阅读说明：本技术 阿片类药物过量监测 (Opioid overdose monitoring ) 是由 M·J·E·基尼 B·穆辛 A·艾尔-阿里 K·W·印多夫 O·艾哈迈德 J·诺瓦克 W 于 2019-06-05 设计创作，主要内容包括：阿片类药物的过量可能导致用户停止呼吸,从而导致死亡。生理监测系统基于来自与智能移动装置通信的指尖脉搏血氧仪的氧饱和度读数来监测呼吸,并将阿片类药物监测信息从智能移动装置发送到阿片类药物过量监测服务。当阿片类药物监测信息指示非遇险状态时,阿片类药物过量监测服务会通知第一组联系人,而当阿片类药物监测信息指示药物过量事件时,通知第二组联系人。该通知可以是给指定人员、紧急人员或第一响应者的电话呼叫或文本消息,并且可以包括智能移动装置的位置。智能移动装置还可以包括具有用于治疗阿片类药物过量的紧急药物(例如纳洛酮)的最近治疗中心的位置。(An overdose of opioids may cause the user to stop breathing, resulting in death. The physiological monitoring system monitors respiration based on oxygen saturation readings from a fingertip pulse oximeter in communication with the smart mobile device and sends opioid monitoring information from the smart mobile device to the opioid overdose monitoring service. The opioid overdose monitoring service notifies the first set of contacts when the opioid monitoring information indicates a non-distress state and notifies the second set of contacts when the opioid monitoring information indicates an overdose event. The notification may be a phone call or a text message to a designated person, emergency personnel, or first responder, and may include the location of the smart mobile device. The smart mobile device may also include a location with a nearest treatment center for emergency medications (e.g., naloxone) used to treat opioid overdoses.)

1. A system for monitoring an indication of opioid overdose and delivering a therapeutic agent, the system comprising:

a user-wearable sensor configured to obtain data indicative of at least one physiological parameter of the user;

a signal processor configured to process the data to provide the at least one physiological parameter; and

a drug delivery device wearable by a user and configured to deliver one or more doses of a therapeutic drug, the drug delivery device comprising a delivery arrangement comprising a dose of the therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing arrangement for dispensing the therapeutic drug from the reservoir through the drug delivery channel, and an activation circuit for activating the dispensing arrangement.

2. The system of claim 1, further comprising a medical monitoring hub configured to monitor the at least one physiological parameter, the medical monitoring hub comprising a memory storing instructions and one or more computer processors configured to execute the instructions to at least:

comparing the at least one physiological parameter to a threshold value indicative of opioid overdose;

determining that a drug overdose event is occurring or likely to occur based on the comparison; and

transmitting at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug based on the determination.

3. The system of claim 2, wherein the one or more computer processors of the medical monitoring hub are further configured to:

providing an alert in response to determining that the overdose event is occurring or likely to occur;

waiting a period of time after providing the alert and then transmitting the at least one activation signal;

wherein receiving user input during the time period stops transmitting the at least one activation signal.

4. The system of any one of claims 2-3, wherein the one or more computer processors of the medical monitoring hub are further configured to:

receiving an indication of a medical distress of the user; and

sending a notification of the medical distress to one or more contacts, wherein the one or more contacts include a medical professional, a relative, a friend, and a neighbor.

5. The system of any one of claims 1-4, further comprising a housing containing the sensor, the signal processor, and the drug delivery device.

6. The system of any one of claims 1-5, wherein the drug delivery device further comprises a first antenna and a first processor in communication with the first antenna, wherein the sensor further comprises a second antenna and a second processor in communication with the second antenna, and wherein the first processor and the second processor are configured to provide wireless communication between the drug delivery device and the sensor.

7. The system of any of claims 1-6, wherein the drug delivery device is a disposable drug delivery device.

8. The system of any of claims 1-7, wherein the drug delivery device further comprises an antenna for receiving an activation signal.

9. The system according to any of claims 1-8, wherein the drug delivery device comprises at least two drug delivery devices.

10. The system of any of claims 2-9, wherein the medical monitoring hub is in communication with a remote server, the remote server comprising a user database, a memory storing instructions, and one or more computing devices configured to execute the instructions to cause the remote server to access user information associated with the user in the user database, the user information comprising contact information for contacts to notify the user of an overdose status.

11. The system of claim 10, wherein the one or more computing devices of the remote server are further configured to send a notification of the overdose event to at least one contact.

12. The system of claim 11, wherein the notification includes one or more of a location of the user, a location of an opioid receptor antagonist drug, and an indication of the at least one physiological parameter.

13. The system of any of claims 11 and 12, wherein the notification is one or more of a text message, an email, a message on social media, and a phone call.

14. The system of any one of claims 2-13, further comprising a smart device in communication with the signal processor to receive the at least one physiological parameter and in communication with the medical monitoring hub.

15. The system of claim 14, wherein the smart device comprises a memory storing instructions and one or more microprocessors configured to execute the instructions to at least:

comparing the at least one physiological parameter to a threshold value indicative of opioid overdose;

determining that the overdose event is occurring or likely to occur based on the comparison;

determining that the medical monitoring hub failed to transmit the at least one activation signal; and

in response to determining that the medical monitoring hub failed to transmit the at least one activation signal, transmit the at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug.

16. The system of claim 15, wherein the memory of the smart device further stores the contact information, and the one or more microprocessors of the smart device are further configured to notify the contact of the overdose event.

17. The system of any of claims 1-16, wherein the drug delivery device comprises a patch and comprises an adhesive layer for adhering to the user.

18. The system of any one of claims 1-17, wherein the at least one physiological parameter includes one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, and perfusion index.

19. The system of any one of claims 2-18, wherein the medical monitoring hub further comprises an input for receiving user input, a speaker, and an alarm circuit, and wherein the one or more computer processors of the medical monitoring hub are further configured to generate an alarm based on the determination.

20. The system of claim 19, wherein the volume of the alarm is increased until a user input is received.

21. A kit comprising the system of any of claims 1-20.

22. A medical monitoring hub to monitor for indications of opioid overdose, the medical monitoring hub comprising a memory to store instructions and one or more computer processors configured to execute the instructions to at least:

receiving data indicative of at least one physiological parameter of a user obtained by a sensor wearable by the user;

processing the data to provide the at least one physiological parameter;

comparing the at least one physiological parameter to a threshold value indicative of opioid overdose;

determining that a drug overdose event is occurring or likely to occur based on the comparison; and

transmitting at least one activation signal to a drug delivery device to dispense at least one dose of the therapeutic drug based on the determination, the drug delivery device being wearable by a user and configured to deliver one or more doses of the therapeutic drug.

23. The medical monitoring hub of claim 22, wherein the drug delivery apparatus comprises a delivery device including a dose of therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device for dispensing the therapeutic drug from the reservoir through the drug delivery channel, and an activation circuit for activating the dispensing device.

24. The medical monitoring hub according to any one of claims 22-23, wherein the drug delivery apparatus comprises one or more delivery devices, each comprising a dose of therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device for dispensing the therapeutic drug from the reservoir through the drug delivery channel, an activation circuit for activating the dispensing device, and an antenna for receiving the at least one activation signal.

25. The medical monitoring hub of claim 24, wherein each antenna is tuned to receive a respective activation signal at a different frequency.

26. The medical monitoring hub of claim 25, wherein the one or more computer processors are further configured to transmit two or more activation signals, each of the two or more activation signals having a different frequency, such that the respective two or more activation circuits activate at about the same time to dispense two or more doses of the therapeutic drug.

27. A method of monitoring an indication of opioid overdose and delivering a therapeutic drug, the method comprising:

obtaining data indicative of at least one physiological parameter of a user from a sensor wearable by the user;

processing the data with a signal processor to provide the at least one physiological parameter; and

delivering one or more doses of a therapeutic drug from a user-wearable drug delivery device, wherein the delivering comprises:

activating a dispensing device configured to dispense a dose of therapeutic drug stored in a reservoir through a drug delivery channel; and

dispensing the dose of therapeutic drug from the reservoir through the drug delivery channel with the activated dispensing device.

28. The method of claim 27, further comprising monitoring the at least one physiological parameter with a medical monitoring hub comprising one or more computing devices, the monitoring comprising:

comparing the at least one physiological parameter to a threshold value indicative of opioid overdose;

determining that a drug overdose event is occurring or likely to occur based on the comparison; and

sending at least one activation signal to the drug delivery device to activate the dispensing means based on the determination.

29. The method of claim 28, further comprising:

providing an alert in response to determining that the overdose event is occurring or likely to occur; and

waiting a period of time after providing the alert and then transmitting the at least one activation signal;

wherein receiving user input during the time period stops transmitting the at least one activation signal.

30. The method according to any one of claims 28-29, further comprising:

receiving an indication of a medical distress of the user; and

sending a notification of the medical distress to one or more contacts, wherein the one or more contacts include a medical professional, a relative, a friend, and a neighbor.

31. The method of any of claims 27-30, wherein the sensor, the signal processor, and the drug delivery device are housed in a single housing.

32. The method of any of claims 27-31, wherein the drug delivery device further comprises a first antenna and a first processor in communication with the first antenna, wherein the sensor further comprises a second antenna and a second processor in communication with the second antenna, and wherein the first processor and the second processor are configured to provide wireless communication between the drug delivery device and the sensor.

33. The method according to any of claims 27-32, wherein the drug delivery device is a disposable drug delivery device.

34. The method of any of claims 27-33, wherein the drug delivery device further comprises an antenna for receiving an activation signal.

35. A method according to any of claims 27-34, wherein the drug delivery device comprises at least two drug delivery devices.

36. The method of any of claims 28-35, wherein the medical monitoring hub is in communication with a remote server, the remote server comprising a user database, a memory storing instructions, and one or more computing devices configured to execute the instructions to cause the remote server to access user information associated with the user in the user database, the user information comprising contact information for contacts to notify the user of an overdose status.

37. The method of claim 36, further comprising sending, with the remote server, a notification of the medication overdose event to the at least one contact.

38. A method as in claim 37, wherein the notification includes one or more of a location of the user, a location of an opioid receptor antagonist drug, and an indication of the at least one physiological parameter.

39. The method of any of claims 37-38, wherein the notification is one or more of a text message, an email, a message on social media, and a phone call.

40. The method according to any one of claims 28-39, wherein a smart device communicates with the signal processor to receive the at least one physiological parameter and communicates with the medical monitoring hub.

41. The method of claim 40, wherein the smart device comprises a memory storing instructions and one or more microprocessors configured to execute the instructions to at least:

comparing the at least one physiological parameter to a threshold value indicative of opioid overdose;

determining that the overdose event is occurring or likely to occur based on the comparison;

determining that the medical monitoring hub failed to transmit the at least one activation signal; and

in response to determining that the medical monitoring hub failed to transmit the at least one activation signal, transmit the at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug.

42. The method of claim 41, wherein the memory of the smart device further stores the contact information and the one or more microprocessors of the smart device are further configured to notify the contact of the overdose event.

43. The method of any of claims 27-42, wherein the drug delivery device comprises a patch and comprises an adhesive layer for adhering to the user.

44. The method of any one of claims 27-43, wherein the at least one physiological parameter includes one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, and perfusion index.

45. The method according to any one of claims 28-44, wherein the medical monitoring hub further comprises an input for receiving user input, a speaker, and an alarm circuit, and wherein the one or more computer processors of the medical monitoring hub are further configured to generate an alarm based on the determination.

46. The method of claim 45, further comprising increasing the volume of the alert until a user input is received.

47. A method of monitoring an indication of opioid overdose, the method comprising:

receiving data indicative of at least one physiological parameter of a user obtained by a sensor wearable by the user;

processing the data to provide the at least one physiological parameter;

comparing the at least one physiological parameter to a threshold value indicative of opioid overdose;

determining that a drug overdose event is occurring or likely to occur based on the comparison; and

transmitting at least one activation signal to a drug delivery device to dispense at least one dose of the therapeutic drug based on the determination, the drug delivery device being wearable by a user and configured to deliver one or more doses of the therapeutic drug.

48. The method of claim 47, wherein the drug delivery device comprises a delivery device comprising a dose of therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device for dispensing the therapeutic drug from the reservoir through the drug delivery channel, and an activation circuit for activating the dispensing device.

49. The method of any one of claims 47, wherein the drug delivery apparatus comprises one or more delivery devices, each comprising a dose of therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device for dispensing the therapeutic drug from the reservoir through the drug delivery channel, an activation circuit for activating the dispensing device, and an antenna for receiving the at least one activation signal.

50. The method of claim 49, further comprising transmitting two or more activation signals, wherein each antenna is tuned to receive a respective activation signal at a different frequency, and wherein each of the two or more activation signals has a different frequency such that the respective two or more activation circuits activate at about the same time to dispense two or more doses of the therapeutic drug.

51. A system for monitoring a user for opioid overdose events, the system comprising software instructions storable on a memory of a mobile computing device comprising one or more hardware processors, a touch screen display and a microphone, the software instructions causing the one or more hardware processors to:

receiving sound from the microphone;

determining that an opioid overdose event is occurring or will soon occur based on the received sounds;

present a request for user input on the touch screen display based on the determination; and

wirelessly transmitting a notification of the opioid overdose event to one or more recipients based on failing to receive user input.

52. The system of claim 51, wherein the mobile computing device further comprises a camera, and wherein the one or more hardware processors are further configured to receive images from the camera and determine that the opioid overdose event is occurring or will soon occur based on the received sounds and images.

53. The system of any of claims 51-52, wherein the one or more hardware processors are further configured to:

receiving monitoring data from a monitoring service that monitors the user and an environment local to the user; and

transmitting a notification of the opioid overdose event to the monitoring service.

54. The system of any one of claims 51-53, wherein the monitoring service is a security alert service.

55. The system of any one of claims 51-53, wherein the monitoring data includes user data associated with a status of the user and environment data associated with an environment local to the user.

56. The system of any of claims 51-55, wherein the one or more recipients include friends and family having contact information stored in a memory of the mobile computing device.

57. The system of any one of claims 51-56, wherein the one or more recipients comprise one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network.

58. The system of any of claims 51-57, wherein the notification includes one or more of a text message, a telephone call, and an email.

59. The system of any of claims 51-58, wherein the notification includes directions to a location of the mobile computing device.

60. The system according to any one of claims 51-59, wherein the one or more hardware processors further analyzes representations of sounds from the microphone to determine respiratory distress of the user local to the mobile computing device.

61. The system according to any one of claims 51-60, wherein said one or more hardware processors further analyzes a representation of images from said camera to determine respiratory distress of said user in said images.

62. The system of any of claims 51-61, wherein the one or more hardware processors further analyze a representation of an image from the camera to determine an unconscious state of the user in the image.

63. The system of any of claims 51-62, wherein the one or more processors further cause the touch screen display to display care guidance to care for victims of opioid overdose.

64. The system of any of claims 51-63, wherein the mobile computing device further comprises a speaker, and the one or more hardware processors further cause the speaker to output an audible alert based on the determination.

65. The system of any of claims 51-64, wherein the one or more hardware processors further cause the touch screen display to blink, cause the touch screen display to display directions to a location of the mobile computing device, or cause a speaker of the mobile computing to provide audible directions to the location of the user.

66. A system for monitoring a user for opioid overdose events, the system comprising software instructions storable on a memory of a mobile computing device comprising one or more hardware processors, a touch screen display, and a camera, the software instructions causing the one or more hardware processors to:

receiving an image from the camera;

determining, based on the received image, that an opioid overdose event is occurring or will soon occur;

present a request for user input on the touch screen display based on the determination; and

wirelessly transmitting a notification of the overdose event to one or more recipients based on failing to receive user input.

67. The system of claim 66, wherein the one or more hardware processors are further configured to:

receiving monitoring data from a monitoring service that monitors the user and an environment local to the user; and

transmitting a notification of the opioid overdose event to the monitoring service.

68. The system of any one of claims 66-67, wherein the monitoring service is a security alert service.

69. The system of any one of claims 66-67, wherein the monitoring data includes user data associated with a status of the user and environmental data associated with an environment local to the user.

70. The system of any one of claims 66-69, wherein the one or more recipients include friends and family having contact information stored in a memory of the mobile computing device.

71. The system of any one of claims 66-70, wherein the one or more recipients comprise one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network.

72. The system of any of claims 66-71, wherein the notification includes one or more of a text message, a telephone call, and an email.

73. The system of any one of claims 66-73, wherein the notification includes directions to a location of the mobile computing device.

74. The system according to any one of claims 66-73, wherein the one or more hardware processors further analyzes representations of sounds from the microphone to determine respiratory distress of the user local to the mobile computing device.

75. The system according to any one of claims 66-74, wherein the one or more hardware processors further analyze a representation of images from the camera to determine respiratory distress of the user in the images.

76. The system of any one of claims 66-75, wherein the one or more hardware processors further analyze a representation of an image from the camera to determine an unconscious state of the user in the image.

77. The system of any of claims 66-76, wherein the one or more processors further cause the touch screen display to display care guidance to care for victims of opioid overdose.

78. The system of any one of claims 66-77, wherein the mobile computing device further comprises a speaker, and the one or more hardware processors further cause the speaker to output an audible alert based on the determination.

79. The system of any of claims 66-78, wherein the one or more hardware processors further cause the touch screen display to blink, cause the touch screen display to display directions to a location of the mobile computing device, or cause a speaker of the mobile computing to provide audible directions to the location of the user.

80. A system for monitoring a user for opioid overdose events, the system comprising:

one or more sensors configured to sense an indication of a drug overdose condition of a user from an environment local to the user; and

a mobile computing device comprising a touchscreen display, a memory storing software instructions, and one or more hardware processors configured to execute the software instructions to at least:

receiving sensed indications from the one or more sensors;

determining that an opioid overdose event is occurring or will soon occur based on the received indication;

present a request for user input on the touch screen display based on the determination; and

wirelessly transmitting a notification of the overdose event to one or more recipients based on failing to receive user input.

81. The system of claim 80, wherein the one or more hardware processors are further configured to:

receiving monitoring data from a monitoring service that monitors the user and an environment local to the user; and

transmitting a notification of the opioid overdose event to the monitoring service.

82. The system of any one of claims 80-81, wherein the monitoring service is a security alert service.

83. The system of any of claims 80-82, wherein the monitoring data includes user data associated with a status of the user and environment data associated with an environment local to the user.

84. The system of any of claims 80-83, wherein the one or more recipients include friends and family having contact information stored in a memory of the mobile computing device.

85. The system of any of claims 80-84, wherein the one or more recipients comprise one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network.

86. The system of any of claims 80-85, wherein the notification includes one or more of a text message, a telephone call, and an email.

87. The system of any of claims 80-86, wherein the notification includes directions to a location of the mobile computing device.

88. The system of any one of claims 80-87, wherein the one or more hardware processors further analyze representations of sounds from the microphone to determine respiratory distress of the user local to the mobile computing device.

89. The system according to any one of claims 80-88, wherein the one or more hardware processors further analyze a representation of images from the camera to determine respiratory distress of the user in the images.

90. The system of any one of claims 80-89, wherein the one or more hardware processors further analyze a representation of the image from the camera to determine an unconscious state of the user in the image.

91. The system of any of claims 80-90, wherein the one or more processors further cause the touch screen display to display care guidance to care for victims of opioid overdose.

92. The system of any one of claims 80-91, wherein the mobile computing device further comprises a speaker, and the one or more hardware processors further cause the speaker to output an audible alert based on the determination.

93. The system of any of claims 80-92, wherein the one or more hardware processors further cause the touch screen display to blink, cause the touch screen display to display directions to a location of the mobile computing device, or cause a speaker of the mobile computing to provide audible directions to the location of the user.

