Patent Application
20210241874
The present disclosure generally relates to methods and devices for diagnosing and treating drug overdoses.
Drug addiction is a global epidemic and is viewed as a major health concern in many countries, including the United States. Opioid addiction is particularly dangerous and has been increasing in the United States for a number of years. Contributing to opioid addiction are illicit drugs such as heroin, prescription drugs such as oxycodone, and a variety of synthetic opioids such as fentanyl.
In the United States alone, more than 70,000 people died in 2017 from drug overdoses. Of those deaths, nearly 50,000 were attributable to opioid-specific overdose. Further, abuse of prescription opioids costs the healthcare system about $78.5 billion annually.
Opioids work by chemically interacting with opioid receptors in the brain and nervous system. Generally, opioids are prescribed to relieve pain, but frequently are abused for their euphoric effects. Sufferers of opioid addiction frequently turn to illicitly made fentanyl, which can be 50-100 times more potent than morphine. These illegally-made drugs often contain other drugs, unknown to the user, such as heroin or cocaine. Alternatively, a drug user may unwittingly subject themselves to opioids or synthetic opioids if another illicitly-produced drug has been laced with fentanyl or other opioids.
One of the major symptoms of opioid overdose is Opioid Induced Respiratory Depression (OIRD), which results in decreased blood oxygen concentration and a corresponding spike in exhaled carbon dioxide, causing difficulty in breathing. Other symptoms a patient may exhibit while experiencing an opioid—or other drug—overdose include increased heart rate (tachycardia), confusion, nausea, dizziness, unresponsiveness or loss of consciousness, and pain.
The most common countermeasure for opioid overdose is naloxone and it is the only approved countermeasure currently available. Naloxone is an opioid antagonist, which binds to the opioid receptors in the brain and nervous system, blocking and reversing the effects of opioids. It is widely distributed to healthcare professionals, first responders, patients for in-home use, and it is often made accessible to drug addicts. Currently, naloxone may be administered as a nasal spray, auto-injector, or injection. When properly administered, naloxone is effective at reversing OIRD.
However, with the proliferation of a variety of opioid derivatives, including potent compounds such as fentanyl derivatives, the administration of countermeasures, such as naloxone, is often complex and ineffective. Although naloxone is effective at reversing OIRD when properly administered, it has a variable and limited duration of effect from twenty to ninety minutes depending on multiple factors. This duration is shorter than the duration of the effect of most opioid toxicity, including the effects of some potent fentanyl derivatives. Therefore, naloxone may need to be administered multiple times to counter an opioid overdose. The administration of naloxone can be further complicated by the presence of other respiratory depressants such as barbiturates and alcohol, which are not affected by naloxone.
It is therefore an object to provide tools for overdose countermeasure administration that considers the identity and concentration of opioids and other factors, such as patient demographics, that could affect drug metabolism.
The present disclosure is directed, in at least some aspects, to an overdose diagnostic and treatment device and related methods for the diagnosis and treatment of opioid or other drug overdose. It should be understood by those of ordinary skill in the art that the devices and methods can be used for diagnosing and treating overdoses and related overdose symptoms of any drug, such as, but not limited to, morphine, heroin, oxycodone, fentanyl, cocaine, amphetamine, tetrahydrocannabinol (THC), and all related drug classes. An advantage of such devices and methods is that it can be used by first responders, emergency room personnel, physicians, and other healthcare or law enforcement professionals, to guide the administration of countermeasures to a patient experiencing overdose. Additionally, the devices and methods can be utilized in home to assist in countering the symptoms of opioid overdose. Further, the use of the diagnostic and treatment device and method allows for a more accurate and effective administration of overdose countermeasures, such as naloxone, to the patient.
“Patient” refers to a person who is experiencing the overdose and is thus may be treated with overdose countermeasure(s). “User” refers to a person, such as (but not limited to) a medical professional, first responder, or community member and/or family member, who may use the diagnostic and treatment devices and methods on a patient.
In one aspect, a system for detection and countermeasure of drug overdose includes an analyzer and a drug detection apparatus adapted to receive a sample from a person containing at least one drug, determine an identity of the at least one drug, determine a concentration of the at least one drug in the sample, and transmit said identity and concentration to the analyzer. The analyzer is adapted to receive the identity and concentration from the drug detection apparatus, and to receive information about the person including age, ethnicity, sex, weight, and/or race. The analyze is also adapted to determine, based on said identity, concentration, and/or information, an overdose countermeasure for at least partially counteracting an overdose condition of the person. In at least some embodiments, the system includes a blood gas apparatus adapted to measure at least one vital sign of the person including an amount of at least one blood gas in the person's blood and transmit said at least one vital sign to the analyzer. The analyzer is adapted to receive the at least one vital sign from the blood gas apparatus, and to determine, based on the identity, concentration, at least one vital sign and/or information, an overdose countermeasure for at least partially counteracting an overdose condition of the person.
