ELECTRODE SYSTEMS FOR USE WITH MEDICAL MONITORING SYSTEMS

• US 20140235991A1
• Filed: 02/14/2014
• Published: 08/21/2014
• Est. Priority Date: 02/15/2013
• Status: Active Grant

• Current Assignee: Acacia Designs BV (Senzime AB (publ))
• Original Assignee: T4 Analytics, LLC
• Inventors: Gadsby, Peter Donald
• Granted Patent: US 9,814,402 B2
• Time in Patent Office: Days
• US Class Current: 600/391
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/273 Connection of cords, cables or leads to electrodes
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: Y10T 29/49147 Assembling terminal to base

Abstract

Electrode systems for use with neuromuscular monitoring systems are provided herein. An example electrode system for use with a monitoring system can include a flexible substrate, a connector interface, one or more stimulating electrodes, one or more recording electrodes and a plurality of conductive traces carried on the flexible substrate. The connector interface can be configured to communicatively connect the electrode system with the monitoring system. In addition, the one or more stimulating electrodes can be configured to deliver an electrical pulse, and the one or more recording electrodes can be configured to receive an electrical signal. The plurality of conductive traces can electrically connect at least one stimulating electrode or at least one recording electrode with the connector interface. Further, each of the one or more stimulating electrodes can have an elongate shape with a length dimension that is substantially greater than a width dimension.

Claims

1. An electrode system for use with a monitoring system, comprising:

a flexible substrate;

a connector interface carried on the flexible substrate and configured to communicatively connect the electrode system with the monitoring system;

one or more stimulating electrodes carried on the flexible substrate and configured to deliver an electrical pulse;

one or more recording electrodes carried on the flexible substrate and configured to receive an electrical signal; and

a plurality of conductive traces carried on the flexible substrate, the conductive traces electrically connecting at least one stimulating electrode or at least one recording electrode with the connector interface, wherein each of the one or more stimulating electrodes has an elongate shape with a length dimension that is substantially greater than a width dimension.

2. The electrode system of claim 1, wherein the length dimension is at least two times greater than the width dimension.

3. The electrode system of claim 1, wherein the length dimension is at least five times greater than the width dimension.

4. The electrode system of claim 1, wherein each of the one or more stimulating electrodes has a non-rectangular shape.

7. The electrode system of claim 1, wherein each of the one or more stimulating electrodes has at least one rounded corner.

8. The electrode system of claim 7, wherein each of the one or more stimulating electrodes comprises first and second sides that define the length dimension.

9. The electrode system of claim 8, wherein the first and second sides extend substantially in parallel along the length dimension.

10. The electrode system of claim 8, wherein each of the one or more stimulating electrodes comprises third and fourth sides that define the width dimension.

11. The electrode system of claim 10, wherein one of the third and forth sides forms the at least one rounded corner, the at least one rounded corner connecting the first and second sides.

12. The electrode system of claim 10, wherein the at least one rounded corner connects one of the first and second side and one of the third and fourth side.

13. The electrode system of claim 1, wherein each of the one or more stimulating electrodes has a maximum surface area less than or equal to 1.5 cm².

14. The electrode system of claim 1, wherein the flexible substrate defines proximal and distal ends, the connector interface being disposed at the proximal end of the flexible substrate.

15. The electrode system of claim 14, wherein the flexible substrate comprises a first portion on which the stimulating electrodes are disposed and a second portion on which the recording electrodes are disposed.

16. The electrode system of claim 15, wherein the first portion is arranged adjacent to the proximal end of the flexible substrate and the second portion is arranged adjacent to the distal end of the flexible substrate.

17. The electrode system of claim 16, wherein the second portion is an elongate portion extending distally from the first portion.

18. The electrode system of claim 15, wherein the one or more recording electrodes comprise at least two recording electrodes, the recording electrodes being spaced apart on the second portion of the flexible substrate.

21. The electrode system of claim 15, wherein the one or more stimulating electrodes comprise at least two stimulating electrodes, the stimulating electrodes being spaced apart on the first portion of the flexible substrate.

23. The electrode system of claim 1, further comprising a dielectric layer carried on the flexible substrate, the dielectric layer providing electrical insulation between any two of the plurality of conductive traces, the one or more stimulating electrodes and the one or more recording electrodes.

24. The electrode system of claim 1, further comprising a foam layer carried on the flexible substrate, wherein the foam layer defines a plurality of openings around each of the one or more stimulating electrodes and the one or more recording electrodes.

25. The electrode system of claim 24, further comprising a conductive adhesive arranged in at least one of the plurality of openings in the foam layer, the conductive adhesive capable of binding to a subject'"'"'s skin.

27. The electrode system of claim 24, further comprising a transfer adhesive layer that binds the foam layer and the flexible substrate.

29. The electrode system of claim 1, wherein the plurality of conductive traces are formed from at least one of a conductive silver or silver-carbon ink.

30. The electrode system of claim 1, wherein each of the one or more stimulating electrodes and the one or more recording electrodes comprises a first layer carried on the flexible substrate and a second layer carried on the first layer, the first layer being formed from at least one of a conductive silver or silver-carbon ink and the second layer being formed from a conductive silver-silver chloride ink.

31. The electrode system of claim 30, wherein each of the plurality of conductive traces is connected to the first layer of at least one of the one or more stimulating electrodes and the one or more recording electrodes.

32. The electrode system of claim 1, wherein the monitoring system is configured to deliver the electrical pulse to a subject through the one or more stimulating electrodes, and the electrode system is configured to detect electrical activity of at least one of a muscular response or a nerve response to the delivered electrical pulse using the one or more recording electrodes.

