SYSTEMS, METHODS, AND DEVICES USING STRETCHABLE OR FLEXIBLE ELECTRONICS FOR MEDICAL APPLICATIONS

• US 20100298895A1
• Filed: 12/11/2009
• Published: 11/25/2010
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, Arora, William J., de Graff, Bassel, Callsen, Gilman, Kuznetsov, Eugene, Schlatka, Benjamin
• Granted Patent: US 8,886,334 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 : for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 : for measuring pH
• CPC Class Codes: A61B 5/14546 : for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/24 : Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 : Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6879 : Means for maintaining contact with the body A61B5/6847 takes precedence
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/14 : Echo-tomography
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/04 : Electrodes electrosurgical electrodes A61B18/14
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: H01L 27/14609 : Pixel-elements with integrated switching, control, storage or amplification elements scanning details of imagers (circuitry of solid-state image sensors H04N25/00); circuitry of imagers H04N25/70

Abstract

System, devices and methods are presented that integrate stretchable or flexible circuitry, including arrays of active devices for enhanced sensing, diagnostic, and therapeutic capabilities. The invention enables conformal sensing contact with tissues of interest, such as the inner wall of a lumen, a nerve bundle, or the surface of the heart. Such direct, conformal contact increases accuracy of measurement and delivery of therapy.

Claims

1. An apparatus comprising:

a substrate;

circuitry disposed on said substrate, said circuitry comprising;

an array of recording electrodes receiving signals from a plurality of nerve sources when at least a portion of said array of recording electrodes is in electrical contact with said plurality of nerve sources; and

an array of stimulating electrodes; and

a processing facility in electronic communication with said arrays of electrodes that receives said signals from a plurality of nerve sources from said recording electrodes and is configured to determine a pattern of stimulation signals to be effected by said array of stimulating electrodes.

2. The apparatus of claim 1, wherein said electrical contact comprises physical contact.

3. The apparatus of claim 1, further comprising a multiplexer configured to match said signals from said nerve sources and cause said stimulating electrodes to dispatch a corresponding signal to a second plurality of nerves.

4. The apparatus of claim 1, further comprising a user interface to allow an operator to adjust said pattern of stimulation signals.

5. The apparatus of claim 1, wherein said substrate is an inflatable body.

6. The apparatus of claim 5, wherein said inflatable body is a disk.

7. The apparatus of claim 1, wherein said pattern of stimulation signals is dynamically configurable.

8. The apparatus of claim 1, wherein said processing facility is further configured to generate data related to the electrical conductivity of said nerve sources.

9. The apparatus of claim 8, wherein said processing facility is in electronic communication with an output facility and causes said output facility to generate a map, said map being based on said data related to the electrical conductivity of said nerve sources.

10. The apparatus of claim 1, wherein circuitry is encapsulated with a thin polymer layer.

11. The apparatus of claim 1, wherein circuitry is stretchable up to 300%.

12. The apparatus of claim 1, wherein said electrodes are located discretely from one another.

13. The apparatus of claim 1, wherein said circuitry comprises stretchable electrical interconnects.

14. The apparatus of claim 13, wherein said stretchable interconnects electrically connect said electrodes.

15. The apparatus of claim 1, wherein said circuitry comprises temperature sensors.

16. The apparatus of claim 1, wherein said circuitry comprises contact sensors.

17. The apparatus of claim 1, wherein said circuitry comprises pressure sensors.

18. The apparatus of claim 1, wherein said substrate comprises a reservoir in communication with the surface of said substrate.

19. The apparatus of claim 18, wherein said circuitry is configured to open valves operable to release a drug contained within said reservoir.

20. The apparatus of claim 19, wherein said circuitry causes the valves to release said drug in a controlled manner.

21. An apparatus comprising:

an inflatable substrate;

circuitry disposed on said substrate comprising an array of active devices, said circuitry being configured to remain functional upon inflation of the substrate, said array comprising sensing devices for detecting data indicative of a parameter associated with a tissue;

a processing facility in electronic communication with said circuitry, receiving said data indicative of a parameter associated with said tissue; and

an output facility in electronic communication with said processing facility, said processing facility configured to generate output data associated with said tissue and to cause said output facility to generate said output data.

