Measuring a parameter associated with a drug application and a drug application device

Abstract

The present disclosure relates to drug administration. In an exemplary embodiment, a system may include a drug administration device configured to dispense a drug to a patient, a monitoring device configured to record delivery events of delivery of the drug from the drug administration device into the patient, and a sensor configured to sense a patient parameter after delivery of the drug into the patient. In another exemplary embodiment, a drug administration device may include a drug holder configured to hold a drug, a dispensing mechanism configured to dispense the drug, and a sensor configured to sense a patient parameter, and the drug administration device may be configured to locally activate the drug at a targeted location in the patient. In another exemplary embodiment, the present disclosure provides methods, devices, and systems to assess when operation of a medication dispensing mechanism is completed and confirm whether medication administration is successful.

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 a given dose and the time frame during which the dose is delivered, sometimes related to the dose of a previous dose or 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 insufficient or excessive volumes of drugs for specific medical indications.

[0003] In addition, the drug administration device may operate, but may not fully complete the operation, or may not successfully administer the drug. If the problem is not quickly identified, such incomplete operation and unsuccessful administration may each cause harm to the patient.

[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. Summary of the invention

[0006] In one aspect, a method for confirming administration from a drug administration device is provided, and in one embodiment, the method includes: operating a dispensing mechanism of the drug administration device; measuring at least one dispensing mechanism parameter; determining whether operation of the dispensing mechanism is complete based on the at least one dispensing mechanism parameter; measuring at least one administration parameter; and when it is determined that operation of the dispensing mechanism is complete, comparing the measured at least one administration parameter with an acceptable administration parameter to confirm whether the administration was successful.

[0007] The method may have any number of variations. For example, the method may further include modifying an additional operation of the drug administration device based on the at least one dispensing mechanism parameter and / or the at least one administration parameter. In at least some embodiments, the method may further include notifying a user that the additional operation of the drug administration device has been modified. Notifying a user that the additional operation of the drug administration device has been modified may include one or more of visual feedback, auditory feedback, and tactile feedback. Modifying the additional operation of the drug administration device may include preventing the additional operation of the drug administration device when successful administration is not confirmed. Modifying the additional operation of the drug administration device may include: modifying a dose volume to be administered during the additional operation of the drug administration device; modifying a frequency with which the drug is administered by the drug administration device; modifying a maximum number of drug doses that may be delivered from the drug administration device; and / or modifying a rate with which the drug is administered by the drug administration device.

[0008] For yet another example, measuring the at least one dispensing mechanism parameter or measuring the at least one administration parameter may include measuring a speed of a motor of the drug administration device and / or a duration of operation of the motor.

[0009] For yet another example, operating a dispensing mechanism of a drug administration device may include displacing a displaceable component from a first position of the displaceable component. In at least some embodiments, measuring the at least one dispensing mechanism parameter or the at least one administration parameter may include measuring the displacement of the displaceable component. Measuring the displacement of the displaceable component may include using a Hall effect sensor.

[0010] For another example, measuring the at least one dispensing mechanism parameter or the at least one administration parameter may include measuring a flow rate of the drug administered by the drug administration device. For yet another example, measuring the at least one administration parameter may include determining an amount of liquid present near the injection site. For another example, measuring the at least one administration parameter may include measuring a physiological parameter of a user of the drug administration device associated with successful administration.

[0011] For yet another example, the method may include evaluating an operational state of the drug administration device prior to and / or during operation of the dispensing mechanism. In at least some embodiments, evaluating the operational state of the drug administration device may include at least one of analyzing a power source of the drug administration device to verify that the power source has sufficient charge for successful administration, and sensing an angular orientation of the drug administration device relative to a user of the drug administration device and determining whether the sensed angular orientation is a correct angular orientation. Evaluating the operational state of the drug administration device may include moving a displaceable component of the drug administration device a predefined distance.

[0012] For another example, the method may include notifying the user whether the administration was successful.In at least some embodiments, notifying the user whether the administration was successful may include one or more of visual feedback, auditory feedback, and tactile feedback.

[0013] For yet another example, the acceptable administration parameters may include a predefined range of values, and the comparison may include determining whether the at least one administration parameter measured is within the predefined range of values. For another example, the acceptable administration parameters may include a predefined threshold, and the comparison may include determining whether the at least one administration parameter measured is above the predefined threshold. For yet another example, the acceptable administration parameters may include a predefined threshold, and the comparison may include determining whether the at least one administration parameter measured is below the predefined threshold.

[0014] For 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 method for confirming an administration from a drug administration device includes: operating a dispensing mechanism of the drug administration device; measuring at least one dispensing mechanism parameter; determining whether the operation of the dispensing mechanism is complete based on the at least one dispensing mechanism parameter; determining at least one physiological parameter of the user based on the at least one dispensing mechanism parameter; and when it is determined that the operation of the dispensing mechanism is complete, comparing the at least one physiological parameter with an acceptable physiological parameter to confirm whether the administration is successful.

[0016] The method may be varied in any number of ways. For example, measuring the at least one dispensing mechanism parameter may include measuring the flow rate of the drug, and the at least one physiological parameter may be the heart rate of the user.

[0017] For another example, the method may further include modifying an additional operation of the drug administration device based on the at least one dispensing mechanism parameter and / or the at least one physiological parameter. In at least some embodiments, the method may further include notifying a user that the additional operation of the drug administration device has been modified. Notifying a user that the additional operation of the drug administration device has been modified may include one or more of visual feedback, auditory feedback, and tactile feedback. Modifying the additional operation of the drug administration device may include preventing the additional operation of the drug administration device when successful administration is not confirmed. Modifying the additional operation of the drug administration device may include: modifying a dose volume to be administered during the additional operation of the drug administration device; modifying a frequency with which the drug is administered by the drug administration device; modifying a maximum number of drug doses that may be delivered from the drug administration device; and / or modifying a rate with which the drug is administered by the drug administration device.

[0018] For yet another example, operating the dispensing mechanism of the drug administration device may include displacing a displaceable component from a first position of the displaceable component.

[0019] For yet another example, the method may further include evaluating an operational state of the drug administration device prior to operating the dispensing mechanism. In at least some embodiments, evaluating the operational state of the drug administration device may include at least one of analyzing a power source of the drug administration device to verify that the power source has sufficient charge for successful administration, and sensing an angular orientation of the drug administration device relative to a user of the drug administration device and determining whether the sensed angular orientation is a correct angular orientation. Evaluating the operational state of the drug administration device may include moving a displaceable component of the drug administration device a predefined distance.

[0020] For another example, the method may further include notifying the user whether the administration is successful. In at least some embodiments, notifying the user whether the administration is successful may include one or more of visual feedback, auditory feedback, and tactile feedback.

[0021] For yet another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0022] In another aspect, a drug administration system is provided, which in one embodiment includes a drug administration device, the drug administration device including: a dispensing mechanism configured to dispense a drug; and at least one sensor configured to measure at least one dispensing mechanism parameter and output dispensing mechanism data related to the at least one dispensing mechanism parameter. The system is configured to determine whether the operation of the dispensing mechanism is complete based on the dispensing mechanism data. The system also includes at least one sensor configured to measure at least one application parameter and output application data related to the at least one application parameter. The system is configured so that when it is determined that the operation of the dispensing mechanism is complete, the system compares the application data with acceptable application data to confirm whether the application is successful.

[0023] The drug administration system can be varied in any manner. For example, the system may also include a first processor, and the first processor may be configured to receive the dispensing mechanism data, and is configured to determine whether the operation of the dispensing mechanism is completed based on the dispensing mechanism data. In at least some embodiments, the system may also include a second processor, and the second processor may be configured to receive the application data and confirm whether the application is successful when it is determined that the operation of the dispensing mechanism is completed by the first processor. The second processor may be configured to modify the other operation of the drug administration device based on the dispensing mechanism data and / or the application data. The device may also include an indicator, which is configured to inform the user of the drug administration device that the other operation of the drug administration device has been modified. The indicator may be configured to provide one or more of visual feedback, auditory feedback, and tactile feedback. The second processor may be configured to modify the other operation of the drug administration device, and the second processor may be configured to prevent the other operation of the drug administration device when successful application is not confirmed. The second processor may be configured to modify additional operations of the drug administration device, and the second processor may be configured to modify the dose volume to be administered in any additional operation of the drug administration device; to modify the frequency with which the drug is administered by the drug administration device; to modify the maximum number of drug doses that may be delivered from the drug administration device; and / or to modify the rate with which the drug is administered by the drug administration device.

[0024] For another example, the drug administration device may further include a motor, and one of the at least one dispensing sensor and the at least one administration sensor may be configured to measure the speed of the motor and / or the duration of operation of the motor. For yet another example, the at least one sensor configured to measure at least one dispensing mechanism parameter or the at least one sensor configured to measure at least one administration parameter may include a Hall effect sensor. For yet another example, the at least one sensor configured to measure at least one dispensing mechanism parameter or the at least one sensor configured to measure at least one administration parameter may include a volumetric flow meter. For yet another example, the at least one sensor configured to measure at least one administration parameter may include a liquid detection sensor configured to measure the amount of liquid present near the injection site. For yet another example, the at least one sensor configured to measure at least one administration parameter may be configured to measure a physiological parameter of a user of the drug administration device associated with successful administration.

[0025] For another example, the processor may be configured to evaluate the operating state of the drug administration device before and / or while the drug dispensing mechanism dispenses the drug. In at least some embodiments, the drug administration device may further include a power source, and the processor may be configured to evaluate the operating state of the drug administration device by verifying that the power source has sufficient power for dispensing the drug. The dispensing mechanism may further include a displaceable component, and the processor may be configured to evaluate the operating state of the drug administration device by moving the displaceable component a predefined distance.

[0026] For yet another example, the system may include an indicator configured to inform a user of the drug administration device whether the administration was successful. In at least some embodiments, the indicator may be configured to provide visual feedback, auditory feedback, or tactile feedback.

[0027] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0028] In another embodiment, a drug administration system is provided, the drug administration system comprising a drug administration device, the drug administration device comprising: a drug holder configured to hold a drug; and a dispensing mechanism configured to dispense the drug to a patient. The system also includes a first sensor configured to sense a patient parameter. The drug administration system is configured to locally activate the drug at a targeted location in the patient after the drug has been dispensed by the dispensing mechanism and administered to the patient, and the local activation is responsive to the patient parameter and an external stimulus.

[0029] The system can be varied in any manner. For example, the system may further include a second sensor configured to sense an external stimulus. In at least some embodiments, the first sensor and / or the second sensor may be integrated with the drug administration device.

[0030] For another example, a drug administration device may be configured to delay local activation for a period of time after a drug has been administered to a patient such that the local activation coincides with a predicted localization time at a target location, and the predicted localization time may be based on sensed patient parameters and external stimuli.

[0031] For yet another example, the system may further include an energy source configured to provide energy to locally activate the drug at a targeted location in the patient. In at least some embodiments, the amount of energy provided by the energy source may be responsive to patient parameters and external stimuli. The energy source may include one or more of: a light source; an ultrasound source; an electromagnetic field source; and a radioactive material.

[0032] For yet another example, the drug administration device may be further configured to administer a chemical activator to a targeted location in the patient to locally activate the drug. For yet another example, the patient parameters sensed by the first sensor may include one or more of the following: temperature; pH level; biomarkers; glutathione level; skin thickness; subcutaneous tissue thickness; blood oxygen level; blood sugar level; blood pressure; heart rate; and metabolic rate.

[0033] For another example, the external stimulus may include one or more of: user input; geographic location; ambient temperature; pressure; and ultraviolet radiation level. In at least some embodiments, the system may also include a user interface, and the external stimulus may be user input entered via the user interface.

[0034] For another example, the drug administration device may be configured to administer the drug to the patient according to a drug administration regimen. In at least some embodiments, the drug administration regimen may specify one or more of the following drug administration parameters: drug delivery rate; drug delivery duration; drug delivery volume; and drug delivery frequency. The drug administration device may include an automatic syringe, and the drug administration regimen may specify one or more of the following administration parameters: the discharge nozzle advancement depth of the discharge nozzle of the automatic syringe during the administration of the drug to the patient; the discharge nozzle speed of the discharge nozzle of the automatic syringe during the administration of the drug to the patient; and the discharge nozzle acceleration of the discharge nozzle of the automatic syringe during the administration of the drug to the patient. The drug administration regimen may be based on sensed patient parameters and external stimuli. The sensed patient parameters may include subcutaneous tissue thickness, and the drug administration device may be configured to adjust the discharge nozzle advancement depth based on the sensed subcutaneous tissue thickness.

[0035] For another example, the drug administration system may be further configured to determine whether the likelihood of a side effect associated with the drug has increased based on the sensed patient parameters and / or external stimuli, and when it is determined that the likelihood of the side effect has increased, adjust the drug administration regimen to reduce the dose of the drug to be administered and / or adjust the activation device of the drug administration system to reduce local activation of the drug. The activation device may be configured to locally activate the drug. The drug administration device may also include a device indicator, and the drug administration device may be further configured to activate the device indicator when it is determined that the likelihood of the side effect has increased.

[0036] For yet another example, the system may further include a drug capture and release mechanism configured to be implanted in the patient's body.

[0037] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0038] For yet another example, a method of administering a drug to a patient using a drug administration system may include dispensing the drug from a drug holder to administer the drug to the patient; receiving data related to a patient parameter from a first sensor, and receiving data related to an external stimulus; comparing the received data to a lookup table; and locally activating the drug at a targeted location in the patient, wherein the local activation is based on the comparison with the lookup table. In at least some embodiments, local activation of the drug may be delayed after drug dispensing for a period of time corresponding to a localization time determined from the lookup table, and / or the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin afa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0039] In another aspect, a drug administration device is provided, which in one embodiment includes: a dispensing mechanism configured to dispense a drug; and at least one sensor configured to measure at least one dispensing mechanism parameter and output dispensing mechanism data related to the at least one dispensing mechanism parameter. The device is configured to determine whether the operation of the dispensing mechanism is complete based on the dispensing mechanism data. The device also includes at least one sensor configured to measure at least one administration parameter and output administration data related to the at least one administration parameter. The device is configured so that when it is determined that the operation of the dispensing mechanism is complete, the device compares the administration data with acceptable administration data to confirm whether the administration is successful.

