Transdermal drug delivery systems and their use

Abstract

This disclosure provides transdermal drug delivery systems, methods, and platforms. In one example, a smart patch includes a drug-containing layer, a communication interface, and one or more sensors configured to detect changes in the state of the smart patch, the changes in the state of the smart patch include one or more of removing the packaging material from the smart patch and attaching the smart patch to the patient's skin. The smart patch further includes a processor communicatively coupled to one or more sensors and the communication interface, the processor being configured to perform actions including automatically transitioning between a plurality of operating states based on changes in the state of the smart patch, the plurality of operating states of the smart patch including a quiescent mode, a sleep mode, and an active mode, and transmitting smart patch usage data via the communication interface.

Claims

1. A transdermal drug delivery smart patch, Drug-containing layer, Communication interface, One or more sensors configured to detect a change in the state of the smart patch, wherein the change in state includes one or more of the following: (i) removing the packaging material from the smart patch, (ii) removing the liner from the adhesive layer of the smart patch, (iii) attaching the smart patch to the patient's skin, and (iv) removing the smart patch from the patient's skin. A processor that is communicatively coupled to the 1 or more sensors and the communication interface. The processor includes, (a) Automatically transitioning between multiple operating states based on the state change of the smart patch, wherein the multiple operating states of the smart patch include a hibernation mode, a sleep mode, and an execution mode. (b) Transmitting smart patch status data using the communication interface A transdermal drug delivery smart patch configured to perform actions including the following.

2. The transdermal drug delivery smart patch according to claim 1, wherein one or more sensors include an optical sensor, a resistance sensor, or both.

3. The transdermal drug delivery smart patch according to claim 1 or 2, wherein the smart patch is disposable.

4. A transdermal drug delivery smart patch according to any one of claims 1 to 3, further comprising a power supply.

5. The transdermal drug delivery smart patch according to claim 4, wherein the power supply is a printed power supply.

6. The transdermal drug delivery smart patch according to any one of claims 1 to 5, wherein the processor includes a system-on-a-chip (SoC).

7. The transdermal drug delivery smart patch according to claim 6, wherein the SoC includes one or more of a messaging subsystem, a sensor subsystem, a power state subsystem, a communication state subsystem, a communication subsystem, a printable battery, or an event cache subsystem, or any combination thereof.

8. The transdermal drug delivery smart patch according to claim 7, wherein the communication subsystem transmits data to and from a cloud server system.

9. The transdermal drug delivery smart patch according to claim 7, wherein a sensor subunit receives data from one or more sensors.

10. The transdermal drug delivery smart patch according to claim 9, wherein one or more sensors detect information relating to the smart patch status data.

11. A transdermal drug delivery smart patch according to any one of claims 1 to 10, wherein one or more drugs are introduced into the drug-containing layer.

12. The transdermal drug delivery smart patch according to claim 11, wherein one or more of the drugs are lipophilic or hydrophilic.

13. A transdermal drug delivery smart patch according to any one of claims 1 to 12, wherein one or more placebos are introduced into the drug-containing layer.

14. The transdermal drug delivery smart patch according to any one of claims 1 to 13, wherein the drug-containing layer includes a drug-containing adhesive layer.

15. The transdermal drug delivery smart patch according to any one of claims 1 to 14, wherein the drug-containing layer comprises a plurality of drug-containing adhesive layers and a film positioned between them.

16. The transdermal drug delivery smart patch according to any one of claims 1 to 15, wherein the drug-containing layer comprises a drug reservoir, an adhesive layer, and a membrane positioned between them.

17. The transdermal drug delivery smart patch according to any one of claims 1 to 15, wherein the drug-containing layer includes a drug reservoir and an adhesive ring surrounding it.

18. The transdermal drug delivery smart patch according to any one of claims 1 to 17, wherein the drug-containing layer comprises a drug-containing microneedle array and an adhesive layer.

19. The transdermal drug delivery smart patch according to any one of claims 1 to 18, wherein the drug-containing layer comprises one or more excipients that facilitate (i) penetration of the drug into the skin and (ii) drug delivery.

