UNIVERSAL SELF-LIMITING ELECTROSURGICAL RETURN ELECTRODE

• US 20150182280A1
• Filed: 12/26/2014
• Published: 07/02/2015
• Est. Priority Date: 12/26/2013
• Status: Active Grant

• Current Assignee: Megadyne Medical Products Incorporated (Johnson & Johnson)
• Original Assignee: Megadyne Medical Products Incorporated (Johnson & Johnson)
• Inventors: Ehninger, Michael D., Borgmeier, Paul R., Greep, Darcy W., Millis, Roger, Fischer, Melissa K.
• Granted Patent: US 10,085,791 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2018/167 Passive electrodes capacitively coupled to the skin

Abstract

A self-limiting electrosurgical return electrode for use with electrosurgical procedures is disclosed. The return electrode includes a conductive element and pads disposed on opposing sides of the conductive element. The conductive element, optionally in combination with the pads, is configured to limit the density of electrical current that passes from a patient to the return electrode. The conductive element and the pads can cooperate to define two separate working surfaces on opposing sides of the return electrode. The return electrode can also be safely used with patients of substantially any size and without requiring adjustments to the power settings of an electrosurgical generator.

Claims

1. A universal safety electrosurgical return electrode comprising:

a conductive element configured to conduct electrical current, the conductive element having opposing first and second major surfaces;

a first pad positioned adjacent the first major surface of the conductive element, wherein the first pad has a thickness of about 0.120 inches or less;

a second pad positioned adjacent the second major surface of the conductive element, wherein the second pad has a thickness of about 0.120 inches or less,

wherein the thicknesses of the first and second pads enable the universal electrosurgical return electrode to be self-limiting when used with any patient that weighs about 0.8 lbs. or more.

2. A universal safety electrosurgical return electrode according to 1, wherein the universal safety electrosurgical return electrode is configured such that electrical current transferred from a patient to the conductive element is transmitted non-uniformly over the portion of the universal safety electrosurgical return electrode that is contacted by the patient.

3. A universal safety electrosurgical return electrode according to 1, wherein the first pad defines an outer surface configured to be positioned adjacent a patient during an electrosurgical procedure, wherein a first portion of the conductive element is disposed closer to the outer surface than a second portion of the conductive element.

4. A universal safety electrosurgical return electrode accordingly to claim 1, wherein the conductive element has a generally arch or dome shape.

5. A universal safety electrosurgical return electrode according to claim 1, wherein the first and second pads cooperate with the conductive element to define first and second working surfaces on opposing sides of the universal electrosurgical return electrode.

6. A universal safety electrosurgical return electrode according to claim 5, wherein the universal safety electrosurgical return electrode is configured to have either the first working surface or the second working surface positioned toward a patient during an electrosurgical procedure.

7. A universal safety electrosurgical return electrode according to claim 1, wherein each of (i) the first pad and the conductive element and (ii) the second pad and the conductive element limit the density of current flowing through the universal electrosurgical return electrode to below about 100 mA/cm².

8. A universal safety electrosurgical return electrode according to claim 1, wherein at least one of the first and second pads is formed of a gel.

9. A universal safety electrosurgical return electrode according to claim 1, wherein the first and second pads are secured to one another with the conductive element therebetween.

10. A universal safety electrosurgical return electrode according to claim 1, wherein each of the first pad and the second pad has a thickness between about 0.02 inches and about 0.120 inches.

11. A universal safety electrosurgical return electrode according to claim 1, wherein at least one of the first and second pads comprises an inner cover layer and an outer cover layer that define an interior chamber filled with a fill material.

12. A reversible safety electrosurgical return electrode comprising:

a conductive element configured to conduct electrical current, the conductive element having a first planar major surface and an opposing second planar major surface;

a first pad positioned adjacent the first planar major surface of the conductive element, wherein the first pad and the conductive element cooperate to define a first working surface of the reversible electrosurgical return electrode on a first side of the reversible electrosurgical return electrode; and

a second pad positioned adjacent the second planar major surface of the conductive element, wherein the second pad and the conductive element cooperate to define a second working surface of the reversible electrosurgical return electrode on a second side of the reversible electrosurgical return electrode opposite to the first side,

wherein the reversible electrosurgical return electrode is configured to have either the first working surface or the second working surface positioned toward a patient during an electrosurgical procedure.

