APPARATUS AND METHOD FOR TREATING DRUG OVERDOSES
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of United States provisional application no. 62/599,826, filed 18 December 2017, now pending, which is hereby incorporated by reference as though fully set forth herein.
BACKGROUND
[0002] 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).
[0003] In 2017, the President declared the opioid crisis a public health emergency. Indeed, according to the Centers for Disease Control and Prevention (“CDC”), almost 70% of all drug overdose deaths in 2017 involved an opioid.
[0004] Respiratory arrest and loss of consciousness are symptoms of opioid overdose. 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.
[0005] Many opioid users, however, overdose while alone. If they lose consciousness, they will be unable to self-administer Naloxone, increasing their mortality risk. Indeed, even if an opioid user is not alone, others present may not recognize the overdose situation in sufficient time to administer Naloxone and reverse the overdose.
BRIEF SUMMARY
[0006] Disclosed herein is 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.
[0007] In embodiments of the disclosure, the sensor 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.
[0008] 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.
[0009] 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.
[0010] Blood oxygen saturation for the subject can be monitored by monitoring Sp02 for the subject, such as via pulse oximetery.
[0011] 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.
[0012] 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. [0013] In still further aspects, 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.
[0014] The foregoing and other aspects, features, details, utilities, and advantages will be apparent from reading the following description and claims, and from reviewing the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] 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.
[0016] Figures 3a through 3d depict operation of a device for treatment of opioid overdoses according to aspects of the instant disclosure.
DETAILED DESCRIPTION
[0017] Disclosed herein are devices and methods for treating drug overdoses. For purposes of illustration, certain embodiments of the disclosure will be explained with reference to treating opioid overdoses through the automatic administration of an opioid antagonist ( e.g ., Naloxone).
[0018] Figures 1 and 2 depict, in schematic form, a medical device 10 for treatment of opioid overdoses. As shown in Figures 1 and 2, 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.
[0019] In embodiments of the disclosure, 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. According to aspects of the instant teachings, sensor(s) 12 and processor 14 can be integrated onto a printed circuit board.
[0020] Alternatively, it is also within the scope of the instant disclosure for 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).
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] Figures 1 and 2 also illustrate additional aspects of delivery mechanism 16. 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.
[0026] In use, sensor 12 continually monitors one or more physiological parameters that may vary with opioid use. For example, 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.
[0027] One indicator of a subject’s respiratory state is blood oxygen saturation (i.e., the ratio of oxy-hemoglobin to the total concentration of hemoglobin present in the blood). In certain embodiments of the disclosure, therefore, sensor 12 can be a sensor to measure blood oxygen saturation, such as Sp02.
[0028] It is known to measure Sp02 using a pulse oximeter. Various pulse oximeters are known. It is advantageous and desirable, however, for sensor 12 to be non-invasive and convenient, and particularly advantageous and desirable for sensor 12 to be wearable. Even more particularly, it is desirable for sensor 12 to be positioned at or near the subject’s wrist, which facilitates Sp02 measurements using reflective pulse oximetry.
[0029] In this regard, in embodiments of the disclosure, 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 oCare™ Pro 100 medical smart watch from Taiwan Biophotonic Co. The Apple Watch (Apple Inc., Cupertino, California) and the Fitbit Charge 3 activity tracker and Fitbit Ionic smart watch (Fitbit, Inc., San Francisco, California) also include reflective pulse oximetry sensors that would be suitable for use in connection with the teachings herein.
[0030] Sensor 12 can also measure additional physiological characteristics, including, without limitation, heart rate.
[0031] 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.
[0032] For example, 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.
[0033] In embodiments of the disclosure, the Sp02 threshold is preset at a value
symptomatic of impending respiratory arrest and with the subject at or near the point of unconsciousness. For instance, a normal subject’s baseline Sp02 value is about 95% or higher. In a normal subject, Sp02 values below about 90% can indicate compromised respiration, and Sp02 values below about 80% can begin to adversely affect organ function. Thus, for a normal subject, and by way of example only, the threshold can be preset at about 85%.
[0034] It is also known, however, that various medical conditions can impact a subject’s baseline Sp02. For instance, a subject with a chronic lung disease, such as chronic obstructive pulmonary disease (“COPD”), may have a lower baseline Sp02 value of about 85%. Thus, in other aspects of the disclosure, 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. For example, the preset threshold can be about 10% below a subject’s baseline Sp02 value. In embodiments of the disclosure, the subject’s baseline Sp02 value can be established through continuous monitoring of the subject’s Sp02 via sensor 12.
[0035] When processor 14 identifies an indicator that the subject is in, or at risk of entering, respiratory arrest, it 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).
[0036] In aspects of the disclosure, 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.
[0037] Operation of delivery mechanism 16 according to aspects of the instant disclosure will now be described with reference to Figures 3a-3d. 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.
[0038] 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.
[0040] As described above, processor 14 can also communicate, via transceiver 30, with a smartphone, tablet, personal computer, or another suitable external device. Thus, for example, when dosage 40 is delivered in response to a detected overdose situation, 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. As another example, 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).
[0041] Although several embodiments of this invention have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention.
[0042] All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and
counterclockwise) are only used for identification purposes to aid the reader’s understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. 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.
[0043] It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.