20. The transdermal drug delivery smart patch according to claim 19, wherein one or more excipients comprise one or more chemical accelerators.

21. A transdermal drug delivery smart patch according to any one of claims 1 to 20, further comprising a flexible circuit electrically connected to one or more sensors, wherein the flexible circuit comprises one or more conductive pads.

22. The packaging material includes a wrapping material, and one or more of the conductive pads and conductive traces are arranged on the inner surface of the wrapping material so as to be in contact with the smart patch. When the packaging material is removed, one or more sensors detect a change in the electrical signal between the conductive pad on the packaging material and the conductive pad on the flex circuit. The transdermal drug delivery smart patch according to claim 21, wherein the processor controls the smart patch to transition from the hibernation mode to one of the sleep mode and the execution mode.

23. The packaging material includes the liner that contacts the drug-containing layer, the liner is removable, and the removable liner includes one or more conductive pads and conductive traces. The transdermal drug delivery smart patch according to claim 21 or 22, wherein when the liner is removed, one or more sensors detect a change in electrical signal between the conductive pad on the liner and the conductive pad on the flex circuit.

24. A transdermal drug delivery smart patch according to any one of claims 21 to 23, wherein when the smart patch is attached to the skin, one or more sensors detect a change in the electrical signal between the conductive pad on the flex circuit and the skin.

25. The transdermal drug delivery smart patch according to claim 24, wherein the processor analyzes the skin-to-skin electrical reaction between the skin and the conductive pad for the collection and monitoring of clinical diagnostic data.

26. When the smart patch is removed from the skin, one or more sensors detect a change in the electrical signal between the conductive pad on the flex circuit and the skin. The transdermal drug delivery smart patch according to any one of claims 21 to 25, wherein the processor controls the smart patch to transition from the execution mode to one of the sleep mode and the hibernation mode.

27. The transdermal drug delivery smart patch according to any one of claims 21 to 26, wherein the drug-containing layer includes through holes aligned with the conductive pad on the flexible circuit and the conductive pad on the removable liner.

28. Furthermore, the transdermal drug delivery smart patch according to claim 21, wherein one or more sensors include an optical sensor that detects a change in light in response to a change in the state of the smart patch.

29. A transdermal drug delivery smart patch according to any one of claims 1 to 28, further comprising a plurality of light-emitting diodes (LEDs) controlled by the processor that indicate the plurality of operating states of the smart patch.

30. A transdermal drug delivery smart patch according to any one of claims 1 to 29, wherein the processor controls the smart patch to transition from the sleep mode to the execution mode when it receives one or more of the state changes detected by the one or more sensors and communication signals received from the network by the communication interface.

31. The transdermal drug delivery smart patch according to any one of claims 1 to 30, wherein the processor determines the current state of the smart patch based on the state of one or more sensors, a series of state changes, and the timing of each state change.

32. The transdermal drug delivery smart patch according to any one of claims 1 to 31, wherein the processor periodically transmits a smart patch identifier via the communication interface.

33. A transdermal drug delivery smart patch according to any one of claims 1 to 32, wherein the smart patch usage data includes one or more of the following: changes in the state of the smart patch, the dose of the drug, overdose of the drug, missed doses, interrupted doses, timing of the dose, frequency of the dose, current operating state of the smart patch, transitions in the operating state of the smart patch, or any combination thereof.

34. The transdermal drug delivery smart patch according to any one of claims 1 to 33, wherein the processor transmits the smart patch usage data to one or more user devices via the communication interface.

35. The transdermal drug delivery smart patch according to claim 34, wherein the one or more user devices receive patient data including clinical data, geographic location, physical activity, movement, or demographics associated with the patient.

36. The transdermal drug delivery smart patch according to claim 35, wherein the clinical data includes one or more of the following: the prescription of the drug, the expected dose of the drug, the expected timing of administration of the drug, the patient's electronic health record (EHR), or the patient's physiological parameters.

37. The transdermal drug delivery smart patch according to claim 35 or 36, wherein the aforementioned movement includes the sudden fall of the patient.

