Multi-mode communication ingestible event markers and systems, and methods of using the same

• US 8,258,962 B2
• Filed: 03/05/2009
• Issued: 09/04/2012
• Est. Priority Date: 03/05/2008
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Biomedical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Robertson, Timothy, Zdeblick, Mark J.
• Primary Examiner(s): HUNNINGS, TRAVIS R
• Application Number:
  US12/398,941
• Publication Number:
  US 20090256702A1
• Time in Patent Office: 1,279 Days
• Field of Search: 340/572, 340/10, 340/505, 340/539.1
• US Class Current: 340/573.1
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: G06K 7/10297 arrangements for handling protocols designed for non-contact record carriers such as RFIDs NFCs, e.g. ISO/IEC 14443 and 18092 cryptographic protocols H04L9/00; network security protocols H04L63/00; real-time communication protocols in data switching networks H04L65/00; network protocols for data switching network services H04L67/00
• CPC Class Codes: H04B 5/77 for interrogation

Abstract

Aspects of the invention include multi-mode communication ingestible event marker devices. Ingestible event marker devices of the invention include an ingestible component comprising a conductive communication module and at least one additional non-conductive communication module. The non-conductive communication module may be integrated with the ingestible component or at least a portion or all of the non-conductive communication module may be associated with a packaging component of the ingestible event marker device. Additional aspects of the invention include systems that include the devices and one or more receivers, as well as methods of using the same.

Claims

1. A device comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module; and

a second non-conductive communication module;

wherein the second non-conductive communication module comprises at least one optical module; and

wherein the optical module comprises an infrared frequency module.

2. The device of claim 1, wherein the second non-conductive communication module comprises at least one wireless radio-frequency module, wherein the at least one wireless radio-frequency module comprises a radio-frequency identification module.

3. The device of claim 1, wherein the ingestible component comprises a power source.

4. The device of claim 3, wherein the power source comprises a pair of electrodes fabricated from dissimilar materials.

5. The device of claim 3, wherein the device comprises a second power source electrically coupled to the non-conductive communication module.

6. The device of claim 5, wherein the second power source comprises a coil.

7. The device of claim 1, wherein the ingestible component comprises the non-conductive communication module.

8. The device of claim 7, wherein the non-conductive communication module is electrically coupled to the ingestible component integrated circuit.

9. The device of claim 8, wherein the ingestible component integrated circuit, conductive communication module and at least a portion of the non-conductive communication module are integrated into an identifier component.

10. The device of claim 8, wherein the non-conductive communication module comprises a non-conductive transmitter.

11. The device of claim 10, wherein the non-conductive transmitter is associated with the ingestible component.

12. The device of claim 10, wherein the non-conductive transmitter is associated with a packaging component of the device.

13. The device of claim 1, wherein the non-conductive communication module is electrically coupled to a second integrated circuit that is distinct from the ingestible component integrated circuit.

14. The device of claim 13, wherein the second integrated circuit and ingestible component integrated circuit are configured to communicate with each other.

15. The device of claim 1, wherein at least a portion of the non-conductive communication module is configured to be separable from the ingestible component in a manner that does not compromise the function of the conductive communication module.

16. The device of claim 1, wherein the ingestible component comprises an active pharmaceutical agent.

17. The device of claim 1, wherein the ingestible component comprises a physiologically acceptable vehicle.

18. The device of claim 17, wherein the physiologically acceptable vehicle is configured as a tablet or capsule.

29. The device of claim 1, wherein the second non-conductive communication module comprises at least one magnetic induction module.

30. The device of claim 1, wherein the second non-conductive communication module comprises at least one acoustic module.

31. The device of claim 1, wherein the second non-conductive communication module comprises at least one wired module.

19. A system comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module configured to emit a first signal;

a second non-conductive communication module configured to emit a second signal; and

a receiver, wherein the receiver, conductive communication module and non-conductive communication module are configured to provide for transmission of information between the receiver and at least one of the conductive communication module and the non-conductive communication module;

wherein the receiver is configured to receive at least one of the first signal and the second signal;

wherein the receiver is configured to receive the second signal;

wherein the receiver is a component of a manufacturing system.

20. The system of claim 19, wherein the receiver comprises a radio-frequency reader.

21. The system of claim 19, wherein the receiver is configured transmit information to the non-conductive communication module.

