Drug delivery adjustments

Abstract

Provided herein are drug administration devices, methods, and systems for adjusting drug delivery to a patient to allow for adjustment of drug dosage during administration of the drug based on a variety of different factors affecting the patient. In one embodiment, a drug administration device or system may have: a drug holder having a drug to be delivered to a patient therein; one or more sensors configured to collect various data associated with the patient; and at least one processor that can analyze the data collected by the one or more sensors and adjust the delivery of the drug based on the data.

Description

Technical Field

[0001] Embodiments described herein relate to a device for administering and / or providing a drug. The present disclosure further relates to systems and methods of administration in which the device can be used, as well as additional methods associated with the system. Background Art

[0002] Pharmaceutical products (including macromolecular drugs and small molecule drugs, hereinafter referred to as "drugs") are administered to patients in a variety of different ways for the treatment of specific medical indications. Regardless of the mode of administration, care must be taken when administering the drug to avoid adverse effects on the patient. For example, care must be taken not to administer a drug to the patient in excess of a safe amount. This requires consideration of the amount of the dose given and the time frame within which the dose is delivered, sometimes with respect to previous doses or doses of other drugs. In addition, care must be taken not to accidentally administer an incorrect drug or a drug that has deteriorated due to aging or storage conditions to the patient. All of these considerations can be conveyed in the guidance associated with a specific drug or drug combination. However, the guidance is not always followed correctly, for example due to errors such as human errors. This may adversely affect the patient or result in inappropriate drug administration, such as administering an insufficient or excessive volume of drug for a specific medical indication.

[0003] Furthermore, considering the patient's surroundings during drug administration helps avoid adverse reactions caused by various factors that are not only the initial dose of the drug, but may be difficult to assess completely or in a timely manner. As a result, safe drug administration and personalized patient care may be adversely affected.

[0004] Regarding how to administer the drug to the patient, there are various dosage forms that can be used. For example, these dosage forms can include one or more parenteral, inhalation, oral, ophthalmic, nasal, topical and suppository forms of the drug.

[0005] These dosage forms can be administered directly to the patient via a drug administration device.There are a number of different types of drug administration devices that are commonly used to deliver various dosage forms, including: syringes, injection devices (eg, autoinjectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

[0006] It is desirable to monitor compliance with guidelines related to medications administered to patients in various dosage forms. This can ensure that correct procedures are followed and that incorrect and potentially dangerous methods are avoided. Furthermore, this can also enable optimization of medication administration to patients. Summary of the invention

[0007] Generally, provided herein are devices, methods, and systems for drug delivery modulation. The devices, methods, and systems can allow for modulation of drug dosage during drug administration based on one or more ambient conditions of a patient.

[0008] In one aspect, a drug administration device is provided, which in one embodiment includes a drug holder configured to hold a drug therein. The device also includes: a first sensor configured to collect data about a first characteristic associated with a patient; a second sensor configured to collect data about a second characteristic associated with the patient; a memory configured to store therein an algorithm including at least one variable parameter; and a processor. The processor is configured to control the delivery of a first dose of the drug from the drug holder to the patient by executing the algorithm, change the at least one variable parameter of the algorithm stored in the memory based on the data collected by the first sensor and the data collected by the second sensor, and after changing the at least one variable parameter, control the delivery of a second dose of the drug from the drug holder to the patient by executing the algorithm.

[0009] The device may have any number of variations. For example, the processor may also be configured to automatically control the delivery of a dose according to a predetermined dosing schedule for the patient. For another example, the device may include at least one additional sensor, each of which may be configured to collect data about different features, and the processor may be configured to change the at least one variable parameter of the algorithm stored in the memory based on the data collected by the at least one additional sensor. For another example, the processor may be further configured to consider the data collected by each of the first sensor and the second sensor in the hierarchical structure when changing the at least one variable parameter. For another example, the first feature may be a physiological feature of the patient, and the second feature may be a situational feature of the patient. For another example, the first feature may be one of blood sugar level, blood pressure, sweat level and heart rate, and the second feature may be at least one of core temperature, tremor detection, time of day, date, patient activity level, blood pressure, metabolic rate, altitude, temperature of the drug, viscosity of the drug, GPS information, angular velocity, current of the motor for delivering the drug, blood oxygen level, sunlight, permeability and air quality. As another example, the second sensor may be configured to collect data by capturing an image of at least one of the patient and the patient's environment, and the processor may be configured to analyze the image to determine whether at least one of food intake and skin reaction to the drug occurs. As another example, the processor of the drug administration device (e.g., an injection device, a nasal spray device, and an inhaler) may also be configured to move the device operation prevention mechanism from an unlocked state to a locked state based on at least one of the data collected by the first sensor and the data collected by the second sensor, in which the device operation prevention mechanism allows the drug to be delivered to the user, and in the locked state, the device operation prevention mechanism prevents the drug from being delivered to the user. As another example, the drug may include a biologic, and the second feature may be an inflammatory response. As another example, the drug may include insulin, and the first feature may be a blood sugar level. As another example, the drug may include glucagon, and the first feature may be a blood sugar level. As another example, the drug may include a blood pressure drug, and the first feature may be blood pressure. As another example, the at least one variable parameter may include a delivery rate of the drug from the drug holder to the patient. For another example, the at least one variable parameter may include a time interval between dose deliveries, such that a dose delivered after changing the at least one variable parameter is at a different time interval than a dose delivered before changing the at least one variable parameter. For another example, changing the at least one variable parameter may cause the processor to control the delivery of the second dose so that the second dose is not delivered to the patient. For another example, the processor may be configured to automatically change the at least one variable parameter. For another example, the processor may also be configured to provide a notification to the patient based on data collected by the second sensor.

[0010] As another example, the apparatus may further include a communication interface configured to wirelessly transmit data indicative of data collected by the first sensor and data collected by the second sensor to a remotely located computer system, and in response, wirelessly receive a command from the remotely located computer, and the processor may be configured to change the at least one variable parameter only after the communication interface receives the command.

[0011] For another example, the processor may be configured to change the at least one variable parameter of the algorithm during the delivery of the second dose, so that the algorithm changes in real time with the delivery of the second dose. For another example, the processor may be configured to change the at least one variable parameter of the algorithm before the delivery of the second dose begins.

[0012] For another example, the memory may be further configured to store therein manually input data about the patient, and the processor may be further configured to change the at least one variable parameter of the algorithm stored in the memory based on the stored input data. For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratummumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitaate.

[0013] In another embodiment, a drug administration device is provided, the drug administration device comprising: a drug holder configured to hold a drug therein; a first sensor configured to collect data about a physiological characteristic of a patient; a second sensor configured to collect data about a physical characteristic of a patient; a memory configured to store therein an algorithm including at least one variable parameter; and a processor. The processor is configured to control the delivery of a first dose of the drug from the drug holder to the patient by executing the algorithm, change the at least one variable parameter of the algorithm stored in the memory based on the data collected by the first sensor and the data collected by the second sensor, and after changing the at least one variable parameter, control the delivery of a second dose of the drug from the drug holder to the patient by executing the algorithm.

[0014] The device may have any number of variations. For example, the processor may also be configured to automatically control the delivery of the dose according to the patient's predetermined dosing schedule. As another example, changing the at least one variable parameter may compensate for physical characteristics. As another example, the physical characteristic may be one of temperature, metabolic demand, and cognitive function. As another example, the physiological characteristic may be at least one of body temperature and heart rate, and the physical characteristic may be a metabolic demand measured using at least one of food intake and BMR (basal metabolic rate). As another example, the physical characteristic may be weight. As another example, the processor may be configured to change the at least one variable parameter of the algorithm during the delivery of the second dose so that the algorithm changes in real time with the delivery of the second dose. As another example, the processor may be configured to change the at least one variable parameter of the algorithm before the delivery of the second dose begins. As another example, the memory may also be configured to store therein manually input data about the patient, and the processor may also be configured to change the at least one variable parameter of the algorithm stored in the memory based on the stored input data. As another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0015] In another embodiment, a drug administration device is provided, the drug administration device comprising: an automatic injector including a drug holder configured to hold a drug therein; a plurality of sensors configured to collect data about the angular orientation of the automatic injector relative to the skin of a patient; a memory configured to store therein an algorithm including at least one variable parameter; and a processor. The processor is configured to control the delivery of a dose of the drug from the drug holder to the patient by executing the algorithm, changing the at least one variable parameter of the algorithm stored in the memory based on the data collected by the plurality of sensors.

[0016] The device may have any number of variations. For example, the processor may be configured to change at least one variable parameter of the algorithm to prevent the delivery of the drug from the auto-injector in response to the collected data indicating that the auto-injector is not at a substantially vertical angle relative to the patient's skin, and the processor may be configured to change at least one variable parameter of the algorithm to allow the delivery of the drug from the auto-injector in response to the collected data indicating that the auto-injector is at a substantially vertical angle relative to the patient's skin. For another example, the auto-injector may also include a trigger configured to be actuated to deliver the drug from the drug holder to the patient, and the at least one variable parameter of the algorithm may indicate whether the trigger can be actuated by the user to cause the delivery of the drug. For another example, the auto-injector may also include a device operation prevention mechanism configured to move between a locked state and an unlocked state, in which the device operation prevention mechanism prevents the delivery of the drug from the auto-injector, and in the unlocked state, the device operation prevention mechanism allows the delivery of the drug from the auto-injector, and the processor may be configured to move the device operation prevention mechanism from the locked state to the unlocked state in response to the collected data indicating that the auto-injector is at a substantially vertical angle relative to the patient's skin. In another example, the processor may be configured to change the at least one variable parameter of the algorithm before the dose delivery begins. In another example, the plurality of sensors may include a contact sensor. In another example, the plurality of sensors may include a pressure sensor. In another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0017] In another embodiment, a drug administration system is provided, which in one embodiment includes a drug administration device and an accessory. The drug administration device is configured to hold a drug therein for delivery to a patient and includes a sensor configured to collect data about a physiological characteristic of the patient. The accessory includes a processor configured to receive data indicative of the collected data from the sensor and control the delivery of the drug to the patient based on the received data.

[0018] The system may have any number of variations. For example, the accessory and the drug administration device may be separate devices. In at least some embodiments, the accessory may be configured to be worn by the patient and may include one of a headset, a smart watch, a nail sensor, a digital collection patch, augmented reality glasses, and a camera. In at least some embodiments, the accessory may be configured to be implanted in the patient or ingested by the patient. In at least some embodiments, the accessory may be configured to collect data by capturing images of at least one of the patient and the patient's environment, and the processor may also be configured to analyze the image to determine whether at least one of food intake and skin reaction to the drug occurs.

[0019] In another example, controlling delivery may include adjusting at least one of the dosage of the drug, the timing between the dosages of the drug, and the location of drug delivery. In another example, the physiological characteristic may include the patient's response to the drug delivered thereto. In another example, the physiological characteristic may include at least one of angular velocity, blood oxygen level, sunlight, and osmotic pressure. In another example, the sensor may include a biosensor configured to sense an enzyme, an antibody, histamine, or a nucleic acid. In another example, the sensor may include a sensor array or a dual sensor. In another example, the drug may include insulin, and the physiological characteristic may be a blood sugar level. In another example, the drug may include glucagon, and the physiological characteristic may be a blood sugar level. In another example, the drug may include a blood pressure drug, and the physiological characteristic may be blood pressure. In another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin afa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0020] In another aspect, a method of administering a drug is provided, which in one embodiment includes collecting data about a first characteristic associated with a patient using a first sensor. The method also includes collecting data about a second characteristic associated with the patient using a second sensor.

[0021] The method also includes, using a processor, controlling the delivery of a first dose of the drug from the drug administration device to the patient by executing an algorithm stored in the memory, changing at least one variable parameter of the algorithm stored in the memory based on data collected by the first sensor and data collected by the second sensor, and after changing the at least one variable parameter, controlling the delivery of a second dose from the drug administration device to the patient by executing the algorithm.

[0022] The method may have any of a variety of changes. For example, the first feature may be a physiological feature of the patient, and the second feature may be a situational feature of the patient. For another example, the first feature may be one of blood glucose level, blood pressure, sweat level, and heart rate, and the second feature may be at least one of core temperature, tremor detection, time of day, date, patient activity level, blood pressure, metabolic rate, altitude, temperature of the drug, viscosity of the drug, GPS information, angular velocity, blood oxygen level, sunlight, osmotic pressure, and air quality. For another example, the processor may change at least one variable parameter of the algorithm during the delivery of the second dose so that the algorithm changes in real time with the delivery of the second dose. For another example, the processor may change at least one variable parameter of the algorithm before the delivery of the second dose begins. For another example, the memory may also store therein manually input data about the patient, and the processor may change at least one variable parameter of the algorithm stored in the memory based on the stored input data. As another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0023] In another embodiment, a method of administering a drug is provided, the method comprising collecting data about a physiological characteristic associated with a patient using a first sensor. The method also comprises collecting data about a physical characteristic associated with the patient using a second sensor. The method also comprises, using a processor, controlling the delivery of a first dose of the drug from the drug administration device to the patient by executing an algorithm stored in a memory, changing at least one variable parameter of the algorithm stored in the memory based on the data collected by the first sensor and the data collected by the second sensor, and after changing the at least one variable parameter, controlling the delivery of a second dose from the drug administration device to the patient by executing the algorithm.

[0024] The method can be varied in any manner. For example, the processor can automatically control the delivery of the dose according to the patient's predetermined dosing plan. As another example, changing the at least one variable parameter can compensate for physical characteristics. As another example, the physical characteristic can be one of temperature, metabolic demand and cognitive function. As another example, the physiological characteristic can be at least one of body temperature and heart rate, and the physical characteristic can be a metabolic demand measured using at least one of food intake and BMR (basal metabolic rate). As another example, the physical characteristic can be weight. As another example, the processor can change the at least one variable parameter of the algorithm during the delivery of the second dose so that the algorithm changes in real time with the delivery of the second dose. As another example, the processor can change the at least one variable parameter of the algorithm before the delivery of the second dose begins. As another example, the memory can also store therein manually input data about the patient, and the processor can change the at least one variable parameter of the algorithm stored in the memory based on the stored input data. As another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0025] In another embodiment, a method of administering a drug is provided, the method comprising collecting data about a physiological characteristic of a patient using a sensor of a drug administration device. The method further comprises, using a processor as an accessory to a device independent of the drug administration device, receiving data indicative of the collected data from the sensor, and controlling the delivery of the drug from the drug administration device to the patient based on the received data.

[0026] The method can be varied in any manner. For example, the attachment can be worn by the patient and may include one of headphones, smart watches, nail sensors, digital collection patches, augmented reality glasses, and cameras. For another example, the attachment may be implanted in the patient or may be ingested by the patient. For another example, the attachment may collect data by capturing an image of at least one of the patient and the environment in which the patient is located, and the processor may analyze the image to determine whether at least one of food intake and skin response to the drug occurs. For another example, control delivery may include adjusting at least one of the timing between drug doses, drug doses, and drug delivery locations. For another example, physiological characteristics may include the patient's response to the drug delivered thereto. For another example, physiological characteristics may include at least one of angular velocity, blood oxygen level, sunlight, and permeability. For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin afa, risperidone, esketamine, ketamine, and paliperidone palmitate. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention is described with reference to the following drawings:

[0028] Figure 1 is a schematic diagram of a first type of drug administration device, namely an auto-injector;

[0029] Figure 2 is a schematic diagram of a second type of drug administration device, namely an infusion pump;

[0030] Figure 3 is a schematic diagram of a third type of drug administration device, namely an inhaler;

[0031] Figure 4 is a schematic diagram of a fourth type of drug administration device, namely a nasal spray device;

[0032] Figure 5A is a schematic diagram of a general drug administration device;

[0033] Figure 5B is a schematic diagram of a universal drug administration device;

[0034] Figure 6 is a schematic diagram of a housing for a dosage form;

[0035] Figure 7 is a schematic diagram of one embodiment of a drug administration device and a communication network system with which a housing may operate;

[0036] Figure 8 is a schematic diagram of one embodiment of a drug administration device and a computer system with which the housing may operate;

[0037] Fig. 9 is a schematic diagram of another embodiment of a drug administration device;

[0038] Fig.10 is in use Fig. 9 A flow chart of a drug administration device;

[0039] Fig.11 is a graphical representation of the effect of another embodiment of a drug administration device in use on a patient over time;

[0040] Fig.12 is a schematic diagram of another embodiment of a drug administration device;

[0041] Fig.13 is in use Fig.12 A flow chart of a drug administration device;

[0042] Fig.14 is a perspective view of one embodiment of an accessory in the form of an earphone for use with a drug administration device on a patient;

[0043] Fig.15is a perspective view of another embodiment of an accessory in the form of a wristband for use with a drug administration device on a patient;

[0044] Fig.16 is a perspective view of another embodiment of an accessory in the form of a headband for use with a drug administration device on a patient;

[0045] Fig.17 is a perspective view of another embodiment of an attachment for use with a drug administration device attached to a patient's head;

[0046] Fig.18 is a perspective view of another embodiment of an attachment for use with a drug administration device attached to the abdomen of a patient;

[0047] Fig.19 is a perspective view of another embodiment of an attachment for use with a drug administration device attached to a patient's back;

[0048] Fig. 20 is a perspective view of another embodiment of an attachment for use with a drug administration device attached to a patient's nail;

[0049] Fig.21 is a perspective view of another embodiment of an attachment for use with a drug administration device attached to a patient's nail;

[0050] Fig. 22 is a partial cross-sectional view of another embodiment of an attachment for use with a drug administration device implanted in a patient;

[0051] Fig.23 is a perspective view of another embodiment of an accessory in the form of a pair of glasses for use with a drug administration device, the glasses enabling viewing of a patient's food;

[0052] Fig.24 is a perspective view of another embodiment of an accessory in the form of a smart phone for use with a drug administration device, the smart phone taking a picture of a patient;

[0053] Fig.25 is to take pictures and measure the response over time. Fig.24 A graphical representation of a patient's skin;

[0054] Fig.26 To take photos of patients Fig.24 A perspective view of the attachment;

[0055] Fig. 27 is to take pictures and measure the response over time. Fig.26 A graphical representation of a patient's skin;

[0056] Fig.28is a perspective view of another embodiment of an accessory in the form of a smart phone for use with a drug administration device, the smart phone taking a picture of a patient;

[0057] Fig.29 is based on Fig.28 An image of a graphical representation of the patient's estimated weight;

[0058] Fig.30 is a perspective view of another embodiment of a drug administration device;

[0059] Fig.31 Shows that during a series of events Fig.30 front views of a user interface of a device;

[0060] Fig.32 is in use Fig.30 A graphical representation of the effects of a drug administration device on a patient over time;

[0061] Fig.33 is a graphical representation of the effect of another embodiment of a drug administration device in use on a patient over time;

[0062] Fig.34 is a graphical representation of the effect of another embodiment of a drug administration device in use on a patient over time;

[0063] Fig.35 is a front view of another embodiment of a user interface of a drug administration device;

[0064] Fig.36 is in use Fig.35 A graphical representation of the effects of a drug administration device on a patient over time;

[0065] Fig.37 is a side view of a distal portion of one embodiment of an automatic injector;

[0066] Fig.38 yes Fig.37 A distal end view of the automatic injector;

[0067] Fig.39 is in use Fig.37 A side view of an automatic injector;

[0068] Fig.40 yes Fig.37 A side view of a distal portion of an auto-injector of the embodiment of the present invention, the auto-injector not yet in contact with the patient's skin;

[0069] Fig.41 yes Fig.40a side view of a distal portion of an auto-injector of , wherein the auto-injector is in contact with the skin and in a correct angular orientation relative to the skin;

[0070] Fig.42 yes Fig.40 a side view of a distal portion of an auto-injector of , wherein the auto-injector is in contact with the skin and in an incorrect angular orientation relative to the skin; and

[0071] Fig.43 is a schematic diagram of one embodiment of a drug administration device and a motorized add-on module. DETAILED DESCRIPTION

[0072] Certain exemplary embodiments will now be described to understand the principles of the structure, function, manufacture and use of the devices, systems and methods disclosed herein as a whole. One or more examples of these embodiments are shown in the accompanying drawings. It will be appreciated by those skilled in the art that the devices, systems and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the present invention is limited only by the claims. The features shown or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0073] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, each feature of each component with similar names may not necessarily be fully described. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. Those skilled in the art will understand that the dimensions may not be exact values, but are considered to be approximately at the value due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment. The size and shape of the systems and devices and their components may depend at least on the size and shape of the components with which the systems and devices will be used.