13. A reversible safety electrosurgical return electrode according to claim 12, wherein the first pad comprises an inner cover layer and an outer cover layer that define an interior chamber.

14. A reversible safety electrosurgical return electrode according to claim 13, wherein the interior chamber is filled with a material selected from the group consisting of a visco-elastic material, a gel, water, saline, a water based material, a conductive oil, or combinations thereof.

15. A reversible safety electrosurgical return electrode according to claim 13, wherein the inner cover layer is secured to the first planar major surface of the conductive element.

16. A reversible safety electrosurgical return electrode according to claim 12, wherein the second pad comprises an outer cover layer and a fill material.

17. A reversible safety electrosurgical return electrode according to claim 16, wherein edges of the outer cover layer of the second pad are attached to edges of the first pad with the conductive element disposed between the first and second pads.

18. A reversible safety electrosurgical return electrode according to claim 16, wherein the outer cover layer of the second pad and the conductive element at least partially define a second interior chamber in which the fill material of the second pad is disposed.

19. A reversible safety electrosurgical return electrode according to claim 12, wherein the reversible safety electrosurgical return electrode is configured such that electrical current transferred from a patient to the conductive element is transmitted non-uniformly over the portion of the reversible safety electrosurgical return electrode that is contacted by the patient.

20. A reversible safety electrosurgical return electrode according to claim 12, wherein each of the first pad and the second pad has a thickness between about 0.02 inches and about 0.120 inches.

21. A reversible safety electrosurgical return electrode according to claim 12, wherein the reversible safety electrosurgical return electrode is configured to be safely used with patients from multiple industry standard weight categories.

22. A universal safety electrosurgical return electrode comprising:

a conductive element configured to conduct electrical current, the conductive element having a first major surface and an opposing second major surface;

a first pad positioned adjacent the first major surface of the conductive element, wherein the first pad has a generally planar outer surface configured to be positioned adjacent a patient during an electrosurgical procedure; and

a second pad positioned adjacent the second major surface of the conductive element,

wherein the conductive element is secured between the first and second pads in a curved configuration such that a first portion of the conductive element is positioned closer to the outer surface of the first pad than a second portion of the conductive element,

wherein the curved configuration of the conductive element enables the universal safety electrosurgical return electrode to be self-limiting when used with any patient that weighs about 0.8 lbs. or more

23. A universal safety electrosurgical return electrode according to claim 22, wherein the first portion of the conductive element is positioned between about 0.02 inches and about 0.120 inches from the outer surface of the first pad.

24. A universal safety electrosurgical return electrode according to claim 23, further comprising one or more visual indicators identifying the first portion of the conductive element.

25. A universal safety electrosurgical return electrode according to claim 22, wherein the universal safety electrosurgical return electrode is configured such that electrical current transferred from a patient to the conductive element is transmitted non-uniformly over the portion of the universal safety electrosurgical return electrode that is contacted by the patient.

26. A universal safety electrosurgical return electrode comprising:

a conductive element configured to conduct electrical current, the conductive element having a first major surface and an opposing second major surface;

a first pad positioned adjacent the first major surface of the conductive element, the first pad having an outer surface configured to be positioned adjacent a patient during an electrosurgical procedure, the first pad having a first area having a first dielectric constant and a second area having a second dielectric constant, the first dielectric constant being different than the second dielectric constant; and

a second pad positioned adjacent the second major surface of the conductive element,

wherein first and second dielectric constants of the first pad enables the universal safety electrosurgical return electrode to be self-limiting when used with any patient that weighs about 0.8 lbs. or more.

27. A universal safety electrosurgical return electrode according to claim 26, wherein the second pad has an outer surface configured to be positioned adjacent a patient during an electrosurgical procedure.

