Tissue ablation device and method of use

• US 6,855,144 B2
• Filed: 08/30/2002
• Issued: 02/15/2005
• 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): GIBSON, ROY DEAN
• Application Number:
  US10/233,264
• Publication Number:
  US 20030055422A1
• Time in Patent Office: 900 Days
• Field of Search: 606/41, 606 45- 47, 606 49- 50, 607/101, 607/102, 607/122, 600/585, 600/373, 600/375, 600/377, 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 for creating long linear lesions in the tissue of a body space wall which defines at least in part a body space in an animal, comprising:

an elongate body having proximal and distal end portions;

an ablation element on the distal end portion and having first and second ends, said ablation element being adapted to ablate tissue when coupled to an ablation actuator;

a first anchor adjacent the first end which is adapted to secure the first end at a predetermined first location along the body space wall; and

a second anchor adjacent the second end which is adapted to secure the second end at a predetermined second location along the body space wall,

whereby securing the first and second ends to the predetermined locations with the anchors, said ablation element is adapted to substantially contact a length of said tissue adjacent to the ablation element and between the first and second locations without substantially repositioning the distal end portion of the elongate body.

2. The device of claim 1, wherein at least one of said first and second anchors is defined at least in part by said distal end portion and is adapted to secure one of the ablation element ends within an orifice in the body space wall through which the body space communicates with another adjacent body space.

3. The device of claim 2, wherein the first end of the ablation element is adapted to be the distal end, and wherein said first anchor is adapted to secure the first end within a first ostium of a first vessel along an atrial wall, said first anchor comprising:

a distal guidewire tracking member which forms a bore that is adapted to advance the first end over a guidewire and into the first vessel when the guidewire is positioned therein, such that the ablation element extends from the first ostium and along the atrial wall to the second location.

4. The device of claim 3, wherein said distal guidewire tracking member comprises:

a distal guidewire lumen which is located at least in part within said distal end portion and which communicates exteriorly of the elongate body in the region of the distal end portion through a first distal guidewire port and also communicates exteriorly of the elongate body through a second distal guidewire port located proximally of the first distal guidewire port.

5. The device of claim 4, wherein said first anchor further comprises:

a guidewire having a guidewire proximal end portion, a guidewire distal end portion, and a stop on the guidewire distal end portion that has a diameter larger than the first distal guidewire port,

wherein said distal guidewire lumen is adapted to slideably receive the guidewire proximal end portion through the first distal guidewire port and to coaxially advance over the guidewire distal end portion until the first distal guidewire port confronts the stop.

6. The device of claim 5, wherein said first anchor comprises:

a guidewire having a guidewire proximal end portion, a guidewire distal end portion, and a stop on the guidewire distal end portion which has a diameter larger than the second distal guidewire port,

wherein said distal guidewire lumen is adapted to slideably receive the guidewire distal end portion through the second distal guidewire port until the stop confronts the second distal guidewire port.

7. The device of claim 4, wherein said first anchor further comprises:

an expandable region of said distal end portion which is coupled to an actuating means for expanding the expandable region and which is adapted to circumferentially engage at least a portion of the first vessel when expanded therein.

8. The device of claim 1, wherein said ablation element comprises a plurality of electrodes which are adapted to couple to a current source and which are adapted to collectively form a long linear lesion in atrial wall tissue with a length that extends at least along the plurality or electrodes when the electrodes are simultaneously energized.

9. The device of claim 8, further comprising a radiofrequency (RE) current source coupled with said plurality of electrodes.

10. The device of claim 8, further comprising a plurality of temperature sensors, each temperature sensor being in the region of one of said plurality of electrodes and being adapted to couple to a temperature monitoring circuit.

11. The device of claim 10, further comprising a control circuit adapted to adjust the energy supplied to at least one electrode based upon a predetermined temperature monitored at the temperature sensor in the region of the at least one electrode.

12. The device of claim 8, further comprising a control circuit adapted to monitor an electrical parameter in an ablation actuating circuit containing at least one electrode and to adjust the current being supplied to said at least one electrode based upon the measured electrical parameter, said electrical parameter being chosen from the group of electrical parameters consisting of:

output voltage, output current, output power, impedance, reflected power, and change or time rate of change of these parameters.