94. A method of monitoring a user for opioid overdose events, the method comprising:

receiving sound from a microphone of a mobile computing device;

determining, with one or more hardware processors of the mobile computing device, that an opioid overdose event is occurring or will soon occur based on the received sounds;

presenting, with one or more hardware processors, a request for user input on a touch screen display of the mobile computing device, the request based on the determination; and

wirelessly transmitting, with the mobile computing device, a notification of the overdose event to one or more recipients based on failing to receive a user input.

95. The method of claim 94, further comprising:

receiving an image from a camera of the mobile computing device;

determining, with one or more hardware processors of the mobile computing device, that the opioid overdose event is occurring or will soon occur based on the received sound and images.

96. The method of any one of claims 94-95, further comprising:

receiving monitoring data from a monitoring service that monitors the user and an environment local to the user; and

sending a notification of the opioid overdose event to the monitoring service.

97. The method of any of claims 95-96, wherein the monitoring service is a security alert service.

98. The method of any of claims 96-97, wherein the monitoring data includes user data associated with a status of the user and environment data associated with an environment local to the user.

99. The method of any one of claims 94-98, wherein the one or more recipients include friends and family having contact information stored in a memory of the mobile computing device.

100. The method of any one of claims 94-99, wherein the one or more recipients comprise one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network.

101. The method of any of claims 94-100, wherein the notification includes one or more of a text message, a telephone call, and an email.

102. The method of any of claims 94-101, wherein the notification includes directions to a location of the mobile computing device.

103. The method of any of claims 94-102, further comprising analyzing the representation of sounds from the microphone to determine respiratory distress of the user local to the mobile computing device.

104. A method according to any of claims 94-103, further comprising analyzing a representation of images from said camera to determine respiratory distress of said user in said images.

105. The method of any of claims 94-104, further comprising analyzing a representation of an image from the camera to determine an unconscious state of the user in the image.

106. The method of any of claims 94-105, further comprising causing the touch screen display to display care guidance to care for victims of opioid overdose.

107. The method of any of claims 94-106, further comprising outputting an audible alert from the mobile computing device based on the determination.

108. The method of any of claims 94-107, further comprising causing the touch screen display to blink, causing the touch screen display to display directions to a location of the mobile computing device, or causing a speaker of the mobile computing to provide audible directions to the location of the user.

109. A method of monitoring a user for opioid overdose events, the method comprising:

receiving an image from a camera of a mobile computing device;

determining, with one or more hardware processors of the mobile computing device, that an opioid overdose event is occurring or will soon occur based on the received images;

presenting, with one or more hardware processors, a request for user input on a touch screen display of the mobile computing device, the request based on the determination; and

wirelessly transmitting, with the mobile computing device, a notification of the overdose event to one or more recipients based on failing to receive a user input.

110. The method of claim 109, further comprising:

receiving monitoring data from a monitoring service that monitors the user and an environment local to the user; and

transmitting a notification of the opioid overdose event to the monitoring service.

111. The method of claim 110, wherein the monitoring service is a security alert service.

112. The method as recited in any one of claims 110-111, wherein the monitoring data comprises user data associated with a status of the user and environment data associated with an environment local to the user.

113. The method as recited in any one of claims 109-112, wherein the one or more recipients comprise friends and family having contact information stored in a memory of the mobile computing device.

114. The method of any one of claims 109-113, wherein the one or more recipients comprise one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network.

115. The method as recited in any one of claims 109-114, wherein the notification comprises one or more of a text message, a telephone call, and an email.

116. The method as recited in any one of claims 109-115, wherein the notification comprises directions to a location of the mobile computing device.

117. The method as in any one of claims 109-116, further comprising analyzing the representation of sound from the microphone to determine respiratory distress of the user local to the mobile computing device.

118. A method of monitoring a user for opioid overdose events, the method comprising:

receiving, from one or more sensors configured to sense an environment local to the user, an indication of a sensed medication overdose condition of the user;

determining that an opioid overdose event is occurring or will soon occur based on the received indication;

present a request for user input on the touch screen display based on the determination; and

wirelessly transmitting a notification of the overdose event to one or more recipients based on failing to receive user input.

119. The method of claim 118, further comprising:

receiving monitoring data from a monitoring service that monitors the user and an environment local to the user; and

transmitting a notification of the opioid overdose event to the monitoring service.

120. The method of claim 119, wherein the monitoring service is a security alert service.

121. The method of any one of claims 119-120 wherein the monitoring data includes user data associated with the status of the user and environmental data associated with an environment local to the user.

122. The method as set forth in any one of claims 118-121, further comprising analyzing a representation of the images from the camera to determine respiratory distress of the user in the images.

123. The method as set forth in any one of claims 118-121, further comprising analyzing a representation of the image from the camera to determine an unconscious state of the user in the image.

124. The method of any one of claims 118-123, further comprising causing the touch screen display to display care guidance to care for victims of opioid overdose.

125. The method as recited in any one of claims 118-124, further comprising outputting an audible alert from the mobile computing device based on the determination.

126. A system for monitoring indications of opioid overdose events, the system comprising:

software instructions storable in a memory of a first mobile computing device executable by one or more hardware processors of the first mobile computing device to cause the one or more hardware processors to:

continuously receiving data indicative of one or more physiological parameters of a first user being monitored by one or more sensors;

continuously comparing each of the one or more physiological parameters to a respective threshold;

determining that an opioid overdose event is occurring or will soon occur based on the comparison;

triggering an alert on the first mobile computing device based on the determination; and

notifying a second user of the alert by causing a display of a second mobile computing device associated with the second user to display a status of an alert physiological parameter of the first user.

127. The system of claim 126, wherein the one or more hardware processors further cause a display of the first mobile computing device to continuously update the graphical representation of the one or more physiological parameters in response to continuously received data.

128. The system as recited in any one of claims 126-127, wherein the one or more hardware processors further displays user-selectable inputs to view additional information associated with the first user.

129. The system of claim 128, wherein selection of the user-selectable input causes a display of the second mobile computing device to display one or more of a trend and a current value of the alert physiological parameter.

130. The system of any one of claims 128-129, wherein selection of the user-selectable input causes the display of the second mobile computing device to display the location of the first mobile computing device on a map.

131. The system of any one of claims 128-130 wherein selection of the user-selectable input causes the display of the second mobile computing device to display a time of the initial alert.

132. The system of any one of claims 128-131 wherein selection of the user-selectable input causes the display of the second mobile computing device to provide access to directions from the location of the second mobile computing device to the first mobile computing device.

133. The system of any one of claims 128-132 wherein selection of the user-selectable input causes the display of the second mobile computing device to provide access to the call of the first mobile computing device.

134. The system of any one of claims 126-133, wherein the one or more physiological parameters are represented as a dial on the display.

135. The system of any one of claims 126-134, wherein the one or more physiological parameters include one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, perfusion index, and respiratory effort index.

136. The system of any one of claims 126-135, wherein the alarm is an audible and visual alarm.

137. The system as claimed in any one of claims 126-136 wherein each of the respective thresholds can be adjusted to suppress false positive alarms based on characteristics of the first user.

138. The system as recited in any one of claims 126-137, wherein the one or more hardware processors further transmit an indication of the one or more physiological parameters to a remote server.

139. The system of any one of claims 126-138, wherein the one or more hardware processors further transmit an indication of the one or more physiological parameters to a medical monitoring hub for storage in a memory of the medical monitoring hub.

140. The system of any one of claims 126-139, wherein the one or more hardware processors wirelessly communicate with a local internet of things connected device to receive additional data for determining the opioid overdose event.

141. The system as recited in any one of claims 126-140, wherein the one or more hardware processors further notify emergency services of the alert.

142. The system of any one of claims 126-141, wherein the first mobile computing device and the second mobile computing device are smartphones.

143. A method of monitoring indications of opioid overdose events, the method comprising:

continuously receiving, with a first mobile computing device, data indicative of one or more physiological parameters of a first user being actively monitored by one or more sensors;

continuously comparing, with the first mobile computing device, each of the one or more physiological parameters to a respective threshold;

determining, with the first mobile computing device, that an opioid overdose event is occurring or will soon occur based on the comparison;

triggering, with the first mobile computing device, an alert on the first mobile computing device based on the determination; and

notifying a second user of the alert with a first mobile computing device associated with the second user by causing a display of the second mobile computing device to display a status of an alert physiological parameter of the first user.

144. The method of claim 143, further comprising causing a display of the first mobile computing device to continuously update the graphical representation of the one or more physiological parameters in response to continuously received data.

145. The method as recited in any one of claims 143-144, further comprising displaying a user-selectable input to view additional information associated with the first user.

146. The method of any of claims 145, wherein selecting the user-selectable input causes a display of the second mobile computing device to display one or more of a trend and a current value of the alert physiological parameter.

147. The method of any one of claims 145-146 wherein selecting the user-selectable input causes a display of the second mobile computing device to display the location of the first mobile computing device on a map.

148. The method of any one of claims 145-147 wherein selecting the user-selectable input causes the display of the second mobile computing device to display a time of the initial alert.

149. The method of any one of claims 145-148 wherein selecting the user-selectable input causes a display of the second mobile computing device to provide access to directions from the location of the second mobile computing device to the first mobile computing device.

150. The method of any one of claims 145-149 wherein selecting the user-selectable input causes the display of the second mobile computing device to provide access to the call of the first mobile computing device.

151. The method of any one of claims 143-150 wherein the one or more physiological parameters are represented as a dial on the display.

152. The method of any one of claims 143-151 wherein the one or more physiological parameters include one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, perfusion index, and respiratory effort index.

153. The method as set forth in any one of claims 143-152 wherein the alarm is an audible and visual alarm.

154. The method of any one of claims 143-153 wherein each of the respective thresholds can be adjusted to suppress a false positive alarm based on a characteristic of the first user.

155. The method of any one of claims 143-154 further comprising transmitting an indication of the one or more physiological parameters to a remote server.

156. The method as set forth in any one of claims 143-155, further comprising: transmitting an indication of the one or more physiological parameters to a medical monitoring hub for storage in a memory of the medical monitoring hub.

157. The method of any one of claims 143-156, further comprising wirelessly communicating with a local internet of things connected device to receive additional data for determining the opioid overdose event.

158. The method as recited in any one of claims 143-157, further comprising notifying emergency services of the alert.

159. The method of any one of claims 143-158, wherein the first mobile computing device and the second mobile computing device are smartphones.

Technical Field

The present disclosure relates generally to the field of detecting opioid overdose, and more particularly to detecting low oxygen saturation in the blood of opioid users and automatically notifying responders.

Background

Drug abuse disorders affect the lives of millions of people. Opioid overdose may occur when a person takes an illegal opioid such as heroin or morphine in excess. Physicians prescribe many controlled substances for medical use. Patients may accidentally take additional doses or intentionally abuse the prescribed opioid. The use of prescribed opioids in combination with other prescribed drugs, alcohol or over-the-counter drugs may result in drug overdose. Accidental overdose is particularly prone to occur if children take drugs that are not suitable for them. Opioid overdose can be life threatening and requires immediate emergency treatment.

Disclosure of Invention

Opioid overdose is due to overdose or toxicity caused by opioids. Symptoms of opioid overdose include overt confusion, or intoxication; vomiting frequently; a very small pupil; extreme lethargy or inability to wake up; intermittent loss of consciousness; respiratory problems, including slow or irregular breathing; apnea (absence of breathing); respiratory depression (breathing disorders characterized by slow and inefficient breathing); and skin around the lips or under the nails is cold, damp-cold or dull.

Inhibited breathing is the most dangerous side effect of opioid overdose. Cerebral hypoxia not only causes permanent nervous system damage, but may also be accompanied by extensive failure of other organ systems, including the heart and kidneys. If a person takes an excessive amount of opioids, is isolated and falls asleep, the person may easily die because of the increased respiratory depression.

Blood oxygenAssays can be used to detect inhibited respiration. Oximetry uses a non-invasive optical sensor to measure a physiological parameter of a person. Typically, the sensor has a Light Emitting Diode (LED) that transmits optical radiation into the tissue site and a detector that responds to the intensity of the optical radiation after being absorbed (e.g., by transmission or transflectance) by, for example, pulsating arterial blood flowing within the tissue site. Based on the response, the processor may determine a peripheral oxygen saturation (SpO)₂) (which is an estimate of the percentage of oxygen bound to hemoglobin in the blood), pulse rate, plethysmograph waveform (which indicates the change in arterial blood volume with each pulse beat), and perfusion quality index (e.g., an index that quantifies the pulse intensity at the sensor site), among other measurements.

Note that "oximetry" as used herein encompasses its broad general meaning known to those skilled in the art, including at least those non-invasive procedures for measuring parameters of circulating blood by spectroscopy. Furthermore, as used herein, a "plethysmograph" (often referred to as a "photoplethysmograph") encompasses its broad general meaning known to those skilled in the art, which includes at least data representing the change in absorption of light of a particular wavelength as a function of changes in body tissue caused by pulsating blood.

Oximeters compatible with handheld monitors such as mobile computing devices may be used to monitor physiological parameters. The oximeter may detect a decrease in oxygen saturation in the user's blood. A decrease in oxygen saturation in the blood of the user is an indication of respiratory distress, which may be an indication of opioid overdose. Once the oxygen saturation of the user falls below an acceptable threshold, a software application in the mobile computing device may alert others to provide emergency assistance. A threshold may be set to provide an early indication of an overdose event. If the drug overdose is known at an earlier point, emergency treatment can be provided before irreparable harm occurs.

A system for monitoring an indication of opioid overdose and delivering a therapeutic agent may include: a user-wearable sensor configured to obtain data indicative of at least one physiological parameter of a user; a signal processor configured to process data to provide at least one physiological parameter; and a drug delivery device wearable by a user and configured to deliver one or more doses of a therapeutic drug. The drug delivery device may comprise: a delivery device comprising a dose of therapeutic drug stored in a reservoir; a drug delivery channel; dispensing means for dispensing the therapeutic drug from the reservoir through the drug delivery channel; and an activation circuit for activating the dispensing device.

The system may also include a medical monitoring hub configured to monitor at least one physiological parameter. The medical monitoring hub may include: a memory storing instructions; and one or more computer processors configured to execute the instructions to at least compare at least one physiological parameter to a threshold indicative of opioid overdose; determining that a drug overdose event is occurring or likely to occur based on the comparison; and transmitting at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug based on the determination.

The one or more computer processors of the medical monitoring hub may be further configured to provide an alert in response to determining that an overdose event is occurring or likely to occur; waiting a period of time after providing the alert and then transmitting at least one activation signal; wherein receiving the user input during the time period stops transmitting the at least one activation signal. The one or more computer processors of the medical monitoring hub may be further configured to receive an indication of a medical distress of the user; and sending a notification of the medical distress to one or more contacts, wherein the one or more contacts include the medical professional, the relative, the friend, and the neighbor.

The system may further comprise a housing containing the sensor, the signal processor and the drug delivery device. The drug delivery device may further comprise a first antenna and a first processor in communication with the first antenna, wherein the sensor may further comprise a second antenna and a second processor in communication with the second antenna, and wherein the first and second processors may be configured to provide wireless communication between the drug delivery device and the sensor. The drug delivery device may be a disposable drug delivery device. The drug delivery device may further comprise an antenna for receiving the activation signal. The drug delivery device may comprise at least two drug delivery means.

The medical monitoring hub may be in communication with a remote server that includes a user database, a memory storing instructions, and one or more computing devices configured to execute the instructions to cause the remote server to access user information associated with a user in the user database. The user information may include contact information for contacts to inform the user of the overdose status.

The one or more computing devices of the remote server may be further configured to send a notification of the overdose event to the at least one contact. The notification may include one or more of a location of the user, a location of the opioid receptor antagonist drug, and an indication of the at least one physiological parameter. The notification may be one or more of a text message, an email, a message on social media, and a phone call.

The system may also include a smart device in communication with the signal processor to receive the at least one physiological parameter and in communication with the medical monitoring hub. The smart device may include: a memory storing instructions; and one or more microprocessors configured to execute the instructions to at least compare at least one physiological parameter to a threshold indicative of opioid overdose; determining that a drug overdose event is occurring or likely to occur based on the comparison; determining that the medical monitoring hub failed to transmit the at least one activation signal; and in response to determining that the medical monitoring hub failed to transmit the at least one activation signal, transmit the at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug. The memory of the smart device may also store contact information, and the one or more microprocessors of the smart device may also be configured to notify the contacts of the overdose event.

The drug delivery device may comprise a patch and may comprise an adhesive layer for adhering to a user. The at least one physiological parameter may include one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, and perfusion index. The medical monitoring hub may further include an input for receiving user input, a speaker, and an alarm circuit, and wherein the one or more computer processors of the medical monitoring hub may be further configured to generate an alarm based on the determination. The volume of the alarm may be increased until a user input is received. A kit may include any of the systems disclosed herein.

A medical monitoring hub for monitoring indications of opioid overdose may include: a memory storing instructions; and one or more computer processors configured to execute instructions to at least receive data indicative of at least one physiological parameter of a user obtained by a sensor wearable by the user; processing the data to provide at least one physiological parameter; comparing the at least one physiological parameter to a threshold value indicative of opioid overdose; determining that a drug overdose event is occurring or likely to occur based on the comparison; and sending at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug based on the determination. A drug delivery device wearable by a user may be configured to deliver one or more doses of a therapeutic drug.

The drug delivery device may comprise a delivery means comprising a dose of a therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing means for dispensing the therapeutic drug from the reservoir through the drug delivery channel, and an activation circuit for activating the dispensing means. The drug delivery device may comprise one or more delivery means. Each drug delivery device may include a dose of therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device for dispensing the therapeutic drug from the reservoir through the drug delivery channel, an activation circuit for activating the dispensing device, and an antenna for receiving at least one activation signal. Each antenna may be tuned to receive a respective activation signal at a different frequency. The one or more computer processors may also be configured to transmit two or more activation signals. Each of the two or more activation signals may have a different frequency such that the respective two or more activation circuits activate at about the same time to dispense two or more doses of the therapeutic drug.

A method of monitoring an indication of opioid overdose and delivering a therapeutic agent may comprise: obtaining data indicative of at least one physiological parameter of a user from a sensor wearable by the user; processing the data with a signal processor to provide at least one physiological parameter; and delivering one or more doses of the therapeutic drug from the user-wearable drug delivery device. The delivery may include activating a dispensing device configured to dispense a dose of the therapeutic drug stored in the reservoir through the drug delivery channel; and dispensing a dose of the therapeutic drug from the reservoir through the drug delivery channel with the activated dispensing device.

The method may further comprise: at least one physiological parameter is monitored with a medical monitoring hub, which may include one or more computing devices. The monitoring may include: comparing the at least one physiological parameter to a threshold value indicative of opioid overdose; determining that a drug overdose event is occurring or likely to occur based on the comparison; and sending at least one activation signal to the drug delivery device to activate the dispensing means based on the determination. The method may further include providing an alert in response to determining that a drug overdose event is occurring or likely to occur; and waiting a period of time after providing the alert and then transmitting at least one activation signal; wherein receiving the user input during the time period may stop transmitting the at least one activation signal. The method may further comprise: receiving an indication of a medical distress of a user; and sending a notification of the medical distress to one or more contacts, wherein the one or more contacts include the medical professional, the relative, the friend, and the neighbor.

The sensor, the signal processor and the drug delivery device may be accommodated in a single housing. The drug delivery device may further comprise a first antenna and a first processor in communication with the first antenna, wherein the sensor may further comprise a second antenna and a second processor in communication with said second antenna. The first and second processors may be configured to provide wireless communication between the drug delivery device and the sensor. The drug delivery device may be a disposable drug delivery device. The drug delivery device may further comprise an antenna for receiving the activation signal. The drug delivery device may comprise at least two drug delivery means.