[0040] The drug administration device may have any number of variations. For example, the device may also include a first processor, and the first processor may be configured to receive dispensing mechanism data, and is configured to determine whether the operation of the dispensing mechanism is completed based on the dispensing mechanism data. In at least some embodiments, the device may also include a second processor, and the second processor may be configured to receive application data and confirm whether the application is successful when it is determined that the operation of the dispensing mechanism is completed by the first processor. The second processor may be configured to modify additional operations of the drug administration device based on the dispensing mechanism data and / or the application data. The device may also include an indicator configured to inform the user of the drug administration device that additional operations of the drug administration device have been modified. The indicator may be configured to provide one or more of visual feedback, auditory feedback, and tactile feedback. The second processor may be configured to modify additional operations of the drug administration device, and the second processor may be configured to prevent additional operations of the drug administration device when successful application is not confirmed. The second processor may be configured to modify additional operations of the drug administration device, and the second processor may be configured to modify the dose volume to be administered in any additional operation of the drug administration device; configured to modify the frequency with which the drug is administered by the drug administration device; and / or configured to modify the rate with which the drug is administered by the drug administration device.

[0041] For another example, the drug administration device may further include a motor, and one of the at least one dispensing sensor and the at least one administration sensor may be configured to measure the speed of the motor and / or the duration of operation of the motor. For yet another example, the at least one sensor configured to measure at least one dispensing mechanism parameter or the at least one sensor configured to measure at least one administration parameter may include a Hall effect sensor. For yet another example, the at least one sensor configured to measure at least one dispensing mechanism parameter or the at least one sensor configured to measure at least one administration parameter may include a volumetric flow meter. For yet another example, the at least one sensor configured to measure at least one administration parameter may include a liquid detection sensor configured to measure the amount of liquid present near the injection site. For yet another example, the at least one sensor configured to measure at least one administration parameter may be configured to measure a physiological parameter of a user of the drug administration device associated with successful administration.

[0042] For another example, the processor may be configured to evaluate the operating state of the drug administration device before and / or while the drug dispensing mechanism dispenses the drug. In at least some embodiments, the drug administration device may further include a power source, and the processor may be configured to evaluate the operating state of the drug administration device by verifying that the power source has sufficient power for dispensing the drug. The dispensing mechanism may further include a displaceable component, and the processor may be configured to evaluate the operating state of the drug administration device by moving the displaceable component a predefined distance.

[0043] For yet another example, the device may include an indicator configured to inform a user of the drug administration device whether the administration was successful. In at least some embodiments, the indicator may be configured to provide visual feedback, auditory feedback, or tactile feedback.

[0044] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0045] In another embodiment, a drug administration device includes: a dispensing mechanism configured to dispense a drug; and at least one sensor configured to measure at least one dispensing mechanism parameter and output dispensing mechanism data related to the at least one dispensing mechanism parameter. The device is configured to determine whether the operation of the dispensing mechanism is complete based on the dispensing mechanism data. The device also includes a processor configured to determine at least one physiological parameter of a user of the drug administration device based on the dispensing mechanism data, and the processor is configured to compare the at least one physiological parameter with an acceptable physiological parameter when determining that the operation of the dispensing mechanism is complete to confirm whether the administration is successful.

[0046] The drug administration device may be varied in any number of ways. For example, the at least one sensor may be configured to measure the flow rate of the drug, and the at least one physiological parameter may be the heart rate of the user.

[0047] For another example, the device may further include a second processor, and the second processor may be configured to modify additional operations of the drug administration device based on the dispensing mechanism data and / or the at least one physiological parameter. In at least some embodiments, the device may further include an indicator configured to inform a user of the drug administration device that additional operations of the drug administration device have been modified. The indicator may be configured to provide one or more of visual feedback, auditory feedback, and tactile feedback. The second processor is configured to modify additional operations of the drug administration device, and the modified drug administration device may include a second processor configured to prevent additional operations of the drug administration device when successful administration is not confirmed. The second processor is configured to modify additional operations of the drug administration device, and the modified drug administration device may include a second processor configured to modify the dose volume to be administered in any additional operation of the drug administration device; is configured to modify the frequency with which the drug is administered by the drug administration device; and / or the second processor is configured to modify the rate with which the drug is administered by the drug administration device.

[0048] For yet another example, the processor may be configured to evaluate the operating state of the drug administration device before the drug dispensing mechanism dispenses the drug. In at least some embodiments, the drug administration device may further include a power source, and the processor may be configured to evaluate the operating state of the drug administration device by verifying that the power source has sufficient power for dispensing the drug. The dispensing mechanism may further include a displaceable component, and the processor may be configured to evaluate the operating state of the drug administration device by moving the displaceable component a predefined distance.

[0049] For another example, the device may further include an indicator configured to inform a user of the drug administration device whether the administration is successful. In at least some embodiments, the indicator may be configured to provide visual feedback, auditory feedback, or tactile feedback.

[0050] For yet another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0051] In another aspect, a drug administration and monitoring system is provided, which in one embodiment includes: a drug administration device configured to dispense a drug to a patient; a monitoring device configured to record at least one delivery event of the drug from the drug administration device to the patient; and a sensor configured to sense at least one patient parameter after the drug is delivered to the patient.

[0052] The administration and monitoring system may have any number of variations. For example, the drug administration device, monitoring device, and sensor may all be integrated with each other into a single device.

[0053] For another example, the drug administration device and the monitoring device may both be integrated with each other into a single device, and the sensor may be a separate device.In at least some embodiments, the patient sensor may be configured for real-time in vivo monitoring of a patient.

[0054] For yet another example, the drug administration device, the monitoring device, and the sensor can each be a separate discrete device.In at least some embodiments, the patient sensor can be configured for real-time in vivo monitoring of a patient.

[0055] For yet another example, the drug administration device, the monitoring device, and the sensor may each be configured to be able to communicate data with each other. For another example, the monitoring device may be configured to receive data related to the drug delivery event from the drug administration device, and to receive the at least one patient parameter from the sensor.

[0056] For yet another example, the monitoring device may be configured to determine a drug response associated with the at least one drug delivery event on the patient based on the at least one patient parameter sensed, and to determine and store data related to a patient result, the patient result being associated with the determined drug response and the at least one drug delivery event. In at least some embodiments, the patient result may be one or more of: a time period during which the drug response is sensed on the patient after the at least one drug delivery event; an intensity of the drug response determined at a given time or within a given time period after the drug is administered to the patient; and a duration of the determined drug response associated with the at least one drug delivery event.

[0057] For another example, the monitoring device may be further configured to generate a notification to the patient or a remote patient monitoring device based on the patient result. For yet another example, the at least one patient parameter sensed by the sensor may include one or more of the following: temperature; pH level; biomarker; glutathione level; skin thickness; subcutaneous tissue thickness; blood oxygen level; blood glucose level; blood pressure; heart rate; and metabolic rate.

[0058] For yet another example, the monitoring device may be further configured to check the consistency of the at least one drug delivery event with a prescribed drug administration regimen. In at least some embodiments, if the at least one drug delivery event is inconsistent with the prescribed drug administration regimen, the monitoring device may be further configured to generate a notification to the patient or a remote patient monitoring device. The drug administration regimen may specify one or more of the following drug administration parameters: drug delivery rate; drug delivery duration; drug delivery volume; and drug delivery frequency.

[0059] For another example, the system may include an environmental sensor configured to detect an external stimulus. In at least some embodiments, the environmental sensor may be configured to detect one or more of: user input to the drug administration device; geographic location; ambient temperature; pressure; and ultraviolet radiation level. The system may also include a user interface, and the external stimulus may be a user input entered via the user interface. The monitoring device may be further configured to determine whether the likelihood of a side effect associated with the drug has increased based on at least one patient parameter and / or external stimulus sensed, and upon determining that the likelihood of the side effect has increased, if the at least one drug delivery event is inconsistent with the prescribed drug administration regimen, a notification is generated to the patient or a remote patient monitoring device. The monitoring device may include a device indicator, and the drug administration device may be further configured to activate the device indicator when it is determined that the likelihood of a side effect has increased.

[0060] For another example, the monitoring device may be configured to provide multiple notifications related to the at least one drug delivery event and / or the at least one patient parameter to the patient or a remote monitoring device, and may provide the multiple notifications in sequence according to a predefined priority order based on the at least one drug delivery event and / or the at least one patient parameter.

[0061] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0062] In another aspect, a method for monitoring drug administration is provided, which in one embodiment includes: dispensing a drug from a drug administration device to a patient; recording at least one drug delivery event of the drug administration device to the patient; and after delivering the drug to the patient and recording the at least one drug delivery event, sensing at least one patient parameter.

[0063] The method can have any number of variations. For another example, the drug can include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] The present invention is described with reference to the following drawings:

[0065] Figure 1 is a schematic diagram of a first type of drug administration device, namely an auto-injector;

[0066] Figure 2is a schematic diagram of a second type of drug administration device, namely an infusion pump;

[0067] Figure 3 is a schematic diagram of a third type of drug administration device, namely an inhaler;

[0068] Figure 4 is a schematic diagram of a fourth type of drug administration device, namely a nasal spray device;

[0069] Figure 5A is a schematic diagram of a general drug administration device;

[0070] Figure 5B is a schematic diagram of a universal drug administration device;

[0071] Figure 6 is a schematic diagram of a housing for a dosage form;

[0072] 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;

[0073] Figure 8 is a schematic diagram of one embodiment of a drug administration device and a computer system with which the housing may operate;

[0074] Fig. 9 is a schematic diagram of one embodiment of a drug administration device including a volumetric flow meter and a Hall effect sensor;

[0075] Fig.10 is a flow chart of one embodiment of a method of confirming administration from a drug administration device;

[0076] Fig.11 is a schematic diagram of one embodiment of a monitoring system for use with the drug administration devices and systems described herein;

[0077] Fig.12 is a schematic diagram of one embodiment of sensor communications for use with the drug administration devices and systems described herein;

[0078] Fig.13 is a flow chart of one implementation of a notification priority matrix;

[0079] Fig.14 is a schematic diagram of one embodiment of a sensor operating in conjunction with a drug administration device;

[0080] Fig.15 is a schematic diagram of one embodiment of a medication holder;

[0081] Fig.16 Yes Fig.15A schematic diagram of an embodiment of a drug delivery system of a drug holder;

[0082] Fig.17 is a schematic diagram of one embodiment of a drug administration device configured to mix a first liquid drug and a second liquid drug;

[0083] Fig.18 is a schematic diagram of one embodiment of a drug administration device configured to mix a first liquid drug and a second solid drug; and

[0084] Fig.19 is a schematic diagram of one embodiment of a drug delivery system in which local activation is employed. DETAILED DESCRIPTION

[0085] 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.

[0086] 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.

[0087] 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.

[0088] Auto-injectors

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] Although the foregoing description relates to an example of an automatic injector, this example is for illustration only and the present invention is not limited to such an automatic injector. It will be appreciated by those skilled in the art that various modifications to the described automatic injector may be implemented within the scope of the present disclosure.

[0096] 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.

[0097] Infusion Pump

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] The power source 295 provides power to the pump 216 and may take the form of an energy source integral to the pump 216 and / or a mechanism for connecting the pump 216 to an external power source.

[0104] 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.

[0105] 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.

[0106] Inhaler

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] Although the foregoing description relates to a specific example of an inhaler, this example is illustrative only. The description should not be considered to be 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 vibrations, compressed gas, vibrating nets or heat sources.

[0112] 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.

[0113] Nasal spray device

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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 .

[0118] 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 a dose of medicament to both nostrils simultaneously in response to a single actuation.

[0119] The dispensing head 406 is configured to be pushed toward the medication holder 402, e.g., by a user pushing down on the depth guide 410 to depress, to actuate the nasal spray device 400. In other words, the dispensing head 406 is configured as an actuator so as to be actuated to drive the medication from the medication holder 402 out of the nasal spray device 400. In an exemplary embodiment, the nasal spray device 400 is configured to be self-administered, so that the user who actuates the nasal spray device 400 is the patient who receives the medication from the nasal spray device 400, but another person may also actuate the nasal spray device 400 for delivery to another person.

[0120] 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.

[0121] 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.

[0122] 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., )

[0123] Drug administration device

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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 4 The drug administration device 500 includes a housing 30 that houses a drug holder 10 and a dispensing mechanism 20.

[0128] 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 50. 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.

[0129] 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.

[0130] 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 exists, such as the temperature of the environment, the humidity of the environment, the location, and the time. 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.

[0131] 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 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, device sensors 92, communication interfaces 99, position sensors 98, and / or user interface 80, and process the data to provide data output, for example, to the indicator 85 and / or communication interface 99.

[0132] 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.

[0133] 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.

[0134] Drug dosage form

[0135] Conventionally, drug administration devices utilize liquid dosage forms. However, it will be appreciated that other dosage forms are available.

[0136] 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.

[0137] 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.

[0138] 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. Specifically, 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.

[0139] 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 irrigations, 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, PI3K 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, TNF α 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, transthyroid Protein stabilizers, triazine antispasmodics, tricyclic antidepressants, trifunctional monoclonal antibodies, ultrasound contrast agents, upper respiratory tract combination drugs, urea antispasmodics, urea cycle disorder drugs, urinary anti-infective drugs, urinary antispasmodics, urinary pH regulators, uterotonics, combination vaccines, vaginal anti-infective drugs, 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.

[0140] 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).

[0141] Drug Shell

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] 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.

[0147] 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.

[0148] 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 85.

[0149] Electronic Communications

[0150] 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 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 via a communication network 702. The communication interface 99 can be configured to access the system 700 through 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.

[0151] 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 username, 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.

[0152] Computer Systems

[0153] 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.

[0154] 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, 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.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] 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 the 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.

[0159] 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.

[0160] 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 web pages and / or delivering web pages to client computer systems.

[0161] 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.

[0162] 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.

[0163] 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.

[0164] 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 interrupting the functionality of any other aspect 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.

[0165] The computer system may also include any of a variety of other software and / or hardware components, including, by way of 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 that 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 when communication with another computer system is not required.

[0166] Specific implementation

[0167] Confirmation of drug administration

[0168] It may be desirable to monitor compliance with instructions associated with administering a drug to a patient in various dosage forms. Such compliance monitoring can ensure that the correct procedures are followed and that incorrect and potentially dangerous methods are avoided. Additionally, this can also enable optimization of the administration of the drug to the patient. The various methods, systems, and devices described herein can confirm successful administration of a drug to a patient, which can improve patient safety and compliance by quickly identifying problems that occur when administering the drug.

