Self-limiting electrosurgical return electrode

• US 6,454,764 B1
• Filed: 05/12/2000
• Issued: 09/24/2002
• Est. Priority Date: 10/30/1996
• Status: Expired due to Term

• Current Assignee: Megadyne Medical Products Incorporated (Johnson & Johnson)
• Original Assignee: Megadyne Medical Products Incorporated (Johnson & Johnson)
• Inventors: Isaacson, James D., Fleenor, Richard P., Kieda, David B.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/569,998
• Time in Patent Office: 865 Days
• Field of Search: 606/32, 606/35, 606/39, 607/152, 128/908
• US Class Current: 606/32
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: Y10S 128/908 Patient protection from electric shock

Abstract

A self-limiting electrosurgical return electrode for use with electrosurgery. Through the selection of impedance characteristics for the electrode materials of the principal body of the electrode, and through tailoring of electrode geometries, the return electrode of the present invention is self-regulating and self-limiting as to current density and temperature rise so as to prevent patient trauma. The electrosurgical return electrode includes a sheet of material having an effective bulk impedance equal to or greater than about 4,000 Ω·cm and one or more connectors for making electrical connection to the sheet. The effective bulk impedance of the sheet may arise from resistive components, capacitive components, inductive components, or combinations thereof. The configuration of the presently described return electrode allows the electrode to self-limit the electrode'"'"'s current densities, thereby preventing burning of a patient during surgery. Furthermore, through employment of washable surface areas, the electrode is made readily cleanable, disinfectable, sterilizable, and reusable. An optional sleeve is provided for cooperative use with the electrode.

Claims

1. An electrosurgical return electrode comprising:

(a) a sheet of material having an effective bulk impedance equal to or greater than about 4,000 Ω

·

cm when a working surface of the sheet is in close proximity to a patient or in contact with the patient without use of a gel; and

(b) connecting means for making electrical connection to said sheet.

2. An electrosurgical return electrode according to claim 1, wherein said sheet comprises electrically conducting material having an effective bulk impedance equal to or greater than about 4,000 Ω

·

cm.

3. An electrosurgical return electrode according to claim 1, wherein said sheet comprises normally insulating material impregnated with electrically conducting fibers to render said sheet to have an effective bulk impedance equal to or greater than about 4,000 Ω

·

cm.

4. An electrosurgical return electrode according to claim 1, wherein said sheet comprises normally insulating material impregnated with electrically conducting carbon black to render said sheet to have an effective bulk impedance equal to or greater than about 4,000 Ω

·

cm.

5. An electrosurgical return electrode according to claim 1, wherein said effective bulk impedance of said sheet comprises electrical components selected from the group consisting of resistance, capacitive, inductive, and combinations thereof.

6. An electrosurgical return electrode according to claim 1, wherein said sheet comprises:

(i) a first layer of predetermined limited electrical conductivity; and

(ii) a second layer of dielectric material having a predetermined capacitive reactance, said second layer contacting and overlying said first layer.

7. The electrosurgical return electrode of claim 1, wherein said working surface having a surface area within a range from about 11 to about 1500 square inches.

8. An electrosurgical return electrode according to claim 1 wherein the return electrode is sterilizable.

9. An electrosurgical return electrode according to claim 1 wherein the return electrode is washable.

10. An electrosurgical return electrode according to claim 1 wherein the return electrode is reusable.

11. An electrosurgical return electrode according to claim 1 wherein the return electrode is disinfectable.

12. An electrosurgical return electrode according to claim 1 wherein the return electrode is disposable.

13. The reusable electrosurgical return electrode of claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 further comprising an insulating sleeve substantially enclosing said sheet.

14. An electrosurgical return electrode according to claim 1 or 7, wherein said sheet has a predetermined thickness and wherein the relationship between the bulk impedance, the surface area and the predetermined thickness are defined by the equation:

$t=\frac{1.2<br><br>A<br><br>\left(75\right)<br><br>\mathrm{\beta <br><br>}<br><br>\sqrt{1+{\mathrm{\omega <br><br>}}^2<br><br>{\mathrm{\eta <br><br>}}^2<br><br>{\mathrm{\kappa <br><br>}}^2<br><br>{\mathrm{\varepsilon <br><br>}}_0^2}}{\mathrm{\rho <br><br>}}$

where

t=thickness (cm)

κ

=dielectric constant of insulating material

β

=total impedance divided by the AAMI standard (75 ohms)

ω

=angular frequency of electrosurgical generator (radians/sec)

η

=bulk impedance (Ω

·

cm)

A=electrode area (cm²)

∈

₀=electrical permittivity constant (F/cm).