[0074] Examples of various types of drug administration devices, namely, an auto-injector 100 , an infusion pump 200 , an inhaler 300 , and a nasal spray device 400 , are described below with reference to the above-mentioned drawings.

[0075] Auto-injectors

[0076] Figure 11 is a schematic, exemplary view of a first type of drug delivery device, i.e., an injection device, in this example, an auto-injector 100, that can be used with the embodiments described herein. The auto-injector 100 includes a drug holder 110 that retains the drug to be dispensed and a dispensing mechanism 120 that is configured to dispense the drug from the drug holder 110 so that the drug can be administered to a patient. The drug holder 110 is typically in the form of a container containing the drug, for example, it can be provided in the form of a syringe or a vial, or any other suitable container that can hold the drug. The auto-injector 100 includes a discharge nozzle 122, such as a needle of a syringe, which is disposed at the distal end of the drug holder 110. The dispensing mechanism 120 includes: a drive element 124, which itself may also include a piston and / or a piston rod; and a drive mechanism 126. The dispensing mechanism 120 is located proximal to the end of the drug holder 110 and is positioned toward the proximal end of the auto-injector 100.

[0077] The auto-injector 100 includes a housing 130 that contains a drug holder 110, a drive element 124, and a drive mechanism 126 within the body of the housing 130, and includes a discharge nozzle 122 that will typically be completely contained within the housing prior to injection, but will extend from the housing 130 during the injection sequence to deliver the drug. The dispensing mechanism 120 is arranged so that the advancing drive element 124 passes through the drug holder 110 so as to dispense the drug through the discharge nozzle 122, thereby allowing the auto-injector to administer the drug retained in the drug holder 110 to the patient. In some cases, the user can manually advance the drive element 124 through the drug holder 110. In other cases, the drive mechanism 126 may include a stored energy source 127 that advances the drive element 124 without user assistance. The stored energy source 127 may include a resilient biasing member such as a spring or pressurized gas, or an electric motor and / or a gear box.

[0078] The autoinjector 100 includes a dispensing mechanism protection mechanism 140. The dispensing mechanism protection mechanism 140 generally has two functions. First, the dispensing mechanism protection mechanism 140 can function to prevent access to the discharge nozzle 122 before and after an injection. Second, the autoinjector 100 can function so that the dispensing mechanism 120 can be activated when placed in an activated state, for example, when the dispensing mechanism protection mechanism 140 is moved to an unlocked position.

[0079] When the drug holder 110 is in its retracted position located proximally within the housing 130, the protection mechanism 140 covers at least a portion of the discharge nozzle 122. This is to hinder contact between the discharge nozzle 122 and the user. Alternatively or in addition, the protection mechanism 140 itself is configured to retract proximally to expose the discharge nozzle 122 so that the discharge nozzle can be brought into contact with the patient. The protection mechanism 140 includes a shield member 141 and a return spring 142. When no force is applied to the distal end of the protection mechanism 140, the return spring 142 acts to extend the shield member 141 from the housing 130, thereby covering the discharge nozzle 122. If the user applies a force to the shield member 141 against the action of the return spring 142 to overcome the bias of the return spring 142, the shield member 141 retracts into the housing 130, thereby exposing the discharge nozzle 122. Alternatively or in addition, the protection mechanism 140 may include an extension mechanism (not shown) for extending the discharge nozzle 122 beyond the housing 130 and may also include a retraction mechanism (not shown) for retracting the discharge nozzle 122 into the housing 130. Alternatively or in addition, the protection mechanism 140 may include a housing cover and / or a discharge nozzle cover that may be attached to the autoinjector 100. Removing the housing cover will typically also remove the discharge nozzle cover from the discharge nozzle 122.

[0080] The auto-injector 100 also includes a trigger 150. The trigger 150 includes a trigger button 151 located on an outer surface of the housing 130 such that the trigger button is accessible to a user of the auto-injector 100. When the user depresses the trigger 150, the trigger acts to release the drive mechanism 126, causing the drug to be expelled from the drug holder 110 via the drive element 124 and subsequently via the discharge nozzle 122.

[0081] The trigger 150 may also cooperate with the shield member 141 in such a way that the trigger 150 is prevented from being activated until the shield member 141 has been fully retracted proximally into the housing 130 to enter the unlocked position, for example by pushing the distal end of the shield member 141 against the patient's skin. When this has been done, the trigger 150 is unlocked and the auto-injector 100 is activated so that the trigger 150 can be depressed and an injection and / or drug delivery sequence is then initiated. Alternatively, retracting the shield member 141 alone into the housing 130 in the proximal direction can be used to activate the drive mechanism 126 and initiate an injection and / or drug delivery sequence. In this way, the auto-injector 100 has a device operation prevention mechanism that prevents the mechanism from preventing the dispensing of the drug by, for example, preventing an accidental release of the dispensing mechanism 120 and / or an accidental actuation of the trigger 150.

[0082] Although the foregoing description relates to one example of an autoinjector, this example is presented for illustration only and the present invention is not limited to such an autoinjector. Those skilled in the art will appreciate that various modifications to the described autoinjector may be implemented within the scope of the present disclosure.

[0083] The autoinjectors of the present disclosure may be used to administer any of a variety of drugs, such as any of epinephrine, rebif, etanercept, enrofloxacin, atropine, pralidoxime chloride, and diazepam.

[0084] Infusion Pump

[0085] In other cases, patients may require precise continuous drug delivery or drug delivery that occurs periodically or frequently at set periodic intervals. Infusion pumps can provide such controlled drug infusions by facilitating administration of the drug at a precise rate that keeps drug concentrations within the therapeutic range without requiring frequent attention from a healthcare professional or patient.

[0086] Figure 2 2 is a schematic illustrative view of a second type of drug delivery device, i.e., an infusion pump 200, which can be used with the embodiments described herein. The infusion pump 200 includes a drug holder 210 in the form of a reservoir for accommodating the drug to be delivered, and a dispensing mechanism 220 including a pump 216, which is suitable for dispensing the drug contained in the reservoir so that the drug can be delivered to the patient. These components of the infusion pump are located in the housing 230. The dispensing mechanism 220 also includes an infusion line 212. The drug is delivered from the reservoir via the infusion line 212 when the pump 216 is actuated, and the infusion line can be in the form of a cannula. The pump 216 can be in the form of a motor-controlled piston in an elastic pump, a peristaltic pump, an osmotic pump, or a syringe. Typically, the drug is delivered intravenously, but subcutaneous infusion, arterial infusion, and epidermal infusion can also be used.

[0087] The infusion pumps of the present disclosure may be used to administer any of a variety of drugs, such as any of insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, and zoledronic acid.

[0088] The infusion pump 200 includes control circuitry, such as a processor 296, in addition to a memory 297 and a user interface 280, which together provide a trigger mechanism and / or a dose selector for the pump 200. The user interface 280 may be implemented by a display screen located on the housing 230 of the infusion pump 200. The control circuitry and user interface 280 may be located within the housing 230, or external to the housing, and communicate with the pump 216 via a wired or wireless interface to control the operation of the pump.

[0089] The actuation of pump 216 is controlled by processor 296, which communicates with pump 216 to control the operation of the pump. Processor 296 can be programmed by a user (e.g., a patient or a healthcare professional) via user interface 280. This enables infusion pump 200 to deliver drugs to a patient in a controlled manner. The user can input parameters such as infusion duration and delivery rate. The delivery rate can be set to a constant infusion rate by the user, or can be set to a set interval for periodic delivery, which is usually within pre-programmed limits. The programming parameters for controlling pump 216 are stored in a memory 297 that communicates with processor 296 and retrieved from the memory. User interface 280 can take the form of a touch screen or keyboard.

[0090] Power source 295 provides power to pump 216 and may take the form of an energy source integral to pump 216 and / or a mechanism for connecting pump 216 to an external power source.

[0091] The infusion pump 200 can take a variety of different physical forms depending on its intended use. It can be a fixed, non-portable device, such as for use at a patient's bedside, or it can be an ambulatory infusion pump designed to be portable or wearable. The integrated power source 295 is particularly beneficial for ambulatory infusion pumps.

[0092] Although the foregoing description relates to an example of an infusion pump, this example is provided for illustration only. The present disclosure is not limited to such an infusion pump. Those skilled in the art will appreciate that various modifications to the described infusion pump may be implemented within the scope of the present disclosure. For example, the processor may be preprogrammed so that the infusion pump does not have to include a user interface.

[0093] Inhaler

[0094] Figure 33 is a schematic diagram of a drug application device of the third type, i.e., an inhaler 300. The inhaler 300 includes a drug holder 310 in the form of a can. The drug holder 310 contains a drug that will generally be in the form of a solution or suspension with a suitable carrier fluid. The inhaler 300 also includes a dispensing mechanism 320, which includes a pressurized gas for pressurizing the drug holder 310, a valve 325, and a nozzle 321. The valve 325 forms the outlet of the drug holder 310. The valve 325 includes a narrow opening 324 formed in the drug holder 310 and a movable element 326 controlling the opening 324. When the movable element 326 is in a stationary position, the valve 325 is in a closed or unactuated state, in which the opening 324 is closed and the drug holder 310 is sealed. When the movable element 326 is actuated from the stationary position to the actuated position, the valve 325 is actuated to an open state, in which the opening 324 is open. The actuation of movable element 326 from rest position to actuation position comprises that movable element 326 is moved in the medicine holder 310.Movable element 326 is elastically biased in the rest position.In the open state of valve 325, pressurized gas will be in the medicine of solution or suspension form with suitable liquid and pushes out medicine holder 310 through opening 324 at a high speed.Liquid causes liquid atomization through narrow opening 324 at a high speed, that is to say, changes the mist of liquid fine droplets and / or changes into gas cloud from bulk liquid.The patient can suck the mist of fine droplets and / or gas cloud in the respiratory tract.Therefore, inhaler 300 can be delivered to the patient's respiratory tract by the medicine that is retained in the medicine holder 310.

[0095] The medicine holder 310 is removably held in the housing 330 of the inhaler 300. The passage 333 formed in the housing 330 connects the first opening 331 in the housing 330 and the second opening 332 in the housing 330. The medicine holder 310 is received in the passage 333. The medicine holder 310 can be slidably inserted into the passage 333 through the first opening 331 of the housing 330. The second opening 332 of the housing 330 forms an oral piece 322 configured to be placed in the oral cavity of the patient, or a nasal piece configured to be placed in the nostril of the patient, or a mask configured to be placed on the mouth and nose of the patient. The medicine holder 310, the first opening 331 and the passage 333 are sized so that air can flow through the passage 333, flow around the medicine holder 310, and flow between the first opening 331 and the second opening 332. The inhaler 300 can be provided with a dispensing mechanism protection mechanism 140 in the form of a cap (not shown), which can be assembled to the oral piece 322.

[0096] Inhaler 300 also includes trigger 350, and this trigger includes valve actuation feature 355, and this valve actuation feature is configured to actuate valve 325 when trigger 350 is activated.Valve actuation feature 355 is the protrusion of housing 330 into passage 333.Medicine holder 310 can be slidably moved to second position from first position in passage 333.In first position, the end of movable element 326 in static position abuts valve actuation feature 355.In second position, medicine holder 310 can be shifted toward valve actuation feature 355, so that valve actuation feature 355 moves movable element 326 into medicine holder 310 to actuate valve 325 to open state.The hand of user provides required force to move medicine holder 310 from first position to second position with movable element 326 against elastic bias.Valve actuation feature 355 includes inlet 356 connected to nozzle 321. Inlet 356 of valve actuation feature 355 is sized and positioned to couple to opening 324 of valve 325 so that a sprayed mist of droplets and / or a gas cloud can enter inlet 356 and exit nozzle 321 to enter passage 333. Nozzle 321 facilitates atomizing bulk liquid into a mist of droplets and / or a gas cloud.

[0097] The valve 325 provides a metering mechanism 370. The metering mechanism 370 is configured to close the valve after a measured amount of liquid, and therefore medicament, has passed through the opening 324. This allows a controlled dose to be administered to the patient. Typically, the measured amount of liquid is preset, however, the inhaler 300 may be equipped with a dose selector 360 that can be operated by the user to change the defined amount of liquid.

[0098] Although the foregoing description relates to a specific example of an inhaler, this example is illustrative only. The description should not be considered as being limited to this inhaler. It is understood by those skilled in the art that numerous other types of inhalers and sprayers can be used together with the present disclosure. For example, the medicine can be in powdered form, the medicine can be in liquid form, or the medicine can be atomized by a dispensing mechanism 320 of other forms including ultrasonic vibration, compressed gas, vibrating net or heat source.

[0099] The inhaler of the present disclosure can be used to administer any of a variety of drugs, such as any of mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium, glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol, and olodaterol.

[0100] Nasal spray device

[0101] Figure 44 is a schematic diagram of a fourth type of drug administration device, namely a nasal spray device 400. The nasal spray device 400 is configured to discharge the drug into the patient's nose. The nasal spray device 400 includes a drug holder 402, which is configured to contain the drug therein for delivery from the device 400 to the patient. The drug holder 102 may have a variety of configurations, such as a bottle-shaped reservoir, a box, a vial (as in the embodiment shown), a blow-fill-seal (BFS) capsule, a blister package, etc. In an exemplary embodiment, the drug holder 402 is a vial. The exemplary vial is formed by one or more materials such as glass, polymers, etc. In some embodiments, the vial may be formed by glass. In other embodiments, the vial may be formed by one or more polymers. In yet other embodiments, different parts of the vial may be formed by different materials. The exemplary vial may include a variety of features to facilitate sealing and storing the drug therein, as described herein and shown in the accompanying drawings. However, those skilled in the art will appreciate that the vial may include only some of these feature structures and / or may include a plurality of other feature structures known in the art. The vials described herein are intended to represent certain exemplary embodiments only.

[0102] The opening 404 of the nasal spray device 400 through which the drug leaves the nasal spray device 400 is formed in the tip 408 of the distribution head 406 of the nasal spray device 400. Tip 408 is configured to be inserted into the patient's nostril. In an exemplary embodiment, tip 408 is configured to be inserted into the first nostril of the patient during the first operation stage of the nasal spray device 400, and inserted into the second nostril of the patient during the second operation stage of the nasal spray device 400. The first operation stage and the second operation stage involve two separate actuations of the nasal spray device 400, the first actuation corresponding to the first dose of the drug delivered and the second actuation corresponding to the second dose of the drug delivered. In some embodiments, the nasal spray device 400 is configured to be actuated only once to deliver a nasal spray. In some embodiments, the nasal spray device 400 is configured to be actuated three or more times to deliver three or more (e.g., four times, five times, six times, seven times, eight times, nine times, ten times, etc.) nasal sprays.

[0103] The dispensing head 406 includes a depth guide 410 configured to contact the patient's skin between the first and second nostrils of the patient such that the longitudinal axis of the dispensing head 406 is substantially aligned with the longitudinal axis of the nostril into which the tip 408 is inserted. Those skilled in the art will appreciate that the longitudinal axes may not be precisely aligned, but are considered to be substantially aligned due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment.

[0104] In an exemplary embodiment, as in Figure 44, the dispensing head 406 has a conical shape, wherein the dispensing head 406 has a smaller diameter at its distal end than at its proximal end where the opening 404 is located. The opening 404 having a relatively small diameter facilitates spraying the drug out of the opening 404, as will be appreciated by those skilled in the art. The spray chamber 412 through which the drug is configured to pass before leaving the opening 404 is located within the proximal portion of the conical dispensing head 406 away from the opening 404. As the drug quickly passes through the spray chamber 412, the spray chamber 412 facilitates the generation of a fine mist that passes through the opening 404 in a consistent spray pattern. Figure 4 Arrow 414 in shows the path that the drug travels from drug holder 402 and out of opening 404 .

[0105] In some embodiments, dispensing head 406 may include two tips 408, each having an opening 404 therein, such that nasal spray device 400 is configured to deliver certain doses of medicament to both nostrils simultaneously in response to a single actuation.

[0106] Dispensing head 406 is configured to be pushed toward medication holder 402, e.g., by a user pushing down on depth guide 410 to depress, to actuate nasal spray device 400. In other words, dispensing head 406 is configured as an actuator so as to be actuated to drive medication from medication holder 402 out of nasal spray device 400. In an exemplary embodiment, nasal spray device 400 is configured to be self-administered, such that the user actuating nasal spray device 400 is a patient receiving medication from nasal spray device 400, but another person may also actuate nasal spray device 400 for delivery to another person.

[0107] like Figure 4 As shown by arrow 416 in FIG. 4 , actuation (e.g., depression) of the dispensing head 406 is configured to cause air to enter the drug holder 402. The air entering the drug holder 402 displaces the drug in the drug holder through the tube 418 and then into the metering chamber 420, which displaces the drug proximally through the cannula 422, through the spray chamber 412, and then out of the opening 404. In response to the release of the dispensing head 406, for example, the user stops pushing down on the dispensing head 406, the biasing spring 426 causes the dispensing head 406 to return to its default resting position to position the dispensing head 406 relative to the drug holder 402 for subsequent actuation and drug delivery.

[0108] Although the foregoing description relates to a specific example of a nasal spray device, the example is illustrative only. The description should not be considered limited to such a nasal spray device. Those skilled in the art understand that the nasal spray device 400 may include different features in different embodiments according to various requirements. For example, the nasal spray device 400 may lack a depth guide 410 and / or may include any one or more of a device indicator, a sensor, a communication interface, a processor, a memory, and a power source.

[0109] The nasal spray devices of the present disclosure can be used to administer any of a variety of drugs, such as ketamine (e.g., ), esketamine (e.g. and ), naloxone (e.g. ) and sumatriptan (e.g., )

[0110] Drug administration device

[0111] As will be appreciated from the foregoing, the various components of a drug delivery device are common to all such devices. These components form the basic components of a universal drug administration device. A drug administration device delivers a drug to a patient, wherein the drug is provided in a defined dosage form within the drug administration device.

[0112] Figure 5A is a generalized schematic diagram of such a universal drug administration device 501, and Figure 5B is an exemplary embodiment of such a universal drug administration device 500. Examples of the universal drug administration device 500 include injection devices (eg, auto-injectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

[0113] like Figure 5A As shown, the drug administration device 501 includes in general form the features of a drug holder 10 and a dispensing mechanism 20. The drug holder 10 holds the drug in a dosage form to be administered. The dispensing mechanism 20 is configured to release the dosage form from the drug holder 10 so that the drug can be administered to a patient.

[0114] Figure 5BAnother generic drug administration device 500 is shown that includes a number of additional features. Those skilled in the art will appreciate that these additional features are optional to different embodiments and may be used in a variety of different combinations, such that the additional features may be present in or omitted from a given embodiment of a particular drug administration device depending on requirements such as the type of drug, the dosage form of the drug, the medical indication for treatment with the drug, safety requirements, whether the device is powered, whether the device is portable, whether the device is for self-administration, and many other requirements that will be apparent to those skilled in the art. Similar to Figure 5A The drug administration device 500 includes a housing 30 that houses a drug holder 10 and a dispensing mechanism 20.

[0115] The device 500 is provided with a trigger mechanism 50 for initiating the release of the drug from the drug holder 10 via the dispensing mechanism 20. The device 500 includes a feature of a metering / dosing mechanism 70 that measures out a set dose for release from the drug holder 10 via the dispensing mechanism 20. In this way, the drug administration device 500 can provide a known dose of a determined size. The device 500 includes a dose selector 60 that enables a user to set a dose volume of the drug to be dispensed by the metering mechanism 70. The dose volume can be set to a specific value of a plurality of predefined discrete dose volumes, or any value of a predefined dose volume within a dose volume range.

[0116] The device 500 may include a device operation prevention mechanism 40 or 25, which, when in a locked state, will prevent and / or stop the dispensing mechanism 20 from releasing the drug from the drug holder 10, and when in an unlocked state, will allow the dispensing mechanism 20 to release the drug dose from the drug holder 10. This can prevent accidental administration of the drug, for example, to prevent administration at an incorrect time or to prevent unintentional actuation. The device 500 also includes a dispensing mechanism protection mechanism 42, which prevents access to at least a portion of the dispensing mechanism 20, for example, for safety reasons. The device operation prevention mechanism 40 and the dispensing mechanism protection mechanism 42 can be the same component.