[0169] It may be desirable to monitor the delivery of a drug to identify delivery problems or other problems, particularly with respect to drug trials or consistency with a dosing prescription. In addition, for some drugs, it may be desirable to administer the drug to a patient in an inactive form and to activate the drug at a targeted location in the body in order to improve efficacy and safety. For example, a chemotherapy drug may be delivered to a patient systemically but activated only at the tumor site, such that the chemotherapy drug is effective against tumor cells while minimizing damage to healthy cells elsewhere in the patient. By improving local drug activation, the various methods, systems, and devices described herein can improve drug efficacy, as well as safety and compliance.

[0170] In an exemplary embodiment, at least one dispensing mechanism parameter may be compared to an acceptable dispensing mechanism parameter, and at least one administration parameter may be compared to an acceptable administration parameter. These comparisons may convince the user of the drug administration device that the drug administration device has been successfully operated. In this article, successful administration is used to indicate that the operation of the dispensing mechanism of the drug administration device is determined to be complete. For the patient receiving the drug, such confirmation of successful administration may make the drug administration procedure safer because if successful administration is not confirmed, the patient and / or healthcare professional may be quickly alerted and may therefore take corrective measures to intervene when necessary, such as ordering a new drug administration device, repairing the drug administration device, using a different drug administration device to deliver the drug, increasing the maximum number of drug administrations allowed by the drug administration device one or more times to allow one or more doses of the drug to be delivered from the drug administration device. Since the source of the problem can be more easily identified, confirming administration may prevent incorrect decisions from being made regarding future administrations. Confirming administration may reduce the waste of drugs. If part of the drug is not successfully administered, the patient and / or healthcare professional may be alerted to such unsuccessful administration to allow future administrations to be adjusted to reduce waste.

[0171] Generally speaking, acceptable parameters define values ​​(or ranges of values) indicating successful delivery of a drug from a drug administration device. The acceptable parameters may be predefined before using the drug administration device, such as established by a manufacturer of the drug administration device and / or the drug delivered by the drug administration device. For example, when the drug administration device is a syringe including a needle, acceptable parameters may include the speed at which the needle of the drug administration device is inserted into the patient. Too slow a speed may indicate a failure in needle insertion, and thus a failure in drug delivery. For another example, acceptable parameters may include the angular orientation of the injection device relative to the patient. The injection device is not in the correct angular orientation relative to the patient during drug delivery, which may indicate that the ejection of the drug from the injection device is unlikely to result in all the drug being correctly injected into the patient. The correct angular orientation of the injection device may be a vertical, substantially vertical orientation relative to the patient's skin, rather than an improper position at a non-vertical angle relative to the patient's skin. Those skilled in the art will appreciate that the angle may not be exactly vertical (to 90°), but is considered to be substantially vertical for any of a variety of reasons such as manufacturing tolerances and / or the sensitivity of the measuring device. For yet another example, acceptable parameters may include the movement of the drug canister of the inhaler. Too little vertical movement of the drug canister downward may indicate that the drug is not properly discharged or not fully discharged. For another example, acceptable parameters may include the movement of the dispensing head of the nasal spray device, which is configured to push downward to allow the drug to be delivered through the opening in the dispensing head. Too little vertical movement of the dispensing head downward may indicate that the drug is not properly discharged or not fully discharged. For another example, acceptable parameters may include the angular orientation of the nasal spray device relative to the patient. The nasal spray device is not in the correct angular orientation relative to the patient during drug delivery, which may indicate that the drug spray entering the patient's nostrils (or both nostrils of the patient for a dual-spray nasal spray device) is unlikely to be properly dispersed in the patient's nasal cavity. The correct angular orientation of the nasal spray device may be in the range of 30° to 60°. For another example, acceptable parameters may involve the motor of the drug administration device, such as the speed of the motor or the duration of the operation of the motor. Too slow a speed may indicate a failure in drug delivery, or a failure in a motor-driven drug mixing attempt in the drug administration device before drug delivery. Too short a duration of the operation of the motor may indicate a failure in drug delivery, or a failure in a motor-driven drug mixing attempt in the drug administration device before drug delivery. For another example, the acceptable parameters may include the flow rate of the drug administered by the drug administration device. A flow rate that is too low may indicate a drug delivery failure. For another example, the acceptable parameters may include the amount of liquid present near the injection site. When the drug is a liquid, too much liquid on the patient's skin surface may indicate a drug delivery failure. For another example, the acceptable parameters may include the patient's heart rate.A heart rate that is too high may indicate that an incorrect medication dose has been administered, for example, too much medication has been administered. For another example, acceptable parameters may include the patient's blood pressure. A blood pressure that is too high may indicate that an incorrect medication dose has been administered, for example, too much medication has been administered.

[0172] In an exemplary embodiment, the comparison of a parameter (e.g., a dispensing mechanism parameter or an administration parameter) to an acceptable parameter is performed by a processor, such as a processor of a drug administration device, or a processor of an external device that is external to the drug administration device and in electronic communication with the drug administration device. The comparison of a parameter (e.g., a measured dispensing mechanism parameter or a measured administration parameter) to an acceptable parameter can be performed in a variety of ways. For example, the acceptable parameter may include a predefined range of values, and the comparison may include determining whether the measured parameter is within the predefined range of values ​​to indicate successful drug delivery. For another example, the acceptable parameter may include a predefined threshold, and the comparison may include determining whether the measured parameter is above the predefined threshold to indicate successful drug delivery. For another example, the acceptable parameter may include a predefined threshold, and the comparison may include determining whether the measured parameter is below the predefined threshold to indicate successful drug delivery.

[0173] The drug administration device may be any drug administration device described herein. The drug administration device may be one that automatically enables administration of the drug, for example, without manual user input. Alternatively, the drug administration device may require manual user input in order to initiate administration.

[0174] The at least one dispensing mechanism parameter may be any parameter associated with dispensing a drug from a drug administration device. Generally, a dispensing mechanism parameter is an operational characteristic of a dispensing mechanism of a drug administration device. In this way, the dispensing mechanism parameter provides an indication of the completion of the operation of the dispensing mechanism, for example, the operation of the dispensing mechanism has reached an expected degree. A plurality of dispensing mechanism parameters may be measured and utilized to determine whether the operation of the dispensing mechanism is complete. Measuring and comparing a plurality of dispensing mechanism parameters may result in a more accurate assessment of whether the operation of the dispensing mechanism is complete than measuring and comparing only one dispensing mechanism parameter. The plurality of dispensing mechanism parameters measured may include any plurality of dispensing mechanism parameters described herein.

[0175] Measuring at least one dispensing mechanism parameter provides an initial indication that the drug has been successfully dispensed by the drug administration device. As described above, the measured dispensing mechanism parameters are compared to acceptable dispensing mechanism parameters. The acceptable dispensing mechanism parameters may be stored in a memory, such as a memory of the drug administration device and / or in a memory of an external device that is external to the drug administration device and in electronic communication with the drug administration device. The acceptable dispensing mechanism parameters may be predefined as dispensing mechanism parameters that are known to indicate a completed dispensing mechanism operation as discussed above.

[0176] The at least one administration parameter can be any parameter associated with administering a drug. Generally speaking, an administration parameter is a characteristic of administering a drug from a drug administration device. The at least one administration parameter is different from the at least one dispensing mechanism parameter. The at least one administration parameter can be measured simultaneously with the at least one dispensing mechanism parameter. The at least one administration parameter can be measured after the at least one dispensing mechanism parameter. Measuring the at least one administration parameter allows confirmation that the drug has been successfully administered and serves as an independent check for confirmation that the operation of the dispensing mechanism is complete. Measuring the at least one administration parameter increases the chance of detecting an unsuccessful administration compared to measuring only the dispensing mechanism parameter, thereby allowing faster intervention to prevent harm to the patient.

[0177] When confirming whether the administration is successful, multiple administration parameters can be measured and utilized. Compared with measuring and comparing only one administration parameter, measuring and comparing multiple administration parameters may lead to a more accurate assessment of whether the administration is successful because more checks are performed. The measured multiple administration parameters may include any multiple administration parameters described herein.

[0178] As discussed above, acceptable administration parameters may be predefined, and these acceptable administration parameters may be stored in a memory of a drug administration device and / or in a memory of an external device external to the drug administration device and in electronic communication with the drug administration device. In at least some embodiments, acceptable administration parameters may be calculated using measured dispensing mechanism parameters. The calculation results may be calculated by a processor (such as a processor of a drug administration device or a processor of an external device external to the drug administration device and in electronic communication with the drug administration device). The calculation results allow acceptable administration parameters to vary according to the operating characteristics of the dispensing mechanism. The calculation results illustrate the possibility that acceptable administration parameters may be determined by the specific operation of the dispensing mechanism. For example, an increase in the volume of drug administered to a patient may be associated with an expectation that the patient's physiological response will increase. Therefore, in the case where the physiological response is the measured administration parameter, the acceptable administration parameters will need to be adjusted to account for the increased volume of drug. In such cases, a predefined baseline for the administration parameters may be established as an acceptable administration parameter as discussed above, and the baseline may be adjusted according to the associated measured dispensing mechanism parameters.

[0179] A user of the drug administration device may be notified of an unsuccessful administration as determined by comparing the at least one dispensing mechanism parameter to acceptable dispensing mechanism parameters and comparing the at least one administration parameter to acceptable administration parameters. Alternatively or in addition, a user may be notified of a successful administration as determined by comparing the at least one dispensing mechanism parameter to acceptable dispensing mechanism parameters and comparing the at least one administration parameter to acceptable administration parameters. The notification may relate to whether the administration was successful. The notification may be implemented by a device indicator.

[0180] Additional operations of the drug administration device may be modified based on the at least one dispensing mechanism parameter and / or the at least one administration parameter. Enabling modifications to additional operations of the drug administration device allows adjustments to be made to the drug administration device that may make additional administrations of the drug administration device more likely to be successful. These modifications may also reduce additional waste of the administered drug.

[0181] The drug administration device may be configured to automatically implement the modification, e.g., without requiring user input. Alternatively, the drug administration device may be configured to prompt a user to manually implement the modification. The drug administration device may be configured to prompt a user via a device indicator and / or a user interface. The required modification may be determined based on measured dispensing mechanism parameters and / or measured administration parameters. A lookup table may be stored in a memory associated with the device (on-board or off-board drug administration device) that defines the required operational changes for a given parameter. The changes may then be implemented automatically by the device, or the user may be prompted to make the required changes based on the operational changes indicated in the lookup table.

[0182] Modifying the additional operation of the drug administration device may include preventing additional operation of the drug administration device when successful administration is not confirmed. Such prevention of additional operation prevents additional unsuccessful administration and may allow the user to be prompted to resolve the problem that caused the unsuccessful administration before the additional operation of the drug administration device. Preventing additional operation of the drug administration device may include any method of stopping the additional administration of the drug. For example, preventing additional operation of the drug administration device may include disabling a power source of the drug administration device, in particular disabling a power source of a dispensing mechanism of the drug administration device. The disabled power source may include, for example, a processor configured to open or close a switch that allows the power source to be powered when closed and prevents the power source from being powered when open. For another example, preventing additional operation of the drug administration device may include enabling a device operation prevention mechanism. For yet another example, the drug administration device may be prevented from delivering a subsequent dose of the drug by changing at least one variable parameter of the algorithm, thereby effectively causing the subsequent dose to be equivalent to zero drug administered. The algorithm may be stored on the drug administration device (e.g., in a memory of the drug administration device) and may be executed on board the drug administration device (e.g., by a processor of the drug administration device) to administer a dose of the drug from the drug administration device to the patient. The algorithm is stored in the form of one or more groups 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 at least one variable parameter is among the data points of the algorithm, for example, included in the instructions for drug delivery, so each variable parameter can be changed by changing one or more of the stored multiple data points of the algorithm. After the at least one variable parameter has been changed, the subsequent execution of the algorithm applies another dose of the drug according to the changed algorithm. Therefore, by considering the actual situation of the patient and the actual effect of the patient receiving the drug dose, the drug delivery over time can be managed for the patient to increase the beneficial effect of the drug. Change the at least one variable parameter to effectively cause the subsequent dose to be equivalent to zero drug that can be applied, such as by changing the dose frequency variable parameter to a time period that can never be achieved, and / or by changing the maximum number of remaining device actuation variable parameters to zero, thereby changing the dose variable parameter to zero.

[0183] Modifying the additional operation of the drug administration device may include modifying the dose volume to be administered during the additional operation of the drug administration device. If the at least one administration parameter indicates that the administered dose volume is too low or too high, such modification of the dose volume can increase or decrease the dose volume. Such modification of the dose volume prevents the user of the drug administration device from suffering from the adverse effects associated with too low or too high a dose. A processor (e.g., a processor of the drug administration device or a processor located remote from the drug administration device, located outside the drug administration device, and in electronic communication with the drug administration device) may calculate the change in dose volume. The drug administration device may be configured to automatically update the dose volume. The drug administration device may be configured to require input from a user, such as via a user interface, to confirm that the newly calculated dose volume should be applied to subsequent administrations. Modifying the dose volume may include, for example, changing at least one variable parameter of an algorithm that defines a dose volume by increasing or decreasing the value of the parameter.

[0184] Modifying the additional operation of the drug administration device may include modifying the frequency with which the drug is administered by the drug administration device. Such frequency modification can change the interval at which the drug is administered. If the at least one administration parameter indicates that the drug is administered too frequently or too infrequently, which may cause harm to the patient, then such an interval change may be desirable. If the at least one dispensing mechanism parameter indicates that a successful administration is not achieved, then such an interval change may be desirable to change to a frequency that can never be achieved, which may indicate that a device failure of the drug administration device is desired to be repaired before further use, otherwise the drug administration device can no longer be effectively used to deliver the drug. A processor (e.g., a processor of the drug administration device or a processor located remote from the drug administration device, located outside the drug administration device and in electronic communication with the drug administration device) may be configured to calculate the change in frequency. The drug administration device may be configured to automatically update the frequency. The drug administration device may be configured to require input from a user, such as via a user interface, to confirm that the newly calculated frequency is applied to subsequent administrations. Modifying the frequency may include, for example, changing at least one variable parameter of an algorithm that defines a frequency with which the drug is administered by the drug administration device, by increasing or decreasing the value of the parameter.

[0185] Modifying additional operations of the drug administration device may include modifying the rate of the drug administered by the drug administration device. In other words, the rate at which the drug is dispensed from the drug administration device during an administration event may be modified. Such rate modification can change the time at which the drug is dispensed. If the at least one administration parameter indicates that the drug is administered too quickly or too slowly, which may cause harm to the patient, then such rate modification may be desirable. A processor (e.g., a processor of the drug administration device or a processor located remote from the drug administration device, located outside the drug administration device, and in electronic communication with the drug administration device) may be configured to calculate the change in rate. The drug administration device may be configured to automatically update the rate. The drug administration device may be configured to require input from a user, such as via a user interface, to confirm that the newly calculated rate is applied to subsequent administrations. Modifying the rate may include, for example, changing at least one variable parameter of an algorithm that defines the rate at which the drug administration device administers the drug by increasing or decreasing the value of the parameter. For another example, modifying the rate may include changing the speed at which the motor drives the drug to be delivered from the drug administration device, wherein a decrease in speed corresponds to a decrease in rate, and an increase in speed corresponds to an increase in rate.