22. The apparatus of claim 21, wherein said substrate is stretchable.

23. The apparatus of claim 21, wherein said circuitry is in conformal contact with said tissue.

24. The apparatus of claim 21, wherein said circuitry is encapsulated with a thin polymer layer.

25. The apparatus of claim 21, wherein said circuitry is stretchable up to 300%.

26. The apparatus of claim 21, wherein said active devices are located discretely from one another.

27. The apparatus of claim 21, wherein said circuitry comprises stretchable electrical interconnects.

28. The apparatus of claim 27, wherein said stretchable interconnects electrically connect said devices.

29. The apparatus of claim 21, wherein said sensing devices comprise temperature sensors.

30. The apparatus of claim 21, wherein said sensing devices comprise contact sensors.

31. The apparatus of claim 21, wherein said sensing devices comprise pressure sensors.

32. The apparatus of claim 21, wherein said sensing devices comprise ultrasound emitters and receivers.

33. The apparatus of claim 32, wherein said processing facility receives data generated by said sensing devices and produces an image of said tissue.

34. The apparatus of claim 21, wherein said sensing devices are configured to be in an active matrix.

35. The apparatus of claim 34, wherein said circuitry comprises at least one of an amplifier and a logic circuit to operate said sensors in said active matrix.

36. The apparatus of claim 21, wherein said apparatus further comprising a multiplexer.

37. The apparatus of claim 36, wherein said substrate is a balloon coupled with a catheter guide wire, and said multiplexer is located at the base of said guide wire.

38. The apparatus of claim 21, wherein said processing facility is within said circuitry.

39. The apparatus of claim 21, wherein said processing facility is separate from said circuitry.

40. The apparatus of claim 21, wherein said output data related to said tissue is a map.

41. The apparatus of claim 40, wherein said map comprises a map of electrical activity of said tissue.

42. The apparatus of claim 21, wherein said output data comprises data related to temperature heterogeneity present in arterial plaque.

43. The apparatus of claim 21, wherein said output data comprises an indication of plaque type.

44. The apparatus of claim 21, wherein said circuitry comprises a therapeutic facility.

45. The apparatus of claim 44, wherein said therapeutic facility is configured to ablate said tissue.

46. The apparatus of claim 21, wherein said circuitry comprises light emitting electronics.

47. The apparatus of claim 21, wherein said circuitry comprises an array of photodetectors in communication with said processing facility.

48. The apparatus of claim 47, wherein said processing facility is configured to generate image of said tissue and to cause said output facility to output an image.

49. The apparatus of claim 48, wherein said image is high resolution.

50. The apparatus of claim 47, wherein said circuitry is delivered via a catheter having a guide wire, and wherein said guide wire comprises a light source to provide light to said photodetectors.

51. The apparatus of claim 50, wherein said light source is an optical fiber.

52. The apparatus of claim 21, wherein said tissue is a pulmonary vein.

53. The apparatus of claim 21, wherein said tissue is a septal wall of a heart.

54. The apparatus of claim 21, wherein said tissue is an atrial surface of a heart.

55. The apparatus of claim 21, wherein said tissue is a ventricular surface of a heart.

56. The apparatus of claim 21, wherein said substrate comprises reservoir in communication with the surface of said substrate.

57. The apparatus of claim 56, wherein said circuitry is configured to open valves on the substrate to release a drug contained within said reservoir.

58. The apparatus of claim 57, wherein said circuitry causes the valves to release said drug in a controlled manner.

59. A method of detecting parameters associated with a lumen in the body of an individual, said method comprising:

a. inserting an un-inflated balloon catheter into said lumen, said balloon catheter having a stretchable balloon having stretchable circuitry applied thereto, the stretchable circuitry comprising sensing devices;

b. directing said sensing devices to be in an area of interest within said lumen; and

c. inflating said balloon and causing said sensing devices to come into conformal contact with surface of said area of interest within said lumen.

60. The method of claim 59, wherein said circuitry is stretched up to 300% upon said inflation.

61. The method of claim 59, wherein said sensing devices are located discretely from one another.

62. The method of claim 59, wherein said circuitry comprises stretchable electrical interconnects.

63. The method of claim 62, wherein said stretchable interconnects electrically connect said devices.

64. The method of claim 59, wherein said sensing devices comprise temperature sensors.

65. The method of claim 59, wherein said sensing devices comprise contact sensors.

66. The method of claim 59, wherein said sensing devices comprise pressure sensors.

67. The method of claim 59, wherein said sensing devices comprise ultrasound emitters and receivers.

68. The method of claim 59, further comprising utilizing said sensing devices to generate data indicative of a parameter of said area of interest when said sensing devices are in conformal contact with said area of interest.

69. The method of claim 68, utilizing said generated data to produce an image of said area of interest.

70. The method of claim 68, utilizing said generated data to produce a map of said area of interest.

71. The method of claim 70, wherein said map comprises a data indicative of the electrical activity of said area of interest.