[0117] The device 500 may include a device indicator 85 configured to present information about the status of the drug administration device and / or the drug contained therein. The device indicator 85 may be a visual indicator such as a display screen, or an audio indicator. The device 500 includes a user interface 80, which may be configured to present information about the device 500 to a user of the device 500 and / or enable the user to control the device 500. The device 500 includes a device sensor 92, which is configured to sense information related to the drug administration device and / or the drug contained therein, such as dosage form and device parameters. For example, in an embodiment including a metering mechanism 70 and a dose selector 60, the embodiment may also include one or more device sensors 92, which are configured to sense one or more of the following: a dose selected by a user using the dose selector 60, a dose metered by the metering mechanism 70, and a dose dispensed by the dispensing mechanism 20. Similarly, an environmental sensor 94 is provided, which is configured to sense information related to the environment in which the device 500 is located, such as the temperature, location, and time of the environment. There may be a dedicated location sensor 98 configured to determine the geographic location of the device 500, for example via satellite location determination such as GPS. The device 500 also includes a communication interface 99 that can communicate data about the device and / or medication that has been acquired from various sensors to the outside.

[0118] If desired, the device 500 includes a power source 95 for delivering electrical power to one or more electrical components of the device 500. The power source 95 can be a power source integral to the device 500 and / or a mechanism for connecting the device 500 to an external power source. The drug administration device 500 also includes a device computer system 90, which includes a processor 96 and a memory 97, which are powered by the power source 95 and communicate with each other and optionally with other electrical and control components of the device 500, such as the environmental sensor 94, the position sensor 98, the device sensor 92, the communication interface 99, and / or the indicator 85. The processor 96 is configured to obtain data acquired from the environmental sensor 94, the device sensor 92, the communication interface 99, the position sensor 98, and / or the user interface 80, and process the data to provide data output, for example, to the indicator 85 and / or the communication interface 99.

[0119] In some embodiments, the drug administration device 500 is packaged in a package 35. The package 35 may also include a combination of a processor 96, a memory 97, a user interface 80, a device indicator 85, a device sensor 92, a position sensor 98, and / or an environmental sensor 94 as described herein, and these may be located externally on the housing of the device 500.

[0120] Those skilled in the art will appreciate that the universal drug administration device 500 including the drug holder 10 and the dispensing mechanism 20 can be provided with the various optional features described above in a variety of different combinations. In addition, the drug administration device 500 can include more than one drug holder 10, optionally with more than one dispensing mechanism 20, such that each drug holder has its own associated dispensing mechanism 20.

[0121] Drug dosage form

[0122] Conventionally, drug administration devices utilize liquid dosage forms. However, it will be appreciated that other dosage forms are available.

[0123] One such common dosage form is a tablet. Tablets can be formed from a combination of drug and excipients compressed together. Other dosage forms are pastes, creams, powders, ear drops, and eye drops.

[0124] Additional examples of drug dosage forms include skin patches, drug eluting stents, and intrauterine devices. In these examples, the body of the device includes the drug and can be configured to allow the drug to be released in certain circumstances. For example, a skin patch may include a polymer composition containing the drug. The polymer composition allows the drug to diffuse out of the polymer composition and into the patient's skin. Drug eluting stents and intrauterine devices can operate in a similar manner. In this way, patches, stents, and intrauterine devices themselves can be considered as drug holders with associated dispensing mechanisms.

[0125] Any of these dosage forms may be configured to initiate drug release by certain conditions. This may allow the drug to be released at a desired time or location after the dosage form has been introduced into the patient. In particular, drug release may be initiated by an external stimulus. In addition, these dosage forms may be contained in a housing prior to administration, which may be in the form of a package. The housing may include some of the above-mentioned optional features that are utilized with the universal drug administration device 500.

[0126] The drug administered by the drug administration device of the present disclosure may be any substance that causes physiological or psychological changes in an organism when consumed. Examples of drugs that can be administered by the drug administration device of the present disclosure include 5-α-reductase inhibitors, 5-aminosalicylate, 5HT3 receptor antagonists, ACE inhibitors and calcium channel blockers, ACE inhibitors and thiazides, adamantane antivirals, adrenocortical steroids, adrenocortical steroid inhibitors, adrenal bronchodilators, hypertensive emergency drugs, pulmonary hypertension drugs, aldosterone receptor antagonists, alkylating agents, allergen preparations, α-glucosidase inhibitors, alternative medicines, anti-amoebic drugs, aminoglycoside antibiotics, aminopenicillins, aminosalicylate, AMPA receptor antagonists, amylin analogs, analgesic complexes, and sedatives. Combinations, analgesics, androgens and anabolic steroids, angiotensin converting enzyme inhibitors, angiotensin II inhibitors and calcium channel blockers, angiotensin II inhibitors and thiazides, angiotensin receptor blockers, angiotensin receptor blockers and enkephalinase inhibitors, anorectal preparations, anorectal agents, antacids, anthelmintics, antiangiogenic ophthalmic agents, anti-CTLA-4 monoclonal antibodies, anti-infectives, anti-PD-1 monoclonal antibodies, (central) antiadrenergics and thiazides, (peripheral) antiadrenergics and thiazides, centrally acting antiadrenergics, peripherally acting antiadrenergics, anti Androgens, antianginal drugs, antiarrhythmic drugs, antiasthmatic combination drugs, antibiotics / antineoplasty drugs, anticholinergic antiemetic drugs, anticholinergic antiparkinsonian drugs, anticholinergic bronchodilators, anticholinergic chronotropic drugs, anticholinergic / antispasmodic drugs, anticoagulant reversal agents, anticoagulants, antispasmodics, antidepressants, antidiabetic drugs, antidiabetic combination drugs, antidiabetic drugs, antidiarrheal drugs, antidiuretic hormones, antidote, antiemetic / antivertigo drugs, antifungal drugs, antigonadotropins, antigout drugs, antihistamines, antihyperlipidemic drugs, antihyperlipidemic combination drugs, antihypertensive combination drugs, antihyperuric acid drugs, antimalarials, antimalarial combination drugs, antimalarial quinolones, antimanic drugs, anti-metastatic drugs Anti-inflammatory drugs, anti ... Anticonvulsants, benzodiazepines beta-blockers and calcium channel blockers, beta-blockers and thiazides, beta-adrenergic blockers, beta-lactamase inhibitors, bile acid sequestrants, biologics, bisphosphonates, bone morphogenetic protein, bone resorption inhibitors, bronchodilator combination drugs, bronchodilators, calcimimetics, calcineurin inhibitors, calcitonin, calcium channel blockers, carbamate antispasmodics, carbapenems, carbapenem / beta-lactamase inhibitors, carbonic anhydrase inhibitors antispasmodics, carbonic anhydrase inhibitors, cardiac stress medications, cardioselective beta-blockers, cardiovascular drugs, catecholamines, cation exchange resins, CD20 monoclonal antibodies, CD30 monoclonal antibodies, CD33 monoclonal antibodies, CD38 monoclonal antibodies, CD52 monoclonal antibodies, CDK 4 / 6 inhibitors, central nervous system drugs, cephalosporins, cephalosporins / β-lactamase inhibitors, cerumen-lytics, CFTR combination drugs, CFTR potentiators, CGRP inhibitors, chelators, chemokine receptor antagonists, chloride channel activators, cholesterol absorption inhibitors, cholinergic agonists, cholinergic muscle stimulants, cholinesterase inhibitors, CNS stimulants, coagulation regulators, colony stimulating factors, contraceptives, adrenocorticotropic hormone, coumarins and indanediones, cox-2 inhibitors, decongestants, dermatological drugs, diagnostic radiopharmaceuticals, diarylquinolines, dibenzazepines antispasmodics, digestive enzymes, dipeptidyl peptidase 4 inhibitors, diuretics, dopaminergic antiparkinsonian drugs, drugs for alcohol dependence, echinocandins, EGFR inhibitors, estrogen receptor antagonists, estrogens, expectorants, factor Xa inhibitors, fatty acid derivative antispasmodics, fibric acid derivatives, first-generation cephalosporins, fourth-generation cephalosporins, functional bowel disease drugs, gallstone dissolving drugs, gamma-aminobutyric acid analogs, gamma-aminobutyric acid reuptake inhibitors, gastrointestinal drugs, general anesthetics, genitourinary drugs, GI stimulants, glucocorticoids, glucose-raising drugs, glycopeptide antibiotics, glycoprotein platelet inhibitors, glycylcyclines, gonadotropin-releasing hormone, gonadotropin-releasing hormone antagonists, gonadotropins, I group antiarrhythmics, group II antiarrhythmics, group III antiarrhythmics, group IV antiarrhythmics, group V antiarrhythmics, growth hormone receptor blockers, growth hormone, guanylate cyclase-C agonists, Helicobacter pylori eradicators, H2 antagonists, hedgehog pathway inhibitors, hematopoietic stem cell mobilizers, heparin antagonists, heparin, HER2 inhibitors, herbal products, histone deacetylase inhibitors, hormones, hormone / antineoplastic agents, hydantoin anticonvulsants, hydrazide derivatives, illegal (street) drugs, immunoglobulins, immunologic agents, immunostimulants, immunosuppressants, impotence agents, in vivo diagnostic biologics, incretin analogs, inhaled anti-infectives, inhaled corticosteroids, inotropes, insulin, insulin growth factors, integrase strand transfer inhibitors, interferons, interleukin inhibitors, interleukins, intravenous nutrition products, iodinated contrast media, ionized iodinated contrast media, iron products, ketolides, laxatives, antileprosy drugs, leukotriene modifiers, lincomycin derivatives, local injectable anesthetics, local injectable anesthetics and corticosteroids, loop diuretics, pulmonary surfactants, lymph stains, lysosomal enzymes, macrolide derivatives, macrolide drugs, magnetic resonance imaging contrast agents, mast cell stabilizers, medical gases, glinides, metabolic drugs, methylxanthines, mineralocorticoids, minerals and electrolytes, miscellaneous drugs, miscellaneous analgesics, miscellaneous antibiotics, miscellaneous anticonvulsants, miscellaneous antidepressants, miscellaneous antidiabetic drugs, miscellaneous antiemetics, Miscellaneous antifungals, miscellaneous antihyperlipidemics, miscellaneous antihypertensive combination drugs, miscellaneous antimalarials, miscellaneous antineoplastics, miscellaneous antiparkinsonian drugs, miscellaneous antipsychotics, miscellaneous antituberculosis drugs, miscellaneous antivirals, miscellaneous anxiolytics, sedatives and hypnotics, miscellaneous bone resorption inhibitors, miscellaneous cardiovascular drugs, miscellaneous central nervous system drugs, miscellaneous coagulation regulators, miscellaneous diagnostic dyes, miscellaneous diuretics, miscellaneous genitourinary drugs, miscellaneous GI drugs, miscellaneous hormones, miscellaneous metabolic drugs, miscellaneous ophthalmic drugs, miscellaneous otic drugs, miscellaneous respiratory drugs, miscellaneous sex hormones, miscellaneous topical drugs, miscellaneous unclassified drugs, miscellaneous vaginal drugs, mitotic inhibitors, monoamine oxidase inhibitors, oral and throat products, mTOR inhibitors, mucolytics, multikinase inhibitors,Muscle relaxants, mydriatics, narcotic analgesics, narcotic analgesics, nasal anti-infectives, nasal antihistamines and decongestants, nasal lubricants and lavages, nasal preparations, nasal steroids, natural penicillins, enkephalinase inhibitors, neuraminidase inhibitors, neuromuscular blockers, neuronal potassium channel openers, next generation cephalosporins, nicotinic acid derivatives, NK1 receptor antagonists, NNRTIs, non-cardioselective beta-blockers, non-iodinated contrast media, non-ionic iodinated contrast media, non-sulfonylureas, non-steroidal anti-inflammatory drugs, NS5A inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), health products, nutritional products, ophthalmic anesthetics, ophthalmic anti-infectives, ophthalmic anti-inflammatory drugs, ophthalmic antihistamines and decongestants, ophthalmic Diagnostic drugs, ophthalmic glaucoma drugs, ophthalmic lubricants and irrigants, ophthalmic preparations, ophthalmic steroids, ophthalmic steroids and anti-infectives, ophthalmic surgery drugs, oral nutritional supplements, other immunostimulants, other immunosuppressants, ear anesthetics, ear anti-infectives, ear preparations, ear steroids, ear steroids and anti-infectives, oxazolidinedione antispasmodics, oxazolidinedione antibiotics, parathyroid hormone and analogs, PARP inhibitors, PCSK9 inhibitors, penicillinase-resistant penicillins, penicillins, peripheral opioid receptor antagonists, peripheral opioid receptor mixed agonists / antagonists, peripheral vasodilators, peripherally acting anti-obesity drugs, phenothiazine antiemetics, phenothiazine antipsychotics, phenylpiperazine antidepressants, phosphate binders, P13K inhibitors, plasma expanders, platelet aggregation inhibitors, platelet stimulants, polyene drugs, potassium-sparing diuretics and thiazides, potassium-sparing diuretics, probiotics, progesterone receptor modulators, progestin preparations, prolactin inhibitors, prostaglandin D2 antagonists, protease inhibitors, protease-activated receptor-1 antagonists, proteasome inhibitors, proton pump inhibitors, psoralens, psychotherapeutic drugs, psychotherapeutic combination drugs, purine nucleosides, pyrrolidine anticonvulsants, quinolones, radiocontrast agents, radiation adjuvants, radiation therapy drugs, radiation co-operators, radiopharmaceuticals, recombinant human erythropoietin, renin inhibitors, respiratory system drugs, respiratory inhalation products, rifamycin derivatives, salicylates, sclerosing drugs, second-generation cephalosporins, select Estrogen receptor modulators, selective immunosuppressants, selective phosphodiesterase-4 inhibitors, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, serotonin-containing neural tube enterocyte regulators, sex hormone combination drugs, sex hormones, SGLT-2 inhibitors, skeletal muscle relaxant combination drugs, skeletal muscle relaxants, smoking cessation drugs, somatostatin and somatostatin analogs, spermicides, statins, sterile irrigation solutions, streptogramins, streptomyces derivatives, succinimide antispasmodics, sulfonamides, sulfonylureas, synthetic ovulation stimulants, tetracyclic antidepressants, tetracyclines, therapeutic radiopharmaceuticals, therapeutic vaccines, thiazide diuretics, thiazolidinediones, thioxanthenes, third-generation cephalosporins,Thrombin inhibitors, thrombolytics, thyroid medications, TNFα inhibitors, labor suppressants, topical acne medications, topical medications, topical allergy diagnostics, topical anesthetics, topical anti-infectives, topical anti-rosacea medications, topical antibiotics, topical antifungals, topical antihistamines, topical antineoplastics, topical antipsoriatics, topical antivirals, topical astringents, topical debridements, topical depigmenting agents, topical emollients, topical keratolytics, topical nonsteroidal anti-inflammatory drugs, topical photochemotherapeutics, topical rubefacients, topical steroids, topical steroids and anti-infectives, transthyretin stabilizers, triazine antispasmodics, tricyclic antidepressants, trifunctional monoclonal antibodies, ultrasound contrast agents, upper respiratory tract combination drugs, urea antispasmodics, urea cycle disorder drugs, urinary anti-infectives, urinary antispasmodics, urinary pH regulators, uterotonics, combination vaccines, vaginal anti-infectives, vaginal preparations, vasodilators, vasopressin antagonists, vasopressors, VEGF / VEGFR inhibitors, viral vaccines, viscosupplements, vitamin and mineral combination drugs, vitamins or VMAT2 inhibitors. The drug administration device of the present disclosure can administer drugs selected from the following: epinephrine, rebif, etanercept, enrofloxacin, atropine, pralidoxime chloride, diazepam, insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, zoledronic acid, mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium bromide, glycopyrrolate, tiotropium bromide, aclidinium bromide, indacaterol, salmeterol and olodaterol.

[0127] As mentioned above, a drug administration device may be used to deliver any of a variety of drugs. Examples of drugs that may be delivered using a drug administration device as described herein include (Infliximab), (Ustekinumab), (golimumab), Simponi (golimumab), (daratumumab), (guselkumab), (epoetin alfa), Risperdal (risperidone), Invega (Palipidone Palmitate), (esketamine), ketamine, and Invega (Palipidone palmitate).

[0128] Drug Shell

[0129] As described above, the dosage form can be provided in a holder suitable for the particular dosage form utilized. For example, a drug in a liquid dosage form can be held in a holder in the form of a vial with a stopper or in a syringe with a plunger prior to administration. A drug in a solid or powder dosage form (e.g., as a tablet) can be contained in a housing that is arranged to securely hold the tablet prior to administration.

[0130] The housing may include one or more drug holders, wherein each holder contains a dosage form, for example, the drug may be in tablet dosage form, and the housing may be in the form of a blister pack, wherein a tablet is held in each of the plurality of holders. The holders are in the form of recesses in the blister pack.

[0131] Figure 6 A housing 630 is depicted that includes a plurality of medication holders 610, each containing a dosage form 611. The housing 630 may have at least one environmental sensor 94 configured to sense information related to the environment in which the housing 630 exists, such as the temperature, time, or location of the environment. The housing 630 may include at least one device sensor 92 configured to sense information related to medications contained in the dosage forms 611 within the holders 610. There may be a dedicated location sensor 98 configured to determine the geographic location of the housing 630, for example, via satellite location determination, such as GPS.

[0132] The housing 630 may include an indicator 85 configured to present information to a user of the medication housing regarding the status of the medication in dosage form 611 contained within the holder 610. The housing 630 may also include a communication interface 99 that may communicate information to the outside via wired or wireless data transfer of data related to the medication housing 630, the environment, time or location, and / or the medication itself.

[0133] If desired, the housing 630 may include a power source 95 for delivering electrical power to one or more electrical components of the housing 630. The power source 95 may be a power source integral to the housing 630 and / or a mechanism for connecting the housing 630 to an external power source. The housing 630 may also include a device computer system 90, which includes a processor 96 and a memory 97, which are powered by the power source 95 and communicate with each other and optionally with other electrical and control components of the housing 630, such as environmental sensors 94, position sensors 98, device sensors 92, communication interfaces 99, and / or indicators 85. The processor 96 is configured to obtain data acquired from the environmental sensors 94, the device sensors 92, the communication interfaces 99, the position sensors 98, and / or the user interface 80, and process the data to provide data outputs to the indicators 85 and / or the communication interfaces 99, for example.

[0134] The housing 630 may be in the form of a packaging. Alternatively, there may be an additional packaging to contain and surround the housing 630.

[0135] The retainer 610 or an attached packaging itself may include one or more of the device sensor 92, environmental sensor 94, indicator 85, communication interface 99, power source 95, position sensor 98 and device computer system as described above, the device computer system including a processor 96 and memory 97.

[0136] Electronic Communications

[0137] As mentioned above, the communication interface 99 may be associated with the drug administration device 500 or drug housing 630 by being included within or on the housing 30, 630 or alternatively within the packaging 35. Such a communication interface 99 may be configured to communicate with a remote computer system such as Figure 7 The central computer system 700 shown communicates with the Figure 7 As shown, the communication interface 99 associated with the drug administration device 500 or the housing 630 is configured to communicate with the central computer system 700 via a communication network 702 from any number of locations such as a medical facility 706 (e.g., a hospital or other medical care center), a residential base 708 (e.g., a patient's home or office or a caregiver's home or office), or a mobile location 710. The communication interface 99 can be configured to access the system 700 via a wired and / or wireless connection to the network 702. In an exemplary embodiment, Figure 6 The communication interface 99 is configured to wirelessly access the system 700, such as via a Wi-Fi connection, which may facilitate accessibility to the system 700 from nearly anywhere in the world.

[0138] Those skilled in the art will appreciate that the system 700 may include security features such that aspects of the system 700 available to any particular user may be determined based on, for example, the identity of the user and / or the location from which the user is accessing the system. To this end, each user may have a unique user name, password, biometric data, and / or other security credentials to facilitate access to the system 700. Received security parameter information may be checked against a database of authorized users to determine whether the user is authorized and the extent to which the user is permitted to interact with the system, view information stored in the system, and the like.

[0139] Computer Systems

[0140] As discussed herein, one or more aspects or features of the subject matter described herein, such as components of the central computer system 700, processor 96, power source 95, memory 97, communication interface 99, user interface 80, device indicator 85, device sensor 92, environmental sensor 94, and position sensor 98, may be implemented in digital electronic circuits, integrated circuits, specially designed application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), computer hardware, firmware, software, and / or combinations thereof. These various aspects or features may include specific implementations in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from and transmit data and instructions to a storage system, at least one input device, and at least one output device. A programmable system or computer system may include clients and servers. Clients and servers are typically remote from each other and typically interact through a communication network such as the Internet, a wireless wide area network, a local area network, a wide area network, or a wired network. The relationship of client and server is obtained by virtue of computer programs running on respective computers having a client-server relationship to each other.

