Interconnection of drug administration systems

Abstract

To provide interconnection of drug administration systems.SOLUTION: A drug administration device and a remotely located server can establish a unique key for wireless communication between the device and the server. The drug administration device can be configured to sense information relating to at least one of the device and a drug and can be configured to anonymize data indicative of the sensed information using the key stored in memory of the device. The drug administration device can also be configured to use the key in decrypting data received from the server.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] SUMMARY OF THE INVENTION The embodiments described herein relate to devices for administering and / or delivering medication. The present disclosure further relates to systems in which the devices may be used, and methods of administration, as well as systems. Further related methods are also described. [Background technology]

[0002] Pharmaceutical products (including large molecule and small molecule drugs, hereinafter referred to as "drugs") are used for specific medical indications. For treatment, drugs may be administered to patients in a variety of different ways. Regardless of the mode of administration, Care must be taken when administering drugs to avoid adverse effects. Care must be taken to ensure that patients are not given more than is necessary. The amount of dose received and how the dose is sometimes delivered relative to previous doses or doses of other drugs. Furthermore, the time frame in which the drug is used must be considered. Care must be taken to avoid inadvertently administering degraded drugs to patients. All of these considerations are conveyed in the guidance associated with a particular drug or drug combination. However, this guidance may be necessary due to mistakes, for example, human error. This can lead to adverse patient outcomes or inappropriate drug administration. This may result in, for example, insufficient or excessive volumes for a particular medical indication. Medication is administered.

[0003] Regarding how the drug is administered to the patient, there are various dosage forms that can be used. For example, these dosage forms may include parenteral, inhaled, oral, ophthalmic, nasal, and topical administration of one or more drugs. , and suppository forms.

[0004] The dosage form may be administered directly to a patient via a drug administration device. (e.g., autoinjectors, jet injectors, and infusion pumps), nasal sprays - Many different types of devices and inhalers are commonly available for the delivery of various dosage forms. There are many drug delivery devices.

[0005] It is desirable to monitor compliance with the guidance associated with drugs administered to patients in various dosage forms. This provides assurance that the correct procedures are being followed and This avoids the need for precise and potentially dangerous approaches. It may also be possible to optimize the administration of substances.

[0006] Additionally, the patient's medical history, current health status, and / or therapeutic treatment, such as the use of drug delivery devices, may be used. Data relating to the device is typically kept private and shared only between the patient and appropriate medical professionals. Data encryption allows users and computers to communicate in a secure and anonymous manner. Data encryption allows data to be shared between private and public computer systems. Risk that data, such as medical data, may be exposed to unintended users for its nature or content. This can be done using a key-based encryption system to ensure that the data can be shared securely without Key-based cryptography systems use public / private key architectures to secure data. Anyone can encrypt data using the public key to enable data transmission, but The encrypted data can only be decrypted with the recipient's private key. Patients are not familiar with the device, and medical information is provided in a timely manner to prevent harm to patients. Due to many factors, including the need to communicate, the patient-managed devices must be properly configured. It can be difficult to communicate effectively with

[0007] Patients typically administer medications according to instructions, but may not receive any notification or guidance regarding the administration of the medication. Often there is no feedback at all, so patients may forget to take their medication or or administering medication incorrectly based on the patient's interpretation of the instructions; and and / or administering drugs without any awareness of their own physiological state. Failure to administer the drug or follow the instructions of a medical professional can result in serious, even fatal, consequences for the patient. This can have life-threatening consequences.

[0008] Patients receiving a drug may experience negative side effects or adverse clinical outcomes associated with the administration of the drug. alternatives that may alleviate the side effects or adverse conditions that patients usually experience Consult the appropriate physician who prescribed the drug to review the drug, drug delivery device, and / or instructions. The patient must initiate communication with the appropriate healthcare professional. This may delay the return of the patient and thus reduce the adverse effects that the patient may be experiencing. may worsen, may inadvertently not report relevant information, and / or may be New drug dosage or delivery schedules may alleviate the problem of drug administration in patients. This may contribute to further delays in adjusting or reconfiguring the device. be.

[0009] Furthermore, a large number of patients with a given condition provides a valuable tool for accumulating data on physiological responses. It represents a potentially useful resource. However, collecting all of this data is Because of the difficulty, potential trends and correlations may be missed. Summary of the Invention [Means for solving the problem]

[0010] In one aspect, a drug delivery device is provided that is configured to hold a drug therein, In embodiments, the drug delivery device comprises a drug delivery device and / or a drug delivery device. The medication delivery device also includes a sensor configured to sense information related to the medication. The stored data includes a memory configured to store the data therein. The key is stored in the medication administration device and in the remotely located server. The medication administration device also transmits data indicative of the sensed information to a remotely located communication device. The communication interface is configured to wirelessly transmit the drug to the communication interface. The substance dispensing device also uses the key to authenticate the sensed information before transmitting data indicative of the sensed information. The processor is configured to anonymize data indicative of the information.

[0011] The drug delivery device can have many variations. For example, the drug delivery device can be a syringe. The device may include one of a syringe, an inhaler, a nasal spray device, and an infusion pump. In an example, the processor may include a communication interface that is remotely located from the communication interface. In yet another example, the key may be configured to be used to anonymize all data sent to the In this case, the processor repeatedly uses the key to generate multiple data sets representing the information sensed by the sensors. The method may be configured to anonymize the data.

[0012] In yet another example, the communication interface may be a remotely located communication interface. The processor may be configured to receive data wirelessly through a remotely located communication interface. The interface may be configured to use the key when decrypting data received from the interface. In some embodiments, the processor may receive the data from a remotely located communication interface. The key may be configured to be used in decrypting all received data.

[0013] In another example, the communication interface may transmit data from a remotely located communication interface. The drug delivery device may be configured to wirelessly receive data indicating when the drug is being delivered. The drug delivery device may include information regarding proper disposal of the drug delivery device after use. In an embodiment, the processor may provide information regarding appropriate disposal information to a user of the medication administration device. It may be configured to provide notifications.

[0014] In yet another example, the drug delivery device may comprise a drug delivery device. A label containing information regarding proper disposal of the product delivery device may be included.

[0015] In yet another example, the processor may determine whether or not to administer the medication based at least in part on the sensed information. In yet another example, the drug may be administered by an injection mechanism. Fliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin Alpha, risperidone, esketamine, ketamine, and paliperidone palmitate It may include at least one of these.

[0016] In another embodiment, the drug administration device comprises an alginate containing at least one variable parameter. a memory configured to store therein a algorithm; and a remotely located communication interface. a communication interface configured to wirelessly receive data from a drug administration device; and configured to use an algorithm in controlling delivery of a drug from the device to the patient. and a processor, the processor also receiving from a remotely located communication interface. and changing at least one variable parameter of an algorithm stored in memory based on the received data. The system is configured to change the meter.

[0017] The drug delivery device can have many variations. For example, the drug delivery device can be a syringe. The device may include one of a syringe, an inhaler, a nasal spray device, and an infusion pump. In an example, the medication delivery device includes a medication holder configured to hold a medication therein. and controlling delivery of the drug from the drug administration device to the patient includes dispensing the drug from the drug holder. In yet another example, the drug delivery device may include controlling the release of and an automatic injector configured to automatically advance a needle, the automatic injector including at least one variable parameter. The meter may include a rate at which the needle is automatically advanced into the patient, and may include a remotely located communication interface. The data received from the interface determines different speeds at which the needle is automatically advanced into the patient. and varying the at least one variable parameter may include: In another example, the updated speed may include replacing the speed of at least one possible The variable parameters are the rate of delivery of the drug from the drug administration device to the patient, the rate of drug delivery from the drug administration device to the patient, and determining at least one of the timing between doses of the drug delivered to the patient and the temperature of the drug. In yet another example, data received from a remotely located communication interface may include requesting changes to algorithm inputs at a remotely located computer system; The information may be based on the doctor.

[0018] In another example, the processor also includes a communication interface located remotely from the communication interface. The algorithm may be configured to cause the interface to send a request, the request requesting an update of the algorithm. The data received from the remotely located communication interface may be responsive to the request. In at least some embodiments, the communication interface does not require algorithm updates. receiving a response to the request from a remotely located communication interface indicating that The processor may adjust at least one variable parameter of an algorithm stored in the memory. Do not change the data.

[0019] In yet another example, the processor may include an access control module for controlling delivery of a drug from a drug administration device. and then using the algorithm to control the further delivery of the drug from the drug administration device to the patient. The algorithm may be configured to use:

[0020] In another example, the drug delivery device may include a drug delivery device and / or drug delivery device. In at least some embodiments, the sensor may include a sensor configured to sense information related to the The communication interface transmits data representing the sensed information to a remotely located communication interface. and configured to transmit to the interface and receive from a remotely located communication interface. The collected data may be based at least in part on data indicative of sensed information. In an embodiment, the processor also transmits data indicative of the sensed information to a remotely located communication interface. It uses the sensed information to generate an address stored in memory without first transmitting it to the interface. The algorithm may be configured to change at least one variable parameter of the algorithm.

[0021] In yet another example, data received from a remotely located communication interface is without responding to requests from the communication interface for rhythm updates. The message can be automatically sent to the interface.

[0022] In yet another example, the communication interface may also be a remotely located communication interface. The processor may also be configured to wirelessly receive algorithm data from The algorithm stored in the memory is executed based on the data received from the communication interface located In at least some embodiments, the algorithm Modifying the algorithm adds at least one additional variable parameter to the algorithm. This may include:

[0023] In another example, the drug is infliximab, golimumab, ustekinumab, daratumumab , guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paclitaxel Paliperidone lumitate.

[0024] In another embodiment, the drug administration device comprises a memory configured to store an algorithm. and configured to wirelessly receive data from a remotely located communication interface. a medication holder configured to hold a medication therein; Controlling delivery of a dose of drug from a drug holder to a patient by executing an algorithm and a processor configured to: and adjusting the algorithm stored in the memory based on the data received from the interface. By executing an algorithm, the delivery of subsequent doses of the medication holder to the patient is controlled. It is configured to do so.

[0025] The drug delivery device can have many variations. For example, the drug delivery device can be a syringe. The device may include one of a syringe, an inhaler, a nasal spray device, and an infusion pump. In an example, the algorithm may include at least one variable parameter, and the processor may Tuning an algorithm involves changing at least one variable parameter of the algorithm. In yet another example, adjusting the algorithm may include adjusting at least one possible In another example, the drug may be an influx of Ximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa fa, risperidone, esketamine, ketamine, and paliperidone palmitate It may include at least one.

[0026] In one embodiment, the drug delivery device includes a drug reservoir configured to hold the drug therein. The device includes a controller, a display, and a processor. The processor controls the dosage of the drug to be delivered to the drug holder. Reminders of the current required to be manually administered to the patient from the device, scheduled in advance, Summary of doses of medication from the medication holder to the patient, and previously delivered doses from the medication holder to the patient and the timing of at least one medical event experienced by the patient. and causing a display to display at least one of the indications of the correlation between the It is being done.

[0027] The drug delivery device can have many variations. For example, the drug delivery device can be a syringe. The device may include one of a syringe, an inhaler, a nasal spray device, and an infusion pump. In an example, the processor of the device may cause at least the reminder to be displayed on the display. In yet another example, the processor of the device may be configured to display at least the summary. The summary may be configured to display on the screen a summary of the failure of a previously scheduled dose. All dose readings received, all doses successfully delivered within the previously scheduled doses an indication of the timing of previously delivered doses compared to the predetermined delivery schedule of doses; indication of the intended therapeutic effect of the drug on the patient, and prediction of the effect of the drug on the patient. In yet another example, the processor may include at least one of: an indication of a remaining lifespan; The device may be configured to cause a display to show at least an indication of the correlation.

[0028] In another example, the device may wirelessly receive data from a remotely located communication interface. a communication interface configured to receive the signal, and the processor may be located remotely. Displaying information indicating data received from the communication interface on the display In at least some embodiments, a remotely located communication interface In at least some embodiments, the data received from the device may include historical patient information. The data received from the remotely located communication interface is used to determine the correctness of the medication administration device. The processor may also display information indicating the help information. The display may be configured to display the

[0029] In yet another example, the device may store information regarding at least one of a drug delivery device and a drug. The sensor may include a sensor configured to sense information, and the processor may generate information indicative of the sensed information. In at least some embodiments, the display may be configured to display: The device wirelessly transmits data indicative of the sensed information to a remotely located communication interface. and subsequently communicating with a remotely located communication interface based at least in part on the transmitted data. a communication interface configured to wirelessly receive data from the The processor may receive information indicative of data received from the remotely located communication interface. In another example, the drug may be infliximab or a combination thereof. Mab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa , risperidone, esketamine, ketamine, and paliperidone palmitate. It may contain at least one

[0030] In another aspect, a drug delivery system is provided, and in one embodiment, the drug delivery system a communications interface configured to wirelessly receive data and wirelessly transmit data; a server including a key source, a memory configured to store the key therein, and a processor. The system also includes a medication administration device that includes a memory configured to store the key therein. The key is unique to the medication administration device and the server. , wirelessly transmits data to the communication interface of the server, and The drug administration device includes a communication interface configured to wirelessly receive data from the drug administration device. The device also uses the key to authenticate all data sent to the server's communication interface. and a processor configured to anonymize the information before transmitting the information. The key is used to encrypt all data sent to the communication interface of the medication administration device. It is configured to anonymize data before transmission.

[0031] This system can be varied in many ways, for example, the communication interface of the server The data sent to the interface includes data in response to data requests received from the server. In yet another example, the drug delivery device may be a syringe, injector, inhaler, or nasal spray. The device may include one of: a device; and an infusion pump.

[0032] In another example, the drug administration device also includes a drug delivery device and / or a drug delivery device. a sensor configured to sense information relating to the communication interface of the server; The data transmitted to the sensor may include data indicative of the sensed information. In an embodiment, the processor of the medication administration device determines whether or not the medication is being administered based at least in part on the sensed information. The drug administration device may be configured to control delivery of a drug to a patient.

[0033] In another example, the processor of the server may use the key to communicate with the communication interface of the medication administration device. The drug administration device may be configured to decode all data received from the interface. The processor uses the key to decrypt all data received from the server's communication interface. In yet another example, the processor of the server may be configured to The data received from the communication interface is transmitted to the patient's electronic health record associated with the medication administration device. Electronic Health Record (EHR) and Drug Risk Assessment and Mitigation Strategies At a minimum, patient monitoring forms for REMS (Revised Evaluation and Mitigation Strategies) In another example, the drug may be configured to be automatically uploaded to either Riximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin Of lufa, risperidone, esketamine, ketamine, and paliperidone palmitate It may include at least one of:

[0034] In another embodiment, the drug administration system holds a drug therein for delivery to a patient. a display and a display showing medical information about a patient; a communication interface configured to wirelessly receive data; and a processor. The processor delivers the medication to the patient from a medication delivery device configured to hold the medication therein. Reminders of the current required to manually administer a dose of a drug, scheduled in advance, Summary of the dose of drug from the drug holder to the patient and previously delivered from the drug administration device The timing of the patient's drug dose and the timing of at least one medical event experienced by the patient The method is configured to display at least one of an indication of the correlation between the measurement and the log.

[0035] The drug delivery system can have any number of variations. For example, the drug delivery device can be The device may include one of a syringe, an inhaler, a nasal spray device, and an infusion pump. In another example, the system wirelessly receives data from a remotely located communication interface. The processor may include a communication interface configured to communicate with a remotely located communication The display is configured to show information indicating the data received from the communication interface. It can be done.

[0036] In yet another example, the system may include a system for receiving information about at least one of a drug delivery device and a drug. The sensor may include a sensor configured to sense information, and the processor may generate information indicative of the sensed information. In at least some embodiments, the display may be configured to display: The system wirelessly transmits data indicative of the sensed information to a remotely located communication interface. and subsequently communicating with a remotely located communication interface based at least in part on the transmitted data. a communication interface configured to wirelessly receive data from the The processor may receive information indicative of data received from the remotely located communication interface. In at least some embodiments, the information may be displayed on a display. , the medication administration device of the system may include a communications interface.

[0037] In yet another example, the medication administration device may include a display and a processor. In yet another example, the server may include a display and a processor. The mobile device may include a display and a processor. The drugs include infliximab, golimumab, ustekinumab, daratumumab, guselkumab, Epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate The composition may include at least one of the following:

[0038] In another aspect, a drug administration method is provided, and in one embodiment, the drug administration method comprises administering a drug For wireless communication between an administration device and a server located remotely from the drug administration device The method includes establishing a unique key, which is stored in the memory of the medication administration device and in the memory of the server. The method also includes detecting the presence or absence of a drug in the drug administration device and the drug administration device at a sensor of the drug administration device. The method also includes sensing information about at least one of the following: The processor uses a key stored in the memory of the medication administration device to indicate the sensed information. The method also includes anonymizing the data in the processor of the medication administration device. The key stored in the memory of the medication administration device is used to decrypt the data received from the This includes:

[0039] The method may have many variations. For example, the method may be implemented by a processor of a drug administration device. and controlling delivery of the drug from the drug administration device based at least in part on the sensed information. In another example, the drug administration device may be a syringe, injector, inhaler, or the like. In another example, the drug may include one of: a syringe, a nasal spray device, and an infusion pump. Infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetinib Chin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate may include at least one of:

[0040] In yet another example, the data may be stored in a drug delivery device after the drug has been delivered from the drug delivery device. In at least some embodiments, the method may include information regarding the proper disposal of the chair. The processor may be used to communicate information regarding appropriate disposal information to a user of the medication delivery device. This may include having the person provide knowledge.

[0041] In another embodiment, the drug administration method includes using a processor of the drug administration device to and executing an algorithm that controls delivery of a dose of drug from the administration device to the patient. The algorithm is stored in a memory of the drug administration device. In the communication interface of the device data, a communication device remote from the medication administration device is and wirelessly receiving data from the communication interface. The method also includes causing the processor to and storing the data received from the remotely located communication interface in a memory. The method includes modifying at least one variable parameter of the algorithm stored in the memory. The method also includes using the processor to control delivery of another dose of the drug from the drug administration device to the patient. This includes implementing a modified algorithm that controls the

[0042] The method can have many variations. For example, the drug can be infliximab, golimumab, Ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, It may contain at least one of sketamine, ketamine, and paliperidone palmitate. do.

[0043] In another aspect, a sensor configured to sense information regarding a physiological parameter of a patient. In one embodiment, the sensor is configured to store data internally. a memory, the stored data including a key established with a remotely located server; This key is unique to the sensor and the remotely located server, and is stored in memory and represents the sensed information. a communication interface configured to wirelessly transmit the data to a remotely located communication interface. The interface and the sensed information are then encrypted using a key before transmitting data representing the sensed information. and a processor configured to anonymize data indicative of the information.

[0044] The sensor can have many variations. For example, the processor can be connected to a communication interface. The key is used to anonymize all data sent from the In another example, the processor may be configured to repeatedly use the key to The system may be configured to anonymize the plurality of data sets indicative of the sensed information. In some embodiments, the sensor provides information about the patient's physiological parameters via at least It may be configured to be acquired once every 24 hours.

[0045] In yet another example, the communication interface of the sensor may be a remotely located communication interface. The processor may be configured to wirelessly receive data from a remotely located communication source. The key may be configured to be used in decrypting data received from the interface. In at least some embodiments, the processor is connected to a remotely located communication interface. The key may be configured to be used in decrypting all data received from the source.

[0046] In yet another example, the physiological parameters measured by the sensor may include blood glucose level, blood oxygen concentration, and the like. The information may be at least one of temperature, weight, blood pressure, heart rate, and sleep duration. The drugs are infliximab, golimumab, ustekinumab, daratumumab, and glucuronide. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate The pharmaceutical composition may include at least one of the following: paliperidone;

[0047] In another example, a sensor system may include a sensor and configured to receive data wirelessly. a communication interface configured to store the key therein; a memory configured to store the key therein; The server may include a processor.

[0048] The sensor can have many variations. For example, the server's processor uses the key to: All data sent to the sensor's communication interface is anonymized before transmission. In at least some embodiments, the server's processor may use the key to and may be configured to decode all data received from the communication interface of the sensor. The sensor's processor uses the key to authenticate all data received from the server's communication interface. The data transmitted to the communication interface of the server may be decrypted. The data may include data in response to a data request received from a server.

[0049] In another example, the sensor system may further include a plurality of sensors, In at least some embodiments, the multiple sensors may be one of: The device may include sensors configured to measure different physiological parameters of the subject. The device further includes sensors configured to measure corresponding physiological parameters in a plurality of patients. The server may include a server that communicates data indicative of the sensed information with the patient along with the physiological parameter readings. The server may be configured to store the patient-related medication information associated with each patient in a The server may be configured to receive and store data indicative of information about the nutritional intake of each patient. In yet another example, the drug may be an insulin-like substance. Fliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin Alpha, risperidone, esketamine, ketamine, and paliperidone palmitate It may include at least one of these.

[0050] In another aspect, a method for sensing information regarding a physiological parameter of a patient is provided, comprising: In an embodiment, the method includes wireless communication between the sensor and a server located remotely from the sensor. establishing a unique key for the sensor, the key being stored in the sensor's memory and in the server's memory; and establishing a unique key that is stored in the sensor and that stores information about the patient's physiological parameters. and a processor in the sensor detects the information and executes the key stored in the sensor's memory. The sensor processor anonymizes the data representing the sensed information received from the server. and using a key stored in the memory of the sensor in decrypting the received data. .

[0051] The method can have many variations. For example, the drug can be infliximab, golimumab, Ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, It may contain at least one of sketamine, ketamine, and paliperidone palmitate. do. [Brief explanation of the drawings]

[0052] The present invention will now be described with reference to the accompanying figures in which: [Figure 1] 1 is a schematic diagram of a first type of drug administration device, namely an autoinjector. [Figure 2] 1 is a schematic diagram of a second type of drug administration device, namely an infusion pump. [Figure 3] FIG. 1 is a schematic diagram of a third type of drug administration device, namely an inhaler. [Figure 4] FIG. 1 is a schematic diagram of a fourth type of drug delivery device, namely a nasal spray device. [Figure 5A] 1 is a schematic diagram of a typical drug delivery device. [Figure 5B] FIG. 1 is a schematic diagram of a universal drug administration device. [Figure 6] FIG. 1 is a schematic diagram of the housing of the dosage form. [Figure 7] 1 is a schematic diagram of one embodiment of a communication network system in which the medication administration device and housing may operate. [Figure 8] FIG. 1 is a schematic diagram of one embodiment of a computer system in which the medication administration device and housing may operate. [Figure 9] 1 is a schematic diagram of an embodiment of a medication administration system including a cloud computing system and a medication administration device. [Figure 10] 1 is a flow chart illustrating one embodiment of a method for administering medication using a key-based security system. [Figure 11] 1 is a schematic diagram of an embodiment of a drug administration system including a drug administration device and a remote computer system. [Figure 12] 1 is a schematic diagram of another embodiment of a drug administration system including a drug administration device and a remote computer system. [Figure 13] 1 is a flow chart illustrating one embodiment of a method for administering a drug using a control algorithm. [Figure 14] FIG. 2 is a schematic diagram of one embodiment of a user interface. [Figure 15] FIG. 1 is a schematic diagram of one embodiment of a system using sensors. [Figure 16] 10 is a flow chart illustrating an embodiment of a method for updating a patient monitoring form and identifying one or more abnormal sensed parameters. DETAILED DESCRIPTION OF THE INVENTION

[0053] Principles of structure, function, manufacture, and use of the devices, systems, and methods disclosed herein To provide a general understanding of the present invention, certain exemplary embodiments will now be described. One or more examples of these embodiments are illustrated in the accompanying drawings. The devices, systems, and The methods are non-limiting exemplary embodiments, and the scope of the invention is defined only by the claims. It will be understood that the terms "interface" and "interfaces" are defined as follows: The features of any of the embodiments may be combined with those of other embodiments. are intended to be included within the scope of the present invention.

