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WO2019126114A1 - Appareil et procédé pour traiter des surdoses de médicament - Google Patents

Appareil et procédé pour traiter des surdoses de médicament Download PDF

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Publication number
WO2019126114A1
WO2019126114A1 PCT/US2018/066150 US2018066150W WO2019126114A1 WO 2019126114 A1 WO2019126114 A1 WO 2019126114A1 US 2018066150 W US2018066150 W US 2018066150W WO 2019126114 A1 WO2019126114 A1 WO 2019126114A1
Authority
WO
WIPO (PCT)
Prior art keywords
subject
identifying
sensor
overdose
oxygen saturation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2018/066150
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English (en)
Inventor
Allison THALER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2019126114A1 publication Critical patent/WO2019126114A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4845—Toxicology, e.g. by detection of alcohol, drug or toxic products
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14204—Pressure infusion, e.g. using pumps with gas-producing electrochemical cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14272—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body for emergency, field or home use, e.g. self-contained kits to be carried by the doctor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/08—Limbs
    • A61M2210/083—Arms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure

Definitions

  • the instant disclosure relates generally to the treatment of drug overdoses. More specifically, the instant disclosure relates to apparatus and methods for treating opioid overdoses without outside intervention (e.g ., from a paramedic responding to an emergency call, from a bystander, or from a family member).
  • opioid overdoses without outside intervention (e.g ., from a paramedic responding to an emergency call, from a bystander, or from a family member).
  • Naloxone is an opioid antagonist, and can reverse opioid overdose, restoring normal respiration.
  • Naloxone can be administered intravenously, intramuscularly, subcutaneously, and/or by nasal spray.
  • a medical device for treating opioid overdose including: a sensor to measure a respiratory condition of a subject; an opioid antagonist delivery mechanism; and a processor configured to: receive the measured respiratory condition of the subject as input; identify a respiratory arrest risk indicator from the measured respiratory condition of the subject; and cause the opioid antagonist delivery mechanism to deliver an opioid antagonist to the subject automatically upon identifying the respiratory arrest risk indicator.
  • the senor measures blood oxygen saturation, such as Sp02, which can be measured using a pulse oximeter.
  • the opioid antagonist delivery mechanism can include a Naloxone injector or auto-injector.
  • Also disclosed herein is a method of treating opioid overdose, including the steps of: identifying a respiratory arrest risk indicator in a subject; and automatically administering an opioid antagonist upon identifying the respiratory arrest risk indicator in the subject.
  • the step of identifying a respiratory arrest risk indicator in a subject can include: monitoring blood oxygen saturation for the subject; and identifying the respiratory arrest risk indicator in the subject when blood oxygen saturation for the subject falls below a preset threshold.
  • the preset threshold can be an absolute blood oxygen saturation value, such as 85% Sp02, or a value computed relative to a baseline blood oxygen saturation value for the subject, such as 90% of the baseline blood oxygen saturation value for the subject.
  • Blood oxygen saturation for the subject can be monitored by monitoring Sp02 for the subject, such as via pulse oximetery.
  • the step of automatically administering an opioid antagonist upon identifying the respiratory arrest risk indicator in the subject can include automatically injecting Naloxone into the subject upon identifying the respiratory arrest risk indicator in the subject. It is also contemplated, however, that a warning can be emitted prior to automatically administering the opioid antagonist.
  • the instant disclosure also provides a medical device for treating overdoses, including: a sensor to measure a physiological parameter of a subject, wherein the physiological parameter varies with use of a drug; a delivery mechanism for delivering an agent to counteract effects of the drug; and a processor configured to: receive the measured physiological parameter of the subject as input; identify an overdose indicator from the measured physiological parameter of the subject; and cause the delivery mechanism to deliver the agent to the subject automatically upon identifying the overdose indicator.
  • the instant disclosure relates to a method of treating drug overdose, including the steps of: identifying an overdose indicator in a subject; and automatically administering an agent to counteract the drug upon identifying the overdose indicator in the subject.