The medical monitoring hub may be in communication with a remote server, which may include a user database, a memory storing instructions, and one or more computing devices configured to execute the instructions to cause the remote server to access user information associated with a user in the user database. The user information may include contact information for contacts to inform the user of the overdose status.

The method may further include sending, with the remote server, a notification of the overdose event to the at least one contact. The notification may include one or more of a location of the user, a location of the opioid receptor antagonist drug, and an indication of the at least one physiological parameter. The notification may be one or more of a text message, an email, a message on social media, and a phone call.

The smart device may be in communication with the signal processor to receive the at least one physiological parameter and may be in communication with the medical monitoring hub. The smart device may include: a memory storing instructions; and one or more microprocessors configured to execute the instructions to at least compare at least one physiological parameter to a threshold indicative of opioid overdose; determining that a drug overdose event is occurring or likely to occur based on the comparison; determining that the medical monitoring hub failed to transmit the at least one activation signal; and in response to determining that the medical monitoring hub failed to transmit the at least one activation signal, transmit the at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug. The memory of the smart device may also store contact information, and the one or more microprocessors of the smart device may also be configured to notify the contacts of the overdose event.

The drug delivery device may comprise a patch and may comprise an adhesive layer for adhering to a user. The at least one physiological parameter may include one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, and perfusion index. The medical monitoring hub may further include an input for receiving user input, a speaker, and an alarm circuit, wherein the one or more computer processors of the medical monitoring hub may be further configured to generate an alarm based on the determination. The method may further include increasing the volume of the alert until user input is received.

A method of monitoring an indication of opioid overdose may comprise: receiving data indicative of at least one physiological parameter of a user obtained by a sensor wearable by the user; processing the data to provide at least one physiological parameter; comparing the at least one physiological parameter to a threshold value indicative of opioid overdose; determining that a drug overdose event is occurring or likely to occur based on the comparison; and transmitting at least one activation signal to the drug delivery device to dispense at least one dose of the therapeutic drug based on the determination. A drug delivery device wearable by a user may be configured to deliver one or more doses of a therapeutic drug.

The drug delivery device may comprise a delivery means comprising a dose of a therapeutic drug stored in a reservoir, a drug delivery channel, dispensing means for dispensing the therapeutic drug from the reservoir through the drug delivery channel, and an activation circuit for activating the dispensing means. The drug delivery device may comprise one or more delivery means. Each drug delivery device may include a dose of therapeutic drug stored in a reservoir, a drug delivery channel, a dispensing device for dispensing the therapeutic drug from the reservoir through the drug delivery channel, an activation circuit for activating the dispensing device, and an antenna for receiving at least one activation signal.

The method may further include transmitting two or more activation signals, wherein each antenna may be tuned to receive a respective activation signal at a different frequency, and wherein each of the two or more activation signals may have a different frequency such that the respective two or more activation circuits activate at about the same time to dispense two or more doses of the therapeutic drug.

A system for detecting a user for an opioid overdose event may include software instructions storable on a memory of a mobile computing device including one or more hardware processors, a touch screen display, and a microphone. The software instructions may cause the one or more hardware processors to receive sound from the microphone; determining that an opioid overdose event is occurring or will soon occur based on the received sounds; based on determining to present a request for user input on the touch screen display; and wirelessly transmitting a notification of the opioid overdose event to one or more recipients based on failing to receive the user input.

The mobile computing device may also include a camera, and the one or more hardware processors may be further configured to receive images from the camera and determine that an opioid overdose event is occurring or will soon occur based on the received sounds and images. The one or more hardware processors may be further configured to receive monitoring data from a monitoring service that monitors the user and an environment local to the user; and transmitting a notification of the opioid overdose event to a monitoring service. The monitoring service may be a security alarm service.

The monitoring data may include user data associated with a state of the user and environment data associated with an environment local to the user. The one or more recipients may include friends and family having contact information stored in a memory of the mobile computing device. The one or more recipients may include one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network. The notification may include one or more of a text message, a telephone call, and an email. The notification may include directions to the location of the mobile computing device.

The one or more hardware processors may also analyze the representations of sounds from the microphones to determine respiratory distress of a user local to the mobile computing device. The one or more hardware processors may also analyze the representation of the images from the camera to determine respiratory distress of the user in the images. The one or more hardware processors may also analyze the representation of the image from the camera to determine the user's unconsciousness in the image. The one or more processors may also cause the touch screen display to display care instructions to care for victims of opioid overdose.

The mobile computing device may also include a speaker, and the one or more hardware processors may further cause the speaker to output an audible alert based on the determination. The one or more hardware processors may also cause the touch screen display to blink, cause the touch screen display to display directions to the location of the mobile computing device, or cause a speaker of the mobile computing to provide audible directions to the location of the user.

A system for monitoring a user for opioid overdose events may include software instructions storable on a memory of a mobile computing device including one or more hardware processors, a touch screen display, and a camera, the software instructions causing the one or more hardware processors to receive images from the camera; determining, based on the received image, that an opioid overdose event is occurring or will soon occur; based on determining to present a request for user input on the touch screen display; and wirelessly transmitting a notification of the overdose event to one or more recipients based on failing to receive the user input.

The one or more hardware processors may be further configured to receive monitoring data from a monitoring service that monitors the user and an environment local to the user; and transmitting a notification of the opioid overdose event to a monitoring service. The monitoring service may be a security alarm service. The monitoring data may include user data associated with a state of the user and environment data associated with an environment local to the user. The one or more recipients may include friends and family having contact information stored in a memory of the mobile computing device. The one or more recipients may include one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network. The notification may include one or more of a text message, a telephone call, and an email. The notification may include directions to the location of the mobile computing device.

The one or more hardware processors may also analyze the representations of sounds from the microphones to determine respiratory distress of a user local to the mobile computing device. The one or more hardware processors may also analyze the representation of the images from the camera to determine respiratory distress of the user in the images. The one or more hardware processors may also analyze the representation of the image from the camera to determine the user's unconsciousness in the image. The one or more processors may also cause the touch screen display to display care instructions to care for victims of opioid overdose. The mobile computing device may also include a speaker, and the one or more hardware processors may further cause the speaker to output an audible alert based on the determination. The one or more hardware processors may also cause the touch screen display to blink, cause the touch screen display to display directions to the location of the mobile computing device, or cause a speaker of the mobile computing to provide audible directions to the location of the user.

A system for monitoring a user for opioid overdose events may include: one or more sensors configured to sense an indication of a drug overdose condition of a user from an environment local to the user; and a mobile computing device comprising a touch screen display, a memory storing software instructions, and one or more hardware processors configured to execute the software instructions to at least receive sensed indications from the one or more sensors; determining that an opioid overdose event is occurring or will soon occur based on the received indication; based on determining to present a request for user input on the touch screen display; and wirelessly transmitting a notification of the overdose event to one or more recipients based on failing to receive the user input.

The one or more hardware processors may be further configured to receive monitoring data from a monitoring service that monitors the user and an environment local to the user; and transmitting a notification of the opioid overdose event to a monitoring service. The monitoring service is a security alert service. The monitoring data may include user data associated with a state of the user and environment data associated with an environment local to the user. The one or more recipients may include friends and family having contact information stored in a memory of the mobile computing device. The one or more recipients may include one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network. The notification may include one or more of a text message, a telephone call, and an email. The notification may include directions to the location of the mobile computing device.

The one or more hardware processors may also analyze the representations of sounds from the microphones to determine respiratory distress of a user local to the mobile computing device. The one or more hardware processors may also analyze the representation of the images from the camera to determine respiratory distress of the user in the images. The one or more hardware processors may also analyze the representation of the image from the camera to determine the user's unconsciousness in the image. The one or more processors may also cause the touch screen display to display care instructions to care for victims of opioid overdose. The mobile computing device may also include a speaker, and the one or more hardware processors may further cause the speaker to output an audible alert based on the determination. The one or more hardware processors may also cause the touch screen display to blink, cause the touch screen display to display directions to the location of the mobile computing device, or cause a speaker of the mobile computing to provide audible directions to the location of the user.

A method of monitoring a user for opioid overdose events may comprise: receiving sound from a microphone of a mobile computing device; determining, with one or more hardware processors of the mobile computing device, that an opioid overdose event is occurring or will soon occur based on the received sound; presenting, with one or more hardware processors, a request for user input on a touch screen display of a mobile computing device, the request based on the determination; and wirelessly transmitting, with the mobile computing device, a notification of the overdose event to one or more recipients based on failing to receive the user input.

The method may further comprise: receiving an image from a camera of a mobile computing device; and determining, with one or more hardware processors of the mobile computing device, that an opioid overdose event is occurring or will soon occur based on the received sound and images. The method may further comprise: receiving monitoring data from a monitoring service monitoring a user and an environment local to the user; and transmitting a notification of the opioid overdose event to a monitoring service. The monitoring service is a security alert service. The monitoring data may include user data associated with a state of the user and environment data associated with an environment local to the user. The one or more recipients may include friends and family having contact information stored in a memory of the mobile computing device. The one or more recipients may include one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network. The notification may include one or more of a text message, a telephone call, and an email. The notification may include directions to the location of the mobile computing device.

The method may also include analyzing the representation of sounds from the microphone to determine respiratory distress of a user local to the mobile computing device. The method may further comprise analyzing the representation of the images from the camera to determine respiratory distress of the user in the images. The method may further include analyzing the representation of the image from the camera to determine an unconscious state of the user in the image. The method may further include causing the touch screen display to display care instructions to care for victims of opioid overdose. The method may also include outputting an audible alert from the mobile computing device based on the determination.

The method may also include flashing the touch screen display, causing the touch screen display to display directions to the location of the mobile computing device, or causing a speaker of the mobile computing device to provide audible directions to the location of the user.

A method of monitoring a user for opioid overdose events may further comprise: receiving an image from a camera of a mobile computing device; determining, with one or more hardware processors of the mobile computing device, that an opioid overdose event is occurring or will soon occur based on the received images; presenting, with one or more hardware processors, a request for user input on a touch screen display of a mobile computing device, the request based on the determination; and wirelessly transmitting, with the mobile computing device, a notification of the overdose event to one or more recipients based on failing to receive the user input.

The method may further comprise: receiving monitoring data from a monitoring service monitoring a user and an environment local to the user; and transmitting a notification of the opioid overdose event to a monitoring service. The monitoring service may be a security alarm service. The monitoring data may include user data associated with a state of the user and environment data associated with an environment local to the user. The one or more recipients may include friends and family having contact information stored in a memory of the mobile computing device. The one or more recipients may include one or more of a first responder, an emergency service, a local fire department, an ambulance service, a rehabilitation center, an addiction treatment center, and a ride share network. The notification may include one or more of a text message, a telephone call, and an email. The notification may include directions to the location of the mobile computing device. The method may also include analyzing the representation of sounds from the microphone to determine respiratory distress of a user local to the mobile computing device.

A method of monitoring a user for opioid overdose events may comprise: receiving, from one or more sensors configured to sense an environment local to the user, an indication of a sensed medication overdose condition of the user; determining that an opioid overdose event is occurring or will soon occur based on the received indication; based on determining to present a request for user input on the touch screen display; and wirelessly transmitting a notification of the overdose event to one or more recipients based on failing to receive the user input.

The method may further comprise: receiving monitoring data from a monitoring service monitoring a user and an environment local to the user; and transmitting a notification of the opioid overdose event to a monitoring service. The monitoring service may be a security alarm service. The monitoring data may include user data associated with a state of the user and environment data associated with an environment local to the user. The method may further comprise analyzing the representation of the images from the camera to determine respiratory distress of the user in the images.

The method may further include analyzing the representation of the image from the camera to determine an unconscious state of the user in the image. The method may further include causing the touch screen display to display care instructions to care for victims of opioid overdose. The method may also include outputting an audible alert from the mobile computing device based on the determination.

A system of monitoring indications of opioid overdose events may include software instructions storable in a memory of a first mobile computing device. The software instructions executable by the one or more hardware processors of the first mobile computing device may cause the one or more hardware processors to continuously receive data indicative of one or more physiological parameters of the first user being monitored by the one or more sensors; continuously comparing each of the one or more physiological parameters to a respective threshold; determining that an opioid overdose event is occurring or will soon occur based on the comparison; triggering an alert on the first mobile computing device based on the determination; and notifying the second user of the alert by causing a display of a second mobile computing device associated with the second user to display a status of the alert physiological parameter of the first user.

The one or more hardware processors may also cause a display of the first mobile computing device to continuously update the graphical representation of the one or more physiological parameters in response to the continuously received data. The one or more hardware processors may also display a user-selectable input to view additional information associated with the first user.

Selecting the user-selectable input may cause a display of the second mobile computing device to display one or more of a trend and a current value of the alert physiological parameter. Selecting the user-selectable input may cause a display of the second mobile computing device to display the location of the first mobile computing device on the map. Selecting the user-selectable input may cause a display of the second mobile computing device to display a time of the initial alert. Selecting the user-selectable input may cause a display of the second mobile computing device to provide access to directions from the location of the second mobile computing device to the first mobile computing device. Selecting the user-selectable input may cause a display of the second mobile computing device to provide access to the call of the first mobile computing device.

The one or more physiological parameters may be represented as a dial on a display. The one or more physiological parameters may include one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, perfusion index, and respiratory effort index. The alarm may be an audible or visual alarm. Each of the respective thresholds may be adjusted based on characteristics of the first user to suppress false positive alarms.

The one or more hardware processors may also transmit an indication of the one or more physiological parameters to a remote server. The one or more hardware processors may also transmit an indication of the one or more physiological parameters to the medical monitoring hub for storage in a memory of the medical monitoring hub. One or more hardware processors may wirelessly communicate with a local internet of things connected device to receive additional data for determining opioid overdose events. The one or more hardware processors may also notify emergency services of the alert. The first and second mobile computing devices may be smartphones.

A method of monitoring indications of opioid overdose events may include: continuously receiving, with a first mobile computing device, data indicative of one or more physiological parameters of a first user being actively monitored by one or more sensors; continuously comparing, with the first mobile computing device, each of the one or more physiological parameters to a respective threshold; determining, with the first mobile computing device, that an opioid overdose event is occurring or will soon occur based on the comparison; triggering, with the first mobile computing device, an alert on the first mobile computing device based on the determination; and notifying, with the first mobile computing device, the second user of the alert by causing a display of a second mobile computing device associated with the second user to display a status of the alert physiological parameter of the first user.

The method may further comprise: in response to the continuously received data, causing a display of the first mobile computing device to continuously update the graphical representation of the one or more physiological parameters. The method may also include displaying a user-selectable input to view additional information associated with the first user.

Selecting the user-selectable input may cause a display of the second mobile computing device to display one or more of a trend and a current value of the alert physiological parameter. Selecting the user-selectable input may cause a display of the second mobile computing device to display the location of the first mobile computing device on the map. Selecting the user-selectable input may cause a display of the second mobile computing device to display a time of the initial alert. Selecting the user-selectable input may cause a display of the second mobile computing device to provide access to directions from the location of the second mobile computing device to the first mobile computing device. Selecting the user-selectable input may cause a display of the second mobile computing device to provide access to the call to the first mobile computing device.

The one or more physiological parameters may be represented as a dial on a display. The one or more physiological parameters may include one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, perfusion index, and respiratory effort index. The alarm may be an audible or visual alarm. Each of the respective thresholds may be adjusted based on characteristics of the first user to suppress false positive alarms.

The method may also include transmitting an indication of the one or more physiological parameters to a remote server. The method may also include transmitting an indication of the one or more physiological parameters to a medical monitoring hub for storage in a memory of the medical monitoring hub. The method may also include wirelessly communicating with a device connected to the local internet of things to receive additional data for determining opioid overdose events. The method may also include notifying emergency services of the alert. The first and second mobile computing devices may be smartphones.

For purposes of summarizing the disclosure, certain aspects, advantages, and novel features have been discussed herein. It should be understood that not necessarily all such aspects, advantages or features will be embodied in any particular embodiment of the invention, and that the skilled person will recognize the myriad combinations of such aspects, advantages or features from the disclosure herein.

Drawings

Various embodiments will be described hereinafter with reference to the accompanying drawings. The drawings and the associated descriptions are provided to illustrate embodiments of the disclosure and not to limit the scope of the claims. In the drawings, like elements have like reference numerals.

Figure 1A is an overview of an exemplary opioid usage monitoring system.

Fig. 1B is a schematic diagram of an exemplary network associated with monitoring opioids.

Figure 1C is an overview of another exemplary opioid usage monitoring system.

Fig. 2A is a block diagram of an exemplary physiological monitoring system.

Fig. 2B is a flow chart of an exemplary process of monitoring physiological parameters for opioid use and providing a notification.

Fig. 3A-3E illustrate various exemplary software applications that provide information, notifications and alerts to opioid users, first responders, medical personnel and friends.

Figure 4 is a flow chart of an exemplary process for monitoring opioid overdose.

Fig. 5A-5F illustrate various exemplary software applications that trigger an alarm and notify a friend when opioid overdose is indicated.

Fig. 6A-6J illustrate various examples of physiological parameter sensors and signal processing devices.

Fig. 7A is a block diagram of an exemplary opioid user system environment and an exemplary cloud environment.

FIG. 7B is a block diagram illustrating exemplary components of a cloud environment.

Fig. 7C is a block diagram of exemplary components of an opioid user system illustrating an exemplary opioid user system environment.

Fig. 8 is a flow chart of an exemplary process of notifying an opioid user's notification network of the status of the opioid user.

Fig. 9A is a block diagram of an exemplary physiological monitoring and drug administration system.

Fig. 9B and 9C are schematic views of an exemplary self-administering drug applicator.

Figure 10 is a flow chart of an exemplary process of monitoring opioid overdose and administering a drug that reverses the effects of the overdose.

Fig. 11A-11C are schematic views of an exemplary needle-free injection multi-dose self-administration drug applicator.

Fig. 12A and 12B are schematic views of an exemplary injectable multi-dose self-administration drug applicator with a hypodermic needle for injection.

Fig. 13 is a schematic view of an exemplary wearable self-administration drug applicator.

Fig. 14 is a block diagram of an exemplary activation circuit for a multi-dose self-administration drug applicator.

Fig. 15 is a flow chart of an exemplary process of administering a drug from a self-administering drug applicator.

Fig. 16A and 16B are flow charts of exemplary processes for administering multiple doses of a drug from a self-administering drug applicator.

Fig. 17 is a schematic view of another exemplary wearable self-administration drug applicator.

Figure 18A is a block diagram of an exemplary opioid usage monitoring system.

Fig. 18a1-18a25 illustrate various exemplary software applications that trigger an alarm and notify friends when opioid overdose is indicated.

Fig. 18B is a flow chart of an exemplary process for administering an opioid receptor antagonist using the system of fig. 18A.

Fig. 19 is an example of a medical monitoring hub device for use on the opioid usage monitoring system of fig. 18.

Fig. 20A and 20B are schematic diagrams of exemplary prescribed and over-the-counter opioid overdose monitoring kits.

Detailed Description

Although specific embodiments and examples are described below, the disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Therefore, it is intended that the scope of the disclosure should not be limited by any particular embodiment described below.

SUMMARY

An application of a mobile computing device used in conjunction with a physiological parameter monitoring component to detect a physiological parameter of an opioid user may include determining a physiological condition of the opioid user based at least in part on the physiological parameter, and providing a notification based at least in part on the physiological condition of the opioid user. The physiological parameter monitoring component may be a pulse oximeter that includes a sensor and a signal processing device. An example of a physiological parameter that may be monitored is peripheral oxygen saturation (SpO)₂) Respiratory and Perfusion Indices (PI). The application may be based on SpO alone₂Breath alone, PI, SpO alone₂And respiratory combinations, SpO₂And PI, respiratory and PI, or SpO₂The respiration, and the PI to determine the physiological condition of the user.

