Capacitive reusable electrosurgical return electrode

• US 20010021848A1
• Filed: 01/24/2001
• Published: 09/13/2001
• Est. Priority Date: 10/30/1996
• Status: Active Grant

• 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.
• Granted Patent: US 6,582,424 B2
• Time in Patent Office: Days
• US Class Current: 606/32
• 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 capacitive reusable electrosurgical return electrode pad for use with electrosurgery. Through selection of the electrode geometries and the impedance characteristics of the electrode, the electrode is self-regulating and self-limiting as to current density and temperature rise so as to prevent patient trauma. The electrosurgical return electrode can include a connector and a sheet of material having an effective bulk impedance equal to or greater than about 100,000 Ω·cm. The electrode can have a working surface area from about 11 to about 1,500 square inches (or about 70 to about 10,000 square centimeters). The electrode can be disposed on the working surface of an operating table or dentist'"'"'s chair immediately underlying a patient during electrosurgery. This very large working surface area eliminates the need for direct contact or contact through conducting gels and by employing washable surface areas, it is made readily cleanable and reusable.

Claims

1. An electrosurgical return electrode comprising:

(a) a sheet of material having an effective bulk impedance equal to or greater than about 100,000 Ω

·

cm; 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 100,000 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 100,000 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 100,000 Ω

·

cm.

5. 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.

6. The electrosurgical return electrode of

claim 1

, wherein said sheet comprises a working surface for being positioned in contact with or in close proximity to a patient, said working surface having a surface area equal to or greater than about 11 square inches.

7. The electrosurgical return electrode of

claim 6

, wherein said working surface having a surface area within a range from about 11 to about 1,500 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 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 6

or

7

, wherein said sheet has a predetermined thickness and wherein the relationship between a bulk resistivity, the surface area, and the predetermined thickness are defined by the equation:

$t=\frac{1.2<br><br>A<br><br>\text{\hspace{1em}<br><br>}<br><br>\left(75<br><br>\mathrm{\beta <br><br>}\right)<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{\epsilon <br><br>}}_0^2}}{\mathrm{\rho <br><br>}<br><br>\text{\hspace{1em}<br><br>}}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{where}$$\begin{array}{c}t=\mathrm{thickness}\\ \mathrm{\kappa <br><br>}=\mathrm{dielectric}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{constant}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{of}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{insulating}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{material}\\ \mathrm{\beta <br><br>}=\mathrm{total}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{impedance}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{divided}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{by}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{the}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{AAMI}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{standard}<br><br>\text{\hspace{1em}<br><br>}<br><br>\left(75<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{ohms}\right)\\ \mathrm{\omega <br><br>}=\mathrm{angular}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{frequency}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{of}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{electrosurgical}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{generator}<br><br>\text{\hspace{1em}<br><br>}<br><br>\left(\mathrm{radians}/\sec \right)\\ \mathrm{\rho <br><br>}=\mathrm{bulk}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{resistivity}<br><br>\text{\hspace{1em}<br><br>}<br><br>\left(\mathrm{\Omega <br><br>}·<br><br>\mathrm{cm}\right)\\ A=\mathrm{electrode}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{or}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{pad}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{area}<br><br>\text{\hspace{1em}<br><br>}<br><br>\left({\mathrm{cm}}^2\right)\\ {\mathrm{\epsilon <br><br>}}_0=\mathrm{electrical}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{permeability}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{constant}<br><br>\text{\hspace{1em}<br><br>}<br><br>\left(F/m\right).\end{array}$

15. A reusable electrosurgical return electrode comprising a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm, said sheet having connection means for making electrical connection to said sheet;

said sheet having a first major surface including a working surface adapted for disposition immediately adjacent the trunk region of a patient positioned for electrosurgery, wherein said area of said working surface is at least substantially equal to or greater than the projected area of the entire trunk region of said patient.

16. The reusable electrosurgical return electrode according to

claim 15

wherein said major surface is sterilizable.

17. The reusable electrosurgical return electrode according to

claim 15

wherein said major surface is washable.

18. An electrosurgical return electrode according to

claim 15

wherein the return electrode is disinfectable.

19. An electrosurgical return electrode according to

claim 15

, wherein the return electrode is disposable.

20. The reusable electrosurgical return electrode according to

claim 15

wherein said sheet is principally comprised of electrically conducting material having limited conductivity.

21. The reusable electrosurgical return electrode according to

claim 15

wherein said sheet is comprised of normally insulating material impregnated with electrically conducting fibers to render said sheet at least partially conductive.

22. The reusable electrosurgical return electrode according to

claim 15

wherein said sheet is comprised of normally insulating material impregnated with electrically conducting carbon black to render said sheet at least partially conductive.

23. The reusable electrosurgical return electrode according to

claim 15

wherein said area of said major surface is greater than the projected area of the entire body of the said patient.

24. The reusable electrosurgical return electrode according to

claim 15

wherein said area of said working surface is at least substantially equal to the projected area of the entire body of said patient.

25. The electrosurgical electrode according to

claim 15

, wherein the electrode is incorporated within a supporting means for supporting the patient during treatment and having an insulating material coupled thereto.

26. The electrosurgical electrode according to

claim 15

, wherein the electrode includes a single sheet of material.

30. In combination, a reusable electrosurgical return electrode according to

claim 21

further including a second major surface and a metallized conductive region upon one of said major surfaces.