28. A universal safety electrosurgical return electrode according to claim 26, wherein the second pad has a first area having a first dielectric constant and a second area having a second dielectric constant, the first dielectric constant being different than the second dielectric constant.

29. A universal safety electrosurgical return electrode according to claim 26, further comprising one or more visual indicators identifying at least one of the first area and the second area.

30. A universal safety electrosurgical return electrode comprising:

a conductive element configured to conduct electrical current, the conductive element having one or more structural surface features that render non-uniform an electrical current density of the electrical current conducted by the conductive element;

a first pad positioned adjacent a first major surface of the conductive element;

a second pad positioned adjacent a second major surface of the conductive element,

wherein the one or more structural surface features enable the universal electrosurgical return electrode to be self-limiting when used with any patient that weighs about 0.8 lbs. or more.

31. A universal safety electrosurgical return electrode according to claim 30, wherein the one or more structural surface features comprise a plurality of apertures extending through the conductive element.

32. A universal safety electrosurgical return electrode according to claim 31, wherein the plurality of apertures are arranged in two or more aperture distribution areas.

33. A universal safety electrosurgical return electrode according to claim 32, wherein:

a first aperture distribution area of the plurality of aperture distribution areas comprises apertures configured in a first density; and

a second aperture distribution area of the plurality of aperture distribution areas comprises apertures configured in a second density, the second density being different than the first density.

34. A universal safety electrosurgical return electrode according to claim 33, wherein the first aperture distribution area is concentric with the second aperture distribution area.

35. A universal safety electrosurgical return electrode according to claim 33, wherein the first aperture distribution area and the second aperture distribution area do not overlap one another.

36. A universal safety electrosurgical return electrode according to claim 33, wherein the first aperture distribution area and the second aperture distribution area overlap one another.

37. A universal safety electrosurgical return electrode according to claim 32, further comprising one or more visual indicators that identify at least one or the two or more aperture distribution areas.

38. A universal safety electrosurgical return electrode according to claim 30, wherein the one or more structural surface features comprise a plurality of protrusions extending from at least one major surface of the conductive element.

39. A universal safety electrosurgical return electrode according to claim 38, wherein the plurality of protrusions are arranged in two or more protrusion distribution areas.

40. A universal safety electrosurgical return electrode according to claim 39, wherein:

a first protrusion distribution area of the plurality of protrusion distribution areas comprises protrusions configured in a first density; and

a second protrusion distribution area of the plurality of protrusion distribution areas comprises protrusions configured in a second density, the second density being different than the first density.

41. A universal safety electrosurgical return electrode according to claim 40, wherein the first protrusion distribution area is concentric with the second protrusion distribution area.

42. A universal safety electrosurgical return electrode according to claim 40, wherein the first protrusion distribution area and the second protrusion distribution area do not overlap one another.

43. A universal safety electrosurgical return electrode according to claim 40, wherein the first protrusion distribution area and the second protrusion distribution area overlap one another.

44. A universal safety electrosurgical return electrode according to claim 39, further comprising one or more visual indicators that identify at least one or the two or more protrusion distribution areas.

45. A universal safety electrosurgical return electrode comprising:

a conductive element configured to conduct electrical current, the conductive element having a first major surface and an opposing second major surface;

a first pad positioned adjacent the first major surface of the conductive element, wherein the first pad has a generally planar outer surface defining a first working surface configured to be positioned adjacent a patient during an electrosurgical procedure; and

a second pad positioned adjacent the second major surface of the conductive element, wherein the second pad has a generally planar outer surface defining a second working surfaced configured to be positioned adjacent a patient during an electrosurgical procedure;

wherein the conductive element is secured between the first and second pads in a wavy configuration such that the conductive element forms alternating peaks and valleys, the peaks being positioned adjacent the first working surface and the valleys being positioned adjacent the second working surface,

wherein the wavy configuration of the conductive element enables the universal safety electrosurgical return electrode to be self-limiting when used with any patient that weighs about 0.8 lbs. or more

46. A universal safety electrosurgical return electrode according to claim 45, wherein the conductive elements forms a first distribution area and a second distribution area, the peaks of the conductive element being positioned closer together in the first distribution area than in the second distribution area.