72. The method of claim 59, wherein said area of interest includes arterial plaque and further comprising utilizing said parameters to generate data related to temperature heterogeneity present in arterial plaque.

73. The method of claim 59, wherein said area of interest includes arterial plaque and further comprising utilizing said parameters to generate data indicative of plaque type.

74. The method of claim 59, further comprising delivering a therapy to said area of interest based on data indicative of said area of interest.

75. The method of claim 74, wherein step of delivering a therapy includes ablating said area of interest.

76. The method of claim 74, wherein step of delivering a therapy includes delivering a drug to said area of interest.

77. The method of claim 59, wherein said area of interest is a pulmonary vein.

78. The method of claim 59, wherein said area of interest is a septal wall of a heart.

79. The method of claim 59, wherein said area of interest is an atrial surface of a heart.

80. The method of claim 59, wherein said area of interest is a ventricular surface of a heart.

81. A method of detecting parameters associated with a lumen in the body of an individual, said method comprising:

a. inserting an un-inflated balloon catheter into said lumen, said balloon catheter having a stretchable balloon having stretchable circuitry applied thereto, the stretchable circuitry comprising sensing devices;

b. directing said sensing devices to be in an area of interest within said lumen; and

c. inflating said balloon and causing said sensing devices to come into partial sensing contact with said area of interest within said lumen.

82. A method of detecting a parameter of a tissue, comprising:

a. placing an array of active sensing devices in conformal contact with said tissue, said array comprising stretchable circuitry;

b. generating data with said sensing devices; and

c. determining said parameter from said generated data.

83. The method of claim 82, wherein said circuitry is stretched up to 300%.

84. The method of claim 82, wherein said sensing devices are located discretely from one another.

85. The method of claim 82, wherein stretchable interconnects electrically connect said sensing devices.

86. The method of claim 82, wherein said sensing devices comprise temperature sensors.

87. The method of claim 82, wherein said sensing devices comprise contact sensors.

88. The method of claim 82, wherein said sensing devices comprise pressure sensors.

89. The method of claim 82, wherein said sensing devices comprise ultrasound emitters and receivers.

90. The method of claim 82, wherein said parameter comprises an image of said tissue.

91. The method of claim 90, wherein said image comprises a data indicative of the electrical activity of said tissue.

92. The method of claim 82, wherein said parameter comprises temperature heterogeneity present in arterial plaque.

93. The method of claim 82, wherein said parameter comprises plaque type.

94. The method of claim 82, further comprising delivering a therapy to said tissue based on said parameter.

95. The method of claim 94, wherein step of delivering a therapy includes ablating said tissue.

96. The method of claim 94, wherein step of delivering a therapy includes delivering a drug to said tissue.

97. The method of claim 82, wherein said tissue is a pulmonary vein.

98. The method of claim 82, wherein said tissue is a septal wall of a heart.

99. The method of claim 82, wherein said tissue is an atrial surface of a heart.

100. The method of claim 82, wherein said tissue is a ventricular surface of a heart.

101. A tissue screening device, comprising:

a stretchable substrate conformable to the contour of an area of interest on a body;

stretchable circuitry affixed to said substrate, said circuitry comprising an array of active devices;

a processing facility in electronic communication with said array of active devices; and

an output facility in electronic communication with said processing facility, wherein said processing facility is programmed to generate output data based on data generated by said array of active devices and to cause said output facility to display said output data.

102. The device of claim 101, wherein said substrate is inflatable.

103. The device of claim 101, wherein said substrate is affixed to a bra.

104. The device of claim 101, wherein said circuitry is in conformal contact with said area of interest.

105. The device of claim 101, wherein said circuitry is encapsulated with a thin polymer layer.

106. The device of claim 101, wherein said circuitry is stretchable up to 300%.

107. The device of claim 101, wherein said active devices are located discretely from one another.

108. The device of claim 101, wherein said circuitry comprises stretchable electrical interconnects.

109. The device of claim 108, wherein said stretchable interconnects electrically connect said devices.

110. The device of claim 101, wherein said active devices comprise sensing devices.

111. The device of claim 110, wherein said sensing devices comprise temperature sensors.

112. The device of claim 110, wherein said sensing devices comprise contact sensors.

113. The device of claim 110, wherein said sensing devices comprise pressure sensors.

114. The device of claim 113, wherein said active devices comprise an on-off switch coupled to said pressure sensor to indicate whether said pressure sensor has been activated.

115. The device of claim 110, wherein said sensing devices comprise ultrasound emitters and receivers.

116. The device of claim 115, wherein said processing facility receives data generated by said sensor devices and produces an image of said tissue.

