System and method for applying thermal energy to tissue

• US 5,891,134 A
• Filed: 09/24/1996
• Issued: 04/06/1999
• Est. Priority Date: 09/24/1996
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Gynecare, Inc. (New Jersey) (Johnson & Johnson)
• Inventors: Warner, Robert, Goble, Colin
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/719,133
• Time in Patent Office: 924 Days
• Field of Search: 606/27-31, 606/41, 606/42, 606/45-50, 606/191-194, 607/100-102, 607/104, 607/105, 607/154, 607/156, 604/96-103
• US Class Current: 606/27
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

An apparatus, system, and method for treating body tissue using controlled application of heat includes a control unit providing electrical power to a bipolar electrode positioned within an expandable member filled with conductive fluid. Electrical power applied to the bipolar electrode by the control unit causes current to pass from the active electrode, into the conductive fluid, and to the return electrode, thereby heating the conductive fluid. The temperature of the conductive fluid is monitored by the control unit, and power is increased and decreased in accordance with a comparison of the monitored temperature against the desired temperature range. The control unit also includes a pressure sensor for regulating the pressure in the bladder. Pressure and temperature displays and other operator controls are located on the control unit.

Claims

1. An apparatus for treating tissue at a selected operation site, the apparatus comprising:

a bladder; and

a bipolar electrode assembly positioned within the bladder, said bipolar electrode assembly including an active electrode and a shield configured to prevent the active electrode from contacting the bladder.

2. The apparatus of claim 1, wherein the shield comprises a return electrode.

3. The apparatus of claim 2, wherein the return electrode is disposed on an inner surface of the shield, and the shield has an outer surface which is electrically non-conductive.

4. The apparatus of claim 1, wherein the shield further comprises one or more openings therethrough which allow a fluid to pass therethrough.

5. The apparatus of claim 1, wherein the bladder is filled with a conductive fluid.

6. The apparatus of claim 5, wherein the electrode assembly further comprises a return electrode, and the apparatus further comprises an RF power generator having bipolar outputs in electrical contact with the electrode assembly.

7. An apparatus for treating tissue at a selected operation site, the apparatus comprising:

a bladder; and

a bipolar electrode assembly positioned within the bladder, said bipolar electrode assembly including an active electrode and a return electrode, wherein the active electrode has an effective area, and the return electrode has an effective area different from the active electrode effective areas,

wherein the return electrode effective area is at least twice as large as the active electrode effective area,

wherein the active electrode is at a distal tip of the shaft, the return electrode is proximal to the return electrode on the shaft, and further comprising an insulator between the active electrode and return electrode, and

wherein the return electrode is coaxial with the active electrode.

8. The apparatus of claim 7, further comprising an RF power generator having bipolar outputs in electrical contact with the electrode assembly.

9. An apparatus for delivering controlled heat to a selected operation site, the apparatus comprising:

an expandable device, wherein the expandable device has a delivery configuration and an expanded configuration, wherein the expandable device may be transformed from the delivery configuration to the expanded configuration and subsequently returned to the delivery configuration;

a shaft having a distal end disposed within the expandable device, said shaft configured for movement within the expandable device, wherein the shaft passes through an opening in the expandable device, and said shaft is configured for pivotal movement within said opening; and

an electrode assembly at the shaft distal end.

10. The apparatus of claim 9, wherein said shaft is configured to longitudinally move within said opening.

11. The apparatus of claim 9, wherein the expandable device is an expandable cage.

12. The apparatus of claim 9, wherein the expandable device is a distensible bladder.

13. An apparatus for delivering controlled heat to a selected operation site, the apparatus comprising:

a shaft having a distal end;

an electrode assembly at the shaft distal end, said electrode assembly comprising at least one active electrode and at least one return electrode; and

a mechanically expandable device for the shaft distal end, wherein the mechanically expandable device has a delivery configuration and an expanded configuration,

wherein the mechanically expandable device may be transformed from the delivery configuration to the expanded configuration and subsequently returned to the delivery configuration, the mechanical device in the expanded configuration defining a space therein, wherein at least one of said electrodes is positioned within said defined space,

wherein the mechanically expandable device comprises an expandable cage, and

wherein at least one of said electrodes is disposed on the mechanically expandable device.

14. An apparatus for delivering controlled heat to a selected operation site, the apparatus comprising:

a shaft having a distal end;

a mechanically expandable device at the shaft distal end, wherein the mechanically expandable device has a delivery configuration and an expanded configuration; and

an electrode assembly at the shaft distal end, said electrode assembly comprising at least one active electrode and a plurality of return electrodes, wherein said return electrodes are disposed on the mechanically expandable device.

15. A method of treating tissue using a surgical device, wherein the surgical device has a distal end having an expandable device and a bipolar electrode assembly thereon, the bipolar electrode assembly comprising at least one active electrode and at least one return electrode, the method comprising the steps of:

(a) introducing the distal end of the surgical device into a selected operation site;

(b) expanding the expandable device, wherein the expandable device comprises an expandable cage having a plurality of cage bars, said cage bars having underlying portions of the tissue when the expandable cage is in the expanded configuration;

(c) filling the expandable device with a conductive fluid;

(d) applying RF output power to the bipolar electrode assembly to cause current to flow between the active electrode and the return electrode through the conductive fluid, thereby increasing the temperature of the conductive fluid;

(e) monitoring the impedance between the active electrode and return electrode;

(f) determining the temperature of the conductive fluid from the monitored impedance;

(g) positioning the bipolar electrode assembly at a location within the expandable device which is adjacent specifically targeted tissue;

(h) applying RF output power to the bipolar electrode assembly to effect treatment of the specifically targeted tissue;

(i) moving one or more cage bars to reveal the underlying tissue;

(j) placing the bipolar electrode assembly adjacent to the revealed underlying tissue; and

(k) applying output power to the bipolar electrode assembly sufficient to effect treatment of the revealed underlying tissue.

16. The method of claim 15, wherein step (c) comprises the step of filling the expandable device with a saline solution.