22. The system of claim 19, wherein the receiver is associated with a sorter.

23. The system of claim 19, wherein the receiver is associated with an encoder.

24. The system of claim 19, wherein the first signal comprises non-physiologic data.

25. The system of claim 24, wherein the receiver is configured to be removably attached to a living being.

26. The system of claim 25, wherein the receiver comprises an adhesive component.

27. The system of claim 19, wherein the receiver is an implantable receiver.

28. The system of claim 19, wherein the receiver is configured as an electrical stimulation device.

32. A device comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module; and

a second non-conductive communication module;

wherein the ingestible component comprises a power source; and

wherein the power source comprises a pair of electrodes fabricated from dissimilar materials.

33. The device of claim 32, wherein the second non-conductive communication module comprises at least one module selected from the group consisting of a wireless radio-frequency module, a magnetic induction module, an optical module, an acoustic module, and a wired module.

34. The device of claim 33, wherein the wireless radio-frequency module comprises a radio-frequency identification module.

35. The device of claim 33, wherein the optical module comprises an infrared frequency module.

36. The device of claim 32, wherein the device comprises a second power source electrically coupled to the non-conductive communication module.

37. The device of claim 36, wherein the second power source comprises a coil.

38. The device of claim 32, wherein the ingestible component comprises the non-conductive communication module.

39. The device of claim 38, wherein the non-conductive communication module is electrically coupled to the ingestible component integrated circuit.

40. The device of claim 39, wherein the ingestible component integrated circuit, conductive communication module and at least a portion of the non-conductive communication module are integrated into an identifier component.

41. The device of claim 39, wherein the non-conductive communication module comprises a non-conductive transmitter.

42. The device of claim 41, wherein the non-conductive transmitter is associated with the ingestible component.

43. The device of claim 41, wherein the non-conductive transmitter is associated with a packaging component of the device.

44. The device of claim 32, wherein the non-conductive communication module is electrically coupled to a second integrated circuit that is distinct from the ingestible component integrated circuit.

45. The device of claim 44, wherein the second integrated circuit and ingestible component integrated circuit are configured to communicate with each other.

46. The device of claim 32, wherein at least a portion of the non-conductive communication module is configured to be separable from the ingestible component in a manner that does not compromise the function of the conductive communication module.

47. The device of claim 32, wherein the ingestible component comprises an active pharmaceutical agent.

48. The device of claim 32, wherein the ingestible component comprises a physiologically acceptable vehicle.

49. The device of claim 48, wherein the physiologically acceptable vehicle is configured as a tablet or capsule.

50. A device comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module; and

a second non-conductive communication module;

wherein the ingestible component comprises a power source; and

wherein the device comprises a second power source electrically coupled to the non-conductive communication module.

51. The device of claim 50, wherein the second non-conductive communication module comprises at least one module selected from the group consisting of a wireless radiofrequency module, a magnetic induction module, an optical module, an acoustic module, and a wired module.

52. The device of claim 51, wherein the wireless radio-frequency module comprises a radio-frequency identification module.

53. The device of claim 51, wherein the optical module comprises an infrared frequency module.

54. The device of claim 50, wherein the power source comprises a pair of electrodes fabricated from dissimilar materials.

55. The device of claim 50, wherein the second power source comprises a coil.

56. The device of claim 50, wherein the ingestible component comprises the non-conductive communication module.

57. The device of claim 56, wherein the non-conductive communication module is electrically coupled to the ingestible component integrated circuit.

58. The device of claim 57, wherein the ingestible component integrated circuit, conductive communication module and at least a portion of the non-conductive communication module are integrated into an identifier component.

59. The device of claim 57, wherein the non-conductive communication module comprises a non-conductive transmitter.

60. The device of claim 59, wherein the non-conductive transmitter is associated with the ingestible component.

61. The device of claim 59, wherein the non-conductive transmitter is associated with a packaging component of the device.

62. The device of claim 50, wherein the non-conductive communication module is electrically coupled to a second integrated circuit that is distinct from the ingestible component integrated circuit.

63. The device of claim 62, wherein the second integrated circuit and ingestible component integrated circuit are configured to communicate with each other.

64. The device of claim 50, wherein at least a portion of the non-conductive communication module is configured to be separable from the ingestible component in a manner that does not compromise the function of the conductive communication module.

65. The device of claim 50, wherein the ingestible component comprises an active pharmaceutical agent.

66. The device of claim 50, wherein the ingestible component comprises a physiologically acceptable vehicle.

67. The device of claim 66, wherein the physiologically acceptable vehicle is configured as a tablet or capsule.

68. A device comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module; and

a second non-conductive communication module;

wherein the ingestible component comprises the non-conductive communication module;

wherein the non-conductive communication module is electrically coupled to the ingestible component integrated circuit; and

wherein the non-conductive communication module comprises a non-conductive transmitter.

