Therapy and monitoring electrodes with patient accommodating features

• US 6,965,799 B2
• Filed: 03/08/2002
• Issued: 11/15/2005
• Est. Priority Date: 03/08/2002
• Status: Expired due to Fees

• Current Assignee: Physio-Control Incorporated (Stryker Corporation)
• Original Assignee: Medtronic Physio-Control Manufacturing Corp. (Medtronic Plc)
• Inventors: Sullivan, Joseph L., Nova, Richard C., Covey, Kevin K.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/094,949
• Publication Number:
  US 20030171797A1
• Time in Patent Office: 1,348 Days
• Field of Search: 607/142, 607/148, 607/149, 607/152, 607/2, 607 4- 9, 600/372, 600391-393, 206/727, 206/390, D24/187
• US Class Current: 607/142
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/257 using adhesive means, e.g. adhesive pads or tapes
• CPC Class Codes: A61B 5/266 containing electrolytes, conductive gels or pastes
• CPC Class Codes: A61B 5/273 Connection of cords, cables or leads to electrodes
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence

Abstract

Medical electrode arrangements are provided for electrotherapy and monitoring applications. In one embodiment, each electrode arrangement includes a smaller electrode that is releasably attached to the back of a larger electrode. For adult applications, the larger electrode is applied to the patient. For pediatric applications, the larger electrode is preferably removed, and the smaller electrode is applied to the patient. Face-to-face and back-to-back electrode arrangement configurations are also provided. In a further embodiment, an electrode arrangement is comprised of first and second conductive regions of a common substrate that are separable by a division line in the substrate. For adult applications, stored energy is conducted through both conductive regions. For pediatric applications, the second region of the substrate is removed along the division line. A sensing mechanism is also provided to detect whether the electrode arrangement has been placed in an adult or pediatric configuration.

Claims

1. An electrode arrangement, comprising:

a first electrode disposed in a first plane and a second electrode disposed in a second plane that is other than the first plane, at least a portion of the first electrode overlying at least a portion of the second electrode, each of the first and second electrodes having a back formed of an electrically nonconductive substrate and a face that includes a conductive surface area adapted for placement on a patient, the face of the first electrode is releasably attached to a first nonconductive liner, and the face of the second electrode is releasably attached to a second nonconductive liner, and the backs of the first and second electrodes are attached to each other;

wherein the conductive surface area of the second electrode is smaller than the conductive surface area of the first electrode;

wherein the conductive surface areas of the first and second electrodes are electrically connected to each other; and

wherein if the electrical connection between the conductive surface areas of the first and second electrodes is broken, the conductive surface area of only one of the first or second electrodes is placed on the patient.

2. The electrode arrangement of claim 1, wherein the backs of the first and second electrodes are integrated to form a single nonconductive substrate.

3. The electrode arrangement of claim 1, further comprising a sensing mechanism that senses whether the conductive surface area of the first or second electrode is to be placed on the patient.

4. An electrode arrangement, comprising:

a first electrode disposed in a first plane and a second electrode disposed in a second plane that is other than the first plane, at least a portion of the first electrode overlying at least a portion of the second electrode, each of the first and second electrodes having a back formed of an electrically nonconductive substrate and a face that includes a conductive surface area adapted for placement on a patient, the face of the first electrode is releasably attached to a first nonconductive liner, and the face of the second electrode is releasably attached to a second nonconductive liner, and the backs of the first and second electrodes are attached to each other;

wherein the conductive surface areas of the first and second electrodes are electrically connected to each other;

wherein if the electrical connection between the conductive surface areas of the first and second electrodes is broken, only one of the first or second electrodes is placed on the patient; and

wherein the second electrode is configured to transfer less electrical energy to the patient than the first electrode when electrical energy is to be delivered to the patient.

5. The electrode arrangement of claim 4, wherein the backs of the first and second electrodes are integrated to form a single nonconductive substrate.

6. The electrode arrangement of claim 4, further comprising a sensing mechanism that senses whether the conductive surface area of the first or second electrode is to be placed on the patient.

7. The electrode arrangement of claim 4, further comprising an energy attenuator that causes the second electrode to transfer less electrical energy to the patient than the first electrode.

8. The electrode arrangement of claim 4, wherein the conductive surface area of the second electrode is smaller than the conductive surface area of the first electrode.