38. The transdermal drug delivery smart patch according to any one of claims 34 to 37, wherein one or more user devices determine the patient's adherence to medication based on the smart patch usage data and the patient data.

39. The transdermal drug delivery smart patch according to claim 38, wherein one or more user devices generate the medication compliance alert, reporting message, or intervention message.

40. The transdermal drug delivery smart patch according to claim 39, wherein one or more user devices transmit the alert, the reporting message, or the intervention message to another device via a network.

41. The transdermal drug delivery smart patch according to claim 40, wherein the network includes a mesh network.

42. The transdermal drug delivery smart patch according to any one of claims 34 to 41, wherein the one or more user devices include a patient device, a healthcare provider device, or a business device associated with the patient's medical care or the support of the healthcare provider, or any combination thereof.

43. The transdermal drug delivery smart patch according to any one of claims 34 to 42, wherein the processor communicates with one or more user devices using a communication protocol selected from the group consisting of Bluetooth, Wi-Fi, ZigBee, Thread, Z-Wave, LoRa, Near Field Communication (NFC), Broadband, Narrow Band-Internet of Things (NB-IoT), Radio Frequency Identification System (RFID), WLAN, 3G, 4G, and 5G, or future revisions of the above protocol standards.

44. The transdermal drug delivery smart patch according to any one of claims 34 to 43, wherein the processor wirelessly communicates with one or more user devices via Bluetooth Low Energy (BLE).

45. A method of treating patients who require it using a transdermal drug delivery smart patch, (a) The step of receiving communication data from the transdermal drug delivery smart patch, (b) A step of determining a change in the state of the smart patch using one or more sensors associated with the smart patch, wherein the change in the state of the smart patch includes one or more of the following steps: (i) removing the packaging material from the smart patch, (ii) removing the liner from the adhesive layer of the smart patch, (iii) attaching the smart patch to the patient's skin, and (iv) removing the smart patch from the patient's skin. (c) A step of automatically transitioning between a plurality of operating states of the smart patch based on the determined state change of the smart patch, wherein the plurality of operating states include a hibernation mode, a sleep mode, and an execution mode. Methods that include...

46. The method according to claim 45, wherein the smart patch includes a flexible circuit that is electrically connected to one or more sensors, and the flexible circuit includes one or more conductive pads.

47. The packaging material includes a packaging material, and one or more of the conductive pads and conductive traces are arranged on the inner surface of the packaging material so as to be in contact with the smart patch, and the method is When the packaging material is removed, the procedure includes detecting a change in the electrical signal between the conductive pad on the packaging material and the conductive pad on the flexible circuit. The steps of transitioning from the aforementioned sleep mode to the non-sleep mode and The method according to claim 46, further comprising:

48. The method according to claim 47, wherein the non-hibernation mode includes the sleep mode and the execution mode.

49. The packaging material includes a removable liner that contacts the drug-containing layer, and the removable liner includes one or more conductive pads and conductive traces, and the method is The method according to any one of claims 46 to 48, further comprising the step of detecting a change in electrical signal between the conductive pad on the liner and the conductive pad on the flex circuit when the liner is removed.

50. When the smart patch is attached to the skin, the step of detecting a change in the electrical signal between the conductive pad on the flex circuit and the skin. The method according to any one of claims 46 to 49, further comprising:

51. When the smart patch is removed from the skin, the steps include detecting a change in the electrical signal between the conductive pad on the flex circuit and the skin, A step of transitioning from the execution mode to one of the sleep mode and the hibernation mode. The method according to any one of claims 46 to 50, further comprising:

52. The step of transmitting smart patch usage data to a wireless network via the communication interface on the smart patch. The method according to any one of claims 45 to 51, further comprising:

53. The method according to claim 52, wherein the wireless network uses a communication protocol selected from the group consisting of Bluetooth, Wi-Fi, ZigBee, Thread, Z-Wave, LoRa, Near Field Communication (NFC), Broadband, Narrow Band-Internet of Things (NB-IoT), Radio Frequency Identification System (RFID), WLAN, 3G, 4G, and 5G, and future revisions of the above protocol standards.