The application may request user input and determine a physiological condition of the user based at least in part on the received user input and the physiological parameter from the pulse oximeter. May be based on user input and peripheral oxygen saturation (SpO)₂) One or more of respiration and Perfusion Index (PI) to determine a condition of the user. The application may learn a user's physiological response trend to opioid use based at least in part on the stored physiological parameters to better predict a user's overdose event.

The application may notify one or more of the caregiver, the relatives, the friends, and the first responder of the overdose event. The application may provide "everything is ok" notifications to related family and friends on demand or on a regular basis. The application may provide detailed care instructions to the first responder. The application may provide a location of the user, a location of the nearest medication to reverse the effects of opioid overdose, or a location of the nearest medical personnel. The application may provide one or more of visual, audible and sensory (vibration) alerts to the user at an increased frequency and intensity.

Applications of a mobile computing device for use in conjunction with sensors and signal processing devices to detect abnormal low oxygen saturation indicative of a drug overdose event in a user may include triggering an alarm and notifying others of the drug overdose event. This increases the likelihood that opioid users, their immediate personal network, and first responders will be able to reverse the effects of drug overdose by administering the drug, thereby identifying and reacting to the drug overdose. Such drugs may be considered opioid receptor antagonists or partial inverse agonists. Naloxone orAre drugs that reverse the effects of opioid overdose and are opioid receptor antagonists. Buprenorphine orIs used for treating opioid addiction. With naloxone orBuprenorphine in combination is a drug that can also be used to reverse the effects of opioid overdose. Other exemplary drugs are naltrexone, nalorphine and levorphanol. Administration can be accomplished by intravenous injection, intramuscular injection, and intranasal application (spraying a liquid form of the drug into the nostrils of the user). Administration of the drug may also be via endotracheal intubation, sublingually (gel or tablet of drug applied sublingually) and transdermally (drug may be a gel applied directly to the skin or in a transdermal patch applied to the skin).

A system for monitoring a user for an opioid overdose condition may include a sensor configured to monitor one or more physiological parameters of the user, a signal processing device configured to receive raw data representative of the monitored one or more physiological parameters and provide filtered parameter data, and a mobile computing device configured to receive the one or more physiological parameters from the signal processing device. The mobile computing device comprisesA user interface, a display, network connectivity, memory to store applications as executable code, and one or more hardware processors. The application monitors physiological parameters to determine the user's condition and provides notifications to the user, to crowd-sourced communities of friends, family, and other opioid users who have also downloaded the application to their computing devices, as well as to emergency providers and healthcare personnel. A home Pulse oximetry system for opioid users may include a Pulse oximeter (e.g., Masimo Rad-97 Pulse)) And sensors (e.g. Masimo)Adhesive sensors, etc.) to detect blood oxygen levels and provide warnings and alerts when the blood oxygen level of the opioid user falls below a threshold. The family monitoring system may provide an alert notification that may, for example, alert family members, the remote caregiver, and the first responder to wake the opioid user and administer an overdose of antidote to the opioid, such as an opioid receptor antagonist.

The mobile computing device may be configured to receive filtered parameter data from the signal processing device; displaying a representation of the filtered parameter data on a display, wherein the filtered parameter data includes at least oxygen saturation data regarding an oxygen level in the blood of the user; comparing the current oxygen saturation value with the minimum oxygen saturation level; triggering an alarm when the current oxygen saturation value is below the minimum oxygen saturation level; and providing a notification to the other over the network when the current oxygen saturation value is below the minimum oxygen saturation level.

The display may display a representation of the filtered parameter data as a scale indicating acceptable and acceptable ranges. The filtered parameter data may include one or more of heart rate data, respiration rate data, volume wave variability data, perfusion index data, and respiratory effort index data. The application may provide notifications to the user and may provide notifications to others. The notification may be one or more of a text message, an email, and a telephone call. The notification may include a current value of oxygen saturation and a chart indicating a trend of oxygen saturation level. The notification may also include one or more of the user's phone number, the user's location, directions to the user's location, naloxone, or other medication's closest location for reversing the effects of opioid overdose. The notification may be an automatic call to an emergency responder.

A system for monitoring a user for opioid overdose conditions may include one or more computing devices associated with an opioid overdose monitoring service. The opioid overdose monitoring service may be configured to: identifying opioid monitoring information from at least one physiological monitoring system associated with the user, wherein the opioid monitoring information includes one of an overdose alert and a non-distress state; retrieving notification information associated with a user over a network, wherein the notification information includes first contact information associated with an overdose alert and second contact information associated with a non-distress state; in response to the opioid monitoring information indicating an overdose alert, sending an overdose notification using the first contact information; and in response to the opioid monitoring information indicating the non-distress state, sending a non-distress notification using the second contact information.

The system may also include a physiological monitoring system comprising: the system includes a sensor configured to monitor one or more physiological parameters of a user, a signal processing board configured to receive raw data representative of the monitored one or more physiological parameters and provide filtered parameter data, and a mobile computing device including a display, a network connection, a memory storing executable code, and one or more hardware processors. The mobile computing device may be configured to: receiving filtered parameter data from the signal processing board; displaying a representation of the filtered parameter data on a display, wherein the filtered parameter data includes at least oxygen saturation data regarding an oxygen level in the blood of the user; comparing the current oxygen saturation value to the minimum oxygen saturation level; and trigger an alarm when the current oxygen saturation value is below the minimum oxygen saturation level.

The mobile computing device may be configured to receive the filtered parameter data from the signal processing board, generate opioid monitoring information based on the filtered parameter data, and send the opioid monitoring information to an opioid overdose monitoring service over a network. The filtered parameter data may include one or more of current oxygen saturation values, heart rate data, respiration rate data, volume wave variability data, perfusion index data, and respiratory effort index data. The overdose and non-distress notifications may include one or more of text messages, emails, and phone calls. The drug overdose and non-distress notifications may include a current value of oxygen saturation and a chart indicating a trend in oxygen saturation levels. The medication overdose notification may include one or more of a user's phone number, a user's location, directions to a user's location, naloxone, or other medication's closest location for reversing the effects of opioid overdose. The overdose notification may automatically call an emergency responder. The network may be the internet.

A kit for monitoring opioid overdose events may include a sensor for sensing a physiological parameter and a medical monitoring hub device for receiving an indication of the sensed physiological parameter and receiving an indication of the opioid overdose event. The kit may also include a delivery device to deliver the drug in response to the indication of the opioid overdose event. The delivery device may automatically administer the opioid receptor antagonist in response to an indication of an opioid overdose event. The delivery device may comprise a patch comprising a reservoir with the drug, a needle and a battery. The hub device may include a memory for storing an indication of the sensed physiological parameter. The hub device may receive and store data from monitoring devices other than sensors. The data from the monitoring device may include data associated with the health of the user. The kit is available without a prescription.

Figure 1A is an overview of an exemplary opioid usage monitoring/notification system. Opioid users' support networks may include friends, family, emergency services, care providers, and overdose care networks, which communicate, for example, over a network (e.g., the internet). The support network receives notification and/or status updates of opioid user status. The optional monitoring device may monitor the respiration of the opioid user and other biological parameters, such as heart rate, blood oxygen saturation, perfusion index, and provide these parameters to the smart device. An application running on the smart device may determine whether an opioid overdose event is imminent and/or occurring. The application may also provide additional information such as care guidance, patient trends, opioid information, care guidance, user location, the location of naloxone, buprenorphine in combination with naloxone, or other drugs used to reverse the effects of opioid overdose, and the like. The support network, upon receiving the notification, may communicate with the central server to obtain additional information.

Figure 1B is a schematic diagram of an exemplary support network associated with monitoring opioid use. The figure shows an example of an opioid use support network. Opioid users may want to notify friends, family and care givers when urgent care is needed due to an impending or ongoing indication of an opioid overdose. The figure shows an example of an opioid use support network. Different notifications may be received by the subnets within the support network. Such as a caregiver (e.g., emergency 911 service), a shared ride service (e.g.,and) A treatment center, a prescription care provider, a professional care provider, an ambulance service may receive a possible medication overdue alert to provide immediate lifesaving care to the user; the point-of-care provider may receive care instructions; friends and family may receive periodic status messages indicating that no overdose events have occurred; and the delivery service may receive medication (e.g., naloxone, buprenorphine) with an effect for reversing opioid overdoseA combination of buprenorphine and naloxone, etc.). Other subnets receiving different notifications are possible.

Figure 1C is an overview of another exemplary opioid usage monitoring system. As shown above in fig. 1A, the opioid user's support network may include friends, family, emergency services, care providers, and an overdose care network, which communicate, for example, over a network such as the internet. The support network receives notification and/or status updates of opioid user status. A monitoring device including sensors may monitor the respiration of opioid users and other biological parameters, such as heart rate, blood oxygen saturation, perfusion index, and provide these parameters to a HUB device that may communicate over a network. An example of a HUB device is shown in fig. 6H. The HUB device receives sensor data from the sensors. The HUB device may transmit the sensor data to the server over the network. The HUB device may process the sensor data, at least in part, and transmit the at least partially processed sensor data to the server. The server processes the sensor data, or at least a portion of the processed sensor data, and determines whether an overdose event is imminent and/or occurring. The server notifies the support network and the mobile application on the opioid user's mobile device when an overdose event is about to occur and/or is occurring.

Meter sensor and signal processing device

Fig. 2A illustrates an exemplary physiological monitoring system 100. The illustrated physiological monitoring system 100 includes a sensor 102, a signal processing device 110, and a mobile computing device 120.

The sensor 102 and the signal processing means 110 may comprise a pulse oximeter. Pulse oximetry is a non-invasive method for monitoring the oxygen saturation of a person. The sensor 102 is placed on the user's body and passes light of two wavelengths through the body part to the light detector. The sensor 102 may provide the raw data 104 to the signal processing device 110, which signal processing device 110 determines the absorption of light due to the pulsating arterial blood. The pulse oximeter generates a plethysmograph waveform from which the oxygen saturation of arterial blood, pulse rate and perfusion index, as well as other physiological parameters, may be determined and provides the physiological parameters 118 to the mobile computing device 120.

The pulse oximeter may be transmissive, where the sensor 102 may be placed on a thin portion of the user's body, such as a fingertip or earlobe; or reflective, wherein the sensor 102 may be placed on, for example, the forehead, feet, or chest of the user.

The sensor 102 and the signal processing device 110 may be packaged together. The sensor 102 may not be packaged with the signal processing device 110, but rather communicate with the signal processing device 110 wirelessly or via a cable.

An example of a pulse oximeter is MIGHTYSAT RX, all manufactured by Masimo Corporation of Lwan, CalifHand-held pulse CO oximeter andCO oximeters, which can be fixed to a finger or toe, such as a finger.

Since opioid users may wish to be discrete when monitoring opioid usage for indicating an overdose event, an invisible sensor 102 may provide additional privacy to the user. The sensor 102 may be applied to the toe and the signal processing device 110 may comprise an ankle brace. The sensor 102 may be a ring on a user's finger or a bracelet on a user's wrist, and the signal processing device 110 may be located in an armband hidden under the user's sleeve. The sensor 102 or the sensor 102 and the signal processing device 110 may be integrated into an exercise device worn on the wrist of the user. Such pulse oximeters may be reflective or transmissive. The sensor 102 may be an ear sensor that is not readily visible.

Other variations of the sensor 102 may be used, such as an adhesive sensor, a combination reusable/disposable sensor, a soft and/or flexible wrap sensor, an infant or pediatric sensor, a multi-site sensor, or a sensor shaped for making measurements at a tissue site (e.g., an ear).

Other sensors 102 may be used to measure physiological parameters of the user. For example, the modulated physiological sensor may be a non-invasive device that responds to a user's physiological response to internal or external perturbations that propagate into the surface area of the skin. The modulated physiological sensor has a detector, such as an accelerometer, configured to generate a signal in response to a physiological response. The modulator alters the coupling of the detector to the skin so as to maximize the detector signal at least intermittently. The sensor processor controls the modulator and receives an effectively amplified detector signal, which is processed to calculate a physiological parameter indicative of a physiological response. The MODULATED PHYSIOLOGICAL SENSORs and corresponding SENSOR processors are described in U.S. publication No.2013/0046204 entitled "MODULATED PHYSIOLOGICAL SENSORs SENSOR" filed on 2013, 21.2.2013 and assigned to massio Corporation, gulf, california, which is hereby incorporated by reference.

The sensors 102 may include an electroencephalograph ("EEG") that may be configured to measure electrical activity along the scalp. The sensor 102 may include a capnometer or capnometer that may be configured to measure the composition of exhaled breath.

The acoustic sensor 102 may be used to determine the user's breathing rate. An acoustic sensor using a piezoelectric device attached to the neck can detect sound waves caused by vibrations in the trachea due to the inflow and outflow of air between the lungs and the nose and mouth. The sensor output may be demodulated to derive a modulated acoustic wave envelope of the breathing rate. The ACOUSTIC respiration rate sensor and corresponding sensor processor are described in U.S. publication No.2011/0125060 entitled "acostic RESPIRATORY MONITORING SYSTEMS AND METHODS" by Masimo Corporation, ltd, 2010, filed by Telfort et al on 14/10 and assigned to gulf, california, which is incorporated herein by reference.

The mobile computing device 120 may include an accelerometer configured to detect motion of the mobile computing device 120. When a user holds the mobile computing device 120 or attaches the mobile computing device 120 to his clothing in a manner in which the accelerometer detects the user's motion, the accelerometer can be used to detect the user's lack of motion. The user's lack of motion may be used to determine the user's condition, as described below.

When the user holds the mobile computing device 120, the accelerometer may sense vibrations from the user indicative of the user's heart rate. The absence of vibrations sensed by the accelerometer may indicate no heart rate, and a reduced occurrence of vibrations sensed by the accelerometer may indicate cardiac discomfort. As described below, indications of cardiac activity sensed by an accelerometer in a mobile computing device may be used to determine a condition of a user.

The sensor 102 may be a centroid patch worn by the user that includes an accelerometer. Data indicative of the motion of the accelerometer may be wirelessly transmitted to the mobile computing device 120. Based on the motion detected by the accelerometer, the application detects the user's respiration rate. An oxygen sensor configured to monitor the breathing of the user may wirelessly transmit an indication of oxygen present in exhaled air of the user.

The physiological sensor 102 and the mobile computing device 120 may be connected via one or more cables, and the signal processing device 110 may be connected between the sensor 102 and the mobile computing device 120 to perform signal processing on the raw data 104 before the physiological parameters 118 are transmitted to the mobile computing device 120. The MOBILE PHYSIOLOGICAL parameter monitoring system is described in U.S. patent 9,887,650 entitled "physical monitoring WITH MOBILE COMPUTING DEVICE CONNECTIVITY" issued to Muhsin et al, 30/1.2018, assigned to Masimo Corporation, Inc., of gulf, Calif., which is incorporated herein by reference.

In various oximeter examples, the sensor 102 provides the data 104 in the form of an output signal indicative of the amount of attenuation of human tissue (e.g., a finger or toe, a nose or portion of an ear, a foot, etc.) to light of a predetermined wavelength (wavelength range). The predetermined wavelength typically corresponds to specific physiological parameter data as desired, including, for example, blood oxygenation information, such as oxygen contentVolume (SpOC), oxygen saturation (SpO)₂) Blood glucose, total hemoglobin (SbHb), methemoglobin (SbMet), carboxyhemoglobin (SpCO), bulk tissue property measurements, water content, pH, blood pressure, respiration-related information, cardiac information, Perfusion Index (PI), volume wave variability index (PVI), etc., which may be used by the mobile computing device 120 to determine a condition of the user. The sensor data 104 may provide information about physiological parameters 118, such as EEG, ECG, beats per minute, acoustic respiration rate (RRa), breaths per minute, end tidal carbon dioxide (EtCO)₂) Respiratory effort index, return of spontaneous circulation (ROSC), etc., which may be used to determine a physiological condition of the user.

Referring to fig. 2A, the sensor 102 may transmit the raw sensor data 104 to the signal processing device 110, and the signal processing device 110 may convert the raw sensor data 104 into data representative of the physiological parameter 118 for transmission to the mobile computing device 120 for display, monitoring, and storage. The sensor data 104 may useNear field communication protocols, Wi-Fi, etc., are transmitted wirelessly, or the sensor data 104 may be transmitted to the signal processing device 110 via a cable.

For example, noise due to patient motion, electromagnetic interference, or ambient light can corrupt the sensor data 104. The physiological parameter monitoring system 100 may apply noise filtering and signal processing to provide the physiological parameters 118 for analysis and display on the mobile computing device 120. Such complex processing techniques may exceed the processing capabilities of the mobile computing device 120, and thus the signal processing device 110 may process the signal processing of the raw sensor data 104 and transmit the processed physiological parameters 118 to the mobile computing device 120.

In the case of pulse oximetry, the signal processing device 110 may use adaptive filter techniques to separate the arterial signals detected by the pulse oximeter sensor 102 from non-arterial noise (e.g., venous blood movement during movement). During routine patient movements (tremor, wave, tap, etc.), the noise generated can be substantial and can easily overwhelm conventional rate-based oximetry systems. This may provide accurate oximetry measurements even during patient motion, low perfusion, strong ambient light, and electrocautery disturbances. Thus, false alarms may be substantially eliminated without sacrificing true alarms.

The signal processing device 110 can useThe physiological parameters 118 are wirelessly transmitted to the mobile computing device 120 by a near field communication protocol, Wi-Fi, or the like, or the signal processing device 110 may transmit the physiological parameters 118 to the mobile computing device 120 by a cable.

Fig. 6A-6J illustrate various exemplary sensors 102 and signal processing devices 110. Fig. 6A shows a mobile physiological monitoring system 610 that includes a fingertip pulse oximeter sensor 102, the fingertip pulse oximeter sensor 102 being connected to a mobile computing device 120 (which is shown as a smartphone) through a cable that includes a signal processing device 110.

Fig. 6B-6D illustrate other exemplary mobile physiological sensor components that can be in physical communication with a user to collect physiological data of the user and send an indication of a physiological parameter of the user to the mobile computing device 120. Fig. 6B shows a mobile physiological sensor assembly 620 that includes an electroencephalograph ("EEG") that can be configured to measure electrical activity along the scalp. Fig. 6C shows a mobile physiological sensor assembly 630 that includes a capnometer or capnograph that may be configured to measure the composition of exhaled breath. Fig. 6D illustrates a mobile physiological sensor assembly 640 that includes an acoustic respiration monitoring sensor that can be configured to measure respiration rate using an adhesive sensor with an integrated acoustic transducer.

FIG. 6E shows a schematic representation of a product manufactured by Masimo Corporation of Lwan, CaliforniaA hand-held pulsed CO oximeter 650. Oximeter 650 has a fingertip oximeter sensor 102 that passes throughThe cable transmits the raw data 104 to a signal processing device 110 that includes display capabilities.

FIG. 6F shows MIGHTYSAT RX from Masimo Corporation of Lwan, California660. The sensor 102 and the signal processing device 110 of the oximeter 660 are integrated into a single package.

Fig. 6G shows a physiological parameter assembly 670 including a sensor 102 applied to the toe and a signal processing device 110 in the ankle strap for discreetly monitoring opioid overdose conditions.

FIG. 6H shows a monitoring hub 680 including a hub havingOf pulse oximeter 200Monitoring hub 326, both manufactured by Masimo Corporation of Lwan, California. The medical monitoring hub 680 may extend monitoring functionality by concentrating signal processing and display for multiple physiological parameters (e.g., brain function monitoring, regional oximetry, and capnography).

