Self-limiting electrosurgical return electrode

• US 6,666,859 B1
• Filed: 09/09/2002
• Issued: 12/23/2003
• 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:
  US10/238,085
• Time in Patent Office: 470 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 selection of impedance characteristics for the materials of the principal body of the electrode, and through tailoring of electrode geometries, the electrode is self-regulating and self-limiting as to current density and temperature rise to prevent patient trauma. The return electrode includes a sheet of material having an effective bulk impedance equal to or greater than about 4,000Ω.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. Configuration of the return electrode allows the electrode to self-limit the electrode'"'"'s current densities, thereby preventing burning of a patient during surgery. 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 electrode configured to be disposed beneath a patient during electrosurgery to provide a return path for an electrosurgical current used in electrosurgery, the electrosurgical electrode comprising:

a sheet of material having an effective bulk resistivity equal to or greater than about 8,000Ω

.cm;

an upper surface having sufficient area to limit a current density to safe thresholds while obviating the need for direct contact between the patient and the electrode, wherein the effective impedance of the electrode is inversely proportional to the effective contact area between the patient and the electrode and the electrosurgical electrode being self-limiting so that the electrosurgical current is limited to safe thresholds so as to prevent an undesirable patient burn at a contact area between the patient and the electrode in the event of an accidental reduction in the contact area below a threshold level.

2. The electrosurgical electrode of claim 1, wherein the sheet of material comprises electrically conducting material having an effective bulk resistivity equal to or greater than about 8,000Ω

.cm.

3. The electrosurgical electrode of claim 1, wherein the sheet comprises normally insulating material impregnated with electrically conducting fibers to render the sheet to have an effective bulk resistivity equal to or greater than about 8,000Ω

.cm.

4. The electrosurgical electrode of claim 1, wherein the sheet comprises a normally insulating material impregnated with electrically conducting carbon black to render the sheet to have an effective bulk resistivity equal to or greater than about 8,000Ω

.cm.

5. The electrosurgical electrode of claim 1, wherein the sheet of material has a predetermined thickness and includes a resistive material having a predetermined bulk resistivity, and wherein a relationship of the bulk resistivity, the contact area and the predetermined thickness is defined by the equation $t=\frac{A}{}$

(75)

β



1+ω

2

(ρ

1.2)2

κ

2

ɛ

02ρ

/1.2

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)

ε

_o=electrical permittivity constant (F/cm).

6. An electrosurgical electrode configured to be disposed beneath a patient during electrosurgery to provide a return path for an electrosurgical current used in electrosurgery, the electrosurgical electrode comprising:

a sheet of material having an effective bulk resistivity equal to or greater than about 8,000Ω

.cm;

an upper surface having a greater surface area than that of the projected area of the buttocks or torso of a patient allowing the patient to move during the course of a procedure while a sufficient portion of the patient will remain in contact with the electrode such that the effective impedance of the electrode allows sufficient current to permit electrosurgery while self-limiting a current density to safe thresholds so as to prevent an undesirable patient burn at a contact area between the patient and the electrode in the event of an accidental reduction in the contact area below a threshold level, the surface area obviating the need for direct contact between the patient and the electrode, wherein the effective impedance of the electrode is inversely proportional to the effective contact area between the patient and the electrode.

7. The electrosurgical electrode of claim 6, wherein the electrode is sterilizable.

8. The electrosurgical electrode of claim 7, wherein the electrode is washable.

9. The electrosurgical electrode of claim 8, wherein the electrode is reusable.

10. The electrosurgical electrode of claim 9, further comprising an insulating sleeve substantially enclosing the sheet.

11. An electrosurgical electrode configured to be disposed beneath a patient during electrosurgery to provide a return path for an electrosurgical current used in electrosurgery, the electrosurgical electrode comprising:

a sheet of material having an effective bulk resistivity equal to or greater than about 8,000Ω

.cm;

an upper surface having sufficient area to self-limit a current density to no more than 100 mA/cm² so as to prevent an undesirable patient burn at a contact area between the patient and the electrode in the event of an accidental reduction in the contact area below a threshold level while obviating the need for direct contact between the patient and the electrode, wherein the effective impedance of the electrode is inversely proportional to the effective contact area between the patient and the electrode.

12. The electrosurgical electrode of claim 11, wherein the sheet has a surface area equal to or greater than about 100 square centimeters.

13. The electrosurgical electrode of claim 11, wherein the effective impedance of the sheet is within the range of about one to about 250Ω

.cm.

14. The electrosurgical electrode of claim 11, wherein the sheet has a surface area within a range from about 100 to 20,000 square centimeters.

15. The electrosurgical electrode of claim 11, wherein the sheet continuously and automatically regulates the electrosurgical current flowing through the electrode.

16. The electrosurgical electrode of claim 15, wherein the electrosurgical electrode is configured to limit the temperature rise of patient tissue in registration with the electrode to six degrees (6°

) Celsius when current is flowing through the electrode during a surgical procedure.

17. The electrosurgical electrode of claim 11, wherein the sheet of material comprises electrically conducting material having an effective bulk resistivity equal to or greater than about 8,000Ω

.cm.

18. The electrosurgical electrode of claim 11, wherein the sheet comprises normally insulating material impregnated with electrically conducting fibers to render the sheet to have an effective bulk resistivity equal to or greater than about 8,000Ω

.cm.

19. The electrosurgical electrode of claim 11, wherein the sheet comprises a normally insulating material impregnated with electrically conducting carbon black to render the sheet to have an effective bulk resistivity equal to or greater than about 8,000Ω

.cm.

20. The electrosurgical electrode of claim 11, wherein the electrode is at least one of sterilizable, washable, and reusable.