54. The method according to claim 52 or 53, wherein the smart patch usage data includes one or more of the following: changes in the state of the smart patch, the dose of the drug, overdose of the drug, missed doses, interrupted doses, timing of the dose, frequency of the dose, current operating state of the smart patch, transitions in the operating state of the smart patch, or any combination thereof.

55. The step of transmitting a unique smart patch identifier to the wireless network via the communication interface on the smart patch. The method according to any one of claims 45 to 54, further comprising:

56. A computer implementation method to enhance medication adherence for patients who require it. (a) A step of transmitting information associated with the state of the smart patch from the transdermal drug delivery smart patch, (b) A step of receiving information associated with a plurality of operating states of the smart patch, wherein the plurality of operating states include hibernation mode, sleep mode, and run mode, (c) A step of generating smart patch usage data based on the plurality of operating states of the smart patch, wherein the smart patch usage data includes at least one of the smart patch state, the dose of the drug administered to the patient, the timing of the administration, or the frequency of administration, and the smart patch state includes one or more of the following: (i) removing the packaging material from the smart patch, (ii) removing the liner from the adhesive layer of the smart patch, (iii) attaching the smart patch to the patient's skin, and (iv) removing the smart patch from the patient's skin. (d) A step of determining the patient's medication compliance based on the smart patch usage data and the patient's medical records stored on the network. Methods that include...

57. The method according to claim 56, wherein the medical record includes one or more of the following: prescription information, the expected dosage of the drug, or the expected timing for administering the drug.

58. The steps include receiving patient data, including physiological parameters, geographical location, physical activity, movement, and demographics associated with the patient, A step of determining the patient's drug response based on the smart patch usage data and the patient data. The method according to claim 56 or 57, further comprising:

59. The method according to claim 58, wherein the movement includes the sudden fall of the patient.

60. The method according to claim 58 or 59, further comprising the step of generating the medication compliance alert, reporting message, or intervention message.

61. The method according to claim 56, further comprising the step of generating smart patch state data to average the values ​​of one or more sensor inputs of the smart patch using a processor housed within the transdermal drug delivery smart patch.

62. The method according to claim 61, further comprising the step of determining medication compliance by comparing individual values ​​measured by one or more sensors of the smart patch with the average value of the sensor inputs of the smart patch.

63. A computer-implemented transdermal drug delivery system, The smart patch includes a transdermal drug delivery smart patch, and the smart patch is Drug-containing layer, Communication interface, One or more sensors configured to detect a change in the state of the smart patch, wherein the change in the state of the smart patch includes one or more of the following: removing the packaging material from the smart patch and attaching the smart patch to the patient's skin. A processor that is communicatively coupled to the one or more sensors and the communication interface, (a) Automatically transitioning between multiple operating states based on the state change of the smart patch, wherein the multiple operating states of the smart patch include a hibernation mode, a sleep mode, and an execution mode, and (b) Transmitting smart patch usage data via the communication interface. A processor configured to perform operations including, A backend application system comprising one or more computer processors, wherein the one or more computer processors (i) Receiving information from the smart patch via the wireless network that is associated with the multiple operating states of the smart patch, (ii) generating smart patch usage data based on the plurality of operating states of the smart patch, wherein the smart patch usage data includes one or more of the state changes of the smart patch, the dose of the drug administered to the patient, the timing of the administration, or the frequency of administration, and (iii) Determining the patient's adherence to medication based on the smart patch usage data and the patient's medical records stored on the wireless network. A backend application system and that are individually or collectively programmed to perform actions including the following: A system that includes this.

64. The system according to claim 63, wherein the medical record includes one or more of the following: a drug prescription, an expected dosage of the drug, or an expected timing for administering the drug.

65. Receiving patient data including physiological parameters, geographical location, physical activity, movement, and demographics associated with the patient, Based on the smart patch usage data and the patient data, the patient's drug response is determined. The system according to claim 63 or 64, further comprising:

66. The system according to any one of claims 63 to 65, further comprising aggregating and processing data from two or more patients.