[0141] These computer programs (also referred to as programs, software, software applications, components or codes) include machine instructions for programmable processors and can be implemented in high-level programming languages, object-oriented programming languages, functional programming languages, logical programming languages ​​and / or in assembly / machine languages. As used herein, the term "machine-readable medium" refers to any computer program product, device and / or device (e.g., disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as machine-readable signals. The term "machine-readable signal" refers to any signal used to provide machine instructions and / or data to a programmable processor. A machine-readable medium can store such machine instructions in a non-transient manner, such as a non-transient solid-state memory or a magnetic hard drive or any equivalent storage medium. Alternatively or in addition thereto, a machine-readable medium can store such machine instructions in a transient manner, such as a processor cache or other random access memory associated with one or more physical processor cores.

[0142] To enable interaction with a user, one or more aspects or features of the subject matter described herein, such as a user interface 80 (which may be integrated or separate from the applicator 500 or housing 630), may be implemented on a computer having a display screen for displaying information to a user, such as, for example, a cathode ray tube (CRT) or a liquid crystal display (LCD) or a light emitting diode (LED) monitor. The display screen may allow input thereto directly (e.g., as a touch screen) or indirectly (e.g., via an input device, such as a keypad or voice recognition hardware and software). Other types of devices may also be used to provide interaction with a user. For example, the feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user may be received in any form, including, but not limited to, sound, voice, or tactile input. As described above, in addition to the user interface 80, the feedback may be provided via one or more device indicators 85. The device indicator 85 may interact with one or more of the device sensor 92, the environmental sensor 94, and / or the position sensor 98 to provide the feedback or receive input from the user.

[0143] Figure 8 An exemplary embodiment of a computer system 700 depicted as computer system 800 is shown. The computer system includes one or more processors 896 configured to control the operation of the computer system 800. The processor 896 may include any type of microprocessor or central processing unit (CPU), including a programmable general-purpose or special-purpose microprocessor and / or any of a variety of proprietary or commercially available single-processor systems or multi-processor systems. The computer system 800 also includes one or more memories 897 configured to provide temporary storage for code to be executed by the processor 896 or for data obtained from one or more users, storage devices, and / or databases. The memory 897 may include read-only memory (ROM), flash memory, one or more random access memories (RAM) (e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM (SDRAM)), and / or a combination of memory technologies.

[0144] The various elements of the computer system are coupled to a bus system 812. The bus system 812 shown is an abstract concept that represents any one or more separate physical buses, communication lines / interfaces, and / or multi-point or point-to-point connections connected through appropriate bridges, adapters, and / or controllers. The computer system 800 also includes one or more network interfaces 899 (also referred to herein as communication interfaces), one or more input / output (IO) interfaces 880, and one or more storage devices 810.

[0145] The communication interface 899 is configured to enable the computer system to communicate with a remote device (e.g., other computer systems and / or devices 500 or housing 630) via a network, and may be, for example, a remote desktop connection interface, an Ethernet adapter, and / or other local area network (LAN) adapters. The IO interface 880 includes one or more interface components to connect the computer system 800 to other electronic devices. For example, the IO interface 880 may include a high-speed data port, such as a universal serial bus (USB) port, a 1394 port, Wi-Fi, Bluetooth, etc. In addition, the computer system may be accessible to a human user, and therefore the IO interface 880 may include a display, a speaker, a keyboard, a pointing device, and / or various other video, audio, or alphanumeric interfaces. The storage device 810 includes any conventional media for storing data in a non-volatile and / or non-transient manner. Therefore, the storage device 810 is configured to keep data and / or instructions in a persistent state, wherein the value is retained despite interruption of power to the computer system. The storage device 810 may include one or more hard disk drives, flash drives, USB drives, optical disk drives, various media cards, disks, optical disks, and / or any combination thereof, and may be directly connected to a computer system or remotely (such as via a network) connected to the computer system. In an exemplary embodiment, the storage device 810 includes a tangible or non-transitory computer-readable medium configured to store data, such as a hard disk drive, flash drive, USB drive, optical disk drive, media card, disk, or optical disk.

[0146] Figure 8 The elements shown in the figure may be some or all of the elements of a single physical machine. In addition, not all elements shown need to be located on or in the same physical machine.

[0147] The computer system 800 may include a web browser for: retrieving web pages or other markup language streams, presenting those pages and / or streams (visually, audibly, or otherwise), executing scripts, controls, and other code on those pages / streams, accepting user input with respect to those pages / streams (e.g., for the purpose of completing input fields), issuing Hypertext Transfer Protocol (HTTP) requests with respect to those pages / streams or otherwise (e.g., for submitting server information from completed input fields), etc. The web pages or other markup languages ​​may be Hypertext Markup Language (HTML) or other conventional forms, including embedded Extensible Markup Language (XML), scripts, controls, etc. The computer system 800 may also include a web server for generating and / or delivering web pages to client computer systems.

[0148] like Figure 7 As shown above Figure 8The computer system 800 may form part of a central computer system 700 that communicates with one or more of the device computer systems 90 of one or more individual drug administration devices 500 or housings 630. Data, such as operating data of a device 500 or housing 630, medical data of a patient acquired by such a device 500 or housing 630, may be exchanged between the central computer system 700 and the device computer system 90.

[0149] As mentioned, the computer system 800 described above may also form part of a device computer system 90 that is integrated into or proximate to the drug administration device 500 or housing 630. In this regard, the one or more processors 896 correspond to the processor 96, the network interface 799 corresponds to the communication interface 99, the IO interface 880 corresponds to the user interface 80, and the memory 897 corresponds to the memory 97. Furthermore, additional storage devices 810 may also be present in the device computer system 90.

[0150] In an exemplary embodiment, the computer system 800 may form the device computer system 90 as a single unit, such as contained within a single drug administration device housing 30, contained within a single package 35 for one or more drug administration devices 500, or a housing 630 including a plurality of drug holders 610. The computer system 800 may form the central computer system 700 as a single unit, a single server, or a single tower.

[0151] The individual units may be modular such that various aspects thereof may be swapped in and out as needed for, e.g., upgrades, replacements, maintenance, etc., without disrupting the functionality of any other aspects of the system. Thus, the individual units may also be expandable, with the ability to be added as additional modules and / or additional functionality as desired and / or to improve upon existing modules.

[0152] The computer system may also include any of a variety of other software and / or hardware components, including (as an example) an operating system and a database management system. Although an exemplary computer system is depicted and described herein, it should be understood that this is for reasons of generality and convenience. In other embodiments, the architecture and operation of the computer system may be different from those shown and described herein. For example, the memory 897 and the storage device 810 may be integrated together, or the communication interface 899 may be omitted if communication with another computer system is not required.

[0153] Specific implementation

[0154] When delivering a drug using any of the drug delivery devices discussed above or any other drug delivery device, in addition to the initial drug dose itself, a variety of factors can affect drug administration, absorption, and the effects on the patient. For example, the physiology or state of the individual patient, the physiological effects of drug administration on the patient, the external conditions around the patient, etc., can affect the results of drug administration to the patient. Therefore, it is beneficial for the patient to allow adjustment of drug delivery based on various factors that occur during the use of the drug administration device, thereby providing more personalized treatment, while also helping the patient accept and / or the doctor provide specialized care for the specific patient being treated. In addition, being able to automatically make as many drug delivery adjustments as possible can help simplify the delivery process for patients and doctors while improving patient outcomes.

[0155] As mentioned above, a drug administration device may be used to deliver any of a variety of drugs. Examples of drugs that may be delivered using a drug administration device as described herein include (Infliximab), (Ustekinumab), (golimumab), Simponi (golimumab), (daratumumab), (guselkumab), (epoetin alfa), Risperdal (risperidone), Invega (Palipidone Palmitate), (esketamine), ketamine, and Invega (Palipidone palmitate).

[0156] In at least some specific implementations, drug delivery can be changed based on one or more characteristics associated with the patient, the characteristics being determined based on the patient's situational awareness. In an exemplary embodiment, the drug administration device includes at least a first sensor and a second sensor, each of which is configured to collect data about different characteristics associated with the patient. An algorithm stored on the device (e.g., in its memory) can be executed online on the device (e.g., by its processor) to administer a dose of drug to the patient. The algorithm is stored in the form of one or more sets of multiple data points that define and / or represent instructions, notifications, signals, etc. to control the function of the device and the administration of the drug. The data collected by the first sensor and the second sensor are used, for example, by the processor to change at least one variable parameter of the algorithm. The at least one variable parameter is among the data points of the algorithm, for example, included in the instructions for drug delivery, and therefore each variable parameter can be changed by changing one or more of the stored multiple data points of the algorithm. After changing the at least one variable parameter, the subsequent execution of the algorithm administers another dose of the drug according to the changed algorithm. In this way, the drug delivery of the patient over time can be managed to increase the beneficial results of the drug by considering the actual situation of the patient and the actual results of the patient receiving the drug dose. The at least one variable parameter is automatically varied and / or the one or more doses are administered themselves to improve patient outcomes.Thus, the drug administration device may be configured to provide personalized medication based on the patient and the patient's surrounding conditions to provide an intelligent system for drug delivery.

[0157] Use by example Figure 5B The universal drug administration device 500 of the present invention may have an algorithm stored therein in the memory 97, and the processor 96 may be configured to execute the algorithm to control the delivery of a dose of the drug dispensed by the dispensing mechanism 20. The processor 96 may also be configured to use data collected by at least two of the one or more device sensors 92, the environmental sensor 94, and the position sensor 98 to change at least one variable parameter of the algorithm, so that the dose delivered after changing the at least one variable parameter will be controlled by executing the changed algorithm. As described above, those skilled in the art will understand that the universal drug administration device 500 may be provided with the above-mentioned various optional features in a variety of different combinations, for example, excluding any of the sensors 92, 94, 98 used by the processor 96 to change the variable parameters of the algorithm (but including sensors for collecting required contextual awareness data), excluding the packaging 35, excluding the user interface 80, etc.

[0158] Fig. 9An embodiment of a universal drug administration device 1000 is shown that is configured to change the drug delivery to a patient based on one or more various characteristics associated with the patient, the characteristics being determined based on the patient's situational awareness. In the illustrated embodiment, the drug administration device 1000 includes a housing 1002, a drug holder 1010, a dispensing mechanism 1020, sensors 1030, 1040, 1045, a memory 1050 in which an algorithm 1052 including at least one variable parameter is stored, a processor 1060, a user interface 1080, an indicator 1085, a power source 1095, and a communication interface 1099. The sensors 1030, 1040, 1045 can each be configured to measure a different parameter, as further discussed below. In addition, similar to the above description of Figure 5B As mentioned above, those skilled in the art will understand that Fig. 9 The universal drug administration device 1000 including the drug holder 1010, the dispensing mechanism 1020, the processor 1060, the memory 1050 and the sensors 1030, 1040, 1045 can be provided with the above-mentioned various features in various different combinations. For example, the device 1000 may include at least two sensors instead of all sensors 1030, 1040, 1045, may not have the user interface 1080, etc.

[0159] The first sensor 1030, the second sensor 1040, and the third sensor 1045 are each housed within the housing 1002 or on an outer surface of the housing 1002, and each sensor 1030, 1040, 1045 is configured to collect data about a feature associated with the patient. The sensors 1030, 1040, 1045 may each include a device sensor (similar to the device sensor 92 discussed above), an environmental sensor (similar to the environmental sensor 94 discussed above), or a position sensor (similar to the position sensor 98 discussed above). Each of the sensors 1030, 1040, 1045 is configured to collect data of different features. The features may be physiological features and / or situational features of the patient. Various different physiological characteristics can be monitored, such as blood glucose level (e.g., using a glucose monitor, etc.), blood pressure (e.g., using a blood pressure monitor, etc.), sweat level (e.g., using a fluid sensor, etc.), heart rate (e.g., using a heart rate monitor, etc.), breathing rate (e.g., using a breathing monitor, a thermal sensor configured to be located near the nose or mouth and use thermal detection or detect in / out air flow movement during exhalation, a pressure sensor configured to be located near the nose or mouth and use thermal detection or detect in / out air flow movement during exhalation, a spirometer, etc.), etc.In addition, many different contextual characteristics can be monitored, such as core temperature (e.g., using a temperature sensor), tremor detection (using an accelerometer, etc.), fall detection (using an accelerometer, etc.), irregular gait detection (using an accelerometer, etc.), time of day (e.g., using a timer, etc.), date (e.g., using a timer, etc.), patient activity level (e.g., using a motion sensor, etc.), blood pressure (e.g., using a blood pressure monitor, etc.), metabolic rate (e.g., using heart rate as discussed herein, etc.), altitude (e.g., using an altimeter, etc.), medication temperature (e.g., using a temperature sensor), medication viscosity (e.g., using a viscometer, using a viscosity versus temperature curve of a medication, etc.), GPS information (e.g., using a location sensor, etc.), weather information (e.g., using a temperature sensor, a humidity sensor, etc.), room or outside temperature (e.g., using a temperature sensor), angular velocity rate (e.g., using an inertial measurement unit (IMU) or MARG (magnetic, angular rate and gravity) sensor), body orientation (e.g., using an IMU, etc.), motor current for delivering medication (e.g., using a current sensor), blood oxygen level (e.g., using a blood oxygen sensor), sunlight (e.g., using a UV sensor, etc.), osmotic pressure (e.g., using a blood monitor, etc.), air quality (e.g., using a UV sensor, etc.), inflammatory response, one or more images and / or videos of the patient and / or the environment in which the patient is located (e.g., to analyze food intake; to determine whether solid food or liquids are being consumed; to determine the patient's position or activity; to determine the patient's condition, such as skin reactions, breathing, eye dilation, sedation, schizophrenia, vocal characteristics such as tone and pitch; etc.), user input data such as overall health status, pain score, or cycle time between specific disease episodes, etc. In an exemplary embodiment, one sensor 1030, 1040, 1045 is configured to monitor either a physiological characteristic or a contextual characteristic, while the other of the sensors 1030, 1040, 1045 is configured to monitor the other of the physiological characteristic or the contextual characteristic. In another exemplary embodiment, each of the sensors 1030, 1040, 1045 is configured to monitor a different physiological characteristic. In another exemplary embodiment, each of the sensors 1030, 1040, 1045 is configured to monitor a different situational characteristic.

[0160] Although in Fig. 9 , but device 1000 may include only two sensors or may include more than three sensors. Any additional sensors may be configured similarly to sensors 1030, 1040, 1045 and configured to monitor features different from sensors 1030, 1040, 1045 and features different from each other.

[0161] The memory 1050 of the device 1000 is located in the housing 1002. In the illustrated embodiment, the memory 1050 is configured to store data from the sensors 1030, 1040, 1045, however in other embodiments, the data may be stored in other locations, such as in another memory onboard the device 1000 and / or in a remote memory accessible to the device 1000 via the communication interface 1099. The algorithm 1052 stored in the memory 1050 represents the device 1000 instructions on how to administer the medication in the medication holder 1010 and is configured to be executed by the processor 1060. The algorithm 1052 is stored in the form of a plurality of data points defining and / or representing instructions, notifications, signals, etc. that control the administration of the medication, wherein the at least one variable parameter is among the data points, such that a change in the at least one variable parameter of the algorithm 1052 results in at least one change in how the medication is administered. The at least one variable parameter may be any of a plurality of different delivery and / or medication parameters. Examples of variable parameters include the rate of delivery of the drug from the drug holder 1010 to the patient, the time interval between dose deliveries (such that the dose delivered after changing at least one variable parameter is at a different time interval than the dose delivered before the change), the amount of the dose, the concentration of the dose, whether to deliver any additional doses, such as stopping the second or any subsequent dose or restarting administration after previously stopping administration before the first dose or before any subsequent dose after the first dose, etc.

[0162] The processor 1060 is configured to receive and analyze data from one or more sensors 1030, 1040, 1045, and execute the algorithm 1052 to control the administration of one or more doses of the drug to the patient. In an exemplary embodiment, the processor 1060 executes the algorithm 1052 to control the delivery of at least a first dose of the drug to the patient, changes at least one variable parameter of the algorithm 1052 based on the data collected by the sensors 1030, 1040, 1045, and executes the algorithm 1052 to control the delivery of at least one subsequent dose of the drug after changing the at least one variable parameter. In some embodiments, the processor can change at least one variable parameter of the algorithm 1052 to control the delivery of the first dose based on the data collected by the sensors 1030, 1040, 1045 before executing the algorithm 1052, such as by changing the variable parameter from indicating that drug administration is stopped (e.g., because the device operation prevention mechanism of the drug administration device is in a state that prevents drug delivery, the power source 1095 lacks sufficient power to deliver the dose, etc.) to indicating that drug administration is allowed (e.g., the device operation prevention mechanism of the drug administration device is in a state that allows drug delivery, the power source 1095 has sufficient power to deliver the dose, etc.). To execute the algorithm 1052, the processor 1060 is configured to run a program stored in the memory 1050 to access a plurality of data points of the algorithm 1052 in the memory 1050. To change at least one variable parameter of the algorithm 1052, the processor 1060 is configured to modify or update the data point of the at least one variable parameter in the memory 1050. The processor 1060 may also be configured to execute instructions stored in the memory 1050 to generally control the device 1000, including other electrical components of the device, such as the communication interface 1099, the indicator 1085, and the user interface 1080. The processor 1060 may be configured to change at least one variable parameter of the algorithm 1052 during delivery of the dose, so that the algorithm 1052 changes in real time as the dose is delivered, which may adapt to real-time sensed conditions, or the processor 1060 may be configured to change at least one variable parameter of the algorithm 1052 before delivery of the dose begins, which may consume less memory and use less processing resources during execution of the algorithm 1052 compared to real-time changes to the algorithm 1052.

[0163] The processor 1060 can be configured to automatically control the delivery of the drug dose based on one or more predetermined dosing schedules or intervals for the patient, which can be predetermined prior to the initial dose or can be determined during use of the device 1000 after the delivery of the first dose and set so that future doses can be based on the predetermined schedule. The predetermined schedule can also be determined by a physician or other care provider, automatically created based on the algorithm 1052 and / or the sensors 1030, 1040, 1045 used, or some combination of both.

[0164] Processor 1060 may be configured to provide notifications to a patient and / or physician or other care provider based on data collected from one or more of sensors 1030 , 1040 , 1045 , such as via device indicator 1085 , user interface 1080 , and / or communication interface 1099 .

[0165] Because the processor 1060 is configured to change at least one variable parameter based on data collected by one or more sensors in the sensors 1030, 1040, 1045, an automatic reaction response based on the patient's situational awareness is possible. In at least some embodiments, at least one variable parameter is changed to provide adaptive dosage adjustment based on various readings and / or data and / or user input from one or more sensors in the sensors 1030, 1040, 1045. For example, a user can record the cycle time between the onset of disease or discomfort, at which time the drug administration plan as reflected in the algorithm 1052 can be adjusted by the processor 1060 and / or by a doctor or other care provider remotely to take it into account, thereby achieving better disease control. For another example, a change in the patient's altitude may change the effect of the drug, and even cause toxicity in some cases. In this way, the duration of the patient at different altitudes can be read by one or more sensors in the sensors 1030, 1040, 1045, and is used by the processor 1060 and / or a doctor or other care provider to adjust the subsequent drug dosage by changing at least one variable parameter by the processor 1060. As another example, therapy may be completely interrupted based on one or more sensor readings, and the patient may likewise be notified via the device indicator 1085 and / or the user interface 1080. One or more possible complications may be anticipated based on best practices, and the processor 1060 and memory 1050 may operate together to provide various digitally ready responses to common complications (identified through situational awareness) to alert the patient, attempt to change the patient's behavior, notify a physician, etc. In various embodiments, at least one of the sensors 1030, 1040, 1045 includes a camera, and the processor 1060 is configured to analyze images and / or video captured by the camera, such as analyzing any food intake and / or determining one or more side effects, such as patient skin reaction to medication, patient sedation level, patient schizophrenia level, vomiting, etc. Facial ID may be used to identify the patient in images captured by at least one of the sensors 1030, 1040, 1045 that includes a camera to help ensure that relevant data is collected and analyzed.

