MINIATURIZED DUAL-MODE ELECTROSURGICAL DEVICE AND METHODS OF USING SAME

• US 20140364844A1
• Filed: 06/06/2014
• Published: 12/11/2014
• Est. Priority Date: 06/06/2013
• Status: Abandoned Application

• Current Assignee: ElectroMedical Associates, Inc.
• Original Assignee: ElectroMedical Associates, Inc.
• Inventors: VAN WYK, Robert A.
• Application Number:
  US14/297,785
• Publication Number:
  US 20140364844A1
• Time in Patent Office: Days
• US Class Current: 606/37
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00446 Brain
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61B 2018/00607 Coagulation and cutting with the same instrument
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/128 generating two or more frequencies

Abstract

Described herein is a miniaturized dual-mode high-efficiency electrosurgical device that uses radio frequency (RF) energy to cut, resect, ablate, vaporize, denaturize, drill, coagulate and/or form lesions in soft tissues by means of a current-dispersing active element, with or without the use of externally supplied liquids, when operating in a first mode and then uses energy and same active element to thermally cauterize and/or spot coagulate tissues as needed when operating in a second mode. The miniaturized dual-mode RF electrosurgical devices of the instant invention find particular utility in the field neurosurgery, more particularly in the removal of brain tumors.

Claims

1. A dual-mode electrosurgical/thermal device comprising:

a. a proximal handle portion having a proximal end configured for connection to an external power source, wherein said handle portion contains a switching and control circuitry module that allows the device to be operated in either a first electrosurgical mode or a second thermal mode;

b. an elongate tubular portion affixed to the distal end of said handle portion;

c. a distal assembly affixed to the distal end of said elongate tubular portion that comprises;

i. an insulator; and

ii. an active element formed from an electrically conductive material that is in electrical communication with said external power source, wherein said active element takes the form of an elongate wire loop comprising of first and second axial sections and a third tranverse section, wherein the respective proximal ends of said first and second axial sections are affixed to the distal end of said insulator and the respective distal ends of said first and second axial sections connected to each other by means of the third transverse section;

d. circuity and cabling that extends from the proximal end of the handle portion to said distal assembly so as to define a current path from handle portion to said active element and back;

wherein said active element operates as a current-dispersing ablation electrode when the device is in the first electrosurgical mode and as a cauterizing heating element when said device is in the second thermal mode.

2. The dual-mode electrosurgical/thermal device of claim 1, wherein said device is a monopolar device that operates in conjunction with a return electrode in form of a remotely mounted dispersive pad.

3. The dual-mode electrosurgical/thermal device of claim 1, wherein said distal assembly further comprises a return electrode in close proximity to the active element.

4. The dual-mode electrosurgical/thermal device of claim 1, wherein said distal assembly further comprises a conductive floating electrode that is not in electrical communication with any power source positioned in close proximity to the active element, wherein the floating electrode coordinates with the active element to concentrate the power in the vicinity of the active element and increase the energy density in the region surrounding the active element.

5. The dual-mode electrosurgical/thermal device of claim 1, wherein when the device is operating in the electrosurgical mode, the energy supplied to the active element is RF energy.

6. The dual-mode electrosurgical/thermal device of claim 1, wherein when the device is operating in the thermal mode, the energy supplied to the active element is selected from the group consisting of rectified RF energy, low frequency alternating current or direct current.

7. The dual-mode electrosurgical/thermal device of claim 1, wherein said external source comprises an electrosurgical generator capable of supplying a radio-frequency (RF) signal.

8. The dual-mode electrosurgical/thermal device of claim 1, wherein said switching and control circuitry module further includes circuitry for converting an RF signal from an external power source to a voltage and frequency suitable for operating in said active element in said second thermal mode.

9. The dual-mode electrosurgical/thermal device of claim 1, wherein said switching and control circuitry module further includes a potentiometer or an electronic regulating circuit in the current path that allows the user to adjust the degree of heating of the active element when the device is operating in the thermal mode.

