Self-limiting electrosurgical return electrode

• US 7,166,102 B2
• Filed: 05/09/2002
• Issued: 01/23/2007
• 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., Borgmeier, Paul R., Fleenor, Richard P., Kieda, David B.
• Primary Examiner(s): Cohen; Lee S.
• Application Number:
  US10/142,253
• Publication Number:
  US 20030040741A1
• Time in Patent Office: 1,720 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 removable semi-insulating sheet for use in self-limiting electrosurgical return semi-insulating sheet for use with electrosurgery. Through the selection of impedance characteristics for the electrode materials of the principal body of the semi-insulating sheet, and through tailoring of semi-insulating sheet 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 semi-insulating sheet has an effective bulk impedance equal to or greater than about 4,000 Ω·cm. 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.

Claims

1. A semi-insulating member for use with a separate conducting element to provide a return path for electrosurgical current used in electrosurgery, the separate conducting element being electrically coupled to an electrosurgical generator, the member comprising:

a sheet of material enclosed by an insulating sleeve, said sheet with said insulating sleeve having an effective bulk impedance equal to or greater than about 4,000 Ω

·

cm when said insulating sleeve is substantially in contact with at least a part of the separate conducting element such that the combination of said sheet, said insulating sleeve, and the separate conducting element are 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 a patient and said sheet, said insulating sleeve, or the separate conducting element in the event of an accidental reduction in the contact area below a threshold level.

2. The member according to claim 1, wherein said effective bulk impedance of said sheet enclosed by said sleeve comprises at least one electrical component selected from the group consisting of a resistive component, a capacitive component, and an inductive component.

3. The member according to claim 1, wherein said sheet enclosed by said sleeve comprises a layer of dielectric material having a defined capacitive reactance, said sheet and said sleeve being adapted to contact and overly the conducting element when in use.

4. The member according to claim 1, wherein said sheet enclosed by said sleeve comprises a layer of electrically conducting material having a designed bulk impedance equal to or greater than about 4,000 Ω

·

cm when said sleeve is substantially in contact with at least a part of the separate conducting element.

5. The member of claim 1, wherein said sheet enclosed by said sleeve comprises a working surface configured to be positioned in contact with or in close proximity to a patient.

6. The member of claim 1, wherein said sheet is reusable.

7. A member according to claim 1, wherein said sheet enclosed by said sleeve has a predetermined thickness and wherein the relationship between the bulk impedance, the surface area, and the predetermined thickness of said sheet enclosed by said sleeve when said sleeve is substantially in contact with at least a part of the conducting element 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=sheet area (cm²)

ε

₌electrical permittivity constant (F/cm).

8. A member for use with a separate conducting element to provide a return path for electrosurgical current used in electrosurgery, the separate conducting element having an electrical connector to an electrosurgical generator and in combination with the member acts as an electrosurgical electrode, the member comprising:

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

·

cm when said sheet of material is substantially in contact with at least a part of the separate conducting element such that the combination of said sheet and the separate conducting element are 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 a patient and the electrode in the event of an accidental reduction in the contact area below a threshold level, said sheet comprises a layer of dielectric material having at least one of a defined capacitive reactance or a defined inductive reactance, said sheet being adapted to contact and overly the conducting element when in use.

9. A member according to claim 8, wherein said sheet has a predetermined thickness and wherein the relationship between the bulk resistivity, the surface area and the predetermined thickness of the sheet when said sheet of material is substantially in contact with at least a part of the separate conducting element are defined by the equation:

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

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)

ρ

=bulk impedance (Ω

·

cm)

A=sheet area (cm²)

ε

₀=electrical permittivity constant (F/cm).

10. A member according to claim 8, wherein said sheet is adapted to be removably coupled to the conducting element.

11. A removable member for use as a part of an electrosurgical electrode that comprises the removable member and a separate conducting element having an electrical connector to an electrosurgical generator, the removable member comprising:

a sheet of material configured to substantially cover the separate conducting element and having an effective bulk impedance equal to or greater that about 4,000 Ω

·

cm when said sheet of material is in contact with at least a part of the separate conducting element when a working surface of said sheet is in close proximity to a patient or in contact with the patient without use of a gel.