In another aspect, a system for detection and countermeasure of drug overdose includes first means and second means for receiving a sample from a person containing at least one drug. The second means if further for determining an identity of the at least one drug, for determining a concentration of the at least one drug in the sample, and for transmitting said identity and concentration to the first means. The first means is for receiving the identity and concentration from the second means, for receiving information about the person including age, ethnicity, sex, weight, and/or race, and for determining, based on said identity, concentration, and/or information, an overdose countermeasure for at least partially counteracting an overdose condition of the person. Some embodiments include third means for measuring at least one vital sign of the person including an amount of at least one blood gas in the person's blood and for transmitting said at least one vital sign to the first means, and the first means is further for receiving the at least one vital sign from the third means, and for determining, based on the identity, concentration, at least one vital sign and/or information, an overdose countermeasure for at least partially counteracting an overdose condition of the person. In some such embodiments, the first means includes an analyzer, the second means includes a drug detection apparatus, and the third means includes a blood gas apparatus.
In another aspect, a method for treating a drug overdose includes collecting a sample from a person containing at least one drug, inputting the sample into a drug detection apparatus adapted to receive the sample, determine an identity of the at least one drug in the sample, and determine a concentration of the at least one drug in the sample, and inputting into an analyzer information about the person including age, ethnicity, sex, weight, and/or race. The analyzer is operatively connected to the drug detection apparatus and adapted to receive the identity and concentration therefrom. The analyzer is also adapted to determine, based on the identity, concentration, and/or information, an overdose countermeasure for at least partially counteracting an overdose condition of the person. The method further includes perceiving at least one communication from the analyzer specifying a countermeasure for the overdose condition, and administering the countermeasure to the person.
In some embodiments, the method includes operatively connecting a blood gas apparatus to the person, which is adapted to measure at least one vital sign of the person including an amount of at least one blood gas in the person's blood. In some such embodiments, the analyzer is operatively connected to the blood gas apparatus and adapted to receive the at least one vital sign therefrom, and is adapted to determine, based on the identity, concentration, at least one vital sign and/or information, an overdose countermeasure for at least partially counteracting an overdose condition of the person.
In yet another aspect, a method for countermeasure of drug overdose includes receiving an identity and a concentration of at least one drug present in a sample from a person, receiving information about the person including age, ethnicity, sex, weight, and/or race, and determining an overdose countermeasure for at least partially counteracting an overdose condition of the person based on the identity, concentration, and/or information. In further embodiments, the method includes receiving at least one vital sign of the person including an amount of at least one blood gas in the person's blood, and determining an overdose countermeasure for at least partially counteracting an overdose condition of the person based on the identity, concentration, at least one vital sign and/or information.
An additional aspects comprises a software program or non-transitory computer-readable medium having computer-readable instructions stored thereon. When executed by a computer system, the computer system receives an identity and a concentration of at least one drug present in a sample from a person, receives information about the person including age, ethnicity, sex, weight, and/or race, determines an overdose countermeasure for at least partially counteracting an overdose condition of the person based on the identity, concentration, and/or information. In some aspects, the computer system, when executing the program or instructions, receives at least one vital sign of the person including an amount of at least one blood gas in the person's blood, and determines an overdose countermeasure for at least partially counteracting an overdose condition of the person based on the identity, concentration, at least one vital sign and/or information.
In at least some aspects, the overdose diagnostic and treatment device includes a housing case, a power source, a charging port, a sample collection kit, a drug of abuse (DOA) detection apparatus, a non-invasive blood gas apparatus for measuring and monitoring blood gases, and a analyzer with or operatively connected/connected to a decision support application for determining the dosage concentration/amount and timing/frequency of administrations of overdose countermeasure. In at least some embodiments, the housing case contains the power source, charging port, sample collection kit, DOA detection device, non-invasive blood gas device, and analyzer therein. In at least some embodiments, the overdose diagnostic and treatment device further includes an amount of drug overdose countermeasure. Yet further, in some such embodiments, the housing case also includes the amount of drug overdose countermeasure therein.
At least some embodiments are devices and methods for prescribing appropriate and effective concentration of countermeasure to a patient experiencing a drug overdose. At least some embodiments include identification of a patient experiencing a potential drug overdose, collecting a sample of saliva, blood, and/or urine from said patient, inputting the collected sample into a DOA detection device, affixing or operatively connected the non-invasive blood gas device to the patient, inputting information about said patient into the analyzer containing the decision support application, generating instructions or information regarding the administration of a countermeasure or countermeasures, and administering countermeasure(s) to the patient.
