second guidewire tracking member located at least in part along the second anchoring region and which is adapted to moveably engage a second guidewire positioned within the second pulmonary vein and to track over the second guidewire until the second guidewire tracking member is positioned at least in part within the second pulmonary vein.

11. The tissue ablation device assembly of claim 1, wherein at least one of said first and second anchors further comprises an expandable member which is adapted to couple to an expansion actuator and to expand to engage a pulmonary vein wall of a pulmonary vein.

12. The assembly of claim 1, wherein

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

13. A tissue ablation device assembly for ablating a region of tissue along an atrial wall of an atrium in a patient, comprising:

an ablation member with first and second end portions and an ablation element between the first and second end portions;

a first guidewire;

a second guidewire;

a first guidewire tracking member located along the first end portion and which is adapted to moveably engage the first guidewire; and

a second guidewire tracking member located along the second end portion and which is adapted to moveably engage the second guidewire.

14. The tissue ablation device assembly of claim 13, wherein

the assembly further comprises an elongate body having a proximal end portion, a distal end portion, and a longitudinal axis;

the first guidewire tracking member comprises a first guidewire passageway extending along the elongate body between a first distal port located along the distal end portion and a first proximal port located along the elongate body proximally of the first distal port, the first guidewire passageway being adapted to slideably receive the first guidewire through the first distal and proximal ports; and

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

15. The tissue ablation device assembly of claim 14, wherein

the second guidewire tracking member comprises a second guidewire passageway extending along the elongate body between a second distal port located proximally of the first distal port along the elongate body and a second proximal port located proximally of the second distal port along the elongate body, the second guidewire passageway being adapted to slideably receive the second guidewire through the second distal and proximal ports.

16. The assembly of claim 13, wherein

the first guidewire is moveably engaged with the first guidewire tracking member;

and

the second guidewire is moveably engaged with the second guidewire tracking member.

17. The assembly of claim 13, wherein

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

18. The assembly of claim 13, wherein the first and second guidewire tracking members are not adapted to simultaneously, engage and track over a single guidewire when the single guidewire is positioned within a pulmonary vein.

19. The assembly of claim 13, wherein

the first guidewire tracking member has a first guidewire passageway which is adapted to moveably engage the first guidewire;

the second guidewire tracking member has a second guidewire passageway which is adapted to moveably engage the second guidewire; and

an elongate body has a proximal end portion, a distal end portion coupled to the ablation member, and a common section, wherein each of the first and second guidewire passageways extends at least in part along the common section.

20. The assembly of claim 13, wherein

the first guidewire is adapted to be positioned within a first pulmonary vein extending from a left atrium;

and

the first guidewire tracking member is adapted to track over the first guidewire and to be positioned within the left atrium,

wherein the second guidewire tracking member is also positioned within the left atrium without engaging the first guidewire.

21. The assembly of claim 13, wherein at least one of the first and second guidewire tracking members forms at least a portion of an anchor which is positionable within a pulmonary vein extending from a left atrium.