[0186] The user may be notified that additional operation of the drug administration device has been modified. This notification enables the user to stay informed of changes to the operation of the drug administration device so that the user can check whether they approve of the modifications made to the operation of the drug administration device. This notification is particularly valuable when the drug administration device performs the modifications automatically.

[0187] Notification to the user that additional operations of the drug administration device have been modified can be achieved through a device indicator. The notification may include one or more of visual feedback, auditory feedback, and tactile feedback. The notification can easily alert the user to any modifications made to the additional operations of the drug administration device. LEDs can be used to provide visual feedback. The LEDs can be configured to flash to indicate that additional operations of the drug administration device have been modified. Depending on the modifications made, the LEDs can be configured to flash at different rates or different colors of LEDs may flash. Visual feedback can be provided via a display screen of a computer system. Auditory feedback may include a series of warning sounds. These warning sounds may vary depending on the modifications made. Tactile feedback may include vibration of the drug administration device. The frequency or magnitude of the vibration may vary depending on the modifications made.

[0188] When the dispensing mechanism includes a motor, the at least one dispensing mechanism parameter may include operating characteristics of the motor. For example, the at least one dispensing mechanism parameter may be the speed at which the motor operates, the power consumed by the motor, and / or the duration of the motor operation. The motor may be any motor capable of operating the dispensing mechanism. The at least one application parameter may include operating characteristics of the motor as detailed with respect to the at least one dispensing mechanism parameter, provided that the application parameter utilized is different from the dispensing mechanism parameter.

[0189] When the dispensing mechanism includes a displaceable component, the at least one dispensing mechanism parameter may include characteristics of the displaceable component. Operation of the dispensing mechanism may include displacing the displaceable component from a first position to a second position. For example, the at least one dispensing mechanism parameter may include a distance the displaceable component has moved, a speed at which the displaceable component has moved, and / or an acceleration of the displaceable component. The at least one application parameter may include operating characteristics of the displaceable component as detailed with respect to the at least one dispensing mechanism parameter, provided that the application parameter utilized is different from the dispensing mechanism parameter. Examples of displaceable components include: a needle of an infusion pump or injection device that moves into a patient; a spring of an infusion pump or injection device that moves to move the needle of the injection device into a patient; a needle shield or other dispensing mechanism protection mechanism of an injection device that slides into the housing of the injection device to allow access to the discharge nozzle of the injection device; a spring of a nasal spray device that moves to release the drug from the drug holder of the nasal spray device and spray through the nozzle of the nasal spray device; a trigger or other triggering mechanism of an injection device, infusion pump, inhaler, or nasal spray device; a drive element of an injection device; a dispensing head of a nasal spray device that is configured to be pushed downward to deliver the drug through an opening in the dispensing head; a valve of an inhaler; and a drug canister or other drug holder of an inhaler that moves during drug delivery.

[0190] Hall effect sensors may be used to measure the displacement of the displaceable component. Hall effect sensors provide reliable displacement measurements because they are not affected by the presence of dust particles or other physical objects (which may block the view of other sensors and thus affect the measurement). For example, motion sensors and / or pressure sensors may be used instead or in addition to measure the displacement of the displaceable component.

[0191] The at least one dispensing mechanism parameter may include a moving characteristic of the drug. For example, the at least one dispensing mechanism parameter may include a flow rate of the drug administered by the drug administration device, which may enable the total volume of the drug administered to be calculated and may therefore be used to confirm the operation of the device. The flow rate may be measured by a volume flow meter. The flow rate may be measured by a piston flow meter. The flow rate may be measured by an oval gear flow meter. The flow rate may be measured by a pressure-based measuring instrument. The flow rate may be measured by a venturi flow meter. The flow rate may be measured near the outlet of the drug administration device. Near the outlet of the drug administration device generally refers to an area close to the outlet but not directly at the outlet to provide flow rate data substantially the same as the flow rate of the drug at the outlet without providing any sensors and / or other measuring mechanisms that are too close to the outlet to interfere with the drug flowing therethrough. The flow rate may be measured at the outlet of the drug administration device. The at least one application parameter may include a moving characteristic of the drug as detailed with respect to the at least one dispensing mechanism parameter, provided that the application parameter utilized is different from the dispensing mechanism parameter.

[0192] The at least one administration parameter may include characteristics related to a drug administration site on a patient, such as an area of ​​the patient that receives the drug, such as an area surrounding an injection site on the patient. By monitoring the drug administration site on a patient, changes associated with a successful or unsuccessful administration may be used to determine whether a particular administration was successful. For example, measuring the at least one administration parameter may include determining an amount of liquid present near an injection site. The vicinity of an injection site generally refers to an area that is near an injection site but not directly at the injection site to provide information indicative of an injection site without providing any sensors and / or other measuring mechanisms that are too close to the injection site to potentially interfere with the injection of the drug at the injection site.

[0193] Measuring the amount of liquid can be performed using any method suitable for determining the amount of liquid at a certain location. Measuring the amount of liquid present near the injection site is a check for whether the liquid drug has been successfully administered to the patient, or alternatively, whether the liquid drug has only been deposited on the patient's surface (such as an event that may occur when the drug leaks and / or is wasted). Such liquid measurements can therefore indicate potential administration problems. Determining the amount of liquid present near the injection site can be accomplished by a liquid detection sensor. Determining the amount of liquid present near the injection site can be accomplished by a humidity sensor.

[0194] The at least one administration parameter may include the angular orientation of the drug administration device. The angular orientation may be measured using, for example, an accelerometer, a gyroscope, a tilt / angle switch (mercury-free), a position sensor, etc. As mentioned above, some drug administration devices should be in a specific angular orientation relative to the patient during drug administration to help ensure proper delivery of the drug.

[0195] The at least one administration parameter may include a physiological parameter of a user of the drug administration device, such as a physiological characteristic of the patient. Since the drug has a physiological effect on the user, measuring the at least one physiological parameter may enable confirmation that the drug has been successfully administered. Such confirmation of successful administration may make the drug administration procedure safer for the patient, because if successful administration is not confirmed, the patient and / or healthcare professional may be quickly alerted and may therefore intervene quickly if necessary. The physiological parameter may be any physiological parameter of the user that will change with the administration of the drug, such that the physiological parameter can be used to confirm successful administration. The physiological parameter may be the user's heart rate. The user's heart rate may be measured using, for example, a heart rate monitor. The physiological parameter may be the user's blood pressure. The user's blood pressure may be measured using, for example, a sphygmomanometer or a blood pressure monitor.

[0196] Alternatively or in addition to the at least one administration parameter being measured and the physiological parameter of the user of the drug administration device, at least one physiological parameter may be measured via the at least one dispensing mechanism parameter during successful administration of the drug. For example, when the at least one dispensing mechanism parameter includes a flow rate of the drug, the measured flow rate may be used to determine the at least one physiological parameter. For example, periodic changes in the flow rate are indicative of the user's heart rate. Detection of the heart rate via the flow rate indicates that the connection of the drug administration device to the patient's vein is intact. The absence of a characteristic change in the flow rate caused by the heart rate indicates that the connection between the vein and the drug administration device is interrupted. Therefore, it can be determined that the heart rate is an indication of successful administration.

[0197] Additional operation of the drug administration device may be modified based on the at least one dispensing mechanism parameter and / or the at least one physiological parameter. As discussed herein, enabling modification of additional operation of the drug administration device allows adjustments to be made to the drug administration device, which may make additional administration of the drug administration device more likely to be successful.

[0198] The operating state of the drug administration device may be evaluated before operating the dispensing mechanism. Such an evaluation may include evaluating any features of the drug administration device that are required to successfully administer the drug. Since the operating state of the dispensing mechanism has been evaluated, such an evaluation enables the user to have confidence that the drug administration device will successfully administer the drug.

[0199] Evaluating the operational state of the drug administration device may include analyzing a power source of the drug administration device to verify that the power source has sufficient power for successful administration. The sufficient power may be a predefined minimum power required for successful administration. The predefined minimum power may be stored in a memory for access by a processor performing the analysis. This analysis of the power source confirms whether there is sufficient power for successful administration and thus narrows down potential causes of failure in the event of an unsuccessful administration.

[0200] Evaluating the operational state of the drug administration device may also include, or alternatively include, moving a displaceable component of the drug administration device a predefined distance. By confirming that such movement is complete, it can be confirmed whether the displaceable component is functioning properly, and thus narrowing down the potential causes of failure in the event of an unsuccessful administration.

[0201] If evaluation of the operational state of the drug administration device indicates that administration will not be successful, operation of the drug administration device may be prevented. Such prevention will prevent administration from being only partially completed, which may cause harm to the patient. Preventing operation of the drug administration device may include any of the methods described herein. For example, preventing operation of the drug administration device may include disabling a power source to a motor of the drug administration device. For another example, preventing operation of the drug administration device may include enabling a device operation prevention mechanism. For yet another example, preventing operation of the drug administration device may include changing at least one variable parameter of an algorithm used to control drug administration from the drug administration device.

[0202] The user of the drug administration device may be notified that operation of the drug administration device is being prevented. Notification to the user may include any of the methods of notifying the user described herein. Specifically, the notification may include one or more of visual feedback, auditory feedback, and tactile feedback.

[0203] The user may be notified whether the administration was successful. The notification provides assurance to the user that the administration was successful and alerts the user when action is required. Notifying the user whether the administration was successful may include any of the methods described herein for notifying the user. Specifically, the notification may include one or more of visual feedback, auditory feedback, and tactile feedback.

[0204] The sensor may be configured to measure the at least one dispensing mechanism parameter. Such sensors are also referred to herein as "dispensing sensors". One or more dispensing sensors may be used. Such measurements generate dispensing mechanism data that allow a drug administration system or drug administration device to determine whether a drug has been successfully dispensed by the drug administration device. The dispensing mechanism data corresponding to each dispensing mechanism parameter may be used to perform the comparisons described herein regarding comparing a dispensing mechanism parameter to an acceptable dispensing mechanism parameter.

[0205] The sensor may be configured to measure the at least one administration parameter. Such sensors are also referred to herein as "administration sensors". One or more administration sensors may be used. This measurement generates administration data, and the drug administration system or drug administration device may compare these administration data with acceptable administration parameters. At least one administration sensor may be configured to measure the at least one administration parameter while the at least one dispensing sensor measures the at least one dispensing mechanism parameter. After the at least one dispensing sensor measures the at least one dispensing mechanism parameter, the at least one administration sensor may be configured to measure the at least one administration parameter. Measuring the at least one administration parameter may allow confirmation that the drug has been successfully administered and may serve as an independent check for confirmation that the operation of the dispensing mechanism is complete. Measuring the at least one administration parameter may also increase the chance of detecting an unsuccessful administration compared to the at least one administration parameter that is not measured, and allow faster intervention to prevent the patient from being harmed.

[0206] The processor may be configured to receive the dispensing mechanism data and to determine whether the operation of the dispensing mechanism is complete based on the dispensing mechanism data. Such a determination may enable confirmation that the dispensing mechanism has operated as intended. The processor may be present as part of the drug administration device or as part of an external device that is external to the drug administration device and may be remote from the drug administration device.

[0207] As discussed herein, the external device can be a device distinct from the drug administration device that includes components required to determine the completion of operation of the dispensing mechanism and to compare the at least one administration parameter to an acceptable administration parameter. Thus, the external device can include a computer system that includes a memory for storing acceptable administration parameters and a communication interface for receiving data from the drug administration device. Thus, the drug administration device can include a corresponding communication interface that is configured to electronically transmit data, such as drug administration data and / or administration data.

[0208] In an exemplary embodiment, the external device may be a smart device, such as a smart phone, tablet computer, smart watch, etc., capable of wirelessly communicating with the drug administration device.

[0209] In cases where the administration sensor is not part of the drug administration device, the administration sensor may include a communication interface for sending administration data to the drug administration device or an external device.

[0210] The second processor can be configured to receive administration data from the at least one administration sensor and confirm whether the administration is successful when it is determined that the operation of the dispensing mechanism is completed by the first processor. As described in more detail above, this confirmation enables the system or device to confirm that the drug has been successfully administered, which may lead to improved patient safety. Therefore, the second processor can provide a safety feature by confirming whether the delivery is successful. The second processor may be present on the drug administration device or an external device. In the absence of a second processor, the first processor can be configured to perform operations related to both the at least one dispensing mechanism parameter and the at least one administration parameter. Specifically, the first processor can be configured to perform all required processing functions.

[0211] In embodiments where the second processor is present on the external device, in response to successful administration, the external device (e.g., its second processor) may be configured to automatically trigger the mailing (or other delivery, as the case may be) of a new medication administration device to the patient (or to another location for the patient to pick up or use, as the case may be), so that the patient can receive the new medication administration device in a timely manner before the next scheduled medication dose is due, and / or so that the patient has a limited supply of the medication on hand at any given time. Having a limited supply of the medication on hand at any given time may be particularly important for controlled substances that may be abused and / or may be more likely to develop into addiction than other drugs. Some medication administration devices are single-use devices, which may make automatically triggering the mailing or other delivery of a new single-use medication administration device particularly useful.

[0212] In embodiments where the second processor is present on the external device, in response to a successful administration, the external device (e.g., its second processor) may be configured to automatically trigger scheduling of a pickup of the used drug administration device by an authorized agent. Some drug administration devices may require or may recommend recycling by an authorized agent after use and / or help ensure that any drug remaining in the drug administration device (whether due to non-use of the drug administration device or remaining drug remaining in the drug administration device after proper use of the drug administration device) is safely disposed of and not accessible to any unauthorized personnel, which may be particularly important for controlled substances (such as esketamine and ketamine). The drug administration device may include a location sensor configured to sense a geographic location via GPS or otherwise, and the drug administration device may be configured to transmit location data collected by the location sensor to the second processor. Thus, the second processor is able to know where the used drug administration device should be picked up. It may be more efficient for an authorized agent to pick up multiple drug administration devices at a time when the device is in use than to pick up one drug administration device at a time. Thus, the second processor may be configured to use the sensed location data received from each medication administration device to know when a minimum number of medication administration devices are ready for pickup at a particular location, and then automatically trigger an authorized agent to schedule the pickup of used medication administration devices only when the minimum number of medication administration devices are ready for pickup at the particular location.