[0166] The device indicator 1085 and / or the user interface 1080 may be configured to operate independently of each other, or to operate together to provide various notifications of any output of contextual awareness to the patient and / or physician or other care provider based on the sensor readings and any complications that these readings may indicate. Thus, the patient is able to quickly respond to any negative results of drug administration and / or complications that arise as a result of treatment. In at least some embodiments, the device 1000 may be configured to provide activities that patients may seek to best manage their conditions, such as by providing suggested activities via the user interface 1080. In addition, contextually aware information based on the sensor readings and any complications that these readings may indicate may be forwarded to the patient's physician or other care provider, who may then communicate with the patient.

[0167] In at least some embodiments, basic operations on the device 1000 itself can notify the patient of any detected deviation from the so-called "five pairs" of drug administration. During drug administration, best practices require ensuring that the "five pairs" of drug use are followed: the right patient, the right drug, the right time, the right dose, and the right route. Therefore, by tracking the patient's situational awareness using sensors 1030, 1040, 1045, it can be detected whether any of the "five pairs" has been violated, at which time the patient and / or doctor or other care provider can be notified. In addition, in some embodiments, confirmation of the "five pairs" by a doctor or off-site medical personnel or the patient himself may be required to help eliminate drug errors and / or ensure compliance with the risk assessment and mitigation strategy (REMS) of the drug. In severe cases, a notification that immediate medical attention is needed can be provided to the patient and / or doctor or other care provider.

[0168] The communication interface 1099 may be configured to allow one-way communication (such as providing data to a remote server and / or receiving instructions or commands from a remote server) or two-way communication (such as providing information, messages, data, etc. about the device 1000 and / or the data stored thereon, and receiving instructions such as from a doctor, a remote server about software updates), etc. In this way, the doctor / care provider interaction can provide additional adjustments to the care. For example, a doctor or other care provider may receive relevant information and data from the device 1000 and / or directly from the patient via the communication interface 1099, and may provide remote feedback and / or any adjustments to the device 1000 (e.g., requesting the processor 1060 to change at least one variable parameter to change a subsequent dose) and / or to the patient (e.g., providing a recommended next step based on the current sensor reading and feedback from the patient) based on the received information. In at least some embodiments, any record or data of the event and the data leading to and resulting from the event may be provided to the doctor and / or remote care individual and / or a remote server for storage, and the recipient may analyze and summarize the data to determine recommendations for overcoming or effectively resolving any current complications. In at least some embodiments, processor 1060 is configured to change at least one variable parameter only after communicating with and receiving any instructions from the remote server.

[0169] Although in the illustrated embodiment, sensors 1030, 1040, 1045 are all included in device 1000, one or more of sensors 1030, 1040, 1045 may be separate from device 1000 by, for example, being worn on the patient, placed in a geographic space shared with the patient, attached to other equipment or instruments, as part of a mobile phone application used by the patient, etc.

[0170] Varying at least one variable parameter may result in an adjusted injection or flow rate for each dose provided, for example, the at least one variable parameter may include an injection or flow rate. Alternatively or in addition, the temperature of the drug may be varied to produce a constant flow rate, as discussed in U.S. Patent Publication No. 2002 / 0042596, entitled "Method And Apparatus To Sense Temperature In An Implantable Pump," published on April 11, 2002, which is hereby incorporated by reference in its entirety.

[0171] In at least some embodiments, pain at the drug delivery site can be minimized by monitoring patient usage, patient preferences, patient physical attributes, one or more sensory features associated with the patient, various parameters of the drug, etc. through the device 1000. For example, patient factors such as weight, BMI, age, etc.; type of drug delivery mechanism such as bolus delivery, continuous delivery, inhalation, nasal spray, etc.; total number and history of injections of injectable drugs at the intended location; volume of the drug; measured parameters about the state and condition of the drug itself such as viscosity, temperature, pH level; can all be used to predict the pain involved in the next drug administration (such as the next injection, the next inhalation, the next nasal spray, etc.). Various delivery parameters of the drug such as speed, waiting period, pressure, location suggestions, etc. can then be updated by at least one variable parameter to minimize patient pain and discomfort.

[0172] In at least some embodiments, allowing the device 1000 to have more contextual awareness of the patient can facilitate patient compliance. The drug administration device 1000 can be used to increase patient compliance and / or increase familiarity with how the device 1000 operates in any number of different ways. For example, the device 1000 can be configured to provide reminders, updates, adaptive training, etc. to the patient based on patient compliance data and / or patient compliance data stored on or pushed to the device 1000 to enhance healthy behaviors, teach the steps for using the device, and other details. Increasing compliance and familiarity with the device 1000 can help reduce patient risk when administering medication, the importance of which is discussed, for example, in U.S. Patent Publication No. 2015 / 0359966, entitled "System For Monitoring And Delivering Medication To A Patient And Method Of Using The Same To Minimize The Risks Associated With Automated Therapy," published on December 17, 2015, which is hereby incorporated by reference in its entirety.

[0173] Fig.10An embodiment of the use of a drug administration device 1000 is shown. Prior to the first delivery of a dose of drug, the drug administration device 1000 collects data about a first characteristic associated with a patient using a first sensor 1030, collects data about a second characteristic using a second sensor 1040, and collects data about a third characteristic using a third sensor 1045. The first delivery of a dose may be an initial dose delivered to the patient from the device 1000, or it may be the first dose delivered to the patient from the device 1000 after at least one dose has been provided to the patient and after a sufficient amount of data has been collected by the sensors 1030, 1040, 1045. Additional data about additional characteristics associated with the patient may optionally be collected by using additional secondary sensors. The collected data represents a plurality of data points defining each characteristic and is stored in the memory 1050. The processor 1060 then controls the delivery of the first dose of drug from the device 1000 to the patient by executing the algorithm 1052 stored in the memory 1050. The sensors 1030, 1040, 1045 continue to collect data. Based on any such subsequently collected data, the processor 1060 changes at least one variable parameter of the algorithm 1052. After changing the at least one variable parameter, the processor 1060 controls the delivery of at least a second dose from the device 1000 to the patient by executing the algorithm 1052. The processor 1060 executing the algorithm 1052 to deliver the dose may be automatic, manual, or some combination of both, and it may be in accordance with a predetermined dosing schedule as discussed above.

[0174] exist Fig.10 During any part of the administration process, the device 1000 can communicate with one or more remote computer systems using the communication interface 1099 to provide data to it and / or receive instructions from it, and / or can communicate with the user via the device indicator 1085 and / or the user interface 1080 to provide information to it and / or receive instructions from it. In some embodiments, the administration of the first dose, the second dose, and / or any subsequent doses may depend on receiving instructions from one or more remote computer systems. In addition, the second or any subsequent dose can also be completely blocked based on the change of the variable parameter, thereby effectively causing the second or subsequent dose to be equivalent to zero drug administered.

[0175] It may be desirable to prevent the administration of a second or any subsequent dose, or even a first dose, from the drug administration device 1000 for any of a variety of reasons. For example, one of the sensors 1030, 1040, 1045 may be configured to monitor the patient's location, such as GPS or other location information. It may be desirable for the drug administration device 1000 to be used only in a certain location, such as in a hospital or other medical care facility where a patient must receive medication from the drug administration device 1000 because, for example, the medication is a controlled substance such as esketamine or ketamine that must be administered in a controlled facility, the patient is still learning how to properly use the drug administration device 1000 and is in a period of observation for use of the device 1000, etc. It may be desirable for the drug administration device 1000 to be used only in any of a number of hospitals or other medical facilities that are certified to provide medication to patients when the medication is esketamine, ketamine, or other controlled substances, in a particular city where the patient resides, in a particular city where the patient has pre-registered for a visit on a certain day / time, etc. The patient may be expected to remain at the medication administration location to help ensure that any side effects of the medication delivered from the medication administration device 1000 dissipate before the patient drives or otherwise leaves the medication administration location (e.g., driven by another person, walking, etc.), such that a change in the patient's location before a predetermined threshold amount of time has passed since the delivery of a medication dose may prevent the patient from receiving medication from the medication administration device 1000 in the future. If one of the sensors 1030, 1040, 1045 monitors that the patient's location is not at the expected location for medication administration and / or a predetermined threshold amount of time has passed since the delivery of a medication dose, at least one variable parameter may be changed (or maintained) to effectively make subsequent doses equivalent to zero medication administered. Such as when the medication is esketamine, ketamine, or other controlled substances, the medication administration device 1000 may be expected to be used by a particular patient only at a particular location or locations (e.g., at a particular GPS location, at the patient's primary care physician's office, at the patient's primary care hospital, at the patient's residence, etc.), and the location of medication use may be important to help ensure that the medication is not diverted or used by unauthorized parties. For some drugs, such as esketamine, ketamine, or other controlled substances, the REMS for the drug may require recording the location of drug administration. The patient may be expected to remain at the drug administration location to help ensure that any side effects of the drug delivered from the drug administration device 1000 dissipate before the patient drives or otherwise leaves the drug administration location (e.g., is driven by another person, walks, etc.), such that a change in the patient's location before a predetermined threshold amount of time has passed since the delivery of a dose of the drug may prevent the patient from receiving the drug from the drug administration device 1000 in the future.If one of the sensors 1030, 1040, 1045 monitors that the patient's position is not in the expected location for drug administration and / or a predetermined threshold amount of time has passed since the delivery of the drug dose, at least one variable parameter may be changed (or maintained) to effectively make the subsequent dose equivalent to zero drug administered. In some cases, the expected drug administration location for a particular patient is the patient's residence. If one of the sensors 1030, 1040, 1045 monitors that the patient's position is not in the expected location for drug administration and / or a predetermined threshold amount of time has passed since the delivery of the drug dose, the patient may not be able to administer the drug at home, but may need to be administered at a doctor's office or other medical care facility, or the drug administration device will switch to a locked state in which drug delivery from the drug administration device is prevented.

[0176] As another example, one of the sensors 1030, 1040, 1045 may be configured to monitor the angular orientation of the drug administration device 1000, for example using an accelerometer, a gyroscope, a tilt / angle switch (mercury-free), a position sensor, etc. Some drug administration devices should be in a specific angular orientation relative to the patient during drug administration to help ensure that the drug is properly delivered. For example, the correct angular orientation of the injection device may be a vertical, substantially vertical orientation relative to the patient's skin, such as substantially 90°, rather than an incorrect position at a non-vertical angle relative to the patient's skin. Those skilled in the art will understand that the angle may not be exactly vertical (exactly 90°), but is still considered to be substantially vertical for any of a variety of reasons, such as manufacturing tolerances and sensitivity of the measuring equipment. As another example, the correct angular orientation of the nasal spray device may be in the range of 30° to 60°, in the range of 30° to 40°, in the range of 30° to 50°, in the range of 40° to 50°, in the range of 50° to 60°, or in the range of 40° to 60°. One of the sensors 1030, 1040, 1045 configured to monitor the angular orientation of the drug administration device 1000 may allow for detection of the angular orientation of the drug administration device 1000 to allow for determination of whether the drug administration device 1000 is in the correct angular orientation for drug delivery. If one of the sensors 1030, 1040, 1045 monitors that the patient's position is not in the correct angular orientation for drug delivery, at least one variable parameter may be changed (or maintained) to effectively make the subsequent dose equivalent to zero drug administered. When the correct angular orientation is detected, at least one variable parameter may be changed from zero to allow administration of the drug.

[0177] Figure 37 to Figure 39An embodiment of a drug administration device 900 is shown that should be in a specific angular orientation relative to the patient during drug administration to help ensure that the drug is properly delivered from the drug administration device 900 to the patient. In the illustrated embodiment, the drug administration device 900 is an automatic injector, such as Figure 1 The correct angular orientation of the auto-injector 900 for drug delivery is a vertical, substantially perpendicular orientation relative to the patient's skin, while an incorrect position of the auto-injector 900 for drug delivery is at a non-perpendicular angle relative to the patient's skin. Fig.40 The auto-injector 900 is shown relative to the patient's skin 904 before the auto-injector 900 contacts the skin 904 . Fig.39 and Fig.41 The autoinjector 900 is shown in a correct angular orientation relative to the skin 904 after the autoinjector 900 contacts the skin 904, and in this illustrated embodiment, the dispensing mechanism protection mechanism of the autoinjector in the form of a needle shield 906 has been pushed into the housing 908 of the autoinjector 900, and the needle 910 of the autoinjector 900, which was previously obscured by the needle shield 906, has penetrated the skin 904 in response to the autoinjector 900 contacting the skin 904 and being pushed toward the skin. Fig.39 The autoinjector 900 is shown prior to drug delivery. Fig.41 The autoinjector 900 is shown during drug delivery, with the drug 912 exiting the needle 910 and entering the patient's body. Fig.42 The autoinjector 900 is shown in one of a plurality of possible incorrect angular orientations of the autoinjector 900 relative to the skin 904 after the autoinjector 900 has contacted the skin 904 and the needle shield 906 has been partially advanced into the housing 908 in response to the autoinjector 900 contacting the skin 904 and being advanced toward the skin. Due to the incorrect angular orientation, the needle shield 906 is only partially advanced into the housing 908.

[0178] The autoinjector 900 includes at least one sensor 902 configured to monitor the angular orientation of the drug administration device 900. The at least one sensor 902 extends distally from the needle shield 906. The at least one sensor 902 is operatively coupled to the needle shield 906 so that movement of the needle shield 906, such as sliding of the needle shield 906 in the proximal direction into the housing 908, also causes movement of the at least one sensor 902. The sensors 902 are arranged equidistantly around the periphery of the needle shield 906, such as Fig.38As shown, this allows data to be collected from different areas and allows a more reliable assessment of the angular orientation of the auto-injector relative to the skin 904. In an exemplary embodiment, the at least one sensor 902 includes a plurality of sensors, as in the illustrated embodiment, to help allow data to be collected from different areas and allow a more reliable assessment of the angular orientation of the auto-injector relative to the skin 904. In the illustrated embodiment, the at least one sensor 902 includes four sensors, but as discussed herein, other numbers of sensors may also be used. Fig.37 , Fig.40 and Fig.42 In each of , each of sensors 902 is obscured from view.

[0179] In the illustrated embodiment, each of the sensors 902 is a contact sensor configured to measure its contact with a surface. If, for example, it is determined by a processor of the auto-injector 900 that all of the sensors 902 are in direct contact with a surface (e.g., the surface of the skin 904), the auto-injector 900 may be considered to be in the correct angular orientation for drug delivery. If, for example, it is determined by a processor of the auto-injector 900 that any one or more of the sensors 902 are not in direct contact with a surface (e.g., the surface of the skin 904), the auto-injector 900 may be considered to be in an incorrect angular orientation for drug delivery.

[0180] In another embodiment, each of the sensors 902 may be a pressure sensor configured to measure pressure. If, for example, it is determined by the processor of the auto-injector 900 that all sensors 902 measure substantially the same pressure, the auto-injector 900 may be considered to be in the correct angular orientation for drug delivery. The sensors 902 that all measure the same pressure indicate that all sensors 902 have been pressed equally against the skin 904 to make the auto-injector 900 contact the skin 904 horizontally, so that the auto-injector 900 is substantially perpendicular to the skin 904. If, for example, it is determined by the processor of the auto-injector 900 that any one or more of the sensors 902 do not measure substantially the same pressure as the other sensors 902, the auto-injector 900 may be considered to be in an incorrect angular orientation for drug delivery. The sensors 902 that all do not measure the same pressure indicate that not all sensors 902 are pressed equally against the skin 904 to make the auto-injector 900 contact the skin 904 horizontally, so that the auto-injector 900 is not substantially perpendicular to the skin 904.

[0181] In response to the data collected by the at least one sensor 902, the automatic injector 900 is determined to be in the correct angular orientation, and the automatic injector 900 (e.g., its processor) can be configured to move the automatic injector 900 from a locked state that prevents drug delivery to an unlocked state that allows drug delivery. In the locked state, the trigger 914 of the automatic injector cannot be pressed to inject the drug 912 into the patient. In the unlocked state, the trigger 914 can be pressed to inject the drug 912 into the patient. The automatic injector 900 can move from the locked state to the unlocked state in a variety of ways. For example, the automatic injector 900 (e.g., its processor) can change the variable parameters of the algorithm, which controls the delivery of the dose as discussed herein, so as to effectively make the subsequent dose equivalent to the zero drug administered. For another example, the automatic injector 900 may include a device operation prevention mechanism, which is in response to the data collected by the at least one sensor 902, the automatic injector 900 is determined to be in the correct angular orientation, so that the automatic injector 900 (e.g., its processor) moves from its locked state to its unlocked state.

[0182] The automatic injector 900 includes a user interface 916 configured to provide information to the user of the automatic injector 900, as described herein. The light allows the user of the automatic injector 900 to easily see whether the automatic injector 900 is in the correct position for drug administration. In the embodiment shown, the user interface 916 includes a light that is configured to be lit when the automatic injector 900 is in the correct angular orientation and is not lit when the automatic injector 900 is in the incorrect angular orientation. In other embodiments, the light can be configured to light with a first color when the automatic injector 900 is in the correct angular orientation, and light with a different second color when the automatic injector 900 is in the incorrect angular orientation. The processor of the automatic injector is configured to light up the control light. The user interface 916 can have other configurations as described herein.

[0183] In the illustrated embodiment, the lights include multiple light strips of increasingly shorter lengths in the proximal direction. In the illustrated embodiment, the lights include five light strips, but other numbers of light strips may also be used. In addition, different types of lights may be used. The autoinjector 900 (e.g., its processor) is configured to sequentially illuminate the light strips in the proximal direction after pressing the trigger 914 to visually signal the user a countdown for drug delivery (e.g., ejection of the drug through the needle 910). Fig.39 All light strips are shown illuminated, indicating that drug delivery is occurring.Notifying the user when drug delivery begins and when drug delivery occurs can help provide user confidence that the auto-injector 900 is functioning correctly.

[0184] For yet another example of preventing a second or any subsequent dose or even a first dose of drug from being administered by drug administration device 1000, one of sensors 1030, 1040, 1045 may be configured to monitor elapsed time, for example using a timer, a counter, etc. Some drug administration devices should not deliver a second dose until a certain amount of time has passed since the first dose was delivered. For example, a certain amount of time that passes between doses delivered by a nasal spray device that delivers a spray into one nostril at a time can help ensure that the nasal spray device has moved from one nostril to another nostril before delivering the second dose. As another example, a certain amount of time that passes between doses can help prevent overdosing. If one of sensors 1030, 1040, 1045 monitors that the time that has passed since the first dose is not less than a predetermined threshold amount of time, at least one variable parameter may be changed (or maintained) to effectively make the subsequent dose equivalent to zero drug administered. When a predetermined threshold amount of time has passed, at least one variable parameter may be changed from zero to allow the drug to be administered.

[0185] Fig.43 Another embodiment of a drug administration device 9000 is shown that is configured to visually signal a user a countdown to drug delivery from the drug administration device 9000. In this illustrated embodiment, a powered add-on module 9002 is configured to attach to the drug administration device 9000 and provide a countdown to drug delivery on a user interface of the add-on module 9002 (e.g., on a display thereof) using a light, using sound, etc. The add-on module 9002 includes an onboard power source configured to provide power to the user interface of the add-on module 9002. In this illustrated embodiment, the drug administration device 9000 is an auto-injector including a needle 9004, but other types of drug administration devices may also be used with the add-on module 9002.

[0186] The additional module 9002 is configured to be attached to the proximal end of the drug administration device 9000 opposite the distal end of the drug administration device 9000 (e.g., the end where the needle 9004 of the drug administration device 9000 is located). The additional module 9002 may be configured to be non-removably attached to the drug administration device 9000 before the user accepts the drug administration device 9000, which may help ensure that the drug administration device 9000 is used with the additional module 9002. Alternatively, as in the illustrated embodiment, the additional module 9002 may be configured to be removably attached to the drug administration device 9000 by the user of the drug administration device 9002 or by another entity. A removable additional module 9002 may allow the additional module 9002 to be used with each of a plurality of drug administration devices, thereby making the additional module 9002 more cost-effective. The additional module 9002 may be non-removably attached to the drug administration device 9000 by, for example, a distal end of the additional module 9002 comprising a cavity configured to securely seat a firing button at a proximal end of the autoinjector 9000, such as by a press fit.