[0054] Furthermore, in this disclosure, like-named components of the embodiments generally have similar characteristics. Therefore, in certain embodiments, each feature of each similarly named component may be In addition, the disclosed system, To the extent that linear or circular dimensions are used in describing devices and methods, such dimensions The present invention relates to a variety of shapes that can be used in conjunction with such systems, devices, and methods. The present invention is not intended to limit the scope of the present invention. Those skilled in the art will appreciate that such a direct It will be appreciated that the equivalent linear and circular dimensions can be readily determined. Those skilled in the art will recognize that even if the dimensions are not exact values, various factors such as manufacturing tolerances and the sensitivity of measuring equipment will be taken into account. It will be understood that the value is likely to be close to that value due to the reasons. The size and shape of the devices and their components are The size and shape of the components may depend at least on the size and shape of the components.

[0055] Examples of various types of drug administration devices include an autoinjector 100, an injection port, The pump 200, inhaler 300, and nasal spray device 400 are shown in the figures referenced above. This is explained below.

[0056] autoinjector FIG. 1 illustrates a first type of drug delivery device that can be used in the embodiments described herein. 1 is a schematic, illustrative diagram of an injection device, in this example, an autoinjector 100. The autoinjector 100 includes a drug holder 110 that holds the drug to be dispensed, and a drug dispenser 112 that dispenses the drug. The device is configured to dispense the medication from the medication holder 110 so that the medication can be administered to the patient. and a dispensing mechanism 120 for dispensing the drug. The drug holder 110 is typically a container for containing the drug. For example, the medication holder 110 may be provided in the form of a syringe or a vial. or any other suitable container capable of holding a drug. 100 includes a discharge nozzle 122, e.g., a syringe, provided at the distal end of the medication holder 110. The dispensing mechanism 120 includes a drive element 124, which itself also includes a piston. The dispensing mechanism 120 may include a piston and / or a piston rod, and a drive mechanism 126. Located proximal to the end of object holder 110 and toward the proximal end of autoinjector 100 do.

[0057] The autoinjector 100 includes a housing 130, and the housing 130 includes a main body. The housing not only houses the medication holder 110, the drive element 124, and the drive mechanism 126, but also Prior to injection, the drug is typically contained entirely within the housing, but during the injection sequence, the drug is The housing also houses a discharge nozzle 122 that extends from the housing 130 for delivery. The dispensing mechanism 120 includes a nozzle 122 for dispensing the drug. , the drive element 124 is advanced through the medication holder 110, thereby causing the auto-injector The vector is adapted to allow the drug held in the drug holder 110 to be administered to the patient. In some cases, the user may drive the drive element 124 through the medication holder 110. Alternatively, the drive mechanism 126 may be manually advanced. The stored energy source 127 may include a stored energy source 127 for propelling the 124. or pressurized gas or electronically powered motor and and / or may include a resilient biasing member such as a gearbox.

[0058] Autoinjector 100 includes a dispensing mechanism protection mechanism 140. The dispense mechanism protector 140 typically has two functions. First, the dispense mechanism protector 140 protects the dispenser before and after injection. Second, the automatic injection may function to prevent access to the discharge nozzle 122 after injection. The injector 100 is armed, e.g., the dispense mechanism protection mechanism 140 is unlocked. When moved to the unloaded position, the dispensing mechanism 120 can function such that it can be activated.

[0059] The protection mechanism 140 prevents the medication holder 110 from being in a retracted position proximally within the housing 130. When the nozzle 122 is inserted, it covers at least a part of the nozzle 122. Alternatively or additionally, the protection mechanism 140 may be The body is configured to retract proximally to expose the discharge nozzle 122, such that: The discharge nozzle 122 can be brought into contact with a patient. The protection mechanism 140 includes a shield member 141. and a return spring 142. The return spring 142 is configured to support the shield member 141 in the housing. 130, so that when no force is applied to the distal end of the protection mechanism 140, When the user overcomes the bias of the return spring 142, the discharge nozzle 122 is covered. As shown, when a force is applied to the shield member 141 against the action of the return spring 142, the shield The hood member 141 retracts within the housing 130, thereby exposing the discharge nozzle 122. The protection mechanism 140 may alternatively or additionally protect the discharge nozzle from beyond the housing 130. An extension mechanism (not shown) may be provided to extend the nozzle 122 within the housing 130. The protection mechanism 140 may further include a retraction mechanism (not shown) for retracting the roller 122. Alternatively or additionally, a housing cap may be attached to the autoinjector 100. The housing cap may include a cap and / or a discharge nozzle boot. The discharge nozzle boot is also removed from the discharge nozzle 122.

[0060] The autoinjector 100 also includes a trigger 150. The trigger 150 on the exterior of the housing 130 so as to be accessible by a user of the projector 100. The trigger 150 is located at the Upon actuation, trigger 150 acts to release drive mechanism 126, resulting in drive element 124, the drug is then expelled from the drug holder 110 through the discharge nozzle 122. will be done.

[0061] Trigger 150 may also be used, for example, to press the distal end of shield member 141 against the patient's skin. By doing so, the shield member 141 is sufficiently proximally unlocked within the housing 130. The seal is secured in a manner that prevents the trigger 150 from being actuated until it is retracted to the release position. When this is done, trigger 150 is unlocked and the trigger The trigger 150 can then be depressed to initiate the injection and / or drug delivery sequence. Alternatively, the shield member 141 may be used alone. Retracting the drive mechanism 126 proximally into the housing 130 activates the drive mechanism 126, causing the injection and / or may act to initiate a drug delivery sequence. Injector 100 may be configured to prevent, for example, accidental release of dispensing mechanism 120 and / or trigger 15 Device activation prevention mechanism that prevents accidental activation of the device, thereby preventing drug dispensing. It has.

[0062] Although the above description relates to one example of an autoinjector, this example is provided purely for illustrative purposes. As presented, the present invention is not limited to only such autoinjectors. Those skilled in the art will appreciate that various modifications to the autoinjector described will be within the scope of this disclosure. Understand that it can be done.

[0063] The autoinjector of the present disclosure is capable of administering epinephrine, Rebif, Enbrel, Aran Various drugs such as esp, atropine, pralidoxime chloride, and diazepam It can be used to administer either

[0064] infusion pump In other situations, patients require precise continuous delivery of medication or regular doses at set periodic intervals. Infusion pumps can be used to administer medications to patients in a timely or frequent manner, either by a healthcare professional or by the patient. Facilitates administration of drugs at precise rates that keep drug concentrations within therapeutic limits without requiring careful attention Such controlled drug infusion can be provided by

[0065] FIG. 2 illustrates a second type of drug delivery device that can be used in the embodiments described herein. 2 is a schematic, exemplary diagram of an infusion pump 200. Infusion pump 200 delivers a drug holder 210 in the form of a reservoir for containing a drug and by which the drug may be delivered to the patient; and a pump 216 adapted to dispense the drug contained in the reservoir, such that and a dispensing mechanism 220. These components of the infusion pump are housed within a housing 230. The dispensing mechanism 220 further comprises an infusion line 212. The drug is delivered to the pump 216. In operation, fluid is delivered from the reservoir via an infusion line 212, which may take the form of a cannula. The pump 216 may be an elastomeric pump, a peristaltic pump, an osmotic pump, or a syringe pump. Typically, drugs are delivered intravenously, but Subcutaneous, intraarterial, and epidural injections may also be used.

[0066] The infusion pump of the present disclosure is capable of administering insulin, atropine sulfate, avibactam sodium, Bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiraceta oxaliplatin, paclitaxel, pantoprazole sodium, treprostin Any of a variety of drugs, including benzodiazepine, vasopressin, voriconazole, and zoledronic acid It can be used to administer either

[0067] The infusion pump 200 includes control circuitry, such as a memory 297 and a user interface 298. 80, further comprising a processor 296, which together control the trigger mechanism and / or The user interface 280 provides a dose selector for the pump 200. The control circuit may be implemented by a display screen located on the housing 230 of the pump 200. The path and user interface 280 may be located within the housing 230 or external to it. may communicate with the pump 216 via a wired or wireless interface to control its operation. do.

[0068] The operation of the pump 216 is controlled by a process that communicates with the pump 216 to control the operation of the pump. The user interface 280 is controlled by a processor 296. It can be programmed by a user (e.g., a patient or a medical professional) via the This allows the infusion pump 200 to deliver medication to the patient in a controlled manner. The user can input parameters such as injection duration and delivery rate. is typically pre-programmed by the user for a constant infusion rate or for periodic delivery. It can be set as a set interval within programmed limits. The programmed parameters are stored in a memory 297 in communication with the processor 296; The user interface 280 may be a touch screen or may take the form of a keypad.

[0069] Power supply 295 is an energy source that provides power to pump 216 and is integral with pump 216. and / or may take the form of a mechanism for connecting the pump 216 to an external power source.

[0070] Infusion pump 200 may take a variety of different physical forms depending on its intended use. Infusion pump 200 may be a fixed, non-portable device, for example, for use at a patient's bedside. or ambulatory infusion devices designed to be portable or wearable. The integrated power supply 295 is particularly useful for ambulatory infusion pumps.

[0071] Although the foregoing description relates to one example of an infusion pump, this example is provided purely for illustrative purposes. The present disclosure is not limited to such infusion pumps. Those skilled in the art will recognize that the infusion pumps described It will be understood that various modifications to the pump may be made within the scope of this disclosure. The processor is pre-programmed so that the infusion pump does not need to include a user interface. It may be rammed.

[0072] inhaler Figure 3 is a schematic diagram of a third type of drug delivery device, namely an inhaler 300. The container 300 includes a medication holder 310 in the form of a canister. Typically, the inhaler contains the drug in a solution or suspension using a suitable carrier liquid. 00 includes a pressurized gas for pressurizing the medication holder 310, a valve 325, and a nozzle 321. The medication holder 310 further includes a dispensing mechanism 320 including a valve 325 defining an outlet for the medication holder 310. The valve 325 is formed by a narrow opening 324 formed in the medication holder 310 and an opening and a movable element 326 that controls the movement of the moving element 324. When the movable element 326 is in the rest position, The valve 325 is in a closed state, in which the opening 324 is closed and the medication holder 310 is sealed, or When the movable element 326 is actuated from the rest position to the actuated position, the valve 32 5 is actuated to an open state in which the opening 324 is open. Actuation of the element 326 includes moving the movable element 326 into the medication holder 310. The moving element 326 is resiliently biased to a rest position. The drug in solution or suspension with a suitable liquid is then injected through opening 324. The high velocity of the liquid passing through the narrow opening 324 pushes the liquid out of the medication holder 310. The body is atomized, i.e., converted from the bulk liquid into a mist of fine droplets of liquid and / or gas. The patient may inhale a mist of fine droplets and / or a cloud of gas into the respiratory tract. Therefore, the inhaler 300 injects the drug held in the drug holder 310 into the patient's respiratory system. It can be delivered into the tract.

[0073] The medication holder 310 is removably held within the housing 330 of the inhaler 300. A passage 333 formed in the housing 330 is connected to a first opening 333 in the housing 330. 31 and a second opening 332 in the housing 330. The medication holder 310 is The medication holder 310 is received within the passage 333 of the housing 330. 1 and 3. The second opening in the housing 330 is slidably insertable into the passage 333 through the second opening in the housing 330. 332 is a mouthpiece 322 configured to be placed in the patient's mouth or nose a nosepiece configured to be placed within the bore or over the patient's mouth and nose; The mask is configured as follows: The medication holder 310, the first opening 331, and the passage 333 is a flow passage for allowing air to pass through the medication holder 31 between the first opening 331 and the second opening 332. The inhaler 300 is sized to allow the blood to flow through the passageway 333 at about 0. a dispensing mechanism protector 140 in the form of a cap (not shown) that can be fitted onto the dispenser 322; It may be prepared.

[0074] The inhaler 300 includes a trigger 350 that, when activated, activates a valve. trigger 350 including a valve actuation feature 355 configured to actuate valve 325. The valve actuation feature 355 protrudes from the housing 330 into the passage 333. The medication holder 310 is slidable within the passageway 333 from a first position to a second position. In the first position, the end of the movable element 326 in the rest position is movable in the direction of the valve actuation. In the second position, the medication holder 310 abuts the valve actuation feature 355. moves the movable element 326 into the medication holder 310 and actuates the valve 325 to an open state. The user's hand can be displaced toward the valve actuation feature 355 to actuate the drug dispenser. The roller 310 is moved from the first position to the second position against the resiliently biased movable element 326. The valve actuation feature 355 is connected to the nozzle 321 and provides the force necessary to move the valve actuation feature 355. The inlet 356 of the valve actuation feature 355 is connected to the ejected droplets. The mist and / or gas cloud enters the inlet 356 and exits through the nozzle 321 into the passageway 333. 325. The valve 325 is sized and positioned to mate with the opening 324 of the valve 325 so that the Nozzle 321 supports the atomization of bulk liquid into a mist of droplets and / or a gas cloud. Support.

[0075] Valve 325 provides a metering mechanism 370. Metering mechanism 370 dispenses a measured amount of liquid. , and is configured to close the valve after the drug has passed through opening 324. This allows a controlled dose to be administered to the patient. The measured volume of the body is preset, but the inhaler 300 varies the defined volume of the liquid. A user operable dose selector 360 may be provided so as to

[0076] Although the foregoing description relates to one particular example of an inhaler, this example is purely illustrative. The description should not be seen as being limited to only such inhalers. Those skilled in the art will recognize that many other types of inhalers and nebulizers may be used with the present disclosure. For example, can the drug be in powder form, can the drug be in liquid form, Alternatively, the drug may be delivered by other forms of delivery mechanisms including ultrasonic vibration, compressed gas, vibrating mesh, or a heat source. 320 can be atomized.

[0077] The inhaler of the present disclosure can be used to administer mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, Tazone, vilanterol, salmeterol, formoterol, umeclidinium, glycol Copyrrolate, tiotropium, aclidinium, indacaterol, salmeterol, and olodaterol. do.

[0078] nasal spray device FIG. 4 is a schematic diagram of a fourth type of medication delivery device, namely, a nasal spray device 400. 1 is a diagram showing a nasal spray device 400 configured to deliver a medication into a patient's nose. The nasal spray device 400 contains a drug substance therein for delivery from the device 400 to the patient. The medication holder 102 includes a medication holder 402 configured to receive the medication. servers, cartridges, vials (as in this exemplary embodiment), blow fillers It may have various configurations such as Blow-Fill-Seal (BFS) capsules, blister packs, etc. In one exemplary embodiment, the medication holder 402 is a vial. are formed of one or more materials, such as glass, polymers, etc. In embodiments, the vial may be formed of glass. In yet another embodiment, the vial may be formed from one or more polymers. Different portions of the vial may be formed of different materials. As shown in the drawings, various features are provided to facilitate the sealing and storage of medication therein. However, a vial may contain only some of these features. Those skilled in the art will recognize that the present invention may include various other features and / or configurations known in the art. It is understood that the vials described herein represent specific exemplary embodiments. It's just something that was intended.

[0079] The opening 404 of the nasal spray device 400 through which the medication exits the nasal spray device 400 is Within the dispensing head 406 of the nasal spray device 400, within the tip 408 of the dispensing head 406 The tip 408 is configured to be inserted into the patient's nostril. In one embodiment, the tip 408 contacts the patient during a first phase of operation of the nasal spray device 400. into a first nostril of the patient, and into a second nostril of the patient during a second phase of operation of the nasal spray device 400. , configured to be inserted. The first and second stages of operation are a first actuation corresponding to a second dose of drug being delivered; and a second actuation corresponding to a second dose of drug being delivered. In some embodiments, this involves two separate actuations of the nasal spray device 400: In other words, the nasal spray device 400 is configured to be actuated only once to deliver one nasal spray. In some embodiments, the nasal spray device 400 is configured to: 3 doses to deliver 3 or more nasal sprays, such as 5, 6, 7, 8, 9, 10, etc. The above configuration is configured to operate as follows.

[0080] The dispensing head 406 is configured such that the longitudinal axis of the dispensing head 406 is aligned with the nose where the tip 408 is inserted. a first nostril and a second nostril of the patient so that the first nostril and the second nostril are substantially aligned with the longitudinal axis of the nostril; The depth guide 410 is configured to contact the skin. Those skilled in the art will appreciate that the manufacturing tolerances and measurement equipment The longitudinal axis may not be precisely aligned due to any number of factors, such as the sensitivity of the device. It will be appreciated that although there may be differences, they may be considered to be substantially aligned.

[0081] In an exemplary embodiment, as shown in FIG. 4, the dispensing head 406 has a tapered shape. , the dispensing head 406 is more flexible at its distal end than at its proximal end where the opening 404 is located. The opening 404 having a relatively small diameter is known to those skilled in the art. As can be seen from the figure, this facilitates spraying of the drug from the opening 404. A spray chamber 412 through which the spray is configured to pass before exiting section 404 is 4. The drug is sprayed into the proximal portion of the tapered dispensing head 406, distal to the nozzle 404. The rapid passage through the chamber 412 allows the spray chamber 412 to The arrow 414 in FIG. 4 indicates the location of the drug. The path of drug migration from object holder 402 and out opening 404 is shown.

[0082] In some embodiments, the dispensing head 406 may be configured to allow the nasal spray device 400 to and configured to deliver a dose of drug simultaneously into two nostrils in response to the movement of the nostril. Each may include two tips 408 having an opening 404 therein.

[0083] The dispensing head 406 is pushed towards the medication holder 402, e.g., by the user. Depressing the guide 410 activates the nasal spray device 400. In other words, the dispensing head 406 dispenses the medication from the medication holder 402. and configured as an actuator that is actuated to expel the nasal spray device 400. In one exemplary embodiment, the nasal spray device 400 is The actuating user is the patient receiving the medication from the nasal spray device 400. A nasal spray that is configured to be self-administered but that can be administered by another person for delivery to another person. The device 400 may be operated.

[0084] Actuation, e.g., pressing, of the dispensing head 406 occurs as indicated by arrow 416 in FIG. , configured to allow ventilation air to enter the medication holder 402. The air transports the drug in the drug holder through the tube 418 and then into the metering chamber 420. The metering chamber 420 then pumps the drug through the cannula 422 proximally and into the spray chamber. through chamber 412 and then out opening 404. For example, if a user: In response to releasing the dispensing head 406, such as ceasing to push the dispensing head 406 downward, A biasing spring 426 returns the dispensing head 406 to its default rest position for subsequent operations. The dispensing head 406 is positioned relative to the drug holder 402 for movement and drug delivery.

[0085] Although the foregoing description relates to one particular example of a nasal spray device, this example is purely illustrative. This description is not intended to be limited to such nasal spray devices. Those skilled in the art will appreciate that the nasal spray device 400 can be configured to: It is understood that different embodiments may include different features. For example, a nasal spray device The device 400 may lack a depth guide 410 and / or may include device indicators, sensors, communication One or more of a communication interface, a processor, a memory, and a power supply may include:

[0086] The nasal spray device of the present disclosure is capable of administering ketamine (e.g., Ketalar®), Sketamine (e.g., Spravato®, Ketanest®, and Ketanest-S®), naloxone (e.g., Narcan® sumatriptan (e.g., Imitrex®), It may be used to administer any of a variety of drugs.

[0087] Drug Delivery Devices As will be appreciated from the foregoing, the various components of the drug delivery device are These components are common to all devices. The drug administration device delivers a drug to a patient, the drug being in a defined dosage form. provided in a drug administration device.

[0088] FIG. 5A is a generalized schematic diagram of such a universal drug delivery device 501. FIG. 5B shows an exemplary embodiment of such a universal drug delivery device 500. Examples of universal drug delivery devices 500 include injection devices (e.g., injectors, jet injectors, and infusion pumps), nasal spray devices, and suction Examples include containers.

[0089] As shown in FIG. 5A, the drug delivery device 501, in its general form, includes a drug host The medication holder 10 includes features of a medication holder 10 and a dispensing mechanism 20. The medication holder 10 holds the medication in the dosage form to be administered. The dispensing mechanism 20 dispenses the dosage form from the medication holder 10 so that the medication can be administered to the patient. configured to emit

[0090] FIG. 5B illustrates a further universal drug delivery device 500 that includes several additional features. Those skilled in the art will appreciate that these additional features are optional for different embodiments and may be used interchangeably. the type of item, the drug dosage form, the medical indication being treated with the drug, safety requirements, and the device power source whether the device is portable; whether the device is used for self-administration; Depending on the requirements, such as whether or not the Additional features may be present or omitted from a given embodiment of a particular drug delivery device. It will be understood that various different combinations may be used to obtain the desired results. Similar to the monkey device, the drug administration device 500 comprises a drug holder 10, a dispensing mechanism 20, and The housing 30 accommodates the

[0091] The device 500 is configured to initiate the release of the drug from the drug holder 10 by the dispensing mechanism 20. The device 500 includes a trigger mechanism 50 for dispensing the medication from the medication holder 1 via the dispensing mechanism 20. 0. The dispenser 70 includes a metering / dispensing mechanism 70 that measures the set dose released from the dispenser 70. , the drug delivery device 500 can provide a known dose of a determined size. 00 allows the user to set the dose volume of the drug to be measured by the metering mechanism 70. The dose volume is selected from a plurality of predetermined individual dose volumes. or any value of a given dose volume within a range of dose volumes. obtain.