[0213] The second processor can be configured to modify additional operations of the drug administration device based on the dispensing mechanism data and / or the administration data. As discussed above, enabling modification of additional operations of the drug administration device allows adjustments to be made to the drug administration device, which may make additional administrations of the drug administration device more likely to be successful and may reduce additional waste of administered drug.

[0214] The second processor may be configured to record real-time data during operation of the dispensing mechanism. The second processor may be configured to use the real-time data to determine whether there are one or more safety issues during operation of the dispensing mechanism. The second processor may be configured to notify a user of any determined safety issues. The one or more safety issues may include too high a back pressure. The one or more safety issues may include too high a flow rate. The one or more safety issues may include too slow a flow rate.

[0215] The second processor may be configured to automatically trigger the use of one or more sensors to collect data related to one or more physiological parameters of the patient in response to successful administration to the patient. Examples of physiological parameters include the following: blood glucose level (e.g., measurable using a blood glucose monitor, etc.), blood pressure (e.g., measurable using a blood pressure monitor, etc.), sweat level (e.g., measurable using a fluid sensor, etc.), heart rate (e.g., measurable using a heart rate monitor, etc.), respiratory rate (e.g., measurable using a respiratory monitor, a thermal sensor configured to be located near the nose or mouth and configured to use heat detection or detect in and out airflow movement during exhalation, a pressure sensor configured to be located near the nose or mouth and configured to use pressure detection or detect in and out airflow movement during exhalation, a spirometer), temperature (e.g., using a temperature sensor, etc.), blood oxygen level (e.g., using a blood oxygen sensor, etc.), sedation, dissociation, etc. Measuring the at least one physiological parameter of the patient may enable confirmation that the drug has been successfully administered to the patient because the drug has a physiological effect on the patient, and / or may facilitate monitoring of the patient's condition after the drug is administered. Some drugs require monitoring of the patient to whom the drug has been administered for a period of time after the drug is administered. A risk evaluation and mitigation strategy (REMS) for a drug (e.g., a REMS for esketamine, ketamine, or other controlled substances) may require such monitoring. Automatically triggering measurement of the at least one physiological parameter of the patient after drug administration can help facilitate the required monitoring.

[0216] In some embodiments, one or more sensors (e.g., patient sensors) configured to collect data related to one or more physiological parameters of a patient may have been planned to collect data after drug administration, such as as part of routine treatment and monitoring of the patient. In such cases, the second processor automatically triggers one or more sensors configured to collect data related to one or more physiological parameters of the patient, which may include causing one or more sensors to collect data at a specific elapsed time after drug administration, and / or collecting data at a regularly scheduled frequency (e.g., increasing the regularly scheduled frequency, which may include continuous data collection) different from what was previously planned for one or more sensors. Collecting data at a specific elapsed time after drug administration (e.g., every ten minutes after drug administration, every twenty minutes after drug administration, every thirty minutes after drug administration, every hour after drug administration, once forty minutes after drug administration and once two hours after drug administration, once forty minutes after drug administration and then once every hour after drug administration, etc.) can help ensure that useful physiological parameter data is collected for analyzing the effects of drugs on patients. Similarly, collecting data at different regularly scheduled frequencies can help ensure that useful physiological parameter data is collected for analyzing the effects of drugs on patients.

[0217] The second processor may be configured to modify additional operation of the drug administration device in any manner described herein. As discussed above, a notification output may be provided to inform a user of the drug administration device that additional operation of the drug administration device has been modified. For example, for the additional operation being modified, the second processor may be configured to prevent additional operation of the drug administration device when successful administration is not confirmed. This prevention of additional operation prevents additional unsuccessful administration and means that the problem that caused the unsuccessful administration must be resolved before the drug administration device can deliver a dose of drug again. The second processor configured to prevent additional operation of the drug administration device may include a second processor configured to disable a power source for a motor of the drug administration device, such as by opening or closing a switch as discussed above; the second processor is configured to cause a device operation prevention mechanism to be enabled; and / or the second processor is configured to cause a change in at least one variable parameter of an algorithm for controlling drug administration from the drug administration device.

[0218] The at least one dispensing sensor or the at least one application sensor may include any of a variety of sensors, such as a Hall effect sensor, a motion sensor, a pressure sensor, etc. As mentioned above, the Hall effect sensor provides reliable displacement measurement, even if the Hall effect sensor is physically blocked by dust particles or otherwise, it will not affect the measurement.

[0219] For another example, the at least one dispensing sensor or the at least one administration sensor may include a volumetric flow meter. This enables the total volume of the administered drug to be calculated and may therefore be used to confirm the operation of the device or the administration of the drug. The volumetric flow meter may include a piston flow meter. The volumetric flow meter may include an oval gear flow meter. The volumetric flow meter may be positioned near or at the outlet of the drug administration device.

[0220] For yet another example, the at least one dispense sensor or the at least one application sensor may include a pressure-based meter.The pressure-based meter may include a venturi flow meter.

[0221] For another example, as discussed herein, the at least one administration sensor can include a fluid detection sensor configured to measure an amount of fluid present near an injection site.

[0222] For yet another example, the at least one administration sensor may be configured to monitor the angular orientation of the drug administration device, such as using an accelerometer, a gyroscope, a tilt / angle switch (mercury-free), a position sensor, etc. As mentioned above, some drug administration devices should be in a specific angular orientation relative to the patient during drug administration to help ensure proper delivery of the drug.

[0223] Fig. 9is a schematic diagram of an embodiment of a drug administration device 900 that includes a volumetric flow meter 930 and a Hall effect sensor 940. In this example, the drug administration device 900 is a specific implementation of the universal drug administration device 500 described herein. Any compatible drug administration device may be used in this example.

[0224] The drug administration device 900 includes a drug holder 910 that retains the drug to be dispensed and a dispensing mechanism 920 that is configured to dispense the drug from the drug holder 910 so that the drug can be administered to a user. In this example, the dispensing mechanism 920 is a plunger. The drug administration device 900 includes a Hall effect sensor 940, and the dispensing mechanism 920 includes a magnet 942. As the displacement D of the dispensing mechanism 920 changes, the reading on the Hall effect sensor 940 will change due to changes in the vicinity of the magnet 942. The Hall effect sensor 940 can be calibrated so that each reading corresponds to a different displacement D. Therefore, the reading of the Hall effect sensor 940 can be used to confirm the operation of the dispensing mechanism 920 or the administration of the drug by confirming the expected distance that the dispensing mechanism has moved. In this example, the Hall effect sensor 940 is configured to measure at least one dispensing mechanism parameter and output dispensing mechanism data related to the at least one dispensing mechanism parameter. Those skilled in the art will appreciate that the location of the Hall effect sensor 940 is shown by way of example only, and the Hall effect sensor 940 may be positioned at any location where the reading of the Hall effect sensor 940 will change as the displacement D of the dispensing mechanism 920 changes. In an alternative configuration, the displacement mechanism 920 may include the Hall effect sensor 940, and the drug administration device 900 may include the magnet 942.

[0225] When the drug is dispensed by the dispensing mechanism 920 through the discharge nozzle 922, the drug passes through the volume flow meter 930. The volume flow meter 930 is configured to measure the amount of the drug dispensed by the dispensing mechanism 920. In this example, the volume flow meter is one of the at least one administration sensor. It will be understood by those skilled in the art that the position of the volume flow meter 930 is shown only by way of example, and the volume flow meter 930 can be positioned at any position where the drug passes when the drug is administered. The volume flow meter 930 can be positioned near the outlet of the drug administration device 900. By measuring the amount of liquid passing through the volume flow meter 930, it can be confirmed that the drug has been successfully administered.

[0226] Fig.10 A flow chart showing an embodiment of a method 1000 of confirming administration from a drug administration device is shown.

[0227] Optionally, an operational state of the drug administration device is evaluated 1010 prior to operating the device. A dispensing mechanism of the drug administration device is then operated 1020. At least one dispensing mechanism parameter is measured 1030. The at least one dispensing mechanism parameter may be any dispensing mechanism parameter described herein. At least one administration parameter is measured 1040. The at least one administration parameter may be any administration parameter described herein. It is then determined 1050 whether operation of the dispensing mechanism is complete based on the at least one dispensing mechanism parameter.

[0228] When the operation of the dispensing mechanism is determined to be complete, the at least one administration parameter is compared to acceptable administration parameters to confirm whether the administration was successful 1060. Optionally, a user of the drug administration device may then be notified whether the administration was successful 1080. If the operation of the dispensing mechanism is determined to be incomplete, the user may optionally be notified that the dispensing mechanism did not complete the operation 1070. Optionally, after notifying the user whether the administration was successful 1080, or after notifying the user that the dispensing mechanism did not complete the operation 1070, additional operations of the drug administration device may then be modified 1090. Optionally, the user may then be notified of the modification to the additional operations of the drug administration device 1092.

[0229] Medication delivery consistency, notifications and prioritization

[0230] As described above, it may be desirable to monitor the delivery of a drug to identify delivery problems or other problems, particularly with respect to drug trials or consistency with a dosing prescription. In an exemplary embodiment, a drug administration and monitoring system includes a drug administration device, a monitoring device, and a sensor. The drug administration device, the monitoring device, and the sensor may all be integrated with each other as a single device. Alternatively, both the drug administration device and the monitoring device may be integrated with each other as a single device, and the sensor may be a separate device. In another alternative, the drug administration device, the monitoring device, and the sensor may each be a separate discrete device.

[0231] The sensor may be configured for real-time in vivo monitoring of a patient and is configured to sense at least one patient parameter. Therefore, the sensor of the drug administration and monitoring system is also referred to herein as a "patient sensor". The patient sensor may be configured to be placed on, in, or away from the patient, or near the patient. For example, the patient sensor may be integrated into a wearable device such as a smart watch, or carried by the patient, for example by integration into a mobile user device such as a smartphone.

[0232] The monitoring device is made into an electronic device, such as a computer system as described herein. In an exemplary embodiment, the monitoring device is a mobile computer system, such as a mobile phone, smart watch, etc., which can allow the user to access information at many different locations of the user via the monitoring device.

[0233] The drug administration device, the monitoring device, and the patient sensor each communicate data with each other. The communication can be one way (unidirectional), such as from the drug administration device to the monitoring device and from the patient sensor to the monitoring device. Alternatively, the data communication can be bidirectional.

[0234] The monitoring device may be configured to receive data related to drug delivery events from the drug administration system and to receive at least one patient parameter from the patient sensor.

[0235] The monitoring device can be configured to record drug delivery events, determine a drug response associated with a drug delivery event on a particular patient based on at least one patient parameter sensed by a patient sensor, and determine and store data related to a patient outcome associated with the drug response and the drug delivery event. The drug delivery event record and / or the determined data can be stored in the patient's electronic health record (EHR), and / or in a form required for use with the administered drug (such as a patient monitoring form for a risk evaluation and mitigation strategy (REMS) for a particular drug). Esketamine, ketamine, and other controlled substances typically have a REMS. Therefore, the EHR and / or the form can be updated accurately and timely.

[0236] The determined patient outcomes can be one or more of the following: the time period over which a drug response is sensed after delivery of an administered drug; the intensity of a drug response determined at a given time or over a given time period after administration of the drug to the patient; the duration of a drug response determined in relation to a drug delivery event; and the effectiveness or response of the drug in the patient in relation to specific symptoms following a drug delivery event that are associated with the medical indications treated by the drug.

[0237] The monitoring device may be configured to generate a notification to the patient and / or a remote patient monitoring device based on the determined patient outcome. The remote patient monitoring device may be an external device as described herein.

[0238] The at least one patient parameter sensed by the sensor may include one or more of: temperature, pH level, biomarkers, glutathione level, skin thickness, subcutaneous tissue thickness, blood oxygen level, blood glucose level, blood pressure, heart rate, respiratory rate, sleep, and metabolic rate.

[0239] The monitoring device may be configured to check the consistency of the drug delivery event and the optional one or more additional drug delivery events with the prescribed drug administration regimen through the drug administration device. The monitoring device may be further configured to generate a notification to the patient and / or a remote patient monitoring device if the drug delivery event and the optional one or more additional drug delivery events are inconsistent with the prescribed drug administration regimen. The prescribed drug administration regimen may specify one or more of the following drug administration parameters: drug delivery rate, drug delivery duration, drug delivery volume, and drug delivery frequency.

[0240] The drug administration system may further include an environmental sensor configured to detect an external stimulus. The environmental sensor of the drug administration system may be configured to detect one or more of: user input to the drug administration device, geographic location, ambient temperature, pressure, and ultraviolet radiation level. The drug administration system may further include a user interface, the external stimulus may be a user input, and the user input may be input via the user interface.

[0241] The monitoring device may also be configured to determine whether the likelihood of a side effect associated with the drug has increased based on at least one patient parameter and / or external stimulus sensed, and upon determining that the likelihood of the side effect has increased, if the drug delivery event and optionally one or more additional drug delivery events are inconsistent with the prescribed drug administration regimen, a notification is generated to the patient and / or a remote patient monitoring device. The monitoring device may include a device indicator, and the drug administration device may be configured to activate the device indicator upon determining that the likelihood of a side effect has increased.

[0242] The monitoring device may be configured to provide multiple notifications to the patient and / or a remote monitoring device regarding a drug delivery event, optionally one or more additional drug delivery events, and / or at least one patient parameter, and may notify the multiple notifications in sequence according to a predefined priority order based on the detected drug delivery event and optionally one or more additional drug delivery events, and / or based on at least one patient parameter.

[0243] Fig.11 5 to 6. The embodiment of the drug administration and monitoring system is shown, which includes a monitoring device 901, which is a smart monitoring device for a patient, and the monitoring device is connected to the drug administration device 500 or the housing 630 (FIG. 5 to Figure 7 ) and communicate with the central system 700 ( Figure 7 The monitoring device 901 is configured to monitor drug delivery events of the drug administration device 500 or the housing 630, and is configured to send data related to the drug delivery events to the central system 700.

[0244] like Fig.12As shown, the drug administration and monitoring system also includes one or more patient sensors 1001 in communication with the monitoring device 901 and one or more environmental sensors 1002 in communication with the monitoring device 901. As mentioned above, the patient sensor 1001 can be configured to sense one or more current conditions of the patient, including any one or more of temperature, pH level, biomarkers, glutathione level, skin thickness, subcutaneous tissue thickness, blood oxygen level, blood sugar level, blood pressure, heart rate, respiratory rate, sleep, and metabolic rate. As also mentioned above, the environmental sensor 1002 (e.g., Figure 5B or Figure 6 One or more of the environmental sensor 94, the position sensor 98, and the device sensor 92) can be configured to sense one or more of the following: user input to the drug administration device, geographic location, ambient temperature, pressure, and ultraviolet radiation level.