In at least some embodiments, the diagnostic and treatment device includes a power source. The power source may include a rechargeable battery and power connection(s) thereto to provide power to components of the diagnostic and treatment device that require power. In at least some such embodiments, the power source is connected and provides power to the DOA detection device, the analyzer, and the non-invasive blood gas device. In at least some embodiments, the power source is housed within the housing case. In some such embodiments, the power source is configured to be charged while the housing case is open or closed via a charging port located within the housing case but externally accessible when the case is closed. In at least some embodiments, the power source is turned on when the housing case is opened, causing the components attached thereto via the power connection to turn on in kind.
In at least some embodiments, the diagnostic and treatment device includes a sample collection kit. In at least some such embodiments, the sample collection kit includes at least one sample collection tool, e.g., a swab for the collection of saliva, a lancet and capillary tube for the collection of blood (e.g., peripheral), and a sample collection cup for a urine sample. Additionally, in at least some such embodiments, the sample collection kit also includes dilution tubes and sample diluent.
In at least some embodiments, the diagnostic and treatment device includes a DOA detection device. In at least some such embodiments, the DOA detection device is a point-of-care device that utilizes high performance electrophoresis in a microfluidic capillary to separate drugs of abuse and a direct optical detection method for detecting and quantitating the drugs of abuse present in the patient's saliva, blood, and/or urine. In at least some such embodiments, the DOA detection device includes a cover, an internal power supply, a waste container, a port for receiving a sample of the patient's, a light source, a photodiode array, a capillary, a mechanism to apply charge across the capillary, a mechanism to generate pressure on the capillary, a wash mechanism, a mechanism to add buffer to the sample, a system control mechanism, a mechanism to acquire and analyze data from the detector, a reference database, and a connectivity port. The sample is injected into the receptacle wherein it is forced or otherwise through a capillary by pressure, charge, solvent liquid flow, and/or capillary action. The DOA detection device detects the types and concentrations of any DOA present in the patient's sample. In at least some embodiments, the communication port allows electronic communication between the DOA detection device and the analyzer via Wi-Fi, USB cable, Bluetooth, and/or other transmission path. In at least some embodiments, the DOA detection device electronically transmits the information regarding the DOA in the patient's sample to the analyzer.
It should be understood by those of ordinary skill in the art that the DOA detection device is not limited to a capillary electrophoretic device. It should be further understood that the DOA detection device is not limited to detecting and quantitating drugs in the patient's saliva, blood, or urine, and other samples from the patient and detection techniques may be used.
In at least some embodiments, the diagnostic and treatment devices and methods include a non-invasive blood gas device, configured to measure and monitor blood gases and respiration transcutaneously. In at least some such embodiments, the non-invasive blood gas device includes a wearable patch and/or cuff, which is placed directly onto the patient, e.g., against or adjacent the skin, and a sensor and control, which includes a communication port, a power supply, a data acquisition mechanism, a gas inlet and outlet, as well as a connection cable to the wearable patch and/or cuff and a gas exchange tube in connection with the wearable patch and/or cuff. In some embodiments, the wearable patch is disposable. In other embodiments, it is reusable. In at least some embodiments, the cuff is a sleeve that is slipped or placed over a patient's appendage. In some embodiments, the user places the patch upon the patient's skin and places the cuff over the patch. In at least some embodiments, the non-invasive blood gas device is configured to measure blood pressure. In at least some embodiments, the non-invasive blood gas device detects and/or measures for respiration, generating information relating to diagnosis and monitoring of patients experiencing OIRD. In at least some embodiments, the communication port allows communication between the non-invasive blood gas device and the analyzer via Wi-Fi, USB cable, Bluetooth, and/or other transmission path.
In at least some embodiments, the diagnostic and treatment device and related method includes an analyzer. In at least some embodiments, the analyzer is a commercially available tablet, or other similarly-equipped technology or computerized device, with at least some embodiments including a rechargeable power source, such as a rechargeable battery. In at least some embodiments, the analyzer has multiple communication modalities, including, but not limited to, cell phone connectivity, Wi-Fi, and Bluetooth connection capabilities. In at least some embodiments, the analyzer is adapted to electronically communicate with the non-invasive blood gas device, wherein the non-invasive blood gas device transmits to the analyzer blood gas concentration(s), respiration information, and/or heart rate information measured from the patient. Additionally, in at least some embodiments, the DOA detection device is in electronic communication with the analyzer, wherein the DOA detection device transmits the results of the DOA detection to the analyzer. The non-invasive blood gas device and/or DOA detection device may be in electronic communication with the analyzer through, but not limited to, Wi-Fi, USB cable connection, and/or Bluetooth connection.