Fig. 6I shows a physiological parameter component 690 including the sensor 102 and the signal processing device 110 that may be worn as a glove. When the glove is placed on the user's hand, the sensor 102 may be placed on one of the fingertips. The sensor 102 may be a disposable sensor. The sensor 102 may be built into or out of the finger of the glove. The sensor 102 may be integrated into the finger of the glove. The cable of the signal processing device 110 may be integrated into the glove. Advantageously, the glove is easy to wear, remains in place, and can be easily removed when the user does not require opioid overdosing monitoring. Glove 690 may be secured to the wrist with straps, hook and loop fasteners, or the like. The sensors 110 may be wireless and use sensors such asEtc. to communicate with the mobile device 120.

Fig. 6J shows a physiological parameter component 695, which includes the sensor 102 and a cable for connection to a signal processing device. The sensor 102 may be a disposable sensor. The sensor 102 may be placed around a finger. The sensors 102 may wirelessly transmit sensor data.

Meter-mobile computing device

Any mobile computing device 120 that is compatible with the physiological parameter components including the sensors 102 and the signal processing device 110 may be used. The compatible mobile computing device may be one of a variety of mobile devices, such as, but not limited to, a mobile communication device (e.g., a smartphone), a laptop, a tablet, a netbook, a PDA, a media player, a mobile gaming device, a watch, a wearable computing device, or other microprocessor-based device configured to interface with the signal processing device 110 and provide notifications based at least in part on the monitored physiological parameters 118.

Referring to fig. 2A, the mobile computing device 120 may include a display 122 for displaying physiological parameters, for example, in a user interface and/or software application, as discussed in more detail below. The display 122 may include a display screen, such as an LED or LCD screen, and may include touch sensitive technology in combination with the display screen. The mobile computing device 120 may include software configured to display some or all of the output measurement data on a display screen. The data display may include numerical or graphical representations of blood oxygen saturation, heart rate, respiration rate, volume wave variability, perfusion index, and/or respiratory effort index, and the numerical and graphical data representations may be displayed simultaneously.

The mobile computing device 120 may include a user interface 126 that may receive user inputs. The user interface 126 may include buttons, a keyboard, touch sensitive technology of the display screen 122, and other user input mechanisms commonly found on various exemplary mobile computing devices 120.

The mobile computing device 120 may also include a data storage device 124, which may be configured as a software application for storing the physiological parameters 118 and parameter history data and/or monitoring physiological parameters to indicate drug overdose and provide notifications. The storage 124 may be physical storage of the mobile computing device 120, and the storage 124 may be remote storage, such as on one or more servers of a data hosting service.

The mobile computing device 120 may also include a network connection feature 128 that provides network connection capabilities such as one or more of a cellular network, a satellite network, bluetooth, ZigBee, a wireless network connection such as Wi-Fi, and a wired network connection. The mobile computing device 120 may also include a data transfer port.

Overview of application functionality

The mobile computing device 120 may include software, such as an application 130, configured to manage the physiological parameter 118 from the physiological parameter monitoring device 110. Application functions may include trend analysis, current measurement information, alarms associated with above/below threshold readings, reminders to acquire measurement data at particular times or periods, display customization, iconic data (e.g., heart beat, color coordination, bar graphs, gas columns, charts, graphics, etc.), all of which may be used by a caregiver or application user to provide medical monitoring of particular physiological parameters. The display 122 may display the physiological parameter 118 as a numerical value, a graph, a chart, a dial, or the like.

The application 130, via the mobile computing device 120, may also alert the user and/or a person designated by the user to abnormal data readings. For example, abnormally low blood oxygen saturation readings may cause mobile computing device 120 to beep, vibrate, or otherwise notify the user of the abnormal reading and transmit a notification or alert to the user, designated personnel, or medical personnel to the network via network connection 128.

In addition, application 130 includes one or more processes to monitor physiological parameters 118 for a condition of the user, particularly for signs of opioid overdose. The application 130 may be set up by the user or a caregiver to notify the other of the overdose event. This increases the likelihood that opioid users, their direct personal network, and first responders will be able to identify drug overdose and respond to it by administering drugs (such as naloxone) that reverse the effects of opioid overdose. Naloxone is a drug reversal drug of drug overdose. In some states, a person at risk of opioid overdose or a person who knows someone at risk of opioid overdose may go to a pharmacy or community program to receive training in naloxone administration and receive naloxone as a "long-term order," meaning that patient-specific prescriptions are not required. Naloxone, when administered in a timely manner, can restore a victim of drug overdose to breathe long enough to allow trained medical assistance to be reached. In some cases, other drug overdose reversal drugs may be used, such as buprenorphine, and combinations of buprenorphine and naloxone, among others.

The applications 130 may include processes and information to monitor and provide care to opioid users, such as, but not limited to, an overdose detection process 131 configured to determine a condition of the user and indicate medical care based at least on the physiological parameters 118, an alarm management process 132 configured to manage alarms to the user and other users in the user's network based at least in part on the condition of the user, and care/treatment information (e.g., critical care guide video 133) for opioid use.

Opioid overdose monitoring

Fig. 2B illustrates an exemplary process 200 of monitoring physiological parameters 118 for opioid use and providing a notification. At block 205, the sensor 102 collects raw data 104 from the user. In the case of a pulse oximeter sensor, the sensor 102 passes light, such as red and infrared light, through the body part to the light detector. Raw data 104 from sensor 102 provides respiratory information due to absorption of light in the pulsating arterial blood.

At block 210, the signal processing device 110 receives the raw data 104 from the sensors 102, processes the raw data 104 to provide one or more parameters 118 to the mobile computing device 120. In the case of a pulse oximeter, the signal processing device 110 generates a plethysmograph waveform from which it can be ascertainedDetermining at least peripheral blood oxygen saturation (SpO) of arterial blood₂) Respiration, pulse rate and Perfusion Index (PI). Other physiological parameters that can be determined are, for example, oxygen content (SpOC), blood glucose, total hemoglobin (SbHb), methemoglobin (SbMet), carboxyhemoglobin (SpCO), bulk tissue property measurements, water content, pH, blood pressure, cardiac information, and volume wave variability index (PVI). The sensor data 104 may provide information about physiological parameters 118, such as EEG, ECG, beats per minute, acoustic respiration rate (RRa), breaths per minute, end tidal carbon dioxide (EtCO)₂) Respiratory effort index, and recovery of spontaneous circulation (ROSC).

User input

At block 215, the application 130, via the mobile computing device 120, may query the user and receive user input. The mobile computing device 120 may present the questions on the display 122 and the user may reply using the user interface 126. For example, the user may be queried for information on the prescription label, the dose and/or frequency of opioid being consumed, and any other medications the user is consuming. Mobile computing device 120 may ask the user to input his weight, age, and other physical attributes that may be factors in the user's response to the dosage of opioids and naloxone or the like for reversing the effects of drug overdose. The mobile computing device 120 may ask the user whether the user is normal or needs assistance. The response from the user may indicate that the user is conscious and has not had an overdose of medication. When the analysis of the parameters 118 indicates a drug overdose event, the application 130 may query the user for a response, and if a response is received indicating that the user is conscious and has no drug overdose, the application 130 may refine the threshold for determining the drug overdose event. The mobile computing device 120 may confirm the user name and location.

Trend of the

At block 220, the application 130 may use the past monitored physiological parameters 118 from storage device 124 along with user input relating to weight, age, dose, frequency, and other medications being consumed to generate trends in the user's opioid use. The trend may be based on the parameters 118 and user input (if received).

For example, opioid consumers, who are also cannabis consumers, may develop greater tolerance to opioids. In addition, opioids initially cause an increase in perfusion index due to vasodilatation, and then cause a decrease in perfusion index due to vasoconstriction. The increase and decrease in perfusion index creates a perfusion curve. Users with greater tolerance to opioids may have a different perfusion profile than users who do not use cannabis in combination with opioids.

The application 130 may use the user input (if any) along with stored physiological parameters (e.g., perfusion curves) and current physiological parameters to generate trends in opioid use and/or opioid tolerance for the user, which may more accurately predict overdose events. The application 130 may use a "near miss" that occurred in the past to further refine the conditions that may be predictive of an overdose event. "proximal error" refers to an event that provides an indication of drug overdose, such as an indication that breathing is below a threshold, but does not result in a drug overdose event. Opioid doses associated with similar errors may provide an indication of a user's tolerance to opioids and may be used by the application 130 to refine the determination of an impending or ongoing opioid overdose event.

Using the history of the physiological parameters 118 including similar errors and user input (if available), the application 130 may learn which combination of events and parameter values indicates that an overdose event may be imminent. Over-reporting is desirable because time is critical for administering drugs (such as naloxone) to reverse or reduce the effects of overdose on drug overdose victims, but over-reporting of opioid notifications may desensitize responders. It is important that the application 130 learn the specific triggers for a particular user to improve the accuracy of determining an overdose event for a particular user. The application 130 can learn the conditions that lead to overdose events and improve its algorithms to notify others when assistance is needed and to discern false positive events.

The application 130 may use the tolerance of the user and the physical attributes of the user, such as weight and age, to refine the amount of drug (e.g., naloxone, etc.) that reverses or reduces the effects of drug overdose, which should be administered in the event of drug overdose to revitalize the user. The application 130 may monitor the dose of the drug and report the dose to a clinician who can determine whether the dose is too high or too low.

The process 200 refines the indication of the overdose event using one or more of user input, current physiological parameters, stored physiological parameters, a "near error" event, an overdose event, so that the occurrence of the overdose event can be more accurately determined without notifying others that the wrong overdose event is the result. Because time is critical in responding to drug overdose victims, the application 130 may make mistakes in over-notifying, but may learn triggers for specific users to avoid "false alarms," which may result in others ignoring the notification.

Data analysis

At block 225, the application 130 determines a condition of the user based on one or more of the physiological parameters, the user input, and the trend. For example, the application 130 may compare the physiological parameter 118 to a threshold to determine whether an overdose event is occurring or about to occur. For example, opioids inhibit the user's breathing. The application may determine that a drug overdose event has occurred if one or more of the oxygen saturation, number of breaths per minute, perfusion index, and respiratory effort index is indicative of respiratory failure, but less than a threshold. The threshold may be a predetermined threshold that is adjusted when the application 130 learns a medication overdose trigger associated with the user. As the application 130 trends, the application may refine the threshold values for the one or more physiological parameters 118.

The application 130 may use the user's perfusion index to determine the likelihood of a drug overdose event. For example, opioids initially cause the perfusion index to increase due to vasodilation and then decrease due to vasoconstriction. This may be an identifiable perfusion curve that predicts a drug overdose event.

The application 130 may use one or more physiological parameters 118 to determine a condition of the user. The application 130 may use Perfusion Index (PI), respiration, and peripheral oxygen saturation (SpO)₂) To determine the condition of the user. For example, the application 130 may use, but is not limited to, Perfusion Index (PI), respiration, and peripheral oxygen saturation (SpO) alone₂) Each of (a); PI, respiration and SpO₂A combination of (1); a combination of PI and respiration; PI and SpO₂A combination of (1); or respiration and SpO₂To determine the condition of the user. The analysis of the physiological parameter 118 may indicate that the physiological parameter is within a normal range and that the user does not require assistance, or the analysis may indicate that an overdose event is imminent, occurring, or has occurred.

The other physiological parameters 118 may be analyzed, alone or in other combinations, to determine whether the physiological parameters 118 of the user are within normal ranges, or whether an overdose event is about to occur, is occurring, or has occurred.

The application 130 may query the user to determine the user's condition. The absence of any response by the user may indicate that the user is unconscious and may trigger an overdose event notification or alarm. As described above, the response from the user may indicate that the user is conscious, and the application 130 may use this information to refine the change in the user's physiological parameter 118 that indicates that opioid overdose is occurring or will occur soon.

As described above, the mobile computing device 120 may include an accelerometer that may detect user motion. The lack of user motion sensed by the accelerometer may indicate that the user is unconscious and may trigger an overdose event notification or alarm. The movement sensed by the accelerometer may indicate that the user is conscious, and the application 130 may use this information to refine changes in the user's physiological parameters 118 that indicate that opioid overdose is occurring or will occur soon.

As described above, the mobile computing device 120 may include an accelerometer that may sense vibrations from the user indicative of the user's heart rate. The lack of vibration detected by the accelerometer may indicate no heart rate, and a decrease in vibration detected by the accelerometer may indicate cardiac discomfort, which may trigger an overdose event notification or alarm. A heart rate within normal parameters may indicate that the user does not need to be assisted by an overdose event.

At block 230, the application 130 may determine whether care is useful based on the user's condition. If care is indicated such that the physiological parameter indicates suppressed breathing but not a life-threatening level, the application moves to block 235. At block 235, the application 130 queries the user. If a response is received, process 200 moves to the END block. The response indicates that the user is conscious and does not need immediate assistance.

If at block 230, the application 130 determines that care is needed because the evaluation of the physiological parameters 118 indicates a life-threatening condition, the process 200 moves to block 240. Further, if no response is received from the user query at block 235, the process 200 moves to block 240.

Notification

At block 240, the application 130 provides a notification based at least in part on the user's condition. For example, the application 130 may display on the display 122 physiological parameters of the user, such as one or more of oxygen saturation, beats per minute, breaths per minute, volume wave variability, perfusion index, and respiratory effort. The physiological parameter 118 may be displayed as a chart, graph, bar graph, numerical value, or the like. The application 130 may display a trend of the physiological parameter 118.

The application 130 may provide a notification to the selected friend indicating no overdose condition. The "all is normal" notification may be sent periodically or on demand. An "all is normal" notification may be sent at a known exposure time. For example, a "everything is normal" notification may be sent every 30 minutes, from 6:00PM, where the user typically returns to work, to 11:00PM, where the user typically falls asleep.

Application 130 may also report "proximity errors" to the caregiver. As described above, "proximal error" refers to an event that provides an indication of drug overdose, such as an indication that respiration is below a threshold, but does not result in a drug overdose event.

Once the application 130 determines that an overdose condition is about to occur, is occurring, or has occurred, the application 130 may provide a notification of the overdose to selected families, friends, caregivers, clinicians, and medical personnel. Notifications may be sent to a community of crowd sources of users, friends, and medical personnel that are in close relation to each other. The application 130 may provide the user's location and/or directions to the user's location. The notification may include the location of the most recent medical care and/or the location of the most recent medication that reduces or reverses the effects of the overdose. Examples of such drugs are, but are not limited to, naloxone, buprenorphine, combinations of naloxone and buprenorphine,And so on. The application 130 may indicate whether the victim of the drug overdose is conscious or unconscious.

The notification may include a protocol for the first responder to provide assistance to the user. The application 130 may provide user data to medical personnel to assist them in administering the correct dose of a drug (e.g., naloxone, etc.) to a user to reduce or reverse the effects of drug overdose. For example, if a drug overdose victim is also a user of heroin or cannabis, the drug overdose victim may require a larger dose of naloxone to reverse the effects of opioid overdose than a drug overdose victim who does not use heroin or cannabis simultaneously. In addition, naloxone dosage may also need to be adjusted according to the body weight and age of the drug overdose victim. For example, adults may require larger doses of naloxone than children to reverse the respiratory depression effect of opioid overdose.

The application may continuously provide trend data to medical personnel or designated care givers, or may provide trend data with medication overdose notifications. The dosage of a drug, such as naloxone, for reducing or reversing the effects of drug overdose may be adjusted based at least in part on the trend data.

The application 130 may notify the userAnd requests confirmation from the user. For example, the application 130 may provide a visual notification on the display 122 and then cause the mobile computing device 120 to provide an audible notification, such as an audible alarm, which may be escalated to an increasingly loud, harsh sound in an attempt to wake the user. The audible notification may include the user's name. The application 130 may be associated with a network such asEtc. to create an alert. For example, the application 130 may contact the mobile computing device 120 or the home system with a live person who may provide instant care guidance to the first responder.

The application 130 may provide notification to others in the community of users who have downloaded the application 130 onto their mobile computing devices. The application 130 may cause the mobile computing device 120 to send, for example and without limitation, text messages, emails, and phone calls to selected contacts in the user's mobile device 120 that may or may not have downloaded the application 130 to their mobile computing device 120. The mobile computing device 120 may automatically dial 911 or other emergency response number. The application 130 may transmit the user's location to one or more selected ambulances and caregivers.

Fig. 3A-3E illustrate various exemplary software applications that provide information, notifications and alerts to opioid users, first responders, medical personnel and friends.

FIG. 3A is a screenshot 300 illustrating a request for user input. The illustrated screenshot 300 shows the question "do you get good? Do you need medical assistance? "and selection of a user response. If no response is received, the user may be assumed to be unconscious. If a response is received, the application 130 may refine the algorithm using the physiological parameters 118 associated with the response to determine an overdose event for the particular user. The refinement may include a refinement of the overdose threshold of the physiological parameter 118 or may include a refinement of a parameter trend associated with an overdose event.

FIG. 3B is a screen shot 310 illustrating a periodic status alert that may be sent via text message or email to a friend or family that has set up a periodic health check for the user in the user's application 130. The illustrated screenshot 310 also indicates the time when the next health check will occur.

FIG. 3C is a screen shot 320 illustrating a status alert that may be sent via text message or email to a friend or family that has set up a periodic health check for the user in the user's application 130. The illustrated screen shot 320 indicates the current value of the monitored physiological parameter and provides a "View Trend (SEE TRENDS)" section to view trend data for the physiological parameter. The illustrated screen shot 320 also indicates the date and time of the most recent overdose event.

Fig. 3D is a screen shot 330 illustrating a first responder agreement. The illustrated screenshot 330 shows resuscitation information for a person responding to a medication overdue notification.

Screenshot 340 of FIG. 3E shows the closest location to the user with available naloxone. The illustrated screenshot 340 displays an address and location map.

Notifying friends

Fig. 4 shows an exemplary process 400 for monitoring opioid overdose using the mobile physiological parameter monitoring system 100 including the sensor 102 and the signal processing device 110 and the mobile computing device 120. The user or caregiver downloads the application 130 into the mobile computing device 120. When application 130 determines that an opioid overdose event is occurring, the user or caregiver may select one or more persons to be notified by mobile computing device 120. The mobile computing device 120 may include a mobile communication device such as a smartphone. The user attaches the sensor 102 to a body part, for example, clamps the sensor 102 on a finger, toe, forehead, and connects it wirelessly or via a cable to a mobile computing device 120 that includes an application 130.

At block 405, the mobile physiological parameter monitoring system 100 collects raw data 104 from the sensors 102. At block 410, the signal processing device 110 processes the raw data and provides the physiological parameters 118 to the mobile computing device 120.

At block 415, the mobile computing device 120 receives the physiological parameter 118 from the physiological parameter monitoring device 110.

At block 420, the application 130 displays the physiological parameter 118 on the display 122 of the mobile computing device 120. The mobile computing device 120 may display numerical indications, graphics, pie charts, dials, and the like. The display may include acceptable and unacceptable ranges for the physiological parameter 118. The display may be color coded. For example, the acceptable range may be colored green, while the unacceptable range may be colored red. The application 130 may display the physiological parameter 118 on the mobile computing device 120 as the physiological parameter 118 is received (in real-time) or at approximately the same time as the physiological parameter 118 is received (in near real-time).

At block 425, the application 130 may monitor the physiological parameter 118 to indicate opioid overdose. The monitored physiological parameters 118 may include physiological parameters most likely to be affected by a drug overdose condition. The physiological parameter 118 may be one or more of oxygen saturation, heart rate, respiration rate, volume wave variability, perfusion index, etc. of the user.