47. A universal safety electrosurgical return electrode according to claim 46, further comprising one or more visual indicators that identify at least one of the first or second distribution areas.

48. A universal safety electrosurgical return electrode comprising:

a first conductive element configured to selectively conduct electrical current, the first conductive element being disposed in a first plane of the return electrode and having a first major surface and an opposing second major surface;

a first pad positioned adjacent the first major surface of the first conductive element, the first pad having a generally planar outer surface defining a working surface configured to be positioned adjacent a patient during an electrosurgical procedure;

a second pad positioned adjacent the second major surface of the first conductive element;

a second conductive element configured to selectively conduct electrical current, the second conductive element being disposed in a second plane of the return electrode and adjacent to the second pad on a side of the second pad opposite the first conductive element, the second conductive element being positioned further from the working surface than the first conductive element; and

a selection mechanism that enables either the first conductive element or the second conductive element to be selected to conduct electrical current from a patient positioned adjacent the working surface.

49. A universal safety electrosurgical return electrode according to claim 48, wherein the first conductive element is spaced apart from the working surface a first predetermined distance to provide a first level a capacitive coupling for a first predetermined category of patients.

50. A universal safety electrosurgical return electrode according to claim 49, wherein the second conductive element is spaced apart from the working surface a second predetermined distance to provide a second level a capacitive coupling for a second predetermined category of patients.

51. A universal safety electrosurgical return electrode according to claim 48, further comprising:

a third pad positioned adjacent the second conductive element on a side of the second conductive element opposite the second pad; and

a third conductive element configured to selectively conduct electrical current, the third conductive element being disposed in a third plane of the return electrode and adjacent to the third pad on a side of the third pad opposite the second conductive element.

52. A universal safety electrosurgical return electrode according to claim 51, wherein the third conductive element is spaced apart from the working surface a third predetermined distance to provide a third level a capacitive coupling for a third predetermined category of patients.

53. A universal safety electrosurgical return electrode comprising:

a first conductive element configured to selectively conduct electrical current, the first conductive element being disposed in a first plane of the return electrode and having a first major surface and an opposing second major surface;

a first pad positioned adjacent the first major surface of the first conductive element, the first pad having a generally planar outer surface defining a first working surface configured to be positioned adjacent a patient during an electrosurgical procedure;

a second conductive element configured to selectively conduct electrical current, the second conductive element being disposed in a second plane of the return electrode and having a first major surface and an opposing second major surface;

a second pad positioned adjacent the second major surface of the second conductive element, the second pad having a generally planar outer surface defining a second working surface configured to be positioned adjacent a patient during an electrosurgical procedure; and

a third pad separating the first conductive element and the second conductive element;

the first conductive element being configured to conduct electrical current from a patient positioned adjacent the first working surface and the second conductive element being configured to conduct electrical current from a patient positioned adjacent the second working surface.

54. A universal safety electrosurgical return electrode according to claim 53, wherein the first conductive element is spaced apart from the first working surface by a first distance and the second conductive element is spaced apart from the second working surface by a second distance that is different than the first distance, such that the first and second conductive elements provide different levels of capacitive coupling to patients.

55. A universal safety electrosurgical return electrode according to claim 53, wherein the first pad has a first dielectric constant and the second pad has a second dielectric constant that is different than the first dielectric constant, such that the first and second conductive elements provide different levels of capacitive coupling to patients.

56. A universal safety electrosurgical return electrode according to claim 53, further comprising one or more visual indicators to distinguish the first working surface from the second working surface.

57. A universal safety electrosurgical return electrode comprising:

a conductive element configured to conduct electrical current, the conductive element having opposing first and second major surfaces;

a first pad positioned adjacent the first major surface of the conductive element;

a second pad positioned adjacent the second major surface of the conductive element; and

one or more visual indicators identifying;

a first area of the return electrode that is configured for use with patients from a first predetermined category; and

a second area of the return electrode that is configured for use with patients from a second predetermined category.