67. The system according to claim 66, further comprising processing the aggregated patient data to determine one or more group characteristics.

68. The system according to claim 66, further comprising processing the aggregated patient data to determine one or more properties of a drug.

69. The system according to claim 65, wherein the aforementioned movement includes the sudden fall of the patient.

70. To generate alerts, reporting messages, or intervention messages regarding medication compliance. The system according to claim 65 or 66, further comprising:

71. A non-temporary computer-readable medium containing machine-executable code that implements a method for treating a patient in need thereof, during execution by one or more computer processors, wherein the method A step of using a transdermal drug smart delivery patch to receive data from one or more sensors and to determine a change in the state of the smart patch, wherein the change in the state of the smart patch includes one or more of the following: (i) removing the packaging material from the smart patch, (ii) removing the liner from the adhesive layer of the smart patch, (iii) attaching the smart patch to the patient's skin, and (iv) removing the smart patch from the patient's skin. A step of automatically transitioning between a plurality of operating states of the smart patch based on the determined state change of the smart patch, wherein the plurality of operating states include a hibernation mode, a sleep mode, and an execution mode. Non-temporary computer-readable media, including [specific examples of such media].

72. The method according to claim 71, wherein the smart patch includes a flexible circuit electrically connected to one or more sensors, and the flexible circuit includes one or more conductive pads.

73. The packaging material includes a wrapping material, and one or more of the conductive pads and conductive traces are arranged on the inner surface of the wrapping material so as to be in contact with the smart patch. When the packaging material is removed, the procedure includes detecting a change in the electrical signal between the conductive pad on the packaging material and the conductive pad on the flexible circuit. The steps of transitioning from the aforementioned sleep mode to the non-sleep mode and The method according to claim 72, further comprising:

74. The method according to claim 73, wherein the non-hibernation mode includes the sleep mode and the execution mode.

75. The packaging material includes a removable liner that contacts the drug-containing layer, and the removable liner includes one or more conductive pads and conductive traces. When the liner is removed, the step of detecting a change in the electrical signal between the conductive pad on the liner and the conductive pad on the flex circuit. The method according to any one of claims 72 to 74, further comprising:

76. When the smart patch is attached to the skin, the step of detecting a change in the electrical signal between the conductive pad on the flex circuit and the skin. The method according to any one of claims 72 to 75, further comprising:

77. When the smart patch is removed from the skin, the steps include detecting a change in the electrical signal between the conductive pad on the flex circuit and the skin, A step of transitioning from the execution mode to one of the sleep mode and the hibernation mode. The method according to any one of claims 72 to 76, further comprising:

78. The step of transmitting smart patch usage data to a wireless network via the communication interface on the smart patch. The method according to any one of claims 71 to 77, further comprising:

79. The method according to claim 78, wherein the wireless network uses a communication protocol selected from the group consisting of Bluetooth, Wi-Fi, ZigBee, Thread, Z-Wave, LoRa, Near Field Communication (NFC), Broadband, Narrow Band-Internet of Things (NB-IoT), Radio Frequency Identification System (RFID), WLAN, 3G, 4G, and 5G, and future revisions of the above protocol standards.

80. The method according to claim 78 or 79, wherein the smart patch usage data includes one or more of the following: changes in the state of the smart patch, the dose of the drug, overdose of the drug, missed doses, interrupted doses, timing of the dose, frequency of the dose, current operating state of the smart patch, transitions in the operating state of the smart patch, or any combination thereof.