The application 130 may determine whether the physiological parameter 118 indicates that the user requires point-of-care. A blood oxygen saturation level below a threshold may indicate an opioid overdose condition. For example, the application 130 may monitor the oxygen saturation of the user and trigger an alarm when the oxygen saturation falls below a threshold. The application 130 may compare the current oxygen saturation level of the user to a threshold that may indicate a minimum acceptable blood oxygen saturation level. An oxygen saturation level below the minimum acceptable blood oxygen saturation level may indicate a drug overdose event. For example, an oxygen saturation level below about 88 may be indicative of respiratory distress.

The application 130 may compare each of the monitored physiological parameters 118 to a threshold value that is indicative of a minimum or maximum acceptable level of the physiological parameter 118. For example, the application 130 may compare the heart rate of the user's beats per minute to an acceptable range of about 50 beats per minute to about 195 beats per minute. The application 130 may compare the user's breath rate per minute to an acceptable range of about 6 breaths per minute to about 30 breaths per minute. The application 130 may compare the user's volume waves to an acceptable range of about 5 to about 40 and compare the user's perfusion index to a minimum acceptable perfusion index of about 0.3.

One or more physiological parameters 118 may be weighted, and the application 130 may trigger notification of an opioid overdose event when a combination of the weighted parameters falls below a threshold. The one or more physiological parameters 118 may be weighted based on trends in the physiological parameters of the user during opioid use, and the application 130 may trigger notification of an opioid overdose event when the combination of weighted parameters falls below a threshold.

When the measured physiological parameter 118 is within the acceptable range, the process 400 may return to block 415, and the mobile computing device 120 may continue to receive the physiological parameter 118 from the sensor 102 via the physiological parameter monitoring device 110. The application 130 may compare one, more than one, or all of the measured physiological parameters 118 to determine a drug overdose event.

When an indication is made that an overdose of medication is imminent or occurring, process 400 moves to block 430. For example, when the user's blood oxygen saturation level is at or below a threshold, the application 130 triggers an alarm at block 430. The process 400 may trigger an alarm when at least one of the monitored parameters 118 is below an acceptable threshold. The alert may be an audible alert that increases in loudness, frequency, or pitch. The alert may be the user's name, vibration or a combination of audible sound, vibration and name.

The mobile computing device 120 may vibrate, audibly alert, display a warning, visibly blink, etc. to notify the user or someone in the same physical location as the mobile computing device 120 of the overdose event. The alert may be an audible alert that increases in loudness, frequency, or pitch. The alert may be the user's name, vibration or a combination of audible sound, vibration and name.

The mobile computing device 120 may display a location and/or directions for naloxone or other drugs that reverse or reduce the effects of drug overdose proximate to the user. The mobile computing device 120 may display the phone number of the person associated with the most recent medication (such as naloxone) that reverses or reduces the effects of overdose. The mobile computing device 120 may display resuscitation directions to the first responder. The mobile computing device 120 may request confirmation from the first responder. The mobile computing device 120 may display resuscitation instructions to the first responder, call medical personnel, and facilitate questions and answers between the first responder and the medical personnel.

If the user is alone, this may not be sufficient to avoid a life-threatening overdose of medication. At block 435, the application 130 may send a notification to the user's network, such as the person selected for notification, emergency personnel, friends, family, caregiver, doctor, hospital. The notification may be sent in conjunction with the network connection 128 of the user's mobile computing device 120. The notification notifies the selected one or more persons of the opioid overdose of the user. For example, the selected one or more people may receive notifications on their mobile computing devices. The selected one or more people may be a friend, a group of friends, a first responder, medical personnel, and the like. The mobile computing device 120 may automatically dial 911 or other emergency response number.

The notification may be sent to a crowd-sourced community of opioid users that are in mutual regard, such as a community of individuals and/or organizations associated with one or more opioid users. The community functions to provide assistance to opioid users, and may include not only other opioid users, but also friends, family, sponsors, first responders, medical personnel, clinicians, and anyone with access to drugs that reverse or reduce the effects of overdose (e.g., naloxone).

The notification may be one or more of a text message, an automatically placed telephone call, an email, and the like. The notification may include one or more of a graphical representation, a numerical value, etc. of the user's unacceptable or out of acceptable range physiological parameters 118, a time of drug overdose, a location of the user, directions to the location, and a phone number of the user's mobile computing device 120. The notification may also provide a location and/or directions for the drug (e.g., naloxone) that most closely approximates the user's effect of reversing or reducing the overdose, as well as a phone number of the person associated with the drug (e.g., naloxone) that most recently reverses or reduces the effect of the overdose.

Fig. 5A-5F illustrate various exemplary software applications that trigger an alarm and notify a friend when opioid overdose is indicated.

Fig. 5A is an exemplary screenshot 510 illustrating active monitoring of a physiological parameter 118. The illustrated monitoring screenshot 510 shows the user's oxygen saturation, heart rate as beats per minute, respiration rate as breaths per minute, volume wave variability, and perfusion index. The physiological parameter 118 is represented as a dial. The dial indicates a normal range and an unacceptable range, which may be above, below, or both above and below the normal range. A pointer within the dial points to a current value of the physiological parameter and a numerical indication of the current value is displayed in the center of the dial.

Fig. 5B is an exemplary screenshot 520 illustrating a home screen with a main menu. The illustrated home screen 520 includes a selection LIVE (real-time) that displays the physiological parameter being monitored in real-time or near real-time, such as shown on the monitoring screen shot 510. The home screen 520 also includes selections of HISTORY (History), HEART RATE RECOVERY (Heart Rate RECOVERY), and NOTIFY A FREEND (NOTIFY FRIENDs).

Selecting HISTORY may display past physiological parameters stored in storage device 124 as one or more of a graph, chart, bar graph, or the like. Application 130 may use HISTORY to generate trends for particular opioid users to more accurately determine when an opioid overdose event is imminent.

Heart rate is the heart rate measured by the number of contractions of the heart per minute (bpm). Heart rate can vary according to the physical needs of the body, including the need to absorb oxygen and excrete carbon dioxide. Selection HEART RATE RECOVERY may display the user's recovered heart rate after an opioid overdose or overdose event is approached.

Selecting NOTIFY a FRIEND allows a user or caregiver to select a contact from the mobile computing device 120 to be notified if the user's physiological parameters 118 indicate that the user is experiencing or will soon experience an overdose event.

The home screen 530 also includes setup portions including DEVICE, SOUND, DATA, MEASUREMENT SETTINGS, APP integrity, ABOUT, and SUPPORT. The user may receive information, such as device data, or select settings, such as which measurements to display, alter the volume of the alarm, etc.

FIG. 5C is an exemplary screenshot 530 illustrating a NOTIFY A FREND screen. The illustrated NOTIFY a FRIEND screen 530 allows a user or caregiver to select one from contacts stored on the mobile computing device 120 to contact when an overdose event occurs. In the illustrated NOTIFY a FRIEND screen 530, a second individual on the contact list has been selected.

Fig. 5D is an exemplary screenshot 540 illustrating real-time or active monitoring of a user having an alarm condition. The parameter monitoring screen 540 shown displays a value 73 at which the oxygen saturation level of the user has dropped below the acceptable threshold 88. This indicates that an overdose event may be occurring. The heart rate, respiration rate, volume wave variability and perfusion index of the user are unchanged from the values displayed on the real-time monitoring screen 510.

Fig. 5D also includes a RESPIRATORY EFFORT INDEX (RESPIRATORY EFFORT INDEX) that provides an indication of whether breathing is occurring or being suppressed. .

Fig. 5E is an exemplary screenshot 550 illustrating a notification screen sent to a friend/selected contact to notify the friend of the user's overdose event. Once an alert is triggered on the user's mobile computing device 120, the selected person is notified of the alert status. The notification screen 550 may display the user's name and alarm condition. The notification screen 550 shown notifies friends that Ellie Taylor has a low oxygen saturation of 73. Selecting or touching VIEW selection provides additional information.

FIG. 5F is an exemplary screenshot 560 illustrating a friend alert including additional information provided to the selected person. Friend alert screen 560 can include trend and current values for alert parameters. For example, the illustrated friend alarm screen 560 displays a graphic and a current value of the user's oxygen saturation. Friend alert screen 560 can also display the user's location on a map, display the time of the initial alert event, provide access to the user's directions from the friend's current location in one touch, and provide access to call the user in one touch. Friends know that the user is experiencing overdose and have information to provide help.

Assistance for responders and caregivers

It is crucial to administer opioid receptor antagonists, such as naloxone, to victims of opioid overdose as soon as possible. This can often be a life-to-death issue for victims of drug overdoses. As described herein, a self-administered delivery device may administer an opioid receptor antagonist without action by the user or responder. Opioid overdose victims without self-administered delivery devices rely on responders, friends or caregivers who first administer the opioid receptor antagonist on site. Assistance that may be provided to the first responder may be useful, and may take a variety of forms. Assistance may be visual or audible indicators and/or directions. The user may wear a band, such as a wrist band, that changes color to indicate an opioid overdose event. When an opioid overdose event is detected, a display, such as a display on a mobile device, may change color or flash to draw attention. The mobile device or other device may transmit a notification or transmit a flashing display to other devices within range to notify others of the opioid overdose event. The display may show directions explaining how to administer an opioid receptor antagonist (e.g., naloxone). The display may show directions to wake the drug overdose victim using olfactory salts, shaking, escalation of painful stimuli, loud noise, or any combination of the above. The responder may be instructed to gradually increase aggressive actions to wake up the drug overdose victim. An example of a gradually increasing aggressive action may be a loud sound followed by a small amount of pain stimulation, followed by administration of a small amount of naloxone or other opioid receptor antagonist, followed by an increasing pain stimulation. A first responder may be instructed to induce pain using acupuncture. The mobile device or other device may speak directions to draw the attention of others in the vicinity. The mobile device or other device may say "please inject naloxone" to indicate an emergency. A mobile device or other device may beep to attract attention. The mobile device or other device may buzz and/or provide voice guidance to help direct the finding of the medication overdose victim.

The mobile device or other device may provide a code to nearby emergency personnel. The mobile device or other device may signal emergency personnel or the police that naloxone needs to be delivered as soon as possible.

First responders may also administer medication to cause vomiting once the drug overdose victim is awake and upright. The user may reflux any opioid (e.g., a pill) that remains in the user's stomach.

Network environment

Fig. 7A illustrates an exemplary network environment 700 in which a plurality of opioid user systems 706, shown as opioid user systems 706a … 706N, communicate with cloud environment 702 via network 704. The components of opioid user system 706 are described in more detail with respect to fig. 7C.

The network 704 may be any wired network, wireless network, or combination thereof. Additionally, the network 704 may be a personal area network, a local area network, a wide area network, an over-the-air broadcast network (e.g., for radio or television), a cable network, a satellite network, a cellular telephone network, or a combination thereof. For example, the network 704 may be a publicly accessible network such as the internet that links networks. Protocols and components for communicating via the internet or any other aforementioned type of communication network are well known to those skilled in the art and are therefore not described in detail herein.

For example, opioid user system 706a.. 706N and cloud environment 702 may each be implemented on one or more wired and/or wireless private networks, and network 704 may be a public network (e.g., the internet) via which opioid user system 706a … 706N and cloud environment 702 communicate with each other. Cloud environment 702 may be a cloud-based platform configured to communicate with a plurality of opioid user systems 706a … 706N. Cloud environment 702 may include a collection of services that are delivered as web services via network 704. The components of cloud environment 702 are described in more detail below with reference to FIG. 7B.

Fig. 7B shows an example of an architecture of an illustrative server for opioid user monitoring. The general architecture of the cloud environment 702 depicted in fig. 7B includes an arrangement of computer hardware and software components that can be used to implement examples of the present disclosure. As shown, cloud environment 702 includes one or more hardware processors 708, a remote application manager 710, a registration manager 712, a map server manager 714, a distress notification manager 716, a non-distress manager 718, and an opioid user database 720, all of which may communicate with each other via a communication bus. The components of cloud environment 702 may be physical hardware components or implemented in a virtualized environment. The remote application manager 710, registration manager 712, map server manager 714, distress notification manager 716, and non-distress manager 718 may include computer instructions that are executed by one or more hardware processors to implement one or more exemplary processes. Cloud environment 702 may include more or fewer components than those shown in FIG. 7B.

Remote application manager 710 may oversee monitoring and notifications associated with a plurality of opioid user systems 706a … 706N. The remote application manager 710 is remote in the sense that it is located in a centralized environment as opposed to the local environment of each opioid user. The remote application manager 710 may oversee a registration manager 712, a map server manager 714, a distress notification manager 716, and a non-distress notification manager 718. Remote application manager 710 may perform one or more of the steps of fig. 2B, 4.

Registration manager 712 may manage information associated with each opioid user registrar as well as contact information provided by each opioid user registrar during registration of the opioid overdose monitoring system. Contact information may include the name, telephone number, email address, etc. of the individual and/or organization representing the opioid user contact when an overdose event is predicted or detected or for status checking information, as well as the name, address, telephone number, email address, etc. of the opioid user registrant. Examples of individuals and organizations are shown in FIG. 1B. Opioid user information and contact information associated with each opioid user registrant may be stored in database 720. Fig. 5B, 5C show examples of interface screens that may be used during registration.

The map server manager 714 may locate maps and directions, such as those shown in fig. 3E and 5F, to display on devices associated with the first responder, friends and family, and other individuals of contact information from opioid users, to display maps or directions to opioid users, the location of naloxone or other similar medications closest to opioid users, and the like in the event of an overdose. Fig. 5E, 5F show examples of distress notification. The map server manager 714 may interface with third party map sites via the network 704 to provide maps and directions.

The distress notification manager may receive an alert from the opioid user's mobile device that an overdose event may soon occur or have occurred. For example, the mobile device 120 or the monitoring device 110 may process sensor data from the sensors 102 and determine that an overdose event is occurring. The mobile device 120 may communicate the occurrence of the overdose event with the distress notification manager 716. Distress notification manager 716 may retrieve contact information from database 720 and provide notification of overdose events or soon to occur overdose events to individuals and organizations indicated by opioid users during registration so that assistance may be provided to opioid users. FIG. 5F illustrates an example of a distress notification.

Non-distress notification manager 714 may receive a status of an opioid user monitored by mobile device 120 and/or monitoring device 110. The non-distress notification manager 718 may periodically receive status. Upon determining that the status of the opioid user indicates that the opioid user is not in distress, the non-distress notification manager may access database 720 to retrieve contact information for individuals and organizations that are to be notified of the health of the opioid user. 3B, 3C, 5D illustrate examples of non-distress notifications.

Fig. 7C shows an exemplary opioid user system 706, which includes a monitoring device 740 and a mobile communication device 722. The monitoring device may include a sensor 120 that senses a physiological state of the opioid user and a signal processing device 110 that processes raw sensor data from the sensor 110 to provide the physiological parameter 118 to the mobile communication device 722. The raw sensor data 104 from the sensor 102 may be input into the mobile communication device 722, which processes the raw sensor data 104 to provide the physiological parameters 118 of the opioid user.

The illustrated mobile communication device 722 includes a display 724 similar to the display 122 described herein, a network interface 726 configured to communicate with at least the cloud environment 702 via the network 704, a native application 728, a monitoring application 730, a distress application 732, a non-distress application 734, a query opioid user application 736, and a native alert application 738. Local application 728, monitoring application 730, distress application 732, non-distress application 734, query opioid user application 736, and local alert application 738 may be software instructions stored in a memory within mobile communication device 722 that are executed by a computing device within mobile communication device 722. The application 728, 738 may be downloaded onto the mobile communication device 722 from a third party or from the cloud environment 702. Mobile communication device 722 may include more or fewer components than those shown in fig. 7C.

Local application 728 may oversee communications with a remote monitoring manager of the cloud environment and may oversee monitoring application 730, distress application 732, non-distress application 734, query opioid user application 736, and local alert application 738. The local application 728 and its associated applications 730 and 738 are local in the sense that the local application 728 is local to the mobile communication device 722 associated with the opioid user, devices associated with organizations that assist the opioid user, and devices associated with individuals associated with the opioid user.

The monitoring application 730 may receive the physiological parameter 118 and process the physiological parameter according to one or more of the steps of fig. 2B, 4. The monitoring application 730 may cause the physiological parameter 118 to be displayed on the display 724 of the mobile communication device 722. Fig. 5A, 5D show display examples of physiological parameters.

The distress application 732 may be invoked when the monitoring application 730 determines that an opioid user is experiencing a medication overdose event or is about to experience a medication overdose event. The distress application 732 may perform one or more steps of fig. 2B, 4, such as issuing a distress notification. Further, the distress application 732 may communicate with the distress notification manager 716 in the cloud environment 702 to cause the distress notification manager to provide distress notifications as described above.

The non-distress application 734 may be invoked when the monitoring application 730 determines that the opioid user has not experienced a overdose event or is about to experience a overdose event. The non-distress application 734 may perform one or more steps of fig. 2B, 4, such as sending a status notification. Further, the non-distress application 734 may communicate with the non-distress notification manager 718 in the cloud environment 702 to cause the non-distress notification manager to provide status notifications as described above.

When monitoring application 730 determines that care is indicated, query opioid user application 736 may be invoked. Query opioid user application 736 queries the user to determine whether the user is conscious in order to reduce false alarms. Query opioid user application 736 may perform step 235 of fig. 2B. Figure 3A illustrates a display for a querying user that may be caused by querying opioid user application 736.

When the monitoring application 730 determines that on-site care is required for the opioid user, the local alert application 738 may be invoked. The local alert application 738 may perform step 430 of fig. 4. The local alert application 738 may cause the mobile communication device 722 to display a first responder instruction, a map or directions to the nearest facility with a medication (e.g., naloxone) that reverses or reduces the effects of overdosing, and the like. The local alert application 738 may cause the mobile communication device 722 to audibly alert and/or visually alert anyone in the vicinity of the mobile communication device 722 of the overdose event. Fig. 3D shows an example of a first responder instruction, and fig. 3E shows an example of a display showing the location of naloxone.

Fig. 8 is a flow diagram of an exemplary process 800 for notifying an opioid user's notification network of the status of the opioid user. Process 800 may be performed by cloud environment 702. At block 802, cloud environment 702 receives a user identification and a user status from opioid monitoring system 706. For example, remote application manager 710 retrieves user information from database 720 based on the user identification.

At block 802, the cloud environment 702 may determine whether care is indicated based on the status of the user. The status information may include the physiological parameter 118 from the monitoring application 730. The status may be an indication as to whether care is indicated. The remote application manager 710 may analyze the physiological parameter 118 to determine whether care is indicated.

If care is indicated at block 804, the process 800 moves to block 806. At block 806, the distress notification manager 716 may retrieve contact information stored in a database and associated with the user identification.

At block 808, the distress notification manager 716 may notify individuals and organizations of contact information of the need for care.

If care is not indicated at block 804, the process 800 moves to block 810. At block 810, the non-distress notification manager 718 may retrieve contact information stored in a database and associated with a user identification.

At block 812, non-distress notification manager 718 may notify individuals and organizations of contact information of the status of opioid users. The non-distress notification manager 718 may send an "all normal" message.

Communication between opioid overdose monitoring applications and transport/ride sharing services

When an overdose event is occurring or is about to occur, a mobile device or other computing device executing an opioid monitoring application may communicate with one or more transport services,such as ride sharing services (e.g., ride sharingOr) A taxi service or any commercial transportation service. This is shown in fig. 1B as a "ride share network" which is located within the location representation of the naloxone message. The opioid monitoring application may communicate with a server associated with the ride share service over a network, such as the internet, via the mobile computing device. The communication may be entered into the transportation service system as if a person normally calls a taxi, Lyft or Uber.