[0245] Fig.14 One embodiment of a patient sensor is shown. Fig.14 In this exemplary embodiment, the drug administration device 500 ( Figure 5B ) is an automatic injector that includes a light source 1201 located at the distal end 1200 of the device 500. The patient sensor is a light detector 1202 that is configured to detect light reflected back from the patient's skin 1203 when the light source 1201 is activated to transmit light 1201a to the patient's skin 1203. Based on the characteristics of the light received back (e.g., intensity, change, etc.), one or more patient parameters (e.g., skin thickness, heart rate, etc.) can be determined. Those skilled in the art will understand how the reflected light can be analyzed, such as by a processor of the monitoring device 901 or other processor, to determine one or more patient parameters sensed via the reflected light.

[0246] at a residential base 708, a medical facility 706, and / or a mobile location 710 ( Figure 7 ) can be configured to receive information from the monitoring device 901 and / or the central system 700 ( Figure 7) receive notifications related to drug delivery events. Specifically, these notifications may relate to any one or more of the following: the quality of the drug product delivered, successful drug delivery, unsuccessful drug delivery, whether self-calibration of the drug administration device 500 occurred between drug deliveries, the timing and duration of drug delivery events, consistency with a prescribed drug delivery profile, unusual or non-prescribed drug delivery of a particular drug, detected symptoms of the medical indication being treated by the drug, detected side effects, patient parameters, emergency events (such as dosing over or under drug delivery), drug delivery errors, and environmental parameters associated with drug delivery. Such emergency events of drug delivery detected by the monitoring device 901 may alert, for example, the patient and / or the patient's caregiver. Fig.13 As shown in the embodiment of FIG. 1 , these notifications can be prioritized and notified in a predetermined order according to a predetermined priority matrix 1100, for example, based on the priority order of patient risk and / or drug trial consistency. These notifications can be alerted by an audible or visual alert on the monitoring device 901 itself and / or the drug administration device 500 and / or the housing 630.

[0247] exist Fig.13 In the exemplary notification sequence 1100 of FIG. 1 , at step 1101, the user is notified of the medication (at Fig.13 The quality of the drug product (referred to as the drug product in step 1102). At step 1102, the user is informed of the successful drug delivery. If an improvement in the patient's (which may be the user) symptoms is recorded, the user is notified at step 1103, after which the user is reminded to take another dose at step 1104. If, after the successful drug delivery at step 1102, a negative impact associated with the drug delivery is detected, the user is notified at step 1105. If the negative impact is determined to be minor, the user is warned at step 1106, and symptoms are additionally monitored at step 1107. Alternatively, if the determined negative impact is major, the user is notified at step 1108 to seek help.

[0248] Reference again Fig.11In some embodiments, the monitoring device 901 is configured to monitor drug delivery events of the drug holder, thereby monitoring drug delivery of the drug administration device 500 or housing 630 used with the drug holder. Knowing when the drug holder was first used may help assess patient compliance, help ensure that the drug is used before the expiration date (e.g., by comparing the date / time of first use with the known expiration date of the drug by the processor), and / or help determine whether drug administration has successfully occurred. The drug holder is configured to send data related to the drug delivery event to the central system 700. Therefore, in such embodiments, the drug administration device 500 or housing 630 can, but need not be, configured to send data related to the drug delivery event to the central system 700.

[0249] Fig.15 and Fig.16 An embodiment of a drug holder 1300 is shown that can be included in a drug administration and monitoring system. In the illustrated embodiment, the drug holder 1300 is a vial configured to hold a drug in a liquid dosage form therein. Fig.15 and Fig.16 The drug holder 1300 includes a septum 1302 that is configured to be pierced to allow access to the drug in the drug holder 1300 through the septum 1302. Fig.16 An embodiment of a needle 1304 of a syringe 1306 is shown that is configured to be inserted through a septum 1302 . Fig.16 Needle 1304 is shown extending through septum 1302 and into medication holder 1300. After the medication is drawn from medication holder 1300 into syringe 1306 through needle 1304, needle 1304 may be withdrawn from septum 1302 to allow syringe 1302 to be used to deliver the medication to a patient.

[0250] The medication holder 1300 also includes a circuit trace 1308 and a chip 1310 in electronic communication 1312 with the circuit trace 1308. The circuit trace 1308 and the chip 1310 are integrated with or otherwise attached to a label 1314 that is configured to be adhered or otherwise applied to an outer surface of the medication holder 1300. The label 1314 can have any of a variety of sizes and shapes. Additionally, the circuit trace 1308 and the chip 1310 can be otherwise attached to the medication holder 1300. The chip 1310 is typically configured as a computer system and includes a power source and a communication interface. The circuit trace 1308 is positioned above the septum 1302 and is configured to be punctured by a needle inserted through the septum 1302. Fig.15Circuit trace 1308 is shown in an unbroken state before being pierced. With circuit trace 1308 in an unbroken state, electronic communication 1312 between circuit trace 1308 and chip 1310 is not broken. Fig.16 The circuit trace is shown in a disconnected state after being punctured, wherein the puncture in this illustrated embodiment is performed by the needle 1304 of the syringe 1306. With the circuit trace 1308 in the disconnected state, the electronic communication 1312 between the circuit trace 1308 and the chip 1310 is disconnected. In other words, the circuit trace 1308 in the disconnected state "disconnects" the electronic communication 1312 between the electronic components. In response to the circuit trace 1308 transitioning from the non-disconnected state to the disconnected state, for example, in response to the electronic communication 1312 being "lost", the communication interface of the chip 1310 is configured to transmit drug delivery event data to the cloud 702 and / or the monitoring device 901. The drug delivery event data indicates that the drug holder 1300 has been used for the first time, and as reflected by the septum 1302 that has been punctured and the circuit trace 1308 that has been "disconnected" by the puncture, the drug administration process may therefore begin. After the needle or other member piercing the septum 1302 is withdrawn from the septum 1302, the circuit trace 1308 remains in the disconnected state. The circuit trace 1308 transitions from the non-disconnected state to the disconnected state, thus indicating the first use of the drug holder 1300.

[0251] The medication holder 1300 may include a cap 1316 that is configured to be positioned over the septum 1302 and is configured to be removed from the medication holder 1300 by a user prior to the insertion of a needle or other member through the septum 1302. Thus, the cap 1316 can provide protection to the circuit traces 1308 and to the septum 1302 to help prevent the circuit traces 1308 from prematurely transitioning from a non-disconnected state to a disconnected state, for example, during shipping or handling. As will be appreciated by those skilled in the art, the cap 1316 can be removably attached to the medication holder 1300 in any number of ways, such as via threads, a snap fit, a hinge configured to allow the cap 1316 to flip over, and the like.

[0252] Reference again Fig.11 In some embodiments, the monitoring device 901 is configured to monitor drug mixing, such as a drug delivery event. Knowing information related to drug mixing (e.g., when or if drug mixing begins, when or if drug mixing ends, etc.) may help determine whether drug administration has occurred successfully, such as by checking whether mixing occurs within a predetermined minimum amount of time known to properly mix drugs together.

[0253] Fig.17An embodiment of a drug administration device 1400 is shown, which, like the drug administration device 500, can be included in a drug administration and monitoring system. The drug administration device 1400 is configured to mix a first drug 1402 and a second drug 1404 on a plate of the device 1400. In the illustrated embodiment, the first drug 1402 and the second drug 1404 are each liquid. The first drug 1402 and the second drug 1404 are different from each other and are mixed in a mixing chamber 1406 of the drug administration device 1400 to form a drug. The mixed drug can be delivered from the mixing chamber 1406 of the drug administration device 1400.

[0254] In the illustrated embodiment, the drug administration device 1400 is a syringe including a plunger configured to drive the mixed drug from the mixing chamber 1406 out of the needle 1408 of the drug administration device 1400. The drug administration device 1400 may have other components as discussed herein for the syringe and for the drug administration device 500.

[0255] Fig.17 A drug administration device 1400 is shown that includes a first motor 1410 and a second motor 1412. The first motor 1410 is configured to drive the first drug 1402 into the mixing chamber 1406, for example by moving the first motor 1410 distally (at Fig.17 The drug administration device 1400 may include a first motor 1410, 1412 that drives a first plunger 1414 (partially shown) of the device 1400, such as by distally driving a second plunger 1416 (partially shown) of the device 1400. The second motor 1412 is configured to drive the second drug 1404 into the mixing chamber 1406, such as by distally driving the second plunger 1416 (partially shown) of the device 1400. The drug administration device 1400 may include a processor that is configured to control the motors 1410, 1412 and, therefore, control the mixing of the drugs 1402, 1404. The motors 1410, 1412 may be configured to drive equal amounts of the first drug 1402 and the second drug 1404 into the mixing chamber 1406 and to drive the first drug 1402 and the second drug 1404 into the mixing chamber 1406 at the same rate as each other. Alternatively, the motors 1410, 1412 can be configured to drive different amounts of the first drug 1402 and the second drug 1404 into the mixing chamber 1406, and / or drive the first drug 1402 and the second drug 1404 into the mixing chamber 1406 at different rates from each other. Depending on one or more factors such as the desired concentration of the mixed drug, the type of the first drug 1402 and the second drug 1404, etc., driving different amounts of the first drug 1402 and the second drug 1404 into the mixing chamber 1406, and / or driving the amounts of the first drug 1402 and the second drug 1404 (the same or different) into the mixing chamber 1406 at different rates may result in the mixed drugs in the mixing chamber 1406 being easiest to inject, the most uniform combination, etc.

[0256] One or more types of data regarding drug delivery events related to the mixing of the first drug 1402 and the second drug 1404 may be transmitted from the drug administration device 1400 to the cloud 702 and / or the monitoring device 901. Examples of the data include: a start date / time of the first motor 1402, a stop date / time of the first motor 1402, a speed of the first motor 1402 during driving the first plunger 1414, a current of the first motor 1402 during driving the first plunger 1414, a start date / time of the second motor 1404, a stop date / time of the second motor 1404, a speed of the second motor 1404 during driving the second plunger 1416, and a current of the second motor 1404 during driving the second plunger 1416.

[0257] Fig.18 An embodiment of a drug administration device 1500 is shown, which, like drug administration device 500, can be included in a drug administration and monitoring system. Drug administration device 1500 is configured to mix a first drug 1502 and a second drug 1504 on a plate of device 1500. In the illustrated embodiment, first drug 1502 is a liquid and second drug 1504 is a solid, such as a powder or other solid. First drug 1502 and second drug 1504 are different from each other and are mixed to form a drug that can be delivered from drug administration device 1500. In the illustrated embodiment, chamber 1506 in which first drug 1502 is placed before mixing acts as a mixing chamber to mix first drug 1502 and second drug 1504 together.

[0258] In the illustrated embodiment, the drug administration device 1500 is a syringe that includes a plunger 1508 configured to drive the second drug 1504 from its initial chamber 1512 into the mixing chamber 1506. The drug administration device 1500 includes a motor configured to drive the plunger 1508. The plunger 1508 is configured to move distally (in the direction of the piston 1508) as the plunger 1508 drives the second drug 1504. Fig.18 The seal 1514 is broken by moving the syringe 1506, 1512 downward in the view of FIG. 1 . The seal 1514 first separates the chambers 1506, 1512 and then keeps the drugs 1502, 1504 separated from each other until the time when mixing is desired. The drug administration device 1500 also includes a needle 1510 through which the mixed drug can exit the drug administration device 1500. The drug administration device 1500 can have other components as discussed herein for the syringe and for the drug administration device 500.

[0259] Fig.18The drug administration device 1500 is shown to include an agitator 1516 that is configured to be driven by a motor of the drug administration device 1500 (which may be the same motor that drives the plunger 1508, or a different motor). The agitator 1516 is configured to move relative to the housing 1522 of the drug administration device 1500 to cause movement (e.g., vertical movement, horizontal movement, rotational movement, or some combination thereof) of the mixing chamber 1506 (and other chambers 1512). The movement of the mixing chamber 1506 causes the first drug 1502 and the second drug 1504 in the mixing chamber 1506 to mix together. The plunger 1508 moves distally to drive the second drug from the chamber 1512 into the mixing chamber 1506, which may act as a proximal end of the mixing chamber 1506 during mixing (e.g., during movement of the agitator 1516). Depending on one or more factors such as the desired concentration of the mixed drug, the type of the first drug 1502 and the second drug 1504, the agitator 1516 can move at different speeds and / or for different lengths of time to result in the mixed drug in the mixing chamber 1506 being easiest to inject, most uniformly combined, etc.

[0260] One or more types of data regarding drug delivery events related to the mixing of the first drug 1502 and the second drug 1504 may be transmitted from the drug administration device 1500 to the cloud 702 and / or the monitoring device 901. Examples of data include: a start date / time when the plunger 1508 moves to drive the second drug 1504, a stop date / time when the plunger 1508 moves to drive the second drug 1504, a start date / time when the plunger 1508 moves to drive the mixed drug from the mixing chamber 1506 out of the needle 1510, a stop date / time when the plunger 1508 moves to drive the mixed drug from the mixing chamber 1506 out of the needle 1510, a speed of the motor during the driving of the plunger 1508 and / or the agitator 1516, and a current of the motor during the driving of the plunger 1508 and / or the agitator 1516.

[0261] Stimuli-responsive drug delivery device for local drug activation

[0262] In another exemplary embodiment, a drug administration system includes a drug administration device including a drug holder configured to hold a drug. The drug administration device also includes a dispensing mechanism configured to dispense the drug. The drug administration system also includes a first sensor configured to sense a patient parameter. The drug administration system is configured to locally activate the drug at a targeted location in the patient after the drug has been dispensed by the dispensing mechanism and administered to the patient. The local activation is responsive to the patient parameter and an external stimulus.