9. An electrode arrangement, comprising:

an electrically nonconductive substrate having a first region coplanar with a second region;

a first electrode having a first electrically conductive area disposed on the first region, the first electrically conductive area having a first outside boundary surface;

a second electrode having a second electrically conductive area disposed on the second region, the second electrically conductive area having a second outside boundary surface;

a sensing mechanism that senses which of the first and second regions has been placed on a patient;

wherein the sensing mechanism causes a change in operation of energy delivery to the patient if only one of the first or second regions has been placed on the patient;

wherein only a first portion of the first outside boundary surface of the first electrically conductive area is physically coupled to only a second portion of the second outside boundary surface of the second electrically conductive area so that the first electrically conductive area is in electrical communication with the second electrically conductive area;

wherein the first portion is less than the entire first outside boundary surface of the first electrically conductive area and the second portion is less than the entire second outside boundary surface of the second electrically conductive area;

wherein the first and the second electrodes are configured to serve as a single electrode when connected together; and

wherein the first and second regions are separable by a user of the electrode arrangement so that one of the first and the second electrodes may be used independent of the other.

10. The electrode arrangement of claim 9, wherein the sensing mechanism that senses whether the second region has been separated from the first region.

11. The electrode arrangement of claim 10, further comprising an energy attenuator that causes less electrical energy to be transferred through the first conductive surface area of the first region if the second region has been separated from the first region.

12. The electrode arrangement of claim 9, wherein the first and second regions are separable by one or more perforations in the substrate.

13. The electrode arrangement of claim 9, wherein the first and second regions are separable along a weakened division in the substrate, the weakened division created by crimping a portion of the substrate.

14. The electrode arrangement of claim 9, wherein the first and second regions are separable along a weakened division in the substrate, the weakened division created by scoring a portion of the substrate.

15. A method of placing electrodes on a patient, comprising:

providing a plurality of electrode arrangements, each electrode arrangement comprising a first electrode disposed in a first plane and a second electrode disposed in a second plane that is other than the first plane, at least a portion of the first electrode overlying at least a portion of the second electrode, each of the first and second electrodes having a back formed of an electrically nonconductive substrate and a face that includes a conductive surface area that is adapted for placement on a patient, a nonconductive liner having opposing sides, wherein the face of the first electrode is releasably attached to one side of the liner and the face of the second electrode is releasably attached to the opposing side of the liner and wherein the conductive surface areas of the first and second electrodes are electrically connected to each other;

separating the first and second electrodes;

for each electrode arrangement, placing the conductive surface area of the second electrode on the patient if the patient is an adult patient; and

for each electrode arrangement, placing the conductive surface area of only the first electrode on the patient if the patient is a pediatric patient.

16. The method of claim 15, wherein for each electrode arrangement, the conductive surface area of the first electrode is smaller than the conductive surface area of the second electrode.

17. The method of claim 15, further comprising electrically disconnecting the second electrode from the first electrode in each electrode arrangement if the patient is a pediatric patient.

18. The method of claim 15, further comprising providing a sensing mechanism that senses whether only the conductive surface area of the first electrode is to be placed on the patient.

19. The method of claim 15, further comprising connecting the plurality of electrode arrangements to an electrotherapy device and transferring electrical energy from the electrotherapy device to the patient through the electrodes placed on the patient.

20. The method of claim 19, further comprising transferring less electrical energy to the patient through the first electrode if the patient is a pediatric patient.

21. A medical device, comprising:

(a) a plurality of electrode arrangements adapted for placement on a patient, each electrode arrangement comprising a first electrode disposed in a first plane and a second electrode disposed in a second plane other than the first plane, at least a portion of the first electrode overlying at least a portion of the second electrode, each of the first and second electrodes having a back formed of an electrically nonconductive substrate and a face that includes a conductive surface area adapted for placement on a patient, the face of the first electrode is releasably attached to a first nonconductive liner, and the face of the second electrode is releasably attached to a second nonconductive liner, and the backs of the first and second electrodes are attached to each other, wherein the conductive surface areas of the first and second electrodes are electrically connected to one other, and wherein for each electrode arrangement, if the electrical connection between the conductive surface areas is broken, the conductive surface area of only one of the first or second electrodes in the electrode arrangement is placed on the patient; and

(b) circuitry in communication with the plurality of electrode arrangements, said circuitry being configured to transfer electrical energy to or receive electrical energy from the patient after at least one electrode in each of the electrode arrangements has been placed on the patient.

22. The medical device of claim 21, further comprising a sensing mechanism that senses which electrode in each electrode arrangement has been placed on the patient.