12. The removable member according to claim 11, wherein the sheet comprises a protective flange.

13. The removable member according to claim 11, wherein the sheet is adapted to enclose the conducting element.

14. The removable member according to claim 11, wherein the sheet has the form of an envelope for enclosing the conducting element.

15. The removable member according to claim 11, wherein the sheet form-fits the conducting element.

16. A removable semi-insulating member comprising a sheet of material configured for use with a separate conducting element as an electrosurgical return electrode, the separate conducting element is electrically coupled to an electrosurgical generator and the sheet of material has an effective bulk impedance equal to or greater that about 4,000 Ω

·

cm, when said sheet of material is substantially in contact with at least a part of the separate conducting element such that the combination of said sheet and the separate conducting element are self-limiting so that an electrosurgical current is limited to safe thresholds so as to prevent an undesirable patient burn at a contact area between a patient and the electrode in the event of an accidental reduction in the contact area below a threshold level, said sheet comprises a layer of dielectric material having at least one of a defined capacitive reactance or a defined inductive reactance, said sheet being adapted to contact and overly the conducting element when in use.

17. An electrosurgical return electrode having substantially self limiting properties, the electrode comprising:

a conducting element; and

a semi-insulating member removably coupled to the conducting element, wherein the conducting element and the semi-insulating member collectively have a bulk impedance equal to or greater than about 4,000 Ω

cm when said semi-insulating member is substantially in contact with at least a part of said conducting element such that the combination of said semi-insulating member and the conducting element are self-limiting so that an electrosurgical current is limited to safe thresholds so as to prevent an undesirable patient burn at a contact area between a patient and the electrode in the event of an accidental reduction in the contact area below a threshold level, said semi-insulating member comprises a layer of dielectric material having at least one of a defined capacitive reactance or a defined inductive reactance, said semi-insulating member being adapted to contact and overly the conducting element when in use.

18. The electrosurgical return electrode as recited in claim 17, further comprising means for supporting a patient.

19. The electrosurgical return electrode as recited in claim 17, wherein the semi-insulating member is configured to be substantially in contact with and substantially cover a surface of the conducting element.

20. The electrosurgical return electrode as recited in claim 17, further comprising a means for providing an electrical connection between the conducting element and an electrosurgical generator.

21. The electrosurgical return electrode as recited in claim 17, wherein said semi-insulating member surrounds the conducting element.

22. The electrosurgical return electrode as recited in claim 21, wherein said semi-insulating member is form-fitted to the conducting element.

23. The electrosurgical return electrode as recited in claim 17, wherein the semi-insulating member comprises an interior adapted to receive the conducting element.

24. A semi-insulating member for use with a separate conducting element to provide a return path for electrosurgical current used in electrosurgery, the separate conducting element being electrically coupled to an electrosurgical generator, the member comprising:

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

·

cm when said sheet of material is substantially in contact with at least a part of the separate conducting element, wherein said sheet has a predetermined thickness and the relationship between the bulk impedance, the surface area, and the predetermined thickness of said sheet when said sheet of material is substantially in contact with at least a part of the separate conducting element are defined by the equation;

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

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=sheet area (cm²)

ε

₀=electrical permittivity constant (F/cm).

25. The member according to claim 24, wherein said effective bulk impedance of said sheet comprises at least one electrical component selected from the group consisting of a resistive component, a capacitive component, and an inductive component.

26. The member according to claim 24, wherein said sheet comprises a layer of dielectric material having a defined capacitive reactance, said sheet being adapted to contact and overly the conducting element when in use.

27. The member according to claim 24, wherein said sheet comprises a layer of electrically conducting material having a designed bulk impedance equal to or greater than about 4,000 Ω

·

cm when said sheet of material is substantially in contact with at least a part of the separate conducting element.

28. The member of claim 24, wherein sheet comprises a working surface configured to be positioned in contact with or in close proximity to a patient.

29. The member of claim 24, wherein said sheet is reusable.

30. The member of claim 24, further comprising an insulating sleeve adapted to enclose said sheet.

31. The member of claim 24, wherein the sheet comprises an interior adapted to receive the separate conducting element.