Systems, methods, and devices using stretchable or flexible electronics for medical applications

• US 9,629,586 B2
• Filed: 10/20/2014
• Issued: 04/25/2017
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, de Graff, Bassel, Callsen, Gilman, Arora, William J., Schlatka, Benjamin, Kuznetsov, Eugene
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/518,856
• Publication Number:
  US 20150099976A1
• Time in Patent Office: 918 Days
• Field of Search: 600374, 600393, 600547, 600549, 606192
• 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:

an inflatable substrate;

circuitry disposed on said substrate comprising an array of active devices, said circuitry including stretchable electrical interconnects that electrically interconnect the active devices of the array of active devices for the circuitry to remain functional upon inflation of the substrate, said array of active devices 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 said 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 create said output data.

2. The apparatus of claim 1, wherein said substrate is stretchable.

3. The apparatus of claim 1, wherein said circuitry is in conformal contact with said tissue.

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

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

6. The apparatus of claim 1, wherein said active devices are located discretely from one another.

7. The apparatus of claim 1, wherein said stretchable interconnects electrically connect said devices.

8. The apparatus of claim 1, wherein said sensing devices comprise temperature sensors.

9. The apparatus of claim 1, wherein said sensing devices comprise contact sensors.

10. The apparatus of claim 1, wherein said sensing devices comprise pressure sensors.

11. The apparatus of claim 1, wherein said sensing devices comprise ultrasound emitters and receivers.

12. The apparatus of claim 11, wherein said processing facility receives data generated by said sensing devices and produces an image of said tissue.

13. The apparatus of claim 1, wherein said sensing devices are configured to be in an active matrix.

14. The apparatus of claim 13, wherein said circuitry comprises at least one of an amplifier and a logic circuit to operate said sensing devices in said active matrix.

15. The apparatus of claim 1, further comprising a multiplexer.

16. The apparatus of claim 15, wherein said substrate is a balloon coupled to a catheter guide wire, and said multiplexer is located at a base of said catheter guide wire.

17. The apparatus of claim 1, wherein said processing facility is within said circuitry.

18. The apparatus of claim 1, wherein said processing facility is separate from said circuitry.

19. The apparatus of claim 1, wherein said output data related to said tissue is a map.

20. The apparatus of claim 19, wherein said map comprises a map of electrical activity of said tissue.

21. The apparatus of claim 1, wherein said output data comprises data related to temperature heterogeneity present in arterial plaque.

22. The apparatus of claim 1, wherein said output data comprises an indication of plaque type.

23. The apparatus of claim 1, wherein said circuitry comprises a therapeutic facility.

24. The apparatus of claim 23, wherein said therapeutic facility is configured to ablate said tissue.

25. The apparatus of claim 1, wherein said circuitry comprises light emitting electronics.

26. The apparatus of claim 1, wherein said circuitry comprises an array of photodetectors in communication with said processing facility.

27. The apparatus of claim 26, wherein said processing facility is configured to generate an image of said tissue as the output data and to cause said output facility to output the image.

28. The apparatus of claim 27, wherein said image is high resolution.

29. The apparatus of claim 26, 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.

30. The apparatus of claim 29, wherein said light source is an optical fiber.

31. The apparatus of claim 1, wherein said tissue is a pulmonary vein.

32. The apparatus of claim 1, wherein said tissue is a septal wall of a heart.

33. The apparatus of claim 1, wherein said tissue is an atrial surface of a heart.

34. The apparatus of claim 1, wherein said tissue is a ventricular surface of a heart.

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

36. The apparatus of claim 35, wherein said circuitry is configured to open valves on the substrate to release a drug contained within said reservoir.

37. The apparatus of claim 36, wherein said circuitry causes the valves to release said drug in a controlled manner.

38. 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 of active devices comprising sensing devices for detecting data indicative of a parameter associated with a tissue, said sensing devices comprising ultrasound emitters and receivers;

a processing facility in electronic communication with said circuitry, receiving said data indicative of said 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 create said output data.

39. The apparatus of claim 38, wherein said substrate is stretchable.

40. The apparatus of claim 38, wherein said circuitry is in conformal contact with said tissue.

41. The apparatus of claim 38, wherein said circuitry is encapsulated with a thin polymer layer.

42. The apparatus of claim 38, wherein said circuitry is stretchable up to 300%.

43. The apparatus of claim 38, wherein said active devices are located discretely from one another.

44. The apparatus of claim 38, wherein said circuitry comprises stretchable electrical interconnects.

45. The apparatus of claim 44, wherein said stretchable interconnects electrically connect said devices.

46. The apparatus of claim 38, wherein said sensing devices comprise temperature sensors.

47. The apparatus of claim 38, wherein said sensing devices comprise contact sensors.

48. The apparatus of claim 38, wherein said sensing devices comprise pressure sensors.

49. The apparatus of claim 38, wherein said processing facility receives data generated by said sensing devices and produces an image of said tissue.

50. The apparatus of claim 38, wherein said sensing devices are configured to be in an active matrix.

51. The apparatus of claim 50, wherein said circuitry comprises at least one of an amplifier and a logic circuit to operate said sensing devices in said active matrix.

52. The apparatus of claim 38, further comprising a multiplexer.

53. The apparatus of claim 52, wherein said substrate is a balloon coupled to a catheter guide wire, and said multiplexer is located at a base of said catheter guide wire.

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

55. The apparatus of claim 38, wherein said processing facility is separate from said circuitry.

56. The apparatus of claim 38, wherein said output data related to said tissue is a map.

57. The apparatus of claim 56, wherein said map comprises a map of electrical activity of said tissue.

58. The apparatus of claim 38, wherein said output data comprises data related to temperature heterogeneity present in arterial plaque.

59. The apparatus of claim 38, wherein said output data comprises an indication of plaque type.

60. The apparatus of claim 38, wherein said circuitry comprises a therapeutic facility.

61. The apparatus of claim 60, wherein said therapeutic facility is configured to ablate said tissue.

62. The apparatus of claim 38, wherein said circuitry comprises light emitting electronics.

63. The apparatus of claim 38, wherein said circuitry comprises an array of photodetectors in communication with said processing facility.

64. The apparatus of claim 63, wherein said processing facility is configured to generate an image of said tissue as the output data and to cause said output facility to output the image.

65. The apparatus of claim 64, wherein said image is high resolution.

66. The apparatus of claim 63, 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.

67. The apparatus of claim 66, wherein said light source is an optical fiber.

68. The apparatus of claim 38, wherein said tissue is a pulmonary vein.

69. The apparatus of claim 38, wherein said tissue is a septal wall of a heart.

70. The apparatus of claim 38, wherein said tissue is an atrial surface of a heart.

71. The apparatus of claim 38, wherein said tissue is a ventricular surface of a heart.

72. The apparatus of claim 38, wherein said substrate comprises a reservoir in communication with a surface of said substrate.

73. The apparatus of claim 72, wherein said circuitry is configured to open valves on the substrate to release a drug contained within said reservoir.

74. The apparatus of claim 73, wherein said circuitry causes the valves to release said drug in a controlled manner.