23. The medical device of claim 22, wherein the medical device is further configured to modify the electrical energy to be transferred to the patient based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

24. The medical device of claim 22, wherein the medical device is further configured to modify a display of information to a user of the medical device based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

25. The medical device of claim 22, wherein the medical device is further configured to modify the waveform of the electrical energy to be transferred to the patient based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

26. The medical device of claim 22, wherein the medical device is further configured to modify the routing of electrical energy to the electrodes in the plurality of electrode arrangements based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

27. The medical device of claim 21, wherein the first and second electrodes in each electrode arrangement are separable prior to placement on the patient.

28. The medical device of claim 27, wherein for each electrode arrangement, the medical device is further configured to electrically disconnect the second electrode from the first electrode if the first and second electrodes in the electrode arrangement are separated.

29. The medical device of claim 21, wherein for each electrode arrangement, the conductive surface area of the first electrode is smaller than the conductive surface area of the second electrode.

30. An electrode arrangement comprising:

an electrically nonconductive substrate having a first region and a second region other than the first region, the first region coplanar with and exclusive of the second region;

a first electrode disposed entirely on the first region, the first electrode having a conductive region;

a second electrode disposed entirely on the second region, the second electrode having a conductive region smaller than the conductive region of the first electrode; and

a sensing mechanism that senses which of the first and second regions has been placed on a patient;

wherein the sensing mechanism causes a change in operation of energy delivery to the patient if only one of the first or second regions has been placed on the patient;

wherein the first electrode and the second electrode are electrically connected to one another and are configured to serve as a single electrode when connected to one another; and

wherein the first and second regions are separable by a user of the electrode arrangement so that one of the first and the second electrodes may be used independently of the other.

31. The electrode arrangement of claim 30, wherein the sensing mechanism senses whether the second region has been separated from the first region.

32. The electrode arrangement of claim 31, further comprising an energy attenuator that causes less electrical energy to be transferred through the first electrode if the second electrode has been separated from the first electrode.

33. The electrode arrangement of claim 30, wherein the first and second regions are separable by one or more perforations in the substrate.

34. The electrode arrangement of claim 30, wherein the first and second regions are separable along a weakened division in the substrate, the weakened division created by crimping a portion of the substrate.

35. The electrode arrangement of claim 30, wherein the first and second regions are separable along a weakened division in the substrate, the weakened division created by scoring a portion of the substrate.

36. A method of placing electrodes on a patient, the method comprising:

providing a plurality of electrode arrangements, each electrode arrangement comprising an electrically nonconductive substrate having a first region coplanar with a second region, wherein upon each region is disposed a conductive surface area having an outside boundary surface, wherein only a portion of each of the outside boundary surfaces are coupled so that the conductive surface areas are in electrical communication with one another and wherein the portion of each of the outside boundary surfaces is less than the entire respective outside boundary surface;

for each electrode arrangement, placing the conductive surface area of or the combined first and second regions on the patient if the patient is of a first size; and

for each electrode arrangement, placing the conductive surface area of the first region on the patient if the patient is of a second size and for each electrode arrangement, placing the conductive surface area of the second region on the patient if the patient is of a third size.

37. The method of claim 36, wherein for each electrode arrangement, the conductive surface area of the first region is smaller than the conductive surface area of the second region.

38. The method of claim 36, further comprising electrically disconnecting the conductive surface area of the second region from the conductive surface area of the first region in each electrode arrangement if the patient is a pediatric patient.

39. The method of claim 36, further comprising providing a sensing mechanism that senses whether only the conductive surface area of the first region is to be placed on the patient.

40. The method of claim 36, further comprising connecting the plurality of electrode arrangements to an electrotherapy device and transferring electrical energy from the electrotherapy device to the patient through the conductive surface areas placed on the patient.

41. The method of claim 36, further comprising placing the conductive surface area of the first region on the patient and transferring less electrical energy to the patient through the conductive surface area of the first region if the patient is a pediatric patient.

42. A method of placing electrodes on a patient, the method comprising:

providing a plurality of electrode arrangements, each electrode arrangement having an electrically nonconductive substrate having a first region coplanar with a second region that is exclusive of the first region, a first electrode having a conductive area disposed entirely on the first region and a second electrode having a conductive area disposed entirely on the second region, wherein the first electrode and the second electrode are electrically connected to one another but the conductive areas of the first electrode and the second electrode are not physically connected to one another;

for each electrode arrangement, placing the combined first and second electrode on the patient if the patient is a first size; and

for each electrode arrangement, separating the first and second regions and placing the first electrode on the patient if the patient is a second size and for each electrode arrangement, separating the first and second regions and placing the second electrode on the patient if the patient is a third size.