[0092] The device 500 may include the device operation prevention mechanism 40 or 25. When the mechanism 40 or 25 is in the locked state, the dispensing mechanism 20 releases the drug from the drug holder 10. When in the unlocked state, the dispensing mechanism 20 prevents and / or stops the drug from being dispensed. This allows for the release of a drug dose from the holder 10, e.g. to prevent accidental administration of medication, to prevent administration in a hospital, or to prevent inadvertent actuation The device 500 may also be configured to shut down the dispensing mechanism 20, for example, for safety reasons. The device includes a dispensing mechanism protection mechanism 42 that prevents access to at least a portion of the device. The stop mechanism 40 and the dispensing mechanism protection mechanism 42 may be the same component.

[0093] The device 500 may provide information about the status of the drug delivery device and / or the drug contained therein. The device may include a device indicator 85 configured to present information related to the device. The indicator 85 may be a visual indicator, such as a display screen, or an audio indicator. The device 500 may present information about the device 500 to the user of the device 500. and / or configured to allow a user to control the device 500. The device 500 includes a user interface 80 that can be used to administer medication. and / or information relating to the drug contained therein, e.g., dosage form and device parameters. By way of example, the device sensor 92 may include a metering mechanism 70 and a throwing mechanism 92 configured to sense the In embodiments that include a dose selector 60, the embodiment may use the dose selector 60 to the dose selected by the user, the dose metered by the metering mechanism 70, and the dose One or more of the dispensed doses are configured to sense one or more of the dispensed doses. The device may further include two or more device sensors 92. Similarly, the device may measure the temperature of the environment, the humidity of the environment, the position The device 500 is configured to sense information about the environment in which the device 500 resides, such as its location and time. Environmental sensors 94 are provided, for example via satellite positioning such as GPS. There is a dedicated location sensor 98 configured to determine the geographic location of the device 500. The device 500 may also include various sensors related to the device and / or the drug. The device includes a communication interface 99 that can communicate data acquired from the device to the outside.

[0094] Optionally, device 500 may include one or more electrical components of device 500. The device 500 includes a power supply 95 for delivering power to the device. The power supply 95 is integral with the device 500. It may be a power source and / or a mechanism for connecting the device 500 to an external power source. The devices 500 are also powered by a power source 95 and communicate with each other and, optionally, with an environmental sensor. 94, position sensor 98, device sensor 92, communication interface 99, and / or The processor communicates with other electrical and control components of the device 500, such as the indicator 85. The device includes a computer system 90 including a processor 96 and a memory 97. 96 includes the environmental sensor 94, the device sensor 92, the communication interface 99, and the position sensor 98, and / or obtain data obtained from the user interface 80 and process it. and outputting data to, for example, the indicator 85 and / or the communication interface 99. It is configured to provide a force.

[0095] In some embodiments, the drug administration device 500 is sealed within packaging 35. The packaging 35 includes a processor 96, memory 98, and 7, user interface 80, device indicator 85, device sensor 92, position The device may further include a combination of position sensors 98, and / or environmental sensors 94, which may It may be located outside the housing of the sensor 500.

[0096] Those skilled in the art will appreciate that the universal medication delivery device 5 comprising the medication holder 10 and the dispensing mechanism 20 00 may have the various optional features described above in several different combinations. It will be appreciated that the medication delivery device 500 further includes a medication holder 504 associated with it. Optionally, two or more dispensing mechanisms 20 may be provided. More than one medication holder 10 may be included.

[0097] Drug dosage form Traditionally, drug delivery devices utilize liquid dosage forms. However, other dosage forms are available. It will be understood that this is possible.

[0098] One such common dosage form is the tablet. Tablets contain a drug and excipients compressed together. Other dosage forms include pastes, creams, powders, ear drops, and eye drops.

[0099] Further examples of drug dosage forms include skin patches, drug-eluting stents, and intrauterine devices. In these examples, the body of the device contains a drug and releases the drug under certain conditions. For example, a skin patch may be constructed to allow the drug to be delivered to the skin. The polymer composition may comprise a composition that allows the drug to diffuse from the polymer composition into the patient's skin. Drug-eluting stents and intrauterine devices may operate in a similar manner. In this way, patches, stents, and intrauterine devices may themselves be associated with It can be thought of as a medication holder with a dispensing mechanism.

[0100] Any of these dosage forms may be configured to trigger drug release upon specific conditions. This allows the drug to be released at the desired time or location after the dosage form is introduced into the patient. In particular, drug release can be initiated by an external stimulus. The dosage form may be contained within a housing, which may be in the form of packaging, prior to administration. This housing may include any of the optional components described above that are utilized in the universal drug delivery device 500. It may include some of the features.

[0101] The drugs administered by the drug administration device of the present disclosure, when consumed, have physiological effects on the organism. or any substance that causes a mood change. Examples of drugs that can be used include 5-alpha-reductase inhibitors, 5-aminosalicylates, 5HT3 receptor antagonists, ACE inhibitors with calcium channel blockers, with thiazides ACE inhibitors, adamantane antivirals, corticosteroids, adrenal corticosteroids Adrenergic bronchodilators, emergency hypertension medications, pulmonary hypertension medications, Ludosterone receptor antagonist, alkylating agent, allergen, α-glucosidase inhibitor Medicines, alternative medicines, amoebicides, aminoglycosides, aminopenicillins, aminosalicylic acids, AMPA receptor antagonists, amylin analogs, analgesic combinations, analgesics, androgens and and anabolic steroids, angiotensin-converting enzyme inhibitors, and calcium channel blockers Angiotensin II inhibitors, angiotensin II inhibitors with thiazides, angiotensin II inhibitors angiotensin receptor blockers, angiotensin receptor blockers and neprilysin inhibitors, anorectal Pharmaceuticals, appetite suppressants, antacids, anthelmintics, anti-angiogenic ophthalmic agents, anti-CTLA-4 monoclonal Antibodies, anti-infectives, anti-PD-1 monoclonal antibodies, anti-adrenergic agents including thiazides (central), antiadrenergics including thiazides (peripheral), antiadrenergics, central acting, antiadrenergic, peripherally acting, antiandrogen, antianginal, antiarrhythmic, Antiasthmatic combinations, antibiotics / antineoplastics, anticholinergic antiemetics, anticholinergic anti Parkinson's agents, anticholinergic bronchodilators, anticholinergic chronotropic agents, anti Cholinergic / antispasmodic, anticoagulant reverser, anticoagulant, anticonvulsant, antidepressant, antidiabetic Antidiabetic drugs, antidiabetic combinations, antidiarrheals, antidiuretic hormones, antidotes, antiemetics / antivertigo drugs , antifungal, antigonadotropic, antigout, antihistamine, hypolipidemic, hypolipidemic Combination, combination of antihypertensive drugs, antihyperuricemia drugs, antimalarials, antimalarials Combination, antimalarial quinolone, antimanic, antimetabolite, antimigraine, antitumor drug combination Combined, antitumor drug antidote, antitumor drug interferon, antitumor drug, antiparkinson drug, anti Platelet inhibitors, antipseudomonal penicillins, antipsoriatic drugs, antipsychotics, antirheumatic drugs, antiseptics and Antiseptics, antithyroid drugs, antitoxins and antivenins, antituberculous drugs, antituberculous combination drugs, antitussives, Antiviral agents, antiviral boosters, antiviral combinations, antiviral inter Feron, anxiolytics, sedatives, and hypnotics, aromatase inhibitors, atypical antipsychotics, Antifungal drugs, bacterial vaccines, barbiturates, anticonvulsants, barbiturates, BCR -ABL tyrosine kinase inhibitors, benzodiazepine anticonvulsants, benzodiazepines, Beta-blockers, including calcium channel blockers; beta-blockers, including thiazides; beta-anticoagulants Adrenergic blockers, beta-lactamase inhibitors, bile acid sequestrants, biologics, bisphosphatase inhibitors phonates, bone morphogenetic proteins, bone resorption inhibitors, bronchodilator combinations, bronchodilators , calcium receptor agonists, calcineurin inhibitors, calcitonin, calcium channels blockers, carbamate anticonvulsants, carbapenems, carbapenem / beta-lactams Anticonvulsants, carbonic anhydrase inhibitors, cardiac stress agents, cardiac Selective beta-blockers, cardiovascular agents, catecholamines, cation exchange resins, CD20 monoclonal antibodies monoclonal antibody, CD30 monoclonal antibody, CD33 monoclonal antibody, CD38 monoclonal antibody Monoclonal antibodies, CD52 monoclonal antibodies, CDK4 / 6 inhibitors, central nervous system drugs , cephalosporins, cephalosporins / beta-lactamase inhibitors, cermenol drugs, CFTR combinations, CFTR potentiators, CGRP inhibitors, chelators, chemokines receptor antagonists, chloride channel activators, cholesterol absorption inhibitors, cholinergic agonists, cholinergic muscle stimulants, cholinesterase inhibitors, CNS stimulants, coagulation modifiers agents, colony-stimulating factors, contraceptives, adrenocorticotropic hormones, coumarins and indanediones, cox-2 inhibitors, decongestants, dermatological drugs, diagnostic radiopharmaceuticals, diarylquinolines, Dibenzazepine anticonvulsants, digestive enzymes, dipeptidyl peptidase 4 inhibitors, diuretics , dopaminergic antiparkinsonian drugs, drugs used in alcoholism, echinocandins Candida, EGFR inhibitor, estrogen receptor antagonist, estrogen, expectorant, factor Xa Factor inhibitors, fatty acid derivative anticonvulsants, fibric acid derivatives, first-generation cephalosporins 4th generation cephalosporins, functional bowel disorder agents, gallstone solubilizers, gamma-aminobutyric acid analogues , gamma-aminobutyric acid reuptake inhibitors, gastrointestinal agents, general anesthetics, genitourinary tract drugs, gastrointestinal stimulants, Glucocorticoids, glucose-elevating agents, glycopeptide antibiotics, glycoprotein platelet inhibitors , glycylcycline, gonadotropin-releasing hormone, gonadotropin-releasing hormone antagonist Drugs, gonadotropins, Group I antiarrhythmics, Group II antiarrhythmics, Group III Antiarrhythmics, Group IV antiarrhythmics, Group V antiarrhythmics, Growth hormone receptor blockade Drugs, growth hormone, guanylate cyclase-C agonist, Helicobacter pylori eradicant, H2 antagonist , hedgehog pathway inhibitor, hematopoietic stem cell mobilizing agent, heparin antagonist, heparin, HER2 inhibitor Antineoplastic agents, herbal products, histone deacetylase inhibitors, hormones, hormone / antineoplastic agents, Dantoin anticonvulsants, hydrazide derivatives, illegal (street) drugs, immunoglobulins, Immunological agents, immunostimulants, immunosuppressants, impotence agents, in vivo diagnostic biological agents, inks Retinomimetics, inhaled anti-infectives, inhaled corticosteroids, inotropics, insulin , insulin-like growth factor, integrase strand transfer inhibitor, interferon, interro Iodine inhibitors, interleukins, parenteral nutrition products, iodinated contrast media, ionic iodine Contrast media, iron products, ketolides, laxatives, antileprosy drugs, leukotriene modifiers, lincomycin derivatives Conductors, local injectable anesthetics, local injectable anesthetics with corticosteroids, loop diuretics Drugs, pulmonary surfactants, lymphatic stains, lysosomal enzymes, macrolide derivatives, macrolides , magnetic resonance imaging contrast agents, mast cell stabilizers, medical gases, meglitinides, metabolic agents, Methylxanthines, mineralocorticoids, minerals and electrolytes, other drugs, other sedatives Pain medications, other antibiotics, other anticonvulsants, other antidepressants, other antidiabetics drugs, other antiemetics, other antifungals, other antihyperlipidemics, other antihypertensives combinations, other antimalarials, other antitumor drugs, other antiparkinsonian drugs, other antipsychotics, other antituberculous drugs, other antiviral drugs, other anxiolytics, sedatives Sedatives and hypnotics, other bone resorption inhibitors, other cardiovascular drugs, other central nervous system drugs, Other coagulation modifiers, other diagnostic dyes, other diuretics, other genitourinary tract drugs, Other gastrointestinal drugs, other hormones, other metabolic agents, other ophthalmic drugs, other otic drugs Other Respiratory Drugs, Other Sex Hormones, Other Topical Drugs, Other Unclassified Drugs, other vaginal drugs, mitotic inhibitors, monoamine oxidase inhibitors, mouth and throat products , mTOR inhibitors, mucolytics, multikinase inhibitors, muscle relaxants, mydriatics, narcotic analgesics Combinations of medications, narcotic pain relievers, nasal anti-infectives, nasal antihistamines and decongestants, nasal Lubricants and cleansers, nasal preparations, nasal steroids, natural penicillins, neprilysin inhibitors , neuraminidase inhibitors, neuromuscular blockers, neural potassium channel openers, next-generation Phalosporins, nicotinic acid derivatives, NK1 receptor antagonists, NNRTIs, non-cardioselective venoms Data blockers, non-iodinated contrast media, non-ionic iodinated contrast media, non-sulfonylureas, non-steroidal anticoagulants Anti-inflammatory drugs, NS5A inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), and nutritional Food supplements, nutritional products, ophthalmic anesthetics, ophthalmic anti-infectives, ophthalmic anti-inflammatory drugs, ophthalmic antihistamines Ophthalmic ophthalmic lubricants and cleaners, ophthalmic diagnostic agents, ophthalmic glaucoma medications, ophthalmic lubricants and cleaners, ophthalmic preparations for eye drops, ophthalmic steroids, ophthalmic steroids including anti-infectives, ophthalmic surgical preparations, oral nutrition Nutritional supplements, other immunostimulants, other immunosuppressants, otic anesthetics, otic anti-infectives, otic preparations, Otic steroids, otic steroids including anti-infectives, oxazolidinedione anticonvulsants, Oxazolidinone antibiotics, parathyroid hormone and analogs, PARP inhibitors, PCSK9 inhibitors, penicillinase-resistant penicillins, penicillins, peripheral opioid receptor antagonists, peripheral Peripheral opioid receptor mixed agonist / antagonist, peripheral vasodilator, peripherally acting anti-obesity agent, Phenothiazine antiemetics, phenothiazine antipsychotics, phenylpiperazine antidepressants, phosphate Binders, PI3K inhibitors, plasma expanders, platelet aggregation inhibitors, platelet stimulators, poly Potassium-sparing diuretics, including enes and thiazides, potassium-sparing diuretics, and probiotics Progesterone receptor modulators, progestins, prolactin inhibitors, prostagrams Randin D2 antagonist, protease inhibitor, protease-activated receptor 1 antagonist, protease asome inhibitors, proton pump inhibitors, psoralens, psychotropic drugs, psychotropic drug combinations Purine nucleosides, pyrrolidine anticonvulsants, quinolones, radiocontrast agents, radiocomplements adjuvant, radiotherapeutic agent, radioconjugate, radiopharmaceutical, recombinant human erythropoietin, Nin inhibitors, respiratory agents, respiratory inhalation products, rifamycin derivatives, salicylic acid, sclerosing agents, 2 Generation cephalosporins, selective estrogen receptor modulators, selective immunosuppressants, selective hormonal inhibitors Phosphodiesterase-4 inhibitors, selective serotonin reuptake inhibitors, serotonin-nor Combination of epinephrine reuptake inhibitors, serotonergic neurointestinal modulators, and sex hormones combination of sex hormones, SGLT-2 inhibitors, and skeletal muscle relaxants; skeletal muscle relaxants; smoking cessation drugs, somatostatin and somatostatin analogues, spermicides, statins, sterile irrigation solutions, Leptogramins, Streptomyces derivatives, succinimide anticonvulsants, sulfonamides drugs, sulfonylureas, synthetic ovulation stimulants, tetracyclic antidepressants, tetracyclines, therapeutic radiation Sexual medicines, therapeutic vaccines, thiazide diuretics, thiazolidinediones, thioxanthenes, Third generation cephalosporins, thrombin inhibitors, thrombolytic agents, thyroid agents, TNF-alpha inhibitors Toxicants, tocolytic agents, topical acne agents, topical agents, topical allergy diagnostic agents, local anesthetics, Topical anti-infectives, topical anti-rosacea agents, topical antibiotics, topical anti-fungals, topical antihistamines, Topical antitumor agents, topical antipsoriatic agents, topical antiviral agents, topical astringents, topical debridements, topical debridements Pigments, topical emollients, topical keratolytic agents, topical nonsteroidal anti-inflammatory drugs, topical photosensitizers topical steroids, topical steroids including anti-infectives, topical rubefacients, topical steroids including anti-infectives, topical Transthyretin stabilizers, triazine anticonvulsants, tricyclic antidepressants, trifunctional monoclonal antibodies Clonal antibodies, ultrasound contrast agents, upper respiratory tract combination agents, urea anticonvulsants, urea cycle disorder agents, urinary Medium anti-infective, urinary antispasmodic, urinary pH adjuster, uterine contraction agent, vaccine combination, vaginal anti-infective Medicines, vaginal preparations, vasodilators, vasopressin antagonists, vasopressors, VEGF / VEGFR inhibitors antivirals, viral vaccines, mucosupplements, vitamin and mineral combinations, vitamins, or The drug administration device of the present disclosure may be used to administer epinephrine, Re, or a VMAT2 inhibitor. bif, Enbrel, Aranesp, atropine, pralidoxime chloride, diazepam , insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, Carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, Paclitaxel, pantoprazole sodium, treprostinil, vasopressin, bovine serum albumin Conazole, zoledronic acid, mometasone, fluticasone, ciclesonide, budesonide, benzamidine Clometasone, vilanterol, salmeterol, formoterol, umeclidinium , glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol - A drug selected from the group consisting of cyclosporine, cyclosporine, and olodaterol may be administered.

[0102] As noted above, any of a variety of drugs can be delivered using the drug administration device. Examples of drugs that can be delivered using the drug administration devices described herein include Remi Cade® (infliximab), Stelara® (ustekinumab) Mab), Simponi® (golimumab), Simponi Aria® (golimumab), Darzalex® (daratumumab), Tremfy® a® (guselkumab), Eprex® (epoetin alfa), R Isperdal Constra® (risperidone), Invega Su stenna® (paliperidone palmitate), Spravato® ) (esketamine), ketamine, and Invega Trinza® (palmitocin) Paliperidone tetanoate).

[0103] Drug Housing As noted above, the dosage form may be provided in a holder appropriate for the particular dosage form utilized. For example, a liquid dosage form of a drug may be placed in a vial with a stopper or a vial with a plunger prior to administration. The dosage form may be a solid or powdered dosage form, e.g., as a tablet, held in a holder in the form of a syringe. The drug is contained within a housing arranged to hold the tablet securely prior to administration. It is possible.

[0104] The housing may include one or more medication holders, each holder containing a dosage form, e.g. For example, the drug may be in the form of a tablet, and the housing may include a plurality of holders each having a tablet held therein. The holder may be in the form of a recess in a blister pack.

[0105] FIG. 6 shows a housing 63 with a plurality of medication holders 610, each containing a dosage form 611. The housing 630 is designed to be able to withstand various environmental conditions, such as temperature, time, or location. At least one environmental sensor configured to sense information about the existing environment 94. The housing 630 may accommodate the drug in the dosage form 611 contained within the holder 610. at least one device sensor 92 configured to sense information related to For example, determining the geographic location of the housing 630 via satellite positioning such as GPS. There may be a dedicated position sensor 98 configured to determine

[0106] The housing 630 stores information regarding the status of the drug in the dosage form 611 contained within the holder 610. The housing may include an indicator 85 configured to present information to a user of the housing. The housing 630 may also include a drug housing 630, an environment, a time, or a place, and and / or communicating information externally via wired or wireless transmission of data relating to the drug itself. The communication interface 99 may include a communication interface 99 capable of

[0107] Optionally, the housing 630 may include one or more electrical components of the housing 630. The device may include a power supply 95 for delivering power to the components. The power supply 95 is integral with the housing 630. The housing 630 may be a power source and / or a mechanism for connecting the housing 630 to an external power source. The housings 630 are also powered by a power supply 95 and are electrically isolated from each other and, optionally, the environment. sensors 94, position sensors 98, device sensors 92, communication interfaces 99, and / or or indicator 85. The device may include a computer system 90 including a processor 96 and memory 97. The processor 96 is connected to the environment sensor 94, the device sensor 92, and the communication interface 99. , acquiring data obtained from the position sensor 98 and / or the user interface 80 and process it, for example, to provide an indicator 85 and / or a communication interface 9 9.

[0108] The housing 630 may be in the form of packaging. Alternatively, additional packaging may be used. A ring may be present to contain and surround the housing 630 .

[0109] The holder 610 or additional packaging may itself be a device cell, as described above. sensor 92, environmental sensor 94, indicator 85, communication interface 99, power supply 95, A position sensor 98 and a device computer system including a processor 96 and a memory 97 The system may include one or more of the following:

[0110] Electronic Communications As mentioned above, the communication interface 99 may be located in or on the housing 30, 630. , or alternatively contained within or on packaging 35 to facilitate drug administration. Such a communication interface may be associated with the device 500 or the medication housing 630. The interface 99 may be connected to a remote computer system such as the central computer system 700 shown in FIG. As shown in FIG. 7, the drug administration device may be configured to communicate with a computer system. The communication interface 99 associated with the housing 630 or the communication network Through network 702, a medical facility 706, such as a hospital or other medical center, a home base 708 (e.g., a patient's home or office, or a caretaker's home or office) 710, access to the central computer system from any number of locations, such as an office, or a mobile location 710. The communication interface 99 is configured to communicate with the network system 700. The system 700 is configured to be accessed via a wired and / or wireless connection to the network 702. In one exemplary embodiment, the communication interface 99 of FIG. 00 wirelessly, for example, via a Wi-Fi connection, and This may facilitate the accessibility of the system 700 from almost any location in the world.

[0111] Those skilled in the art will appreciate that system 700 may be configured to utilize the features of system 700 available to any particular user. may be based, for example, on the identity of the user and / or the location from which the user is accessing the system. It will be understood that the security features may be included as may be determined based on the To facilitate access to the system 700, each user must have a unique username. , passwords, biometric data, and / or other security credentials. The security parameter information provided determines whether the user is authorized and whether the user is To what extent are you allowed to interact with the system, view information stored in the system, etc. The user may be checked against a database of authorized users to determine if the user is authorized.

[0112] Computer Systems As discussed herein, one or more aspects or aspects of the subject matter described herein may be The components of the central computer system 700, such as the processor 96, the power supply 9 5, memory 97, communication interface 99, user interface 80, device interface The indicators 85, device sensors 92, environmental sensors 94, and position sensors 98 are digital electronic circuits, integrated circuits, specially designed application specific integrated circuits (ASICs) Integrated Circuit (ASIC), Field Programmable Gate Array (Field Pro FPGA (Programmable Gate Array) computer hardware, firmware, and software Various aspects or features of these may be implemented in a variety of ways, including, but not limited to, software, hardware, and / or combinations thereof. , executed on a programmable system including at least one programmable processor. involves the execution of one or more computer programs that are executable and / or interpretable The processor may include a storage system, at least one input device, and at least one connected to receive data and instructions from and send data and instructions to two output devices It can be a dedicated or general-purpose processor connected to a programmable system or The computer system may include clients and servers. The servers are generally remote from each other and are typically connected via a communications network, e.g., the Internet. network, wireless wide area network, local area network, wide area network, or The client and server relationships are computer programs that run on computers and have a client-server relationship with each other Produced by grams.

