Device for treating cancer and non-malignant tumors and methods

• US 5,458,597 A
• Filed: 11/08/1993
• Issued: 10/17/1995
• Est. Priority Date: 11/08/1993
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: ZoMed International, Inc.
• Inventors: Sharkey, Hugh R., Edwards, Stuart D., Lax, Ronald G.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/148,439
• Time in Patent Office: 708 Days
• Field of Search: 606/27-31, 606/41, 606/45-50, 607/96, 607/98-102, 607/115, 607/116, 607/120, 607/154, 604/22, 604/21, 128/642
• US Class Current: 606/41
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00476 Hair follicles
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00726 Duty cycle
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• 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 2018/162 : located on the probe body
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61N 5/02 : using microwaves
• CPC Class Codes: A61N 5/04 : Radiators for near-field treatment
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body

Abstract

A method of this invention for treating body tissues containing cancerous cells or non-malignant tumors with RF ablation, alone or in combination with systemic or localized chemotherapy comprising introducing a stylet comprising an electrode surface and a sleeve longitudinally moveable thereon into the vicinity of the body tissues, retracting the sleeve from a portion of the electrode surface, and supplying RF power to the electrode surface sufficient to heat the tissue to a temperature of above about 45° C. for a time to cause reduction of tissue mass in the vicinity of the electrode. The RF power supplied to the electrode surface is sufficient to effect a desiccated fluid diffusion barrier capsule surrounding the body tissue being treated. The stylet can include a hollow tube having fluid distribution ports therein, and the method can include the step of passing fluid through one or more distribution ports into the body tissue being treated. The fluid can be saline or a chemotherapeutic fluid such as liquid or gas containing a cytotoxic agent, for example. The fluid can be administered in a variety of procedures. The fluid can be passed through a distribution port into the body tissue before, during and/or after the RF power is supplied to the electrode surface, for example. Preferably, the fluid is introduced after a barrier capsule has been formed. The devices comprises electrodes having a hollow core and a closed sharpened distal tip. The electrode has a plurality of fluid distribution ports therein for distribution of fluid treatment agents into the tissue.

Claims

1. An RF ablation device for delivering chemotherapeutic agents to a tissue treatment site and for creating a diffusion barrier capsule to impede diffusion of chemotherapeutic agents from the tissue treatment site, the ablation device comprising:

a hollow tubular Rf electrode having a closed, sharpened distal tip and a conductive surface to which Rf power is supplied to heat the tissue treatment site to a temperature between about 45°

C. and 170°

C. to produce a diffusion barrier capsule, the Rf electrode also including a plurality of fluid distribution ports distributed along the length of the electrode for delivering chemotherapeutic agents to the tissue treatment site; and

a fluid distribution port blocking implement positioned within the hollow tubular Rf electrode whose position within the electrode is adjustable to prevent fluid from passing through one or more of the plurality of fluid distribution ports.

2. An Rf ablation device according to claim 1 wherein the device further includes an insulating sleeve covering the electrode, the insulating sleeve being moveable along the length of the electrode to define an electrode conductive surface.

3. An Rf ablation device according to claim 1 wherein the electrode includes a plurality of conductive segments for delivering Rf energy, each conductive segment being insulated from neighboring segments and connected to a power delivery controller which controls the power delivered to each conductive segment.

4. An Rf ablation device according to claim 3 wherein the power delivery controller also controls the polarity of each conductive segment.

5. An Rf ablation device according to claim 3 wherein the device further includes an insulating sleeve covering the electrode, the insulating sleeve being moveable along the length of the electrode to define an electrode conductive surface.

6. An Rf ablation device according to claim 5 wherein the power delivery controller also controls the polarity of each conductive segment.

7. An Rf ablation device according to claim 1 wherein the tubular Rf electrode is composed of a shaped-memory metal.

8. An Rf ablation device according to claim 7 wherein the electrode further includes an insulating sleeve covering the electrode, the insulating sleeve being moveable along the length of the electrode to define an electrode conductive surface.

9. An Rf ablation device according to claim 7 wherein the electrode includes a plurality of conductive segments for delivering Rf energy, each conductive segment being insulated from neighboring conductive segments and connected to a power delivery controller which controls the power delivered to each conductive segment.

10. An Rf ablation device according to claim 9 wherein the power delivery controller also controls the polarity of each conductive segment.