  • Figures 1 and 2 schematically depict a device for treatment of opioid overdoses according to aspects of the instant disclosure. More specifically, Figure 1 depicts such a device in top view, while Figure 2 depicts such a device in front view.
  • Figures 3a through 3d depict operation of a device for treatment of opioid overdoses according to aspects of the instant disclosure.
  • Figures 1 and 2 depict, in schematic form, a medical device 10 for treatment of opioid overdoses.
  • device 10 generally includes one or more sensors 12, a processor 14, and a delivery mechanism 16 for an opioid antagonist. Each is described in turn below.
  • sensor(s) 12, processor 14, and/or delivery mechanism 16 can be integrated into a single device, such as an adjustable, wearable sleeve 18, shown on an arm 20, that integrates sensor(s) 12, processor 14, and delivery mechanism 16.
  • sensor(s) 12 and processor 14 can be integrated onto a printed circuit board.
  • sensor(s) 12, processor 14, and/or delivery mechanism 16 can be two or more separate devices, with communication established therebetween using any suitable protocol (e.g ., Bluetooth, Near Field Communication).
  • any suitable protocol e.g ., Bluetooth, Near Field Communication
  • Device 10 can also include an arm/disarm switch 22, a speaker 24, a display 26 (e.g., an LCD or OLED display), and a power source, such as a rechargeable battery 28. Any or all of switch 22, speaker 24, and display 26 can also be incorporated onto a printed circuit board.
  • Device 10 can also include a transceiver 30, such as a Bluetooth module, a Near Field Communications Module, or other wired or wireless communications module, which can also be incorporated onto a printed circuit board.
  • Transceiver 30 can allow device 10 to communicate with one or more external devices, such as smartphones, tablets, personal computers, and the like.
  • Arm/disarm switch 22 controls whether or not device 10 is active (that is, whether or not device 10 is enabled to administer an opioid antagonist). When switch 26 is set to an “armed” setting, device 10 is active. Conversely, when switch 26 is set to a“disarmed” setting, device 10 is inactive.
  • Speaker 24 and display 26 can provide audible and visual feedback, respectively, to a user of device 10. For example, as discussed in greater detail below, speaker 24 can provide an audible warning preceding delivery of an opioid antagonist in response to a detected overdose situation. Similarly, display 26 can provide a visual readout of information such as the status of rechargeable battery 28 and readings from sensor 12.
  • Delivery mechanism 16 can include a gas cartridge 32, an electronically activated solenoid 34, a plunger 36, an opioid antagonist dosage 38, an injection needle 40, and a spring 42. Operation of delivery mechanism 16 will be described in further detail below. In general, however, it is contemplated that delivery mechanism 16 can be provided as a disposable component of device 10, such that it can be replaced when dosage 38 is expended in response to a detected overdose situation.
  • sensor 12 continually monitors one or more physiological parameters that may vary with opioid use.
  • sensor 12 can monitor the subject’s respiratory condition, because, as discussed above, it is known that depressed respiration is symptomatic of opioid use, and that respiratory arrest is a common symptom of opioid overdose.
  • sensor 12 can be a sensor to measure blood oxygen saturation, such as Sp02.
  • sensor 12 can be a reflective pulse oximetery sensor, such as incorporated into the Oxitone 1000 wrist pulse oximeter from Oxitone Medical Ltd. or the oCareTM Pro 100 medical smart watch from Taiwan Biophotonic Co.
  • the Apple Watch Apple Inc., Cupertino, California
  • the Fitbit Charge 3 activity tracker and Fitbit Ionic smart watch also include reflective pulse oximetry sensors that would be suitable for use in connection with the teachings herein.
  • Sensor 12 can also measure additional physiological characteristics, including, without limitation, heart rate.
  • Processor 14 receives measurements from sensors 12 (e.g ., Sp02 values, heart rates) as input. Processor 14 utilizes the input to identify an indicator that the subject has overdosed, such as identifying an indicator that the subject is in, or at risk of entering, respiratory arrest.
  • sensors 12 e.g ., Sp02 values, heart rates
  • processor 14 can compare the Sp02 measurement from sensor 12 to a preset threshold and determine that the subject is in, or at risk of entering, respiratory arrest (e.g., from an opioid overdose) if the measurement from sensor 12 does not exceed the preset threshold.
  • respiratory arrest e.g., from an opioid overdose
  • the Sp02 threshold is preset at a value
  • a normal subject a normal subject’s baseline Sp02 value is about 95% or higher.
  • Sp02 values below about 90% can indicate compromised respiration
  • Sp02 values below about 80% can begin to adversely affect organ function.