[0113] A computer program is a program, software, or software application. It may also be called a program, application, component, or code. It includes machine instructions for programmable processors, high-level procedural languages, object-oriented programming languages, functional programming languages, logic programming languages, and / or may be implemented in assembly / machine language. As used herein, the term "machine-readable medium" refers to a "Device" includes, for example, magnetic disks, optical disks, memories, and programmable logic devices. Any computer-programmable device, such as a Programmable Logic Device (PLD) refers to any product, device, and / or apparatus that is capable of receiving machine instructions as machine-readable signals. Includes a machine-readable medium for providing machine instructions and / or data to a programmable processor The term "machine-readable signal" is used to describe a signal that can be used to transmit machine instructions to a programmable processor. A machine-readable medium refers to any signal used to provide data, e.g. For example, non-transient solid-state memory or a magnetic hard drive, or any equivalent storage medium. Such machine instructions may be stored non-transitoryly on a machine-readable medium, such as a processor. processor cache, or associated with one or more physical processor cores storing such machine instructions in a temporary manner, such as in a memory or other random access memory; It can be additionally stored.

[0114] To provide for interaction with a user, one or more aspects of the subject matter described herein may be used. The user interface 80 (including the dispensing device 500 or housing 630 or separate) may be used, for example, to display information to the user. Cathode Ray Tube (CRT) or Liquid Crystal Display (LCD) LCD (Light Emitting Diode, LED) monitors and other displays The display screen may be implemented on a computer that can be directly (e.g., touch) screen) or indirectly (e.g., through a keypad or voice recognition hardware and software) Other types of input devices may be used to input data to the display screen. The device can be used to provide for user interaction as well. For example, The feedback provided may be, for example, visual feedback, auditory feedback, or Input from the user, which can be any form of sensory feedback, such as haptic feedback may receive input in any form, including but not limited to acoustic, voice, or tactile input. As mentioned above, this feedback may be displayed on the user interface 80. Additionally, the device may be provided via one or more device indicators 85. The indicator 85 may be used to provide this feedback or to receive input from the user. To receive the signal, the device sensors 92, the environmental sensors 94, and / or the position sensors 98 are used. may interact with one or more of:

[0115] FIG. 8 is an example of computer system 700 shown as computer system 800. 8 shows an exemplary embodiment of a computer system 800. The processor 896 includes one or more processors 896 configured to control the The processor 896 may be a programmable general-purpose or special-purpose microprocessor and / or a variety of Includes either a dedicated or commercially available single or multi-processor system any type of microprocessor or central processing unit The computer system 800 may also include a processor 896. for the code to be executed, or for one or more users, storage devices, and / or or configured to provide temporary storage for data obtained from a database. The memory 897 may include one or more read-only memories (Re Read-Only Memory (ROM), flash memory, one or more of various random access Random Access Memory (RAM) (e.g., static RAM) SRAM, SRAM), Dynamic RAM (DRAM), or Synchronous RAM Synchronous DRAM (SDRAM), and / or a combination of memory technologies It may include.

[0116] The various elements of the computer system are coupled to a bus system 812. The bus system 812 is connected by appropriate bridges, adapters, and / or controllers. Any one or more separate physical buses, communication lines / interfaces connected by abstractions representing the source, and / or multi-drop or point-to-point connections The computer system 800 also includes one or more network interfaces. interface 899 (also referred to herein as a communication interface), one or two or more input / output (IO) interfaces 880 and one or more storage devices 8 Includes 10.

[0117] The communications interface 899 allows the computer system to communicate with remote devices, e.g. , and network with other computer systems and / or devices 500 or housing 630. may be configured to allow communication over a network, or may be configured to allow communication over a remote Desktop connection interface, Ethernet adapter, and / or other local It can be a Local Area Network (LAN) adapter. Interface 880 is one or more devices for connecting computer system 800 to other electronic devices. includes two or more interface components. For example, IO interface 880 includes , Universal Serial Bus (USB) port, 1394 port, Wi-Fi, Blue Additionally, the computer system may include a high speed data port such as a The IO interface 880 may be accessible to users throughout the Playback, speakers, keyboard, pointing device, and / or various other video , audio, or alphanumeric interfaces. This includes any conventional medium for storing data in a transient and / or non-transitory manner. Thus, the storage device 810 retains its value despite an interruption of power to the computer system. The storage device is configured to hold data and / or instructions in a persistent state that is maintained. The 810 can store one or more hard disk drives, flash drives, USB drives, drives, optical drives, various media cards, diskettes, compact discs, and and / or any combination thereof, whether directly connected to a computer system. or may be remotely connected to a computer system, such as via a network. In one embodiment, the storage device 810 may be, for example, a hard disk drive, a flash drive, or Drive, USB drive, optical drive, media card, diskette, or compact disc A tangible or non-transitory computer device configured to store data, such as a hard disk This includes a data-readable medium.

[0118] The elements illustrated in FIG. 8 may be some or all of the elements of a single physical machine. In addition, not all of the illustrated elements need be located on or within the same physical machine. do not have.

[0119] The computer system 800 may process a web page or other markup language stream. to search, and to browse (visually, audibly, or otherwise) those pages and / or streams; presenting the page / stream in a way that allows scripts, controls, and other commands to be executed on those pages / streams to execute commands (e.g., to complete input fields) on those pages / Accepting user input for a stream, H for those pages / streams Issues a HyperText Transfer Protocol (HTTP) request or by other means (e.g., by submitting information from completed input fields to a server). This may include a web browser for displaying web pages or other markup languages. The term stands for HyperText Markup Language (H TML), or Embedded Extensible Markup Language (EML) and other traditional forms including Markup Language (XML), scripts, controls, etc. The computer system 800 may also generate web pages and / or It may include a web server for distribution to an external computer system.

[0120] As shown in FIG. 7, the computer system 800 of FIG. 8 may include one or more The device computer of the two or more individual drug administration devices 500 or housings 630 a central computer system 700 in communication with one or more of the data systems 90; Operational data of the device 500 or the housing 630, such Data, such as patient medical data, acquired by the device 500 or housing 630 can be exchanged between the central and device computer systems 700, 90.

[0121] As previously mentioned, the above-described computer system 800 may also be used in conjunction with the drug administration device 500 or The device computer system may be integrated into the housing 630 or may be located in close proximity to the housing. In this regard, one or more processors may form a component of system 90. 896 corresponds to the processor 96, and the network interface 799 is a communication interface. The IO interface 880 corresponds to the user interface 8 0, and memory 897 corresponds to memory 97. Furthermore, additional storage device 810 also It may also reside within the device computer system 90.

[0122] In one exemplary embodiment, the computer system 800 may, for example, A single unit of one or more medication delivery devices 500 housed within a device housing 30. A single package 35 or a plurality of medication holders 610 are contained within a housing 630. The devices may be integrated into a single computer system 90. The computer system 800 may be implemented as a single unit, as a single server, or as a single The central computer system 700 may be configured as a tower.

[0123] A single unit may be configured such that its various aspects do not disrupt the functioning of any other aspect of the system. can be swapped out as needed, for example for upgrades, replacements, or maintenance, without It can be modular so that it can be plugged in and out. It can also be extensible with capabilities being added as additional modules, and / or additional functionality of existing modules is desired and / or improved.

[0124] A computer system also includes, by way of example, an operating system and a database. various other software and / or hardware components, including the data management system An exemplary computer system is shown and described herein. Although the figures are shown here, it will be understood that this is for generality and convenience. In some embodiments, the computer system may be different in architecture from that shown and described herein. For example, memory 897 and storage 810 together may If it can be integrated or communication with another computer system is not required, Interface 899 may be omitted.

[0125] Implementation In at least some implementations, a communication interface, such as communication interface 99 described above, The interface may be a remote computer system, such as the central computer system 700 described above. In this way, the patient's Drug delivery devices, drugs dispensable or dispensed from such devices, and / or Data on physiological parameters may be inaccessible to patients if the data is intercepted by an unauthorized third party. through the communication interface without identifying patient information that would compromise the patient's privacy. The device may be transmitted from a remote computer system to a device that includes a communication interface. For example, any of the drug delivery devices of FIGS. 1-5B, the drug housings of FIGS. 5B and 6 5B, the packaging 35, the sensor, etc. and the remote computer. A remembered link is established between the computer systems to allow data In an exemplary embodiment, the stored link may be , stored on the device and the remote computer system, respectively. Contains an established key that is unique to the remote computer system, thereby The computer system can receive anonymous data from the device, but use the key to identify that particular As data from the device, and therefore previously processed in the computer system associated with that particular device, programmed, or available from another computer system The data can be accurately identified as relating to a particular patient. Thus, the remote computer system can receive data from the device as well as aggregates data related to the patient's condition and treatment; and / or the effectiveness of the device and / or drug. The evaluation may be performed by a medical professional. It may be performed manually or may be automated by a remote computer system.

[0126] Identification of data as relating to a particular patient does not necessarily include full details of the patient. It is not necessary to identify the data as relating to a specific patient. maintain patient privacy; therefore, data should be individually identified. Although it is not possible to aggregate multiple bits of data related to a single patient, it is still possible to aggregate multiple bits of data related to a single patient. This allows for the evaluation of correlations and trends related to drug administration or other conditions encountered by patients. This anonymous data also allows for the collection of anonymous data that can be used to evaluate clinical trials. It may be used in place of a control group as part of a clinical trial.

[0127] The computer system includes a plurality of drug administration devices, drug housings, and packaging. and / or establish a unique key with each of the sensors to allow the computer system to communicate with different software. This allows data to be aggregated from each of the sources, thereby improving consistency across different patients. Data analysis and / or data analysis across different devices / housings / packaging Such analyses are designed to allow for the evaluation of different patient treatments and the optimal patient consultation for the patient's individual medical treatment plan, enabling optimal clinical outcomes and / or allow insurance companies to better correlate drug use and drug costs. This can be beneficial for a variety of reasons, including allowing for effective correlation.

[0128] The stored link uses encryption to achieve secure, private, and anonymous data communication. In an exemplary implementation, the computer system is capable of data encryption and decryption. To ensure security, it is built on key-based security systems such as public / private key cryptography systems. In an exemplary embodiment, the server includes a medication administration device, a housing, It is a server located remotely to the device or other devices that communicate with it. The server may be configured to communicate with a memory, such as memory 897, and / or a system. and an additional storage device 810 configured to store the public and private keys of the selected device. The public and private keys are encrypted by the server using a cryptographic algorithm. The key can be generated by encrypting data for transmission and sharing between different computing devices. Such a system may be used to decrypt encrypted data received from The system allows data to be encrypted using the public key corresponding to the intended data recipient. However, only the recipient's private key can be used to decrypt the encrypted data. In at least some embodiments, the server uses a public key infrastructure Certification Authorities (CAs) are publicly recognized and include cryptographic systems such as PKI (Public Key Infrastructure), where one or more third parties, known as "certification authorities," The ownership of the public and private key pair can be proven. Key-based security system Examples of RSA include the Diffie-Hellman key exchange protocol, the Digital Signature Standard, Signature Standard (DSS) protocol, Password Authenticated Key Agreement Protocol Le, Rivest-Shamir-Adelman (Rivest-Shamir-Adelman, RSA) Encryption algorithms, Cramer-Shoup cryptosystem, and YAK authentication key algorithm Examples include the com- ment protocol.

[0129] More specifically, encryption is the process of converting text or other data into unrecognizable digital data using a key. Encrypt the message by converting it to a binary form and then restoring it to its original form. This is achieved using a decryption algorithm. The longer the key, the more difficult it is to crack the code. A computer key consists of bits of information of various lengths, e.g. An 8-bit key has 256 (2 to the power of 8) possible values. The key generates 72,000 trillion possible combinations. If the key is 128 bits long, In this case, that is, in the case of a message equivalent to 16 characters on a personal computer, A cryptanalysis attack would be 47 sextillion times more difficult (4,700,000,000,000) than cracking a 56-bit key. Encryption makes it 200,000,000 times more difficult to transmit. Even in the unlikely event that data is intercepted by an unauthorized third party, misuse of the data is unlikely. and is prevented.

[0130] A unique identification (ID) number or code must be provided on the device before use. During the manufacturing process, etc., the memory of the device, e.g., memory 97 of device 500 of FIG. 5B, The ID number / code is unique to the device, but The code is common to multiple devices and is useful for analyzing common trends across multiple related devices. Include additional identifying information such as model or model family numbers or codes that may be useful. In an exemplary embodiment, the ID number may be associated with the drug administration device, drug, and / or sensor. The data is sent to a computer system, and the computer system receives the data. to be easily identified as having been received from that particular device. The data system is used by the computer system to decrypt data received from the device. The device may communicate with the device so that it can identify previously generated keys to use for A rule stored in a computer system that correlates the device's ID number / code with a specific key. This can be done in a variety of ways, such as by searching for an ID number / code in a lookup table. The lookup table can also be used to identify the ID number / code. The data can be correlated to a particular device and / or a particular patient associated with a particular device. The ID number / code is encrypted in the data sent from the device to the computer system. The ID number / code is not encrypted and is used by a computer system to read and decrypt the correct This may allow a new key to be identified.

[0131] Certain devices, such as any of the drug delivery devices of FIGS. 1-5B, 6, any of the drug housings 30, 630, packaging 35 of FIG. 5B, sensors, etc. The key generated in the computer system for communicating with the device as described above. In some embodiments, the computer The computer system generates the key and sends it to the device for storage. Instead, the device performs the key generation and stores it in the computer system. However, the remotely located computer system can transmit the key. Typically, the device has more processing power than the key generation device, so in an exemplary embodiment, In other embodiments, the computer system Each system and device has a specific key generation process that will be understood by those skilled in the art. The key is transmitted to one of the computer systems and devices using the protocol. This prevents the key from being intercepted by an unauthorized third party. This can help improve security by

[0132] As mentioned above, the key stored in the medication administration device is stored in the medication administration device and the medication administration data. In an exemplary embodiment, a patient associated with a drug administration device may be individually identified. The device may store only one key. In such an embodiment, In another exemplary embodiment, the drug delivery device is intended for use by a The medication administration device may store multiple keys, each of which may be used by the medication administration device. The patient's name and medication delivery device are used to identify one of multiple patients. The drug administration device can be used by each of a plurality of patients and can be used to send and receive data. configured to send and receive data specific to only one of the patients based on the key used The drug administration device may be, for example, a drug holder of the drug administration device. After delivery from the drug delivery device, the drug is removed from the drug delivery device. If the medication holder is configured to be replaced with a second medication holder containing the medication to be administered to multiple patients, Therefore, it can be used.

[0133] The data sent from the device to the computer system can be of various types. In an exemplary embodiment, the data may include any of the following: one or more sensors configured to sense information relating to at least one of Any one of the device sensors 92, environmental sensors 94, and position sensors 98 described above This indicates the sensed information collected by the above means.

[0134] The data transmitted from the sensors to the computer system is used to analyze the patient's physiological parameters. The sensor may include information related to one of blood glucose level, blood oxygen level, weight, or sleep time. The sensor may be configured to sense one of the physiological parameters. Further examples of physiological characteristics include blood pressure, sweat level, respiratory rate, heart rate, core temperature, tremor detection, Physiological parameters may also include nutritional intake. Alternatively, nutritional intake can be assessed by imaging the food consumed by the patient. It may be recorded manually by the patient.

[0135] The sensors described herein may be used to measure the device conditions (e.g., the device conditions sensed by the device sensor 92). environmental conditions (e.g., as sensed by environmental sensors 94), and location conditions (e.g., as collect data regarding various conditions, such as the speed of the vehicle (e.g., as sensed by position sensor 98) Examples of conditions include geographic location (e.g., GPS or other location sensing) the position of the object being detected by a position sensor configured to detect the object being detected, time (e.g., a timer or a power time (e.g., as sensed by a timekeeping device such as a magnetic clock), date (e.g., as sensed by a timer) , temperature (e.g., sensed by a temperature sensor), ultraviolet (UV) radiation (e.g., sensed by a UV sensor configured to sense UV levels), humidity degree (e.g., as sensed by a humidity sensor configured to sense the humidity level); Touch (e.g., sensed by a touch sensor) and pressure (e.g., sensed by a pressure sensor) (perceived as a result of the vibration)

[0136] The universal medication delivery device 500 of FIG. 5B and the computer system 700 of FIG. 7 Using the example, the medication administration device 500 may be configured for a key-based security system. data storage operations and data transmission operations between the device 500 and the system 700 Keys can be managed by the device using one of a variety of key establishment protocols. The key can be established between the device 500 and the computer system 700. The device is stored in the memory 97 and in the memory of the computer system 700. The device 500 uses the key to encrypt the data and securely store it in the device 500 or its associated The encrypted data is then sent to the computer system 700 in an anonymous format that does not identify the patient. The device memory 97 may also store the unique ID of the device 500. The device processor 96 may store the D number / code internally. The data indicating the information sensed by one or more of the sensors 92, 94, and 98 is encrypted. The data may be configured to use a key to encrypt the data. The device processor 96 may include metadata of the sensed information, such as the date and time of the device. 00 via the communication interface 99, the encrypted data is transmitted wirelessly to the system 700. The computer system 700 can then be configured to transmit the Receives data through the interface and decodes the received data from the received data. The correct key stored in that memory is identified for use in the authentication process, and then the identified key is used. The stored key can then be used to decrypt the received data. The computer system 700 removes the anonymized aspects of the data and provides the associated The device 500 and the patient may be configured to be uniquely identified, meaning that the key is unique to that particular device. The computer system 700 has a prior knowledge of the device 500 and the patient. As discussed elsewhere herein, accurate patient identification is not required. In some cases, a level of anonymity removal may maintain some degree of patient privacy. Unauthorized third parties may intercept data transmitted by VICE500, and the data may be anonymized. The patient's privacy cannot be removed even if an interception occurs. The medication administration device 500 uses the generated key to All data transmitted from the computer to the system 700 can be encrypted. The system 700 also uses the generated key stored therein to access the device 50 from there. All data sent to the device 500 can be encrypted using its stored key. The information can be decoded using the The data to be transmitted may include, for example, the sensed information to be automatically transmitted to the system 700. In embodiments not configured as such, the sensed information may be transmitted to the system 700. a request to the device 500 to start delivery of a drug from the device 500; 0, change from locked to unlocked (e.g., device 500) By changing the device operation prevention mechanism 40 or 25 from the locked state to the unlocked state, modifying at least one variable parameter of an algorithm stored in the device 500; The user may then initiate a drug administration process (e.g., by administering a dose of a drug to a patient from device 500). The device 500 is required to allow for manual activation of drug delivery from the device 500. Examples of such requests include:

[0137] Figure 9 shows how a key-based security system can be used to securely and anonymously a cloud computing system configured to communicate with one or more devices; 1 shows an embodiment of a drug delivery system 950 including a The medication administration system 950 uses a key-based security system to access cloud computing. a drug administration device 952 configured to communicate with the computing system 951; to communicate with a cloud computing system 951 and a medication administration device 952. A smart mobile device 953 configured and a drug delivery device 952 delivering a drug. and a patient 954 configured to interact with the mobile smart device 953, smart data installed on the smart device 953 and associated with the drug administration device 952 and one or more apps 955 configured to facilitate patient interaction with the device 953. , a computer system for a pharmaceutical company related to drugs, and one or more applications 5 and (e.g., to provide software updates to the app 955, 954), and a drug administration device 952 ( For example, information notifications about medications may be pushed to medication administration devices 952 to inform the device 95 954 via a user interface. A pharmaceutical company computer system 956 and a payer associated with the patient 954, configured to To store data and make it accessible to cloud computing systems 951 and a payer database 957 configured to store drug data related to the manufacture of drugs. , configured to be accessible to a cloud computing system 951; A manufacturing database 958 and a cloud computing system storing patient data associated with the patient 954 are provided. Accessible to the consulting system 951, patient 954, and smart device 953 and a patient database 959 configured to: , configured to be accessible to a cloud computing system 951 The data on the patient 954 is provided by the healthcare provider (HCP) The patient database 959 also includes a smart device 953 under the patient's control. 954, configured to be accessible to the patient 954, such as via Includes patient-side HCP data.

[0138] The key is established between the medication administration device 952 and the client using any of a variety of key establishment protocols. The key may be established between the cloud computing system 951 and the device 952. The memory is stored in the cloud computing system 951. The device 952 uses the key to encrypt the data and store it securely and securely in the device 952 or The data is encrypted and stored in an anonymous format that does not identify the patient 954 involved. The device's memory may also allow the device 9 It can store up to 52 unique ID numbers / codes internally. The device's processor , data representing information sensed by any one or more of one or more sensors of the device The device may be configured to use a key in the encryption. Alternatively, the device may be the sensor itself. and therefore configured to use the key in encrypting data indicative of the sensed information. The data may include metadata of sensed information such as the time and date the data was collected. The processor of the device may transmit the encrypted data via a communication interface of the device. The system may be configured to wirelessly transmit the acquired data to the system 951. The system 951 receives data via its communication interface and decodes the received data. It identifies the correct key stored in its memory from the received data for use in encrypting the and can then decrypt the received data using the identified, stored key. In this way, the system 951 removes the anonymized aspects of the data and This can be configured to identify the device 952 and patient 954 associated with the key. has previously been determined by the system 951 to be associated with that particular device 952 and patient. Conversely, the authority to intercept data transmitted by device 952 is unknown. No unauthorized third party can remove the anonymized aspects of the data and therefore cannot intercept it. The patient's privacy is maintained even if a drug administration device 952 generates The key is used to encrypt all data sent from the device 952 to the system 951. The system 951 can also use the generated key stored therein to All data sent from this device to device 952 can be encrypted, and device 952 , the stored key can be used to decrypt the information. The data transmitted to the device 952 may include, for example, information sensed by the device 952. In embodiments that are not configured to automatically transmit to system 951, A request for the device 952 to transmit information to the system 951, or in another example, a request to the device 952 to begin delivery of a drug from the device 952 to the patient 954; In another example, the device 952 may be changed from a locked state to an unlocked state (e.g., By moving the locking mechanism from the locked state to the unlocked state, the device 952 Modifying at least one variable parameter of the stored algorithm to execute the algorithm on the device 952 952), the user may administer a dose of a drug to a patient 954 from the device 952. A request to the device 952 to enable manual execution of drug delivery from In at least some embodiments, the key is stored in a cloud computing environment. The operating system 951 and other computer systems 953, 957, 958 within the system 950 58, 959 may be similarly established and used with each of any one or more of , the cloud computing system 951 is configured to communicate with them. do.