43. The method of claim 42, wherein for each electrode arrangement, a conductive surface area of the first electrode is smaller than a conductive surface area of the second electrode.

44. The method of claim 42, further comprising electrically disconnecting the second electrode from the first electrode in each electrode arrangement if the patient is a pediatric patient.

45. The method of claim 42, further comprising providing a sensing mechanism that senses whether only the first electrode is to be placed on the patient.

46. The method of claim 42, further comprising connecting the plurality of electrode arrangements to an electrotherapy device and transferring electrical energy from the electrotherapy device to the patient through the electrodes placed on the patient.

47. The method of claim 42, further comprising placing the first electrode on the patient and transferring less electrical energy to the patient through the first electrode if the patient is a pediatric patient.

48. A medical device comprising:

a plurality of electrode arrangements adapted for placement on a patient, each electrode arrangement comprising an electrically nonconductive substrate having a first region coplanar with a second region, wherein upon each region is disposed an electrode comprising an electrically conductive surface area having an outside boundary surface, and wherein;

only a portion of each of the outside boundary surfaces are coupled so that the conductive surface areas are in electrical communication with one another;

the portion of each of the outside boundary surfaces is less than the entire respective outside boundary surfaces; and

if the electrical communication between the conductive surface areas is broken, the conductive surface area the first region in the electrode arrangement is placed on the patient if the patient is of a first size and the conductive surface area of the second region in the electrode arrangement is placed on the patient if the patient is of a second size; and

circuitry in communication with the plurality of electrode arrangements, the circuitry being configured to transfer electrical energy to or receive electrical energy from the patient after at least one of the conductive surfaces has been placed on the patient.

49. The medical device of claim 48, further comprising a sensing mechanism that senses which conductive surface areas in each electrode arrangement has been placed on the patient.

50. The medial device of claim 49, wherein the medical device is further configured to modify the electrical energy to be transferred to the patient based on which conductive surface areas in the plurality of electrode arrangements have been placed on the patient.

51. The medical device of claim 49, wherein the medical device is further configured to modify a display of information to a user of the medical device based on which conductive surface areas in the plurality of electrode arrangements have been placed on the patient.

52. The medical device of claim 49, wherein the medical device is further configured to modify the waveform of the electrical energy to be transferred to the patient based on which conductive surface areas in the plurality of electrode arrangements have been placed on the patient.

53. The medical device of claim 49, wherein the medical device is further configured to modify the routing of electrical energy to the conductive surface areas in the plurality of electrode arrangements based on which conductive surface areas in the plurality of electrode arrangements has bean placed on the patient.

54. The medical device of claim 48, wherein for each electrode arrangement, the conductive surface area of the first region is smaller than the conductive surface area of the second electrode.

55. A medical device comprising:

a plurality of electrode arrangements adapted for placement on a patient, each electrode arrangement comprising an electrically nonconductive substrate having a first region coplanar with a second region that is exclusive of the first region, a first electrode having a conductive area disposed entirely on the first region and a second electrode having a conductive area disposed entirely on the second region, wherein the first electrode and the second electrode are electrically connected to one another but the conductive areas of the first electrode and the second electrode are not physically connected to one another, and wherein, for each electrode arrangement, if the electrical connection between the first and second electrodes is broken, only the first electrode in the electrode arrangement is placed on the patient; and

circuitry in communication with the plurality of electrode arrangements, the circuitry being configured to transfer electrical energy to or receive electrical energy from the patient after at least one of the conductive surfaces has been placed on the patient if the patient is of a first size and only the second electrode in the electrode arrangement is placed on the patient if the patient is of a second size.

56. The medical device of claim 55, further comprising a sensing mechanism that senses which electrodes in each electrode arrangement have been placed on the patient.

57. The medial device of claim 56, wherein the medical device is further configured to modify the electrical energy to be transferred to the patient based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

58. The medical device of claim 56, wherein the medical device is further configured to modify a display of information to a user of the medical device based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

59. The medical device of claim 56, wherein the medical device is further configured to modify the waveform of the electrical energy to be transferred to the patient based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

60. The medical device of claim 56, wherein the medical device is further configured to modify the routing of electrical energy to the electrodes in the plurality of electrode arrangements based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

61. The medical device of claim 56, wherein for each electrode arrangement, a conductive surface area of the first electrode is smaller than a conductive surface area of the second electrode.