10. The dual-mode electrosurgical/thermal device of claim 1, wherein said handle portion further comprises an onboard power source.

11. The dual-mode electrosurgical/thermal device of claim 1, wherein said onboard power source comprises a battery pack.

12. The dual-mode electrosurgical/thermal device of claim 1, wherein said handle portion comprises an array of activation and control elements that coordinate with said switching and control circuitry module to direct the operation of the device in said first electrosurgical mode or said second thermal mode.

13. The dual-mode electrosurgical/thermal device of claim 12, wherein said an array of activation and control elements includes:

a. a first button for activating the application of an RF signal having a first waveform and preselected power level from the external power source to both said first and second axial sections of the active element;

b. an optional second button for activating the application of an RF signal having a second waveform and preselected power level from the external power source to both said first and second axial sections of the active element;

c. a third button for activating the application of electrical current to only the first axial section of said active element, whereby current flows from the first to the third to the second section of said active element so as to cause resistive heating of the element.

14. The dual-mode electrosurgical/thermal device of claim 13, wherein said an array of activation and control elements further includes a slide switch for alternating between electrosurgical mode and thermal mode.

15. The dual-mode electrosurgical/thermal device of claim 14, wherein said slide switch alternates the power source from an external power source of RF energy to an on-board power source of direct current.

16. The dual-mode electrosurgical/thermal device of claim 1, wherein said device is miniaturized to facilitate atraumatic introduction into the tissues of the brain via an incision in the skull.

17. The dual-mode electrosurgical/thermal device of claim 3, wherein the elongate wire loop and the return electrode are each formed from an electrically conductive material selected from the group consisting of tungsten, stainless steel, nickel, titanium and alloys thereof.

18. The dual-mode electrosurgical/thermal device of claim 1, wherein the elongate wire loop has a small diameter on the order of less than 0.03 inches (0.75 mm).

19. The dual-mode electrosurgical/thermal device of claim 1, wherein the elongate wire loop has a small diameter on the order of less than 0.016 inches (0.4 mm).

20. The dual-mode electrosurgical/thermal device of claim 1, wherein said insulator is formed of alumina or another suitable high-temperature dielectric material.

21. A method for removing a brain tumor in a patient in need thereof, said method comprising the steps of:

a. Introducing the dual-mode electrosurgical/thermal device of claim 1 through an incision in the patient'"'"'s skull and advancing the device to be in contact with the brain tumor;

b. Selecting the electrosurgical mode such that said active element operates as a current-dispersing ablation electrode and manipulating said active element so as to ablate or resect the brain tumor; and

c. Selecting the thermal mode such that said active element operates as a cauterizing heating element and manipulating said active element to spot coagulate bleeding tissues.

22. The method of claim 21, wherein said device is miniaturized to facilitate atraumatic introduction into the tissues of the brain via an incision in the skull.

23. The method of claim 21, wherein the distal assembly of said dual-mode electrosurgical/thermal device further comprises a return electrode positioned in close proximity to the active element.

24. The method of claim 23, wherein the distal assembly of said dual-mode electrosurgical/thermal device further comprises a conductive floating electrode that is not in electrical communication with any power source positioned in close proximity to the active element, wherein the floating electrode coordinates with the active element to concentrate the power in the vicinity of the active element and increase the energy density in the region surrounding the active element.

25. The method of claim 21, wherein said selection step (b) involves pressing a first button that activates the application of an RF signal having a first waveform and preselected power level from the external power source to both said first and second axial sections of the active element and said selection step (c) involves pressing a third button that activates the application of electrical current to only the first axial section of said active element, whereby current flows from the first to the third to the second section of said active element so as to cause resistive heating of the element.

26. The method of claim 25, wherein current flows to or through the active element during entire period that the button is depressed.

27. The method of claim 25, wherein each activation causes current flow for a predetermined period of time or a predetermined energy.