[0139] FIG. 10 illustrates an exemplary embodiment of a method 900 for using a key-based security system. 5B. Method 900 is shown in flow diagram form for ease of explanation in conjunction with the drug delivery device of FIG. 7. Although the system 500 and system 700 of FIG. 7 are described with respect to Other devices and systems, such as the sensor itself if not present, may be similarly implemented as described above. The key-based system may include a key for transmitting and receiving data between the drug administration device 500 and the system 700. It is used to encrypt and decrypt data being transmitted, so that the data is secure, It may be passed on in public and anonymous form.

[0140] In operation 905, the key-based security system is configured to connect the medication administration device 500 to the device. A unique key is established for wireless communication between the device 500 and the remotely located system 700. In at least some embodiments, the servers configured in system 700 Implements a key-based security system. A unique key is stored in the memory of a remotely located server. The system 700 may store the information in the memory, as well as in additional storage devices that may be configured in the system 700. can send the key to the device 500 for storage in its memory 97, or As described above, the device 500 stores the key pairs used in the key-based security system. It may be configured to generate its own keys.

[0141] In operation 910, the medication administration device 500 detects one or more of the sensors 92, 94, 98. 500 and / or the drug dispensed therefrom. The sensed information may include, for example, data related to dosage and medication. A delivery schedule for the drug to be administered via the drug administration device 500 may be included.

[0142] In operation 915, the processor 96 of the medication administration device 500 reads the data stored in the memory 97. The generated key is then used to encrypt and anonymize data representing the sensed information. In operation 920, processor 96 transmits the data to remotely located computer system 700. Before transmission, the data is anonymized and encrypted, so that during transmission the data is secure and encrypted. The sending in operation 920 may also be performed by a computer system. , a unique ID for the device to facilitate decryption of data received from the device 500 Includes number / code.

[0143] In operation 925, the medication administration device 500 receives the encrypted data from the system 700. If so, the medication administration device 500 uses the key stored in the memory 97 to Decrypt the data that is being sent.

[0144] A sensor configured to sense information relating to a physiological parameter of a patient. The sensor may provide information about the physiological parameter periodically, e.g., at least every 24 hours. Once every 12 hours, once every 3 hours, once every hour, once every 30 minutes, or This can be configured to obtain data once every 10 minutes, depending on how frequently the data is needed. This data can then be selected at the corresponding frequency, or less frequently, as needed. At a higher frequency, the sensor data may be transmitted anonymously to a server as described herein. without the risk of identifying the original patient and therefore the patient's data collection. It may be possible to collect data in an anonymous manner to facilitate obtaining user consent.

[0145] A single patient may be monitored for measuring different parameters, which may be additional physiological parameters. These sensors may all be associated with the same patient in the system. This may allow for aggregation of data on a server regarding this patient.

[0146] Data related to a single patient other than sensor-acquired physiological information may also be acquired. For example, a drug delivery device associated with a patient may also be used to administer medication to a patient, as described herein. This data is then transmitted and aggregated with physiological information on a server to determine the performance of a specific drug delivery device. The present invention may provide an indication of the physiological response to

[0147] The plurality of patients each have at least one sensor for measuring a physiological parameter. The sensors may be associated with each patient in the system and may store patient-specific data. This allows for storage of a range of patient data, which may aid in the detection of trends and correlations. This allows for the collection of many data points across multiple patients. Multiple studies contribute more data points to support further analysis of observed outcomes. Each of the plurality of patients may have a drug administration device associated therewith. , may provide further data to the server.

[0148] In one embodiment of operation, the device is configured to sense information regarding a physiological parameter of the patient. The sensor senses a physiological parameter.

[0149] In a next step, the sensor uses the key to conceal data indicative of the sensed physiological parameter. a remotely located communication interface for transmitting data indicative of the physiological parameters detected; This is repeated periodically, for example, once every 24 hours. Typical measurements are 48 hours, 7 days, 14 days, 30 days, 90 days, 120 days, and 180 days. The time may be repeated for at least 24 hours, such as 365 days a year. Short-term studies can be completed over hours and days, but longer periods are more suitable. It is also possible to accumulate more data and enable more accurate testing. If the physiological parameters include blood glucose levels and nutritional intake such as carbohydrate intake and body weight, this process This process is repeated for 365 days to achieve high-precision long-term glucose testing that cannot be achieved with conventional methods. This can better inform actual treatment algorithms. Cut.

[0150] A patient is provided with a first sensor and a second sensor, each configured to sense a physiological parameter. and a second sensor, the first sensor being configured to sense a blood glucose level of the patient. and a second sensor may measure nutritional intake, e.g., carbohydrate intake, protein intake, and The device may be configured to sense one or more of: blood pressure, blood sugar, and fat intake. Monitoring may involve monitoring various sensors, such as patient sensor 92, as described elsewhere herein. Thus, glucose testing can be performed every time the patient eats, Therefore, glucose tolerance testing is more convenient and less time-consuming than traditional approaches. A method is provided.

[0151] Figure 15 shows an example of a system that stores data related to one of several patients. The system identifies a patient and therefore records associated with this patient. In this embodiment, the extracted data may include blood glucose levels, carbohydrate levels, and the like. These data were analyzed to determine the patient's response to insulin administration. The short-term 30-day and 7-day average response rate to insulin dose / carbohydrate ratio was measured. The sensed data can also be used to provide average blood glucose levels over 90 days for long-term analysis. The ability to extract such data allows for establishing trends for individual patient situations. Such patient data may be combined with similarly situated patients to allow This allows for the construction of a real picture of trends across any particular portion of the population. This can help optimize dosing schemes for new patients who do not have a history of steroid use.

[0152] The sensor data (and / or other data) received about a particular patient is then stored in the patient's electronic health record. in the Electronic Health Record (EHR), and / or in specific drug risk evaluation and mitigation strategies (REMS), e.g. For example, patient monitoring forms for REMS for esketamine, ketamine, or other controlled substances These can be automatically uploaded to forms required for use with specific medications. Thus, the EHR and / or forms can be updated accurately and in a timely manner.

[0153] FIG. 16 illustrates a patient monitoring system using data sensed by one or more sensors for a particular patient. 12 illustrates one embodiment of a method 1200 for updating a form. The patient monitoring form updates medication administration data. It is updated with other data as well, such as data entered into the device's user interface, and It may be transmitted to a remote computer system, such as computer system 700. For example, The psychological state data is stored in an external device, and the patient's responses to the questionnaire questions are Through the responses, the Kessler Psychological Distress Scale (K10) or various other indicators and scales The user interface of the drug administration device, such as responses to psychological stress tests User input in response to one or more questions presented via a user interface, an external device, through various means, including through the provider's assessment notes about the patient, which are stored in the database. The psychological state data may be collected by any method. to assess which treatments should be delivered and how the user is responding to their current treatment. For example, the information may be used by a processor to determine whether a state of mind is A trend toward improvement may indicate effective drug treatment for depression, resulting in reduced drug dosage and / or In another example, the tendency for a psychological state to decline or the frequency of drug administration may be reduced. The static trends of medications used to treat depression may be related to drug dose and / or drug administration frequency. It may indicate that the intensity should be increased.

[0154] In this exemplary embodiment, the sensed parameters include the patient's heart rate (HR), the patient's respiratory rate (RR), and the patient's blood pressure (BP), but as discussed herein, other The condition may be sensed. One or more sensors may collect data 1202 and provide the drug administration device with The sensor 500 communicates the sensed data to a computer system 700 (or other system described herein). The computer system 700 communicates the received sensor data to the device 1204. , enter the patient monitoring form that is temporarily held 1206. Each of the sensed parameters The computer system 700 may then optionally sense the particular condition being measured. The reported data is above a predetermined maximum threshold or below a predetermined minimum threshold. If not, the sensed data is normal, e.g., within acceptable limits. and the computer system 700 records the detected Input the sensed data for the state 1208. If so, the sensed data is , is considered abnormal, e.g., not within acceptable limits. The determination of abnormality is the first determination of abnormality for this sensed parameter for this patient. This determination of abnormality is made for this patient based on this sensed parameter. If this is the first determination of a data abnormality, the patient monitoring form will not contain any sensed data yet. Instead, after sensing the parameters again 1202, the computer system The system 700 receives the sensed parameter data and temporarily stores the received sensed data. 1206. Enter any abnormal sensing data related to this sensed condition into the patient monitoring form that the patient maintains. This sensory data is then used to measure the specific state being measured, so that it becomes a second instance of the sensor data. above a specified maximum threshold or below a specified minimum threshold, as appropriate. If the computer system 700 determines that For possible intervention, a medical professional, e.g., using the drug administration device 500 Provide alerts to staff on-site with the patient, the patient's healthcare provider, etc. 1210 The alerted medical personnel may, for example, view the data on the display screen of the computer system 700. Identify abnormal sensing data by manually reviewing 1212, e.g., input 1208 input to the user interface of the computer system 700 to trigger 1208, whereby the sensed data is entered into a patient monitoring form. Human review of sensory data and confirmation of abnormal sensory data by personnel is essential to ensure that human activity is not This can help enable reimbursement for the specific condition being measured. and if appropriate, the sensed data is neither above a predetermined maximum threshold nor below a predetermined minimum threshold. If the computer system 700 determines that the first anomaly determination is an anomaly, The computer system 700 is considered to be a computer system having a sensed state. Enter the data into the patient monitoring form 1208.

[0155] In other embodiments of the method 1200, the temporarily retained patient monitoring form may be omitted. In such an embodiment, the patient monitoring form may display all sensed data as abnormal for the first time. Even sensory data determined to be non-specific may be entered 1208, thereby providing a more complete patient experience. Records may be provided.

[0156] In another embodiment of method 1200, the medical personnel may be alerted to a first abnormal sensed condition. This may allow medical intervention to be provided more quickly in an emergency. It can be useful.

[0157] In at least some implementations, any of the drug delivery devices of FIGS. 5B and any of the drug housings 30, 630 of Fig. 6, the packaging 35 of Fig. 5B; From a device such as a sensor to a remote computer such as the central computer system 700 in FIG. The data is transmitted securely and anonymized to the data system, allowing for the modification of drug delivery. To modify drug delivery, the drug may be administered in a secure and anonymous manner, as described above. The remote computer system, using the data received in the format, determines the drug delivery from the device. This can help ensure that changes are made based on information that is verified as relevant to the device. This allows the remote computer system to identify the appropriate key for decryption and The remote computer system can only decrypt the data if it has In other words, the remote computer system Receiving only if the user and device have previously established a secure and anonymized communication protocol It can read the transmitted data and use this data to modify drug delivery, The data is self-validating for use in modifying drug delivery. The data used to change the data will be transmitted by means other than the secure and anonymous communication implementation described above. and can be transmitted from the device to a remote computer system.

[0158] When delivering drugs, various factors affect drug administration, absorption, and and the effect on the patient. For example, the physiology or condition of the individual patient, the drug's effectiveness on the patient, The physiological effects of the drug, the external circumstances surrounding the patient, etc. can all affect the outcome of drug administration to the patient. Therefore, drug delivery may be based on a variety of different factors that arise during use of the drug delivery device. This allows for more personalized care while allowing for more time to be spent on treatment. The patient receives and / or the physician provides specialized patient care. Furthermore, much of the drug delivery coordination can be automated. This helps ease the delivery process for both the patient and the physician, It can improve outcomes.

[0159] In an exemplary embodiment, drug delivery is based on instructions from a remote computer system. The drug administration device, e.g., the algorithm stored in its memory, , executable on the device, for example by its processor, to provide a dose of the drug to the patient. The algorithm generates commands, communications, and other information to control the device's function and drug administration. One or more sets of data points that define and / or represent knowledge, signals, etc. The data received by the medication administration device is stored in the form of a packet. as multiple data points via an interface, for example, by a device processor. It is used to change at least one variable parameter of the algorithm. Another variable parameter is between the data points of the algorithm, e.g., drug delivery. The instructions for the algorithm are included in the stored data. It can be changed by changing one or more of the points. After one variable parameter is changed, subsequent executions of the algorithm are Therefore, drug delivery over time can be achieved by, for example, For example, a medical professional may provide input to a computer system for changes in drug delivery. This can increase the beneficial effects of drugs administered remotely for patients. Alterations in one variable parameter and / or the administration of one or more doses themselves may affect patient outcomes. Therefore, the drug administration device is automated to improve patient-based automation. The present invention may be configured to provide a smart system for drug delivery, providing a drug-based medical treatment. do.

[0160] Typically, patients upgrade their medication delivery device or purchase a new medication delivery device. Upgrading remote computer systems is preferable to acquiring new devices. Therefore, the control of the processing and variable parameters can be reduced. Extend the useful life of medication delivery devices by offloading to remote computer systems and / or (of a drug administration device in communication with a remote computer system (on the remote computer system) instead of multiple updates. It may be possible to perform a single update (vs.

[0161] In an exemplary embodiment, the data by which the device's algorithm is modified is stored in the drug delivery device. and collecting data regarding characteristics associated with the device and / or drugs deliverable therefrom. The data includes at least data collected by at least one sensor configured. Therefore, the drug administration device uses local processing to determine the drug dosage based on the information sensed by the device. and at least in some embodiments, past drug delivery and computer systems and customize drug delivery based on one or more additional factors, such as dosage data collected by the If the device includes more than one sensor, each of the sensors may be customized. In a typical embodiment, data on different characteristics is collected and multiple factors are taken into account. This is designed to help improve customization of the algorithm.

[0162] Examples of sensors that can sense data used to modify the algorithm include the The sensors 92, 94, and 98 sense the temperature and humidity, and the temperature and humidity are used to modify the algorithm. Examples of characteristics that may be considered are patient physiological characteristics, patient physical characteristics, and patient situation characteristics. blood glucose (e.g., using a glucose monitor), blood pressure (e.g., using a blood pressure monitor) (e.g., using a fluid sensor), sweat level (e.g., using a respiratory rate The monitor is positioned near the nose or mouth and uses heat detection on exhaled breath or incoming and outgoing airflow. a thermal sensor located near the nose or mouth and configured to detect the pressure of the exhaled breath; or a pressure sensor configured to detect the airflow in and out, a spirometer. various physiological characteristics, such as heart rate (e.g., using a heart rate monitor) Any of the following may be monitored: core temperature (e.g., using a temperature sensor), tremor detection (e.g., using an accelerometer), (using accelerometers, etc.), fall detection (using accelerometers, etc.), irregular gait detection (using accelerometers, etc.) time (e.g., using a timer), date (e.g., using a timer) using), patient activity level (e.g., using motion sensors), blood pressure (e.g., blood pressure monitor, etc.), metabolic rate (e.g., using heart rate, etc. as described herein), altitude (e.g., using an altimeter), temperature of the medication (e.g., using a temperature sensor), using a viscometer), drug viscosity (using a viscometer, etc.), GPS information (using a location sensors, etc.), weather information (using temperature sensors, humidity sensors, etc.) (using a temperature sensor, for example), room or ambient temperature (using a temperature sensor, for example), angular velocity (using an inertial measurement device, for example), Inertial measurement unit (IMU) or magnetic, angular velocity, gravity rate, and gravity (MARG) sensors), body orientation (e.g., using IMUs) the current of the motor used to deliver the drug (e.g., using a current sensor); Oxygen levels (e.g., using a blood oxygen sensor), sunlight exposure (e.g., using a UV sensor, etc.) ), osmolality (e.g., using blood monitors), air quality (e.g., UV sensors, etc.), inflammatory response, the patient and / or the environment in which the patient is located images and / or videos of the subjects (e.g., whether solid food was consumed or liquid food was consumed to analyze food intake) To determine whether the patient has been ingested, to determine the patient's position or activity, to measure skin reaction, breathing, eyes, To determine the patient's condition, such as dilation, sedation, dissociation, and vocal characteristics such as tone and pitch. User-entered data such as general health status, pain scores, and recurrence cycles of specific diseases Many different situational characteristics can be monitored: temperature, metabolic demand, cognitive function, air pollution levels, food intake. At least one of the following was used: intake and basal metabolic rate (BMR) metabolic demand, such as measured by a cardiogram, weight, and one or more images of the patient and / or the environment in which the patient is located. and / or video (e.g., to analyze food intake, whether solid food was consumed or liquid was consumed) to determine whether the patient has been exposed to radiation, to determine the patient's position or activity, or to monitor the patient's condition, such as skin reactions. Any of a variety of different physical characteristics may be monitored, such as to determine Published on December 1, 2011, "Systems and Methods For Regulating Metabolic Hormone Producing T U.S. Patent Application Publication No. 2011 / 0295337, entitled "An issue," April 2014 Published on the 15th, "Obesity Therapy and Heart Rate U.S. Patent No. 8,696,616, entitled "Effective Variability," August 2016 Published on the 30th, "Devices and Methods For The The 9th issue of the same journal, entitled "Treatment of Metabolic Disorders" ,427,580, and October 27, 2015, "Meal Detection No. 9,168,000, entitled "Devices and Methods for Meal Preparations" and / or further describes specifying the type of information about the beverage, is incorporated herein by reference in its entirety. In various embodiments, the sensor an imaging device such as a camera, and a processor for analyzing all food intake; and / or One or more of the following: patient's skin reaction to the drug, patient's level of sedation, patient's level of dissociation, vomiting, etc. Analyzing images and / or video captured by imaging devices to, for example, determine side effects of The facial ID is detected in an image captured by a sensor including a camera. It may be used to help identify patients and ensure relevant data is collected and analyzed. Published December 27, 2012, the disclosure of which is incorporated herein by reference. Medication Verification and Dispensing U.S. Patent Publication No. 2012 / 0330684, entitled "Image Capture Device," Further described in 2004, the disclosure of which is incorporated herein by reference. Published on February 7, 2012, "Remote Control For A Hospi U.S. Patent Publication No. 2002 / 0014951 entitled "Tal Bed" and U.S. Patent Publication No. 2007 / 0014951 entitled "Tal Bed" "Subnetwork Synchronization" published on November 1st And Variable Transmit Synchronization Te chniques For A Wireless Medical Device N U.S. Patent Publication No. 2007 / 0251835, entitled "Network," describes a method for detecting and detecting a variety of sensors. I am considering it further.

[0163] The universal medication delivery device 500 of FIG. 5B and the computer system 700 of FIG. 7 Using the example, the memory 97 of the device 500 may have an algorithm stored therein. The device's processor 96 may be configured to determine the drug to be dispensed by the device's dispensing mechanism 20. The device may be configured to execute an algorithm that controls the delivery of a dose of the product. The interface 99 is configured to provide a variable parameter for at least one of the stored algorithms. 7. A communication interface of the remote computer system 700 requests a change to the In response to the instructions, the device's processor 96 may be configured to , at least one variable parameter of the algorithm is changed as required, resulting in a small The dose delivered after changing at least one variable parameter is The control may be configured to be controlled by

[0164] FIG. 11 illustrates a local processing system 1051 and a network interface that communicates with the local processing system 1051. a remotely located computer system 1052 (local processing system) configured to remotely located relative to the local processing system 1051 and configured to communicate with the local processing system 1051. The local sensors 1053 (related to the local processing system 1051) are each configured as follows: 10 shows an embodiment of a drug delivery system 1050 including: .

[0165] The local processing system 1051 includes a drug administration device 1054 and a drug administration device 1055. a mobile smart device 1055 configured to electronically communicate with the The memory of the device 1054 may have the algorithm stored therein, The processor controls the delivery of the doses of drug dispensed by the dispensing mechanism of the device. The communication interface of the device may be configured to execute the stored algorithm. A remote computer requests a change to at least one variable parameter of the algorithm. configured to receive instructions from a communication interface of the computer system 1052. In response to the instructions, the processor of the device may The variable parameters are changed as required, resulting in at least one variable parameter change. The dose delivered to the patient is controlled by executing a modified algorithm. Alternatively, the memory of the smart device 1055 may be configured to store the algorithms stored therein. The remote computer system 1052 may be a smart device instead. 1055 to control the updating of the algorithms, and execute the algorithms, thereby The device 1054 may be configured to provide commands for drug delivery to the drug administration device 1054.

[0166] The smart device 1055 and / or the medication administration device 1054 may receive the information from the sensor 1053. It receives data from the In this illustrated embodiment, the sensors 1053 may include subcutaneous sensors, skin sensors, and These include skin patch sensors, implantable sensors, and wearable sensors. The data may be transmitted to a remote system 1052 for analysis as described herein. , which may trigger an algorithm update. Alternatively, the medication delivery device 1054 may include, in addition to any or all of the off-board sensors 1053, Alternatively, each may include one or more on-board sensors. The sensor data is transmitted to a remote system 1052 for analysis as described herein. This may trigger an update of the algorithm.

[0167] FIG. 12 illustrates a universal medication administration device 2002 configured to communicate with each other. and a drug administration system 2000 including a remotely located computer system 3002. 20 shows an embodiment of the drug delivery device 2002. a syringe 2004, a medication holder 2010, a dispensing mechanism 2020, and at least one sensor. 2030, 2040 and a memory configured to store the algorithm 2052 therein. a processor 2060; a user interface 2080; and an indicator 2090. 2085, a power supply 2095, and a communication interface 2099. In the illustrated embodiment, the computer system 3002 includes a server 3004 and a memory 3005. 50, a user interface 3080, a processor 3060, and a communication interface Further, with respect to the universal drug delivery device 500 of FIG. Similar to that described above, one skilled in the art would be able to easily assemble the medication holder 2010, dispensing mechanism 2020, processor 2030, and 12 with 2060, memory 2050, and sensors 2030, 2040. The drug delivery device 2000 can perform the various functions described above in several different combinations. For example, the device 2000 may include a sensor 2030, It may contain at least two sensors, but not all of the 040, 2045, and the user interface 2080, etc. In this illustrated embodiment, The sensors 2030 and 2040 are included in the device 2000, but the sensors 20 30, 20, or 40 may be, for example, a geographical location shared with the patient. Mobile phones used by patients that are attached to other devices or equipment that are placed between The device 2000 may be separated from the device 2000, for example, by being part of an application.