81. The step of transmitting a unique smart patch identifier to the wireless network via the communication interface on the smart patch. The method according to any one of claims 71 to 80, further comprising:

82. A non-temporary computer-readable medium containing machine-executable instructions that enhance medication compliance for patients requiring such instructions when executed by one or more processors, and a method thereof, (a) Receiving information from one or more sensors of a transdermal drug delivery smart patch, wherein the multiple operating states include a pause mode, a sleep mode, and an execution mode. (b) Generating smart patch usage data based on the plurality of operating states of the smart patch, wherein the smart patch usage data includes at least one of the smart patch state, the dose of the drug administered to the patient, the timing of the administration, or the frequency of administration, and the smart patch state includes one or more of the following: (i) removing the packaging material from the smart patch, (ii) removing the liner from the adhesive layer of the smart patch, (iii) attaching the smart patch to the patient's skin, and (iv) removing the smart patch from the patient's skin. (c) Determining the patient's adherence to medication based on the smart patch status data and the patient's medical records stored on the network. Non-temporary computer-readable media, including [specific examples of such media].

83. The method according to claim 82, wherein the medical record includes one or more of the following: prescription information, the expected dosage of the drug, or the expected timing for administering the drug.

84. The steps include receiving patient data, including physiological parameters, geographical location, physical activity, movement, and demographics associated with the patient, A step of determining the patient's drug response based on the smart patch usage data and the patient data. The method according to claim 82 or 83, further comprising:

85. The method according to claim 84, wherein the movement includes the sudden fall of the patient.

86. The method according to claim 84 or 85, further comprising the step of generating the medication compliance alert, reporting message, or intervention message.

87. The method according to claim 82, further comprising the step of generating smart patch state data to average the values ​​of one or more sensor inputs of the smart patch using a processor housed within the transdermal drug delivery smart patch.

88. The method according to claim 87, further comprising the step of determining medication compliance by comparing individual values ​​measured by one or more sensors of the smart patch with the average value of the sensor inputs of the smart patch.

89. Drug-containing layer, Communication interface, A processor and a communication interface connected to the aforementioned communication interface The processor includes, (a) Receiving a wireless signal or current via the communication interface, (b) To release a predetermined amount of drug from the drug-containing layer A transdermal drug delivery smart patch configured to perform actions including the following.

90. The transdermal drug delivery smart patch according to claim 89, wherein the smart patch and the processor include a system-on-a-chip (SoC).

91. The transdermal drug delivery smart patch according to claim 90, wherein the SoC includes one or more of a messaging subsystem, a sensor subsystem, a power state subsystem, a communication state subsystem, a communication subsystem, a printable battery, or an event cache subsystem, or any combination thereof.

92. The transdermal drug delivery smart patch according to claim 91, wherein the communication subsystem receives data from a cloud server system using the wireless signal or the current.

93. A transdermal drug delivery smart patch according to any one of claims 89 to 92, wherein one or more drugs are introduced into the drug-containing layer.

94. The transdermal drug delivery smart patch according to claim 93, wherein one or more of the drugs are lipophilic or hydrophilic.

95. A transdermal drug delivery smart patch according to any one of claims 89 to 94, wherein one or more placebos are introduced into the drug-containing layer.

96. The transdermal drug delivery smart patch according to any one of claims 89 to 95, wherein the drug-containing layer includes a drug-containing adhesive layer.

97. The transdermal drug delivery smart patch according to any one of claims 89 to 96, wherein the drug-containing layer comprises a plurality of drug-containing adhesive layers and a film positioned between them.

98. The transdermal drug delivery smart patch according to any one of claims 89 to 97, wherein the drug-containing layer comprises a drug reservoir, an adhesive layer, and a membrane positioned between them.

99. The transdermal drug delivery smart patch according to any one of claims 89 to 98, wherein the drug-containing layer includes a drug reservoir and an adhesive ring surrounding it.

100. The transdermal drug delivery smart patch according to any one of claims 89 to 99, wherein the drug-containing layer comprises a drug-containing microneedle array and an adhesive layer.

101. The transdermal drug delivery smart patch according to any one of claims 89 to 100, wherein the drug-containing layer comprises one or more excipients that facilitate (i) the penetration of the drug into the skin and (ii) drug delivery.

102. The transdermal drug delivery smart patch according to claim 101, wherein one or more excipients comprise one or more chemical accelerators.

103. The transdermal drug delivery smart patch according to any one of claims 89 to 102, wherein the wireless signal or current received by the communication interface is associated with the release of the drug.

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