[0187] Whether removably or non-removably attached to the auto-injector 9000, the additional module 9002 is configured to be operatively connected to the trigger of the auto-injector 9000. In an exemplary embodiment, the trigger is a trigger button located at the proximal end of the auto-injector 9000. As in the illustrated embodiment, the additional module 9002 may have a proximal surface area larger than the trigger button below, which may make the actuation of the drug application device 9000 easier for at least some users, such as those with limited dexterity and / or strength. The additional module 9002 attached to the auto-injector 9000 is configured to be pushed to actuate the trigger, for example, to push the button, and cause drug delivery. The user interface of the additional module 9002 is configured to provide a countdown of drug delivery from the drug application device 9000 similar to that discussed above. The start of the countdown is in response to the push of the additional module 9002 and the trigger button. The additional module 9002 may include a switch configured to be disconnected before pushing the additional module 9002 and closed in response to pushing the additional module 9002. The switch closure may close the circuit, thereby triggering the countdown to begin. The additional module 9002 may include a processor configured to control a user interface. The user interface may also be configured to indicate that drug delivery is occurring, similar to that discussed above with respect to the light strip, but as described above, the user interface may provide information in a manner other than using lights.

[0188] In at least some embodiments, the processor 1060 is configured to use a hierarchy in how the data from the sensors 1030, 1040, 1045 are used to compare with each other and / or with any additional sensors. The hierarchy prioritizes one of the sensors over another, such that one sensor acts as a primary sensor such as sensor 1030, while the other acts as a secondary or auxiliary sensor such as sensors 1040, 1045. In such embodiments, the feature measured by the primary sensor may be considered a primary feature or a defining feature, and the feature measured by the secondary sensor may be a secondary feature or a feature that affects the primary feature. This prioritization or hierarchy of features (and therefore data) may be helpful when the drug administration device 1000 is used for a treatment that includes a control feature and one or more auxiliary features that may affect or help monitor the control feature, such as when measuring blood pressure when administering a blood pressure medication or when measuring blood sugar levels when administering insulin. Although secondary features can help monitor hypertension or hypoglycemia, the feature of primary interest in each example is the blood pressure itself or the blood sugar level itself, as discussed in detail below. The prioritization of data and inputs from one or more secondary sensors based on a hierarchical relationship can be customized based on desired patient outcomes, various expected or predicted side effects, administered medications, time of day, location, activity level, caloric intake, physical activity, etc. Therefore, the device 1000 may have a predefined hierarchical structure based on the level or severity of the impact of the sensing features from the sensor on the dose. An unlearned algorithm within the medical professional or device 1000 itself can optionally adjust the priority of the level, or reorder the importance of various sensing data and inputs as a result of the dosage and / or administration timeline, as described below. Because so much data can be generated by using multiple sensors, and because data from one sensor may contradict data from another sensor in some cases, effectively using contextual awareness to personalize the administration of medications to each patient can benefit from the prioritization and relative weighting of multiple information sources to obtain the most correct conclusions or recommendations, thereby best helping the patient. This prioritized hierarchical structure can be customized for a specific patient based on how the patient presents at any one moment or over time, thereby providing an adaptive device with a reorderable hierarchical relationship.

[0189] As described above, the hierarchical arrangement can be used in a variety of ways, such as to validate physiological results, such that data from one or more sensors is considered to adjust at least one variable parameter to proactively manage any expected negative impact on the primary characteristic being measured. Fig.11A diagram is shown for tracking the use of a drug administration device 1000 as an insulin pump, but as discussed above, the drug administration device 1000 may also be another type of device. At least one variable parameter of an insulin pump includes the insulin level delivered to the patient by the pump over time. A first sensor 1030 is designated as a primary sensor and is configured to measure a primary feature in the form of a glucose level in the patient. Designated secondary sensors 1040, 1045 are each configured to track secondary features or measurements, in this example, including the patient's activity level, blood pressure, sweating, metabolic rate, sleep quality, and tremor detection, each of which may be sensed with a different sensor, thereby using more than three sensors. Tracking the glucose level as the primary feature and changing the delivered insulin level allows the insulin pump (e.g., its processor 1060) to determine the typical long-term average or basal insulin level that the patient expects to receive, which allows the insulin pump to generally modify how much insulin it expects to deliver to the patient over time. As shown, the average insulin level can remain consistent throughout the day and then can be reduced at night when the patient is usually sleeping. Therefore, tracking the primary feature allows some modifications to the delivered insulin level. However, this is not very personalized for the patient. When tracking one or more secondary features, more personalized and specialized care is possible because the insulin pump can actively manage the administration or application of insulin. In this way, the pump can help maintain the patient's healthy glucose level (e.g., between about 50 mg / dL and 200 mg / dL, more preferably between about 70 mg / dL and 120 mg / dL) on a continuous basis, rather than waiting to detect the various negative results of poorly managed insulin and glucose levels, such as hypoglycemia triggered by very low glucose levels (e.g., about 50 mg / dL or lower), to subsequently correct the dosage level.

[0190] Initially, the patient receives a baseline amount of insulin from the insulin pump via execution of algorithm 1052, and the patient's glucose level as determined by the glucose (primary) sensor is within a healthy range. However, at time t1, the insulin pump detects the beginning of strenuous exercise through one or more secondary sensors, for example, an activity level sensor can detect strenuous activity, a blood pressure sensor detects an increase in the patient's blood pressure, a sweat sensor detects an increase in the amount of sweat, a metabolic rate sensor significantly increases, and a tremor detection sensor can detect a possible tremor of the patient. All of these sensor readings can be analyzed together by processor 1060 to allow the insulin pump to determine that the patient is likely to be exercising based on predefined criteria, which classifies sensor data from various sensors as being within a certain range or having a value indicating exercise. The insulin pump can then reduce the dosage and / or dosing interval by changing at least one variable to reduce the amount of insulin provided to the patient, thereby compensating for exercise and thus maintaining a healthy glucose level.

[0191] At time t2, the insulin pump determines that the exercise has most likely terminated based on predefined criteria, for example, because both the activity level sensor and the tremor detection sensor stop detecting movement, while the other sensors show a gradual return to normal or stationary rates. Therefore, the insulin pump increases the dosing amount and / or the dosing interval, for example, by changing the same at least one previously changed variable, to compensate for the termination of the exercise. However, due to the residual effects of the exercise on the patient, such as an increased metabolic rate that will remain above the long-term average for at least several hours after the exercise, the level does not return to the pre-dose level.

[0192] At time t3, the insulin pump reduces the dosing amount and / or dosing interval because the pump determines, based on predefined criteria, that the patient is likely to fall asleep based on the complete lack of detection readings from the activity level sensor. Due to the hierarchical nature of the sensors, readings from the sleep quality sensor may be prioritized last or not acquired at all during active time when the patient is not sleeping. However, when the patient begins to sleep, the priority of the sleep quality sensor may be increased to more significantly affect the behavior of the insulin pump. Alternatively, the sleep quality sensor may be manually activated by the patient, or may be automatically activated based on various readings from secondary sensors only during sleep time.

[0193] At time t5, the insulin pump can completely terminate insulin delivery due to the detection of a possible hypoglycemic event. Glucose levels can be significantly reduced, activity levels can begin to increase, blood pressure can drop, sweating can be significantly increased, sleep quality sensors can detect bad REM cycles of sleep, and tremor detection sensors can detect possible tremors. The features of these measurements can be analyzed by the insulin pump, which can identify each indicator as meeting hypoglycemia, and the pump therefore terminates insulin delivery by changing at least one variable parameter to reflect the absence of a dose, such as by changing the amount of the dose to zero or by changing the dose frequency to an unreachable time period. Because dosing is terminated immediately at the beginning of a possible hypoglycemic event, rather than waiting until the glucose level drops below a normal or safe threshold and then reacting, the patient's glucose level begins to rise rapidly again, thereby entering a healthier or normal range at time t6 and returning to the ideal range at time t7. Without monitoring one or more secondary features, a hypoglycemic event may not be detected until the patient has had a dangerously low blood sugar level for an extended period of time, and rapid recovery may not be achieved. Thus, an insulin pump can proactively analyze data from a primary sensor and one or more secondary sensors to monitor for the onset of a possible negative consequence that might not be easily or quickly identified without simultaneously monitoring multiple data sources. The pump can then react immediately to the possible event and avoid the negative consequence altogether, or, as the case may be, Fig.11As shown, the negative effects are greatly reduced.

[0194] The hierarchy between the various sensors may be predefined; may be adjusted based on user input, such as input provided through the user interface 1085; may be adjusted based on a processor, an algorithm, any analyzed data, etc.; and / or may be adjusted through communication with a remote computer system, a physician, a remote care provider, etc. The insulin pump may also incorporate various functional components of the infusion pump system described in U.S. Patent Publication No. 2009 / 0069787, entitled “Activity Sensing Techniques for an Infusion Pump System,” published on March 12, 2009, which is incorporated herein by reference in its entirety.

[0195] Additionally, the device indicators 1085, user interface 1080, and communication interface 1099 may allow the insulin pump to alert the user before a hypoglycemic episode is imminent, such as by flashing, beeping, speaking, providing a warning image, etc. Thus, they may allow the insulin pump to provide instructions to the user, such as to eat something or take a glucose tablet, and / or to send data indicative of the collected sensor data to a remote server for later detailed analysis or to prompt immediate review by a medical professional, who may then take appropriate action to help the patient, such as calling the patient, sending a message via the insulin pump, alerting emergency services, etc.

[0196] Although combined Fig.11 The insulin pump of FIG. 10 discusses one possible hierarchy of sensors, but other hierarchies are possible. Generally speaking, the primary feature of the drug administration device may be the control scheme, while the secondary features or schemes may be data obtained from sources surrounding the primary feature and / or sources that may affect and / or be affected by the primary source. For example, blood glucose level is the primary feature of insulin delivery, such as Fig.11As shown, blood pressure is the primary feature of various blood pressure medications. In addition, sources surrounding the primary source can take a variety of different forms, such as glucose levels (e.g., as measured by microneedle application and / or sweat analysis); blood pressure (e.g., as measured by various wearable cuffs); hydration (e.g., as measured by sweat levels); heart rate and / or activity levels (e.g., as measured by various metabolic expenditures, by altitude changes, various gyroscope-determined sitting or sedentary movements); EKG cycles; heart rate fluctuations; various acute effects or activities that trigger measurement (such as sleep or sleep quality detection and / or meal detection, such as by analyzing one or more images of the patient, receiving input from the patient, etc.); dietary discrimination; monitoring various long-term effects of any changes that may inform a new diagnosis or provide an alert to seek evaluation of any possible new conditions; core temperature; tremor detection; image analysis of a camera held / worn by the patient; time of day; digital calendar information; GPS output; device activity; any user interaction with the device; and the like.

[0197] In addition, in addition to combining Fig.11 In addition to those discussed, a variety of ways to sense any surrounding context during drug administration are possible, thereby providing multiple types of context awareness that can be used by one or more drug administration devices. As another example, a form of cognitive analysis can be performed on the patient by combining small interactions with the patient and various automatic sensors on or around the patient to determine the cognitive impact of any drug dose on the patient. Responses to various measures of drug doses can also be analyzed, such as timing of first effect, duration of effect, size of effect, etc. Fig.11 An insulin pump provides an example of ending the continuous application of a drug, however, there are many other examples where such an action can be taken. For example, if a biologic or drug is being delivered continuously, multiple sensors may allow for the detection of the onset of a complex biological response to the biologic or drug, and the drug administration device may have the ability to affect, delay, or terminate the continuous administration of the biologic or drug. Thus, the devices described herein may be configured to provide detection and automatic response to any indirect physiological response to the introduction of a continuous biologic.

[0198] For example, injection reactions may be a problem with some biologics, especially when delivered by IV given delivery times and continuous administration. Thus, the drug administration devices described herein may be configured to detect various onsets of injection reactions, such as by sensors, and thus stop or slow the delivery of the drug. In at least some embodiments, the drug administration devices described herein may be configured to deliver other drugs to stop, mitigate, or counteract drug injection reactions.

[0199] As another example, cytokine release syndrome is a form of systemic inflammatory response syndrome that can be caused by the adverse effects of some monoclonal antibody drugs and adoptive T cell therapy. Once the drug administration device or other systems communicating with the device detect that the pro-inflammatory and anti-inflammatory components in the patient are higher than a predetermined threshold, the drug administration device can be configured to reduce or stop the introduction of treatment. In such an example, the device can also be configured to notify medical personnel or introduce cancellation agents to accelerate the reduction of the response. If the injection reaction is large enough as defined by the predefined criteria, the drug administration device can be configured to automatically upgrade its response from passive indication or dose reduction to the introduction of more active warning notifications or other active countermeasures. Even when medical intervention is required, such as when the patient needs to enter the hospital for emergency treatment, the drug administration device described herein can be configured to use biometric data to detect changes in the patient's body that usually have serious effects, such as body temperature or heart rate. The drug administration device can be configured to notify the patient of the upcoming impact to allow the patient to take preemptive actions before one or more major side effects occur before entering the hospital later, such as taking medicine at home. This early warning can improve patient outcomes by reducing any negative consequences.

[0200] As another example, some drugs may cause drowsiness, dizziness and / or other side effects that may adversely affect the patient's ability to drive and / or navigate safely from a hospital or other drug administration location. When such a drug is administered to a patient at a location where the patient plans to drive home (or other places) from the patient, such as a hospital or other medical care facility, confirming that the patient has not experienced any possible side effects of the drug that may adversely affect the patient's ability to drive can help prevent the patient from driving unsafely after the drug is administered. Once a drug administration device or other systems communicating with the device detect possible side effects of any drug that may adversely affect the patient's ability to drive or navigate safely from a drug administration location, the drug administration device or other systems communicating with the device may be configured to notify medical personnel. Then, medical personnel can help ensure that the patient does not leave the drug administration location until the side effects are resolved and / or medical personnel can be allowed to contact the patient's preferred transportation provider from the drug administration location at an appropriate time, such as a family member, a care provider, a taxi service, a ride-sharing service, etc. Sensor data can also help assess drug side effects in a patient population. In some embodiments, the patient may not plan to drive after drug administration, but being determined not to have experienced any possible side effects of the drug that could adversely affect the patient's ability to drive or navigate safely can help medical personnel assess whether the patient is ready to be released. For some drugs such as esketamine, ketamine, and controlled substances, the patient must wait a minimum amount of time under observation at the drug administration site after drug administration. The sensor can help ensure that at least at the end of the minimum amount of time, the patient does not experience any possible side effects of the drug that could adversely affect the patient's ability to drive, thereby helping medical personnel assess whether the patient is ready to be released from observation.

[0201] In at least some embodiments, drug delivery from a drug administration device varies based on an interaction between the drug administration device and the accessory, representing a collaborative or closed-loop relationship between the drug administration device and the accessory. The accessory may remain in or on the drug administration device, or may be separate from the drug administration device. The accessory includes a processor configured to receive data indicative of a physiological characteristic of a patient from at least one sensor of the drug administration device and to control delivery of the drug from the drug administration device to the patient based on the received data. Thus, the dose may vary over time based on the sensor data and interaction with the accessory to allow for more personalized administration of the drug during each dose and over time, thereby increasing the beneficial outcomes of the drug by taking into account the actual current condition of the patient. This functionality is similar to that described above with reference to Fig. 9 and Fig.10 The functions discussed above differ in that the algorithm controlling the delivery of the drug from the drug administration device is managed by the accessory rather than the drug administration device. Fig. 9 The drug administration device 1000 is less "smart" and therefore smaller and / or cheaper. Moreover, it is generally cheaper and / or easier for a patient to upgrade an accessory and / or acquire a new accessory than it is for a patient to upgrade a drug administration device or acquire a new drug administration device, so the uninstall process and algorithmic control of the accessory can extend the useful life of the drug administration device.

[0202] Fig.12 One embodiment of a drug administration system 2000 is shown, which includes a universal drug administration device 2002 and an accessory 3002. In the illustrated embodiment, the drug administration device 2002 includes a housing 2004, a drug holder 2010, a dispensing mechanism 2020, at least one sensor 2030, 2040, a memory 2050, a processor 2060, a user interface 2080, an indicator 2085, a power source 2095, and a communication interface 2099. In the illustrated embodiment, the accessory 3002 includes a housing 3004, at least one sensor 3030, a memory 3050 configured to store an algorithm 3052 therein, a user interface 3080, a device indicator 3085, a processor 3060, a power source 3095, and a communication interface 3099. In addition, similar to the above, those skilled in the art will appreciate that each of the universal drug administration device 2002 and the accessory 3002 can be provided with the various features described above in a variety of different combinations.

[0203] The first sensor 2030 and the second sensor 2040 of the drug administration device 2002 are similar to those discussed above. Fig. 9Sensors 1030, 1040, 1045. In an exemplary embodiment, each sensor 1030, 1040 is configured to collect data about a physiological characteristic of the patient. For example, the sensed physiological characteristic can be any two or more of the patient's response to a drug delivered thereto, blood glucose level, blood pressure, sweat level, heart rate, breathing rate, atmospheric sensing, angular velocity, body orientation, MARG (magnetism, angular velocity and gravity), internal device sensing, blood oxygen level, sunlight exposure, osmolarity, piezoelectric skin measurements such as changes in ultrasound response, electrical parameters of the dermis such as impedance, biosensing, sensing enzymes, sensing antibodies, sensing histamine, sensing nucleic acids, any of the features discussed for device 1000, air quality tracking, etc. Alternatively or in addition, one or both of the sensors 1030, 1040 may be configured to collect data about the current of a motor used in delivering the drug. U.S. Patent Publication No. 2002 / 0014951, entitled "Remote Control For A Hospital Bed," published on February 7, 2002, and U.S. Patent Publication No. 2007 / 0251835, entitled "Subnetwork Synchronization And Variable Transmit Synchronization Techniques For A Wireless Medical Device Network," published on November 1, 2007, further discuss various sensors and are incorporated herein by reference in their entirety. Sensors 2030, 2040 may monitor the same physiological parameters or monitor different physiological parameters. Monitoring the same parameters may allow for confirmation of a condition, while monitoring different parameters may allow for consideration of more characteristics associated with the patient for drug delivery. Although in Fig.122002, but the device 2002 may include only one sensor such as sensor 2030, or may include three or more sensors. Any additional sensors may operate similarly to sensors 2030, 2040, and may also monitor various physiological characteristics. One or both of sensors 2030, 2040 may be a biosensor, such as a device that includes a biological component and a transducer and is configured to sense biological elements such as enzymes, antibodies, histamine, nucleic acids, etc. Sensors 2030, 2040 may operate together as a sensor array or dual sensors. Sensors 2030, 2040 are configured to sense their respective physiological characteristics, and memory 2060 is configured to store data therein as a plurality of data points defining and / or representing the sensed characteristics. The communication interface 2099 is configured to transmit data indicative of the sensed information to the accessory 3002 , for example to its communication interface 3099 , to allow the received information to be stored in the memory 3050 and analyzed by the processor 3060 to control drug delivery from the device 2002 using the algorithm 3052 .

[0204] The at least one sensor 3030 of the accessory is configured to sense one or more characteristics associated with the patient. The one or more characteristics may be physiological characteristics and / or contextual characteristics of the patient. A variety of different physiological characteristics may be monitored, such as heart rate, respiratory rate, blood pressure, sweat level, etc. Many different contextual characteristics may be monitored, such as core temperature, time of day, date, patient activity level, altitude, GPS information, blood oxygen level, sunlight, osmotic pressure, air quality, inflammatory response, one or more images and / or videos of the patient and / or the patient's environment (e.g., to analyze food intake; to determine whether solid food or liquids are being consumed; to determine the patient's location or activity; to determine the patient's condition, such as skin reactions, breathing, eye dilation, sedation, schizophrenia, vocal characteristics such as tone and pitch; etc.), user input data such as overall health, or cycle time between episodes of a particular disease, etc. The at least one sensor 3030 is configured to sense a characteristic, wherein the memory 3050 stores the collected data as a plurality of data points defining and / or representing the sensed characteristic.

[0205] In at least some embodiments, one of the sensors 2030, 2040 of the drug administration device 2002 can effectively serve as a primary sensor for the administration system 2000 that defines the operating range for closed-loop control of drug dosage and timing administration, and at least one sensor 3030 of the accessory 3002 can serve as a secondary sensor that provides patient feedback and is used to adjust the dose amount, dose timing, dose position, etc. within the range defined by the primary sensor 2030.