[0263] This local activation allows the systemic administration of a non-activated form of a drug or a drug with reduced activity to a patient. The drug is configured to be activated only at a target location in the patient where its therapeutic effect is desired. The location in the patient should be understood to include a location on the patient's surface, such as the skin. Advantageously, the harmful effects associated with the activation form of the drug at an unexpected or non-targeted location in the patient are minimized. Since the drug is only activated at a targeted location in the patient's body (the targeted location is usually a volume rather than a specific point), and the drug therapeutic effect at this time is desired, the benefits of the drug are concentrated, so in addition to the above-mentioned safety benefits, the efficacy of the drug can also be improved. Therefore, the required drug dose may also be reduced. By making the local activation responsive to the sensed patient parameters and external stimuli, efficacy and safety can be additionally improved, because only when the drug administration device determines that, for example, the patient parameters and external stimuli are suitable or appropriate, or after enough time, the drug will be positioned at the desired target location in the patient, the drug will be activated. Making local activation responsive to sensed patient parameters and external stimuli can also improve compliance because the drug administration device controls when the drug is activated based on suitable or appropriate conditions, rather than relying entirely on when the user administers the drug. Such activation may be particularly important for applications outside of clinical settings, where the drug may be administered by the patient themselves rather than by a medical professional, and drug administration may be performed at suboptimal times and / or under suboptimal conditions. Certain suboptimal conditions (e.g., inappropriate temperature of the drug, inappropriate pH level of the drug, elevated glutathione levels, low blood pressure, etc.) may cause the drug to be ineffective at its conventional dose, and / or may cause increased side effects. Therefore, it is beneficial if local activation of the drug is responsive to these suitable or appropriate conditions.

[0264] Local activation in response to patient parameters and external stimuli may include activation that occurs when the patient parameters and external stimuli meet predetermined criteria. The predetermined criteria may be patient parameters and external stimuli that exceed or fall below a threshold level, or alternatively, patient parameters and external stimuli that meet a predetermined mathematical relationship. The degree of local activation may also be responsive to the patient parameters and external stimuli.

[0265] The first sensor comprises a device configured to detect or measure a physical characteristic or parameter associated with a patient. The first sensor may be integral to the drug administration device and may be placed on a surface of the drug administration device. Alternatively, the first sensor may be free to move independently of the rest of the drug administration device to allow for more convenient measurement of patient parameters. The first sensor is configured to communicate with other components of the drug administration device via wired or wireless means, such that local activation can be responsive to an output of the first sensor.

[0266] The drug administration device may further include a second sensor configured to sense an external stimulus. The second sensor may be integral to the drug administration device and may be placed on a surface of the drug administration device. Alternatively, the second sensor may be free to move independently of the rest of the drug administration device to allow for more convenient measurement of the external stimulus, wherein the second sensor communicates with other components of the drug administration device via a wired or wireless manner.

[0267] Generally speaking, an external stimulus is a physical property outside the patient's body. For example, an external stimulus may be an environmental parameter. An environmental parameter is a characteristic of the patient's local environment. For example, an environmental parameter may be an ambient temperature or an ambient pressure.

[0268] The second sensor may allow for identification and / or quantification of external stimuli, such as environmental parameters, which may affect the localization time, efficacy, and / or side effects associated with the drug. For example, the ambient temperature may affect the viscosity of the drug, which in turn affects the time required for the drug to reach or be located at a target location in the patient. If the drug is overheated (e.g., if the temperature of the drug is above a predetermined threshold temperature or outside a predefined safe temperature range), the drug may become less viscous and may then travel more freely to the target location in the patient at a faster speed. Increasing the temperature of the drug may also result in an increased heart rate and vasodilation, resulting in faster localization of the drug at the target site. The temperature of the drug stabilizes to the ambient temperature, so the ambient temperature may indicate the temperature of the drug. Therefore, making local activation responsive to such external stimuli may improve efficacy and / or minimize side effects.

[0269] The drug administration device may include an energy source configured to provide energy to locally activate a drug at a targeted location in a patient. The supply of such energy may have the effect of activating the drug at a precise location by targeted application of energy to the patient. The energy source may be configured to target not only a surface location on the patient, but also be set to a desired penetration depth to provide a precise targeted location within the patient (which is typically a volume rather than a specific point). The energy source may include multiple energy sources of different types to provide different penetration and activation characteristics.

[0270] The drug may be configured to interact with the energy provided by the energy source to assume an activated form of the drug. Alternatively, an activation device implanted in the patient may trigger activation of the drug at a targeted location in response to the energy provided by the energy source.

[0271] The amount of energy provided by the energy source may be responsive to patient parameters and external stimuli. Such responsiveness of the amount of energy may have the effect of being responsive to patient parameters and external stimuli, and therefore more accurately controlling the degree and rate of drug activation to improve the efficacy and safety of the drug. For example, if the drug administration device determines that a condition (as indicated by patient parameters and external stimuli) is such that the patient is unable to take up (e.g., absorb, metabolize, etc.) the drug at a normal rate at the targeted location, it may be desirable to activate the drug more gradually by providing a smaller amount of energy over a longer period of time. Therefore, another benefit of this gradual activation may be that less drug is wasted.

[0272] The energy source may include one or more of a light source, an ultrasound source, an electromagnetic field source, and a radioactive material.

[0273] As mentioned above, the energy source can be configured to interact with a drug or implant device. As mentioned above, a combination of multiple types of energy sources can be provided to provide variable penetration characteristics. For example, an energy source capable of providing electromagnetic fields of different wavelengths can be used. Where appropriate, the frequency of the energy source can be adjusted by the drug administration device to control the rate and amount of energy delivered, as well as the penetration depth. Each energy source can be provided to the drug administration device as a separate unit or as an integral part of the drug administration device.

[0274] The drug administration device can be configured to administer a chemical activator to a targeted location in a patient to locally activate the drug. Although such chemical activator administration requires a drug administration device capable of administering both the drug and the chemical activator, which may require an additional associated dispensing mechanism and an additional holder for the chemical activator, such a drug administration device advantageously does not require an energy source to activate the drug, and therefore may have a simpler structure in some aspects. The additional holder of the chemical activator may be arranged in series with the drug holder so that the same dispensing mechanism can be used to dispense both the drug and the chemical activator. Alternatively, the holder may be arranged in parallel with an independent dispensing mechanism.

[0275] The chemical activator can be administered to the targeted location before or after the drug is administered to the patient by the drug administration device. For example, the chemical activator can be administered to the tumor before or after the chemotherapeutic drug is delivered to the patient systemically in an inactive form or a reduced active form. The chemical activator can be configured to remain in the tumor so that the chemotherapeutic drug is activated at the targeted location only by chemical reaction with the chemical activator or a chemical reaction triggered by the chemical activator.

[0276] The patient parameters sensed by the first sensor may include one or more of the following: temperature, pH level, biomarker, glutathione level, skin thickness, subcutaneous tissue thickness, blood oxygen level, blood glucose level, blood pressure, heart rate, and metabolic rate. For example, patient parameters including pH level may be beneficial because if the pH level is above or below a certain level, some drugs may be less effective, and therefore delaying the administration of the drug until the pH level is restored or within a desired range or enhancing activation to compensate for suboptimal conditions may be beneficial. For another example, in the case where the patient parameter is a biomarker, the biomarker may be a naturally occurring molecule, gene, or other feature that provides an indication of the state of a particular pathological or physiological process or disease. Various sensors capable of sensing biomarkers are known to those skilled in the art, such as using microfluidics, and exist in various forms, such as skin patches. For another example, glutathione levels are particularly important for chemotherapeutic drugs because elevated glutathione levels in cells protect cells from the effects of chemotherapeutic drugs. Therefore, it may be beneficial to delay activation until glutathione levels drop below an acceptable threshold level, or to enhance the degree of activation to compensate for the enhanced protection of cells by glutathione. For another example, skin thickness and subcutaneous thickness measurements can be used to ensure activation, such as by penetration of the energy source to a sufficient depth. For yet another example, various parameters related to blood circulation (e.g., blood oxygen levels, blood pressure, heart rate, and metabolic rate) affect the efficacy and safety of the drug, and therefore adjusting activation according to the value of one or more parameters related to blood circulation can improve efficacy and safety.

[0277] The external stimulus may include one or more of: user input, geographic location, ambient temperature, pressure, and ultraviolet radiation levels. Making the local activation responsive to the external stimulus may ensure that external factors or other environmental parameters are taken into account to optimize the timing or extent of the local activation, which external factors may include user input indicating that the user is ready to receive the medication. Environmental parameters may affect the efficacy or safety of the medication, and therefore it may be advantageous to adjust the activation accordingly. For example, certain medications may cause increased side effects at high temperatures, and therefore it may be beneficial to delay or reduce the extent of activation in such cases.

[0278] The drug administration device may include a user interface, as discussed herein. The external stimulus may include a user input entered via the user interface. As discussed above, the user interface may take the form of a touch screen and / or one or more buttons to allow a user to provide input, such as indicating that the user is ready to deliver and / or activate the drug as an external stimulus.

[0279] The drug administration device may be configured to administer a drug to a patient according to a drug administration regimen. Such a drug administration regimen may be pre-set by a physician or other healthcare professional based on the needs of the patient, and may be based on parameters such as the patient's weight, height, and age to provide a starting drug administration regimen that may be effective for the patient. The drug administration regimen may specify one or more of the following drug administration parameters: drug delivery rate, drug delivery duration, drug delivery volume, and drug delivery frequency.

[0280] The drug administration device may include a syringe, as discussed above, and the drug administration regimen may specify one or more of the following administration parameters: a discharge nozzle advancement depth of the discharge nozzle of the syringe during administration of the drug to the patient; a discharge nozzle velocity of the discharge nozzle of the syringe during administration of the drug to the patient; and a discharge nozzle acceleration of the discharge nozzle of the syringe during administration of the drug to the patient. The discharge nozzle may be a needle of a syringe. Thus, the advancement depth may be an exposed portion of the needle beyond the housing of the syringe.

[0281] The drug dosing regimen may be based on patient parameters and external stimuli, which may allow for additional optimization of the parameters of the drug dosing regimen based on factors that affect drug efficacy and safety.

[0282] As mentioned above, the patient parameters may include subcutaneous tissue thickness, and the drug administration device may be configured to adjust the discharge nozzle advancement depth based on the sensed subcutaneous tissue thickness when the drug administration device includes an advanceable discharge nozzle. Such adjustment can ensure that the drug can be administered into the patient's tissue (where the drug will be more easily absorbed), injection site leakage can be minimized, backflow of the drug can be prevented, and the risk of tissue damage and scarring caused by drug administration can be reduced.

[0283] The drug administration device may be configured to determine whether the likelihood of a side effect associated with the drug has increased based on patient parameters and / or external stimuli, and when it is determined that the likelihood of the side effect has increased, adjust the drug administration regimen to reduce the dose of the drug to be administered and / or adjust the activation device to reduce the local activation of the drug, the activation device being configured to provide local activation. Since the activation form of the drug may be associated with side effects, such adjustment of the drug administration regimen may minimize the risk of increased side effects by reducing the amount of drug administered or by reducing the activation of the drug under conditions that lead to increased side effects (such as higher body temperature or ambient temperature). Adjustment of activation may include stopping activation entirely, or reducing the extent to which activation occurs, such as by reducing the energy provided by the energy source.

[0284] The drug administration device may include a device indicator as discussed above, and the drug administration device may be configured to activate the device indicator when it is determined that the likelihood of a side effect has increased. Such a notification may be used to alert the user to change their use of the drug administration device, such as stopping operation of the drug administration device, or to change a parameter of the drug administration device, such as the depth of advancement of the discharge nozzle when the drug administration device includes an advanceable discharge nozzle. As discussed above, the indicator may be an audible indicator, a visual indicator (such as an LED), or a tactile indicator (such as a locking mechanism or vibration).

[0285] The drug administration device can be used as part of a drug administration system that includes the drug administration device and a drug capture and release mechanism configured to be implanted in the body of a patient. A variety of drug capture and release mechanisms are known to those skilled in the art, such as those for capturing a bolus in the stomach and releasing the bolus into the digestive tract when activated.

[0286] In an exemplary embodiment, Fig.19 As shown, the drug administration system 1500 includes a drug administration device 1510, which in the illustrated embodiment is in the form of an automatic syringe. The drug holder of the drug administration device is in the form of a container 1550 that retains the drug to be dispensed, such as a syringe or a vial. As described above, the dispensing mechanism of the drug administration device includes a drive element 1560, which may include a piston and / or a rod, and a drive mechanism.

[0287] The patient sensor 1520 is separate from the auto-injector 1510 and is connected to the auto-injector 1510 by wire or wireless means to transmit data. Alternatively, when the drug administration device 1510 is positioned for administering the drug to the patient, the patient sensor 1520 may be placed on the surface of the auto-injector 1510 and arranged to be close to the patient's skin.

[0288] The user pierces the skin to release a small amount of blood, and the patient sensor 1520 is configured to measure the blood glucose level in the blood sample placed on the sensor 1520. In the illustrated embodiment, the energy source 1540 in the form of an electromagnetic field source is arranged on the housing of the automatic injector 1510 to guide the electromagnetic field toward the target location in the patient so as to activate the drug (insulin in the illustrated embodiment) after the drug has been applied to the target location of the patient. In the illustrated embodiment, the external stimulus sensor 1530 is in the form of a temperature sensor, which is placed at a location away from the patient and is configured to measure the ambient temperature. The frequency of the electromagnetic field delivered by the energy source 1540 is configured to be changed by the drug administration device 1510, for example, it is configured to change the amount of energy delivered in response to the measured blood glucose level and the measured ambient temperature. Specifically, the measured value is compared with a lookup table to determine the frequency to be used. The frequency determines the penetration depth of the energy and the degree of activation.

[0289] In an alternative embodiment, the automatic injector 1510 can be used to administer chemotherapy drugs, the patient sensor 1520 can be a sphygmomanometer, and the external stimulus sensor 1530 can be used to measure the ambient temperature. The data collected by the patient sensor 1520 and the external stimulus sensor 1530 can be transmitted to the automatic injector 1510 via a wired or wireless manner. The processor on the automatic injector 1510 board can be used to calculate the time to delay the activation of the chemotherapy drug after the drug has been administered to the patient based on the sensed blood pressure data and the measured ambient temperature. Such calculations can be based on algorithms, or alternatively derived from a lookup table. The delay can be calculated so that the activation provided by the energy source 1540 in the form of a light source 1540 for the tumor site is consistent with the localization time of the drug reaching the target location in the patient. Since the drug is carried to the target location in the blood, the localization time depends on the blood pressure as well as the ambient temperature, which affects various physiological parameters of the patient and the characteristics of the drug itself, such as viscosity.

[0290] 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.

[0291] It may be preferred to sterilize the devices disclosed herein prior to use. This can be accomplished by any 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 means known to those skilled in the art.