69. The device of claim 68, wherein the second non-conductive communication module comprises at least one module selected from the group consisting of a wireless radiofrequency module, a magnetic induction module, an optical module, an acoustic module, and a wired module.

70. The device of claim 69, wherein the wireless radio-frequency module comprises a radio-frequency identification module.

71. The device of claim 69, wherein the optical module comprises an infrared frequency module.

72. The device of claim 68, wherein the ingestible component comprises a power source.

73. The device of claim 72, wherein the power source comprises a pair of electrodes fabricated from dissimilar materials.

74. The device of claim 72, wherein the device comprises a second power source electrically coupled to the non-conductive communication module.

75. The device of claim 74, wherein the second power source comprises a coil.

76. The device of claim 68, wherein the ingestible component integrated circuit, conductive communication module and at least a portion of the non-conductive communication module are integrated into an identifier component.

77. The device of claim 68, wherein the non-conductive transmitter is associated with the ingestible component.

78. The device of claim 68, wherein the non-conductive transmitter is associated with a packaging component of the device.

79. The device of claim 68, wherein the non-conductive communication module is electrically coupled to a second integrated circuit that is distinct from the ingestible component integrated circuit.

80. The device of claim 79, wherein the second integrated circuit and ingestible component integrated circuit are configured to communicate with each other.

81. The device of claim 68, wherein at least a portion of the non-conductive communication module is configured to be separable from the ingestible component in a manner that does not compromise the function of the conductive communication module.

82. The device of claim 68, wherein the ingestible component comprises an active pharmaceutical agent.

83. The device of claim 68, wherein the ingestible component comprises a physiologically acceptable vehicle.

84. The device of claim 83, wherein the physiologically acceptable vehicle is configured as a tablet or capsule.

85. A device comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module; and

a second non-conductive communication module;

wherein the non-conductive communication module is electrically coupled to a second integrated circuit that is distinct from the ingestible component integrated circuit; and

wherein the second integrated circuit and ingestible component integrated circuit are configured to communicate with each other.

86. The device of claim 85, wherein the second non-conductive communication module comprises at least one module selected from the group consisting of a wireless radiofrequency module, a magnetic induction module, an optical module, an acoustic module, and a wired module.

87. The device of claim 85, wherein the wireless radio-frequency module comprises a radio-frequency identification module.

88. The device of claim 86, wherein the optical module comprises an infrared frequency module.

89. The device of claim 85, wherein the ingestible component comprises a power source.

90. The device of claim 89, wherein the power source comprises a pair of electrodes fabricated from dissimilar materials.

91. The device of claim 89, wherein the device comprises a second power source electrically coupled to the non-conductive communication module.

92. The device of claim 91, wherein the second power source comprises a coil.

93. The device of claim 85, wherein the ingestible component comprises the non-conductive communication module.

94. The device of claim 93, wherein the non-conductive communication module is electrically coupled to the ingestible component integrated circuit.

95. The device of claim 94, wherein the ingestible component integrated circuit, conductive communication module and at least a portion of the non-conductive communication module are integrated into an identifier component.

96. The device of claim 94, wherein the non-conductive communication module comprises a non-conductive transmitter.

97. The device of claim 96, wherein the non-conductive transmitter is associated with the ingestible component.

98. The device of claim 96, wherein the non-conductive transmitter is associated with a packaging component of the device.

99. The device of claim 85, wherein at least a portion of the non-conductive communication module is configured to be separable from the ingestible component in a manner that does not compromise the function of the conductive communication module.

100. The device of claim 85, wherein the ingestible component comprises an active pharmaceutical agent.

101. The device of claim 85, wherein the ingestible component comprises a physiologically acceptable vehicle.

102. The device of claim 101, wherein the physiologically acceptable vehicle is configured as a tablet or capsule.

103. A system comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module configured to emit a first signal;

a second non-conductive communication module configured to emit a second signal; and

a receiver, wherein the receiver, conductive communication module and non-conductive communication module are configured to provide for transmission of information between the receiver and at least one of the conductive communication module and the non-conductive communication module;

wherein the receiver is configured to receive at least one of the first signal and the second signal; and

wherein the receiver is a component of supply chain management system.

104. The system of claim 103, wherein the receiver comprises a radio-frequency reader.

105. The system of claim 103, wherein the receiver is configured transmit information to the non-conductive communication module.