117. The device of claim 101, wherein said processing facility is within said circuitry.

118. The device of claim 101, wherein said processing facility is separate from said circuitry.

119. The device of claim 101, wherein said output data comprises a contour map of said area of interest.

120. The device of claim 101, further comprising a storage facility in communication with said processing facility.

121. The device of claim 120, wherein said processing facility causes at least one of data generated by said active devices and said output data to be stored in said storage facility.

122. The device of claim 121, wherein said processing facility generates output data related to said stored data.

123. The device of claim 120, wherein said processing facility causes at least one of data generated by said active devices and said output data to be aggregated.

124. The device of claim 123, wherein said processing facility generates output data related to said aggregated data.

125. A method of examination for cancerous or suspicious tissue, comprising the steps of:

providing a subject with a wearable device conforming to an area of interest on subject'"'"'s body, said wearable device comprising a stretchable array of pressure sensors;

exerting a manual force on said wearable device sufficient to activate said array of pressure sensors;

receiving data from said pressure sensors; and

characterizing the tissue in the area of interest based on said received data.

126. The method of claim 125, further comprising instructing said subject to exert said manual force.

127. The method of claim 125, wherein said wearable device is inflatable.

128. The method of claim 125, wherein said wearable device is affixed to a bra.

129. The method of claim 125, wherein said wearable device is a sheet.

130. An endoscopic device, comprising:

a housing;

curvilinear circuitry that is at least one of mounted to and mounted within said housing, said circuitry comprising a focal plane array generating visual data;

a transmission facility in electronic communication with said circuitry configured to wirelessly transmit said visual data; and

an output facility receiving and displaying said visual data.

131. The device of claim 130, wherein said circuitry is stretchable.

132. The device of claim 130, wherein said housing is a capsule.

133. The device of claim 132, wherein said circuitry, transmission facility, and said output facility are mounted within said capsule.

134. The device of claim 130, wherein said housing is located at a tip of said endoscopic device.

135. The device of claim 130, wherein said circuitry further comprises light emitting electronics.

136. The device of claim 135, wherein said circuitry is configured to illuminate select portions of the light emitting electronics.

137. The device of claim 130, wherein said circuitry is stretchable.

138. The device of claim 130, wherein said circuitry is affixed to an exterior surface of said housing.

139. The device of claim 130, wherein said circuitry is affixed to an interior surface of said housing.

140. The device of claim 130, wherein said circuitry further comprises sensing devices.

141. The device of claim 140, wherein said sensing devices comprise sensors capable of generating data related to enzymatic activity.

142. The device of claim 140, wherein said sensing devices comprise sensors capable of generating data related to chemical activity.

143. The device of claim 130, wherein said endoscopic device comprises a temperature sensor.

144. The device of claim 130, wherein said endoscopic device comprises a contact sensor.

145. The device of claim 130, wherein said endoscopic device comprises a pressure sensor.

146. The device of claim 130, wherein said circuitry is configured to be in conformal contact with a tissue.

147. The device of claim 130, wherein said circuitry is encapsulated.

148. The device of claim 130, wherein said circuitry is stretchable up to 300%.

149. The device of claim 130, wherein said endoscopic device comprises an ultrasound emitter and receiver.

150. The device of claim 130, wherein said circuitry comprises sensing devices and a processing facility receiving data from said sensing devices, said processing facility in electronic communication with said output facility.

151. The device of claim 150, wherein said processing facility causes said output facility to display information related to data generated by said sensing devices.

152. The device of claim 130, further including a processing facility within said circuitry.

153. The device of claim 130, further including a processing facility separate from said circuitry.

154. The device of claim 130, wherein said visual data is an image.

155. The device of claim 130, wherein said visual data is a map.

156. A configurable sheet of electronic devices,

a substantially flat substrate,

stretchable circuitry on said substrate, said circuitry containing an array of electronic devices in electronic communication with one another;

and

a processing facility capable of polling said array of electronic devices to determine a first set of information related to the identity and location of each electronic device in said array, said processing facility configured to adjust the operation of said array based upon information related to a second set of information related to the identity and location of each electronic device in said array.

157. The configurable sheet of claim 156, wherein the second set of information is received after said circuitry is reshaped.

158. The configurable sheet of claim 157, wherein said reshaping is caused by cutting said circuitry.

159. The configurable sheet of claim 156, wherein said array of electronic devices comprise sensor devices.

160. The configurable sheet of claim 159, wherein said sensor devices generate data of a tissue of interest when said sheet is at least one of partial electrical contact and partial conformal contact with said tissue of interest.