27. In combination, an operating table and a reusable electrosurgical return electrode comprising a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm, said sheet having connection means for making electrical connection to said sheet;

said sheet having a major surface including a working surface adapted for disposition immediately adjacent the trunk region of a patient when positioned for electrosurgery on said operating table, wherein said area of said major surface is sufficient to substantially cover said operating table when said patient is in a horizontal position on said operating table.

28. In combination, an operating table and a reusable electrosurgical return electrode comprising a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm, said sheet having connection means for making electrical connection to said sheet;

said sheet having a major surface, including a working surface adapted for disposition immediately adjacent the trunk region of a patient when positioned for electrosurgery on said operating table wherein said area of said major surface is sufficient to substantially cover said operating table when said patient is in a horizontal position on said operating table, and an insulating sleeve substantially covering said major surface of said sheet when said sheet is disposed on the patient-supporting surface of said operating table.

29. In combination, a reusable electrosurgical return electrode comprising a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm, said sheet having connection means for making electrical connection to said sheet;

said sheet having a first major surface including a working surface adapted for disposition immediately adjacent the trunk region of a patient positioned for electrosurgery, wherein said area of said working surface is at least substantially equal to the projected area of the entire trunk region of said patient, and an insulating sleeve substantially covering said major surface of said sheet.

31. A reusable electrosurgical return electrode comprising a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm, said sheet having connection means for making electrical connection to said sheet;

said sheet having a major surface including a working surface adapted for disposition immediately adjacent the trunk region of a patient positioned for electrosurgery, said working surface having an area of at least 11 square inches, and self-limiting means including said predetermined limited electrical conductivity for limiting density of electrosurgical current flowing through said electrode to less than 100 milliamperes per square centimeter of said working surface area.

32. A reusable electrosurgical return electrode according to

claim 31

wherein said self-limiting means includes means for limiting temperature rise of patient tissue in registration with said electrode to six degrees (6°

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

33. In combination, a reusable electrosurgical return electrode according to

claim 31

and means including an electrosurgical instrument in operating deployment.

34. A reusable electrosurgical return electrode comprising:

(a) a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm; and

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

wherein the effective bulk resistivity of said electrode automatically and continuously limits the density of electrosurgical current flowing through said electrode to less than 100 milliamperes per square centimeter.

38. The reusable electrosurgical return electrode of

claim 34

,

35

, 36, or 37, wherein said sheet has a surface area equal to or greater than about 100 square centimeters.

39. The reusable electrosurgical return electrode of

claim 34

,

35

, 36, or 37, wherein said sheet has a surface area within a range from about 11 to about 1,500 square inches.

40. The reusable electrosurgical return electrode of

claim 34

,

35

, 36, or 37, further comprising an insulating sleeve substantially enclosing said sheet.

35. A reusable electrosurgical return electrode comprising:

(a) a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm; and

(b) connection means for making electrical connection to said sheet; and

(c) self-limiting means for limiting the density of electrosurgical current flowing through said electrode to less than 100 milliamperes per square centimeter of said electrode.

36. A reusable electrosurgical return electrode comprising:

(a) a sheet of material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm and having a working surface adapted for disposition adjacent the tissue of a patient positioned thereon for electrosurgery; and

(b) connecting means for making electrical connection to said sheet, wherein the effective bulk resistivity of said sheet continuously and automatically regulates the electrosurgical current flowing through said electrode as a function of the area of contact between said electrode and said patient'"'"'s tissue so as to limit the density of said electrosurgical current to less than 100 milliamperes per square centimeter.

37. A reusable electrosurgical return electrode comprising:

(a) a sheet of electrically-conductive material having an effective bulk resistivity equal to or greater than about 100,000 Ω

·

cm and having a working surface adapted for disposition adjacent the tissue of a patient positioned thereon for electrosurgery; and

(b) connection means for making electrical connection to said sheet;

wherein the effective impedance of the electrode varies as an inverse function of the area of contact between said electrode and said patient'"'"'s tissue so as to continuously and automatically limit the density of electrosurgical current passing through the electrosurgical return electrode to less than 100 milliamperes per square centimeter.

41. In combination, a reusable electrosurgical return electrode according to

claim 37

and means including an electrosurgical instrument in operating deployment, wherein said self-limiting means includes means for noticeably reducing the effectiveness of said electrosurgical instrument when said density of said electrosurgical current rises to approach a predetermined level.

42. The reusable electrosurgical return electrode according to

claim 37

wherein said sheet of material is sterilizable.

43. A reusable electrosurgical return electrode according to

claim 37

wherein said sheet of material is washable.

44. A reusable electrosurgical return electrode according to

claim 37

wherein the sheet of material is disinfectable.

45. A reusable electrosurgical return electrode according to

claim 37

wherein the sheet of material is disposable.

46. A reusable electrosurgical return electrode according to

claim 37

wherein said sheet is principally comprised of electrically conducting material having limited conductivity.

47. A reusable electrosurgical return electrode according to

claim 37

wherein said sheet is comprised of normally insulating material impregnated with electrically conducting fibers to render said sheet at least partially conductive.

48. A reusable electrosurgical return electrode according to

claim 37

wherein said sheet is comprised of normally insulating material impregnated with electrically conducting carbon black to render said sheet at least partially conductive.

49. A reusable electrosurgical return electrode according to

claim 37

wherein the area of said sheet is greater than the projected area of the entire body of the said patient.

50. A reusable electrosurgical return electrode according to

claim 37

wherein the area of said sheet is at least substantially equal to the projected area of the entire body of said patient.