58. A universal safety electrosurgical return electrode according to claim 57, wherein the first area of the return electrode is configured for use with patients that weight less than about 5 kg.

59. A universal safety electrosurgical return electrode according to claim 57, wherein the second area of the return electrode is configured for use with patients that weight between about 5 kg and 15 kg.

60. A universal safety electrosurgical return electrode according to claim 57, wherein the one or more visual indicators further identify a third area of the return electrode that is configured for use with patients from a third predetermined category.

61. A universal safety electrosurgical return electrode according to claim 60, wherein the third area of the return electrode is configured for use with patients that weight above about 15 kg.

62. A universal safety electrosurgical return electrode according to claim 57, wherein the one or more visual indicators include color coding, labels, images, outlines, or combinations thereof.

63. A universal safety electrosurgical return electrode according to claim 57, wherein the first area is disposed on a first side of the return electrode and the second area is disposed on an opposing second side of the return electrode.

64. A universal safety electrosurgical return electrode according to claim 57, wherein the first area and the second area are both disposed on a first side of the return electrode.

65. A method for safely transferring electrosurgical current in non-uniform current densities from a patient to an electrosurgical return electrode via capacitive coupling, comprising:

passively controlling an impedance of the return electrode.

66. A method according to claim 65, wherein passively controlling an impedance of the return electrode comprises positioning a first conductive element of the return electrode a first predetermined distance from a working surface of the return electrode.

67. A method according to claim 66, wherein passively controlling an impedance of the return electrode comprises positioning a second conductive element of the return electrode a second predetermined distance from a working surface of the return electrode.

68. A method according to claim 67, wherein passively controlling an impedance of the return electrode comprises positioning a third conductive element of the return electrode a third predetermined distance from a working surface of the return electrode.

69. A method according to claim 68, wherein passively controlling an impedance of the return electrode further comprises selecting one of the first conductive element, the second conductive element, and the third conductive element for conducting electrosurgical current from the patient.

70. A method according to claim 65, wherein passively controlling an impedance of the return electrode comprises selecting one or more dielectric constants of a pad of the return electrode, the pad being disposed between a conductive element of the return electrode and a working surface of the return electrode.

71. A method according to claim 65, wherein passively controlling an impedance of the return electrode comprises providing one or more structural surface features on a conductive element of the return electrode.

72. A method according to claim 65, wherein providing one or more structural surface features on a conductive element comprises forming one or more apertures through the conductive element.

73. A method according to claim 65, wherein forming one or more apertures through the conductive element comprises forming two or more aperture distribution areas in the conductive element.

74. A method according to claim 73, wherein forming two or more aperture distribution areas comprised forming a first aperture distribution area having a first aperture distribution density and a second aperture distribution area having a second aperture distribution density that is different than the first aperture distribution density.

75. A method according to claim 65, wherein providing one or more structural surface features on a conductive element comprises forming one or more protrusions on the conductive element.

76. A method according to claim 75, wherein forming one or more protrusions on the conductive element comprises forming two or more protrusion distribution areas on the conductive element.

77. A method according to claim 76, wherein forming two or more protrusion distribution areas comprised forming a first protrusion distribution area having a first protrusion distribution density and a second protrusion distribution area having a second protrusion distribution density that is different than the first protrusion distribution density.

78. A method according to claim 65, wherein passively controlling an impedance of the return electrode comprises forming a conductive element of the return electrode in a non-planar configuration.

79. A method according to claim 78, wherein forming the conductive element of the return electrode in a non-planar configuration comprises forming the conductive element in an arch, domed, or curved configuration.

80. A method according to claim 78, wherein forming the conductive element of the return electrode in a non-planar configuration comprises forming the conductive element in a wavy configuration such that the conductive element forms alternating peaks and valleys.

81. A method according to claim 65, wherein passively controlling an impedance of the return electrode comprises

positioning a first conductive element of the return electrode a first predetermined distance from a first working surface of the return electrode;

positioning a second conductive element of the return electrode a second predetermined distance from a second working surface of the return electrode; and

selectively using either the first working surface or the second working surface based on a weight or size category of the patient being operated upon.