[0206] The processor 3060 of the accessory 3002 is configured to control the delivery of medication from the device 2002 to the patient based on the sensed data received from the device 2002 and, in at least some embodiments, additionally or alternatively based on data collected by at least one sensor 3030 of the accessory. Similar to the above, the processor 3060 is configured to control the delivery of medication by changing at least one variable parameter of the algorithm 3052, such as adjusting at least one variable parameter for the dose of medication, the timing between doses of medication, the location of delivery of medication, the concentration of the dose, actuating a set number or a continuous number of discrete doses, actuating continuous doses, actuating an initial bolus dose and then actuating subsequent occasional or repeated smaller doses as needed, terminating a dose, skipping one or more doses, etc. The data received at the accessory 3002 from the device 2002 is in the form of a plurality of data points defining sensed physiological characteristic data of the patient. Processor 3060 may be configured to change at least one variable parameter of algorithm 3052 during delivery of a dose, such that algorithm 3052 changes in real time as the dose is delivered, which may adapt to conditions sensed in real time, or processor 3060 may be configured to change at least one variable parameter of algorithm 3052 before delivery of a dose begins, which may consume less memory and use less processing resources during execution of algorithm 3052 compared to real-time changes to algorithm 3052.

[0207] The processor 3060 is configured to control drug delivery from the device 2002 by any of a number of different mechanisms, such as by transmitting commands to the device 2002 using the communication interface 2099, 3099, wherein the processor 2060 of the device executes the commands to cause drug delivery (e.g., by providing a plurality of data points defining one or more instructions to the device 2002). Instead of the algorithm 3052 stored at the accessory 3002, the algorithm for controlling drug delivery from the device 2002 can be stored at the device 2002, such as in its memory 2050. Similar to the above, the accessory 3002 can be configured such that at least one variable parameter of the algorithm stored at the device 2002 is changed based on data collected by at least one sensor 2030, 2040 of the device and / or based on data collected by at least one sensor 3030 of the accessory, such as by transmitting commands to the device 2002 using the communication interface 2099, 3099, wherein the processor 3060 of the device executes the commands to change the at least one variable parameter as instructed. An algorithm stored at device 2002 rather than accessory 3002 can help ensure that drug delivery occurs because delivery is locally controlled and can occur even if communication between device 2002 and accessory 3002 is interrupted, for example due to device 2002 and accessory 3002 being outside of each other's wireless communication range, due to network system problems, due to power loss at accessory 3002, etc.

[0208] Fig.13 An embodiment of the use of a drug administration device 2002 and an accessory 3002 is shown. The use is similar to the above in conjunction with Fig.10 The uses discussed are different, except that the processor 3050 of the accessory 3002 is involved in the data analysis and control of the dose delivery.

[0209] Various delivery types from the drug administration device 2002 can be used, such as mealtime or basal delivery. For example, based on the severity of the hyperglycemic or hypoglycemic reaction, large-dose mealtime delivery can be used to prevent further deterioration of the patient's body. As another example, the automated system can adjust the basal insulin target dose size based on long-term tracking of blood sugar, continuously adjust around the target basal level based on continuous monitoring, and then introduce mealtime levels only for severe adjustments.

[0210] In at least some embodiments, the drug administration device 2002 is a smart drug administration device that performs some analysis on its own, and the attachment 3002 provides additional smart functions to help improve dosage effectiveness, safety and / or accuracy. For example, the smart drug administration device can be a smart insulin pump that allows blood glucose detection, such as Medtronic's MiniMed 670G, so that the pump tracks the patient's continuous glucose level while adjusting the proximity between the pump and the sensor. For another example, the smart drug administration device can be a glucagon delivery device that treats severe hypoglycemia (defined by blood glucose below 70) by injecting glucagon to raise glucose levels to a desired basal level. For another example, the smart drug administration device can be an insulin delivery device that continuously adjusts the amount of insulin it delivers from one minute to the next based on readings from a continuous glucose monitor.

[0211] The accessory 3002 may take a variety of different forms. The accessory 3002 may be used alone to help control the delivery of medication from the medication administration device 2002. Alternatively, the accessory 3002 may have an additional purpose other than the delivery of medication from the medication administration device 2002 and thus be multifunctional.

[0212] Embodiments of the accessory include headphones, earphones, smart watches, nail sensors, digital collection patches (with or without direct skin contact), augmented reality or smart glasses, implantable or ingestible components, headbands, digital connection devices for transmitting weight, wearable cameras (e.g., in smart glasses), portable cameras (e.g., in smart phones, mobile tablets, etc.), handheld diabetes management devices, smart mobility assistance devices, tracking and monitoring mechanisms, etc. U.S. Patent Publication 2014 / 0081659, entitled "Systems And Methods For Surgical And Interventional Planning, Support, Post-Operative Follow-Up, And Functional Recovery Tracking," published on March 20, 2014, describes various embodiments of tracking and monitoring mechanisms and is incorporated herein by reference in its entirety. U.S. Patent Publication 2012 / 0095318, entitled "Handheld Diabetes Management Device With Bolus Calculator," published on April 19, 2012, describes embodiments of a handheld diabetes management device, which is incorporated herein by reference in its entirety. U.S. Patent Publication No. 2017 / 0172462, filed on June 22, 2017, and entitled “Multi-Functional Smart Mobility Aid Devices And Methods Of Use,” describes an implementation of a smart mobility aid device, which is incorporated herein by reference in its entirety.

[0213] Figures 14 to 24 , Fig.26 and Fig.28 Various embodiments of accessories that may be used as accessory 3002 are shown. Fig.14 An embodiment of an accessory 4010 in the form of a headphone is shown, which is configured to be worn by a patient 4000 around his or her right or left ear. Fig.15 Another embodiment of an accessory 4020 in the form of a wristband or smart watch is shown, which is configured to be worn on the right or left wrist of the patient 4000. Fig.16 and Fig.17 An embodiment of accessories 4030, 4040 is shown that is configured to be worn on the head of a patient 4000. Accessory 4030 is a headband that is worn around the patient's head, while accessory 4040 is a device that is attached directly to the skin of the patient's head, such as by an adhesive. Fig.18 and Fig.19An embodiment of an attachment 4050, 4060 configured to be worn on the body of a patient 4000 is shown. Attachment 4050 is an abdominal patch or device placed directly on the patient's abdominal skin, while attachment 4060 is a patch or device attached to the patient's back skin. Attachments 4050, 4060 can be attached in a variety of ways, such as by using an adhesive. Fig. 20 and Fig.21 Embodiments of accessories 4070, 4080 are shown, which are wearable nail sensors configured to be worn on one or more nails of a patient 4000. Accessory 4070 is a light or optical sensing wearable nail sensor configured to detect the presence of various types of light (e.g., UV sunlight), and accessory 4080 is a chemical sensing wearable nail sensor configured to detect the presence and / or concentration of various chemicals. Fig. 22 An embodiment of an accessory 4090 configured to be implanted within a patient 4000 and / or ingested by the patient is shown. Fig. 22 It also shows something like Fig.12 An embodiment of a drug administration device 4092 of the drug administration device 2002 that is located external to the patient and is configured to electronically communicate with an implanted / ingested accessory 4090.

[0214] As described above, image analysis can be used to capture data in the environment surrounding the patient. For example, as will be appreciated by those skilled in the art, image analysis can be used for meal detection, such as to confirm that a meal is being consumed; analysis of the meal itself, such as volume or carbohydrate, protein, and fat content; image analysis of skin color, injection sites, and / or other anatomical structures to determine redness, inflammation, and / or other reactions; and image analysis based on body area (e.g., mg / m 2 ) calculation of the dosage of the medication administered, such that an image of the patient's body can be used to calculate the dosage in addition to any patient inputs (such as weight, age, etc.); image analysis to provide relevant medication information through interconnection between the image taken by the patient and any smart digital patient device, which will allow the device to provide user information about medication, dosage, timing, function, etc. The image capture device is further described in U.S. Patent Publication 2012 / 0330684, entitled "Medication Verification And Dispensing," published on December 27, 2012, which is incorporated herein by reference in its entirety. In response to detecting a meal, the accessory can be configured to adjust the delivery of medication from a medication administration device in communication with the accessory.

[0215] Fig.23An embodiment of an accessory 5000 in the form of smart glasses having a camera 5002 built therein is shown. The patient 4000 can wear the accessory 5000 like a pair of ordinary glasses, however the accessory 5000 (e.g., its processor) is configured to analyze the images captured by the camera 5002 to visually identify various types of information about the meal 5004 and / or beverage 5006 consumed by the patient 4000, such as the type of food, the amount of food, the amount of food left on the plate, etc. U.S. Patent Publication No. 2011 / 0295337, entitled “Systems and Methods For Regulating Metabolic Hormone Producing Tissue,” filed on December 1, 2011, U.S. Patent No. 8,696,616, entitled “Obesity Therapy And Heart Rate Variability,” published on April 15, 2014, U.S. Patent No. 9,427,580, entitled “Devices And Methods For The Treatment Of Metabolic Disorders,” published on August 30, 2016, and U.S. Patent No. 9,168,000, entitled “Meal Detection Devices And Methods,” published on October 27, 2015, further describe types of information identified about meals and / or beverages, and the entirety of each of the patents is incorporated herein by reference. Definitely detecting the occurrence of eating / drinking is important for safety, efficacy, and cost, and can be combined with information sensed through contextual awareness, as discussed above with respect to device 1000, to improve the accuracy of the meal detection methods described herein.

[0216] The attachments configured for meal detection, such as attachment 5000, can be used for a variety of different situations. For example, it is known that the activation of brown adipose tissue (BAT) can increase metabolic activity. BAT activity leads to heat production, which can be measured with a certain temperature probe. When associated with a meal, activation of BAT can have a large metabolic impact. Therefore, the attachments configured for meal detection can be used to detect meals, and the detected meals can trigger the release of drug doses for BAT activation. The confirmation of activation can then be determined with a temperature probe worn near the BAT reservoir. For example, the U.S. Patent No. 9,610,429, entitled "Methods And Devices For Activating Brown Adipose Tissue With Targeted Substance Delivery", published on April 4, 2017, and the U.S. Patent No. 9,381,219, entitled "Brown Adipocyte Modification", published on July 5, 2016, further describe drug-based activation means, and the patents are incorporated herein by reference in their entirety. Temperature probes are further described in U.S. Patent 8,812,100, entitled “Device And Method For Self-Positioning Of A Stimulation Device To Activate Brown Adipose Tissue Depot In A Supraclavicular Fossa Region,” which issued on August 19, 2014 and is incorporated herein by reference in its entirety.

[0217] As described above, in both the drug administration device and / or the accessory, different sensor configurations and interactions can be used to generate primary and secondary measurements of the patient's physiological characteristics. For example, the sensors used can be modular sensor arrays, configurable sensor arrays, dual sensors that provide interactive sensing, dual cooperative remote sensing arrays, etc. In such examples, one or more sensors configured to detect physiological responses to drug administration in the patient can be remotely positioned to the injection site to prevent the drug administration itself from interfering with the results. In addition, a second sensor array can be positioned close to the injection site and / or the drug administration device to determine acute local reactions and verify that the drug administration device has been properly operated.

[0218] Fig.24 and Fig.26 An embodiment of an accessory 5010 including a camera is shown, the camera being configured to collect images of the patient's eyes and / or the patient's skin 4000 at different points on the patient's body. The accessory 5010 is configured to collect images of the patient's eyes and / or the patient's skin at a single point or at different points on the patient's body. Fig.25 (For example, Fig.24The data collected were analyzed as shown) and Fig. 27 (For example, Fig.26 The patient's eyes and / or skin color are monitored over time as shown (the collected data is analyzed) to track any possible reactions to the medication (e.g., sleep, drowsiness, lethargy, etc.) and / or observe any inflammation (caused by the administration of the medication or caused by a secondary source and the medication is administered to treat), and in response to detecting a drug reaction and / or inflammation, adjusting drug delivery from a drug administration device that communicates with accessory 5010. Fig.25 and Fig. 27 The corresponding light color diagrams of the patient's skin color at times t1, t2, t3, t4, t5 and t6 and each time point are shown (in Fig.25 and Fig. 27 ). Fig.25 and Fig. 27 The dashed lines depicted on the graph in represent mild inflammation and severe inflammation, such that image analysis (performed electronically by the system or manually by a care professional) allows for tracking of inflammation and alerts, notifications, preemptive actions, responsive actions, etc. in response to skin tone passing through mild and / or severe inflammation. Fig.24 An image is shown taken at a random point 5012 on the patient 4000 . Fig.26 An image of a patient's face 5014 is shown taken at a medication administration point in the form of an IV port 5016. Since the administration site (IV port 5016) is the first point of contact between the medication and the patient 4000, and a person's face can exhibit possible adverse reactions such as allergic reactions, etc., the administration point and the patient's 4000 face 5014 can be a useful area to monitor for any adverse or beneficial reactions to the administered medication.

[0219] although Fig.24 and Fig.26 The camera is shown as part of a smartphone, but the accessory configured to collect images may be a device other than a smartphone, such as a mobile tablet, smart watch, etc. Fig.24 and Fig.26 The images are shown to be collected by the same attachment 5010, but two different attachments may also collect Fig.24 and Fig.26 data.

[0220] Fig.28An embodiment of an accessory 5020 including a camera is shown that is configured to collect images of the body of the patient 4000, for example in a mirror 5022. In this illustrated embodiment, the accessory 5020 is a smart phone, but as described above, it can be another type of accessory configured to collect images. The accessory 5020 is configured to estimate the weight of the patient 4000 based on one or more of the collected images, and use the estimated weight to change an algorithm for drug delivery from a drug administration device associated with the patient 4000. The dosage of various drugs can depend on the weight, and one or more images of the whole body of the patient 4000 can allow the accessory 5020 and the corresponding drug administration device to provide the correct dosage based on the estimated weight of the patient 4000 in a simple manner. Fig.29 An embodiment of a graph correlating estimated body weight and dosage is shown, and accessory 5020 is configured to adjust dosage delivery based on estimated body weight.

[0221] In at least some embodiments, drug delivery from a drug administration device is altered based on a perception of the patient's state, such as altering drug delivery based on at least one physiological characteristic of the patient and at least one relevant physical characteristic of the patient. These specific implementations are similar to those discussed above in conjunction with altering drug delivery based on one or more characteristics determined based on the patient's situational perception associated with the patient, except that the characteristics associated with the patient are determined based on at least one physiological characteristic of the patient and at least one relevant physical characteristic of the patient. Implementations that take into account physiological and physical characteristics allow for altering the dose based on the patient's state (represented by the patient's physiological and physical characteristics) to achieve personalized care, an adaptive drug administration process that improves patient care, and / or automatic dose adjustments that increase successful drug use for patients. Various different physiological characteristics of the patient can be monitored, such as body temperature, heart rate, blood sugar levels, blood pressure, sweat levels, etc. Various different physical characteristics of the patient may be monitored, such as temperature, metabolic demand, cognitive function, metabolic demand (such as measured using at least one of food intake and BMR (basal metabolic rate)), weight, one or more images and / or videos of the patient and / or the patient's environment (e.g., to analyze food intake, to determine whether solid food or liquids are being consumed, to determine the patient's position or activity, to determine the patient's condition such as skin reactions, etc.), etc. Various different physical characteristics of the patient's environment may be monitored, such as the percentage of atmospheric pollutants, ambient temperature, etc.

[0222] Use by example Figure 5BThe universal drug administration device 500 of the present invention may store therein an algorithm executable to administer a dose of a drug to a patient, and the processor 96 may be configured to execute the algorithm to control the delivery of a dose of a drug dispensed by the dispensing mechanism 20. The processor 96 may also be configured to use physiological data representing at least one physiological characteristic of the patient and physical data representing at least one physical characteristic of the patient to change at least one variable parameter of the algorithm, so that the dose delivered after changing the at least one variable parameter will be controlled by executing the changed algorithm. As described above, those skilled in the art will understand that the universal drug administration device 500 may be provided with the above-mentioned various optional features in a variety of different combinations, for example, excluding any of the sensors 92, 94, 98 used by the processor 96 to change the variable parameters of the algorithm (but including sensors for collecting required physical and physiological characteristic data), excluding the packaging 35, excluding the user interface 80, etc. The processor 96 may be configured to change at least one variable parameter of the algorithm during delivery of the dose, so that the algorithm changes in real time as the dose is delivered, which can adapt to real-time sensed conditions, or the processor 96 may be configured to change at least one variable parameter of the algorithm before delivery of the dose begins, which can consume less memory and use less processing resources during algorithm execution compared to real-time changes to the algorithm.

[0223] As another example use Fig. 9 The universal drug administration device 1000 of Fig. 9 and Fig.10The memory 1050 has stored therein an algorithm 1052, and the processor 1060 is configured to execute the algorithm 1052 to control the delivery of a dose of the drug dispensed by the dispensing mechanism 1020. The processor 1060 is also configured to use the body characteristic data and the physiological characteristic data collected by at least two sensors of the sensors 1030, 1040, 1045 to change at least one variable parameter of the algorithm 1052, so that the dose delivered after changing the at least one variable parameter will be controlled by executing the changed algorithm 1052. As described above, those skilled in the art will understand that the universal drug administration device 1000 can be provided with the above-mentioned various optional features in a variety of different combinations, for example, not including any sensor of the sensors 1030, 1040, 1045 used by the processor 1060 to change the variable parameters of the algorithm 1052 (but including sensors for collecting the required body and physiological characteristic data), not including the user interface 1080, etc. Processor 1060 may be configured to change at least one variable parameter of the algorithm during delivery of a dose, so that the algorithm changes in real time as the dose is delivered, which can adapt to real-time sensed conditions, or processor 1060 may be configured to change at least one variable parameter of the algorithm before delivery of the dose begins, which can consume less memory and use less processing resources during algorithm execution compared to real-time changes to the algorithm.

[0224] In at least some embodiments, at least one physiological characteristic is directly related to the treatment administered by the drug administration device, and the device is configured to determine and adjust the dosage using local or immediate treatment to compensate for or overcome the sensed one or more current physical characteristics. In such embodiments, as further discussed below, at least one physiological characteristic is a primary characteristic that defines the response range of the drug administration device and at least one variable parameter, and the one or more physical characteristics are secondary characteristics used to fine-tune or affect the device dosage by changing at least one variable parameter.

[0225] Embodiments of drug delivery from a drug administration device based on changes in the perception of the patient's state can allow detection of any number of physiological characteristics and / or physical characteristics. For example, the detection of activity level, metabolism and / or physical characteristics of metabolic level can affect the dosage adjustment based on increased physiological needs. Typically, metabolism and metabolic rate are a mixture of total energy consumption and energy balance between heat intake and loss. Therefore, accurate measurements of activity, heat intake, feces heat output, oxygen consumption / CO2 generation, etc. can be used to inform metabolic activity. In such embodiments, metabolic activity can be a measured physiological characteristic, and one or more physical characteristics can be measured, such as activity, heat intake, feces heat output, oxygen consumption / CO2 generation, etc., to guide the adjustment of drug administration based on the measured physiological characteristics. In other embodiments, various different measurements such as activity measurement, food intake measurement, BMR, physiological measurement (such as body temperature or temperature change, ambient temperature and / or heart rate) can be used as various approximations of the patient's real-time metabolic rate, rather than attempting more direct measurements. Metabolic rate is discussed in, for example, LamYY and Ravussin, E., “Analysis of energy metabolism in humans: A review of methodologies,” Mol Metab. 2016 Nov;5(11):1057-1071 (available at<https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC5081410 / > Acquisition), which is incorporated herein by reference in its entirety.

[0226] In a specific implementation in which drug delivery adjustment from a drug administration device based on a perceived change in patient state can be a fully automatic, partially automatic and partially manual, or a fully manual, partially automatic or fully automatic device. A certain degree of automatic dose adjustment is particularly beneficial in cases where the patient may have difficulty applying any recommended changes caused by various patient conditions, environmental cues and / or physiological cues on their own. For example, patient ability and / or competency level can be used as one or more means to determine a fully automatic response of a drug administration device and / or varying degrees of partial control of the user over dose adjustment. For example, a patient is generally able to interact with the device safely, but during various emergency situations, the patient's ability may be impaired and automatic action may be required.

[0227] Fig.30 One embodiment of a drug administration device 7000 is shown, which is configured to have drug delivery performed therefrom based on a sensed change in a patient's state. Device 7000 is a partially automated insulin pump and includes a Fig. 9 User interface 1080 and user interface 7080 of device indicator 1085. Fig.31 Also shown are five exemplary views of user interface 7080 showing information associated with five different events A, B, C, D, and E discussed further below. Fig.32 As shown, the device 7000 is configured to measure blood glucose as a physiological characteristic, measure activity level and food intake as two different physical characteristics, and vary the level of insulin delivered as at least one variable parameter. Fig.32 Identify Fig.31 The timing of events A, B, C, D, and E. In the illustrated embodiment, the device 7000 is configured to provide three types of possible interactions with the patient using the device 7000: a fully automatic mode with no manual override but providing alerts / suggestions, an automatic mode that provides alerts / suggestions to the patient and accepts user input, and an automatic mode that does not provide alerts / suggestions.