62. An electrode arrangement, comprising:

a first electrode disposed in a first plane and a second electrode disposed in a second plane that is other than the first plane, at least a portion of the first electrode overlying at least a portion of the second electrode, each of the first and second electrodes having a back formed of an electrically nonconductive substrate and a face that includes a conductive surface area adapted for placement on a patient, a nonconductive liner having opposing sides;

wherein the face of the first electrode is releasably attached to one side of the liner and the face of the second electrode is releasably attached to the opposing side of the liner;

wherein the conductive surface areas of the first and second electrodes are electrically connected to each other;

wherein if the electrical connection between the conductive surface areas of the first and second electrodes is broken, only one of the first or second electrodes is placed on the patient; and

wherein the second electrode is configured to transfer less electrical energy to the patient than the first electrode when electrical energy is to be delivered to the patient.

63. The electrode arrangement of claim 62, further comprising a sensing mechanism that senses whether the conductive surface area of the first or second electrode is to be placed on the patient.

64. The electrode arrangement of claim 62, further comprising an energy attenuator that causes the second electrode to transfer less electrical energy to the patient than the first electrode.

65. The electrode arrangement of claim 62, wherein the conductive surface area of the second electrode is smaller than the conductive surface area of the first electrode.

66. An electrode arrangement, comprising:

a first electrode disposed in a first plane and a second electrode disposed in a second plane that is other than the first plane, at least a portion of the first electrode overlying at least a portion of the second electrode, each of the first and second electrodes having a back formed of an electrically nonconductive substrate and a face that includes a conductive surface area adapted for placement on a patient, a nonconductive liner having opposing sides;

wherein the face of the first electrode is releasably attached to one side of the liner and the face of the second electrode is releasably attached to the opposing side of the liner;

wherein the conductive surface area of the second electrode is smaller than the conductive surface area of the first electrode;

wherein the conductive surface areas of the first and second electrodes are electrically connected to each other; and

wherein if the electrical connection between the conductive surface areas of the first and second electrodes is broken, the conductive surface area of only one of the first or second electrodes is placed on the patient.

67. The electrode arrangement of claim 66, further comprising a sensing mechanism that senses whether the conductive surface area of the first or second electrode is to be placed on the patient.

68. A medical device, comprising:

(a) a plurality of electrode arrangements adapted for placement on a patient, each electrode arrangement comprising a first electrode disposed in a first plane and a second electrode disposed in a second plane other than the first plane, at least a portion of the first electrode overlying at least a portion of the second electrode, each of the first and second electrodes having a back formed of an electrically nonconductive substrate and a face that includes a conductive surface area adapted for placement on a patient, a nonconductive liner having opposing sides, wherein the face of the first electrode is releasably attached to one side of the liner and the face of the second electrode is releasably attached to the opposing side of the liner and wherein the conductive surface areas of the first and second electrodes are electrically connected to one other, and wherein for each electrode arrangement, if the electrical connection between the conductive surface areas is broken, the conductive surface area of only one of the first or second electrodes in the electrode arrangement is placed on the patient; and

(b) circuitry in communication with the plurality of electrode arrangements, said circuitry being configured to transfer electrical energy to or receive electrical energy from the patient after at least one electrode in each of the electrode arrangements has been placed on the patient.

69. The medical device of claim 68, further comprising a sensing mechanism that senses which electrode in each electrode arrangement has been placed on the patient.

70. The medical device of claim 69, wherein the medical device is further configured to modify the electrical energy to be transferred to the patient based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

71. The medical device of claim 69, wherein the medical device is further configured to modify a display of information to a user of the medical device based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

72. The medical adevice of claim 69, wherein the medical device is further configured to modify the waveform of the electrical energy to be transferred to the patient based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

73. The medical device of claim 69, wherein the medical device is further configured to modify the routing of electrical energy to the electrodes in the plurality of electrode arrangements based on which electrodes in the plurality of electrode arrangements have been placed on the patient.

74. The medical device of claim 68, wherein the first and second electrodes in each electrode arrangement are separable prior to placement on the patient.

75. The medical device of claim 74, wherein for each electrode arrangement, the medical device is further configured to electrically disconnect the second electrode from the first electrode if the first and second electrodes in the electrode arrangement are separated.

76. The medical device of claim 68, wherein for each electrode arrangement, the conductive surface area of the first electrode is smaller than the conductive surface area of the second electrode.