In at least some embodiments, the analyzer is equipped with a decision support application configured to determine dosage concentration/amount and frequency/timing of administrations of a drug overdose countermeasure. In at least some such embodiments, the decision support application utilizes pharmacological data of DOA(s) or DOA class(es), the identity and concentration of each DOA identified in a sample taken from a patient, patient-specific information and/or demographics, such as, but not limited to, age, sex, weight, and race, and vital sign information, such as, but not limited to, heart rate, respiration rate, and blood gases, to guide the overdose countermeasure administration. The decision support application is configured to utilize some or all of said data to generate a recommendation for specific countermeasure(s) to administer to a patient, the dose/amount of said countermeasure(s), the number of doses, and a countdown timer between each administration of the required countermeasure dosage(s). In at least some embodiments, the decision support application is configured to determine whether successful reversal of an overdose condition has been achieved using information regarding the patient's vital signs, e.g., a non-invasive blood gas device. In at least some embodiments, the decision support application receives the data regarding the identity and concentration of each DOA from the DOA detection device. Further, in at least some embodiments, the decision support application receives data regarding heart rate, respiration, and blood gases from the non-invasive blood gas device. Yet further, the decision support application receives the data regarding patient-specific information and/or demographics from user input into the analyzer.
In at least some embodiments, the analyzer includes a graphical user interface, in which instructions, recommendation and information can be displayed to the user regarding how to operate the diagnostic and treatment device and treat the patient. In at least some such embodiments, the graphical user interface contains an input functionality wherein the user may input relevant data regarding the patient, such as, but not limited to, the sex, weight, age, and ethnicity of the patient. In at least some such embodiments, the analyzer receives said inputs and, using the decision support application, determines therefrom the appropriate dosage of countermeasure to administer to the patient.
In at least some embodiments, the analyzer has a human readable touch screen. In at least some embodiments, the analyzer may be equipped with a visible and audible alarm and may issue alerts, such as the patient's countermeasure dosage amount, notifications regarding the next countermeasure dosage and when to administer it, and system maintenance notifications. In at least some such embodiments, the analyzer may display a countdown timer for informing the user when the next dosage of countermeasure should be administered to the patient. In at least some such embodiments, the analyzer displays output data obtained by the non-invasive blood gas device, such as the level of oxygen and/or carbon dioxide in the patient's blood. In at least some such embodiments, the analyzer displays data obtained from the DOA detection device, such as the types of drugs contained within the patient's system and the concentrations of those drugs. Further, in at least some embodiments, the analyzer displays clinical alerts, such as recommending the patient be transported to the hospital.
In at least some embodiments, the analyzer may include therein data storage for certain data including, but not limited to, patient-specific information, data from a DOA detection device, data from a non-invasive blood gas device, analyzer activity logs, information about the decision support application, and/or data regarding drugs of abuse and countermeasure-specific information. Further, in at least some embodiments, the analyzer may include communication protocols for receiving information from a non-invasive blood gas device and/or the DOA detection device, as well as for communicating or receiving information from other external parties or devices.
One advantage of certain embodiments is the speed and accuracy with which the user can diagnose and administer a correct dosage of countermeasure to the patient, as compared to prior systems and processes, especially where the quantities and types of drugs are unknown to the user and the patient is unresponsive or unable to communicate. Where such guesswork is eliminated or reduced, the patient has a higher likelihood of positively responding to the countermeasure. Another advantage of certain embodiments is the ability of non-medically trained users to use the system on patients exhibiting clinical symptoms of a drug overdose.
Those of ordinary skill in the art should understand that, in the future, new countermeasures to drug overdoses may become available. These new countermeasures may have a different mode of action, may be for countering specific drugs or classes of drugs, and may have a different duration of effectiveness. Therefore, these countermeasures may be more appropriate than naloxone in certain situations. This will ultimately lead to an increase in complexity of administering overdose countermeasures, especially where the patient is nonresponsive, or does not know or cannot remember what DOA that patient has taken. Therefore, another advantageous aspect of certain embodiments is that the user will not have to engage in complex or time-consuming medical testing to determine what drugs of abuse are in the patient's system, or what specific countermeasures and in what concentrations will be most effective at treating the patient.
These and other unique features of the device and method disclosed herein will become more readily apparent from the following detailed description of currently preferred embodiments, the accompanying drawings, and the appended claims.