15. An electrosurgical return electrode comprising:

(a) a sheet of material having an effective bulk resistivity equal to or greater than about 4,000 Ω

·

cm when a working surface of the sheet is in close proximity to a patient or in contact with the patient without use of a gel; and

(b) connecting means for making electrical connection to said sheet.

16. An electrosurgical return electrode according to claim 15, wherein said sheet comprises electrically conducting material having an effective bulk resistivity equal to or greater than about 4,000 Ω

·

cm.

17. An electrosurgical return electrode according to claim 15, wherein said sheet comprises normally insulating material impregnated with electrically conducting fibers to render said sheet to have an effective bulk resistivity equal to or greater than about 4,000 Ω

·

cm.

18. An electrosurgical return electrode according to claim 15, wherein said sheet comprises normally insulating material impregnated with electrically conducting carbon black render said sheet to have an effective bulk resistivity equal to or greater than about 4,000 Ω

·

cm.

19. An electrosurgical return electrode according to claim 15, wherein said sheet comprises:

(i) a first layer of predetermined limited electrical conductivity; and

(ii) a second layer of dielectric material having a predetermined capacitive reactance, said second layer contacting and overlying said first layer.

20. An electrosurgical return electrode according to claim 15, wherein said sheet comprises:

(i) a first layer of predetermined limited electrical conductivity; and

(ii) a second layer of dielectric material having a predetermined inductive reactance, said second layer contacting and overlying said first layer.

21. The electrosurgical return electrode of claim 15, wherein said working surface having a surface area within a range from about 11 to about 1500 square inches.

22. An electrosurgical return electrode according to claim 15, wherein the return electrode is sterilizable, washable, reusable, disinfectable, or disposable.

23. The reusable electrosurgical return electrode of claim 15, 16, 17, 18, 19, 20, 21, or 22 further comprising an insulating sleeve substantially enclosing said sheet.

24. An electrosurgical return electrode according to claim 15 or 21, wherein said sheet has a predetermined thickness and wherein the relationship between the bulk resistivity, the surface area and the predetermined thickness are defined by the equation:

$t=\frac{1.2<br><br>A<br><br>\left(75\right)<br><br>\mathrm{\beta <br><br>}<br><br>\sqrt{1+{\mathrm{\omega <br><br>}}^2<br><br>{\mathrm{\rho <br><br>}}^2<br><br>{\mathrm{\kappa <br><br>}}^2<br><br>{\mathrm{\varepsilon <br><br>}}_0^2}}{\mathrm{\rho <br><br>}}$

where

t=thickness (cm)

κ

=dielectric constant of insulating material

β

=total impedance divided by the AAMI standard (75 ohms)

ω

=angular frequency of electrosurgical generator (radians/sec)

ρ

=bulk resistivity (Ω

·

cm)

A=electrode area (cm²)

∈

₀=electrical permittivity constant (F/cm).

25. An electrosurgical return electrode comprising:

(a) a sheet of material having a working surface, each square centimeter of said working surface presenting an effective resistance equal to or greater than about 8000Ω

when said working surface of the sheet is in close proximity to a patient or in contact with the patient without use of a gel; and

(b) connecting means for making electrical connection to said sheet.

26. An electrosurgical return electrode according to claim 25, wherein said sheet comprises:

(i) a first layer of predetermined limited electrical conductivity; and

(ii) a second layer of dielectric material having a predetermined capacitive reactance, said second layer contacting and overlying said first layer.

27. An electrosurgical return electrode according to claim 25, wherein said sheet comprises:

(i) a first layer of predetermined limited electrical conductivity; and

(ii) a second layer of dielectric material having a predetermined inductive reactance, said second layer contacting and overlying said first layer.

28. The electrosurgical return electrode of claim 25, wherein said working surface having a surface area within a range from about 11 to about 1500 square inches.

29. An electrosurgical return electrode according to claim 25, wherein the return electrode is sterilizable, washable, reusable, disinfectable, or disposable.

30. An electrosurgical return electrode according to claim 25, wherein said sheet comprises electrically conducting material.

31. An electrosurgical return electrode according to claim 25, wherein said sheet comprises normally insulating material impregnated with electrically conducting fibers to render said sheet to have each square centimeter of said working surface to present an effective resistance equal to or greater than about 8000Ω

.

32. An electrosurgical return electrode according to claim 27, wherein said sheet comprises normally insulating material impregnated with electrically conducting carbon black to render said sheet to have each square centimeter of said working surface to present an effective resistance equal to or greater than 8,000Ω

.

33. The reusable electrosurgical return electrode of claim 25, 26, 27, 28, 29, 30, 31, or 32 further comprising an insulating sleeve substantially enclosing said sheet.