14. The method according to claim 1 wherein the device further includes a moveable insulating sleeve covering the electrode, the method further comprising the step of positioning the insulating sleeve along the length of an electrode to define the electrode conductive surface.

15. The method according to claim 14 wherein the tubular Rf electrode is composed of a shaped-memory metal, the method further comprising the step of moving the insulating sleeve to expose a portion of the electrode wherein the portion of the electrode exposed reverts to its memory shape.

16. The method according to claim 1 further comprising the step of passing fluid through the fluid distribution ports while Rf energy is supplied to the electrode in order to reduce dehydration of tissue at the tissue treatment site during ablation.

11. A method for delivering chemotherapeutic agents to a tissue treatment site and for impeding diffusion of the chemotherapeutic agents from the tissue treatment site through the creation of a diffusion barrier capsule, the method comprising the steps of:

a) introducing an Rf ablation device into a tissue treatment site, the device including a hollow tubular Rf electrode having a closed, sharpened distal tip, an electrode conductive surface for conducting Rf ablation, and a plurality of fluid distribution ports distributed along the length of the electrode for delivering chemotherapeutic agents to the tissue treatment site;

b) supplying Rf power to the electrode to produce a diffusion barrier capsule at the tissue treatment site; and

c) introducing chemotherapeutic agents to the tissue treatment site through at least one of the fluid distribution ports, the diffusion barrier capsule impeding the diffusion of the chemotherapeutic agents from the tissue treatment site.

12. The method according to claim 11 wherein the device further includes a fluid distribution port blocking implement positioned within the hollow tubular Rf electrode, further comprising the step of positioning the position of the blocking implement within the electrode being adjustable to prevent fluid from passing through one or more of the plurality of fluid distribution ports.

13. The method according to claim 11 further comprising the step of heating the body tissues to a temperature between about 80°

C. and 170°

C. to produce the diffusion barrier capsule.

17. A method for delivering chemotherapeutic agents to a tissue treatment site and for impeding diffusion of the chemotherapeutic agents from the tissue treatment site through the creation of a diffusion barrier capsule, the method comprising the steps of:

a) introducing an Rf ablation device into a tissue treatment site, the device including a hollow tubular Rf electrode having a closed, sharpened distal tip, an electrode conductive surface for conducting Rf ablation, and a plurality of fluid distribution ports distributed along the length of the electrode for delivering chemotherapeutic agents to the tissue treatment site, the device further including a fluid distribution port blocking implement positioned within the hollow tubular Rf electrode, the position of the blocking implement within the electrode being adjustable to prevent fluid from passing through one or more of the plurality of fluid distribution ports;

b) supplying Rf power to the electrode to produce a diffusion barrier capsule at the tissue treatment site;

c) adjusting the position of the blocking implement to prevent fluid from passing through one or more of the plurality of fluid distribution ports; and

d) introducing chemotherapeutic agents to the tissue treatment site through at least one fluid distribution port, the diffusion barrier capsule impeding the diffusion of the chemotherapeutic agents from the tissue treatment site.

18. A method for delivering chemotherapeutic agents to a tissue treatment site and for impeding diffusion of the chemotherapeutic agents from the tissue treatment site through the creation of a diffusion barrier capsule, the method comprising the steps of:

a) introducing an Rf ablation device into a tissue treatment site, the device including a hollow tubular Rf electrode having a closed, sharpened distal tip, a plurality of fluid distribution ports distributed along the length of the electrode for delivering chemotherapeutic agents to the tissue treatment site, and a plurality of conductive segments for delivering Rf energy, each segment being insulated from neighboring segments and connected to a power delivery controller which controls the power delivered to each conductive segment;

b) selecting the power delivered to each conductive segment using the power delivery controller;

c) supplying Rf power to the electrode to produce a diffusion barrier capsule at the tissue treatment site; and

d) introducing chemotherapeutic agents to the tissue treatment site through at least one fluid distribution port, the diffusion barrier capsule impeding the diffusion of the chemotherapeutic agents from the tissue treatment site.

19. A method according to claim 18 wherein the device further includes a fluid distribution port blocking implement positioned within the hollow tubular Rf electrode, the position of the blocking implement within the electrode being adjustable to prevent fluid from passing through one or more ports of the plurality of fluid distribution ports, the method comprising the further step of:

adjusting the position of the blocking implement within the hollow tubular Rf electrode to prevent fluid from passing through one or more ports of the plurality of fluid distribution ports.