106. The system of claim 105, wherein the first signal comprises non-physiologic data.

107. The system of claim 106, wherein the receiver is configured to be removably attached to a living being.

108. The system of claim 107, wherein the receiver comprises an adhesive component.

109. The system of claim 105, wherein the receiver is an implantable receiver.

110. The system of claim 105, wherein the receiver is configured as an electrical stimulation device.

111. A system comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module configured to emit a first signal;

a second non-conductive communication module configured to emit a second signal; and

a receiver, wherein the receiver, conductive communication module and non-conductive communication module are configured to provide for transmission of information between the receiver and at least one of the conductive communication module and the non-conductive communication module;

wherein the receiver is configured to receive at least one of the first signal and the second signal;

wherein the first signal comprises non-physiologic data; and

wherein the receiver is configured to be removably attached to a living being.

112. The system of claim 111, wherein the receiver comprises a radio-frequency reader.

113. The system of claim 111, wherein the receiver is configured transmit information to the non-conductive communication module.

114. The system of claim 111, wherein the receiver is a component chosen from a system selected from the group consisting of manufacturing systems, supply chain management systems and health care management systems.

115. The system of claim 114, wherein the receiver is associated with a sorter.

116. The system of claim 114, wherein the receiver is associated with an encoder.

117. The system of claim 114, wherein the receiver is associated with a tracker.

118. The system of claim 114, wherein the receiver is associated with a scanner.

119. The system of claim 114, wherein the receiver is associated with an encoder.

120. The system of claim 111, wherein the receiver comprises an adhesive component.

121. The system of claim 111, wherein the receiver is an implantable receiver.

122. The system of claim 111, wherein the receiver is configured as an electrical stimulation device.

123. A system comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module configured to emit a first signal;

a second non-conductive communication module configured to emit a second signal; and

a receiver, wherein the receiver, conductive communication module and non-conductive communication module are configured to provide for transmission of information between the receiver and at least one of the conductive communication module and the non-conductive communication module;

wherein the receiver is configured to receive at least one of the first signal and the second signal; and

wherein the receiver is an implantable receiver.

124. The system of claim 123, wherein the receiver comprises a radio-frequency reader.

125. The system of claim 123, wherein the receiver is configured transmit information to the non-conductive communication module.

126. The system of claim 123, wherein the receiver is a component chosen from a system selected from the group consisting of manufacturing systems, supply chain management systems and health care management systems.

127. The system of claim 126, wherein the receiver is associated with a sorter.

128. The system of claim 126, wherein the receiver is associated with an encoder.

129. The system of claim 126, wherein the receiver is associated with a tracker.

130. The system of claim 126, wherein the receiver is associated with a scanner.

131. The system of claim 126, wherein the receiver is associated with an encoder.

132. The system of claim 123, wherein the first signal comprises non-physiologic data.

133. The system of claim 132, wherein the receiver is configured to be removably attached to a living being.

134. The system of claim 133, wherein the receiver comprises an adhesive component.

135. The system of claim 123, wherein the receiver is configured as an electrical stimulation device.

136. A system comprising:

an ingestible component comprising an integrated circuit comprising a conductive communication module configured to emit a first signal;

a second non-conductive communication module configured to emit a second signal; and

a receiver, wherein the receiver, conductive communication module and non-conductive communication module are configured to provide for transmission of information between the receiver and at least one of the conductive communication module and the non-conductive communication module;

wherein the receiver is configured to receive at least one of the first signal and the second signal; and

wherein the receiver is configured as an electrical stimulation device.

137. The system of claim 136, wherein the receiver comprises a radio-frequency reader.

138. The system of claim 136, wherein the receiver is configured transmit information to the non-conductive communication module.

139. The system of claim 136, wherein the receiver is a component chosen from a system selected from the group consisting of manufacturing systems, supply chain management systems and health care management systems.

140. The system of claim 139, wherein the receiver is associated with a sorter.

141. The system of claim 139, wherein the receiver is associated with an encoder.

142. The system of claim 139, wherein the receiver is associated with a tracker.

143. The system of claim 139, wherein the receiver is associated with a scanner.

144. The system of claim 139, wherein the receiver is associated with an encoder.

145. The system of claim 136, wherein the first signal comprises non-physiologic data.

146. The system of claim 145, wherein the receiver is configured to be removably attached to a living being.

147. The system of claim 146, wherein the receiver comprises an adhesive component.

148. The system of claim 136, wherein the receiver is an implantable receiver.