The transport service may receive a notification from a mobile device or other computing device that the opioid overdose monitoring application is being deployed. The notification may be an alarm. The alert may be for an ongoing or impending opioid overdose event. The notification may include the address of the opioid user, the address of the nearest facility with medications (e.g., naloxone, buprenorphine, a combination of buprenorphine and naloxone, etc.) that reverse or reduce the effects of overdose, and the address of the nearest caregiver, emergency services, treatment centers, and other organizations or individuals that may provide life saving care to the opioid user.

The transport service may transport opioid users to receive care, transport opioid users to locations with medications, transport medications to opioid users, take medications away and transport medications to opioid users, and so forth.

The transport service or ride share service may bill for the transport generated after receiving the alert or notification generated by the opioid overdose monitoring application as a special bill or a charitable bill. The transport service or ride share service may bill the transport in the same manner as its transport service bills a typical customer.

A transportation service or ride share service may participate in a community abduction project to provide transportation in response to receiving an alert or notification generated by an opioid monitoring application.

Physiological monitoring and drug administration system including activation circuit

Fig. 9A is a block diagram of an exemplary physiological monitoring and drug administration system 900. The illustrated physiological monitoring and drug administration system 900 is similar to the physiological monitoring system 100 of fig. 2A, except that applicator 904 has a drug that reverses or reduces the effects of opioid overdose, such as an opioid receptor antagonist, and at least a signal 902 from the actuating applicator 904 of mobile communication device 120 is included in the physiological monitoring and drug administration system 900.

The user may wear the applicator 904 in a manner that facilitates application of the medicament. For example, applicator 904 may be strapped to the user's wrist, as shown in fig. 13, and the medicament may be applied through the skin, intramuscularly, or intravenously. The applicator may be configured as a wristband, bracelet, vest-style garment against the user's skin, or the like. The applicator may be configured to apply the medicament intranasally, sublingually, or in other methods of application.

Fig. 9B and 9C are schematic illustrations 940, 950 of exemplary self-administered drug applicators. Fig. 9B shows an applicator 944 configured to apply topical medications to reverse or reduce the effects of opioid overdose. The applicator 944 includes an actuator 946 and a medicament 946 in gel form. For example, the gel 946 may be contained in a pouch or container having a frangible seal. The actuator 946 can receive the actuation signal 902 from the mobile device 120 to initiate an actuation process. In the illustrated applicator, the actuation signal 902 is received via an antenna. Actuation signal 902 may be in electrical communication with applicator 944 via one or more electrical wires. Once the applicator 944 receives the actuation signal 902, the actuator can actuate to dispense the gel 948 onto the skin or tissue of the user. For example, the actuator can include a gas detonator that, when activated, generates a pressurized gas or fluid in fluid contact with the gel 948, e.g., via one or more conduits. The pressurized fluid forces the gel 948 to break a frangible seal near the tissue, causing the gel 948 to be applied to the surface of the tissue.

Fig. 9C shows an applicator 954 configured to inject a drug that reverses or reduces the effects of opioid overdose into the tissue of a user. The applicator 954 includes a vial or container of injectable drug, an actuator, and a needle 960. The needle 960 may be a microneedle. The actuator may receive an actuation signal from the mobile communication device 120 to initiate an actuation process. In the illustrated applicator, the actuation signal 902 is received via an antenna. Actuation signal 902 may be in electrical communication with applicator 944 via one or more electrical wires. Once the applicator 944 receives the actuation signal 902, the actuator 958 may be actuated by using pressure as described above to force, for example, the injectable drug 956 through the needle 960. The needle 960 may be configured to inject the drug 956 into tissue under pressure generated by the actuator 958.

Fig. 10 is a flow chart of an exemplary process 1000 for monitoring opioid overdose and administering medication to reverse the effects of the overdose. Process 1000 is similar to process 400 of fig. 4, except that process 1000 includes the step of activating an applicator worn on the body of the user (such as applicators 904, 944, 954, etc.) to apply medication that reverses or reduces the effects of opioid overdose. Once the need for point of care is determined at block 425, the process 1000 moves to block 430 to trigger an alarm and also moves to block 1002. At block 1002, applicators 904, 944, 954 receive actuation signal 902, which actuation signal 902 actuates applicators 904, 944, 954. At block 1004, the medication is dispensed from applicators 904, 944, 954 and applied to the user. The drug may be administered topically to the user by intramuscular injection, by intravenous injection, or the like, to reverse or reduce the effects of opioid overdose.

Fig. 11A-11C are schematic views of an exemplary needle-free injection, multi-dose, self-administering drug applicator 1100. Applicator 1100 may be configured to inject one or more doses of a drug that reverses or reduces the effects of opioid overdose into the tissue of a user without the use of a hypodermic needle. Fig. 11A shows a side view of a needleless injection, multi-dose, self-administration drug applicator 1100, the applicator 1100 including an adhesive layer 1102 configured to adhere the applicator 1100 to the skin and a protective or safety layer 1104 configured to prevent accidental dispensing of the drug. Other safety mechanisms, such as latches or safety hooks, may be used to prevent accidental dispensing of the medicament. To prepare applicator 1100 for use, the user or caregiver removes safety layer 1104 and adheres applicator 1100 to the skin of the opioid user.

Fig. 11B shows a cross-sectional side view of the applicator 1100, the applicator 1100 further comprising one or more activation circuits 1106, an antenna 1114, a plunger or other dispensing mechanism 1108, a reservoir 1110 and a drug delivery channel 1112. The activation circuit 1106 is configured to receive an activation signal via the antenna 1114 and activate the delivery mechanism 1108 to dispense the medicament in the reservoir 1110 through the skin, muscle or vein via the medicament delivery channel 1112. The drug may be naloxone, which is an opioid receptor antagonist, or the like, to reduce the effects of opioid overdose events. The delivery mechanism 1108 may be a plunger, pump motor, spring, etc. that is advanced by a pusher such as a CO2 cartridge, gas detonator, compressed air, and N2 gas cylinder. The drug delivery channel 1112 can be a small diameter tube that forces the drug through the adhesive 1102 and the skin as a high pressure spray (e.g., a jet spray). Applicator 1100 deposits the drug in the tissue below the site of administration.

Fig. 11C shows a top cross-sectional view of an example of a needleless injection multi-dose self-administration drug applicator 1100. Applicator 1100 also includes multiple doses of a drug. In the example shown, the applicator includes 1 to N applications, with each application being performed by an activation circuit that activates a plunger or other dispensing mechanism to dispense the medicament in the reservoir through the medicament delivery channel, as described above in fig. 9B. Each activation circuit 1106 may receive an activation signal via antenna 1114, where each antenna 1114(1) through 1114(N) may be tuned to receive a unique activation signal such that only one activation circuit is activated. More than one of antennas 1114(1) through 1114(N) may be tuned to be activated with the same signal to dispense medication from more than one reservoir upon receipt of the activation signal.

Fig. 12A-12B are schematic views of an exemplary injectable, multi-dose, self-administering drug applicator 1200. Applicator 1200 is configured to inject one or more doses of a drug that reverses or reduces the effects of opioid overdose into the tissue of a user using a hypodermic needle. Fig. 12A shows a cross-sectional side view of an injectable multi-dose self-administration drug applicator 1200, the applicator 1200 including an adhesive layer 1202 configured to adhere the applicator 1200 to the skin, one or more activation circuits 1206, an antenna 1214, a plunger or other dispensing mechanism 1208, a reservoir 1210, and a needle 1212 (shown in a retracted state). In the example shown, the safety layer configured to prevent accidental dispensing of the medicament has been peeled off, and the applicator 1200 is adhered to the user's skin at the dispensing site. Other safety mechanisms may be used, such as a latch, safety hook, or cap over the needle 1212 to prevent accidental dispensing of the medicament. To prepare applicator 1200 for use, the user or caregiver removes the safety layer and adheres applicator 1200 to the skin of the opioid user. The needle 1212 may be a microneedle.

The activation circuit 1206 is configured to receive an activation signal via the antenna 1214 and activate the delivery mechanism 1208 to dispense the medicament in the reservoir 1210 through the skin, intramuscularly, or intravenously through the needle 1212. The drug may be naloxone, which is an opioid receptor antagonist, or the like, to reduce the effects of opioid overdose events. The delivery mechanism 1208 may be a plunger, pump motor, spring, etc. that is advanced by a pusher such as a CO2 cartridge, gas detonator, compressed air, and N2 gas cylinder. Pressure from the delivery mechanism 1208 pushes the drug through the needle and causes the needle 1212 to move forward through the adhesive layer 1202 and into the skin, muscle, vein, etc. at the delivery site. The needle 1212 may be a hypodermic needle or any sharp object configured to inject a drug into the body. Applicator 1200 deposits the drug in the tissue below the application site.

Fig. 12B shows a top cross-sectional view of an example of an injectable multi-dose self-administering drug applicator 1200. Applicator 1200 also includes multiple doses of a drug. In the example shown, the applicator 1200 includes 1 to N applications, with each application being performed by an activation circuit that activates a plunger or other dispensing mechanism to dispense the medicament in the reservoir through the needle, as described above in fig. 9B. Each activation circuit 1206 may receive an activation signal via antenna 1214, where each antenna 1214(1) through 1214(N) may be tuned to receive a unique activation signal such that only one activation circuit is activated. More than one of the antennas 1214(1) through 1214(N) may be tuned to be activated with the same signal to dispense medication from more than one reservoir upon receipt of the activation signal.

Fig. 14 is a block diagram of an exemplary activation circuit 1400 for a multi-dose, self-administering drug applicator (e.g., applicators 1100 and 1200). The illustrated activation circuit 1400 includes one or more antennas 1414, a processing circuit 1402, and a plurality of delivery circuits and mechanisms 1410. A battery 1412 may be used to power the activation circuit 1400.

Applicator 1100 may also include opioid overdose detection sensor 1406, which may be considered a local opioid overdose detection sensor because it is local to the user. Local opioid overdose detection sensor 1406 may receive sensor data from opioid users. Local opioid overdose detection sensor 1406 sends sensor data to processing circuit 1402. Processing circuitry 1402 receives sensor data from local opioid overdose detection sensor 1406, processes the sensor data, and determines whether an opioid overdose event is occurring or will soon occur. Local opioid overdose detection sensor 1406 may send sensor data to transceiver 1404. The transceiver 1404 transmits the sensor data to at least one of the mobile device 120, the server, and the hub via one or more antennas 1414 for processing. Once the data is processed, transceiver 1404 may receive a signal via one or more antennas 1414 indicating that an opioid overdose event is occurring or is about to occur soon. The transceiver 1404 sends an indication to the processing circuit 1402 that an opioid overdose event is occurring or is about to occur soon.

Applicators 1100, 1200 may not include opioid overdose detection sensor 1408, such that opioid overdose detection sensor 1408 may be considered remote from applicators 1100, 1200. Remote opioid detection sensor 1408 may transmit sensor data to at least one of mobile device 120, a server, and a hub, and when the processed sensor data indicates that an opioid overdose event is occurring, transceiver 1404 receives a signal via one or more antennas 1414 indicating that an opioid overdose event is occurring or is about to occur. The transceiver 1404 sends an indication to the processing circuit 1402 that an opioid overdose event is occurring or is about to occur soon. Remote opioid detection sensor 1408 may send sensor data to processing circuitry 1402 wirelessly or through a wired connection.

Processing circuit 1402 may determine that an opioid overdose event is occurring or will occur soon by processing sensor data from local opioid overdose detection sensor 1406, or may receive an indication from transceiver 1404 that an opioid overdose event is occurring or will occur soon. Processor 1402 may generate one or more activation signals ACTIVATE (1) through ACTIVATE (N) to DELIVERY systems deliver (1) through deliver (N), respectively, to dispense one or more up to N doses of the drug. For example, if the physiological condition of the user is such that a single dose of medication is insufficient, the processing circuit 1402 may be programmed to deliver multiple doses at about the same time.

The processing circuit 1402 may generate more than one activation signal at about the same time to deliver more than one dose of medication to the user at about the same time. The processing circuit 1402 may generate a continuous activation signal in response to a continuous indication of a drug overdose event. For example, if the application of the first dose of medication does not reverse the effects of opioid overdose, the processing circuit 1402 may generate a second activation signal to provide the user with a second dose of medication. When the applicators 1100, 1200 are empty, the activation circuit 1400 may count the number of doses dispensed and provide an alert.

Fig. 15 is a flow chart of an exemplary process 1500 of administering a drug from a self-administering drug applicator 1100, 1200. In step 1415, the activation circuit 1400 receives an indication that an opioid overdose event is occurring or is soon to occur. At step 1420, processing circuit 1402 transmits at least one activation signal to at least one DELIVERY circuit DELIVERY (1) through DELIVERY (N) to dispense at least one dose of the drug.

Fig. 16A and 16B are flow diagrams of exemplary processes 1500, 1550 for administering multiple doses of a drug from a self-administering drug applicator. The processes 1500, 1550 utilize a bi-directional communication link between the activation circuit 1400 and at least one of the mobile device 120, a server, and a medical monitoring hub.

Referring to fig. 16A, at the beginning of process 1500, a counter m may be initialized to zero. At step 1505, the activation circuit 1400 receives an alarm signal indicative of a drug overdose event. At step 1505, a counter is incremented. At step 1515, the processing circuit 1402 transmits an activation signal to the delivery circuit to deliver the medication to the user. At step 1520, the processing circuit 1402 determines whether all of the doses in the multi-dose self-administration drug applicator 1100, 1200 have been activated. The count m may be compared to the number N of doses in the applicators 1100, 1200. When there is a remaining dose in the applicators 1100, 1200 (m < N), the process 1500 returns to step 1505. When there are no more doses of drug (m ═ N) in the applicators 1100, 1200, the process 1500 moves to step 1525. At step 1525, the processing circuit 1402 transmits via the transceiver 1404 and the one or more antennas 1414 a notification of: the applicators 1100, 1200 are empty.

Referring to fig. 16B, in process 1550, the activation circuit 1400 receives an alert signal that an opioid event is occurring or will soon occur. At step 1560, the processing circuit 1402 transmits an activation signal to one or more of the delivery circuits 1410 to deliver the medication to the user. At step 1465, the activation circuit 1400 transmits an indication of the number of doses remaining in the applicators 1100, 1200 via the transceiver 1404 and the one or more antennas 1414.

Patch with pressurized reservoir

Fig. 17 is a schematic diagram of an exemplary wearable self-administering drug applicator 1700 comprising an antenna, a reservoir 1710, a needle 1712, a processor 1714, a sensor 1716, a battery 1718, a fabric layer 1720, and an adhesive layer 1722. Self-administered drug application may be configured as patch 1700 adhered to the skin of the user by adhesive layer 1722. Patch 1700 may provide opioid overdose monitoring and administration of opioid receptor antagonists. The patch 1700 may be a single use, pre-loaded disposable device.

Reservoir 1710 may include an opioid receptor antagonist, such as naloxone, which is dispensed into the user via needle 1712. The needle 1712 may be a microneedle. The sensors 1716 may be internal to the patch 1700 and monitor physiological parameters of the user. Instead of the patch 1700 including the internal sensor 1716, the external sensor 1717 may monitor a physiological parameter of the user and may wirelessly communicate with the patch 1700 via an antenna. External sensors 1717 may be wired to the patch 1700 and provide sensor data via wires. The external sensor 1717 may be a finger sensor wrapped around or over a finger or toe. The sensor 1716 or the sensor 1718 may include a pulse oximeter, a respiration monitor, and other sensor devices disclosed herein that monitor physiological parameters of a user. The processor 1714 may process the sensor data to detect a drug overdose event. Patch 1700 may transmit sensor data to an external processing device, such as a mobile device or hub device, to detect opioid overdose events.

The needle 1712 may be spring-loaded (e.g., in a manner similar to a switch blade). Fabric layer 1720 may hold spring-loaded needles 1712 in a compressed state without the spring-loaded needles piercing fabric layer 1720. When an opioid overdose event is detected, the battery 1718 may release a charge that passes through at least a portion of the fabric layer 1720. The fabric layer 1720 receives an electrical charge from the battery 1718, which can cause the fabric layer 1720 to burn or shrink and the spring-loaded needles are no longer restrained. The needle 1712 releases and may inject an opioid receptor antagonist, such as naloxone, stored in a reservoir to the user. When the needle is released, the reservoir 1710 may be pressurized to assist in the injection of the opioid receptor antagonist. An external pump may pressurize the reservoir 1710. Patch 1700 may not have a mechanical trigger. Battery 1718 may be sized to provide approximately one week of operating power. Battery 1718 can be sized to provide operating power for more than one week, more than two weeks, more than one month, or longer.

Opioid monitoring system based on concentrator

Fig. 18A is a block diagram of an exemplary opioid usage monitoring system 1800 that includes sensors 1802, delivery devices 1804, a medical monitoring hub device 1806, and a network 1812 (e.g., the internet hosting a cloud server, which may be considered a remote server because it is remote from the user). The sensor 1802 is configured to monitor a physiological parameter of a user, and the delivery device 1804 is configured to deliver a dose of an opioid receptor antagonist, such as naloxone or the like, when an opioid overdose event is detected. The sensor 1802 may be an oximetry device, a respiratory monitor, a device for obtaining physiological parameters of a user as described herein, or the like. The sensor 1802 may be an acoustic sensor, a capnography sensor, or an impedance sensor to monitor the user's breathing rate. The sensor 1802 may include a signal processing device 110 to process raw sensor data.

The delivery device 1804 may be a self-administering device, such as devices 940, 950, 1100, 1200, 1700. The delivery device may be a user or responder activated device. The sensor 1802 can be internal to the delivery device 1804. The sensor 1802 can be external to the delivery device 1804.

The hub device 1806 may be configured to collect data and transmit the data to a cloud server for evaluation. The hub device 1806 may include communication circuitry and protocols 1810 to communicate with one or more of the delivery device 1804, the sensors 1802, the network 1812, the mobile communication device 1818 (e.g., a smartphone, etc.), and other devices 1816 having monitoring capabilities. For example, the communication may be Bluetooth or Wi-Fi. The hub device 1806 may also include a memory 1807 for data storage, a memory 1808 for application software, and a processor 1809. The application software may include a reminder to wear the patch before sleeping. The hub device 1806 is powered by AC (alternating current) household current and includes a battery backup circuit 1818 for operation when power is off. The hub device 1806 may be powered through a USB port using a charger connected to an AC outlet or to a USB charging port of the automobile. The hub device 1806 may notify that the battery is low.

Hub device 1806 may be of Masimo, Lkay, CalifThe hub 1806 may include at least a memory 1807 for data storage, and a battery backup circuit 1818 may be associated with the memoryPhysically interface and communicate. The hub device 1806 may be in communication withTo a telephone cradle interface.

The sensors 1802 can monitor physiological parameters of the user and transmit raw sensor data to the delivery device 1804 via wired or wireless communication. Alternatively, the sensors 1802 may transmit raw sensor data to the hub device 1806 via wired or wireless communication. The delivery device 1804 may process the raw sensor data to determine when an opioid overdose event has occurred. The hub device 1806 may process the raw sensor data to determine when an opioid overdose event has occurred. The hub device 1806 may transmit the raw sensor data to a cloud server for processing to determine when an opioid overdose event has occurred. When an opioid overdose event is about to occur or is occurring, the cloud server may transmit instructions to the delivery device 1804 via the hub device 1806 to activate and deliver an opioid receptor antagonist (such as naloxone). The cloud server may also transmit messages to contacts 1814, such as friends, family emergency personnel, paramedics, police, ambulance services, other addicts, hospitals, and so forth. The hub device 1806 may send an activation instruction to the delivery device 1804.