  • the threshold can be preset at about 85%.
  • the preset threshold may be implemented as a relative deviation from a specific subject’s baseline Sp02 value, as opposed to an absolute Sp02 value.
  • the preset threshold can be about 10% below a subject’s baseline Sp02 value.
  • the subject’s baseline Sp02 value can be established through continuous monitoring of the subject’s Sp02 via sensor 12.
  • processor 14 can cause delivery mechanism 16 to deliver an opioid antagonist, such as Naloxone, to the subject to counter the overdose.
  • Delivery mechanism 16 can be an automatic Naloxone injector, such as the EVZIO® auto injector, and can provide a dosage of between about 0.4 mg and about 4 mg of the antagonist. The precise dosage can be adjusted ( e.g ., a lower dosage can be administered to older subjects and a higher dosage administered to younger subjects).
  • actual delivery of the opioid antagonist can be preceded by a warning, such as a series of beeps, in order to allow a subject to interrupt the delivery of the opioid antagonist.
  • Figure 3a depicts a“ready to inject” state, with switch 22 set to“armed” and processor 14 monitoring the output of sensor 12 to detect an indicator that the subject has overdosed.
  • processor 14 Upon detecting an indicator that the subject has overdosed, processor 14 commands solenoid 34 to puncture gas cartridge 32 as shown in Figure 3b. As gas exits gas cartridge 32, it exerts a force on plunger 36, which in turn forces needle 40 into arm 20, compressing spring 42 and injecting dosage 38 to the subject as shown in Figure 3c. [0039] Once gas cartridge 32 is exhausted and dosage 38 delivered, spring 42 will decompress and retract needle 40 from arm 20. Delivery mechanism 16 can then be replaced, allowing the subject to reuse device 10.
  • processor 14 can also communicate, via transceiver 30, with a smartphone, tablet, personal computer, or another suitable external device.
  • processor 14 can trigger one or more desirable communications from the external device, such as a 911 call and/or a call and/or electronic message to one or more designated emergency contacts.
  • ongoing readings from sensor 12 can be communicated to the external device and incorporated with other health data stored on such device (e.g ., step counts from a fitness tracker).
  • All directional references e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and
  • joinder references e.g., attached, coupled, connected, and the like are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Toxicology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Optics & Photonics (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne un dispositif pour traiter des surdoses de médicament qui comprend généralement un capteur pour mesurer un paramètre physiologique d'un sujet qui varie avec l'utilisation d'un médicament, un mécanisme de distribution pour administrer un antidote au médicament, et un processeur. Le processeur reçoit un signal depuis le capteur, surveille le paramètre physiologique, et identifie un indicateur de surdose à partir de celui-ci. Lors de l'identification de l'indicateur de surdose, le processeur amène automatiquement le mécanisme de distribution à délivrer l'antidote. Le dispositif peut être utilisé pour traiter des surdoses d'opioïdes en surveillant la saturation en oxygène du sang du sujet et en administrant un antagoniste d'opioïde (par exemple, la naloxone<i />) si la saturation en oxygène du sang du sujet diminue à une valeur indicative d'un arrêt respiratoire et/ou d'une perte de conscience imminents. Le dispositif peut être mettable (par exemple, porté au poignet).<i />
PCT/US2018/066150 2017-12-18 2018-12-18 Appareil et procédé pour traiter des surdoses de médicament Ceased WO2019126114A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762599826P 2017-12-18 2017-12-18
US62/599,826 2017-12-18

Publications (1)

Publication Number Publication Date
WO2019126114A1 true WO2019126114A1 (fr) 2019-06-27

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PCT/US2018/066150 Ceased WO2019126114A1 (fr) 2017-12-18 2018-12-18 Appareil et procédé pour traiter des surdoses de médicament

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WO (1) WO2019126114A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170172522A1 (en) * 2015-12-22 2017-06-22 Joseph Insler Method and Device for Automatic Identification of an Opioid Overdose and Injection of an Opioid Receptor Antagonist
US20170246390A1 (en) * 2016-02-25 2017-08-31 David Tchao Device for the Prevention of Overdose by Opiate and Depressant Users

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170172522A1 (en) * 2015-12-22 2017-06-22 Joseph Insler Method and Device for Automatic Identification of an Opioid Overdose and Injection of an Opioid Receptor Antagonist
US20170246390A1 (en) * 2016-02-25 2017-08-31 David Tchao Device for the Prevention of Overdose by Opiate and Depressant Users

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