33. The electrode system of claim 32, wherein the monitoring system is configured to monitor neuromuscular blockade in the subject.

34. The electrode system of claim 1, wherein a surface area of each of the one or more stimulating electrodes is greater than a surface area of each of the one or more recording electrodes.

35. The electrode system of claim 34, wherein the surface area of each of the one or more stimulating electrodes is approximately 1.5 times greater than the surface area of each of the one or more recording electrodes.

36. The electrode system of claim 1, further comprising a temperature sensor for measuring a temperature of a subject to which the electrode system is applied, the temperature sensor being carried on the flexible substrate.

37. The electrode system of claim 1, further comprising a security IC chip configured to provide authentication between the electrode system and the monitoring system, the security IC chip being carried on the flexible substrate.

38. The electrode system of claim 1, wherein the electrode system does not include a common ground electrode.

5. (canceled)

6. (canceled)

19. (canceled)

20. (canceled)

22. (canceled)

26. (canceled)

28. (canceled)

39. A method for manufacturing an electrode system, comprising:

providing a flexible substrate;

providing a connector interface on the flexible substrate, the connector interface being configured to communicatively connect the electrode system with a monitoring system;

providing one or more stimulating electrodes on the flexible substrate, the one or more stimulating electrodes being configured to deliver an electrical pulse;

providing one or more recording electrodes on the flexible substrate, the one or more recording electrodes being configured to receive an electrical signal; and

providing a plurality of conductive traces on the flexible substrate, the conductive traces electrically connecting at least one stimulating electrode or at least one recording electrode with the connector interface, wherein each of the one or more stimulating electrodes has an elongate shape with a length dimension that is substantially greater than a width dimension.

40. The method of claim 39, wherein the length dimension is at least two times greater than the width dimension.

41. The method of claim 39, wherein the length dimension is at least five times greater than the width dimension.

45. The method of claim 39, wherein each of the one or more stimulating electrodes has at least one rounded corner.

51. The method of claim 39, wherein each of the one or more stimulating electrodes has a maximum surface area less than or equal to 1.5 cm².

61. The method of claim 39, further comprising providing a dielectric layer on the flexible substrate, wherein the dielectric layer provides electrical insulation between any two of the plurality of conductive traces, the one or more stimulating electrodes and the one or more recording electrodes.

62. The method of claim 39, further comprising providing a foam layer on the flexible substrate, wherein the foam layer defines a plurality of openings around each of the one or more stimulating electrodes and the one or more recording electrodes.

63. The method of claim 62, further comprising providing a conductive adhesive arranged in at least one of the plurality of openings in the foam layer, the conductive adhesive capable of binding to a subject'"'"'s skin.

65. The method of claim 62, further comprising providing a transfer adhesive layer that binds the foam layer and the flexible substrate.

68. The method of claim 39, wherein providing the plurality of conductive traces further comprises printing at least one of a conductive silver or silver-carbon ink on the flexible substrate.

69. The method of claim 39, wherein each of the one or more stimulating electrodes and the one or more recording electrodes comprises a first layer carried on the flexible substrate and a second layer carried on the first layer, the first layer being formed from at least one of a conductive silver or silver-carbon ink and the second layer being formed from a conductive silver-silver chloride ink.

70. The method of claim 69, wherein providing one or more stimulating electrodes and one or more recording electrodes further comprises printing the first layer formed from the at least one of a conductive silver or silver-carbon ink on the flexible substrate and printing the second layer formed from the conductive silver-silver chloride ink on the first layer.

71. The method of claim 70, wherein each of the plurality of conductive traces is connected to the first layer of at least one of the one or more stimulating electrodes and the one or more recording electrodes.

72. The method of claim 39, wherein a surface area of each of the one or more stimulating electrodes is greater than a surface area of each of the one or more recording electrodes.

73. The method of claim 72, wherein the surface area of each of the one or more stimulating electrodes is approximately 1.5 times greater than the surface area of each of the one or more recording electrodes.

74. The method of claim 39, further comprising providing a temperature sensor for measuring a temperature of a subject to which the electrode system is applied on the flexible substrate.

75. The method of claim 39, further comprising providing a security IC chip configured to provide authentication between the electrode system and the monitoring system on the flexible substrate.

76. The method of claim 39, wherein the electrode system does not include a common ground electrode.

42-44. -44. (canceled)

46-50. -50. (canceled)

52-60. -60. (canceled)

64. (canceled)

66. (canceled)

67. (canceled)

77. A system for assessing muscle electrical activity in a subject, comprising:

a motor nerve stimulator configured generate an electrical pulse to stimulate a targeted motor nerve of the subject;

a recording apparatus for recording electrical activity of a muscle innervated by the motor nerve; and

an electrode system comprising;

a flexible substrate;

a connector interface carried on the flexible substrate and configured to communicatively connect the electrode system with the system for assessing muscle electrical activity;

one or more stimulating electrodes carried on the flexible substrate and configured to deliver the generated electrical pulse to a motor nerve of the subject;

one or more recording electrodes carried on the flexible substrate and configured to receive a muscle electrical activity of a muscle innervated by the motor nerve; and

a plurality of conductive traces carried on the flexible substrate, the conductive traces electrically connecting at least one stimulating electrode or at least one recording electrode with the connector interface, wherein each of the one or more stimulating electrodes has an elongate shape with a length dimension that is substantially greater than a width dimension.

78. The system of claim 77, wherein the electrode system does not include a common ground electrode.

79. (canceled)