[0292] 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 method for confirming administration from a drug administration device, the method comprising: operating a dispensing mechanism of the drug administration device; measuring at least one dispensing mechanism parameter; determining whether operation of the dispensing mechanism is complete based on the at least one dispensing mechanism parameter; determining at least one physiological parameter of the user based on the at least one dispensing mechanism parameter; as well as When the operation of the dispensing mechanism is determined to be complete, the at least one physiological parameter is compared to an acceptable physiological parameter to confirm whether the administration was successful.

2. The method according to claim 1, wherein: Measuring the at least one dispensing mechanism parameter includes measuring a flow rate of the drug, and wherein the at least one physiological parameter is a heart rate of the user.

3. The method according to claim 1 or claim 2, further comprising: Further operations of the drug administration device are modified based on the at least one dispensing mechanism parameter and / or the at least one physiological parameter.

4. The method according to claim 3, further comprising: A user is notified that the further operation of the drug administration device has been modified.

5. The method according to claim 4, wherein: Notifying the user that the further operation of the drug administration device has been modified includes one or more of visual feedback, auditory feedback, and tactile feedback.

6. The method according to any one of claims 3 to 5, wherein: The further operations of modifying the drug administration device include: The further operation of the drug administration device is prevented when successful administration is not confirmed.

7. The method according to any one of claims 3 to 5, wherein: The further operations of modifying the drug administration device include: modifying a dose volume to be administered during further operation of the drug administration device; modifying a frequency with which a drug is administered by the drug administration device; modifying the maximum number of drug doses that may be delivered from the drug administration device; and / or A rate at which a drug is administered by the drug administration device is modified.

8. The method according to any one of claims 1 to 7, wherein: Operating the dispensing mechanism of the drug administration device comprises: The displaceable component is displaced from a first position of the displaceable component.

9. The method according to any one of claims 1 to 8, further comprising: An operational state of the drug administration device is evaluated prior to operating the dispensing mechanism.

10. The method according to claim 9, wherein: Evaluating the operational status of the drug administration device comprises at least one of: analyzing a power source of the drug administration device to verify that the power source has sufficient charge for successful administration; and An angular orientation of the drug administration device relative to a user of the drug administration device is sensed, and a determination is made as to whether the sensed angular orientation is a correct angular orientation.

11. A method according to claim 9 or claim 10 when directly or indirectly dependent on claim 8, wherein Assessing the operational status of the drug administration device comprises: The displaceable component of the drug administration device is moved a predefined distance.

12. The method according to any one of claims 1 to 11, further comprising: The user is informed whether the administration was successful.

13. The method according to claim 12, wherein: Notifying the user whether the administration was successful includes one or more of visual feedback, auditory feedback, and tactile feedback.

14. The method according to any one of claims 1 to 13, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

15. A drug administration device, comprising: a dispensing mechanism configured to dispense the medication; at least one sensor configured to measure at least one dispensing mechanism parameter and to output dispensing mechanism data related to the at least one dispensing mechanism parameter; wherein the apparatus is configured to determine whether an operation of the dispensing mechanism is complete based on the dispensing mechanism data; and a processor configured to determine at least one physiological parameter of a user of the drug administration device based on the dispensing mechanism data; Wherein the processor is configured to compare the at least one physiological parameter with an acceptable physiological parameter to confirm whether the administration was successful when it is determined that the operation of the dispensing mechanism is complete.

16. The device according to claim 15, wherein: The at least one sensor is configured to measure a flow rate of the medication, and wherein the at least one physiological parameter is a heart rate of the user.

17. An apparatus according to claim 15 or claim 16, further comprising a second processor, wherein the second processor is configured to modify further operation of the drug administration device based on the dispensing mechanism data and / or the at least one physiological parameter.

18. The device of claim 17, further comprising an indicator configured to inform a user of the drug administration device that the further operation of the drug administration device has been modified.

19. The device according to claim 18, wherein: The indicator is configured to provide one or more of visual feedback, auditory feedback, and tactile feedback.

20. The device according to any one of claims 17 to 19, wherein The second processor is configured to modify the further operation of the drug administration device to include: The second processor is configured to prevent the further operation of the drug administration device when successful administration is not confirmed.

21. The device according to any one of claims 17 to 19, wherein: The second processor is configured to modify the further operation of the drug administration device to include: the second processor being configured to modify a dose volume to be administered in any further operation of the drug administration device; the second processor being configured to modify a frequency with which the drug is administered by the drug administration device; The second processor is configured to modify a maximum number of drug doses that may be delivered from the drug administration device; and / or The second processor is configured to modify a rate at which the drug is administered by the drug administration device.

22. The device according to any one of claims 15 to 21, wherein The processor is configured to evaluate the operational status of the drug administration device before the drug dispensing mechanism dispenses the drug.

23. The device according to claim 22, wherein: The drug administration device further includes a power source, and wherein the processor is configured to evaluate an operational status of the drug administration device by verifying that the power source has sufficient charge to dispense the drug.

24. The device according to claim 22 or 23, wherein: The dispensing mechanism further comprises a displaceable component, wherein the processor is configured to evaluate the operational state of the drug administration device by moving the displaceable component a predefined distance.

25. The device of any one of claims 15 to 24, further comprising an indicator configured to inform a user of the drug administration device whether the administration was successful.

26. The device according to claim 25, wherein The indicator is configured to provide visual feedback, audible feedback, or tactile feedback.

27. The device according to any one of claims 15 to 25, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

28. A drug administration and monitoring system, comprising: a drug administration device configured to dispense a drug to a patient; a monitoring device configured to record at least one delivery event of a drug from the drug administration device to the patient; and A sensor is configured to sense at least one patient parameter after delivering the drug to the patient.

29. The drug administration and monitoring system of claim 28, wherein: The drug administration device, the monitoring device, and the sensor are all integrated with each other into a single device.

30. The drug administration and monitoring system of claim 28, wherein: Both the drug administration device and the monitoring device are integrated with each other into a single device, and the sensor is a separate device.

31. The drug administration and monitoring system of claim 28, wherein: The drug administration device, the monitoring device, and the sensor are each separate discrete devices.

32. A drug administration and monitoring system according to claim 30 or claim 31, wherein: The patient sensor is configured to perform real-time in-vivo monitoring of the patient.

33. A drug administration and monitoring system according to any one of claims 28 to 32, wherein: The drug administration device, the monitoring device, and the sensor are each configured to be in data communication with each other.

34. A drug administration and monitoring system according to any one of claims 28 to 33, wherein: The monitoring device is configured to receive data related to drug delivery events from the drug administration device and is configured to receive the at least one patient parameter from the sensor.

35. A drug administration and monitoring system according to any one of claims 28 to 34, wherein: The monitoring device is configured to: determining a drug response associated with the at least one drug delivery event on the patient based on the at least one patient parameter sensed; as well as Data related to a patient outcome associated with the determined drug response and the at least one drug delivery event is determined and stored.

36. The drug administration and monitoring system of claim 35, wherein: The patient outcome is one or more of the following: a time period during which the drug response is sensed on the patient after the at least one drug delivery event; the magnitude of a drug response determined at a given time or over a given period of time after administration of the drug to the patient; and A duration of the determined drug response associated with the at least one drug delivery event.

37. A drug administration and monitoring system according to any one of claims 28 to 36, wherein: The monitoring device is further configured to: A notification is generated to the patient or a remote patient monitoring device based on the patient results.

38. A drug administration and monitoring system according to any one of claims 28 to 37, wherein: The at least one patient parameter sensed by the sensor comprises one or more of: temperature; pH level; biomarker; glutathione level; Skin thickness; Subcutaneous tissue thickness; Blood oxygen level; Blood sugar level; Blood pressure; Heart rate; and metabolic rate.

39. A drug administration and monitoring system according to any one of claims 28 to 38, wherein: The monitoring device is further configured to check the at least one drug delivery event for consistency with a prescribed drug administration regimen.

40. The drug administration and monitoring system of claim 39, wherein: If the at least one drug delivery event is inconsistent with the prescribed drug administration regimen, the monitoring device is further configured to generate a notification to the patient or a remote patient monitoring device.

41. The drug administration and monitoring system of claim 40, wherein: The drug dosing regimen specifies one or more of the following drug dosing parameters: drug delivery rate; duration of drug delivery; drug delivery volume; and Frequency of drug delivery.

42. The drug administration and monitoring system of any one of claims 28 to 41, further comprising an environmental sensor configured to detect external stimuli.

43. The drug administration and monitoring system of claim 42, wherein: The environmental sensor is configured to detect one or more of: user input to the drug administration device; geographic location; ambient temperature; pressure; and ultraviolet radiation level.

44. The medication administration and monitoring system of claim 43, further comprising a user interface, wherein the external stimulus is a user input entered via the user interface.

45. A drug administration and monitoring system according to any one of claims 42 to 44, wherein: The monitoring device is further configured to: determining whether the likelihood of a side effect associated with the drug has increased based on the sensed at least one patient parameter and / or the external stimulus; and Upon determining that the likelihood of the side effect has increased, a notification is generated to the patient or a remote patient monitoring device if the at least one drug delivery event is inconsistent with the prescribed drug dosing regimen.

46. ​​The drug administration and monitoring system of claim 45, wherein: The monitoring device includes a device indicator, wherein the drug administration device is further configured to activate the device indicator upon determining that the likelihood of the side effect has increased.

47. A drug administration and monitoring system according to any one of claims 28 to 46, wherein: The monitoring device is configured to provide a plurality of notifications related to the at least one drug delivery event and / or the at least one patient parameter to a patient or a remote monitoring device, and wherein the plurality of notifications are provided sequentially according to a predefined priority order based on the at least one drug delivery event and / or the at least one patient parameter.

48. A drug administration and monitoring system according to any one of the preceding claims, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

49. A method of monitoring drug administration, the method comprising: dispensing a drug from a drug administration device to a patient; recording at least one drug delivery event of the drug administration device into the patient; as well as After delivering the drug to the patient and recording the at least one drug delivery event, at least one patient parameter is sensed.

50. The method of claim 49, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

51. A drug administration system, comprising: A drug administration device, wherein the drug administration device comprises: a medication holder configured to hold a medication; and a dispensing mechanism configured to dispense the drug to a patient; a first sensor configured to sense a patient parameter, wherein the drug administration system is configured to locally activate the drug at a targeted location in the patient after the drug has been dispensed by the dispensing mechanism and administered to the patient, and Wherein the local activation is responsive to the patient parameter and the external stimulus.

52. The drug administration system of claim 51, further comprising a second sensor configured to sense the external stimulus.

53. The drug administration system of claim 52, wherein: The first sensor and / or the second sensor are integrated with the drug administration device.

54. The drug administration system according to any one of claims 51 to 53, wherein The drug administration device is configured to delay the local activation for a period of time after the drug has been administered to the patient such that the local activation coincides with a predicted localization time at the target location, wherein the predicted localization time is based on the sensed patient parameters and the external stimulus.

55. The drug administration system of any one of claims 51 to 54, further comprising an energy source configured to provide energy to locally activate the drug at the target location in the patient.

56. The drug administration system of claim 55, wherein: The amount of energy provided by the energy source is responsive to the patient parameter and the external stimulus.

57. The drug administration system according to claim 55 or 56, wherein: The energy source includes one or more of the following: a light source; an ultrasonic source; an electromagnetic field source; and Radioactive materials.

58. The drug administration system according to any one of claims 51 to 57, wherein The drug administration device is further configured to administer a chemical activating agent to the targeted location in the patient to locally activate the drug.

59. The drug administration system according to any one of claims 51 to 58, wherein The patient parameters sensed by the first sensor include one or more of: temperature; pH level; biomarkers; glutathione level; skin thickness; subcutaneous tissue thickness; blood oxygen level; blood glucose level; blood pressure; heart rate; and Metabolic rate.

60. The drug administration system according to any one of claims 51 to 59, wherein The external stimulus includes one or more of the following: user input; geographic location; ambient temperature; pressure; and ultraviolet radiation levels.

61. The drug administration system of claim 60, further comprising a user interface, wherein the external stimulus is a user input entered via the user interface.

62. The drug administration system according to any one of claims 51 to 61, wherein The drug administration device is configured to administer the drug to the patient according to a drug dosing regimen.

63. The drug administration system of claim 62, wherein: The drug dosing regimen specifies one or more of the following drug dosing parameters: drug delivery rate; duration of drug delivery; drug delivery volume; and Frequency of drug delivery.

64. The drug administration system according to claim 62 or 63, wherein: The drug administration device comprises an autoinjector, and wherein the drug dosing regimen specifies one or more of the following dosing parameters: a discharge nozzle advancement depth of a discharge nozzle of said autoinjector during administration of said medicament to said patient; a discharge nozzle velocity of the discharge nozzle of the autoinjector during administration of the medicament to the patient; and a discharge nozzle acceleration of the discharge nozzle of the autoinjector during administration of the medicament to the patient.

65. The drug administration system according to any one of claims 62 to 64, wherein The drug administration regimen is based on the sensed patient parameters and the external stimulus.

66. A drug administration system according to claim 65 when appended to claim 64, wherein: The sensed patient parameter includes subcutaneous tissue thickness, and wherein the drug administration device is configured to adjust the discharge nozzle advancement depth based on the sensed subcutaneous tissue thickness.

67. The drug administration system according to any one of claims 51 to 66, wherein The drug administration system is further configured to: determining whether the likelihood of a side effect associated with the drug has increased based on the sensed patient parameters and / or the external stimulus; and Upon determining that the likelihood of the side effect has increased, adjusting the drug administration regimen to reduce the dose of the drug to be administered and / or adjusting an activation device of the drug administration system to reduce local activation of the drug, the activation device being configured to locally activate the drug.

68. The drug administration system of claim 67, wherein: The drug administration device further includes a device indicator, and wherein the drug administration device is further configured to activate the device indicator upon determining that the likelihood of the side effect has increased.

69. The drug administration system of any one of claims 51 to 68, further comprising a drug capture and release mechanism configured to be implanted in the patient's body.

70. The drug administration system according to any one of claims 51 to 69, wherein The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

71. A method of administering a drug to a patient using the drug administration system according to any preceding claim, the method comprising: dispensing the medication from the medication holder to administer the medication to the patient; receiving data related to the patient parameter from the first sensor, and receiving data related to the external stimulus; comparing the received data to a lookup table; as well as The drug is locally activated at the targeted location in the patient, wherein the local activation is based on the comparison to the lookup table.

72. The method of claim 71, wherein: The local activation of the drug is delayed after the dispensing of the drug for a period of time corresponding to a localization time determined from the lookup table.

73. The method of claim 71 or claim 72, 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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