[0168] The memory 2050 is configured to store data from the sensors 2030, 2040. However, in other embodiments, this data may be stored in a separate memory on the device 2000 and / or Remote memory accessible to device 2000 via communication interface 2099 The algorithm 2052 stored in the memory 2050 may be stored in a memory location other than the memory. 20 represents instructions for the device 2000 on how to administer the medication in the medication holder 2010; The algorithm 2052 is configured to be executed by the processor 2060. A plurality of data defining and / or representing commands, notifications, signals, etc. for controlling drug administration. The at least one variable parameter is stored in the form of a data point. By varying at least one variable parameter of the two, the method of administration of the drug can be at least At least one variable parameter is common to all data points so that all data points have one change. The parameter can be any of a variety of different delivery and / or drug parameters. Examples of variable parameters include the rate of delivery of the drug from the drug holder 2010 to the patient, The dose delivered after a change in at least one variable parameter is different from the dose delivered before the change. The time interval between dose delivery, the dose amount, the dose strength, the second dose or any subsequent doses, Stopping doses or before the first dose or before all subsequent doses after the first dose Whether and how any additional doses will be delivered, such as by resuming administration after previously stopping administration, will be determined. These include the speed at which the needle of the device automatically advances into the patient, and the temperature of the drug. It can be important to adjust the speed at which the needle of the device automatically advances into the patient. If the speed is too slow, the needle may not penetrate the patient at all or to the intended depth. If the speed is too fast, it may cause discomfort to the patient.

[0169] The processor 2060 of the device 2002 executes the algorithm 2052 to In an exemplary embodiment, the drug is administered in a controlled manner. The processor 2060 executes the algorithm 2052 to administer at least a first dose of the drug. The remote system 3002 controls the delivery of the object to the patient and executes the algorithm in response to commands from the remote system 3002. Change at least one variable parameter of the system 2052 and After changing the data, the algorithm 2052 is executed to determine the dosage of at least one subsequent dose of the drug. In some embodiments, the processor 2060 controls the delivery of the a parameter indicative of whether or not a drug delivery device has stopped delivery of the drug (e.g., whether or not a device operation prevention mechanism of the drug delivery device has stopped delivery of the drug) The drug administration device power supply does not have enough power to deliver the dose. etc.), parameters that indicate administration is acceptable (e.g., drug administration device the device operation prevention mechanism is in a state that allows drug delivery, and the power supply of the drug administration device is in use. By changing the variable parameters (e.g., having enough power to deliver the required amount of Therefore, at least one variable parameter of the algorithm 2052 is changed before the algorithm 2052 is executed. The meter may be altered to control delivery of the first dose. The processor 2060 executes a program stored in the memory 2050. The algorithm 2052 in 2050 is configured to access multiple data points. To change at least one variable parameter of the algorithm 2052, The processor 2060 stores the data points of at least one variable parameter in the memory 2050. The processor 2060 is also generally configured to: Communication interface 2099, indicator 2085, and user interface 2 2050 to control the device 2000, which may include other electrical components such as a The processor may be configured to execute instructions stored therein.

[0170] The processor 2060 may be configured to predetermine the initial dose or to determine the dose after delivery of the first dose. This can be determined during use of VICE 2000 so that future doses can be based on a predetermined schedule. The administration of a drug according to one or more predetermined schedules or administration intervals for the patient. The predetermined schedule may also be configured to automatically control the delivery of the dose. The algorithm 2052 and / or security used may be determined by other healthcare providers. It can be automatically generated based on the 2030, 2040, or some combination of the two. In at least some embodiments, at least one variable parameter includes inter-dose timing, and instructions to change variable parameters of inter-dose timing are , as reflected in data received by system 3002 from device 2000. and reporting to System 3002 by appropriate health care professionals after recognizing a decline in a specific clinical outcome for a patient. It may be changed based on new drug delivery schedule input.

[0171] In some cases, the drug administration device may be configured to deliver a dose even when the device is actuated. However, they may malfunction and not deliver the dose properly. The delivery device allows the inhaler to deliver the medication before the inhaler is inserted into the patient's mouth. or a nasal spray device that dispenses medication through its nozzle before the nozzle is inserted into the patient's nostril. It may be accidentally activated, such as by an object being delivered to it. In the event of an accidental actuation, etc., the medication delivery device must be able to deliver at least the prescribed amount of medication. Even though it was activated once, the patient may not have received the prescribed amount of medication. Therefore, to ensure that the prescribed amount of drug is actually delivered to the patient, 2, 2 to 3, 2 to 4, 3 to 4, 4 to 5, 4 to 6, etc. It may be beneficial to increase the maximum number of tolerated doses (and / or the timing between doses). Instructions to change variable parameters (e.g., device lock / unlock status, dosage, etc.) will operate the device at least one additional time due to a device failure or accidental activation. by an appropriate medical professional after receiving notification that a medical examination is required. The medical professional may modify the device in the event of a malfunction or accidental activation. By being present with the patient at the time, or by text message, email, phone call, etc. by receiving communications from patients through various methods, such as by email, phone, or other notification mechanisms. In an exemplary embodiment, the algorithm determines whether an acceptable device In other embodiments, the allowable number of additional activations may be increased by one. The number of additional actuations of the device that are possible may be more than one. However, the number of additional doses that can be delivered may vary. A one-time limit may help prevent drug abuse and / or may help medical professionals Deepen the intervention to allow, for example, two or more accidental activations before an additional dose is allowed. Evaluate whether additional training is required if the device is damaged, assess whether a new device is needed rather than an additional dose from the previous device etc. may be possible.

[0172] The processor 3060 of the remote system 3002 may be configured to process one or more of the Receive and analyze data representing information collected during the 2030 and 2040 surveys, and based on this analysis, Based on the algorithm, the device is configured to change at least one variable parameter of the algorithm 2052. The processor 3060 is configured to transmit instructions to the device 2002. Use interface 2099, 3099 to send commands to device 2002, The device's processor 2060 executes commands (e.g., one or more (by providing the device 2002 with a plurality of data points that define the instructions for Drug delivery from device 2002 through any of a variety of different mechanisms, such as by The control circuit is configured to control the

[0173] The algorithm uses data collected by one or more of the sensors 2030, 2040. It is configured to change based on patient data, allowing for automatic responses based on patient situation awareness. In at least some embodiments, at least one variable parameter The data may include various readings and / or data from one or more of the sensors 2030, 2040. The device 200 may be modified to provide adaptive adjustment of the dose based on the data. The user can record the cycle time of the disease or disorder recurrence period, and at this point The drug administration schedule reflected in the algorithm 2052 is It will be adjusted after analysis by 060 and better disease control will be achieved taking this into account.

[0174] As another example, changes in a patient's altitude can potentially alter the effectiveness of a drug, possibly Therefore, the period during which the patient is at a different altitude is determined by the sensor 203 0, 2040 and is read by one or more of the remote processors 3060. and is used to change at least one variable parameter in the local processor 2060. By adjusting the dose, subsequent drug dosages can be adjusted.

[0175] In another example, the remote computer system 3002 may receive one or more sensor readings. and in at least some embodiments, may be configured to discontinue treatment entirely based on The patient may then use the device indicators 2085 and / or the user interface 2080 For example, glucose levels may drop significantly. activity levels may begin to increase, blood pressure may drop, and sweating may increase Insufficient REM cycles can be detected by sleep quality sensors. These measurements may be taken by a tremor detection sensor. The defined characteristics allow each indicator to be identified as being consistent with hypoglycemia. The insulin can then be analyzed by the remote processor 3060, in this example. The device 2002 may be an insulin pump configured to deliver, for example, a dose By changing to zero, or by making the frequency of administration unattainable for a period of time, etc. , by changing at least one variable parameter to reflect a zero dose. The administration is initiated when glucose levels are normal, i.e., safe. Monitor potential hypoglycemic events rather than waiting until they fall below a critical threshold and then responding. Because the onset of the condition ends quickly, the patient's glucose level begins to spike again and then drops more rapidly. This will bring your insulin levels back into the healthy, or normal, range and into the ideal range. The embodiment of the invention is described in "Activity Sensing" filed on September 7, 2007. g Techniques for an Infusion Pump System ,” U.S. Patent Application Publication No. 2009 / 0129999, which is incorporated herein by reference in its entirety. This is further described in US Pat. No. 0069787.

[0176] In another example, varying at least one variable parameter may be The infusion rate can be adjusted, i.e., the flow rate can be adjusted, for example, by adjusting at least one variable parameter. In yet another example, on April 11, 2002, Published, "Method And Apparatus To Sense Tem "Perature In An Implantable Pump" U.S. Patent Application Publication No. 2002 / 0042596, the entire contents of which are incorporated herein by reference. As described in, the temperature of the drug can be varied to create a constant flow rate.

[0177] In another example, the system 3002, e.g., its processor 3060, may analyze data received from device 2000, such as patient and / or physical characteristic data, The frequency of drug administration is excessive, which can lead to negative side effects and, in some cases, overdosing. It can be determined that this is causing a risk.

[0178] The remote system 3002 may, for example, monitor the patient's blood pressure, as sensed using a glucose monitor. In response to receiving data over a period of time that continuously monitors a sensed variable, such as a glucose level; For example, the device 2002 may be configured to update the algorithm 2052. If configured to administer insulin to a patient, the algorithm 2052 may , updated in response to monitoring the patient's blood glucose level over a day, week, month, etc. The blood glucose data may be used by the system 3002 to implement the control algorithm 20 52, and the algorithm updates the drug delivery device 2002. When delivered as instructions, the algorithm 2052 is executed by the processor 2060. This allows the amount and timing of insulin that can be administered to the patient to be controlled. In some embodiments, the control algorithm 2052 controls at least one variable parameter. The control algorithm 2052 may be updated by adding appropriate data. Medical professionals have identified new features that were not previously considered in Algorithm 2052 but are now being considered by the system. Secondary parameters as deemed appropriate by a medical professional after reviewing the sensory data received by the system 3002. In this case, we want to control drug administration through data, i.e., control variables. In this embodiment, the control algorithm 2052 may include a calibration routine for the drug administration device 2002. The calibration process may be updated based on the processor 3060 completing the calibration or process. , the accuracy of the device's sensors 2030, 2040 and the The accuracy of the administration is determined and is adjusted to at least one variable parameter of the control algorithm 2052. One or more calibration variables may be determined that may be common.

[0179] In at least some embodiments, in response to an analysis of data received from the device 2002, Instead of being automatically updated by the system 3002 in response to 52 provides input to the device 2002 via a user interface 2080. The patient using the device 2002 may 7, or at a medical facility such as medical facility 706 of FIG. 7, or at a mobile location 710 can provide input to a remote system 3002 at a mobile location. The system may be configured to be updated as required by medical professionals who provide treatment guidance to patients. The user may not be aware of the algorithm 2052 at all or in detail. Therefore, while we do not specifically require changes to Algorithm 2052, we recommend that alternatives be implemented. Instead, the drug delivery device is essentially a requested change to algorithm 2052. A user may request a change more generally. For example, a user may request a change to, for example, device 2002. or a computer system at a medical facility such as medical facility 706 of FIG. 7 or system 3002, such as a computer system at a mobile location, such as mobile location 710; and establish a communication link with a computer system in communication with the by the data of the sensors 2030, 2040 and / or the user interface 208 0, which is transmitted to the system 3002. , updating the control algorithm 2052 based on the side effects or clinical outcomes the patient is experiencing; can be requested.

[0180] The system 3002 analyzes the data received from the device 2002 and responds accordingly. By adjusting the algorithm 2052, the algorithm 2052 can be automatically adjusted in response to requests. Alternatively, the system 3002 may be configured to dynamically update the device 2002. and stored, for example, in memory 2050. Algorithm configuration, e.g., different variable parameters for one or more sets of algorithms 2052 The user may be configured to present the user with alternative control settings. The selection of algorithm is based on sensory information received by the system 3002 and / or is determined by the processor 3060 of the system based on the patient-reported clinical outcome. The system 3002 may determine whether a user has entered a user interface for the device 2002, for example. The interface 2080 or computer through which the user interacts with the system 3002 Alternative algorithm configurations are presented via the system's user interface. and transmits the variable parameter settings of the selected algorithm to the device 2002. and thus allowing the device 2002 to update the algorithm 2052 In other embodiments, the system 3002 may be configured to allow a user to Based on the medical professional's analysis of the data received by the system 3002, the algorithm 20 52 as a medical professional, so that the user A more nuanced algorithm than the alternative algorithms provided by the system 3002 to select algorithm 2052 may be possible.

[0181] In at least some embodiments, the system 3002 includes a plurality of drug delivery devices. The algorithms stored in each are configured to be updated in bulk. For example, a new version of the device firmware or operating system When available to device manufacturers, bulk updates are preferred In such cases, the algorithms updated by the system 3002 may Each device is related to the other, such as being the same model or from the same manufacturing batch. In another example, a medical professional may provide a Multiple drugs associated with each patient in a group or experiencing a common side effect It may be desirable to initiate a bulk update of the control algorithms in the drug delivery device. For example, see "Infusion Pump With A" published on June 20, 2002. n Electronically Loadable Drug Library A nd A User Interface For Loading The Library No. 2,629,393, entitled "U.S. Patent Application Publication No. 200500223344," which is incorporated herein by reference in its entirety. No. 002 / 0077852 relates to drug delivery of various drugs that can be delivered by infusion pumps. Various embodiments of parameters and protocols are described.

[0182] In at least some implementations, the medication administration device 2002 may administer medication at the explicit user's command. Without a command or a request from the system 3002 to update the control algorithm 2052, the control The drug administration device 20 may be configured to autonomously update the control algorithm 2052. 02 is either a specific algorithm setting, variable parameters, security updates, etc. The device may be configured to check for updates to the control algorithm for one or more of the drugs. The administration device 2052 may be connected to the system 3002 via a wireless network. Continuously searches for open communication channels and enables system 3002 to update its control algorithms. and determining that an update to the device's algorithm 2052 is available. Updates are sent to the device 2002 so that the algorithm 2052 can be modified according to the updates. Such a configuration may be configured to require the patient to use The device is turned off because it is no longer in use, or the device is out of range of the network. The system 3002 may request an update for a device that is currently unavailable for update, for example, due to a Alternatively, once the communication channel is established, the medication administration device 2 may 002, for example, that processor 2060 is updated with the latest available version of the control algorithm. The version received from the system 3002 is then used as the The currently installed algorithm 2052 stored in the device memory 2050 If necessary, we compare it with the version of the original file and determine whether it needs to be updated. If so, we use Algorithm 2. 052 with the latest available version. The rhythm 2052 may be configured to be updated.

[0183] that the medication delivery device 2002 has an update available for the control algorithm 2052; Upon recognizing the channel, the device 2002 switches to check for algorithm updates. The device 2002 may search continuously or according to a predetermined schedule. The device either periodically pings the system 3002 requesting an update. The device 2002 may be a user associated with the device 2002, such as a patient or a patient-related Generates notifications to healthcare professionals and updates necessary to install control algorithm updates The notification may be configured to identify an input that is via the system's user interface 3080 or via the user's Other computers accessible to the user, such as through apps installed on the mobile device. This may be provided in a variety of ways, such as audio and / or visual alerts via a computer system.

[0184] Control algorithm updates may be provided by device manufacturers or by medical professionals for specific patient populations. There may be essential updates required by a specialist, such as drug delivery timing or dosing. Alternatively, the control algorithm update may be a may be applicable based on the make, model, and use of a particular medication delivery device 2002. It may be an optional update that may or may not be applicable. Regardless, an update may include adding one or more new variable parameters, modifying one or more existing Deleting an existing variable parameter or changing the coefficient of one or more variable parameters The algorithm 2052 may be updated with one or more variable parameters, such as by It may be the entire algorithm 2052 or a portion of the algorithm 2052. Mandatory and optional control algorithm updates should be customized for specific patients by appropriate medical professionals. Additionally or alternatively, available control algorithms may include customized algorithm updates. Algorithm updates are based on compiling different sets of data by the system 3002. The data collection can be processed to improve safety, patient compliance, and more accurate sensing or detection, which may result in improved diagnostic and / or clinical outcomes or patient responses. The method may determine an updated control algorithm that provides for optimal or optimal dose control.

[0185] Device 2002 and at least one additional drug administration device associated with the same patient Each may be configured to transmit data to the system 3002. In such a case, The system 3002 may collect data from multiple devices, e.g., and / or data input by the user into each of the devices. These data are compiled and compiled to provide insight into the timing of drug delivery and drug dosage over time for patients. The aggregate data may be configured to provide clinical outcomes experienced by patients following drug administration over time. can be correlated with attributable or self-reported status and when a medical professional observes a patient Based on time-based reactions and trends, the control algorithm 2052 (and altering or modifying any control algorithms of the patient and / or other devices associated with the patient It may be possible to provide a number of interconnected devices associated with a drug delivery system. An embodiment of a computing device is described in "De Vice For Enabling Patient Self Testing A nd Treatment Self-Administration And Sys tem Using The Device For Managing The Pa U.S. Patent Application Publication No. 2014 / 0000000 entitled "Patient's Health Care" No. 243635 and "Supplemental" published on February 18, 2016 Device for Attachment to an Injection De These are further described in U.S. Pat. No. 2016 / 0045674, entitled "Advice," which , each of which is incorporated herein by reference in its entirety.

[0186] In at least some implementations, the system 3002 receives from the device 2002 The collected data is aggregated and used to communicate with the device's user interface 2080 and / or system The user interface 3080 or similar displays the drug administration over time as a graphical plot. The response plots can be configured to provide an indication of the dose and clinical outcome. Certain control of the algorithm 2052 being tracked, such as sensory data related to blood glucose levels Sensory data can be displayed along with medication data and diet, sleep, and activity levels. along with any lifestyle or health events reported by the patient, which may include, for example, The appropriate medical professional may evaluate the response plot and determine the appropriateness of the control algorithm 2052. Determine whether any adjustments should be made to A medical professional providing input to the system 3002 via a user interface 3080 By the above, a request for updating an algorithm for the device 2002 is transmitted to the system 3002. It can be flashed.

[0187] In at least some implementations, the device 2002, e.g., its processor 20 60 is a system 3002, e.g., a processor 3060 thereof, that performs the analysis as described above. The system may be configured to perform analysis of the collected information before or instead of collecting the information. The shared analytical responsibility between system 3002 and device 2002 is particularly beneficial for a number of reasons. For example, if the device 2002 has at least one of its sensors 2030, 2040 On the other hand, when the system is configured to collect information continuously, the continuous collection of data is relatively large amounts of data that can be more easily processed by the processors 2060, 3060 In another example, a device that locally processes data indicative of the sensed information may 2002 receives data indicative of the information sensed by the system 3002, and then Identify changes based on analysis of data and then apply the necessary algorithms before the changes can occur. In yet another example, a change to the system 2052 can be identified and effected. In addition to the data from the drug administration device 2002, the system 3002 also includes a number of different drug administration may receive data from various devices, resulting in data fragmentation for various devices. The analysis must be queued and processed one device at a time. The device 2002 for locally processing at least a portion of the sensed information is included in the system 30. Rather than having to queue up data for analysis in O2, Faster analysis reduces the time lag in adjusting Algorithm 2052 In another example, distributed processing may reduce execution time and memory consumption, and / or improve drug administration. Better load balancing of data exchanged between the providing device 2002 and the system 3002 As a result, the drug administration device 2002 can achieve drug administration that does not support distributed processing. The control algorithm operates faster and with less latency than a given device or system. Similarly, the system 3002 is entirely responsible for data analysis. Alternatively, the device 2002 and the system 3002 may share responsibility for data analysis, or at least In some embodiments, the distributed processing is performed by the system 3002 and the medical facility 706 of FIG. 7, one or more computers located at home base 708 of FIG. 7, mobile location 710 of FIG. and may be shared with at least one other computer system, such as a do.

[0188] The device 2002 determines whether changes to the algorithm 2052 may change Data that is configured to be processed locally for the purposes of: analyzes the data collected by one of the sensors 2030 and 2040 and The data collected by the other of the systems 030 and 2040 is sent to the system 3002 for analysis. In another example, the device 2002 may be configured to transmit The data collected within the first period is analyzed to determine whether more sensory data can be collected. The data collected during a second, different time period, such as during typical waking hours, is then submitted to system 30 for analysis. In yet another example, device 2002 may be configured to transmit to device 2002. Data processing as needed, such as when 002 performs continuous monitoring or similar non-stop sensing operations. The patient may be configured to offload the processing of the 2002, such as by providing a drug delivery signal to the drug administration device 2002. The device 2002 may continuously monitor sensed information and / or request a display. This attempts to achieve this, requiring that control algorithm 2052 be run frequently over short periods of time. Therefore, the drug administration device 2002 may delegate or otherwise distribute low priority execution tasks to the system 3002. and can be configured to determine ownership of specific high priority execution tasks. Therefore, a task with a higher priority is assigned to the processor 2060 of the medication administration device 2002. It can be done without excessive strain.

[0189] FIG. 13 illustrates an exemplary implementation of a method 1000 for administering a drug using an algorithm. 12. For ease of explanation, the method 1000 is similar to the drug administration method of FIG. Although the description is given with respect to device 2002 and system 3002, other devices and systems may be used. can be similarly implemented as described above.

[0190] In operation 1005, the drug administration device 2002 executes the algorithm 2052 to The device 2002 controls the delivery of a dose of drug to a patient, e.g., a dispensing mechanism 2020 controls the delivery of a dose of drug to a patient. In operation 1010, the medication delivery device 2010 is released from the holder 2010 to the patient. 002 receives the algorithm 2 from a system 3002 located remotely from the device 2002. 052. As described above, the system The transmission of the command is based on the information collected by one or more of the device's sensors 2030, 2040. and / or to the device 2002 via the user interface 2080. 2002, indicating information received in other ways from the device 2002, such as input from the device 2002. It can be triggered by analysis of the received data. The sending of the command by the mobile device at mobile location 710 of FIG. 7 is configured via a medication administration app, via a computing device at the medical facility 706 in FIG. and / or a medical professional to issue commands or requests to a computer system in communication with system 3002. The device 2002 may implement multiple algorithms 2052. 10, the device 2002 receives the instruction and executes the algorithm 20 Multiple doses may be delivered before changing 52.

[0191] In act 1015, the medication administration device 2002 receives the medication from the remotely located The address stored in the memory 2050 is stored based on the data received from the communication interface. At least one variable parameter of the algorithm 2052 is changed. The drug administration device 2002 executes the modified control algorithm 2052 to administer the drug. The device 2002 controls the delivery of a dose of a drug from the device 2002. The device 2002 is modified The algorithm 2052 is executed multiple times to generate a different algorithm 2052 for the device 2002 in operation 1010. Multiple doses may be delivered before receiving a command to change the algorithm 2052 again.

[0192] In at least some implementations, any of the drug delivery devices of FIGS. 5B and 6, the drug housing 30, 630, such as the packaging 35 of FIG. 5B. from a device to a remote computer system such as central computer system 700 of FIG. Information indicating at least some of the data that will be transmitted to the system in a secure and anonymized manner is , provided by visual and / or audio information via the device's user interface. As mentioned above, this data may be data sensed by sensors on the device. Thus, a patient using the device may provide information collected by the sensors. It can continue to be provided.