It is important to avoid false positive indications of drug overdose events. The user may not wear the self-administration delivery device 1804 if the user experiences delivery of the opioid receptor antagonist when an overdose event is not occurring or not imminent. To avoid false alarm indications, when an overdose event is detected, the wearable delivery device 1804 may induce pain prior to administration of the opioid receptor antagonist to notify the user that the antagonist is about to be administered. The wearable delivery device 1804 may provide an electric shock to a user to induce pain. The induced pain may escalate until a threshold is reached. The user may employ a manual override to indicate that the user is conscious and does not require an opioid receptor antagonist. The override may be a button, switch, or other user input on the transport device 1804, the mobile communication device 722, and/or the hub device 1806. The delivery device 1804, mobile communication device 722, and/or hub device 1806 may wait for a user input for a period of time before triggering release of the opioid receptor antagonist to avoid false positive indications. The time period may be less than 1 minute, less than 5 minutes, less than 10 minutes, between 1 minute and 5 minutes, between 1 minute and 10 minutes, and the like.

The memory 1807 for data storage may store raw sensor data. The memory for data storage may act as a "black box" to record data from multiple sources. It is crucial that the opioid receptor antagonist is administered to the user immediately upon detection of an opioid overdose event. Opioid overdose events may be an indication of respiratory arrest or that breathing will soon cease. The administration may be by a responder such as a friend or emergency personnel, by a self-administration device worn by the user, or by the user. To avoid missing any symptoms that result in opioid overdose events, the hub device 1806 may receive data from any device with monitoring capabilities. For example, many homes have home cameras to provide video feeds. The handset may provide text messages and may also include a microphone to record voice. The handset or smartphone may be configured to listen for breath and transmit breath data. E.g. such as AmazonControlled Echo speaker, Google of GoogleOf applesSuch intelligent personal assistants also include a microphone and have the capability to interface with the internet. Many household appliances, such as refrigerators, washing machines, coffee makers, etc., incorporate internet of things technology and are also capable of interfacing with the internet. The medical monitoring device used by the opioid user for the medical condition (e.g., ECG) may also provide additional data. Data from one or more of these devices may be stored in memory 1807 and used by hub device 1806 or sent to a cloud server and used by the cloud server to detect opioid overdose events. The hub device 1806 may determine which monitoring and internet connected devices are available and wirelessly connect to the available monitoring and internet connected devices to receive data.

The hub device 1806 may be connected to a home network to monitor content, for exampleAn internet filter interface such as an internet filter. The hub device 1806 may determine which network data is directed to the user's health and store the health data.

The data may include text messages, voice recordings, video, and the like. Because of privacy concerns, the hub device 1806 may determine which small portions of data are helpful in determining the user's physical condition and store only those data portions.

Because the device may not be able to connect to the internet, it is important to have a redundant system to report sensor data for drug overdose detection. In the event that the hub device 1806 fails to connect to the internet 1812, a mobile device or other internet connected device found in the home may provide internet connectivity. For example, the hub device 1806 may transmit the sensor data to the mobile device 1818, and the mobile device 1818 may transmit the sensor data to a cloud server for processing. The sensor 1802 or delivery device 1804 may communicate with the mobile device 1818 when the hub device fails to connect to the internet. The intelligent personal assistant and IoT devices may also provide redundant (backup) internet communications. The hub device 1806 may notify when its internet connection fails.

The mobile device 1818 may monitor the respiration rate, SPO2, or ECG in parallel with the sensors 1802 and hub device 1806 monitoring the physiological parameters of the user to increase the likelihood that an impending drug overdose will be detected. The sensor 1802 may monitor the concentration of opioids in the blood of the user. The measured concentration may be a factor in determining opioid overdose events to reduce false positives.

The home security monitoring system may include a hub device 1806, and the home security company may monitor the health of the user via the hub device 1806 and sensors 1802.

Opioid overdose monitoring applications may be integrated into intelligent personal assistants, such as amazon

The delivery device 1804 may include a drug to cause emesis. If desired, the opioid user may ingest a medication that causes emesis to reflux any opioid remaining in the user's stomach. The delivery device 1804 may include a reservoir containing the emesis-inducing drug and a position sensing sensor. The emesis-inducing medication may be automatically dispensed upon receiving a sensor input indicating that the user is in an upright position.

The position sensing sensor may monitor the movement of the user to determine that the user is upright. The delivery device 1804 may include one or more sensors configured to obtain position, orientation, and motion information from a user. The one or more sensors may include an accelerometer, a gyroscope, and a magnetometer configured to determine a position and orientation of a user in three-dimensional space. The delivery device 1804 or the hub device 1806 may be configured to process the received information to determine the location of the user.

Fig. 19 shows an exemplary hub device 1900 of the opioid overdose monitoring system of fig. 18A. Fig. 18B is a flow chart of a process 1850 for administering an opioid receptor antagonist using the system of fig. 18A. At block 1852, the sensor 1802 may collect raw sensor data including physiological data. The sensors 1802 may transmit raw sensor data to the delivery device 1804, and the delivery device 1804 may transmit raw sensor data to the hub device 1806. Alternatively, the sensors 1802 may transmit raw sensor data to the hub device 1806.

At block 1854, the hub device 1806 may store the raw sensor data. At block 1856, the hub device 1806 may collect and store data associated with the user's health from other devices local to the user. For example, the hub device may receive data from one or more home cameras, from a smart home assistant (e.g., a home camera, a home phone, etc.)) E.g. internet data from a home internet filter, etc.

At block 1858, the hub device 1806 may transmit the stored data to a cloud server via the network 1812 for processing. The cloud server may process the data to determine whether an opioid overdose event is occurring or about to occur. At block 1860, hub device 1806 may receive an indication from the cloud server that an opioid overdose event is occurring or is about to occur. The hub device 1806 may transmit an indication to the delivery device 1804.

At block 1862, delivery device 1804 may provide escalated action to the user to prompt the user to activate a manual override to indicate that an opioid overdose event has not occurred. For example, the delivery device may provide an increasing shock to the user up to a threshold.

At block 1864, the transport 1804 may determine whether an override has been received from the user. When an override is indicated, for example, from a user-activated button or switch on the delivery device 1804, the process 1850 returns to block 1852 to continue collecting physiological parameters. When an override is not indicated, the process 1850 moves to block 1866. At block 1866, the delivery device 1804 administers a drug, such as naloxone or other opioid receptor antagonist, and returns to block 1852 to continue monitoring the physiological parameter.

Fig. 18a1-18a25 illustrate various exemplary software applications for triggering an alarm and notifying friends when opioid overdose is indicated. The software application may be downloaded onto the user's smart mobile device 1818.

Fig. 18a1 is an exemplary screen shot showing a welcome message to a new user of an opioid overdose monitoring application. The illustrated screenshot of fig. 18a1 shows an illustration of a hand wearing an exemplary sensor and signal processing device 1802. The user may create an account for the medication overdose monitoring application. Once the account registration is successful, the example application 1808 may instruct the user to establish communication between the mobile device 1818, the sensor and signal processing device 1802, the medical monitoring hub device 1806, and the home Wi-Fi network.

Fig. 18a2 is an exemplary screen shot illustrating instructions for a user to power the medical monitoring hub device 1806 to wirelessly connect to the mobile device 1818. For example, the medical monitoring hub device 1806 may be bluetooth-supported. Fig. 18a3 is an exemplary screen shot illustrating a successful connection of the medical monitoring hub device 1806.

18A4-18A6 are exemplary screen shots illustrating instructions for powering the sensor and signal processing device 1802 to wirelessly connect to the medical monitoring hub device 1806. The illustrated screen shot of fig. 18a4 shows an illustration of the signal processing portion of the sensor and signal processing device 1802, with the sensor and signal processing device 1802 in an open state to receive an integrated circuit ("chip"). The illustrated screenshot of FIG. 18A5 shows an illustration of the sensor and signal processing portion of the signal processing device 1802 in an off state. The illustrated screenshot of FIG. 18A6 shows a sensor in a powered state and an illustration of a sensor portion of a signal processing device 1802.

18A7-18A8 are exemplary screen shots illustrating instructions for pairing the power supply sensor and signal processing device 1802 with the medical monitoring hub device 1806. For example, the sensor and signal processing device 1802 may be bluetooth enabled.

The user may allow the software application to access Wi-Fi settings of a router on a local area network (e.g., a home network). The user may access the Wi-Fi hub settings and select a network from a list of available networks local to the user. The illustrated screen shot of fig. 18a9 is an exemplary screen shot showing an indication that the medical monitoring hub device 1806 is being connected to a local network.

FIG. 18A10 is an exemplary screen shot requiring a user to allow a software application to access location information. When the software application may access the user's location information (e.g., location information found on the user's mobile device 1818), the software application may provide the user's location to emergency personnel, caregivers, friends, and family, etc. when they are notified of the overdose event.

Fig. 18a11 is an exemplary screen shot showing an indication that the medical monitoring hub device 1806 is connecting to the cloud server 1812 via a local area network. After setup is complete, the medical monitoring hub device 1806 may communicate with the sensor and signal processing device 1802, the mobile device 1818 running the software application, and the cloud server 1812.

Fig. 18a12 is an exemplary screen shot showing a prompt to the user to add contact information for the responder to notify the responder that an opioid overdose event is occurring or will soon occur. The user may select from a list of contacts found, for example, in mobile device 1818.

Fig. 18a13 is an exemplary screen shot showing a selected responder to be notified in the event of an opioid overdose event, which may be an overdose that is currently occurring or that will occur very quickly based on the user's physiological parameters sensed by the sensors and signal processing device 1802. The selected responders may also be notified of a situation that may cause the opioid monitoring system to fail uncorrected (e.g., when the user is not wearing a sensor or the sensor battery is low). The illustrated screenshot of FIG. 18A13 shows the name and phone number of the selected responder and provides a selection that the user can select the alert that the responder received. Exemplary options include parameter alerts, sensor off alerts, and low battery alerts. A parameter alert may be sent when the monitored physiological parameter falls outside of an acceptable range of values. When the user is not wearing the sensor and signal processing device 1802, a sensor off alert may be sent. When the battery voltage in the sensor and signal processing device 1802 drops below a threshold, a low battery alarm may be sent.

FIG. 18A19 is an exemplary screen shot illustrating the selection of a parameter notification to be sent to a selected responder. In the illustrated screenshot of fig. a19, the user may choose to send any combination of red, orange and yellow alerts to the responder. For example, for an oxygen saturation parameter, a red alarm may be sent when the oxygen saturation of the user falls within a range of 0-88; an orange alarm may be sent when the oxygen saturation of the user falls within the range of 89-90; and when the oxygen saturation level of the user falls within the range of 91-95, a yellow alert may be sent to provide an indication to the responder of the severity of the overdose event.

18A14-18A15 are exemplary screen shots illustrating real-time monitoring of a physiological parameter of a user. The illustrated screen shots of fig. 18a14-18a15 display a representation of a dial indicating monitored oxygen saturation, heart rate per minute heart beat, and perfusion index. The illustrated screenshot of fig. 18a14 indicates that the monitored oxygen saturation (96), heart rate 102), and perfusion index (8.5) are acceptable values. The illustrated screenshot of fig. 18a15 indicates that the monitored oxygen saturation (86) is no longer within an acceptable range.

Fig. 18a16 is an exemplary screen shot showing a warning message to the user that the sensor has been disconnected.

Fig. 18a17 is an exemplary screen shot illustrating historical averages of monitored physiological parameters of a user. The illustrated screenshot of fig. 18a17 shows the average oxygen saturation, heart rate and perfusion index for the sensor and signal processing device 1802 over a period of time when data was collected on both days 3 month 11 and 3 month 12.

Fig. 18a18 is an exemplary screenshot of session data showing oxygen saturation, heart rate, and perfusion index for 3 months and 7 days. The displayed information in the illustrated example includes a minimum value, a maximum value, and an average value of the monitored physiological parameter.

FIG. 18A20 is an exemplary screen shot illustrating sound options available for a software application. In the illustrated screenshot of fig. 18a20, when the measurement exceeds its threshold range, the software application may cause the mobile device 1818 to play a sound (e.g., beep) consistent with the user's pulse, play a sound (e.g., beep), and play a beep even when the software application is running in the background.

FIG. 18A21 is an exemplary screen shot illustrating customizable alarm values. Some users may have a high tolerance to opioids and opioid events may not occur when the user's physiological parameters fall within a range that generally indicates opioid overdose events. It is desirable to avoid false alarms that may desensitize the responder to notifications. In the illustrated screenshot of fig. 18a21, the range of red, orange, and yellow alarms for oxygen saturation may be customized for the user by, for example, sliding the indicator along a green-yellow-orange-red bar until the desired value is displayed. Selecting the heart beat/minute and the volume wave variability allows the user to customize the alarm ranges for heart rate and perfusion index, respectively.

Fig. 18a22 is an exemplary screenshot illustrating that a user's physiological parameter data may be shared with other Health monitoring applications (e.g., Apple Health).

Fig. 18a23 is an exemplary screenshot showing a reminder to wear the sensors and signal processing device 1802 before going to bed. The software application may provide other reminders such as the time to replace the sensor battery, a notification to turn on, etc.

18A24-18A25 are exemplary screen shots illustrating a request for user input when a physiological parameter of the user indicates that an opioid overdose event is occurring or will soon occur. To avoid sending false alarms, the software application requests user input to confirm that the user is not unconscious or does not wish to send an alarm notification to a responder. In the illustrated screenshot of FIG. 18A24, the user is asked to slide the screen to confirm security. In the illustrated screenshot of FIG. 18A25, the user is asked to enter the illustrated pattern on the screen to confirm security. Different user inputs may be used to confirm different cognitive abilities of the user. For example, entering the pattern shown in FIG. 18A25 is more difficult than sliding the bottom of the screen of FIG. 18A 24.

Opioid monitoring kit

Fig. 20A and 20B are schematic diagrams of exemplary prescription and over-the-counter opioid overdose monitoring kits 2000 and 2050. Fig. 20A is an example of an opioid overdose monitoring kit 2000, which is available only by prescription, according to applicable state or national laws. The kit 2000 may include a hub device 1806, sensors 102, 610, 640, 1802, and delivery devices 940, 950, 1100, 1200, 1702 that include one or more doses of an opioid receptor antagonist receptor, such as naloxone. Figure 20B is an example of an opioid overdose monitoring kit 2050 that may be obtained without a prescription. The kit 2050 may include a hub device 1806 and sensors 102, 610, 640, 1802. Kits 2000, 2050 may include additional components to assist in opioid overdose monitoring.

Other delivery methods/mechanisms

As discussed herein, opioid receptor antagonists may be delivered by intravenous injection, intramuscular injection, and intranasal application (where the drug is sprayed in liquid form into the nostrils of the user). Administration of the drug may also be via endotracheal intubation, sublingually (where a gel or tablet of the drug is applied sublingually) and transdermally (where the drug may be a gel applied directly to the skin or in a transdermal patch applied to the skin).

Other methods of administering opioid receptor antagonists may be via rectal capsules or suppositories. The capsule may also monitor the respiration rate and/or pulse rate and rupture the capsule when an opioid overdose event is about to occur or is occurring.The signal may activate the capsule.

The opioid receptor antagonist may be included in an inhaler by first injecting the user with a preservative and then injecting the opioid receptor antagonist, or administering in the ear or other body orifice. The opioid receptor antagonist may be delivered, for example, through a cannula for a ventilator or respiratory machine.

The opioid receptor antagonist may be stored in a dental fixture, which is crushed to release the stored drug.

Implantable delivery devices can deliver opioid receptor antagonists to chronic opioid users. The device may be implanted in a position similar to a pacemaker. The device may monitor one or more of respiratory rate, pulse rate, ECG, and SPO2, and release a dose of opioid receptor antagonist upon detection of an opioid overdose event. The implantable device may include multiple doses and/or may be refilled by injecting the opioid receptor antagonist into the implantable delivery device. Such delivery devices may be implanted for one or more months. Another example of an implantable delivery device includes a capsule containing an opioid receptor antagonist and an external device, such as a band of transmission resonance frequencies on the capsule. The resonant frequency causes the capsule to rupture and the released opioid receptor antagonist is absorbed by the human body.

The opioid receptor antagonist is contained in a pill, which is activated when needed. The opioid receptor antagonist may be packaged in a gel pouch, ingested or worn on the skin. For example, an ultrasound device worn as a wristband may rupture a gel pack adhered to the skin when an opioid overdose event is detected. The body can absorb the opioid receptor antagonist from the ruptured gel pouch.

Term(s) for

The embodiments disclosed herein are presented by way of example only and do not limit the scope of the appended claims. One of ordinary skill in the art will recognize from the disclosure herein that many variations and modifications can be made without departing from the scope of the present disclosure.

The term "and/or" herein has its broadest, minimally-limiting meaning, i.e., the disclosure includes a alone, B, A and B alone, or a or B alternatively, but neither a nor B nor one of a or B is required. As used herein, the phrase "A, B, and at least one of C" should be understood to mean logic a or B or C (using a non-exclusive logical or).

The description herein is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. For purposes of clarity, the same reference numbers will be used in the drawings to identify similar elements. It should be understood that the steps within a method may be performed in a different order without altering the principles of the present disclosure.

As used herein, the term module may refer to, be part of, or include the following: an Application Specific Integrated Circuit (ASIC); an electronic circuit; a combinational logic circuit; a Field Programmable Gate Array (FPGA); a processor (shared, dedicated, or group) that executes code; other suitable components that provide the described functionality; or a combination of some or all of the above, for example in a system on a chip. The term module may include memory (shared, dedicated, or group) that stores code executed by the processor.

As used above, the term code may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, and/or objects. As used above, shared terminology refers to the fact that some or all code from multiple modules may be executed using a single (shared) processor. Additionally, some or all code from multiple modules may be stored by a single (shared) memory. As used above, the term "group" means that some or all code from a single module may be executed using a group of processors. In addition, a set of memories may be used to store some or all of the code from a single module.

The apparatus and methods described herein may be implemented by one or more computer programs executed by one or more processors. The computer program includes processor-executable instructions stored on a non-transitory tangible computer-readable medium. The computer program may also include stored data. Non-limiting examples of the non-transitory tangible computer readable medium are nonvolatile memory, magnetic storage, and optical storage. While the foregoing invention has been described in terms of certain preferred embodiments, other embodiments will be apparent to those of ordinary skill in the art in view of the disclosure herein. In addition, other combinations, omissions, substitutions and modifications will be apparent to those skilled in the art in view of the disclosure herein. Accordingly, the invention is not intended to be limited by the reaction of the preferred embodiments, but is defined by reference to the claims.

Conditional language, e.g., "may," "e.g.," as used herein, is generally intended to convey that certain embodiments include but other embodiments do not include particular features, elements, and/or states unless specifically stated otherwise or understood otherwise in the context of usage. Thus, such conditional language is not generally intended to imply that features, elements, and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for determining, with or without author input or prompting, whether such features, elements, and/or states are included or are to be performed in any particular embodiment. The terms "comprising," "including," "having," and the like, are synonymous and are used inclusively, in an open-ended fashion, and do not exclude other elements, features, acts, operations, and the like. Also, the term "or" is used in its inclusive sense (and not in its exclusive sense), so that, for example, when used in conjunction with a list of elements, the term "or" refers to one, some, or all of the elements in the list. Further, the term "each," as used herein, in addition to having its ordinary meaning, can also refer to any subset of a set of elements to which the term "each" is applied.

While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the device or algorithm illustrated may be made without departing from the spirit of the disclosure. As will be recognized, certain embodiments of the invention described herein may be embodied within a form that does not provide all of the features and advantages set forth herein, as some features may be used or practiced separately from others.

In addition, all publications, patents and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference.