Method and apparatus for RF ablation and hyperthermia

• US 5,807,395 A
• Filed: 04/22/1997
• Issued: 09/15/1998
• Est. Priority Date: 08/27/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hoey, Michael F., Mulier, Peter M. J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/837,737
• Time in Patent Office: 511 Days
• Field of Search: 606/27-34, 606/41, 606/42, 606/45-50, 607/100-105, 607/154, 607/156, 604/21, 604/22, 600/372-374
• US Class Current: 606/41
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2218/002 : Irrigation

Abstract

A methods and apparatuses for ablation or hyperthermic treatment of body tissue are disclosed, wherein the application of radio-frequency ablative or hyperthermic energy is accompanied by the infusion of a conductive solution into the tissue, such that a virtual electrode is created. The virtual electrode results from the increased conductivity of the tissue in the area being treated due to the presence of conductive solution, such that the area of tissue being treated is enlarged as compared with non-fluid-assisted application of energy. In one embodiment, a catheter having a hollow helical electrode/needle on the distal end thereof is provided, such that the electrode/needle can be screwed into the tissue to be treated. A conductive fluid, such as saline, saturated saline, or Ringer'"'"'s solution, is infused into the tissue to be treated via the hollow electrode and a lumen extending along the length of the catheter. In another embodiment of the invention, an implantable infusion port for fluid-assisted ablation and/or hyperthermia is provided with an elongate catheter having a hollow electrode/needle on the distal end thereof. The port is subcutaneously implanted with the electrode/needle situated within the tissue to be treated. A percutaneous needle facilitates the introduction of conductive fluid and/or chemotherapeutic agents into the tissue via a lumen in the catheter and the hollow electrode/needle. The percutaneous needle also makes electrical contact with a conductor in the catheter, such that as fluid is being introduced into the tissue, radio-frequency energy may be applied to the tissue being treated.

Claims

1. A prostate ablation catheter system, comprising:

an elongate catheter body having proximal and distal ends, a longitudinal fluid-conducting lumen extending between the proximal and distal ends, and an electrical conductor extending between the proximal and distal ends;

a hollow electrode in fluid communication with the longitudinal lumen at the distal end of the catheter body and in electrical contact with the electrical conductor at the distal end of the catheter body, the hollow electrode adapted to be introduced into a patient'"'"'s prostate, and having at least one fluid port, the hollow electrode comprising;

an elongate needle having a distal portion with at least one distal fluid port for enabling fluid to be expelled therefrom, and a proximal portion in fluid communication with the catheter body lumen, the proximal portion having at least one proximal fluid port for enabling fluid to be expelled therefrom, and

a balloon disposed circumferentially around the needle over the at least one proximal fluid port, such that fluid delivered to the needle via the catheter body lumen and expelled from the proximal fluid port inflates the balloon, the balloon thereby minimizing proximally-directed escape of fluid expelled from the distal fluid port;

a radio-frequency electrical generator coupled to the electrical conductor at the proximal end of the catheter body;

a source of conductive fluid, in fluid communication with the lumen at the proximal end of the catheter body, for delivering the conductive fluid through the lumen to be expelled from the fluid port into the prostate simultaneously with the application of energy from the generator to the prostate via the conductor and the electrode.

2. A prostate ablation catheter system in accordance with claim 1, in which the hollow electrode comprises a helical needle.

3. A prostate ablation catheter system in accordance with claim 1, further comprising a heat exchanger in fluid communication with the source of conductive fluid for cooling the fluid prior to delivery of the fluid through the catheter body lumen.

4. A prostate ablation catheter system in accordance with claim 1, further comprising a thermocouple, adapted to be inserted into the prostate at the periphery of the prostate area to be ablated, the thermocouple providing feedback to the generator to modulate the application of energy such that ablation temperature in the prostate is kept within predetermined limits.

5. A prostate ablation catheter system, comprising:

a first elongate catheter having proximal and distal ends, a longitudinal fluid-conducting lumen extending between the proximal and distal ends, and an electrical conductor extending between the proximal and distal ends;

a hollow electrode, having at least one conductive fluid port, which is in fluid communication with the longitudinal lumen at the distal end of the catheter body and in electrical contact with the electrical conductor at the distal end of the catheter body, the hollow electrode adapted to be introduced into a patient'"'"'s prostate;

a radio-frequency electrical generator coupled to the electrical conductor at the proximal end of the first catheter,

a source of conductive fluid, in fluid communication with the lumen at the proximal end of the first catheter, for delivering the conductive fluid through the lumen to be expelled from the fluid port into the prostate simultaneously, with the application of energy from the generator to the prostate via the conductor and the electrode; and

a urethral cooling catheter sub-system, comprising;

a second elongate catheter having proximal and distal ends and a longitudinal lumen extending between the proximal and distal ends, the second catheter being adapted to be introduced into a patient'"'"'s urethra such that the distal end of the second elongate catheter is disposed in the urethra in the region of the prostate;

a third elongate catheter having an outer diameter which allows it to be introduced into the longitudinal lumen of the second catheter, the third catheter having proximal and distal portions and a longitudinal lumen extending between the proximal and distal portions, and further having at least one distal chilled fluid port disposed in the distal portion;

a source of cooled fluid, in fluid communication with the proximal portion of the third catheter, for delivering chilled fluid through the longitudinal lumen of the third catheter to be expelled from the at least one distal chilled fluid port;

such that when the second catheter is introduced into the urethra and the third catheter is introduced into the lumen of the second catheter, chilled fluid directed through the lumen of the third catheter is expelled from the distal chilled fluid port and communicated in the lumen of the second catheter to drain at the proximal end of the second elongate catheter, the flow of fluid through the second and third catheter lumens thereby cooling the urethra during ablation.

6. A prostate ablation catheter system in accordance with claim 5, in which the hollow electrode comprises a helical needle.

7. A prostate ablation catheter system in accordance with claim 5, in which the hollow electrode has a threaded conical configuration adapted to create pressure against prostate tissue into which it is screwed, thereby minimizing proximally-directed fluid escape.

8. A prostate ablation catheter system in accordance with claim 5, in which the hollow electrode comprises an expanding helical needle adapted to compress tissue into which it is screwed, thereby minimizing proximally-directed fluid escape.

9. A prostate ablation catheter system in accordance with claim 5, further comprising a heat exchanger in fluid communication with the source of conductive fluid for cooling the fluid prior to the delivery of the fluid through the catheter body lumen.

10. A prostate ablation catheter system in accordance with claim 5, further comprising a thermocouple, adapted to be inserted into the prostate at the periphery of the prostate area to be ablated, to provide feedback to the generator to modulate the application of energy such that ablation temperature in the prostate is kept within predetermined limits.