[0193] In at least some implementations, any of the drug delivery devices of FIGS. 5B and 6, the drug housing 30, 630, such as the packaging 35 of FIG. 5B. In such devices, a remote computer, such as the central computer system 700 of FIG. The information indicative of at least a portion of the data received from the system may include a user interface for the device. The information may be provided visually and / or audibly via an interface. The patient using the device responds to data received from the remote computer system. and, for example, a device executable by the processor to provide a dosage of a drug to a patient. The patient may be kept informed of any adjustments made to the algorithm that administers the medication.

[0194] In at least some implementations, information about the patient's medication administration device is provided to the user. via an interface to a user, e.g., a patient or a medical professional associated with the patient; In an exemplary embodiment, the information may include information about patient medication, treatment compliance, current feedback and / or configuration of the patient's medication delivery device regarding their current health status and / or Feedback and notifications are used to notify the patient when drug delivery is scheduled. If necessary, any discrepancies in drug delivery can be quickly identified. to facilitate appropriate treatment of patients by notifying and enabling correction of By showing that the delivery was made on schedule, it provides peace of mind and a sense of security to the user. It is designed to provide enhanced patient care. Medical professionals receive data on multiple patients. and thereby allowing patients using the same or different drug delivery devices or housings to Drug dosage and drug delivery data associated with the patient may be monitored.

[0195] In an exemplary embodiment, the feedback and / or notification is provided by a central computer system. system (e.g., system 700 of FIG. 7), and / or a drug administration device and / or The housing (e.g., the drug delivery device 500 of FIG. 5B and / or the housing 6 of FIG. 6) 7, configured to interoperate with at least one instruction device, such as a 7. Medication administration on a mobile computing device at a mobile location, such as drug location 710 The medication administration app will notify the patient via the instruction device. The device is configured to receive instructions directing the device to provide:

[0196] In at least some embodiments, the medication administration app is provided by the mobile device manufacturer. health tracking apps or similar activity tracking programs implemented on mobile devices by Personal data or personal information stored in health tracking apps on mobile devices may be integrated with To avoid sharing data, medication administration apps should not share data with other devices, such as instruction devices. Which other locations the health tracking app remembers when it is operating to send data Similarly, the data may be configured to remove personal and private data that is acquired from the mobile device. When received by the device, the medication administration app extracts data into hierarchical condition categories or other medical In at least some embodiments, medication administration may be configured to remove administrative data. The provided app is different from other health tracking applications that may be installed on a mobile device. At least some of the health or activity data may be configured to be imported from the In this embodiment, the medication administration app converts the user's health and activity data into medication administration data. and / or elsewhere, for example, the drug administration device 500, the housing 630, and and / or a dashboard that integrates relevant medical information that may be available from the system 700 As a result, users can easily access an integrated view of their health status and disease management data. The display can be viewed and interacted with.

[0197] The medication administration app is an application that combines health tracking data and mobile devices. Integration into the app could enable trend analysis of patient health status. is a patient's condition sensed or determined by the drug administration device, housing, and / or system. lifestyle management advice based on trends and corresponding changes identified in the patient's health status In at least some embodiments, the drug administration app may be configured to provide The program performs cost analyses related to patient care and determines projected future costs. The medication administration app may be configured to allow users to access their personal medical records, Allows you to schedule appointments and access patient billing, insurance, and payment information When used by an appropriate medical professional, the medication administration app develop new medical treatments by providing training on new treatments, medications, or alternative therapies This may allow for faster onboarding of specialists. In these embodiments, the medication administration app , may be configured to identify conflicting patient activities and drug side effects, and identify new or Further information about various notifications and their provision may be provided. The explanation is in "Systems and Methods" published on March 20, 2014. ds For Surgical And Interventional Plann ing,Support,Post-operative Follow-up,And U.S. Patent No. 6,239,663, entitled "Functional Recovery Tracking" No. 2014 / 0081659, the entire contents of which are incorporated herein by reference. will be incorporated into

[0198] The medication administration app provides healthcare professionals with medication administration data related to a patient or patient group. It can be configured to provide interactive digital assistance. For example, a medication administration app can automate The device may be configured to provide a controlled dialogue and an assessment of the patient's mental or emotional state. Such dialogue and assessments are crucial to assessing the patient's level of cognitive ability or impairment, as well as their risk of depression, agitation, and stress. In at least some embodiments, the method may be useful for detecting symptoms of depression or anxiety. The Medication Dosage App does not recommend or endorse any medications or other medications that may be prescribed by a healthcare professional regarding dosing instructions, drug interactions, and / or side effects. It can be designed to answer basic questions asked by healthcare professionals regarding medication administration. Further description of the interactive digital assistance that may be provided to users is provided in the aforementioned March 20, 2014 publication. Systems and Methods for Surgical Aids nd Interventional Planning,Support,Post- operative Follow-up,And Functional Recov U.S. Patent Application Publication No. 2014 / 0081659, entitled "Smart Tracking" , and "Intelligent Inhale," published on November 15, 1994. r Providing Feedback To Both Patient And U.S. Patent No. 5,363,844 entitled "Medical Professional" No. 2, which are incorporated herein by reference in their entireties.

[0199] Medication administration apps provide patients with information about their health and lifestyle management The system may be configured to provide interactive digital assistance by formulating questions to be asked. The medication administration app provides quality information tailored to the patient's overall health and / or their current treatment. In at least some embodiments, the drug administration The app may collect patient physiological data, dosage data, dosage delivery schedules, and / or Summarize dosage compliance data so users can extract insights and provide other supporting evidence It may be configured to apply or collect data or metadata, e.g., algorithms is applied to the data based on processing of aggregated data sources to identify the patient's physiological data. determine maintenance or escalation procedures that may be required when thresholds are exceeded. For further information on using data to extract or find supporting data, see , published on February 3, 2005, "Method of Controlling Delivery Of A Service And Devices For Pe "Performing This Method," U.S. Patent Application Publication No. 2005 / 0109994. No. 0027791, the entire contents of which are incorporated herein by reference.

[0200] Digital support functions built into the medication administration app will help improve self-administration and disease prevention. Self-management and health solutions can be provided to patients. For example, digital assistance functions can be used to New treatment providers located within the geographic area may specialize in a patient's specific disease or health condition. In at least some embodiments, the digital The support function is a social network that can provide assistance to patients based on their needs and health status. The drug administration app may be configured to identify a network or online community. Other self-administration and self-management features of the interactive digital assistance functions configured within 714 include: self-reported health status data and sensors on the medication delivery device and / or housing These include proposals for alternative injection sites or drug delivery mechanisms based on sensory information collected by the In at least some embodiments, the digital assistant may use behavioral data, as well as The drug delivery device may include a drug delivery system, ... The system may be configured to generate recommendations for avoiding relapse of substance addiction. For further explanation, see the aforementioned article, "Systems and Methods For Surgical And Interventional Planning,Support,Post-operative Follow- up,And Functional Recovery Tracking" , U.S. Patent Publication No. 2014 / 0081659, and published October 5, 2017 , “Systems and Methods for Predicting Met Abolic and Bariatric Surgery Outcomes and US Pat. No. 2017 / 0286610, which are incorporated by reference in their entirety. No. 60 / 699,493, filed on Oct. 1, 2003, and incorporated herein by reference.

[0201] In at least some embodiments, the feedback / notification is provided when a threshold is exceeded, the patient's Based on some aspect of the data related to the medication delivery device or based on rules, the user In at least some embodiments, the feedback / notification may be provided to a specific The data may be presented hierarchically based on the importance of individual or combined data parameters. For example, data related to the operation of a patient's drug delivery device, such as a decrease in needle penetration depth, may be used to A specific symptom sensed via at least one sensor in the medication administration device, such as elevated blood sugar levels, When combined with physiological conditions, the user interface of the drug administration device may The drug administration device may be configured to take steps to correct any faulty devices that may be causing the elevated values. The feedback / notification may be configured to notify the user. Corrective measures, such as interfering with the drug administration device or requiring updated control algorithms for the drug administration device, may be taken. The location can be identified.

[0202] Notifications and feedback are transmitted between devices associated with a computing system In one embodiment, the medication administration app may be configured to allow a user to administer a medication. The notification settings of the medication administration device and / or housing can be configured. and / or may exchange data with the housing. The administration app allows users to set audio, visual, or tactile notifications It can be configured as follows.

[0203] In some embodiments, a user, for example, via a user interface or app, The feedback / notification provided to the patient is that the drug delivery from the drug administration device is complete and the drug When the administration device is no longer needed or drug delivery is not occurring, the drug administration device is emptied of drug. If not, it may contain information regarding the proper disposal of the medication delivery device. The disposal may be the final disposal of the drug administration device (e.g., as medical waste); or The drug administration device may be recycled. Therefore, proper disposal of the drug administration device The information regarding esketamine, ketamine may be final disposal information or recycling information. Some drugs, such as narcotics and other controlled substances, are controlled by a third party, for example, to ensure that the drug is not taken in by unauthorized persons. To avoid this, we comply with government requirements, such as the requirements of the U.S. Federal Drug Enforcement Administration, non-U.S. federal Disposal may be per local, state, or regional requirements. and even if such drugs are delivered from a drug administration device, Disposal of the drug may still be required. This may be due to, for example, the proper use of the drug administration device. Residues of drugs may subsequently be deposited in the drug delivery device, potentially accessible to unauthorized third parties or users. This is because a certain amount may be left over.

[0204] An example of proper disposal of a medication delivery device is when a user contacts a supplier "X" to dispose of the medication. The purpose of this is to schedule collection of the drug delivery device and provide contact details to supplier "X". Another example of proper disposal of a medication delivery device is when a user The purpose of this is to ship the drug delivery device to company "Y" and provide company "Y" with its mailing address and / or Shipping cost information may be provided.

[0205] In an exemplary embodiment, information regarding the proper disposal of medication delivery devices is provided for all prescription medications. Although the amount is provided after delivery from the drug administration device, this information may be provided at other times. In some embodiments, the medication administration device, e.g., its processor to locally determine that all prescribed doses have been delivered from the drug administration device. For example, the drug administration device may be configured to The processor may include a counter for counting the number of prescribed doses, the counter corresponding to the number of prescribed doses. In another example, the drug administration device may be configured to determine when the predetermined number is reached. , counting down one from the maximum number of prescribed doses each time a dose is delivered from the drug administration device. The processor may include a counter that counts up to 1000, and the processor may be configured to determine when the counter reaches zero. In other embodiments, the drug administration device may be configured to and configured to transmit drug delivery information to a remote computer system, such as a system 700. The remote computer system can be accessed in any of a variety of ways, such as by the examples described above. and configured to determine that all prescribed doses have been delivered from the drug administration device. In response to determining that all prescribed doses have been delivered from the drug administration device, The remote computer system may be configured to: The device may be configured to send a request to provide information regarding the appropriate disposal.

[0206] Information about the proper disposal of medication delivery devices is provided based on the user's geographic location. Medical waste disposal requirements vary by jurisdiction (e.g., county, city, state, federal). information regarding the proper disposal of medication delivery devices based on the user's geographic location, This can be useful to ensure compliance with local jurisdictional regulations. The geographic location of the user can be used to or in another example, by a drug administration device including a physiological sensor, as would be understood by one skilled in the art. Such information may be known by a user's mobile device that includes location sensing capabilities, and may be used by the mobile device. The device may be configured to communicate with a drug administration device and / or a remote computer system. It is composed of:

[0207] Drug delivery devices and and / or a remote computer system that geolocates the disposal instructions for the medication delivery device. For example, each of a plurality of geographic locations may be associated with a specific Disposal instructions for the medication delivery device, including the disposal data in a lookup table that correlates the disposal data with the medication delivery device disposal instructions. The disposition database may be configured to access a remote computer. to the data system and / or by the drug administration device and / or Another computer system, such as that maintained by the manufacturer of the drug being delivered, The data can be maintained in the data system.

[0208] In some embodiments, the disposal database also includes information regarding disposal of the medication administration device. Carbon footprint information, e.g., lookalike information, The carbon footprint can be correlated with each of the geographic locations in a map table. The notification information may include disposal instructions for the medication delivery device and any other information related to the medication delivery device. Alternatively, carbon footprint information may help inform users of environmental factors that may be present in the product. Once the geographic location of a particular medication delivery device is known, it may be disposed of based on the disposal requirements for that geographic location. for example, based on facilities that dispose of or recycle drug administration devices, and / or Based on the geographic location itself, for example, manufacturers of drug delivery devices and / or drugs may or geographically, where they may take actions to reduce their carbon footprint, such as making charitable donations. This may be calculated after a predetermined number of medication delivery devices have been discarded from a location.

[0209] In some embodiments, the drug administration device includes a device that includes a label for proper disposal of the drug administration device. Instead of providing information about the device, the disposal containers contain multiple used drug delivery devices. For example, information regarding the proper disposal of a medication administration device contained therein may be provided, e.g. , may be a smart container configured to provide on its user interface. The container may transmit data and display information similar to that described above for the drug delivery device. The container may be configured to determine the amount of medication contained therein based on the geographic location of the container. The same container is designed to provide information about the proper disposal of the device and can be used in any location. It can be used in any geographic location, but provides information specific to that geographic location. This allows the container to be more efficient as it does not need to be customized for a specific geographic location. In an exemplary embodiment, the container may be manufactured to accommodate a predetermined threshold number of medication delivery devices. Once disposed of, provide information regarding the proper disposal of the medication delivery device contained within. The predetermined threshold number is determined based on the size of the container and the amount of drug waste contained therein. While this may vary based on the size of the product dispensing device, the predetermined threshold number is generally Corresponding to the number of medication delivery devices that are filled or nearly filled. In this case, a site (e.g., a hospital, clinic, or other medical facility) may require a specific type of medication administration data. A smart container may be certified as a supplier of the device and may receive the smart container after such certification. The site is not intended to be used for esketamine, ketamine, or other regulatory purposes that have site certification as a REMS requirement. must be certified for certain types of drugs, such as substances, and therefore Drug administration devices that deliver the drug may need to be certified.

[0210] In some embodiments, the drug delivery device or smart container is a suitable drug delivery device. Rather than providing information about the disposal of the materials, the shipping carton information on the proper disposal of the medication delivery device, e.g., via its user interface. The carton may be a smart carton configured to provide data on a and configured to transmit and display information similar to that described above with respect to the medication administration device. The cartons are used to identify the medications shipped within them based on the carton's geographic location. The same carton is designed to provide information about the proper disposal of the device. It can be used in any geographic location, but provides information specific to that geographic location. Therefore, cartons do not need to be customized for a specific geographic location; The compound can be produced more efficiently.

[0211] In some embodiments, the drug delivery device, smart container, or smart carton Rather than providing information about proper drug delivery device disposal, Smart containers, or smart cartons, can be electronically read and used to administer medications, Drug administration device in a smart container or drug in a smart carton or smart container configured to provide information regarding proper drug delivery device disposal for the delivery device A medication delivery device, smart container, or smart carton (or other (part of a medication delivery device, smart container, or smart carton) The label may have a variety of configurations. For example, the label may be attached to the medication holder. The label may include an integrated circuit configured to transmit medication holder data from another An example may be a radio frequency identification (RFID) tag. In yet another example, the label may be in the form of a bar code. The label may be a single label or There may be multiple labels. If multiple labels are used, each one represents a different tag. They can be of different types (e.g., one containing a barcode and the other containing an RFID tag), allowing for redundancy. and / or certain types of data communications are not currently available, e.g. For example, disposal information can be obtained even if the RFID scanner is absent or out of order. Various types of readers, e.g., barcode scanners, RFID scanners Use a mobile phone with barcode reading capabilities to read the barcode appropriately for the type of label. The label can be read electronically as follows: The reader can then determine the proper disposal of the medication delivery device. The reader may be configured to display a readout on the reader regarding the appropriate medication. and a computer system that displays the readout information regarding the disposal of the substance administration device. It may be configured to convey information.

[0212] FIG. 14 shows a user interface 11 that displays data, feedback, and notifications. 14 shows an embodiment of the user interface. The 1100 delivers insulin via a drug delivery device to lower a patient's blood sugar. However, other types of drugs and other types of drugs may be used as described herein. An administration device may be used.

[0213] The user interface 1100 includes patient identification information 1105 and date and time identification information 1110. a configuration icon 1115; a current status portion 1120; and a reminder portion 1125. It includes a summary portion 1130, a reading portion 1135, and a received data portion 1140. In some embodiments, the identification information and portions of the user interface 1100 The layout and arrangement may be interactively reconfigured by the user, as will be understood by those skilled in the art. In this way, the user can view the content organized to suit the user's preferences. Customizable dashboard-like data displays can be created.

[0214] Patient Identification Information 1105 identifies patient "JaneSmith." The interface 1100 monitors each device with which the user is interacting to help provide a secure system. to display the user's name after properly authenticating themselves to the device or system. Users may choose single-factor, two-factor, multi-factor, and / or strong authentication methods. Users can prove their identity in a variety of ways, such as by using passwords, passphrases, personal identification numbers (PI) N), challenge response, security questions, ID cards, security tokens token, software or hardware token, fingerprint, retina pattern, signature, user's Prove your identity using one or more authentication factors, such as face or voice, biometrics, etc. This can be done.

[0215] The date and time identification information 1110 displays the current date and time. The current date and time is used for reminders, notifications, or other schedule-based data, such as reminders of when to administer the next dose of medication. The time context for the image may be provided to the user.

[0216] The configuration icon 1115, when selected or otherwise activated, The user interface 1100 includes additional information related to the settings and configuration of the user interface. Interactive graphic affordances or icons that reveal additional functionality. Selection / activation of information 1115 identifies information and portions within the user interface. The display of the user interface 1100, such as the arrangement or order, The present invention provides a user with tools to configure the device that displays the interface 1100. In at least some embodiments, the configuration identification information 1115 is configured to: The user interface 1100 provides information about the patient's medication administration device or housing. It is configured to display information that provides help information on the correct use of the tag, for example , the configuration identification information 1115 may be represented by an icon, symbol, or The patient medication delivery device or housing that provides information to the user to ensure correct use. To help users understand the update, additional graphics, such as numbers, may be added to indicate that an update is available. The indicated update may include a user interface affordance or indicator. The patient's medication delivery device or housing may include a downloadable device. and may relate to updated versions of the software available for installation. The range of allowable configuration changes provided by the configuration identity 1115 is It can be adjusted as a preference.

[0217] The current state portion 1120 of the user interface 1100 displays sensor data, e.g. , the sensors 92, 94, 98 of the drug administration device 500 of FIG. 5B, and the user interface 1100 is a sensor of a mobile device or other sensor. In this example, the current status portion 1120 includes the patient's heart rate (beats per minute). 78 breaths per minute), body temperature (99.1°F), respiratory rate (18 breaths per minute), and activity level ( It displays 6,235 steps against a daily goal of 8,000 steps.

[0218] The reminder portion 1125 may include one or more upcoming medication dose reminders, and / or provides reminders regarding other aspects of the patient's treatment plan. In this example, the reminder section Minute 1125 provides a reminder: "Next dose administered: today @ 9:30pm." Therefore, since the current time is 6:24pm, the user knows that their next dose is due in approximately 3 hours. Other examples that may be provided in the reminder portion 1125 include: a reminder indicating the current required to manually administer a dose of the drug to the patient, as well as a reminder indicating the current required to manually administer a dose of the drug to the patient; Replacing the battery in a medication delivery device, charging the battery in a patient's medication delivery device, Reminders to order medication refills for the device. In some embodiments, an audio, visual, or tactile notification is provided in the reminder portion 112. 5. The reminder is provided along with the reminder displayed in the and / or reminders are provided at the scheduled time of the action to be taken and The system may assist in encouraging the user to take action.

[0219] The summary section 1130 provides a summary view of the previously scheduled doses of the drug to the patient. As in this illustrated embodiment, summary portion 1120 also includes the following: "1. Reduces blood sugar." The intended treatment of the drug for the patient, indicated by the "pre-planned dose to As shown in FIG. 14, the summary section 1130 may provide an indication of the effectiveness of the The summary section includes a list of the three doses planned for the study, items a-c, as shown in item a. Minute 1130 indicates that the previously scheduled dose was administered "Today @ 9:30am" and "1 / 30 / 19@9:33am" was successfully delivered ("Completed"). The summary portion 1130 then compares the doses to a predetermined delivery schedule. Intuitively indicate to the user the timing of the delivered dose, as shown in item a, sub-item i. The summary section 1130 also displays a message to the patient saying, "Expiration Date: 1 / 30 / 19 @ 11:00 pm." Item c also provides the user with an indication of the estimated remaining duration of effectiveness of the delivered drug. Shows the information ("Yesterday @ 9:30am - Completed 1 / 29 / 19 @ 9:26am") The previously scheduled dose shown at minute 11:30 also appears in item b "Yesterday @ 9:30 p.m. The time at which a patient failed a previously scheduled dose can be indicated by "m-failure." The summary section 1130 can contain additional summary information, e.g., "Yesterday @ 9:30am" It may be configured to scroll to display previously scheduled doses, etc. Other portions of the user interface 1100 may also be scrolled to display additional information. It can be configured to be able to do so.

[0220] In at least some embodiments, the summary portion 1130 may be selected or acted upon. Once activated, the summary portion 1130 displays the usage information in a graphical format, such as a graph or chart. Other objects, such as tabs or icons, configured to display volume delivery data over time. In at least some embodiments, the overview The dose delivery data included in portion 1130 may be used in conjunction with other clinical outcomes, sensing, or other data provided by the patient. may be provided in connection with reported data events and / or self-reported health status data. In some embodiments, the dose delivery data included in the summary portion 1130 may be used by the system. 700 or via the system 700 and the network 702. The information may be provided in conjunction with data received from other data sources.

[0221] The reading portion 1135 indicates the previously delivered drug from the drug administration device or housing to the patient. provide a correlation between the timing of the drug dose and the timing of the medical event experienced by the patient. In this illustrated embodiment, the reading portion 1135 provides the most recent three previously scheduled readings. This diagram includes a list of doses administered and one or more sensed characteristics of the patient. In the illustrated embodiment, for example, the amount of blood pressure measured by one of the sensors of the drug administration device It also includes the patient's blood glucose levels measured at each of the scheduled doses. As shown by amounts 1 and 3, insulin is administered appropriately according to the pre-scheduled time. Once administered ("Complete" in summary section 1130), the patient's blood glucose level will be "Today @ 9:3 A reading of 85 mg / dL corresponding to Dose 1 completed at "0 am" and "Yesterday @ 9:30 am" The patient's blood glucose level was 78 mg / dL, corresponding to the completed dose 3. The patient's blood pressure remained within normal limits. However, at dose 2 "yesterday @ 9:30 pm" If the test fails ("Failed" in summary section 1130), the patient's blood glucose level will be 225 mg / dL. The reading portion 1135 displays the timing of the previously delivered dose of drug relative to the previously delivered dose. It can be configured to correlate the time of the dose achieved with various medical events that a patient may experience. In at least some embodiments, the medical event data may be derived from a patient's medical record; The reading portion 1135 may include information about the timing of previously delivered doses and medical record data (e.g., clinical The present invention may provide correlations between the results of various clinical trials (including laboratory tests).