The foregoing and other features will be apparent from the following Detailed Description, taken in connection with the accompanying drawings, in which:
Described herein are devices and methods for diagnosing and administering countermeasure for the treatment of drug overdose. The devices and methods may be used, for example, for treating patients who are experiencing an overdose of opioids with naloxone. It should be understood, though, that the devices and methods discussed herein may be utilized for many applications, such as treating patients who are experiencing overdose of other drugs or substances, either illicit, prescribed or non-prescription/over-the-counter, with countermeasures, other than naloxone, that may be known or become known to those having ordinary skill in the art.
Referring to
The DOA detection device 30, as illustrated schematically in
The DOA detection device 30 and its methods of operation and/or use may be in accordance with the disclosures and/or teachings of one or more of the following patents, which are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. Pat. No. 7,041,986, entitled “Device for Discrimination of Fluorescence Lifetimes and Uses Therefor”; U.S. Pat. No. 7,718,353, entitled “Proteins, Sensors, and Methods of Characterizing Analytes Using the Same”; and U.S. Pat. No. 8,993,972, entitled “Fluorescence Based Sensors Utilizing a Mirrored Cavity.”
The non-invasive blood gas device 40 and its methods of operation and/or use may be in accordance with the disclosures and/or teachings of one or more of the following patents, which are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. Pat. No. 8,852,921, entitled “Non-invasive Sensing of Bioprocess Parameters”; U.S. Pat. No. 9,883,823, entitled “System and Method for Determining an In Vivo Concentration of a Small Molecule Substance of Interest in a Noninvasive Manner”; and U.S. Pat. No. 9,538,944, entitled “Non-invasive Analyte Sensing System and Method.”
The analyzer 60 is a commercially available tablet, or other similarly equipped technology, with a rechargeable battery. However, any suitable analyzer may be used. The illustrated analyzer 60 is recharged via power source 20, and is electronically connected or connectable thereto, as schematically indicated by line 65. The analyzer 60 may have one or more of any suitable communication modalities, including, but not limited to, cell phone connectivity, USB connectivity, Wi-Fi, and Bluetooth connection capabilities. The analyzer 60 includes therein data storage configured for storing certain data including, but not limited to, patient-specific information, DOA detection device 30 output data, non-invasive blood gas device 40 output data, analyzer 60 activity logs, information about the decision support application, and data regarding the drugs of abuse and countermeasure-specific information. The analyzer 60 includes communication protocols for receiving output information from the non-invasive blood gas device 40 and/or the DOA detection device 30, as well as for communicating or receiving information from other external parties or devices.
Referring to
Though analyzer 60 is illustrated as having a touch screen, it should be understood that the system may, additionally or alternatively, contain other input/output structures. These include a physical keyboard, which could be either integral or separate from but operatively connected/connectable to the analyzer, voice recognition for data input (e.g., via a microphone), gesture recognition (e.g., via a camera or cameras), and audio transmission to the user. With the latter, for example, the analyzer 60 could audibly provide the user instructions and/or prompt for inputs, e.g., patient data and/or patient sample(s), and/or audibly provide treatment recommendations, reminders/warnings regarding next dose administration, or other instructions, recommendations or information.
The analyzer 60 supports therein a decision support application. A schematic of an embodiment of a decision support application data input and flow is illustrated in
It should be understood to those of ordinary skill in the art that, while in some embodiments the decision support application and/or the data tables may be contained within the analyzer, the analyzer may include multiple separate pieces, each containing different components. By way of example only, the data tables and/or decision support application can be housed within separate objects from that which contains the user interface, which are operatively connected or connectable to each other. In yet other embodiments, the data tables and/or decision support application may be located remotely to the analyzer, such as in a separate computer system, server, The Cloud, etc. In such embodiments, the analyzer may communicate with the remote components by any suitable wireless and/or wired communication.
Further referring to
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As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes, modifications and improvements may be made to the above-described and other embodiments without departing from the spirit of the invention, which is not limited to the appended claims. For example, the sample collection kit may take the form of any of numerous different sample collection kits, that may employ any of numerous different patient sample collecting methods, that are currently known or that later become known. The analyzer may take form of any of numerous different devices, such as tablets, personal computers, laptops, or smartphones, that are currently known or that later become known for performing the respective functions of these devices. Accordingly, this detailed description is to be taken in an illustrative, as opposed to a limiting sense.
This application claims benefit under 35 U.S.C. § 119(e) to U.S. Provisional Application Ser. No. 62/968,276, filed on Jan. 31, 2020, the entirety of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62968276 | Jan 2020 | US |