[0228] Events A, B, C, D, E are determined based on one or more of the physiological characteristics and / or body characteristic sensing data. The occurrence of events A, B, C, D, E is configured to prompt the user to perform a task via a computer such as a computer program product. Fig.31 The user interface 7080 shown provides warnings / advice to the patient and / or prompts the automatic action of the device 7000. For example, at time t a Event A at (see Fig.32 ), an increased activity level is detected, such as due to exercise, which causes the patient's blood glucose level to drop from above 120 mg / dL to the normal range between 120 mg / dL and 70 mg / dL. Although this drop does not cause the patient's blood glucose level to be dangerously low, the slope of the drop indicates that the patient's blood glucose level may continue to drop, which will cause the blood glucose level to be dangerously below 70 mg / dL. This drop triggers a minor alert and suggestion ( Fig.31 Event A in t) to choose between reducing the delivered basal insulin level, eating, or ignoring the recommendation. The user chooses to reduce the basal insulin level by 50%, such as time t a and t b Shown between. Fig.32 The food intake curve in t a The dashed line at indicates that a meal was recommended but not taken.

[0229] At time t b and event B (see Fig.32 At event B in FIG. 7 , an increase in physical activity is again detected, causing the blood glucose level to drop significantly to a potentially low level of 70 mg / dL. This drop triggers the primary alert and advisory ( Fig.31Event B) in the example above gives the patient the choice of eating or ignoring the suggestion. The patient ignores the suggestion. However, the device 7000 is partially automatic, and therefore, the device 7000 determines that at time t b In other embodiments, the device can ask the patient and / or physician about the action to be taken regarding insulin delivery.

[0230] At event C and time t c (See Fig.32 ), the device 7000 provides primary alerts and suggestions on the user interface 7080 ( Fig.31 Event C in ( t ) chooses to eat or stop all physical activity because the previous activity level has not decreased, which causes the blood glucose level to move to the dangerously low range of 70 mg / dL. The device 7000 automatically shuts off insulin delivery, and the device 7000 continues to sound the alarm until food intake and / or all activity has stopped. At time t c The patient eats, Fig.32 The food intake curve is represented by the solid line on the graph.

[0231] At event D and time t d (See Fig.32 ), a gentle alarm sounds to alert the patient that the device 7000 is resuming insulin delivery at 50% of the basal level (see Fig.31 Event D in t). If necessary, the patient can adjust the delivery percentage. d It enters the normal range at t e into the higher range (see Fig.32 ), so that the device 7000 provides the last notification that the insulin level automatically returned to 100% of the basal level (see Fig.31 Event E) in, however, the patient can make changes if necessary. When the patient's blood sugar level drops to a dangerously low level, the patient's ability to think clearly may be impaired, and at this time the device 7000 can automatically take various actions to provide as much help to the patient as possible.

[0232] Thus, the drug administration devices of at least some embodiments described herein can be partially automated, allowing the patient and / or physician to control or override automated actions in various situations, while providing automated actions that cannot be overridden by the patient in various emergency situations. In at least some embodiments, notifications can have their priority or degree, becoming more persistent as the situation becomes more dangerous to the patient. With certain drug administration devices, care providers and / or emergency personnel can be automatically alerted when certain major alarms are sounded. In addition, risk-based treatment assessments can become more aggressive over time if the patient fails to take appropriate de-escalation actions and / or the drug administration device detects a significant lack of self-help by the patient.

[0233] A variety of other patient situations may allow them to partially or fully automate dosage adjustments to some degree. For example, pediatric patients may not yet understand or be able to manipulate a medication administration device in a safe manner, patients may suffer from dementia while suffering from a disease that requires injection or oral medication and cannot understand a medication administration device, patients may suffer from various psychological or psychiatric conditions that affect their ability to use a medication administration device and / or perceive gradual symptom escalation, patients may have difficulty administering medications and need to rely on the automatic action of a medication administration device, etc. In at least some cases, the proposed treatment may allow for medication administration device adjustments that simply make more sense to automate to help improve compliance, such as injections that may be various forms of pumps or other medication administration devices that are almost always worn by the patient. For example, various diabetic side effects may increase the difficulty or inhibit the patient's ability to administer an adjusted dose due to age, dexterity, the onset of various complications (such as hyperglycemia or hypoglycemia), etc.

[0234] Similar to the attachment 5020 discussed above, at least some embodiments of the drug administration device can be configured to automatically adjust the dosage over time based on the patient's weight, such as for pediatric patients, because the weight of pediatric patients tends to fluctuate more during growth. Weight measurement can be performed in a variety of ways, such as automatically transmitting the measured weight to the scale of the drug administration device from home or by analyzing images as described above. It is also possible to provide a warning of weight change before any change in the actual dosage occurs. In some cases, independent verification and / or approval of the patient's care provider may be required before initiating any changes. For example, parents and / or doctors can report the weight of pediatric patients when possible, and then the drug administration algorithm for the patient can be automatically updated with the new weight information. Any changes can be made directly on the device and / or can be made remotely.

[0235] In at least some embodiments in which drug delivery from a drug administration device is altered based on a perception of a patient's state (such as altering drug delivery based on at least one physiological characteristic of the patient and at least one related physical characteristic of the patient), the patient's contextual perception may also be considered in altering drug delivery, similar to the above, e.g., in conjunction with Fig. 9 For example, additional consideration of contextual awareness may allow the drug administration device to refine the sensed data, reduce errors, eliminate or reduce inaccurate outliers, and / or otherwise selectively influence the drug administration device to improve the device's understanding of the patient's physiological response before or after a dose of the drug is administered. Thus, one or more sensors may act as an adaptive sensing array based on the contextual awareness of the patient and / or drug administration device.

[0236] Fig.33An embodiment of an adverse reaction of a drug administration device in the form of an infusion device delivering a dose of a drug to a patient at time t1 is shown. Along with the various physiological characteristics of the patient and the patient's physical characteristics that the drug administration device tracks to determine the appropriate dose of the drug, the drug administration device also monitors the patient's allergic reaction to the drug by measuring physical characteristics and physiological characteristics that may indicate adverse reactions, such as heart rate fluctuations, sweating, and / or pupil dilation. At time t2, heart rate fluctuations, sweating, and pupil dilation all increase measurably, exceeding the smaller warning threshold shown, and prompting a possible adverse reaction to the drug. Therefore, at time t3, the dose of the drug is reduced, and a dose of a drug such as diphenhydramine is administered by the device at a lower dose to offset the patient's reaction. At time t4, heart rate fluctuations, sweating, and pupil dilation all continue to increase, and heart rate fluctuations and sweating all exceed the larger warning threshold. Therefore, the drug administration device delivers a second larger dose of the drug, at which time heart rate fluctuations, sweating, and pupil dilation all begin to decrease to more normal values ​​or baseline values. At this point in time, the patient's reaction is controlled, so the initial drug can continue to be delivered at a reduced dose.

[0237] If the patient does not respond effectively to the drug administration, the initial drug dose may be terminated entirely and restarted at a lower step value only when the various symptoms of the adverse reaction subside. Fig.34 Shown with Fig.33 , and shows measured blood pressure, temperature, and pupil dilation. At time t1, a dose of medication is started to be administered to the patient. At time t2, the temperature and pupil dilation exceed warning thresholds to indicate a possible adverse reaction, and the dose is reduced. At time t3, since the blood pressure has dropped, but both the temperature and pupil dilation continue to increase, a dose of medication is administered. At time t4, the pupil dilation is still increasing, while the temperature has exceeded the larger threshold, and the blood pressure has dropped to the point where it has exceeded the smaller threshold and is now too low. Therefore, the medication dose is stopped completely. At t5, the blood pressure, temperature, and pupil dilation have begun to return to normal levels, so the patient is administered medication again. However, the dose is further reduced. At time t6, when the adverse reaction indications from the blood pressure, temperature, and pupil dilation do not increase significantly, the dose is again slightly increased and temporarily maintained at a lower level.

[0238] In at least some embodiments, the patient can elect to be monitored from one or more sensors in the drug administration device. Fig.35 One embodiment of a user interface 8080 for a drug administration device is shown that allows a patient to select monitoring using one or more sensors on the device itself or via other means such as a patient application associated with the device. Fig.36As shown, when the sensor monitors the patient, the sensor can detect possible or likely early onset of joint pain, such as at t1 and t2. For example, when readings from the activity level sensor and the door analysis sensor indicate that physical activity may be too much for the patient and continued activity will prompt joint pain, a slight warning may be prompted at time t1. As the patient continues to move, Fig.38 Time point A in indicates exceeding a larger threshold of heart rate fluctuation, time point B indicates exceeding a larger threshold of sweating, and time point C indicates exceeding a larger threshold of activity level, at which time an alarm is sounded when all three conditions A, B, and C are met at time t2 to indicate a possible onset of severe joint pain. At this point, the device and / or patient application may prompt the patient to enter a pain score, such as by using user interface 8080, so that the device and any treating care providers can be better informed of the treatment results. The context-aware measurements described herein can be incorporated into any of the above devices to provide greater understanding of treatment and results and greater personalization of care.

[0239] As described above, some form of food intake and / or meal detection may be important when providing advice to patients and when adjusting dosages. Although some exemplary meal detection methods, such as image analysis, are discussed above, various drug administration devices may also use a combination of inputs from various physiological sensors and / or body sensors to confirm that a meal event has occurred and is sufficient to trigger a desired response in the patient. For example, analysis of heart rate fluctuations (HRV), image analysis, gastric pH, LINX reflux management devices, etc. may be used independently or in some combination to provide more accurate meal consumption detection. Providing various redundant measurements can help minimize errors in meal detection.

[0240] All devices and systems disclosed herein can be designed to be discarded after a single use, or can be designed for multiple uses. However, in either case, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of disassembling the device, cleaning or replacing specific parts, and subsequent reassembly steps. Specifically, the device is removable, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific components, the device can be reassembled for subsequent use at a repair facility or by a surgical team just before a surgical operation. Those skilled in the art will appreciate that the reconditioning device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such techniques and the resulting repair device are within the scope of this application.

[0241] It may be preferred that the devices disclosed herein be sterilized prior to use. This can be accomplished by any number of means known to those skilled in the art, including beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., cold soaks). Exemplary embodiments of sterilizing devices including internal circuitry are described in more detail in U.S. Patent Publication No. 2009 / 0202387, published on August 13, 2009 and entitled "System And Method Of Sterilizing An Implantable Medical Device." It is preferred that the device be hermetically sealed if implanted. This can be accomplished by any number of means known to those skilled in the art.

[0242] The present disclosure has been described above by way of example only in the context of the overall disclosure provided herein. It should be understood that modifications may be made within the spirit and scope of the claims without departing from the overall scope of the present disclosure.

Claims

1. A drug administration device, comprising: a medication holder configured to hold a medication therein; a first sensor configured to collect data regarding a first characteristic associated with the patient; a second sensor configured to collect data regarding a second characteristic associated with the patient; a memory configured to store therein an algorithm including at least one variable parameter; and A processor configured to: controlling delivery of a first dose of the drug from the drug holder to the patient by executing the algorithm, changing the at least one variable parameter of the algorithm stored in the memory based on the data collected by the first sensor in a hierarchy and the data collected by the second sensor in the hierarchy, the hierarchy prioritizing data from one of the first sensor and the second sensor over data from the other of the first sensor and the second sensor, and After changing the at least one variable parameter, delivery of a second dose of the drug from the drug holder to the patient is controlled by executing the algorithm.

2. The device according to claim 1, wherein: The processor is also configured to automatically control delivery of the dose according to a predetermined dosing schedule for the patient.

3. The apparatus of claim 1 , further comprising at least one additional sensor, each sensor being configured to collect data about a different characteristic; Wherein the processor is further configured to change the at least one variable parameter of the algorithm stored in the memory based on the data collected by the at least one additional sensor.

4. The device according to claim 1, wherein: The first characteristic is a physiological characteristic of the patient; and The second characteristic is a situational characteristic of the patient.

5. The device according to claim 1, wherein: The first characteristic is one of blood sugar level, blood pressure, sweat level and heart rate; and The second characteristic is at least one of core temperature, tremor detection, time of day, date, patient activity level, blood pressure, metabolic rate, altitude, temperature of the medication, viscosity of the medication, GPS information, angular rate, current of a motor used to deliver the medication, blood oxygen level, sunlight exposure, osmotic pressure, and air quality.

6. The device according to claim 1, wherein: The second sensor is configured to collect data by capturing images of at least one of the patient and an environment in which the patient is located; and The processor is configured to analyze the image to determine whether at least one of food ingestion and skin reaction to the drug occurred.

7. The device according to claim 1, wherein: The processor is also configured to move a device operation prevention mechanism from an unlocked state to a locked state based on at least one of the data collected by the first sensor and the data collected by the second sensor, wherein the device operation prevention mechanism allows the drug to be delivered to the user, and wherein the device operation prevention mechanism prevents the drug from being delivered to the user.

8. The device according to claim 7, wherein: The drug administration device comprises one of an injection device, a nasal spray device, and an inhaler.

9. The device according to claim 1, wherein: The drug comprises a biologic, and the second characteristic is an inflammatory response.

10. The device according to claim 1, wherein: The medication includes insulin and the first characteristic is blood glucose level.

11. The device according to claim 1, wherein: The drug includes glucagon and the first characteristic is blood glucose level.

12. The device according to claim 1, wherein: The medication comprises a blood pressure medication, and the first characteristic is blood pressure.

13. The device according to claim 1, wherein: The at least one variable parameter includes a rate of delivery of the drug from the drug holder to the patient.

14. The device according to claim 1, wherein: The at least one variable parameter includes time intervals between dose deliveries, such that doses delivered after changing the at least one variable parameter are at different time intervals than doses delivered before changing the at least one variable parameter.

15. The device according to claim 1, wherein: Changing the at least one variable parameter causes the processor to control delivery of the second dose such that the second dose is not delivered to the patient.

16. The device according to claim 1, wherein The processor is configured to automatically vary the at least one variable parameter.

17. The device according to claim 1, wherein: The processor is also configured to provide a notification to the patient based on the data collected by the second sensor.

18. The apparatus of claim 1, further comprising a communication interface configured to wirelessly transmit data indicative of the data collected by the first sensor and the data collected by the second sensor to a remotely located computer system and, in response, wirelessly receive commands from the remotely located computer system; Wherein the processor is configured to change the at least one variable parameter only after the communication interface receives the command.

19. The device according to claim 1, wherein: The processor is configured to change the at least one variable parameter of the algorithm during the delivery of the second dose such that the algorithm changes in real time as the second dose is delivered.

20. The device according to claim 1, wherein The processor is configured to change the at least one variable parameter of the algorithm before the delivery of the second dose begins.

21. The device according to claim 1, wherein The memory is further configured to store therein manually entered data regarding the patient; and The processor is further configured to change the at least one variable parameter of the algorithm stored in the memory based on the stored input data.

22. The device according to claim 1, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

23. The device according to claim 1, wherein The first characteristic is a physiological characteristic of the patient and the second characteristic is a physical characteristic of the patient.

24. The device according to claim 23, wherein: The processor is also configured to automatically control delivery of the dose according to a predetermined dosing schedule for the patient.

25. The device according to claim 23, wherein: The at least one variable parameter is varied to compensate for the physical characteristic.

26. The device according to claim 23, wherein The physical characteristic is one of temperature, metabolic demand, and cognitive function.

27. The device according to claim 23, wherein: The physiological characteristic is at least one of body temperature and heart rate; and The physical characteristic is metabolic demand measured using at least one of food intake and BMR (basal metabolic rate).

28. The device according to claim 23, wherein: The physical characteristic is weight.

29. The device according to claim 23, wherein: The processor is configured to change the at least one variable parameter of the algorithm during the delivery of the second dose such that the algorithm changes in real time as the second dose is delivered.

30. The device according to claim 23, wherein: The processor is configured to change the at least one variable parameter of the algorithm before the delivery of the second dose begins.

31. The apparatus of claim 23, wherein: The memory is further configured to store therein manually entered data regarding the patient; and The processor is further configured to change the at least one variable parameter of the algorithm stored in the memory based on the stored input data.

32. The device according to claim 23, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

33. A drug administration device, comprising: An automatic injector, the automatic injector comprising: a drug holder configured to hold a drug therein, a plurality of sensors configured to collect data regarding the angular orientation of the auto-injector relative to the patient's skin, a memory configured to store therein an algorithm including at least one variable parameter, and A processor configured to: controlling the delivery of a dose of the drug from the drug holder to the patient by executing the algorithm, and The at least one variable parameter of the algorithm stored in the memory is altered based on the data collected by the plurality of sensors in a hierarchy that prioritizes data from one of the plurality of sensors over data from another of the plurality of sensors.

34. The device according to claim 33, wherein the processor being configured to, in response to the collected data indicating that the auto-injector is not at a substantially perpendicular angle relative to the patient's skin, change the at least one variable parameter of the algorithm to prevent delivery of the drug from the auto-injector; and The processor is configured to, in response to the collected data indicating that the auto-injector is at the substantially vertical angle relative to the patient's skin, change the at least one variable parameter of the algorithm to allow delivery of the drug from the auto-injector.

35. The device according to claim 33, wherein The autoinjector further includes a trigger configured to be actuated to cause the medicament to be delivered from the medicament holder to the patient; and The at least one variable parameter of the algorithm is indicative of whether the trigger is actuatable by a user to cause the delivery of the drug.

36. The device according to claim 33, wherein the autoinjector further comprising a device operation prevention mechanism configured to move between a locked state in which the device operation prevention mechanism prevents delivery of the medicament from the autoinjector and an unlocked state in which the device operation prevention mechanism allows delivery of the medicament from the autoinjector; and The processor is configured to cause the device operation prevention mechanism to move from the locked state to the unlocked state in response to the collected data indicating that the auto-injector is at a substantially vertical angle relative to the patient's skin.

37. The device according to claim 33, wherein: The processor is configured to change the at least one variable parameter of the algorithm before the delivery of the dose begins.

38. The apparatus of claim 33, wherein: The plurality of sensors includes a contact sensor.

39. The apparatus of claim 33, wherein: The plurality of sensors includes a pressure sensor.

40. The apparatus of claim 33, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

41. A drug administration system, comprising: a drug administration device configured to retain a drug therein for delivery to a patient, the drug administration device comprising at least two sensors configured to collect data regarding a physiological characteristic of the patient; as well as An accessory comprising a processor configured to: Receiving data indicative of the collected data from the at least two sensors, and controlling delivery of the drug to the patient based on the received data from the at least two sensors in a hierarchical structure that prioritizes data from one of the at least two sensors over data from another of the at least two sensors.

42. The system of claim 41, wherein: The accessory and the drug administration device are separate devices.

43. The system of claim 42, wherein: The accessory is configured to be worn by the patient and includes one of a headset, a smart watch, a nail sensor, a digital collection patch, augmented reality glasses, and a camera.

44. The system of claim 42, wherein: The attachment is configured to be implanted in the patient or ingested by the patient.

45. The system of claim 42, wherein: The accessory is configured to collect data by capturing images of at least one of the patient and an environment in which the patient is located; and The processor is also configured to analyze the image to determine whether at least one of food ingestion and skin reaction to the drug occurred.

46. ​​The system of claim 41, wherein: Controlling the delivery of the drug includes adjusting at least one of a dose of the drug, timing between doses of the drug, and a location of delivery of the drug.

47. The system of claim 41, wherein: The physiological characteristics include the patient's response to the drug delivered thereto.

48. The system of claim 41, wherein: The physiological characteristic includes at least one of angular velocity, blood oxygen level, sunlight, and osmolarity.

49. The system of claim 41, wherein: At least one of the sensors comprises a biosensor configured to sense an enzyme, an antibody, histamine, or a nucleic acid.

50. The system of claim 41, wherein: At least one of the sensors comprises a sensor array or a dual sensor.

51. The system of claim 41, wherein: The drug includes insulin and the physiological characteristic is blood glucose level.

52. The system of claim 41, wherein: The drug includes glucagon and the physiological characteristic is blood glucose level.

53. The system of claim 41, wherein: The medication comprises a blood pressure medication and the physiological characteristic is blood pressure.

54. The system of claim 41, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

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