US2018361062A1PendingUtilityA1
Systems And Methods For Monitoring, Managing, And Treating Asthma And Anaphylaxis
Est. expiryNov 18, 2035(~9.4 yrs left)· nominal 20-yr term from priority
Inventors:Andy H. LevineChristoph Matthias KanzlerAymeric GuyDaniel Leo MirandaJoseph MooneyAdam ZapotokSamuel BerryHuy LamJonathan Sabaté Del RíoJohn OsborneMustafa KarabasAlan DunneJames NiemiBenjamin MatthewsDonald E. IngberOlivier HenryPremananda Pai Indic
G16H 50/20A61B 5/0826A61B 5/145A61B 5/08A61M 5/1723A61M 5/00A61M 2205/8206A61M 2230/04A61B 5/7278A61M 2005/1726A61M 2205/50A61B 5/7264A61B 5/02A61M 2230/005A61B 5/00A61B 5/4839A61M 2205/581A61M 37/0015A61M 2005/206A61M 2230/30A61M 5/2053A61K 31/137A61M 37/00A61B 5/1135A61B 5/411A61M 2230/63A61B 5/14546A61M 2230/50A61B 5/113A61M 2205/587A61M 5/14248A61M 2205/18A61B 5/1486A61B 5/1451A61M 5/20A61M 2230/65A61B 5/0809A61B 5/0452A61B 5/086A61B 5/349
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Claims
Abstract
A physiologic sensor module includes at least one wearable sensor that is configured for wearing on a human body part and for measuring at least one biological signal. The module further includes at least one controller communicatively coupled to the wearable sensor and configured to receive the biological signal from the wearable sensor. The controller is further configured to process the biological signal in real-time, extract one or more clinical features from the biological signal, and based on the clinical features, determine detection of anaphylaxis.
Claims
exact text as granted — not AI-modified1 - 22 . (canceled)
23 . A physiologic module for detecting and treating symptoms of anaphylaxis, the physiologic module comprising:
at least one wearable sensor for measuring at least one biological signal; a wearable injector having an enclosure for housing a movable needle in a retracted position and a reservoir for storing epinephrine, the needle being movable at least in part outside the enclosure to an injecting position; and at least one controller communicatively coupled to the wearable sensor and to the wearable injector, the at least one controller configured to
receive the biological signal from the wearable sensor,
process the biological signal in real-time,
extract one or more clinical features from the biological signal,
based on the clinical features, determine presence of an anaphylaxis symptom, and
in response to the anaphylaxis symptom, automatically cause the needle to move to the injecting position and deliver a bolus of the epinephrine to a human body part.
24 . The physiologic module of claim 23 , further comprising a communication port adapted to communicate wirelessly with a mobile device, the at least one controller being further configured to contact a caregiver or emergency services in response to determining the presence of the anaphylaxis symptom.
25 . The physiologic module of claim 23 , further comprising a manual activation button for causing the needle to move to the injecting position and to deliver the bolus of the epinephrine to the human body part.
26 . The physiologic module of claim 23 , wherein the biological signal includes biosensor data indicative of measured histamine levels.
27 . A method for detecting and treating symptoms of anaphylaxis, the method comprising:
measuring, via a wearable sensor, at least one biological signal; sending the biological signal to a controller coupled to the wearable sensor; processing, via the controller, the biological signal in real-time; extracting, via the controller, one or more clinical features from the biological signal; based on the clinical features, determine, via the controller, presence of an anaphylaxis symptom; in response to the anaphylaxis symptom, automatically cause the needle to inject epinephrine in a human body part.
28 . The method of claim 27 , wherein the measuring of the at least one biological signal includes taking a sample of blood or interstitial fluid.
29 . The method of claim 27 , further comprising automatically contacting a caregiver or emergency services in response to the anaphylaxis symptom.
30 . The method of claim 27 , further comprising providing a GPS position of the wearable sensor to a caregiver or emergency services.
31 . The method of claim 30 , wherein the GPS position is communicated via a mobile device.
32 . The method of claim 31 , where the GPS position is communicated in the form of a text message, an e-mail, and/or a voice communication.
33 . The method of claim 27 , further comprising wirelessly communicating the clinical features with a mobile device.
34 . The method of claim 27 , further comprising automatically moving the needle to a retracted position after injecting the epinephrine in the human body part.
35 . The method of claim 27 , wherein the biological signal is responsive to one or more of an electrocardiogram (ECG), a skin temperature, a respiration rate, a galvanic skin response, and biosensor data.
36 . A sensor module comprising:
a histamine sensor configured for measuring a histamine level of a patient, the histamine sensor outputting a signal indicative of the measured histamine level; and at least one controller communicatively coupled to the histamine sensor and configured to
receive the signal from histamine sensor,
process the signal in real-time,
extract one or more clinical features from the signal, and
based on the clinical features, determine detection of an allergic reaction.
37 . The sensor module of claim 36 , wherein the histamine sensor continuously monitors the patient.
38 . The sensor module of claim 36 , further comprising an alarm feature that provides an alert when the allergic reaction is detected.
39 . The sensor module of claim 36 , wherein the alarm feature includes transmitting the alert to a clinician.
40 . The sensor module of claim 36 , wherein the sensor module is located in a clinical or hospital setting.
41 . The sensor module of claim 36 , wherein the histamine level is measured in blood or interstitial fluid of the patient.
42 . A manual injector module comprising:
a wearable injector having an enclosure for housing a movable needle in a retracted position and a reservoir for storing a therapeutic agent, the needle being movable at least in part outside the enclosure to an injecting position; and a manual activator coupled to the injector and configured to, upon activation, cause the needle to move to the injecting position.
43 . The manual injector module of claim 42 , wherein the wearable injector is configured for wearing on a thigh, upper arm, or abdomen.
44 . The manual injector module of claim 42 , further comprising a communication feature for alerting a caregiver or emergency services.
45 . The manual injector module of claim 44 , wherein the communication feature is communicatively coupled to a mobile device.
46 . The manual injector module of claim 44 , wherein the communication feature sends an alert indicative of one or more of an injection occurrence, low batteries, and expired therapeutic agent.
47 . The manual injector module of claim 42 , wherein the therapeutic agent is epinephrine.
48 . The manual injector module of claim 42 , further comprising a GPS feature indicative of a position of the wearable injector.
49 . The manual injector module of claim 42 , wherein the needle automatically retracts to the retracted position from the injecting position.
50 . A method for detecting and treating symptoms of anaphylaxis or asthma, the method comprising:
sensing data via one or more non-invasive sensors; sending the data to a controller configured to with an anaphylaxis detection algorithm; based on the data, and in response to the controller causing the anaphylaxis detection algorithm to determine a high likelihood of anaphylaxis or an asthmatic attack, triggering a biosensor to take a biological sample; in response to the biosensor confirming that anaphylaxis or an asthmatic attack is occurring, trigger a needle to insert an auto-injection of epinephrine.
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