[0222] The received data portion 1140 may be transmitted to a remote location, such as the system 700 of FIG. Data that may be received from remote data sources available through system 700 via As shown in FIG. 14, the received data portion in this illustrated embodiment 1140 contains updated medical record information "1. Updated Medical Records - Now Available." The updated medical record information is stored in a medical record database configured in system 700 of FIG. or from a database associated with a computer system located at medical facility 706 in FIG. In an exemplary embodiment, the user may receive a Click on the provided uniform resource locator (URL) By clicking or otherwise selecting, the updated medical record may be displayed. In this illustrated example, as shown in "b. Click here to view" So, when you click on the word "here", the updated user interface 1100 The URL is configured to display the medical record of the user. may be used without limitation within 100 to provide additional data for display to the user. do.

[0223] As also shown in the received data portion 1140, the user may Data may be received that provides help information regarding the use of the housing. For example, In this illustrated embodiment, the data section 1140 is labeled "2. New Device Software." - Help information may be shown as an update shown as "Available for Download." This includes new device configuration and patient medication delivery devices or housings. This may include product documentation such as the associated user manual. Help information is available by clicking or otherwise selecting It may be transmitted to and installed in a drug administration device or housing.

[0224] The received data portion 1140 may include any data sensed by the patient's medication administration device 500 or housing. or may include data that may be received remotely based on the determined information. In the illustrated embodiment, the received data portion 1140 is "3. From Dr. Jones Includes remote data received as "compliance messages." 22 cases related to the dose not administered "yesterday @ 9:30 pm" A patient's medication delivery device and / or housing that detects a 5 mg / dL increase in blood glucose level. Based on the sensor, the medication delivery device and / or the housing may include a user interface For display in the received data portion 1140 of 1100 (drug delivery and compliance In this illustrated example, the sensed blood glucose level (in addition to the (In addition to summary data showing the missed dose scheduled for "yesterday @ 9:30 pm") As a result of receiving the blood glucose value, the system may, for example, provide a notification in the reminder portion 1125. Through this, patients are provided with the appropriate guidance and medication schedules needed to lower their elevated blood sugar levels. Configure the patient to send a compliance message reminding the patient of the module. In this way, the patient's medication delivery device or housing may be The data sensed or otherwise determined by the The remote computer system may then receive the sensed information and transmit it to the remote computer system. and generating data related to the received information and transmitting it back to the drug administration device or housing to enable the user to The information may be configured to be provided to the user via the user interface 1100.

[0225] the user interface 80 of the medication administration device 500 or the housing 630, or The user interface 2080 of the medication administration device 2002 Further explanation of the data provided in the database and the presentation of the data is available at http: / / www.ibm.com / software / data ... "Remotely Programmable Infusion" U.S. Patent Application Publication No. 2002 / 0091454, entitled "System," and Published on June 12, 2018, "Intelligent Personal Heal th Management Appliance For The Measurem ent And Monitoring Of Health Factors And 200, entitled "Controlled Delivery of Drugs" No. 8 / 0139907, both of which are incorporated herein by reference in their entireties. be absorbed.

[0226] All of the devices and systems disclosed herein are designed to be disposed of after a single use. It may be designed to be used multiple times, or may be designed to be used multiple times. However, the device can be reconditioned for reuse after at least one use. Maintenance involves the steps of disassembling the device, followed by cleaning or replacing specific parts, and then This may include any combination of reassembly steps. Specifically, the device may be disassembled. and the ability to selectively replace any number of the particular pieces or portions of the device in any combination. When certain parts are cleaned and / or replaced, they can be removed for subsequent use. The device is reassembled at a reconditioning facility or by the surgical team immediately prior to surgery. Those skilled in the art will understand that reconditioning of a device requires disassembly, cleaning / replacement, and reassembly. It will be appreciated that various techniques are available for this purpose. The resulting reconditioned devices are all within the scope of the present application.

[0227] It may be preferable that the devices disclosed herein be sterilized before use. Examples of suitable methods include beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., cold immersion). Sterilization can be accomplished by a variety of known methods. The embodiment is described in "System and Method" published on August 13, 2009. d Of Sterilizing An Implantable Medical This is described in more detail in U.S. Patent Publication No. 2009 / 0202387, entitled "A Novel Electromagnetic Wave Propagation Device." When implanted, the device is preferably completely sealed. This can be done by a variety of methods known to those skilled in the art.

[0228] The present disclosure is described through the examples only within the context of the entire disclosure provided herein. Within the spirit and scope of the claims appended hereto without departing from the overall scope of this disclosure. It will be understood that modifications may be made.

Claims

1. 1. A drug delivery device configured to hold a drug therein, comprising: configured to sense information about at least one of the medication administration device and the medication. a sensor formed thereon; a memory configured to store data therein, said stored data comprising: A remotely located server is established, and the drug administration device and the remotely located server are connected to each other. a memory containing a key that is unique to the wirelessly transmitting data indicative of the sensed information to a remotely located communication interface; a communication interface configured to Using the key, the sensed information is transmitted prior to the transmission of the data indicative of the sensed information. a processor configured to anonymize the data indicative of information. 。

2. The drug delivery device may be a syringe, an injector, an inhaler, a nasal spray device, or an injection pot.

10. The device of claim 1, wherein the device is one of:

3. The processor is located remotely from the communication interface. and configured to use the key in anonymizing all data sent to the interface. The device of claim 1 .

4. The processor repeatedly uses the key to generate a plurality of signals indicative of information sensed by the sensor. The device of claim 1 , configured to anonymize a dataset of

5. The communication interface receives data from the remotely located communication interface. and the processor is configured to receive the signal wirelessly from the remotely located communication interface. configured to use the key in decrypting the data received from the interface. The device of claim 1 .

6. The processor receives all data from the remotely located communication interface. The device of claim 5 configured to use the key in decrypting.

7. The communication interface receives data from the remotely located communication interface. and configured to wirelessly receive the data from the drug delivery device.

10. The method of claim 1, further comprising: The device described.

8. The processor may further include a processor for receiving the information regarding appropriate disposal information for a user of the medication administration device. The device of claim 7 , configured to cause notification of

9. Proper disposal of the drug delivery device after the drug has been delivered from the drug delivery device. The device of claim 1 further comprising a label containing disposal information.

10. The processor controls the medication administration device based at least in part on the sensed information. The device of claim 1 , configured to control delivery of the drug from a mechanism.

11. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 10. The device of claim 1, comprising at least one of the following: paliperidone;

12. 1. A drug delivery system comprising: a server, a communications interface configured to wirelessly receive data and wirelessly transmit data; Su and a memory configured to store a key therein; a server including a processor; 1. A drug administration device comprising: a memory configured to store therein said key, said key being associated with said medication administration data; a memory specific to the device and the server; wirelessly transmitting data to the communication interface of the server; a communication interface configured to wirelessly receive data from the communication interface. and, a medication administration device including a processor; The processor of the server uses the key to communicate with the medication administration device. configured to anonymize all data transmitted to the interface prior to said transmission. And, The processor of the medication administration device uses the key to communicate with the server. configured to anonymize all data transmitted to the interface prior to said transmission. The system.

13. The drug delivery device may be a syringe, an injector, an inhaler, a nasal spray device, or an injection pot.

13. The system of claim 12, wherein the pump is one of:

14. The processor of the server uses the key to communicate with the medication administration device. configured to decrypt all data received from the interface; The processor of the medication administration device uses the key to communicate with the server.

13. The method of claim 12, wherein the method is configured to decode all data received from the interface. The system described in

15. The processor of the server receives a communication signal from the communication interface of the medication administration device. and transferring the data received from the patient to a patient electronic health record (EHR) associated with the medication administration device. ) and at least one patient monitoring form for drug risk evaluation and mitigation strategies (REMS) 13. The system of claim 12, wherein the system is configured to automatically upload the data to the user.

16. The drug administration device also includes a drug delivery system for delivering a drug to at least one of the drug administration device and the drug. a sensor configured to sense information relating to the communication interface of the server; 13. The method of claim 12, wherein the data transmitted to the interface includes data indicative of the sensed information. The system described.

17. The processor of the medication administration device determines whether or not a drug is administered based at least in part on the sensed information. and configured to control delivery of the drug from the drug administration device to the patient based on the 17. The system of claim 16, wherein

18. The data transmitted to the communication interface of the server is received from the server. The system of claim 12 including data in response to a data request.

19. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 13. The system of claim 12, comprising at least one of the following: paliperidone acid;

20. A drug administration method comprising: Wireless communication between a drug administration device and a server located remotely from the drug administration device. establishing a unique key for authentication, said key being stored in a memory of said medication administration device; establishing a unique key, which is stored in the server's memory; a sensor of the drug administration device for detecting a signal from the drug administration device and / or the drug; and sensing information related to A processor of the medication administration device, anonymizing data indicative of the sensed information using the key; Decrypting data received from the server at the processor of the medication administration device. and using the key stored in the memory of the medication administration device when ,method.

21. The drug delivery device may be a syringe, an injector, an inhaler, a nasal spray device, or an injection pot.

21. The method of claim 20, wherein the pump is one of:

22. and determining whether the processor of the medication administration device is configured to determine whether the medication administration device is configured to perform a drug administration process based at least in part on the sensed information. and controlling delivery of the drug from the drug administration device based on the measured drug.

20. The method according to claim 20.

23. The data may be stored in the drug delivery device after the drug has been delivered from the drug delivery device.

21. The method of claim 20, including information regarding proper disposal of the chair.

24. Using the processor, providing a user of the medication administration device with appropriate disposal information.

24. The method of claim 23, further comprising causing notification of the information to be provided.

25. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 21. The method of claim 20, comprising at least one of the following: paliperidone acid.

26. 1. A drug administration device comprising: configured to store therein an algorithm including at least one variable parameter; memory and A communication interface configured to receive data wirelessly from a remotely located communication interface. a communication interface; a processor, the processor comprising: Using the algorithm in controlling delivery of a drug from the drug administration device to a patient. death, The memory is connected to the communication interface based on the data received from the remotely located communication interface. and changing at least one variable parameter of said algorithm stored in memory. The device is configured as follows:

27. The drug administration device is one of a syringe, an inhaler, and an infusion pump.

27. The device of claim 26.

28. further comprising a medication holder configured to hold the medication therein; Controlling the delivery of the drug from the drug administration device to the patient comprises:

27. The device of claim 26, further comprising controlling the release of the drug from a lumen.

29. The drug administration device is an autoinjector configured to automatically advance a needle into a patient. It is a projectile, The at least one variable parameter may be configured to automatically advance the needle into the patient. including the speed at which The data received from the remotely located communication interface indicates whether the needle is This includes a different speed that is automatically advanced inside the Changing the at least one variable parameter may be performed by performing a step of the algorithm 27. The device of claim 26, further comprising replacing a recorded rate with the updated rate.

30. The at least one variable parameter is a parameter for determining whether the drug delivery device is the rate of drug delivery, the time between doses of the drug delivered from the drug administration device to the patient; 27. The device of claim 26, wherein the device comprises at least one of: timing; and temperature of the drug. Chair.

31. The data received from the remotely located communication interface is Based on the physician requesting a change to the algorithm input in the computer system 27. The device of claim 26,

32. The processor also controls the delivery of the drug from the drug administration device. After using the algorithm, another delivery of the drug from the drug administration device to the patient is performed.

27. The method of claim 26, wherein the method is configured to use the algorithm in controlling delivery. device.

33. configured to sense information about at least one of the medication administration device and the medication.

27. The device of claim 26, further comprising a sensor configured to:

34. The communication interface transmits data indicative of the sensed information to the remotely located communication interface. configured to transmit to a communication interface, The data received from the remotely located communication interface is 34. The device of claim 33, wherein the device is based at least in part on the data indicative of the information.

35. The processor also transmits data indicative of the sensed information to the remotely located communication interface. The information is stored in the memory based on the sensed information without first being transmitted to the interface. configured to change at least one variable parameter of the stored algorithm.

34. The device of claim 33.

36. The processor also transmits the request to the communication interface. configured to cause a signal to be transmitted to a communication interface, the request requests an update of the algorithm; The data received from the remotely located communication interface is in response to the request.

27. The device of claim 26.

37. a remotely located communication interface indicating that an update of the algorithm is not required; When a response to the request is received from the interface, the processor stores the 37. The method of claim 36, wherein the method does not change at least one variable parameter of the stored algorithm. The device described in

38. The data received from the remotely located communication interface is processed by the algorithm. The communication interface is updated without responding to a request from the communication interface for updating the communication interface.

27. The device of claim 26, wherein the information is automatically transmitted to the interface.

39. The communication interface also transmits the ALPHA signal to the remotely located communication interface. configured to wirelessly receive algorithm data, The processor also receives the data from the remotely located communication interface. configured to modify the algorithm stored in the memory based on the data.

27. The device of claim 26,

40. Modifying the algorithm may involve adding at least one additional variable parameter to the algorithm.

40. The device of claim 39, further comprising adding the algorithm.

41. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 27. The device of claim 26, comprising at least one of the following: paliperidone acid;

42. 1. A drug administration device comprising: a memory configured to store an algorithm therein; A communication interface configured to receive data wirelessly from a remotely located communication interface. a communication interface; a medication holder configured to hold a medication therein; 1. A processor, comprising: By executing the algorithm, the drug is administered from the drug holder to the patient. Controlling the amount delivered The memory is connected to the communication interface based on the data received from the remotely located communication interface. adjusting said algorithm stored in memory; By executing the adjusted algorithm, the medication holder is delivered to the patient. and a processor configured to control delivery of subsequent doses.

43. The drug administration device is one of a syringe, an injector, an inhaler, and an infusion pump.

43. The device of claim 42.

44. The algorithm includes at least one variable parameter, and the processor Adjusting the algorithm includes adjusting the at least one variable parameter of the algorithm.

43. The device of claim 42, further comprising: modifying the parameter.

45. The processor modifying the algorithm includes adding at least one additional variable parameter.

43. The device of claim 42, further comprising adding a parameter to the algorithm.

46. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 43. The device of claim 42, comprising at least one of the following: paliperidone acid;

47. A drug administration method comprising: A processor of the medication administration device is used to administer the medication from the medication administration device to the patient. executing an algorithm for controlling delivery of the dose, said algorithm comprising: Executing an algorithm stored in a memory of the medication administration device; In the communication interface for the medication administration device data, the medication administration device wirelessly receiving data from a communication interface located remotely from the Using the processor, the previous Based on the data, at least one variable of the algorithm stored in the memory is Changing the parameters; using the processor to execute the modified algorithm, and controlling delivery of another dose of the drug from a drug administration device to the patient. and executing an algorithm.

48. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 48. The method of claim 47, comprising at least one of the following: paliperidone acid;

49. 1. A drug administration device comprising: a medication holder configured to hold a medication therein; The display and a processor, the processor comprising: The current required to manually administer a dose of the drug from the drug holder to the patient Minda, a summary of the previously scheduled dose of the drug from the drug holder to the patient; and Beauty the timing and prevalence of previously delivered doses of the drug from the drug holder to the patient; an indication of a correlation between the timing of at least one medical event experienced by the patient; The device is configured to display at least one of the following on the display: Chair.

50. The drug administration device is one of a syringe, an injector, an inhaler, and an infusion pump.

50. The device of claim 49.

51. The processor is configured to cause at least the reminder to be displayed on the display.

50. The device of claim 49, wherein

52. The processor is configured to cause at least the summary to be displayed on the display. The above summary is as follows: an indication of all missed doses among the previously scheduled doses; an indication of all doses successfully delivered among the previously scheduled doses; the timing of previously delivered doses relative to a predetermined delivery schedule for said doses; reading of, an indication of the intended therapeutic effect of the drug on the patient; and an indication of the expected duration of effect of the drug on the patient.

50. The device of claim 49, comprising:

53. The processor causes the display to display at least the indication of the correlation.

50. The device of claim 49, configured as follows:

54. A communication interface configured to receive data wirelessly from a remotely located communication interface. a communication interface; The processor also receives the data from the remotely located communication interface.

50. The method of claim 49, wherein the display is configured to display information indicative of the data. Devices listed.

55. The data received from the remotely located communication interface includes a medical history of the patient.

55. The device of claim 54 containing information.

56. The data received from the remotely located communication interface is Contains help information on the correct use of the device. The processor also causes the display to display information indicating the help information.

55. The device of claim 54, configured as follows:

57. configured to sense information about at least one of the medication administration device and the medication. a sensor configured to The processor also causes the display to display information indicative of the sensed information.

50. The device of claim 49, configured to:

58. wirelessly transmitting data indicative of the sensed information to a remotely located communication interface; and then, based at least in part on the transmitted data, a communications interface configured to wirelessly receive data from the interface; Further preparation, The processor also receives the data from the remotely located communication interface.

58. The method of claim 57, wherein the display is configured to display information indicative of the data. Devices listed.

59. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 50. The device of claim 49, comprising at least one of the following: paliperidone acid;

60. 1. A drug delivery system comprising: a medication administration device configured to hold a medication therein for delivery to a patient; The display and a communications interface configured to wirelessly receive data indicative of medical information regarding the patient; -face and a processor, the processor comprising: A drug delivery device configured to hold a drug therein is used to manually deliver a dose of drug to a patient. Reminder of the current required to be administered in a predetermined approximate dose of the drug from the drug administration device to the patient; Required, and the timing of a previously delivered dose of the drug from the drug administration device to the patient; and an indication of a correlation between the timing of at least one medical event experienced by said patient. and displaying at least one of the following on the display: Hmm.

61. The drug administration device is one of a syringe, an injector, an inhaler, and an infusion pump.

61. The device of claim 60.

62. A communication interface configured to receive data wirelessly from a remotely located communication interface. a communication interface; The processor also receives the data from the remotely located communication interface.

61. The method of claim 60, further comprising causing the display to display information indicative of the data. The system.

63. configured to sense information about at least one of the medication administration device and the medication. a sensor configured to The processor also causes the display to display information indicative of the sensed information.

61. The system of claim 60, configured to:

64. wirelessly transmitting data indicative of the sensed information to a remotely located communication interface; and then, based at least in part on the transmitted data, a communications interface configured to wirelessly receive data from the interface; Further preparation, The processor also receives the data from the remotely located communication interface.

64. The method of claim 63, wherein the display is configured to display information indicative of the data. The system.

65. 65. The system of claim 64, wherein the medication administration device includes the communication interface. Hmm.

66. 7. The medication administration device according to claim 6, wherein the medication administration device comprises the display and the processor. The system described in

67. 61. The system of claim 60, wherein a server includes the display and the processor. Tem.

68. 61. The method of claim 60, wherein a mobile device includes the display and the processor. The system described.

69. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 61. The system of claim 60, comprising at least one of the following: paliperidone acid;

70. a sensor configured to sense information regarding a physiological parameter of a patient, The sensor is a memory configured to store data therein, said stored data comprising: A remotely located server is established with the sensor and the remotely located server. a memory containing a key; wirelessly transmitting data indicative of the sensed information to a remotely located communication interface; a communication interface configured to Using the key, the sensed information is transmitted prior to the transmission of the data indicative of the sensed information. and a processor configured to anonymize the data indicative of the sensor information.

71. The processor is located remotely from the communication interface. the claimant is configured to use the key in anonymizing all data sent to the claimant's interface. The sensor of claim 70.

72. The processor repeatedly uses the key to generate a plurality of signals indicative of information sensed by the sensor.

71. The sensor of claim 70, configured to anonymize the data set of.

73. The sensor provides information about the physiological parameter of the patient for at least 24 hours.

73. The sensor of claim 72, configured to acquire once every 10 seconds.

74. The communication interface receives data from the remotely located communication interface. and the processor is configured to receive the signal wirelessly from the remotely located communication interface. configured to use the key in decrypting the data received from the interface.

71. The sensor of claim 70.

75. The processor receives all data from the remotely located communication interface.

75. The sensor of claim 74, configured to use the key when decrypting.

76. The physiological parameters include at least one of blood glucose level, blood oxygen level, weight, and sleep time.

71. The sensor of claim 70, wherein both

77. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 71. The sensor of claim 70, comprising at least one of the following: paliperidone;

78. 1. A sensor system comprising: a server, a communications interface configured to wirelessly receive data; a memory configured to store a key therein; a server including a processor; 71. A system comprising: a sensor according to claim 70.

79. The processor of the server uses the key to communicate with the communication interface of the sensor. configured to anonymize all data transmitted to the application before said transmission, 79. The system of claim 78.

80. The processor of the server uses the key to access the communication interface of the server. configured to decrypt all data received from the interface; The processor of the sensor uses the key to communicate with the communication interface of the server.

80. The system of claim 79, wherein the system is configured to decode all data received from the system. Stem.

81. The data transmitted to the communication interface of the server is received from the server.

80. The system of claim 79, further comprising data in response to a data request made by said system.

82. 71. The method of claim 70, further comprising: providing a plurality of sensors according to claim 70; 79. The system of claim 78, wherein the system is one of:

83. The plurality of sensors are configured to measure different physiological parameters of the same patient.

83. The system of claim 82, including a sensor.

84. The plurality of sensors are configured to measure corresponding physiological parameters in a plurality of patients.

84. The system of claim 83, further comprising a sensor.

85. The server may provide the data indicative of the sensed information to the physiological parameter reading and 85. The system of claim 84, configured to store the patient's profile and the patient's profile together.

86. The server receives data indicative of information about a medication administration device associated with each patient.

86. The system of claim 85, configured to store:

87. The server is configured to receive and store data indicative of each patient's nutritional intake.

86. The system of claim 85,

88. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 79. The system of claim 78, comprising at least one of the following: paliperidone acid;

89. 1. A method for sensing information regarding a physiological parameter of a patient, comprising: A unique key is generated for wireless communication between a sensor and a server located remotely from the sensor. establishing a key in the memory of the server and establishing a unique key, which is stored in the sensing the information regarding a physiological parameter of the patient with the sensor; at a processor of the sensor, using the key stored in the memory of the sensor; anonymizing data indicative of the sensed information; The processor of the sensor decodes the data received from the server. and using the key stored in the memory of the sensor.

90. The drugs include infliximab, golimumab, ustekinumab, daratumumab, and gusel. Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 90. The method of claim 89, comprising at least one of the following: paliperidone acid.

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