Systems and methods for monitoring, managing, and treating asthma and anaphylaxis

• US 10,080,841 B2
• Filed: 05/10/2017
• Issued: 09/25/2018
• Est. Priority Date: 11/18/2015
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation, President and Fellows of Harvard College (Harvard Corporation), University Of Massachusetts
• Original Assignee: President and Fellows of Harvard College (Harvard Corporation)
• Inventors: Levine, Andy H., Kanzler, Christoph Matthias, Miranda, Daniel Leo, Mooney, Joseph, Lam, Huy, Osborne, John, Karabas, Mustafa, Dunne, Alan, Niemi, James, Matthews, Benjamin, Ingber, Donald E., Henry, Olivier, Indic, Premananda Pai
• Primary Examiner(s): Agahi, Puya
• Application Number:
  US15/591,329
• Publication Number:
  US 20170239418A1
• Time in Patent Office: 503 Days
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
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• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: A61M 5/00 : Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
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• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

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

1. A two-step authentication method for detecting and treating symptoms of anaphylaxis or asthma, the method comprising:

sensing, in a first step, data via one or more non-invasive wearable sensors;

sending the data to a controller configured with an anaphylaxis detection algorithm;

extracting by the anaphylaxis detection algorithm, via the controller, a set of features from the data that are relevant to respiration symptoms of a user;

based on the set of features, calculating by the anaphylaxis detection algorithm, via the controller, an airway obstruction severity (“

AOS”

) score that is associated with the user;

determining when the AOS score deviates from historical or patient normal values based on the AOS score exceeding a threshold value, the deviation being indicative of anaphylaxis or an asthmatic attack;

in response to the AOS score exceeding the threshold value, taking a biological sample with a biosensor in a second step subsequent to the first step, the biosensor being separate and distinct from the non-invasive wearable sensors;

independently confirming from the biological sample that anaphylaxis or the asthmatic attack is occurring; and

in response to the confirming, triggering a wearable needle to insert an auto-injection of epinephrine.

2. The method of claim 1, wherein the biological sample is blood or interstitial fluid.

3. The method of claim 1, wherein the data is indicative of measured histamine levels.

4. The method of claim 1, further comprising contacting a caregiver or emergency services in response to the auto-injection of epinephrine.

5. The method of claim 1, further comprising contacting a caregiver or emergency services in response to determining occurrence of the anaphylaxis or the asthmatic attack.

6. The method of claim 5, wherein the contacting of the caregiver or emergency services is communicated wirelessly between a communication port and a mobile device.

7. The method of claim 1, wherein the biological sample includes biosensor data indicative of measured histamine levels.

8. The method of claim 1, further comprising moving the wearable needle between a retracted position and an injection position, the retracted position being within an enclosure in which a reservoir stores the epinephrine, the injection position having the wearable needle at least in part outside the enclosure.

9. The method of claim 1, further comprising determining when the AOS score deviates from historical or patient normal values in real-time.

10. A physiologic sensor module for a two-step authentication method of detecting and treating symptoms of anaphylaxis or asthma, the physiologic sensor module comprising:

one or more non-invasive wearable sensors for sensing data in a first step of detecting and treating anaphylaxis or an asthmatic attack;

a biosensor separate and distinct from the non-invasive wearable sensors;

a wearable needle; and

at least one controller communicatively coupled to the one or more non-invasive wearable sensors, the biosensor, and to the wearable needle, the at least one controller including an anaphylaxis detection algorithm and being configured to;

receive the data from the one or more non-invasive wearable sensors,

extract by the anaphylaxis detection algorithm a set of features from the data that are relevant to respiration symptoms of a user,

based on the set of features, calculate by the anaphylaxis detection algorithm an airway obstruction severity (“

AOS”

) score that is associated with the user,

determine when the AOS score deviates from historical or patient normal values based on the AOS score exceeding a threshold value, the deviation being indicative of anaphylaxis or an asthmatic attack,

in response to the AOS score exceeding the threshold value, take a biological sample with the biosensor in a second step subsequent to the first step,

independently confirm from the biological sample that anaphylaxis or the asthmatic attack is occurring, and

in response to the confirmation, trigger the wearable needle to insert an auto-injection of epinephrine.

11. The physiologic sensor module of claim 10, wherein the biological sample is blood or interstitial fluid.

12. The physiologic sensor module of claim 10, wherein the data is indicative of measured histamine levels.

13. The physiologic sensor module of claim 10, further comprising a communication port for contacting, via the at least one controller, a caregiver or emergency services in response to the auto-injection of epinephrine.

14. The physiologic sensor module of claim 10, further comprising a communication port for contacting, via the at least one controller, a mobile device of a caregiver or emergency services in response to determining occurrence of the anaphylaxis or the asthmatic attack.

15. The physiologic sensor module of claim 10, wherein the biological sample includes biosensor data indicative of measured histamine levels.

16. The physiologic sensor module of claim 10, further comprising a housing with a reservoir for storing the epinephrine, the wearable needle being enclosed in the housing in a retracted position, the wearable needle being movable at least in part outside the enclosure in an injecting position when the wearable needle inserts the auto-injection of the epinephrine.